On July 20, 2022 BioRay Pharmaceutical Co., Ltd. (hereinafter referred to as "BioRay") reported that the first patient with advanced malignant tumors had been dosed in the Phase I Clinical trial of self-developed Category 1 innovative drug BR105 (Press release, Zhejiang Hisun Pharmaceutical, JUL 20, 2022, View Source;a=index&classid=43&id=1 [SID1234634616]). This is an open-label, dose-escalation, and dose-expansion trial to explore the safety, tolerability, and antitumor activity of BR105. The phase Ia part of the trial aims to evaluate the safety and tolerability of BR105 monotherapy (single and multiple doses) in subjects with advanced malignancies and to explore the maximum tolerated dose (MTD). The leading entity of the clinical trial is Beijing Cancer Hospital, and the principal investigators are Prof. Jun Zhu and Prof. Lin Shen.

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BR105 is a SIRPα-targeting humanized monoclonal antibody that was independently developed by BioRay, which can recognize the common variants of signal-regulated protein α (SIRPα), blocks the binding of SIRPα to CD47, disengage the "don’t eat me" signal and activate macrophages to promote phagocytosis of tumor cells.

SIRPα is a transmembrane protein expressed on the surface of myeloid cells such as macrophages, monocytes, dendritic cells, and granulocytes. The binding of SIRPα to CD47 activates phagocytosis-inhibitory signals in multiple cancer types, and tumor cells are able to evade phagocytosis by macrophages. Blocking CD47/SIRPα signaling potentiates phagocytosis of tumor cells by macrophages, and suppresses tumor growth. CD47/SIRPα can be a viable immune target for antitumor therapy.

Multiple tumor models have demonstrated the effectiveness of targeting CD47/SIRPα. Clinical studies suggest that blockage of CD47–SIRPα signaling pathway may generate antitumor activity in broad-spectrumof malignancies, including various hematologic and solid tumors. CD47/SIRPα-targeted therapy has shown positive efficacy results in acute myeloid leukemia, lymphoma, head, and neck squamous cell carcinoma, gastric cancer, and other tumors.

Unlike CD47, SIRPα has a limited tissue expression pattern. BR105 blocks CD47/SIRPα signaling pathway by targeting SIRPα, which is superior in safety. In addition, CD47 can interact with other proteins such as TSP-1 and SIRPγ, which are involved in more complex signaling pathways, and the corresponding targeted therapeutic regimens have more risk considerations to balance; therefore, developing SIRPα antibodies to block the CD47/SIRPα signaling pathway may be a more effective strategy for oncology drug development.

"CD47/SIRPα is considered one of the most prospective targets for tumor immunotherapy after PD-1/PD-L1," said Dr. Wei Zhu, Chief Medical Officer of BioRay, "BR105 is an important candidate of our tumor immunization pipeline. We are pleased that the first patient’s dosing of BR105 has been completed, and this marks important progress in the innovation and R&D of BioRay. We will next push forward with our research and development projects in the field of popular targets for tumor immunity and autoimmunity to benefit patients."

On January 7, 2022 ImaginAb, Inc., a market leading global biotechnology company focused on developing next generation ImmunoPET imaging agents and therapeutic radiopharmaceuticals and with a history of taking agents into clinical trials, reported an expansion of its development pipeline with six active programs focused on Radiopharmaceutical Therapies (RPT), targeting a number of cancer indications (Press release, ImaginAb, JAN 7, 2022, View Source [SID1234621841]).

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These programs are currently moving through lead selection and IND-enabling studies with a view to the most promising candidates entering clinical trials during 2023.

The RPT pipeline uses ImaginAb’s core biological technology platform which utilizes antibody fragment technologies to deliver high tumor specificity and uptake, whilst providing faster blood clearance to reduce off-target toxicities and irradiation.

This technology allows agents to be tuned "just right" to provide the optimal radiopharmaceutical characteristics, a term which ImaginAb refers to as the "Goldilocks Criteria".

These advantages bring the potential to treat more cancer patients with RPT thereby increasing the potential for radiopharmaceuticals to provide greater impact in treating a range of cancer types.

Ian Wilson, CEO stated
"RPT is gaining significant clinical and commercial interest. However, many of the agents have, to date, focused on small molecules, peptides, or intact antibodies. We believe antibody fragments based on ImaginAb IP protected platform offer greater potential in providing next generation RPT agents, by increasing delivery to tumors and reducing off target toxicity.

Our plan is to focus our R&D team on our RPT programs, expanding our pipeline, and taking candidate RPT agents through IND-enabling studies during 2022 with a view to commencing clinical studies during 2023".

To make this happen, ImaginAb has established dedicated and experienced in-house Discovery, Clinical, and Operations Teams, enabling the business to undertake lead discovery including efficacy screening, radiochemistry optimization, and multicentre clinical trials with therapeutic radiopharmaceuticals.

Wilson continued "Our developing RPT pipeline will extend our product portfolio, and add significant value to our business as we continue to move forward to achieve our vision of helping patients live better and healthier lives"

On January 7, 2022 Absci Corporation reported that inked a research pact with Merck (Press release, Biosortia Pharmaceuticals, JAN 7, 2022, View Source [SID1234607739]). Under the deal, Absci will leverage its Bionic Protein non-standard amino acid technology and its artificial intelligence-powered integrated Drug Creation Platform to create enzymes to meet Merck’s biomanufacturing applications .

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Under the terms of the agreement, Absci is eligible for up to $610 million in upfront fees and milestone payments for three targets. In addition, they are up for research funding and tiered royalties on any sales that come out of the partnership.

On January 7, 2022 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported that interim Phase 1/2 data on MB-106, a CD20-targeted, autologous CAR T cell therapy for patients with relapsed or refractory B-cell non-Hodgkin lymphomas ("NHL") and chronic lymphocytic leukemia ("CLL"), have been selected for a poster presentation at the 2022 Tandem Meetings I Transplantation & Cellular Therapy Meetings of the American Society of Transplantation and Cellular Therapy ("ASTCT") and Center for International Blood & Marrow Transplant Research ("CIBMTR"), taking place February 2 – 6, 2022 in Salt Lake City, Utah ("2022 Tandem Meetings") (Press release, Mustang Bio, JAN 7, 2022, View Source [SID1234598444]). MB-106 is being developed in a collaboration between Mustang and Fred Hutchinson Cancer Research Center ("Fred Hutch").

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Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, "The compelling clinical activity and favorable safety profile that MB-106 continues to demonstrate in the ongoing Phase 1/2 trial at Fred Hutch highlight its potential as an outpatient therapy for patients with relapsed or refractory B-cell non-Hodgkin lymphomas and chronic lymphocytic leukemia. We look forward to the updated data that will be presented by Fred Hutch at the 2022 Tandem Meetings, in particular for patients with diffuse large B cell lymphoma and Waldenstrom’s macroglobulinemia. We also look forward to advancing our MB-106 CD20-targeted CAR T cell therapy program towards a multicenter trial under Mustang’s IND in the current quarter."

Details of the presentation are as follows:

Title: High Efficacy and Low Toxicity of MB-106, a Third Generation CD20 Targeted CAR-T for Treatment of Relapsed/Refractory B-NHL and CLL
Poster Number: 225
Dates and Times: Thursday, February 3, 6:45 pm to 8:15 pm and Saturday, February 5, 6:15 pm to 7:45 pm
Presenter: Mazyar Shadman, M.D., M.P.H., Associate Professor, Clinical Research Division, Fred Hutch, Seattle, WA; Physician at Seattle Cancer Care Alliance; Associate Professor, Division of Medical Oncology, University of Washington School of Medicine

For more information, please visit the 2022 Tandem Meetings website at View Source

Note: Scientists at Fred Hutch played a role in developing these discoveries, and Fred Hutch and certain of its scientists may benefit financially from this work in the future.

About MB-106 (CD20-targeted CAR T Cell Therapy)
CD20 is a membrane-embedded surface molecule which plays a role in the differentiation of B-cells into plasma cells. The CAR T was developed by Mustang’s research collaborator, Fred Hutch, in the laboratories of the late Oliver Press, M.D., Ph.D., and Brian Till, M.D., Associate Professor in the Clinical Research Division at Fred Hutch, and exclusively licensed to Mustang in 2017. The lentiviral vector drug substance used to transduce patients’ cells to create the MB-106 drug product produced at Fred Hutch has been optimized as a third-generation CAR derived from a fully human antibody, and MB-106 is currently in a Phase 1/2 open-label, dose-escalation trial at Fred Hutch in patients with B-NHLs and CLL. The same lentiviral vector drug substance produced at Fred Hutch will be used to transduce patients’ cells to create the MB-106 drug product produced at Mustang Bio’s Worcester, MA, cell processing facility for administration in the planned multicenter phase 1/2 clinical trial to be initiated shortly under Mustang Bio’s IND. It should be noted that Mustang Bio has introduced minor improvements to its cell processing to facilitate eventual commercial launch of the product. In addition, prior to commercial launch, Mustang Bio will replace the Fred Hutch lentiviral vector drug substance with vector produced at a commercial manufacturer. Additional information on the trial can be found at View Source using the identifier NCT03277729.

On January 7, 2022 Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, reported the completion of its previously announced underwritten public offering of 9,523,810 shares of its common stock at a public offering price of $42.00 per share (Press release, Intra-Cellular Therapies, JAN 7, 2022, View Source [SID1234598437]). In addition, the underwriters have exercised in full their option to purchase an additional 1,428,571 shares.

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All of the shares in the offering were sold by Intra-Cellular Therapies, with gross proceeds to Intra-Cellular Therapies of approximately $460.0 million and net proceeds of approximately $433.7 million, after deducting underwriting discounts and commissions and estimated offering expenses.

J.P. Morgan, SVB Leerink, BofA Securities, Evercore ISI and RBC Capital Markets acted as joint book-running managers for the offering. Cantor and Canaccord Genuity acted as co-lead managers for the offering. Needham & Company acted as co-manager for the offering.

The public offering was made pursuant to a shelf registration statement on Form S-3 that was previously filed with the Securities and Exchange Commission (the "SEC") and became effective upon filing. A final prospectus supplement and the accompanying prospectus describing the terms of the offering has been filed with the SEC and is available on the SEC’s website located at View Source, and may be obtained from J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at 1-866-803-9204, or by email at [email protected], SVB Leerink LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at 1-800-808-7525, ext. 6105, or by email at [email protected], BofA Securities, Attention: Prospectus Department, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001 or by e-mail at [email protected], Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, by telephone at (888) 474-0200 or by email at [email protected], or RBC Capital Markets, LLC, Attention: Equity Capital Markets, 200 Vesey Street, 8th Floor, New York, NY 10281, by telephone at (877) 822-4089 or by email at [email protected].

This press release shall not constitute an offer to sell, or a solicitation of an offer to buy, nor will there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.