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Immunocore announces publication of phase 3 data comparing tebentafusp with investigator’s choice in The New England Journal of Medicine

On September 22, 2021 Immunocore Holdings Plc (Nasdaq: IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infection and autoimmune disease, reported that data from a phase 3 randomized trial comparing tebentafusp (IMCgp100) with investigator’s choice in first-line metastatic uveal melanoma (mUM) has been published in The New England Journal of Medicine (NEJM) (Press release, Immunocore, SEP 22, 2021, View Source [SID1234590905]).

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The paper concluded that tebentafusp is the first systemic treatment to show a survival benefit in mUM and should become a new treatment option for this poor prognosis disease.

"The publication of these phase 3 data in a leading peer-reviewed scientific publication like NEJM demonstrates the significance of Immunocore’s work in the field of TCR therapy," said Bahija Jallal, Chief Executive Officer of Immunocore. "This further validates the potential of tebentafusp to provide a much needed treatment option for patients with metastatic uveal melanoma, making a meaningful difference to patients’ lives. In addition, we believe these data show the broader potential of Immunocore’s TCR technology for the treatment of other solid tumors."

Results from the randomized, open-label, phase 3 trial of tebentafusp vs. investigator’s choice in previously untreated HLA-A*02:01-positive patients with mUM demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) as a first-line treatment in mUM. The OS Hazard Ratio (HR) in the intent-to-treat population favored tebentafusp, HR=0.51 (95% CI: 0.37, 0.71); p< 0.0001, over investigator’s choice (82% pembrolizumab; 12% ipilimumab; 6% dacarbazine). Treatment-related adverse events were manageable and consistent with the proposed mechanism.

Tebentafusp has been granted Breakthrough Therapy Designation, Fast Track designation and orphan drug designation by the U.S. Food and Drug Administration (FDA) and Promising Innovative Medicine (PIM) designation under the UK Early Access to Medicines Scheme for metastatic uveal melanoma. Immunocore’s biologics license application for approval of tebentafusp for the treatment of HLA-A*02:01-positive adult patients with metastatic uveal melanoma was recently accepted by the FDA. In addition, the European Medicine Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) accepted Immunocore’s Marketing Authorisation Application (MAA).

Gabriel Yariv, Executive Director of Cannabics Pharmaceuticals and Dr. David Sans will participate at the ICDP Summit in Boston

On September 22, 2021 Cannabics Pharmaceuticals Inc. (OTCQB: CNBX), a global leader in the development of cancer related cannabinoid-based medicine, reported that the Company will present at the 4th Annual International Cannabinoid-Derived Pharmaceuticals Summit in Boston (Press release, Cannabics Pharmaceuticals, SEP 22, 2021, View Source [SID1234590540]). Our team will be participating along with others from across the cannabinoid research and drug development space, including industry and academic experts from major pharmaceutical companies, biotech firms, and world leading universities.

Gabriel Yariv, company President and COO said: "The Cannabinoid Derived Pharmaceuticals Summit in Boston is the world largest conference exclusively devoted to CDP for medical conditions using FDA/EMA approval regularly pathways and with focus on clinical trials across the world and we are honored and proud to have been invited to participate at this 2021 4th Edition in Boston."

Eyal Barad, Cannabics Pharmaceuticals’ Co-founder and CEO commented: "The remarkable success of cannabinoids being approved today is just the beginning and we are excited to participate at the Cannabinoid Derived Pharmaceuticals Summit."

Recent expansion of Cannabics Pharmaceuticals’ Board of Advisors to include: Prof. Caroline Robert (MD, Ph.D.), a Melanoma expert, and, Dr. Sigal Tavor (MD), a Hematology expert, along with Prof. Amos Toren (MD), Prof. Zamir Halpern (MD), Prof. Noam Shomron (Ph.D.), Dr. Erez Scapa (MD), Dr. Dana Ben-Ami Shor (MD), Dr. Sigalit Arieli-Portnoy (Ph.D.) and Dr. Tal Mofkadi (Ph.D.).

Recent expansion of Cannabics Pharmaceuticals’ Board of Directors to include: Dr. Inbar Maymon-Pomeranchik (Ph.D.), and Dr. Gil Feiler (Ph.D.) as Independent Directors.

BiVictriX and IONTAS successfully complete two antibody discovery campaigns

On September 22, 2021 BiVictriX Therapeutics plc (AIM: BVX), an emerging biotechnology company applying a novel approach to develop next generation cancer therapies using insights derived from frontline clinical experience, reported the successful completion of two antibody discovery campaigns with IONTAS, aimed at supporting the optimisation of BiVictriX’s lead program, BVX001 (Press release, FairJourney Biologics, SEP 22, 2021, https://fjb.pt/collaboration/bivictrix-and-iontas-successfully-complete-two-antibody-discovery-campaigns/ [SID1234590246]).

IONTAS, a leading clinical research organisation offering phage and next generation mammalian display antibody discovery services, has successfully identified novel human binders which target BiVictriX’s proprietary "twin cancer antigens", as part of an ongoing collaboration with BiVictriX. These binders cover a broad range of affinities including species cross-reactivity. They will be further assessed in-house by BiVictriX through in vitro characterisation and testing of all possible combinations of targets to validate the efficacy and selectivity in human cell models and further optimise lead program, BVX001.

BiVictriX is using a first-in-class approach to generate a proprietary pipeline of Bi-Cygni therapeutics which are designed to selectively target antigen co-expression fingerprints, or "twin antigens", on tumour cells, which are largely absent from healthy cells. BVX001, BiVictriX’s lead program, is in preclinical development for Acute Myeloid leukaemia, one of the most aggressive forms of blood cancer.

Tiffany Thorn, Chief Executive of BiVictriX Therapeutics plc, commented: "The delivery of these novel binders with species cross-reactivity is an important step for the team and our pipeline and a testament to our successful and ongoing collaboration with IONTAS. The team will begin validating these through in-house testing soon with the aim of determining the efficacy and specificity of the target affinity of each arm as we continue to develop our therapeutics."

António Parada, Chief Executive of IONTAS, added: "We’re delighted to have been able to support the development of BVX001 through our proprietary antibody discovery services. BiVictriX’s Bi-Cygni therapeutics, which target antigen co-expression fingerprints, or "twin antigens", on tumour cells look highly innovative and we wish the company every success as BVX001 progresses in preclinical development."

This announcement follows the recent appointment of Dr Oliver Schon as Vice President of Product Development and Chemistry Manufacturing and Controls and the Company’s successful listing on the London Stock Exchange’s AIM Market in August.

Coriell Institute for Medical Research, Van Andel Institute Awarded Estimated $12.4 Million SPORE Grant from National Cancer Institute

On September 22, 2021 The Coriell Institute for Medical Research and Van Andel Institute (VAI) reported that they have been awarded a prestigious Specialized Programs of Research Excellence (or SPORE) grant from the National Cancer Institute (award P50CA254897) (Press release, Van Andel Institute, SEP 22, 2021, View Source;utm_medium=rss&utm_campaign=spore-award-epigenetics-cancer-research [SID1234590242]). The five-year grant valued at an estimated $12.4 million will support nearly 20 scientists as they work to improve epigenetic therapies for cancer. The project is co-led by Coriell’s President and CEO Jean-Pierre Issa, M.D., Van Andel Institute’s Chief Scientific Officer Peter A. Jones, Ph.D., D.Sc. (hon), and Johns Hopkins University and VAI’s Stephen Baylin, M.D.

NCI utilizes SPORE grants to empower interdisciplinary and collaborative research into specific aspects of cancer. This prestigious grant is the first of its kind at both Coriell and VAI, establishing them as premier institutions for cancer research. The award currently is the only SPORE grant awarded to an organization in New Jersey. This grant, which is also the first to support a thematic SPORE focused on epigenetics in NCI history, can be renewed indefinitely.

"SPORE grants hold a special place in translational cancer research. Through them, the NCI enables groundbreaking work and the trust it puts in the awarded scientists allows for unparalleled freedom and collaboration," said Dr. Issa. "It’s a true honor to receive this grant and it’s a sign of more exciting things to come for the Coriell Institute."

Jones, Baylin and Issa also collaborate on the Van Andel Institute (VAI)–Stand Up To Cancer (SU2C) Epigenetics Dream Team, which has launched more than a dozen epigenetic therapy clinical trials in recent years and will support trials from this SPORE. Jones and Baylin co-led both the first iteration of the SU2C Epigenetics Dream Team, which was established in 2009, and co-lead the current team, which was launched in 2014. Much of the SPORE project’s design was informed by SU2C’s collaborative model, which brings together experts and organizations to unite against cancer.

"Epigenetic therapies hold immense potential to shift the paradigm in cancer treatment," Dr. Jones said. "We’re thrilled to be recipients of a SPORE award, which is an exceptional mechanism for catalyzing collaboration and powering discovery."

Epigenetic therapy aims to treat cancer by correcting abnormal gene expression. In doing so, these therapies can also make other cancer therapies more effective. This SPORE seeks to improve on current epigenetic therapies by exploring new targets, investigating novel combinations of epigenetic therapies with other cancer treatments, and by designing, and running clinical trials to evaluate these promising strategies.

"Research in the last decade has reinforced the promise of epigenetic therapies both as a standalone treatment strategy and as a way to enhance existing approaches such as immunotherapy," Baylin said. "The SPORE award will allow us to investigate the underpinnings of epigenetics in cancer, with the goal of translating our findings to the clinic."
The three research projects in this SPORE include:

Project 1: A collaboration between the Coriell Institute and Hackensack Meridian School of Medicine led by Dr. Issa and Hackensack Meridian’s Yi Zhang, Ph.D., a member of the Hackensack Meridian Center for Discovery and Innovation and part of the Georgetown Lombardi Comprehensive Cancer Center. This group will investigate the potential of a certain group of kinases, enzymes that regulate proteins, as therapeutics targets.
Project 2: A collaboration between Baylin and VAI’s Scott Rothbart, Ph.D. This team will investigate a potentially novel therapeutic strategy for treating solid tumors by inhibiting DNMT and EZH1/2 enzymes.
Project 3: A collaboration between Indiana University’s Ken Nephew, Ph.D., and Kathy Miller, M.D., and University of Maryland School of Medicine’s Feyruz Rassool, Ph.D. This team will investigate the impact of epigenetic therapy on cancers driven by BRCAness, a major cancer-related vulnerability.
To aid these research projects, the SPORE grant also will support two shared scientific resource cores: A Genomics Core at Coriell Institute and a Pathology and Biorepository Core at VAI. Scientists working on these related research projects can utilize these resources in conducting their work.

Additionally, the SPORE will include the creation of a Career Enhancement Program and a Developmental Research Program, which provide research awards to faculty (inside and outside of the SPORE group) to support recruitment and retention of scientists with a focus of bolstering diversity in the field.

Dr. Issa is also currently an investigator on The Joe Moakley Leukemia SPORE, a program supported by a SPORE grant administered out of The University of Texas MD Anderson Cancer Center. That grant is in its 18th year.

Mount Sinai Health System and PerkinElmer Collaborate to Accelerate COVID-19 Screening

On September 22, 2021 PerkinElmer, Inc., a global leader committed to innovating for a healthier world, reported its collaboration with the Mount Sinai Health System to increase accessibility of SARS-CoV-2 testing in New York City (Press release, PerkinElmer, SEP 22, 2021, View Source [SID1234590204]). The laboratory system located at the Mount Sinai Beth Israel hospital campus now has the capacity to process 25,000 (and ultimately up to 100,000) tests per day with PerkinElmer’s instrument and reagents.

RT-PCR testing is the most accurate method for detecting SARS-CoV-2, the virus that causes COVID-19. The relationship forged between Mount Sinai Health System and PerkinElmer makes gold standard RT-PCR based SARS-CoV-2 screening available to schools and businesses throughout New York City.

HOW: According to the U.S. Food & Drug Administration (FDA) companion resource, a highly sensitive RT-PCR test should be used for screening asymptomatic individuals. The PerkinElmer New Coronavirus Nucleic Acid Detection Kit is the most sensitive commercially available COVID-19 molecular diagnostic test authorized for emergency use, as reported by FDA’s reference panel study, and is ideally suited to support screening programs.

WHY:
"Mount Sinai has shown extraordinary commitment and leadership in scientific and clinical efforts to beat this pandemic. We developed one of the first highly sensitive antibody tests, pioneered innovative therapies to treat COVID-19, and are researching the lingering effects suffered by ‘long-haulers.’ The Mount Sinai Covid Lab and testing program is designed to help our community in slowing transmission and getting us back to normal," said David L. Reich, MD, President and Chief Operating Officer, The Mount Sinai Hospital. "We are proud to partner with PerkinElmer in expanding our testing capacity and footprint to serve our communities."

"PerkinElmer is proud to lend its expertise in SARS-CoV-2 testing by supplying and supporting the Mount Sinai Health System with reagents, automation equipment and consumables that are critical to meet laboratory operational needs," said Arvind Kothandaraman, managing director, specialty diagnostics at PerkinElmer. "We are humbled and inspired by the work of our long-standing collaborators at Mount Sinai, who go above and beyond to help underserved communities in New York City that have been profoundly affected by the pandemic."

MORE: As the Delta variant is threatening to upend another school year, RT-PCR testing remains the preferred method for COVID-19 diagnostics. PerkinElmer’s comprehensive SARS-CoV-2 portfolio includes high throughput RNA extraction, RT-PCR, antigen testing, workflow automation, ELISA, chemiluminescence, time-resolved fluorescence and lateral flow based serology testing.