On February 15, 2023 JSR Life Sciences, LLC ("JSR") reported that Similis Bio ("Similis"), its business unit focused on biosimilar development, has announced plans to enter into a partnership with Novel351k to co-develop three biosimilar programs that address a wide range of hard-to-treat diseases (Press release, JSR, FEB 15, 2023, View Source [SID1234627213]). Under the initial agreement, Similis will be responsible for cell line development, analytics, process development, and cGMP production, leading to pharmacokinetics/pharmacodynamic clinical trials. Novel351k will leverage its experience with regulatory and clinical strategies to accelerate the development of the programs toward commercialization.

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"We launched Similis to make a wider selection of biosimilars available to patients, and we look forward to working with the Novel351k team on this important endeavor," said John Gabrielson, JSR Life Science’s Senior Vice President and Head of Similis Bio. "This unique partnership combines Similis’ broad CMC expertise and Novel351k’s innovative clinical approach, underscoring our goal of accelerating the delivery of life-saving medicines to patients at lower costs."

The companies anticipate that the partnership will progress to late-stage development activities and commercial manufacturing, pending a successful outcome of early-stage trials. The therapeutics developed under the partnership have a current annual market value exceeding $15B. The co-development agreement has a projected value of $100MM over more than ten years, including development milestones and royalties.

"Novel351k supports the adoption of groundbreaking scientific approaches to reduce redundant testing and to accelerate the development of biosimilars," said Sarfaraz Niazi, Ph.D., Founder and Chief Scientific Officer of Novel351k. "To that end, we aim to create a positive, measurable impact through our development and manufacturing model with world-class partners."

Keara Sauber, CEO of Novel351k, shares with her team the excitement to push innovative partnership models forward to increase the accessibility of biosimilars globally. "This low-cost, fast-to-market strategy, combined with our CDMO partnerships and deep regulatory experience, is unique to the industry. We look forward to partnering with Similis Bio and JSR to support our goal of improving patients’ lives worldwide."

On February 14, 2023 BullFrog AI Holdings, Inc. (NASDAQ:BFRG; BFRGW) ("Bullfrog AI" or the "Company"), a digital technology company using machine learning to usher in a new era of precision medicine, reported the pricing of its initial public offering of 1,297,318 units (each, a "Unit," collectively, the "Units") at a price of $6.50 per unit for a total of approximately $8.4 million of gross proceeds to the Company (Press release, Bullfrog AI, FEB 14, 2023, View Source [SID1234635365]). Each Unit consists of one share of the Company’s common stock, one tradeable warrant (each, a "Tradeable Warrant," collectively, the "Tradeable Warrants") to purchase one share of common stock at an exercise price of $7.80 per share, and one non-tradeable warrant (each, a "Non-tradeable Warrant," collectively, the "Non-tradeable Warrants"; together with the Tradeable Warrants, each, a "Warrant," collectively, the "Warrants") to purchase one share of the Company’s common stock at an exercise price of $8.125.

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The shares and Tradeable Warrants are expected to begin trading on the Nasdaq Capital Market on February 14, 2023, under the symbol "BFRG" and "BFRGW", respectively. The offering is expected to close on or about February 16, 2023, subject to customary closing conditions.

The underwriters have been granted an option, exercisable within 45-days after the closing of this offering, to purchase shares of the Company’s common stock at a price of $6.48 per share and/or Tradeable Warrants at a price of $0.01 per Tradeable Warrant, and/or Non-tradeable Warrants at $0.01 per Non-tradeable Warrant, or any combination of additional shares of common stock and Warrants representing, in the aggregate, up to 15% of the number of Units sold in this offering, in all cases less the underwriting discount.

WallachBeth Capital, LLC and Kingswood, a division of Kingswood Capital Partners, LLC are Joint Bookrunners and Co- Underwriters for the Offering.

The offering is being made only by means of a prospectus. A copy of the final prospectus related to the offering may be obtained, when available, from Wallachbeth Capital, LLC, via email: [email protected], or by calling +1 (646) 237-8585, or by standard mail at Wallachbeth Capital, LLC, Attn: Capital Markets, 185 Hudson St, Jersey City, NJ 07311, USA. In addition, a copy of the final prospectus, when available, relating to the offering may be obtained via the SEC’s website at www.sec.gov.

A registration statement on Form S-1 (File No. 333-267951) relating to these securities was filed with the Securities and Exchange Commission and was declared effective on February 13, 2023. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On February 14, 2023 CSL reported its 2023 half year results (Presentation, CSL, FEB 14, 2023, View Source [SID1234633001]).

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On February 14, 2023 Otsuka reported its consolidated financial results for the Fiscal Year ended December 31, 2022(Press release, Otsuka, FEB 14, 2023, View Source [SID1234630382]).

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On February 14, 2023 Replay, a genome writing company reprogramming biology by writing and delivering big DNA, and The University of Texas MD Anderson Cancer Center, reported the launch of Syena, a new oncology-focused product company pioneering T-cell receptor (TCR) natural killer (NK) cell therapies (TCR-NKs) (Press release, MD Anderson, FEB 14, 2023, View Source;guce_referrer_sig=AQAAAJAAhemSYE24l9faUASm3LUXhmjR_qWpjEm9-Fgi04E-J2D7CjuenYgaPZ0FJDzjz_XVOKIYD9pS7hT2R1qiFpp_2jBNmVb3bYL-n4XfEhIVwdWm0k9axvkvx0Rhs-NOdbzUEuuH8XkgHTIhTs1FIy0PKT1GoLhuuvNejSbL48qF&guccounter=2 [SID1234627252]).

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Building on the intellectual property and technology from MD Anderson and Replay, Syena has the potential to create the next generation of cell therapy, combining the safety, potency, and scalability of NK cells with the ability of TCRs to target intracellular tumor antigens. The new company’s TCR-NK cell platform is based upon the scientific discoveries of Katy Rezvani, M.D., Ph.D., professor of Stem Cell Transplantation & Cellular Therapy at MD Anderson.

"This first-in-class TCR-NK technology provides an opportunity for Replay to disrupt the existing cell therapy paradigm and positions Syena to become a leader in this space," said Adrian Woolfson, Executive Chairman, President, and Co-Founder of Replay. "While clinical successes in hematological malignancies have demonstrated the transformative potential of engineered cell therapies, these successes have not yet been realized in solid tumors. NK cells offer distinct advantages over T-cells and building on Dr. Rezvani’s research to arm them with TCRs has the potential to significantly impact oncology cell therapy."

Based on the contributions of Replay and MD Anderson, Syena will build a pipeline of engineered cell therapies using its novel TCR-NK cell platform, licensed exclusively from MD Anderson. It is targeting a selection of validated cancer neoantigens, including NY-ESO-1, and additional undisclosed TCRs. The NY-ESO-1 program in hematological malignancies and solid tumors is anticipated to enter the clinic in Q2 2023.

Syena’s TCR-NK cell therapy platform will combine the advantages of engineered TCR cancer therapy with those of NK cells, offering the possibility of improved safety and efficacy through a multi-armored approach incorporating natural and artificial mechanisms. Unlike chimeric antigen receptor (CAR)-based therapies, which recognize specific surface proteins, TCR therapies are engineered to recognize proteins normally found inside the cell. The use of a TCR allows the NK cell to recognize externalized protein fragments presented by the cell’s surface immune proteins.

"NK cells play a pivotal role in anticancer immunity and, following the successes of CAR T-cell therapy, and the potential for CAR-NK therapies, TCR-NK cells are positioned to be a next-generation agent for cancer therapy," said Dr. Katy Rezvani. "We believe that the TCR-NK cell approach will allow targeting of a broad range of tumor antigens, including cancer-specific neoantigens, and could pave the way for potentially safe and efficacious ‘off-the-shelf’ cell therapies for hematological malignancies and solid tumors."

Rezvani’s work at MD Anderson has explored the role of NK cells in mediating innate immunological activity against human malignancies, as well as strategies to enhance their killing function. She was the first investigator to conduct a clinical trial with cord blood derived CAR-NK cells (Liu et al, NEJM 2020), and has successfully advanced 11 cell therapies into the clinic through MD Anderson’s institutional support and commitment to advance innovative science.

"We are delighted to have Dr. Rezvani, a world-leading expert in NK-based cell therapy and pioneer of CAR-NK cell therapy, as the scientific founder of Syena," said Lachlan MacKinnon, CEO and Co-Founder of Replay. "Dr. Rezvani has generated compelling clinical data with CAR-NK cell therapies, and her expertise with engineered NK cells will prove invaluable in guiding our scientific efforts. We believe Syena has the potential to redefine this emerging area of medicine and to provide compelling new cell therapy options for patients in need."

Syena will receive licenses to various Replay cell and genome engineering platform technologies.

"MD Anderson and Dr. Rezvani have advanced outstanding science in this space, and we look forward to working with them to accelerate the development of these novel cell therapies," said Kugan Sathiyanandarajah, Managing Director at KKR and a Board Director at Replay. "Coupled with Replay’s platform technologies and oncology drug development experience, Syena has the potential to have a significant impact on this important life science sector and to make a meaningful contribution to human health."

Ends

Disclosure

MD Anderson has an institutional conflict of interest with Replay and Syena, and these relationships will be managed according to an MD Anderson Institutional Conflict of Interest Management and Monitoring Plan.