Orbis Health Solutions http://www.orbishealthsolutions.com/ Immunotherapy Treatment for Cancer and Beyond Fri, 11 Dec 2020 19:06:10 +0000 en-US hourly 1 https://wordpress.org/?v=6.0.1 Regulator volunteers to take part in COVID vaccine trial http://www.orbishealthsolutions.com/regulator-volunteers-to-take-part-in-covid-vaccine-trial/ http://www.orbishealthsolutions.com/regulator-volunteers-to-take-part-in-covid-vaccine-trial/#respond Fri, 11 Dec 2020 19:06:10 +0000 http://www.orbishealthsolutions.com/?p=412 October 23 2020 By James Whittaker Cayman Compass   The chair of Cayman’s medical regulator has explained the decision to approve a COVID-19 vaccine trial on the island and volunteered to take part himself. Dr. Joseph Marzouca, chair of the Health Practice Commission, confirmed that Perseus Cayman Ltd has been granted approval for a small-scale human […]

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October 23 2020
By James Whittaker
Cayman Compass

 

The chair of Cayman’s medical regulator has explained the decision to approve a COVID-19 vaccine trial on the island and volunteered to take part himself.

Dr. Joseph Marzouca, chair of the Health Practice Commission, confirmed that Perseus Cayman Ltd has been granted approval for a small-scale human trial of a coronavirus vaccine, as reported by the Cayman Compass earlier this week.

He said the commission had conducted a comprehensive assessment of the science behind the proposed trial and was satisfied that it was safe.

Perseus is looking for 20 volunteers to test the vaccine, which has shown promising results in mice.

Marzouca released a statement Friday saying he had high confidence in the safety of the trial and has volunteered to take part himself.

He said the company involved, Perseus Cayman Ltd, had a strong track record of holding successful clinical trials on the island. The company’s previous research has involved ‘medical tourists’ and has been linked to immunotherapy for certain types of cancers.

Marzouca said in a statement Friday, “The Commission has done everything that it can to ensure safety and efficacy as it relates to this trial. We also have the legal power to change or halt the trial should a need become evident.”

The trial is the first in Cayman to focus on local volunteers.

The Health Practice Commission said that over the past few years it has granted around one licence a year for clinical trials related to medical tourism. Such approvals involve extensive vetting by the HPC itself, as well as international experts, the commission stated in a press release.

It stated, In addition to a comprehensive assessment of the science involved in the proposed COVID-19 trials, the Commission also weighed a number of key factors. Among these were: past successful trials by the same company, the involvement of highly respected local physician, Dr. Sook Yin, as the primary investigator, and the fact that the approach that the company is taking to the trial means that there is no risk of onward transmission of the viral disease.”

The Health Practice Commission is an eight-member independent body of medical practitioners, which includes representatives from the local professional healthcare associations, from local healthcare facilities and the Department of Planning.

The Department of Health Regulatory Services, which is responsible for registering healthcare entities, serves as a secretariat for the HPC. Only healthcare providers registered in the Cayman Islands may apply to operate medical trials on island.

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Human trials for new COVID vaccine approved for Cayman http://www.orbishealthsolutions.com/human-trials-for-new-covid-vaccine-approved-for-cayman/ http://www.orbishealthsolutions.com/human-trials-for-new-covid-vaccine-approved-for-cayman/#respond Fri, 11 Dec 2020 18:56:59 +0000 http://www.orbishealthsolutions.com/?p=404 October 21, 2020 By James Whittaker Cayman Compass   A Cayman Islands healthcare facility has been given approval for a phase one clinical trial of a COVID-19 vaccine. Perseus Cayman Limited is looking for 20 volunteers within the islands for the first phase of human trials for its vaccine. The Cayman Islands Health Practice Commission has approved the application to […]

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October 21, 2020
By James Whittaker
Cayman Compass

 

A Cayman Islands healthcare facility has been given approval for a phase one clinical trial of a COVID-19 vaccine.

Perseus Cayman Limited is looking for 20 volunteers within the islands for the first phase of human trials for its vaccine.

The Cayman Islands Health Practice Commission has approved the application to conduct the trial, the Cayman Compass has confirmed.

Anyone interested in volunteering to take part is asked to contact Dr. Sook Yin, the company’s principal investigator, by email at sook.yin@perseuspci.com.

Yin, also the medical director of Perseus Cayman, which is involved in research and treatment of cancer, said she had been working for many years with the US-based scientists behind the new COVID vaccine.

“Running a trial in Cayman ensures that the people of the Caribbean are part of this initiative and puts the islands and the region on the global stage and on the leading edge of vaccine development,” she added.

“Our residents have an opportunity to take part in a trial that may offer a life-saving solution to this unprecedented global public health crisis.”

Trials in mice

Documents provided by the company to the Compass indicate the vaccine has had a 100% success rate in producing antibodies in tests on mice.

Unlike many other vaccines currently being developed, it does not contain the COVID-19 virus itself, the company indicated.

Instead of targeting the active virus, it attacks the spike proteins, which allow it to attach to human cells.

“The enhanced image of COVID-19 virus is now well recognized, largely by virtue of its distinctive external spikes,” Perseus spokesman stated in an email to the Compass.

“The COVID-19 virus attaches itself to human cells using these spike proteins, which in simple terms act as a ‘sort of Velcro’ that attaches to the human cell for long enough to invade that cell.”

Perseus Cayman Limited was originally established, in collaboration with its US scientific partner Orbis Health Solutions, to conduct clinical trials on a highly promising personalised cancer immunotherapy vaccine.

Employing the same specialised technology used to develop its cancer vaccine, the company believes it can create an effective vaccine against COVID-19, through its ability to “successfully deliver and display foreign substances (antigens), such as a virus or tumour cell, to the immune system” to help it recognise the invader and trigger an immune response.

It is believed that if the vaccine can help the immune system recognise and target the “spike proteins” of the COVID-19 virus, then the virus itself will not be able to attach itself to human cells.

Cayman trial

In a statement to the Compass, the Perseus spokesman indicated, “In pre-clinical studies, results have shown that the vaccine has been able to produce antibodies to the COVID-19 spike protein in 100 percent of cases.

“For this initial human trial, 20 volunteers are being sought to receive the vaccine to determine if a similar antibody response can be produced in humans.”

Volunteers would have their blood taken immediately to ensure they do not already have antibodies. After an injection of the vaccine, volunteers will have blood draws after one, two, four and eight weeks to test for the presence of antibodies which target the spike proteins.

Half of the patients will get a second inoculation after two weeks to determine if one or two vaccination injections are required, the spokesperson said.

If the trial is successful, the company will seek permission to expand it to a larger number of volunteers within the territory.

Yin, also founder of the Seven Mile Medical Clinic, added, “I am delighted that the developers of this vaccine chose the Cayman Islands as the site for this trial and that the Health Practice Commission, after due deliberation, has granted permission ​to initiate the trial​…

“Based on years of work with this team of scientists and researchers, I have every confidence in the science and technology behind the vaccine and I am proud to be working with them to advance this cutting-edge study.”

Perseus says it has been successfully and safely conducting clinical trials in the field of cancer immunotherapy since 2012. The COVID-19 vaccine builds on the research breakthroughs it has made in Cayman during that time.

Switch to COVID research

The wife of Dr. Thomas Wagner, the founder of Orbis and a partner in Perseus, is from Wuhan, China – the epicentre of the virus.

“As soon as the virus was identified and its DNA was sequenced in mid-December, our team immediately began work on a DNA vaccine to fight the virus,” the company stated.

Perseus stressed that its proposed solution is believed to be safer than others in the course of development because it does not use the COVID-19 virus itself.

In a statement, the company said, “Perseus and its scientific partners at Orbis believe that if the spike proteins can be recognized and targeted by the immune system, then the virus can be attacked by the immune system before it is able to fasten itself to body cells.

“It is this unique approach, namely the training of the immune system to target the spike proteins of the virus, that is the strategy behind this particular vaccine.

“Unlike other vaccines in development, this particular vaccine avoids using any part of the virus itself, only the DNA encoding the spike protein. It is this encoding DNA that is delivered directly into the dendritic cells.

“For this reason, it is hoped that the Perseus/Orbis approach will prove to be not only effective against the virus but also be an inherently safer vaccine option.”

Cancer research

Perseus has been conducting trials in Cayman using its patented cancer immunotherapy vaccines for the past several years.

To date, more than 100 cancer patients with 15 different tumour types have been treated with a personalised, therapeutic cancer vaccine in Cayman, according to the company. A further 240 high-risk melanoma patients have been vaccinated in related trials (using the same vaccine methodology) in the United States.

“As a result of the success of the trials to date, agreement has been reached with the Food and Drug Administration in the United States to move forward on a registrational Phase III trial in melanoma,” the company added.

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Elios Therapeutics Personalized Cancer Vaccine Demonstrates Long-Term Survival Benefit Among High-Risk Melanoma Patients in Phase IIb Final Analysis http://www.orbishealthsolutions.com/elios-therapeutics-personalized-cancer-vaccine-demonstrates-long-term-survival-benefit-among-high-risk-melanoma-patients-in-phase-iib-final-analysis/ http://www.orbishealthsolutions.com/elios-therapeutics-personalized-cancer-vaccine-demonstrates-long-term-survival-benefit-among-high-risk-melanoma-patients-in-phase-iib-final-analysis/#respond Tue, 11 Aug 2020 14:05:48 +0000 http://www.orbishealthsolutions.com/?p=332 ~ 96 Percent of High-Risk Melanoma Patients Were Alive Three Years After Completing the Vaccine Series Compared to 77 Percent of those Treated with Placebo ~ ~ 52 Percent of Patients Treated with the Vaccine Were Disease-Free at Three Years Compared to 27 Percent in the Placebo Arm ~ ~ New Analysis Reveals Optimized Vaccine […]

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~ 96 Percent of High-Risk Melanoma Patients Were Alive Three Years After Completing the Vaccine Series Compared to 77 Percent of those Treated with Placebo ~
~ 52 Percent of Patients Treated with the Vaccine Were Disease-Free at Three Years Compared to 27 Percent in the Placebo Arm ~
~ New Analysis Reveals Optimized Vaccine Formulation Results in Improved Clinical Outcomes ~
~ Treatment with Vaccine in Combination with Checkpoint Inhibitors Doubled Disease-Free Survival Rate Compared to Checkpoint Inhibitors Alone ~

 

AUSTIN, TX, August 5, 2020 – Elios Therapeutics, a biopharmaceutical company developing innovative personalized therapeutic cancer vaccines, today announced final data from a prospective, randomized, double-blind, placebo-controlled Phase IIb clinical trial evaluating adjuvant use of its personalized tumor lysate, particle-loaded, dendritic cell (TLPLDC) vaccine in patients with Stage III or Stage IV melanoma at high risk of recurrence following complete surgical resection.

“We now have long-term data demonstrating that use of the TLPLDC vaccine for the adjuvant treatment of high-risk melanoma correlates with a 93 percent increase in patients alive at three years without their disease returning. This trial also significantly improves our understanding of the optimal method of vaccine production,” said Buddy Long, chief executive officer of Elios Therapeutics. “These new data, combined with the doubled rate of disease-free survival among patients treated with the vaccine and standard of care checkpoint inhibitors, further strengthen our confidence that the personalized TLPLDC vaccine provides a clinically meaningful benefit for people with high-risk melanoma. We look forward to advancing this vaccine with a registrational Phase III trial that will move us one step closer to bringing this important treatment to patients as soon as possible.”

The TLPLDC vaccine is a personalized treatment that is created using a patient’s own blood and tumor cells. Samples are collected at resection, frozen, and sent to the lab where they are used to create autologous tumor lysate, which is loaded into yeast cell wall particles. This combination is then introduced to the patient’s dendritic cells, leading to the creation of the final TLPLDC vaccine. The time from resection to injection of the vaccine takes approximately three weeks.

The vaccine has been studied in a large randomized Phase IIb trial, and the newly reported data is from the pre-specified 36-month disease-free survival (DFS) and overall survival (OS) assessment by vaccine formulation, stage, and checkpoint inhibition. The analysis included all randomized patients in an intent-to-treat (ITT) analysis. Two versions of the vaccine, one produced by isolating dendritic cells (DCs) from 120 mL of blood (vaccine-A) and one with DCs isolated after a single injection of filgrastim followed by 50-70 mL of blood (vaccine-B), were tested in 144 participants who were randomized to receive either version of the vaccine or placebo to prevent recurrence.

A key finding showed that treatment with vaccine-B resulted in clinical outcomes similar to placebo. Producing the vaccine with filgrastim was intended to increase white blood cell and dendritic cell counts, requiring less blood to be drawn from patients to create the vaccine. While the use of filgrastim increased DC production, it takes only 72-hours to create the vaccine which was not enough time for the DCs to mature, rendering vaccine-B ineffective.

Importantly, vaccine-A, when compared to vaccine-B and placebo, resulted in a statistically significant improvement in 36-month DFS (51.8% vs. 23.4% vs 27.1%, respectively; p=0.027) and OS (92.9% vs. 62.8% vs 70.3%, respectively; p=0.022) in the ITT population.

Furthermore, the DFS improvement with vaccine-A was seen across both Stage III (49.7% vs. 29.4%; p=0.066) and IV (68.6% vs. 9.4%; p=0.0582) patients. Importantly, the addition of vaccine-A to current standard of care checkpoint inhibitors led to a statistically significant increase in 36-month DFS in the ITT population compared to treatment with checkpoint inhibitors alone (48.5% vs. 24.1%; p=0.039). As previously reported, treatment with the vaccine was well-tolerated with 34.7 percent of patients experiencing a treatment-related adverse event, and >90% being grades 1 or 2.

“To demonstrate a long-term survival benefit with low toxicity in a therapeutic is what we hope for in every clinical trial. Achieving this with an aggressive disease like melanoma offers great promise for patients,” said Mark B. Faries, M.D., co-director of the Melanoma Program and head of Surgical Oncology at Cedars-Sinai at The Angeles Clinic and Research Institute, and principal investigator of the study. “With data showing a two-fold increase in disease-free survival with the vaccine alone and in combination with checkpoint inhibitors, we hope to one day change the narrative for people with melanoma – turning this disease into a chronic condition that can be treated and managed over time.”

About Melanoma
Melanoma is more likely to grow and spread than other types of skin cancer. When diagnosed and treated at an early stage, melanoma has a high cure rate, however patients with later stages of the disease carry a high risk for melanoma recurrence because some melanoma cells can remain in the body, even after surgery. In the U.S, the incidence of melanoma has increased over the past decades, with 91,270 estimated new cases and 9,320 related deaths in 2018^1.

About the Phase IIb TLPLDC Study
This Phase IIb study is a prospective, randomized, double-blind, placebo-controlled trial designed to evaluate the safety and efficacy of the TLPLDC (tumor lysate, particle-loaded, dendritic cell) vaccine in patients with resected Stage III and IV melanoma. The primary endpoint of the trial is two-year disease-free survival (DFS), and the secondary endpoint is three-year DFS and overall survival (OS).

In the study, 144 participants were randomized to receive either the vaccine or placebo to prevent recurrence. TLPLDC or placebo vaccines were initiated within three months of completion of standard of care (SoC) therapies and were given at 0, 1, 2, 6, 12, and 18 months. The protocol was amended to allow concurrent checkpoint inhibitor therapy once approved for the adjuvant setting. Study participants were followed for recurrence per SoC. The primary efficacy analysis was performed on the intent-to-treat (ITT) and the per treatment (PT) populations as co-primary analyses given the high early recurrence rate often seen in patients with advanced melanoma. Secondary endpoints include 36-month DFS and overall survival (OS) which will be compared between the vaccinated and control groups as well as by vaccine formulation.

About TLPLDC
The TLPLDC (tumor lysate, particle-loaded, dendritic cell) vaccine is a unique type of immunotherapy, both in how it is made and how it is delivered. The vaccine is personalized, meaning it is made from a patient’s tumor and blood. Every patient’s tumor has a unique antigenic profile unlike any other, and dendritic cells found in the blood are the most potent antigen-presenting cells in the body. Once TLPLDC is administered, it delivers the patient’s complete repertoire of tumor antigens to the immune system, creating a dual innate and adaptive immune response, activating fighter T cells, and triggering the immune system to recognize, and seek out and destroy any cells containing the antigens and specific mutations from their tumor.

Historically, autologous cancer vaccines have been rather onerous to develop, sometimes taking months between the tumor biopsy and administration. Elios has simplified the process so the time from resection to injection is approximately two weeks. This makes the vaccine highly feasible and will ultimately be easy for community and academic oncologists to adopt into their practices.

The TLPLDC vaccine is currently being studied as a monotherapy and in combination with standard-of-care checkpoint inhibitor therapies in a Phase IIb clinical trial for the treatment of late-stage melanoma at leading academic cancer centers in the United States.

About Elios Therapeutics, LLC
Elios Therapeutics, LLC, a wholly owned subsidiary of Perseus Holdings, LLC., is a biopharmaceutical company developing a portfolio of innovative personalized therapeutic cancer vaccines targeting unmet medical needs across a broad range of tumor types. Elios’ lead therapeutic candidate is the TLPLDC (tumor lysate, particle-loaded, dendritic cell) vaccine, a personalized therapeutic cancer vaccine that uses a proprietary particle delivery system to stimulate the body’s immune system to recognize cancer cells as foreign pathogens and fight a patient’s specific cancer. For more information, please visit www.eliostherapeutics.com.

Forward-Looking Statements

This document contains forward‐looking statements relating to the Company’s strategy, objectives, business development plans and financial position. All statements other than statements of historical facts included in this document, including, without limitation, statements regarding the Company’s future financial position, strategy, anticipated investments, costs and results, status and results of clinical trials, size of patient population, plans, outcomes of product development efforts, and objectives of management for future operations, may be deemed to be forward‐looking statements. You can identify forward-looking statements by words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would,” or the negative of those terms, and similar expressions that convey uncertainty or future events or outcomes. These forward‐looking statements involve known and unknown risks, uncertainties, and other factors that may cause the Company’s actual results, performance, or achievements or industry results to be materially different from those contemplated, projected, forecasted, estimated or budgeted, whether expressed or implied, by these forward‐looking statements. Given these risks and uncertainties, investors should not place undue reliance on forward‐looking statements as a prediction of actual results. None of these forward‐looking statements constitutes a guarantee of the future occurrence of such events or of actual results. These statements are based on data, assumptions, and estimates that the Company believes are reasonable. The forward‐looking statements contained in this document are made only as of the date hereof. Except as otherwise required by law, the Company expressly disclaims any obligation or undertaking to release publicly any updates of any forward-looking statements contained in this document to reflect any change in its actual results, assumptions, expectations or any change in events, factors, conditions, or circumstances on which any forward‐looking statement contained in this document is based.

 

Contacts:
Media Relations Vikki Christian
Elixir Health Public Relations
+1 (424) 610-1241
vchristian@elixirhealthpr.com

1  Siegel RL, Miller KD, Jemal A. Cancer statistics, 2018. CA Cancer J Clin 2018; 68:7–30_Accessed at: https://www.ncbi.nlm.nih.gov/pubmed/29313949

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Elios’ Phase IIb Melanoma Data Are Promising, But Present Tricky Issues For Phase III Vaccine Study http://www.orbishealthsolutions.com/elios-phase-iib-melanoma-data-are-promising-but-present-tricky-issues-for-phase-iii-vaccine-study/ http://www.orbishealthsolutions.com/elios-phase-iib-melanoma-data-are-promising-but-present-tricky-issues-for-phase-iii-vaccine-study/#respond Mon, 02 Dec 2019 17:38:58 +0000 http://www.orbishealthsolutions.com/?p=251 SCRIP, July 17, 2019 – By Joseph Haas Executive Summary The biotech’s personalized vaccine shows it can reduce the risk of melanoma recurrence by 50% in the per-treatment population, but Phase III will need to demonstrate a similar benefit in an intent-to-treat population. Elios Therapeutics plans to advance its personalized vaccine for stage III and […]

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SCRIP, July 17, 2019 – By Joseph Haas

Executive Summary

The biotech’s personalized vaccine shows it can reduce the risk of melanoma recurrence by 50% in the per-treatment population, but Phase III will need to demonstrate a similar benefit in an intent-to-treat population.

Elios Therapeutics plans to advance its personalized vaccine for stage III and stage IV melanoma into Phase III – with a partner or on its own – following the release of Phase IIb top-line data that showed the vaccine can reduce the risk of disease recurrence by roughly 50% in patients who completed a full series of treatment.

Austin, TX-based Elios unveiled the data on 17 July, noting that in a per treatment (PT) population of 98 patients, a 29% recurrence rate was seen in the treatment arm compared to 56% in the placebo arm. Overall, the study enrolled 144 patients and in this intent-to-treat (ITT) population, including patients who never received the vaccine or did not complete an 18-month course of therapy, the recurrence rate was 54% for the treatment arm versus 66% for placebo.

The PT arm met statistical significance in the study’s primary endpoint of disease-free survival (DFS), while the ITT data were clinically meaningful, but not statistically significant.

This creates a “math problem” for Elios in designing the planned pivotal Phase III study of the candidate, known as the tumor lysate, particle-loaded, dendritic cell (TLPLDC) vaccine, CEO Buddy Long told Scrip. An autologous cell therapy, the vaccine is produced from the patient’s own tumor and blood cells in a process that takes about two weeks from resection to injection, he said, much shorter than the three months or so typical of other autologous cell therapies.

In the study, patients whose melanoma recurred on standard-of-care (SOC) therapy were randomized to the vaccine or placebo. Treatment was initiated within three months of SOC completion, with patients scheduled to receive TLPLDC at months zero, one, two, six, 12 and 18. Evaluation of the primary endpoint of DFS at 24 months was performed in both the ITT and PT populations as co-primary analyses due to the high early recurrence rate often seen in advance melanoma patients, the company explained.

“I don’t think we’re going to get approval on PT; we’re going to get approval on ITT,” Long said. “When you evaluate a therapy, you have to look at the people who actually got it – but with the benefit that we’ve seen in the ITT, showing a statistical benefit on that is a math problem now. We don’t have a clinical or scientific problem, we need to power a study that appropriately is going to show the statistical value of that benefit that we’ve already seen in the ITT population.”

Single Focus Of Taking TLPLDC To A Development Partner

Elios was founded in 2014 as a subsidiary of Orbis Health Solutions with a singular focus on TLPLDC in melanoma. The company began with a strategy of producing Phase IIb data that would entice a big pharma or other deep-pocketed partner to fund a Phase III program. (Also see “Cancer Immunotherapy Reaches A Tipping Point” – Scrip, 22 Oct, 2014.)

Long said now that his company – a direct subsidiary of Perseus Holdings USA, which is affiliated with Orbis – has the data in hand, it will plan to go ahead into Phase III with or without a partner. But he also conceded that the fastest path to bringing TLPLDC to patients is through a partnership.

“We’re not waiting on a partner,” Long said. “We are completely capable of taking this to the finish line on our own and so we are initiating a crossover phase from a fundraising standpoint, selecting banks in the next couple of weeks, and kicking that off in the next 60 days to run full steam ahead as a standalone product. Any company has to have that posture – we can’t count on the right partner being ready at the right time.”

To date, Elios has had what Long calls “coming attractions” talks with potential partners, but also has had to deal with a recent lack of enthusiasm for the cancer vaccine concept.

In melanoma, Biomedtracker lists seven vaccine candidates in clinical development for melanoma, including TLPLDC. The most advanced are Polynoma LLC’s seviprotimut in Phase III, KAEL-GemVax’s telomerase peptide vaccine GV1001 in Phase II, and Vaccinogen Inc.’s OncoVax in Phase I/II for melanoma and Phase III for colorectal cancer. GV1001 also was investigated in non-small cell lung and pancreatic cancers as well as hepatocellular carcinoma, but those efforts are suspended.

“The bottom line for everyone has been ‘we love the team, love the technology, love the concept, but we’ve got to see a positive clinical benefit in one indication,’” Long noted. “Whatever we do in the immunotherapy space, the bottom line is fundamentally there needs to be a post-immune response that can create an army of tumor-reactive T cells that can not only function as a monotherapy but also combine with other therapies out there that do anything with T cells.”

In addition to its monotherapy study, Elios has been running an open-label trial for patients’ whose melanoma recurs in which they can go on TLPLDC monotherapy or combination therapy with any SOC agent. It also is running a Phase I/II study testing the vaccine with the physician’s choice of checkpoint inhibitor therapy, but Long says the most important thing Elios can do is demonstrate TLPLDC’s efficacy as a monotherapy.

“One thing that is lacking in combination trials is there’s theoretical synergistic benefit, but a lot of times it hasn’t been proven in a rigorously scientific fashion that you have single-agent efficacy that would translate into theoretical, practical benefit in a combination,” he said.

Safety Profile Could Be Ideal For Combination Therapy

However, monotherapy efficacy plus the vaccine’s safety profile might position TLPLDC for combination with a wide range of therapies.

In the Phase IIb monotherapy study, about one-third of patients reported an adverse event, mostly grade 1 or 2 events. By contrast, typical cancer studies often have AE rates of 80% to 90%, sometimes even 100%, with 70%-80% of AEs deemed treatment-related. In potential combination regimens, TLPLDC’s safety profile mean patients can add its benefits with little or no physical cost, Long asserted.

“We don’t create a systemic immune response, we create a cellular immune response,” he explained. The autologous process creates a therapy that delivers a patient’s complete repertoire of tumor antigens to the immune system, yielding a dual innate and adaptive immune response that triggers the immune system to recognize, seek and destroy antigen-containing cells, the company says.

Because the vaccine expresses pathogen related to the patient’s own molecular profile at the cellular level, this enable the immune system sees the antigen as a pathogen, Long said. “The actual presentation of the antigen does not carry any of the autoimmune or other immunological side effects,” he added.

Manufacturing of the personalized vaccine can occur in roughly 48 hours by taking advantage of the process in which monocytic cells turn into dendritic cells, the exec said. “There’s a certain point in time where [the transforming cells] become extremely phagocytic and the delivery mechanism we have takes tumor antigen and captures it in a particle that is phagocytized into the cytotoxic dendritic cell,” he continued.

Down the road, Elios believes its vaccine technology can be applied to a broad range of solid tumors, but the work in recurrent advanced melanoma comes first, Long said.

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Vaccine Slashes High-Risk Melanoma Recurrence http://www.orbishealthsolutions.com/vaccine-slashes-high-risk-melanoma-recurrence/ http://www.orbishealthsolutions.com/vaccine-slashes-high-risk-melanoma-recurrence/#respond Mon, 02 Dec 2019 17:36:40 +0000 http://www.orbishealthsolutions.com/?p=249 Oncology Times, September 17, 2019 – By Rebecca Hepp Researchers on the hunt for a cure for melanoma are one step closer with positive phase IIb results for a personalized cancer vaccine that shows a 50 percent reduction in recurrence for patients who completed the majority of the vaccination series. The prospective, randomized, double-blind, placebo-controlled […]

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Oncology Times, September 17, 2019 – By Rebecca Hepp

Researchers on the hunt for a cure for melanoma are one step closer with positive phase IIb results for a personalized cancer vaccine that shows a 50 percent reduction in recurrence for patients who completed the majority of the vaccination series. The prospective, randomized, double-blind, placebo-controlled clinical trial met its primary endpoints at 24 months without any significant safety concerns—and researchers are forging ahead to the next 36 month benchmark with high hopes.

“We know these patients have a very high risk of recurrence—at least a 50 percent chance, and it’s probably closer to 80 or 90 percent,” noted one of the study’s lead investigators, Adam C. Berger, MD, who is now Chief of Melanoma and Soft Tissue Surgical Oncology at Rutgers Cancer Institute of New Jersey. The data shows the personalized approach can cut that number in half, all without any serious side effects.

 

Personalized Approach

The TLPLDC (tumor lysate, particle-loaded, dendritic cell) vaccine is created using the patient’s own blood and tumor cells to capitalize on the body’s natural defenses. Samples are harvested at resection, frozen, and shipped to the lab where they are used to create autologous tumor lysate, which is loaded into pre-prepared yeast cell wall particles (YCWP). This combination is then introduced to the patient’s dendritic cells for phagocytosis, finally creating the TLPLDC vaccine.

“It was quite easy to create the vaccine; the amount of tumor needed to make the vaccine was quite small, and the turnaround time was such that patients could have their tumors removed and then be able to start the vaccine within [3-4] weeks,” according to Berger.

The 6-month vaccination regimen, which delivers the patient’s own unique blend of tumor antigens to the immune system, kick-starts an innate and adaptive response.

“In the past, researchers have used generic vaccines that contain proteins that are common in a lot of melanomas, but they aren’t specific to that particular patient,” Berger explained. “This is a much more personalized approach designed to retrain the immune system to recognize that these cells or proteins shouldn’t be there and to go find all of those abnormal cells and kill them.”

The added bonus of this approach is the ease of patient education, Berger added.

“Sometimes other treatments such as chemotherapy or immunotherapy have many side effects and it can be complicated,” he noted. “Some patients are turned off by that, but when you talk to them about having a vaccine, they can understand that you are making a vaccine that is really specific to their tumor, and patients tend to like that idea.”

 

Trial Success

To test the safety and efficacy of the novel vaccine, the research team at Thomas Jefferson University, led by Berger, who was the Chief of Surgical Oncology at Thomas Jefferson University at the time, substantially contributed to enrolling 144 patients with resected stage III and IV melanoma. Within 3 months of completing standard-of-care checkpoint inhibitor therapy for their melanoma, the study participants were given either the TLPLDC vaccine or an unloaded YCWP + autologous dendritic cell placebo in six doses over an 18-month span.

Because of the high risk of recurrence and because the vaccine requires time to activate the immune response, the researchers chose to vaccinate and analyze both the intent-to-treat (ITT) and the per treatment (PT) populations. (The study is also designed to offer an active vaccine for patients who experience recurrence in a crossover study fashion, as well as vaccination for control patients who did not experience recurrence at the completion of the trial).

Interim results, released last year at the 2018 ASCO Annual Meeting, showed a 32 percent relative reduction of recurrence at a median 12 months of follow-up, with no difference in the recurrence rate between the ITT and PT patients (Abstract 9525).

The 24-month co-analysis of the ITT and PT populations is a different story. These data show an overall recurrence rate of 54 percent in the vaccine group—which included those who were never or incompletely vaccinated—compared with 66 percent in the placebo group. While this represents a clinically relevant 18 percent relative risk reduction in recurrence, it’s not statistically significant, the researchers noted.

When they looked at the PT patients specifically, all of whom completed at least four of the six vaccine series, they found far more promising results. Only 29 percent of the vaccine group experienced disease recurrence compared with 56 percent in the placebo group—a 50 percent, highly statistically significant reduction in the relative risk of recurrence.

“The first three vaccines are given in the first 3 months, and for patients who have a high risk of developing recurrence, sometimes that’s not enough time for the immune system to mount the response to help prevent recurrence,” Berger explained. “So, we looked at those who received at least four vaccinations, and those were the patients who clearly did much better than the placebo group.”

Added to these promising results, the vaccine, perhaps because of it’s autologous nature, presented few adverse reactions. Only a third of the study patients had an adverse event related to the vaccine and most of them were grade 1 or 2, such as injection site reactions and flu-like symptoms, according to Berger.

“Chemotherapy and immunotherapy hit the whole body, so they can cause side effects, and for immunotherapy there can be immune side effects that are fairly serious,” Berger noted. “With this treatment we have something really targeted to the melanoma cells with low toxicity—it’s very safe.” The approach may prove particularly helpful for patients who can’t handle immunotherapy or who have had unsuccessful immunotherapy, he added.

When the researchers estimated the preliminary 36-month data, they found the vaccine is showing continued benefit beyond the initial 24-month mark.

All of this data means the team is moving ahead with the study’s 36-month endpoint analysis of disease-free and overall survival. The team is also working toward a phase III trial based on the 24-month data to show that the vaccine, likely in combination with other immunotherapies, could be standard of care, Berger said.

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Elios Therapeutics Announces Interim Phase IIb Results of TLPLDC, a Personalized Therapeutic Cancer Vaccine for the Treatment of Melanoma, at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting http://www.orbishealthsolutions.com/elios-therapeutics-announces-interim-phase-iib-results-of-tlpldc-a-personalized-therapeutic-cancer-vaccine-for-the-treatment-of-melanoma-at-the-2018-american-society-of-clinical-oncology-asco-annu/ http://www.orbishealthsolutions.com/elios-therapeutics-announces-interim-phase-iib-results-of-tlpldc-a-personalized-therapeutic-cancer-vaccine-for-the-treatment-of-melanoma-at-the-2018-american-society-of-clinical-oncology-asco-annu/#respond Sat, 05 Jan 2019 21:58:16 +0000 http://www.orbishealthsolutions.com/?p=109 Interim Phase IIb Data Show Promising Reduction In Risk of Recurrence and a Well-Tolerated Safety Profile in Patients with Resected, High-Risk Melanoma————– AUSTIN, Texas, June 1, 2018 /PRNewswire/ — Elios Therapeutics, a biopharmaceutical company developing innovative autologous, particle-delivered, dendritic cell cancer vaccines, today announced interim data from the ongoing prospective, randomized, double-blind, placebo-controlled Phase IIb […]

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Interim Phase IIb Data Show Promising Reduction In Risk of Recurrence and a Well-Tolerated Safety Profile in Patients with Resected, High-Risk Melanoma
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AUSTIN, Texas, June 1, 2018 /PRNewswire/ — Elios Therapeutics, a biopharmaceutical company developing innovative autologous, particle-delivered, dendritic cell cancer vaccines, today announced interim data from the ongoing prospective, randomized, double-blind, placebo-controlled Phase IIb clinical trial of the TLPLDC (tumor lysate, particle-loaded, dendritic cell) vaccine in patients with Stage III and IV, resected melanoma will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting on June 4, 2018 in Chicago, Illinois (Abstract # 9525).

The planned interim analysis was conducted after the first 120 patients enrolled in the trial had been randomized and treated for at least 6 months. In the per treatment population, TLPLDC showed a meaningful 32 percent reduction in the relative risk of recurrence (TLPLDC 29.4 percent vs. placebo 43.3 percent, p = 0.07) with a median follow-up of 12.6 months. There was no difference in recurrence in the intent-to-treat population (TLPLDC 56.6 percent, placebo 54.1 percent, p=0.65) with 11.9 months median follow-up. Overall, TLPLDC was safe and well-tolerated. In the study, only 33 percent of participants experienced any adverse event, and 98.6 percent of those were grade 1 and 2 events that included injection site reactions and flu-like symptoms. No serious adverse events were reported.

“The interim data evaluating the TLPLDC vaccine as an adjuvant treatment to prevent melanoma recurrences are very encouraging, suggesting clinical activity and demonstrating an attractive safety profile,” said George E. Peoples, M.D., chief medical officer at Elios Therapeutics. “These data, combined with the recently reported results of our open label Phase II study demonstrating the synergistic effects of the TLPLDC vaccine in combination with checkpoint inhibitors, suggest a strong rationale for further clinical development in a Phase III program.”

Detailed results from the ongoing Phase IIb study evaluating TLPLDC will be presented on Monday, June 4, 2018:

Abstract 9525 (Poster #352): Interim analysis of a prospective, randomized, double-blind, placebo-controlled, Phase IIb trial of the TLPLDC vaccine to prevent recurrence in resected Stage III or IV melanoma patients
Presenter: John W. Myers, M.D., San Antonio Military Medical Center, Houston, TX
Data/Time: Monday, June 4, 2018 from 1:15 PM – 4:45 PM CDT
Session: Melanoma/Skin Cancers Poster Session – Hall A
About the Study Design
Elios Therapeutics is conducting a prospective, randomized, double-blind, placebo-controlled Phase IIb trial to evaluate the safety and efficacy of TLPLDC in patients with resected Stage III and IV melanoma. The primary endpoint is 2 year disease-free survival (DFS).

In the study, 120 participants were randomized (2:1) to receive either TLPLDC vaccine or placebo to prevent recurrence. TLPLDC or placebo vaccines were initiated within 3 months of completion of standard of care (SoC) therapies and were given at 0, 1, 2, 6, 12, and 18 months. Study participants were followed for recurrence per SoC. The interim analysis was pre-specified at 6 months from randomization of the 120th study participant. Survival analysis was performed on the intent-to-treat and per treatment populations. The latter excludes early recurrences during the primary vaccine series (up to 6 months).

About TLPLDC
The TLPLDC (tumor lysate, particle-loaded, dendritic cell) vaccine is an autologous, personalized, therapeutic cancer vaccine designed to stimulate the immune system to recognize tumor cells and fight a patient’s specific cancer. TLPLDC is made from a patient’s own tumor and dendritic cells – the most potent antigen-presenting cells in the body. Once TLPLDC is injected, the tumor lysate-loaded dendritic cells present the tumor antigens to the immune system, stimulating the induction of tumor-specific, activated T cells that are able to find and destroy tumor cells that may remain in the body. TLPLDC is currently being studied as a monotherapy and in combination with SoC checkpoint inhibitor therapy in a Phase IIb clinical trial for the treatment of late-stage melanoma at leading academic cancer centers in the United States.

About Elios Therapeutics, LLC
Elios Therapeutics, LLC, is a biopharmaceutical company developing a portfolio of innovative therapeutic cancer vaccines targeting unmet medical needs across a broad range of tumor types. Elios’ lead product, TLPLDC, is a personalized therapeutic cancer vaccine designed to attack cancer cells by igniting innate and adaptive immune responses which increase a patient’s own production of T cells to fight their specific cancer. For more information, please visit www.eliostherapeutics.com.

Forward-Looking Statements
This document contains forward‐looking statements relating to the Company’s strategy, objectives, business development plans and financial position. All statements other than statements of historical facts included in this document, including, without limitation, statements regarding the Company’s future financial position, strategy, anticipated investments, costs and results, status and results of clinical trials, size of patient population, plans, outcomes of product development efforts, and objectives of management for future operations, may be deemed to be forward‐looking statements. You can identify forward-looking statements by words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” or the negative of those terms, and similar expressions that convey uncertainty or future events or outcomes.

These forward‐looking statements involve known and unknown risks, uncertainties, and other factors that may cause the Company’s actual results, performance, or achievements or industry results to be materially different from those contemplated, projected, forecasted, estimated or budgeted, whether expressed or implied, by these forward‐looking statements. Given these risks and uncertainties, investors should not place undue reliance on forward‐looking statements as a prediction of actual results. None of these forward‐looking statements constitutes a guarantee of the future occurrence of such events or of actual results. These statements are based on data, assumptions, and estimates that the Company believes are reasonable.

The forward‐looking statements contained in this document are made only as of the date hereof. Except as otherwise required by law, the Company expressly disclaims any obligation or undertaking to release publicly any updates of any forward-looking statements contained in this document to reflect any change in its actual results, assumptions, expectations or any change in events, factors, conditions, or circumstances on which any forward‐looking statement contained in this document is based.

Contacts:

Media Relations
Elixir Health Public Relations
Melyssa Weible
+1 (201) 723-5805
mweible@elixirhealthpr.com

SOURCE Elios Therapeutics, LLC

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Elios Therapeutics Presents Initial Phase 2b Results of TLPLDC, a Personalized Therapeutic Cancer Vaccine for the Treatment of Melanoma, at the American Association for Cancer Research (AACR) 2018 Annual Meeting http://www.orbishealthsolutions.com/elios-therapeutics-presents-initial-phase-2b-results-of-tlpldc-a-personalized-therapeutic-cancer-vaccine-for-the-treatment-of-melanoma-at-the-american-association-for-cancer-research-aacr-2018-ann/ http://www.orbishealthsolutions.com/elios-therapeutics-presents-initial-phase-2b-results-of-tlpldc-a-personalized-therapeutic-cancer-vaccine-for-the-treatment-of-melanoma-at-the-american-association-for-cancer-research-aacr-2018-ann/#respond Sat, 05 Jan 2019 21:57:28 +0000 http://www.orbishealthsolutions.com/?p=105 – TLPLDC Demonstrates Encouraging Clinical Activity and Favorable Safety and Tolerability Profile in Combination with FDA-Approved Systemic Therapies –—————————AUSTIN, Texas, April 17, 2018 /PRNewswire/ — Elios Therapeutics, a biopharmaceutical company developing innovative particle-delivered, dendritic cell vaccines in oncology, today presented initial open-label results from the ongoing Phase 2b clinical trial of the TLPLDC (tumor lysate, […]

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– TLPLDC Demonstrates Encouraging Clinical Activity and Favorable Safety and Tolerability Profile in Combination with FDA-Approved Systemic Therapies –
—————————
AUSTIN, Texas, April 17, 2018 /PRNewswire/ — Elios Therapeutics, a biopharmaceutical company developing innovative particle-delivered, dendritic cell vaccines in oncology, today presented initial open-label results from the ongoing Phase 2b clinical trial of the TLPLDC (tumor lysate, particle-loaded, dendritic cell) vaccine in patients with stage III and IV (resected) melanoma. Results were presented at the American Association for Cancer Research (AACR) 2018 Annual Meeting held April 14-18, 2018 in Chicago, Illinois.

“We are encouraged by these initial open-label results from our Phase 2b trial which demonstrate a compelling safety profile and provide early evidence that the TLPLDC vaccine may enhance the efficacy of commonly used FDA-approved systemic therapies, including checkpoint inhibitors,” said George E. Peoples, M.D., chief medical officer at Elios Therapeutics. “We look forward to continuing our assessment of the TLPLDC vaccine in this ongoing study as we evaluate opportunities for further clinical development of combination therapies.”

In an ongoing prospective, randomized, double-blind, placebo-controlled Phase 2b trial, patients with resected Stage III and IV melanoma were randomized (2:1) to received either TLPLDC vaccine or placebo to prevent recurrence. All patients who recurred on the trial (met study endpoint) were then offered open-label TLPLDC along with standard of care therapy as determined by the patient’s treatment team.

The initial open-label results presented were from 22 patients. Seven patients had their recurrences resected and were treated with the TLPLDC vaccine to prevent a second recurrence. At 12.5 months of median follow-up, only one patient has recurred.

The remaining 15 patients were on a variety of FDA-approved systemic therapies for their non-resectable recurrences. Of these patients, two patients withdrew from the study and one was not treated. In the remaining 12 patients treated with the TLPLDC vaccine in combination with their standard of care systemic therapy, two patients had a complete response (median follow-up 8.6 months), seven had stable disease and two had progressive disease. One patient progressed initially on TLPLDC vaccine alone but was converted to a complete response once checkpoint inhibitor therapy was initiated. Importantly, the addition of the TLPLDC vaccine did not increase the toxicity of checkpoint inhibitors, BRAF/MEK inhibitors, or TVEC in these patients.

To view the full abstract, please visit the AACR website at http://www.aacr.org/Meetings.

About TLPLDC
The TLPLDC (tumor lysate, particle-loaded, dendritic cell) vaccine is an autologous, personalized, therapeutic cancer vaccine designed to stimulate the immune system to recognize tumor cells and fight a patient’s specific cancer. TLPLDC is made from the patient’s own tumor cells and dendritic cells – the most potent antigen-presenting cells in the body. Once TLPLDC is injected, the tumor lysate-loaded dendritic cells present the tumor antigens to the immune system, stimulating the induction of tumor-specific, activated T cells that are able to find and destroy tumor cells that may remain in the body. TLPLDC is currently being studied as a monotherapy and in combination with standard of care checkpoint inhibitor therapy in a Phase 2b clinical trial for the treatment of late-stage melanoma at leading academic cancer centers in the United States.

About Elios Therapeutics, LLC
Elios Therapeutics, LLC, is a biopharmaceutical company developing a portfolio of innovative therapeutic cancer vaccines targeting unmet medical needs across a broad range of tumor types. Elios’ lead product, TLPLDC, is a personalized therapeutic cancer vaccine designed to attack cancer cells by igniting innate and adaptive immune responses which increase a patient’s own production of T cells to fight their specific cancer. For more information, please visit www.eliostherapeutics.com.

Forward-Looking Statements
This document contains forward‐looking statements relating to the Company’s strategy, objectives, business development plans and financial position. All statements other than statements of historical facts included in this document, including, without limitation, statements regarding the Company’s future financial position, strategy, anticipated investments, costs and results, status and results of clinical trials, size of patient population, plans, outcomes of product development efforts, and objectives of management for future operations, may be deemed to be forward‐looking statements. You can identify forward-looking statements by words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” or the negative of those terms, and similar expressions that convey uncertainty or future events or outcomes.

These forward‐looking statements involve known and unknown risks, uncertainties, and other factors that may cause the Company’s actual results, performance, or achievements or industry results to be materially different from those contemplated, projected, forecasted, estimated or budgeted, whether expressed or implied, by these forward‐looking statements. Given these risks and uncertainties, investors should not place undue reliance on forward‐looking statements as a prediction of actual results. None of these forward‐looking statements constitutes a guarantee of the future occurrence of such events or of actual results. These statements are based on data, assumptions, and estimates that the Company believes are reasonable.

The forward‐looking statements contained in this document are made only as of the date hereof. Except as otherwise required by law, the Company expressly disclaims any obligation or undertaking to release publicly any updates of any forward-looking statements contained in this document to reflect any change in its actual results, assumptions, expectations or any change in events, factors, conditions, or circumstances on which any forward‐looking statement contained in this document is based.

Contacts:

Media Relations
Elixir Health Public Relations
Melyssa Weible
+1 (201) 723-5805
mweible@elixirhealthpr.com

SOURCE Elios Therapeutics, LLC

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Personalized Cancer Vaccine Moves to Phase IIb Trial at Leading U.S. Cancer Hospitals http://www.orbishealthsolutions.com/personalized-cancer-vaccine-moves-to-phase-iib-trial-at-leading-u-s-cancer-hospitals/ http://www.orbishealthsolutions.com/personalized-cancer-vaccine-moves-to-phase-iib-trial-at-leading-u-s-cancer-hospitals/#respond Sat, 05 Jan 2019 21:56:32 +0000 http://www.orbishealthsolutions.com/?p=103 AUSTIN, Texas, Dec. 23, 2014 /PRNewswire/ — Elios Therapeutics, LLC recently received FDA approval of its Investigational New Drug (IND) application and its randomized phase IIb trial planned to enroll 120 stage III and IV (resected) melanoma patients to assess the ability of a personalized vaccine to prevent recurrence. The trial will be conducted at […]

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AUSTIN, Texas, Dec. 23, 2014 /PRNewswire/ — Elios Therapeutics, LLC recently received FDA approval of its Investigational New Drug (IND) application and its randomized phase IIb trial planned to enroll 120 stage III and IV (resected) melanoma patients to assess the ability of a personalized vaccine to prevent recurrence. The trial will be conducted at a dozen leading academic cancer research hospitals in the United States.

“The Elios vaccine has shown effectiveness in metastatic patients, and delivered even more promising results in the adjuvant setting. Further, the vaccine has the safety profile to allow for treatment in a preventive setting,” explains George E. Peoples, MD, FACS and Chief Medical Officer, Elios Therapeutics, LLC. “Stage III and IV melanoma patients do not currently have an option for a safe, non-toxic, and effective adjuvant therapy. Melanoma at this stage recurs at an approximately 60-70 percent rate in two years, and once that happens, patients will very likely succumb to their disease. We believe that our vaccine technology can cut that rate significantly, preventing recurrence and death.”

Source: Yahoo.com

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Vaccine for Cancer Comes Closer to Fruition http://www.orbishealthsolutions.com/vaccine-for-cancer-comes-closer-to-fruition/ http://www.orbishealthsolutions.com/vaccine-for-cancer-comes-closer-to-fruition/#respond Sat, 05 Jan 2019 21:55:48 +0000 http://www.orbishealthsolutions.com/?p=101 FOR IMMEDIATE RELEASEContact: Riley Polk riley.polk@perseuspci.com Vaccine for Cancer Comes Closer to Fruition as Immunotherapy Pioneer Joins Orbis Health Solutions New Chief Medical Officer George Peoples, MD, Brings Deep Experience and Innovation to Research Focused on Preventing Relapses in Cancer Patients(Greenville, SC) With decades of highly recognized innovation in the emerging medical frontier of immunotherapy, George […]

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FOR IMMEDIATE RELEASE
Contact: Riley Polk 
riley.polk@perseuspci.com

Vaccine for Cancer Comes Closer to Fruition as Immunotherapy Pioneer Joins Orbis Health Solutions

New Chief Medical Officer George Peoples, MD, Brings Deep Experience and Innovation to Research Focused on Preventing Relapses in Cancer Patients
(Greenville, SC) With decades of highly recognized innovation in the emerging medical frontier of immunotherapy, George Peoples, MD, joins Orbis Health Solutions, LLC, as Chief Medical Officer. His urgent focus: bringing to market vaccines with the potential to vastly improve upon current cancer treatment.

“My passion in life is to develop a viable and widely available vaccine for cancer,” said Dr. Peoples. “Orbis shares that mission and is dedicated to supporting the necessary research to care for and cure those living with cancer.”

A Johns Hopkins-trained physician, Harvard Medical School-trained surgeon, and MD Anderson-trained surgical oncologist, Dr. Peoples was most recently the Director and Principal Investigator of the Cancer Vaccine Development Program and Chief of Surgical Oncology at the San Antonio Military Medical Center. Reaching the rank of Colonel in the United States Army’s Medical Corps, Dr. Peoples also served as Professor of Surgery, Uniformed Services University of the Health Sciences, Bethesda, MD, as well as Professor of Surgical Oncology (adjunct), MD Anderson Cancer Center, Houston, TX.

“We are going to battle to fight a common enemy, cancer, and Col. Peoples is the best officer to lead our mission,” announced Thomas Wagner, MD, renowned biomedical scientist and the creator of Perseus’ breakthrough cancer vaccine, now in clinical trials with Orbis Health Solutions. “With Dr. Peoples’ knowledge and experience in managing cancer trials and navigating protocols, and his passion to cure cancer, we are confident our alternative cancer treatment will soon be accessible worldwide.”
At Orbis, Dr. Peoples hopes to prove the efficacy of the Perseus cancer vaccines as well as extend his groundbreaking work in preventive vaccines for cancer patients at significant risk of relapse.

“Chemotherapy and radiation have proven beneficial for the treatment of many cancers but inadequate for preventing many cancer recurrences or significantly extending the lifespan of most patients with advanced cancers,” says Dr. Peoples. “There is a desperate need for new strategies that restore health and provide quality of life, and we believe this can be achieved through immunotherapy. At Orbis, we are focused on developing a vaccine strategy that can be applied to every type of cancer, and to every type of patient.”

About Orbis Health Solutions, LLC
Orbis Health Solutions, based in Greenville, South Carolina, was established in 2009 to develop and market vaccines for cancer patients. The company is currently conducting clinical trials for its Perseus PCI cancer vaccine, which uses the patient’s own T-cells to destroy tumors and create a lifetime immunity to the disease.

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For More Information Visit: www.PerseusPci.com

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Perseus PCI President Buddy Long announces appointment of Dr. Sook Yin MD as Treating Physician and Clinic Director http://www.orbishealthsolutions.com/perseus-pci-president-buddy-long-announces-appointment-of-dr-sook-yin-md-as-treating-physician-and-clinic-director/ http://www.orbishealthsolutions.com/perseus-pci-president-buddy-long-announces-appointment-of-dr-sook-yin-md-as-treating-physician-and-clinic-director/#respond Sat, 05 Jan 2019 21:54:44 +0000 http://www.orbishealthsolutions.com/?p=98 Buddy Long, president of Perseus PCI, the advanced cancer treatment center headquartered in the Cayman Islands, has announced the appointment of Dr. Sook Yin MD as treating physician and clinic director at the company’s Cayman Islands clinic. Cayman Islands (PRWEB) April 12, 2013 Dr. Sook Yin holds innumerable community, national and professional awards for public […]

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Buddy Long, president of Perseus PCI, the advanced cancer treatment center headquartered in the Cayman Islands, has announced the appointment of Dr. Sook Yin MD as treating physician and clinic director at the company’s Cayman Islands clinic.

Cayman Islands (PRWEB) April 12, 2013

Dr. Sook Yin holds innumerable community, national and professional awards for public service and her clinical work and is internationally known for her work in cancer prevention. She is admitted to private practice in the Cayman Islands and Great Britain. She has served as a director of the non-profit Cayman Islands Cancer Society since April 2001. In that capacity, Dr. Yin has headed efforts to successfully and significantly reduce the incidence of cancer in the Cayman Islands through comprehensive education programs, advanced early detection screening, and no-fee services that provide financial aid and counseling for the most needy.

Said Buddy Long: “We are honored that an internationally renowned clinician, such as Dr. Yin, has agreed to lead our treatment team at our new Cayman Islands clinic. She has a long history of working effectively with the most advanced medical and cancer treatments and an earned reputation for her skill and compassion in patient care and cure.”

Dr. Yin will serve at the new Perseus Caymans Clinic as treating physician for personalized patient care plans coordinated throughout the treatment process by a medical team of U.S.-based and licensed physicians who will evaluate each case for eligibility and function. Members of the U.S. team are also licensed to practice in the Cayman Islands.

Dr. Yin also holds degrees and certificates in surgery, obstetrics and gynecology earned in Great Britain where is also licensed to practice. She was born in Malaysia and speaks fluent English, Mandarin Chinese and Malay.

About Perseus PCI

Perseus PCI is a cancer treatment center headquartered in the Cayman Islands. Perseus provides an effective treatment approach for solid-tumor cancers that produces little to no side effects and can be an alternative to chemotherapy and radiation. The therapy, which uses the natural immune system, is easily administered by injection under the skin surface once a month for four months. This technology’s safety and effectiveness has been proven in US FDA sanctioned trials. The US approval process is ongoing, but this treatment has been approved for manufacture and administration by the Health Practice Commission of the Cayman Islands.

The therapy offered by Perseus is a dendritic cell-based immunotherapy, which has already been shown to be effective against melanoma, renal cell carcinoma and neuroblastoma tumors. Dendritic cells can be stimulated to activate a cytotoxic (killer) response toward the particular tumor. The patient’s dendritic cells are loaded with all of the patient’s tumor cell components to make the vaccine. When the vaccine is administered to the patient, the dendritic cells, a type of antigen-presenting cell, present the tumor antigen to the effector lymphocytes (CD4+ T cells and CD8+ cells), which initiates a cytotoxic response against the tumor cells.

Source: Cayman iNews

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