Race Initiates FTO-Directed Kidney Cancer Preclinical Study

On March 25, 2021 Race Oncology Limited ("Race") reported that it has entered into a new collaborative preclinical research program with The University of Newcastle (Press release, Race Oncology, MAR 25, 2021, View Source [SID1234577243]). The work will be led by eminent cancer researcher, Associate Professor Nikki Verrills, who successfully ran Race’s preclinical breast and ovarian cancer programs (ASX announcements: 24 November 2020, 23 February 2021, 9 March 2021).

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This project will use cellular models to investigate Bisantrene as a novel treatment for clear cell renal cell carcinoma (ccRCC), a devastating form of kidney cancer. While there have been major improvements with kidney cancer treatment in recent decades, the five-year survival rate for advanced ccRCC is still as low as ~12%.

Bisantrene has recently been identified as a potent targeted inhibitor of the Fat Mass and Obesity associated protein (FTO). Previous studies have observed that FTO enzyme activity is essential for ccRCC survival and the inhibition of FTO can directly kill more than 90% of ccRCCs.

Race is pursuing Bisantrene therapies targeted at inhibiting FTO in both melanoma and clear cell renal cell carcinoma, as part of its Three Pillar strategy (ASX announcement: 30 November 2020). This work could lead to new kidney cancer treatments with improved safety and efficacy, especially for treatment resistant cancers.

The results of this study will support Phase II human trials of Bisantrene in ccRCC, currently scheduled to begin in Australia in early 2022.

This project is to start immediately with results expected to be reported over the coming 12 months as received by the Company.

"This is a very important project for Race and we are looking forward to collaborating further with Associate Professor Verrills. Recent scientific developments have identified Bisantrene as a potent targeted agent of FTO which offers the possibility of novel treatment options for patients with kidney cancer that can rapidly be translated into the clinic. We are excited about this research which will further our knowledge of Bisantrene and it adds to the FTO-directed preclinical work we have just initiated in melanoma."

Chief Scientific Officer, Dr Daniel Tillett
Kidney cancer remains one of the most dangerous cancers with approximately 73,750 cases in the USA and 4,193 in Australia in 2020, of which ccRCC makes up approximately 70% of all cases.

PCR Oncology Expands Clinical Trial Offering by Adopting Deep Lens AI-Solution, VIPER™

On March 25, 2021 PCR Oncology and Deep Lens reported a strategic partnership that will integrate artificial intelligence-based clinical trial screening and enrollment platform, VIPER, into the PCR Oncology network (Press release, PCR Oncology, MAR 25, 2021, View Source [SID1234577232]). VIPER uses proprietary cloud-based technology to facilitate, triage and accelerate the clinical trial recruitment process. Through this collaboration, PCR Oncology will be able to more effectively identify, screen and match oncology patients to precision-based clinical trials.

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"PCR Oncology is extremely dedicated to advancing cancer research and has prioritized the expansion of our clinical trial program to be able to offer a broader range of studies to our patient community," said David Palchak, M.D. at PCR Oncology. "The VIPER platform will not only expedite the process for matching patients to existing trials, but it will also assist in bringing additional trials to the PCR network, thereby greatly improving access to care for cancer patients on the Central Coast."

PCR Oncology has a robust clinical trial and research program. It is the first and only location in California that is participating in the National Cancer Institute’s (NCI) Cancer Moonshot program, a five-year initiative designed to advance the knowledge and treatment of cancer via the collection and analysis of biospecimens and data from diverse patient populations across the U.S.

It is estimated that more than 15,000 oncology clinical trials are actively recruiting patients; yet participation in these trials is often as low as three percent. Certain barriers to enrollment — including limited study site capacity and narrow trial eligibility requirements — have been well documented; however, the percentage of patient participation in these trials has not increased significantly over time. VIPER automates the clinical trial screening process and seamlessly matches patients — at the time of diagnosis — to appropriate trials through the ingestion and analysis of customized genomic data, electronic medical records and pathology data. Deep Lens’ VIPER will be integrating directly to their EMR (iKnowMed), molecular data feed (from Caris and Foundation Medicine) and pathology feeds to automatically identify qualified patients for clinical trials. Like PCR Oncology, any iKnowMed practice can be easily integrated and can utilize VIPER and the Deep Lens screening services free of charge.

"We are delighted to be able to help PCR Oncology improve efficiencies and add value to their already comprehensive clinical trial program," said Greg Andreola, Chief Revenue Officer at Deep Lens. "The VIPER platform is designed to assist clinical trial study sites with the complexities involved in patient recruitment and enrollment, which will allow oncology teams to focus more exclusively on providing patient care."

Brooklyn ImmunoTherapeutics Completes Reverse Merger with NTN Buzztime

On March 25, 2021 Brooklyn ImmunoTherapeutics, Inc. (NYSE American: BTX) ("Brooklyn"), a biopharmaceutical company focused on exploring the role that cytokine-based therapy can have in treating patients with cancer, reported the completion of the reverse merger with NTN Buzztime, Inc (Press release, Brooklyn ImmunoTherapeutics, MAR 25, 2021, View Source [SID1234577231]). Brooklyn will focus on the advancement of IRX-2, its cytokine-based compound for the treatment of various cancers, as well as opportunities in the area of gene editing/cell therapy through its option agreement with Factor Bioscience/Novellus. Brooklyn’s common stock will trade on the NYSE American Exchange under the ticker symbol "BTX" commencing on March 26, 2021.

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"The reverse merger with NTN Buzztime is a major step forward for Brooklyn," said Ronald Guido, MS, MS Pharm. Med., Chief Executive Officer of Brooklyn. "We look forward to continuing to evaluate IRX-2, a human cell-derived IL-2 therapeutic in neoadjuvant (pre-surgical) and adjuvant (post-operative) treatment for advanced head and neck squamous cell cancer. IRX-2 has received both fast track designation and orphan drug designation from the FDA for this indication with topline results from our Phase 2b clinical trial expected in the first half of next year. IRX-2 is also being studied in clinical trials in multiple oncology indications, both as a single agent and in combination with other anti-cancer drugs including checkpoint inhibitors."

At the closing under the merger agreement, Brooklyn ImmunoTherapeutics LLC merged with a wholly owned subsidiary of NTN Buzztime and became a wholly owned subsidiary of NTN Buzztime, which changed its name to Brooklyn ImmunoTherapeutics, Inc. Immediately following the closing, the former members of Brooklyn ImmunoTherapeutics LLC collectively own approximately 96.25% of the outstanding common stock of Brooklyn and the stockholders of NTN Buzztime prior to the merger own the remaining 3.75% of Brooklyn’s outstanding common stock. Further, following the closing of the merger, there are approximately 41.5 million post-reverse split shares of common stock outstanding.

In connection with the transaction, Maxim Group LLC served as the financial advisor for Brooklyn.

About IRX-2

IRX-2 is an allogeneic, reproducible, primary, human cell-derived IL-2 therapeutic with multiple active cytokine components that act on various parts of the immune system, to activate the entire tumor microenvironment. In addition to IL-2, IRX-2 contains multiple human cytokines that promote or enhance an immune response. IRX-2 is administered as a subcutaneous injection around lymph node beds.

IL-2 is a powerful immune factor that plays an important role in maintaining and restoring T cell response. IL-2 has induced response in cancer patients however recombinant formulations of IL-2 have been limited by toxicity and high doses of recombinant IL-2 results in significant immune-related adverse effects.

Shanghai ImmuneOnco Raises $89 Million for Cancer Immunotherapies

On March 25, 2021 Shanghai ImmuneOnco Biopharma reported that completed an $89 million Series C funding led by Guangdong’s Greater Homeland Bay Area Investments and Lilly Asia Ventures (Press release, ImmuneOnco Biopharma, MAR 25, 2021, View Source [SID1234577228]). Founded in 2015, ImmuneOnco has established discovery platforms that exploit two types of innate immune cells: macrophages and natural killer (NK) cells. The company has been approved to start two clinical trials: IMM01, an anti-CD47 fusion protein, was approved in China, and IMM0306, a bispecific antibody targeting CD47 and CD20, was approved in the US.

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AllianThera Biopharma comes out of stealth and collaborates on AI with Insilico Medicine

On March 25, 2021 AllianThera Biopharma (ATB), a Suzhou, China-based startup focusing on inventing and developing innovative medicines for a broad range of diseases, and Insilico Medicine, a global leader in deep learning for drug discovery and development, reported a collaboration to discover and develop molecules for novel targets in cancer and autoimmune diseases (Press release, AllianThera Biopharma, MAR 25, 2021, View Source [SID1234577227]).

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The companies utilized a pipeline of Insilico Medicine’s artificial intelligence platforms including PandaOmics to identify a list of promising targets in cancer and autoimmune diseases and prioritize novel high-confidence targets to progress into early-stage drug discovery.

ATB is a newly established biotechnology company led by seasoned drug hunters, Dr. Yuan-Hua Ding (CEO) and Dr. Javier Cote-Sierra (CSO), with seed money from Bohe Angel Fund, Anlong Venture and Katai Capital. Dr. Ding and Dr. Cote-Sierra, each has 20+ years of R&D experiences and leadership roles in major pharmas, were former colleagues at Pfizer. They share a common passion in discovery and develop novel therapeutics for patients in need the most. In the recent past, Dr. Ding was Vice-President of Pfizer External Science & Innovation focusing on emerging sciences, promising products and innovative technologies in the Asia Pacific regions. In this role, Dr. Ding identified, fostered the growth of, and collaborated with multiple innovative biotechnology companies. Dr. Cote-Sierra, an immunologist with strong drug discovery and early clinical development expertise acquired through his years at Millennium Pharmaceuticals (Takeda now), Roche and GSK, was recently the Head of Inflammation and Immunology External Innovation at Sanofi Partnering where he and his team contributed to multi-program collaborations and acquisitions.

Dr. Ding and Dr. Cote-Sierra together with Prof. Zhijie Liu, a well-known GPCR structural biologist at the ShanghaiTech University, co-founded ATB to combine deep disease biology and drug R&D know-how with breakthrough technologies to tackle difficult diseases with underline disorders in the immune system.

"Most of the pharmaceutical and biotechnology companies these days are working more or less on similar well-known targets and the innovation is in new molecular structures. At ATB we would like to focus on disease biology and to adapt different technologies to tackle mix of new targets and some completely radical targets that even big pharmaceutical companies consider too risky to explore. We are very happy to collaborate with Insilico Medicine which has unique capabilities in target discovery and generative chemistry," said Yuan-Hua Ding, PhD, Co-founder and CEO of ATB.

"Dr. Ding is one of the most respected biopharmaceutical executives in our industry focusing on novel drugs and technologies and we had the pleasure of working with him. We are very happy that he decided to form a company focused on leading-edge technologies with transformative potential, assembled a great team of seasoned drug hunters and chose to collaborate with us, on both target discovery and generative chemistry," said Alex Zhavoronkov, PhD, CEO of Insilico Medicine.