On October 9, 2023 HiFiBiO Therapeutics, a clinical stage global biotech company focusing on improving patient lives with single cell precision, reported that the Chinese National Medical Products Administration (NMPA) has approved the company’s Investigational New Drug (IND) application for HFB200301, a pioneering, first-in-class anti-TNFR2 agonistic monoclonal antibody (Press release, HiFiBiO Therapeutics, OCT 10, 2023, View Source [SID1234635720]).

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HFB200301 is currently undergoing Phase I clinical trial (NCT05238883) evaluation in the treatment of advanced solid tumors in the United States and Europe, both as a monotherapy and in combination with tislelizumab, an anti-PD-1 immune checkpoint inhibitor. This trial is guided by HiFiBiO’s proprietary Drug Intelligence Science (DIS) platform, which utilizes patient data to optimize dosages, dosing regimens, indication selection, and biomarker strategies.

Liang Schweizer, PhD, Founder, Chairperson, and CEO of HiFiBiO Therapeutics, commented on this significant development, saying, "The approval of our HFB200301 IND by the NMPA represents yet another pivotal milestone for the program, confirming our strong commitment to developing safe and effective treatments for cancer patients globally."

"Incorporating Chinese patients into our study will provide invaluable insights into the therapeutic potential of HFB200301 across a diverse patient population, ultimately guiding our efforts to develop novel immuno-oncology treatments to patients with significant unmet medical needs," emphasized Robert Andtbacka, MD, CM, CMO of HiFiBiO Therapeutics.

Under the terms of the previously announced clinical supply agreement, Novartis will supply tislelizumab for use in combination with HFB200301, and HiFiBiO Therapeutics will maintain control of the HFB200301 program, including global R&D and commercial rights.

HFB200301

HFB200301 is a first-in-class anti-TNFR2 agonistic monoclonal antibody that binds potently and selectively to TNFR2, and induces the activation of CD4 T cells, CD8 T cells, and NK cells. HFB200301 demonstrates potent antitumor activity as a monotherapy and in combination with anti-PD-1 in animal tumor models. HiFiBiO is implementing a biomarker strategy, leveraging its DIS platform, to identify indications that may benefit the most from HFB200301 as a monotherapy or as a combination therapy.

Tislelizumab
Tislelizumab, an investigational humanized IgG4 anti-PD-1 monoclonal antibody, is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages. Pre-clinical studies have shown that binding to Fcγ receptors on macrophages can compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells.

On October 9, 2023 Kaiyue Life reported the company and other institutions jointly published a paper titled "Development of small molecule inhibitors targeting RNA helicase DHX33 as anti-cancer agents" in the classic journal of medicinal chemistry, Bioorganic and Medicinal Chemistry Letters (BMCL) (Press release, KeYe Life Technologies, OCT 9, 2023, View Source;article_id=84 [SID1234644610]).

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Recently, a collaborative paper titled "Development of small molecule inhibitors targeting RNA helicase DHX33 as anti-cancer agents" co-authored by Kaiyue Life Sciences, the University of Macau, Southern University of Science and Technology, and Heya Pharmaceuticals was published online in BMCL, a long-established journal of medicinal chemistry.

The RNA helicase DHX33 has been identified as a key player in promoting cancer development. Genetic deletion of DHX33 significantly blocks tumorigenesis. Importantly, its helicase activity was found to be critical for exerting cellular functions. In this study, a helicase-based high-throughput screening (HTS) technique was used to discover DHX33 inhibitors from the Chembridge chemical library containing 15,000 small molecules. We discovered a lead compound containing a benzimidazole ring that showed some selectivity for DHX33. Further structural optimization led to the design and synthesis of a series of mimetic inhibitors. Considering the potential role of DHX33 in cancer development, we evaluated these compounds based on their cytotoxic activity against U251-MG cancer cells in vitro. Among them, compound IVa (KY386) was identified as a selective inhibitor of DHX33 helicase with strong anticancer activity and moderate metabolic stability. These results support the important role of DHX33 inhibitors in the development of novel anticancer drugs.

On October 9, 2023 InCephalo AG reported the company , University of Basel and VitroScan receive a competitive Eurostars grant (€2.3M) to accelerate the development of promising new drugs for Glioblastoma patients – CLEIO (Press release, InCephalo Therapeutics, OCT 9, 2023, View Source [SID1234644133]).

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The consortium led by InCephalo AG has received the competitive Eurostar grant. The Swiss – Dutch consortium consist of three collaborating partners: InCephalo AG, University of Basel and VitroScan.
In the CLEIO project: The first-in-kind Compartment Locked and Effective ImmunOtherapy against glioblastoma, the consortium will: i) study the effect of InC01 (InCephalo’s primary asset) treatment on established ex- vivo GBM models based on patient tissue, ii) discover new biomarkers for the response and non-response of InC01, and iii) drive clinical Phase II trial design through stratification of patient populations.

«We are excited to receive this grant as will allow us to de-risk our
clinical development at such an early stage» says Dr. Carlo Bertozzi,
CEO and co-founder of InCephalo.

Willemijn Vader, CEO VitroScan:

«It is a great opportunity for VitroScan to collaborate with these partners and integrate our expertise to develop predictive tools for new novel treatment options for glioblastoma patients».

Prof. G. Hutter, Neurosurgeon and Group leader at both the Unversity of Basel and the University Hospital in Basel:

«As a treating physician, I see that novel therapeutic modalities are needed for brain cancer patients. In this collaboration, we are actively working to push InC01, a promising new modality, closer to the patient and on the way learn more about which patients are more likely to react».

On October 9, 2023 Coeptis Therapeutics Holdings, Inc. (NASDAQ: COEP) ("Coeptis" or "the Company"), a biopharmaceutical company developing innovative cell therapy platforms for cancer, reported that Dan Yerace, Director and Vice President of Operations, will participate in a panel titled, "Ambitious Innovation: Emerging Cell and Gene Therapies," at the BioFlorida Conference on Thursday October 12th from 11:50 AM-12:50 PM (Press release, Coeptis Therapeutics, OCT 9, 2023, View Source [SID1234635732]).

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Details of the panel discussion are as follows:

Event:

BioFlorida Conference

Date & Time:

October 12, 2023, at 11:50 AM, EDT

Panel Title

Ambitious Innovation: Emerging Cell and Gene Therapies

Location:

Sawgrass Marriott Golf Resort & Spa, Ponte Vedra Beach, FL

On October 9, 2023 Ossium Health reported that Kevin Caldwell, CEO, Co-Founder & President, will present at the annual Cell & Gene Meeting on the Mesa to be held October 10-12 in Carlsbad, California and live streamed globally (Press release, Ossium Health, OCT 9, 2023, View Source [SID1234635731]).

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Organized by the Alliance for Regenerative Medicine, the Cell & Gene Meeting on the Mesa is a three-day conference featuring more than 120 dedicated company presentations by leading public and private companies, highlighting technical and clinical achievements over the past 12 months in the areas of cell therapy, gene therapy, gene editing, tissue engineering, and broader regenerative medicine technologies, as well as over 100 panelists and featured speakers.

Kevin will provide attendees with a first glimpse inside Ossium’s landmark clinical study recently launched in collaboration with the National Marrow Donor Program (NMDP) / Be The Match. This study’s initiation serves as a major milestone for the blood cancer community as it will provide safety and efficacy data on Ossium’s bone marrow and unlock a new source of on-demand bone marrow for patients. In addition, Kevin will provide an update on Ossium’s phase 1 study of allogeneic bone marrow-derived cell therapy for the treatment of steroid-refractory acute graft versus host disease and Ossium’s upcoming launch of OssiGraft, a next-generation viable bone allograft.

The following are specific details regarding Ossium Health’s presentation at the conference:

Event: 2023 Cell & Gene Meeting on the Mesa

Date: Wednesday, October 11, 2023

Time: 5:15 – 5:30 pm Pacific Time

Location: Ecolab Life Sciences Ballroom
Park Hyatt Aviara Resort, 7100 Aviara Resort Dr., Carlsbad, CA 92011

Virtual attendance is available which includes a livestream of Ossium Health’s presentation and the ability to view all conference sessions on-demand. Please visit View Source for full information including registration.

Complimentary attendance at this event is available for credentialed investors and members of the media only. Investors should contact Savannah Bryant at [email protected] and interested media should contact Stephen Majors at [email protected].