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."

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.

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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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.

On March 25, 2021 IntelGenx Technologies Corp. (TSX V:IGX)(OTCQX:IGXT) (the "Company" or "IntelGenx") reported financial results for the fourth quarter and twelve-month periods ended December 31, 2020 (Press release, IntelGenx, MAR 25, 2021, View Source,%242.1%20million%20in%20Q4%2D2019. [SID1234577214]). All dollar amounts are expressed in U.S. currency, unless otherwise indicated, and results are reported in accordance with United States generally accepted accounting principles except where noted otherwise.

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2020 Fourth Quarter Financial Highlights:

Revenue was $790,000, compared to $68,000 in the 2019 fourth quarter.
Net comprehensive loss was $1.3 million, compared to $2.7 million in the 2019 fourth quarter.
Adjusted EBITDA loss was $754,000, compared to $2.1 million in Q4-2019.
2020 Full-Year Financial Highlights:

Revenue was $1.5 million, compared to $742,000 in 2019.
Net comprehensive loss was $7.1 million, compared to $10.3 million in 2019.
Adjusted EBITDA loss was $5.3 million, compared to $8.5 million in 2019.
Recent Developments:

Announced a strategic partnership with atai Life Sciences ("atai"), including a proposed equity investment by atai, positioning IntelGenx as a leader within the novel therapeutics field of psychedelics and providing the requisite financial resources to continue to advance its robust portfolio of other innovative pharmaceutical film product candidates towards commercialization.
The Company’s wholly owned subsidiary, IntelGex Corp., also received a $2.0 million secured loan from atai, of which $628,000 was used to fully repay the Company’s outstanding credit facilities with the Bank of Montreal.
Received a Notice of Allowance for US Patent Application 16/110.737, entitled "Film Dosage Form with Extended Release Mucoadhesive Particle," covering novel disintegrating oral film formulations designed for the transmucosal absorption of drug, especially tetrahydrocannabinol (THC), which protects its DisinteQTM products.
Filed a new provisional patent application at the United States Patent and Trademark Office entitled "High Loading Oral Film Formulation," which covers the incorporation of high concentrations of active ingredients in products based on its VetaFilm proprietary veterinary oral film technology.
Announced the appointment of Mr. Tommy Kenny as Vice President, Intellectual Property and Legal Affairs, General Counsel of IntelGenx Corp., the Company’s operating subsidiary.
Received its first purchase order from Heritage Cannabis Holdings, recently upsized from 50,000 to 75,000 CBD Filmstrips, pursuant to a definitive supply agreement.
"While we were pleased to see the positive impact of our performance improvement program continuing to be reflected in our financial results, it was the transformative partnership that we entered into with atai subsequent to year-end that truly served to validate our long-term growth strategy," commented Dr. Horst G. Zerbe, CEO of IntelGenx. "We are confident that this transaction is the best way forward to maximize value for our shareholders, and encourage them to vote "FOR" all related proposals at our Annual Meeting on May 11, 2021."

Financial Results:

Total revenues for the three-month period ended December 31, 202 amounted to $790,000, an increase of $722,000, or 1,062%, compared to $68,000 for the three-month period ended December 31, 2019. The change is mainly attributable to an increase in revenues from licensing agreements of $671,000 and an increase in R&D revenues of $51,000. Operating costs and expenses were $1.8 million for the fourth quarter of 2020, versus $2.4 million for the corresponding three-month period of 2019. For Q4-2020, the Company had an operating loss of $1.0 million, compared to operating loss of $2.4 million for the comparable period of 2019. Net comprehensive loss was $1.3 million, or $0.01 per basic and diluted share, for the fourth quarter of 2020, compared to net comprehensive loss of $2.7 million, or $0.03 per basic and diluted share, for the comparable period of 2019.

Total revenues for the twelve-month period ended December 31, 2020 amounted to $1.5 million, representing an increase of $802,000, or 108% compared, to $742,000 for the year ended December 31, 2019. Operating costs and expenses were $7.8 million for the full year 2020, versus $10.3 million for the corresponding 12-month period of 2019. For the twelve-month period of 2020, the Company had an operating loss of $973,000, compared to an operating loss of $2.4 million for the comparable period of 2019. Net comprehensive loss was $7.1 million, or $0.07 per basic and diluted share, for the twelve-month period of 2020, compared to net comprehensive loss of $10.3 million, or $0.11 per basic and diluted share, for the comparable period of 2019.

As at December 31, 2020, the Company’s cash and short-term investments totalled $2.2 million, which did not include the $2.0 million secured loan granted to IntelGenx Corp. by atai in March 2021.

Annual Filings:

The Company’s annual report on Form 10-K and financial statements for the year ended December 31, 2012, as well as the 2021 Proxy Statement, will be filed with the United States Securities and Exchange Commission and the Canadian Securities regulatory authorities today, March 25, 2021.

Conference Call Details:

IntelGenx will host a conference call to discuss these 2020 fourth quarter and full year financial results today at 4:30 p.m. ET. The dial-in number for the conference call is (877) 876-9174 (Canada and the United States) and (785) 424-1669 (International). The call will be also be webcast live and archived on the Company’s website at www.intelgenx.com under "Webcasts" in the Investors section.