On July 29, 2020 AMERI Holdings, Inc. (NASDAQ: AMRH) ("Ameri"), reported that its proposed amalgamation partner Jay Pharma Inc. ("Jay Pharma" or "the Company") has announced the addition of new senior staff as the Company prepares to file two new investigational new drug (IND) applications for the treatment of radiodermatitis and glioblastoma multiforme (GBM) (Press release, Jay Pharma, JUL 29, 2020, View Source [SID1234562534]).

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Dr. Robert Wilkins is joining Jay Pharma as Chief Medical Officer. He will begin in the role immediately.

"Jay Pharma is seeking to bring oncology drugs to the market through FDA approval," said Dave Johnson, Jay Pharma’s CEO-elect. "With Dr. Wilkins, we are bringing in the skillset necessary to enhance our organization and allow us to navigate the IND process with confidence."

Over the course of a 30-year career, Wilkins has held leadership positions in medical affairs, product development, marketing, commercialization, and business development at leading pharmaceutical companies, such as Abbott, Baxter, and Battelle. Since 2001, Wilkins has consulted with multiple innovators in the medical and pharmaceutical space, such as valve replacement system Endovalve and glucose monitoring equipment GlucoLight.

"Jay Pharma is poised to enter an exciting new stage of growth, and I am delighted to be a part of it," Wilkins said.

Johnson described Wilkins as an "excellent steward" to advance the Company’s plans for filing two INDs: a combination therapy drug for the treatment of GBM, and a topical radiodermatitis treatment.

"We recently announced Investigational Review Board (IRB) approval for a GBM study at the Rabin Institute in Israel, and we plan to commence a study for radiodermatitis in the U.S.," Johnson said. "Bob will be crucial to advancing both of these initiatives."

In addition to Dr. Wilkins, Jay Pharma is pleased to announce the signing of Dr. Steven Weisman and Innovative Science Solutions (ISS) Regulatory Services. Steve and the ISS team have decades of experience developing regulatory strategies, product development, preclinical and clinical testing programs, regulatory submissions, and product defense/communication strategies for drugs, foods, cosmetics, and dietary supplements. Weisman also has specialty knowledge in analyzing the scientific and regulatory aspects of potential new products and the development of responses to FDA rule-makings.

"Steve will be an important voice in the preparation of our INDs, and our quality systems," said Wilkins. "We will work closely to ensure Jay Pharma is properly structured to work with the FDA and other regulatory agencies around the world."

The IND program, administered by the U.S. Food and Drug Administration (FDA), is the process through which a Company receives authorization to conduct human clinical trials in the U.S. According to Johnson, the Company plans to enter clinical trials for both its radiodermatitis and GBM formulations upon receipt of FDA clearance.

The radiodermatitis topical formulation has been designed to utilize the Company’s proprietary cannabidiol (CBD) formula with the cannabinoid Cannabigerol (CBG) and other ingredients to help alleviate the discomfort caused by radiodermatitis, a skin condition that is a consequence of radiation therapy. It is one of the most common side effects experienced by cancer patients. The topical product is intended to be both preventative and to treat existing radiodermatitis.

A rare and aggressive form of brain cancer, glioblastoma multiforme (GBM) is notoriously resistant to currently available cancer treatments. Phase I/II human clinical trials in Israel will administer the Company’s proprietary synthetic CBD formula to 40 enrollees: half of whom will be treated with the CBD formula, and the other half will be treated with the formula in combination with clomiphene, an estrogen binding site inhibitor.

"Our goal is to advance novel treatments that will improve the lives of cancer patients around the world," Johnson said. "With the additions of Dr. Wilkins and Dr. Weisman to the Jay Pharma team, we believe that we have the right individuals to help lead us into this next phase of the Company."

On July 29, 2020 Strata Oncology, Inc., a precision oncology company advancing molecular indications for cancer therapies, reported it has signed an agreement with BioMed Valley Discoveries, Inc. to accelerate patient identification and enrollment for BioMed Valley’s Phase 2 study of BVD-523 (ulixertinib) for patients with advanced malignancies harboring MEK or atypical BRAF alterations (non-BRAF V600E mutations) (Press release, Strata Oncology, JUL 29, 2020, View Source [SID1234562533]).

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Ulixertinib is a first-in-class potent and selective small molecule inhibitor of ERK1/2. BioMed Valley reported positive preliminary Phase I data for ulixertinib in patients harboring MAPK alterations, including atypical BRAF alterations.

Under the terms of the agreement and through the Strata Trial, Strata Oncology will identify patients with advanced solid tumors that harbor mutations in the MAPK signaling pathway and meet other eligibility criteria, for consideration of enrollment into BioMed Valley’s Phase 2 study. The Strata Trial, an ongoing observational study providing tumor molecular profiling for patients with advanced cancer paired with a portfolio of biomarker-guided clinical trials, is available across a network of 25+ select health systems nationwide. Through the Strata Trial, patients with advanced cancer are profiled using StrataNGSTM, a comprehensive molecular profiling test optimized for performance on tissue samples as small as 0.5mm2 surface area.

"This partnership with BioMed Valley Discoveries supports our commitment to improving the lives of patients with cancer by providing local access to promising investigational therapies," said Dan Rhodes, Ph.D., CEO of Strata Oncology. "We are confident our network of health system partners, standardized on the Strata Trial, will help drive rapid enrollment of this important study."

David Chao, President & CEO of BioMed Valley Discoveries, commented, "We are delighted to collaborate with Strata to develop our first-in-class ERK inhibitor. Strata’s ability to rapidly identify patients with specific tumor mutations has the potential to dramatically accelerate the recruitment of patients for our trial."

On July 29, 2020 Horizon Discovery Group plc (LSE: HZD) ("Horizon", "the Company" or "the Group"), a global leader in the application of gene editing and gene modulation for cell line engineering, reported that TrueBinding, Inc. ("TrueBinding", formerly Immutics, Inc.), a biopharmaceutical company, has signed a set of commercial licenses for Horizon’s cGMP-compliant CHOSOURCE platform (Press release, Horizon Discovery, JUL 29, 2020, View Source [SID1234562531]). TrueBinding will use the platform for the development and commercialization of multiple biotherapeutic products for applications in immuno-oncology and other disease areas with great unmet medical need.

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Horizon’s CHOSOURCE platform includes a gene-edited Glutamine Synthetase ("GS") knockout Chinese Hamster Ovary (CHO) K1 cell line, a well-established GS expression system recognized in the industry and by regulators as suitable for high-yield biomanufacturing. TrueBinding has successfully used this platform to develop stable, antibody-expressing cell lines in a proof-of-concept study and will now implement this to support further antibody drug development through commercial manufacturing.

"We are delighted TrueBinding has placed its trust in the capabilities of Horizon’s CHOSOURCE expression platform to support its research and development efforts," commented Jesús Zurdo, Global Head Bioproduction Business Unit, Horizon Discovery. "Horizon is fully committed to supporting innovative organizations of all sizes, from non-profit organizations and early stage startups to clinical stage biotechnology and large pharmaceutical companies, in their journey to develop much-needed novel therapeutic products using our expression platform."

Dr. Fan Chen, SVP of CMC, TrueBinding, explained: "Horizon’s CHOSOURCE platform provides a robust system for generating high protein expression stable cell lines to support TrueBinding antibody drug development through commercial manufacturing. We are very pleased with current program results and move to further collaboration with Horizon Discovery."

Horizon’s proprietary GS knockout CHO line and protocols facilitate the development of stable cell lines for the expression of antibodies and other recombinant proteins. The Company also licenses a CHO expression system to pharmaceutical, biotechnology, and biosimilar companies, as well as contract manufacturing organizations. To enable companies to move from the DNA sequence of their potential biotherapeutic to clinical manufacturing as simply and rapidly as possible, the complete system includes the GS knockout CHO K1 cell line, a comprehensive package of supporting documentation, and an expression vector supplied under license from DNATwoPointO, Inc.

To date, CHOSOURCE has been licensed to 80 organizations globally, with at least seven confirmed biotherapeutics expressed in these cells having progressed to investigational new drug (IND) filings.

On July 29, 2020 The Pershing Square Sohn Cancer Research Alliance reported the seven winners of the 2020 Pershing Square Sohn Prize for Young Investigators in Cancer Research, awarded annually to cancer research scientists and physician-scientists based in the greater New York-area (Press release, The Pershing Square Sohn Cancer Research Alliance, JUL 29, 2020, View Source [SID1234562530]). The Prize, totaling $4.2 million in funding awarded, emboldens early-career investigators to pursue research projects at a stage when traditional funding is lacking. Recipients receive $200,000 per year for up to three years.

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Over the past seven years, over $27 million in funds have been awarded to 46 scientists. With this funding, provided at the early stage of their promising careers, the recipients are contributing to New York’s growing biomedical research hub. In addition to funding, the Alliance provides Prize winners with opportunities to present their work to scientific and business audiences, helping to bridge the gap between academia and industry and across application domains.

"With COVID-19 disrupting lives, especially for those dealing with cancer, enabling early-stage research remains key to the health and wellbeing of patients and their families," said Pershing Square Foundation Trustee Neri Oxman. "This year’s winners, when viewed as a whole, embody research characterized by boldness and interdisciplinarity. We are honored to support our scientists, and the novel work they lead."

The winners of the 2020 Pershing Square Sohn Prize are:

Vinod Balachandran, MD, Memorial Sloan Kettering Cancer Center: Dr. Balachandran’s laboratory is focused on identifying effective immunotherapies to treat pancreatic cancer. Specifically, his project will develop new immunotherapies to activate a recently discovered immune cell called group 2 innate lymphoid cells to kill pancreatic cancers and treat patients.
Tal Danino, PhD, Columbia University: Dr. Danino’s work combines bioengineering and synthetic biology approaches to build innovative drug delivery platforms. His lab will engineer probiotic bacteria to target tumors and controllably deliver lung cancer therapeutics.
Mohamed Abou Donia, PhD, Princeton University: Dr. Donia’s project will employ novel computational and experimental approaches to systematically characterize gut microbiome-derived small molecules that play a role in the etiology of colorectal cancer. Increased understanding of the collection of microbes that live in the human gut and the biologically active chemicals they produce will help inform future endeavors to diagnose, treat, or prevent this disease.
Lydia Finley, PhD, Memorial Sloan Kettering Cancer Center: Dr. Finley focuses on pediatric cancer and how cancer cell metabolism affects pediatric malignancies. Through her work, she hopes to find potentially targetable vulnerabilities in pediatric sarcomas by studying the metabolic pathways that sustain their growth and progression.
Shixin Liu, PhD, The Rockefeller University: Dr. Liu is working to understand how specific gene mutations in particular histones and histone-modifying enzymes cause undesirable epigenetic changes that can lead to a variety of diseases, including cancer. Using cutting-edge biophysical tools, he will record the individual activity of these molecules, which will add a new dimension to our understanding of the relationship between chromatin regulation and cancer biology.
Andrea Schietinger, PhD, Memorial Sloan Kettering Cancer Center: The laboratory of Dr. Schietinger is looking to decode and reprogram cancer-specific T cells for immunotherapy. The goal of the project is to understand how DNA remodeling prevents T cells from finding and destroying cancer cells, and how this process can be prevented or reversed.
Britta Will, PhD, Albert Einstein College of Medicine / Montefiore Medical Center: Dr. Will examines the role of iron homeostasis regulatory pathways in defective blood stem cells, called leukemic stem cells (LSC). She hypothesizes that LSC are negatively affected by the limited availability of cellular iron, which could provide new avenues for cancer therapy and detection.
"We remain committed to cancer research even during this global pandemic. We are extremely impressed by the superb quality of the proposals we received as well as the exceptionally talented researchers that are working in the greater New York area institutions," said Olivia Tournay Flatto, PhD, Co-Founder and Executive Director of the Pershing Square Sohn Cancer Research Alliance and President of The Pershing Square Foundation. "It is our goal to build a community of innovative and talented individuals, and to connect them with a ‘family’ of funders and collaborators in pursuit of novel ideas, therapies, technologies, and, ultimately, knowledge that can further our understanding of disease and fundamental human biology."

"The work to find new treatments and cures for cancer continues to be an urgent global health priority so we are heartened by the research approaches of this year’s Prize winners," said Evan Sohn, Vice President of the Sohn Conference Foundation. "We are confident that with the passion, creativity, and insights we’ve seen from this group of scientists, they will make discoveries that will have a lasting impact for the patients for whom our Foundation fights."

As part of the selection process, the Pershing Square Sohn Cancer Research Alliance relied on the guidance of a highly accomplished advisory board.

Prize Advisory Board members include: Jeanne B. Ackman, MD, Director, Thoracic MRI, Radiologist, Massachusetts General Hospital, and Assistant Professor, Harvard Medical School; Mikael Dolsten, MD, PhD, President, Worldwide Research and Development, Pfizer, Inc.; Allan Goodman, PhD, President and CEO, The Institute of International Education; Pablo Legorreta, Founder and Chief Executive Officer, Royalty Pharma; Richard P. Lifton, MD, PhD, President, The Rockefeller University; Siddhartha Mukherjee, MD, PhD, Assistant Professor, Department of Medicine, Division of Oncology, Columbia University Medical Center, and Author of The Emperor of All Maladies: A Biography of Cancer and The Gene: An Intimate History; James E. Rothman, PhD, Fergus F. Wallace Professor of Biomedical Sciences, Yale University and 2013 Nobel Prize Winner in Physiology or Medicine; Bruce Stillman, PhD, President and CEO, Cold Spring Harbor Laboratory; Craig Thompson, MD, President and CEO, Memorial Sloan Kettering Cancer Center; and George D. Yancopoulos, MD, PhD, President and Chief Scientific Officer, Regeneron.

Additional details about the Prize winners can be found on the PSSCRA website at View Source

On July 29, 2020 Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company focused on developing immune modulators and precision therapies for solid tumor cancers, reported that Tom Civik, Chief Executive Officer of Five Prime Therapeutics, and Helen Collins, M.D., Executive Vice President and Chief Medical Officer of Five Prime Therapeutics, will participate in a fireside chat at the 2020 Wedbush PacGrow Healthcare Virtual Conference on Tuesday, August 11, 2020 at 10:10am Pacific Time (PT) / 1:10pm Eastern Time (ET) (Press release, Five Prime Therapeutics, JUL 29, 2020, View Source [SID1234562529])

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The fireside chat will be webcast and may be accessed from the "Events & Presentations" section of the Company’s website at: View Source Five Prime will maintain an archived replay of the webcast on its website for approximately 30 days after the conference.