Solu Therapeutics Debuts with $31 Million in Seed Funding to Unlock Antibody-Intractable Cell Surface Targets

On August 01, 2023 Solu Therapeutics, a precision-medicine company developing therapeutics to eliminate disease-driving cells, founded by Longwood Fund, reported the closing of an oversubscribed $31 million seed financing co-led by Longwood and Santé Ventures, with additional participation from DCVC Bio, Astellas Venture Management, and Alexandria Venture Investments (Press release, Solu Therapeutics, AUG 1, 2023, View Source [SID1234633613]). The proceeds will be used to leverage and develop the proprietary CyTaC (Cytotoxicity Targeting Chimera) platform and drug candidates which were in-licensed from GSK by the Company. This platform is designed to unlock antibody-intractable cell surface targets and build next-generation medicines that harness the power of biologics with the vast target binding space of small molecules.

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"We are using the CyTaC platform to develop bifunctional small molecules with one arm binding the extracellular target and the other arm binding a proprietary antibody that can recruit the immune system to kill cancer and other pathogenic cells," commented David Donabedian, Ph.D., co-founder and start-up CEO. "The innovative platform and drug candidates were licensed from GSK and have potential applications across multiple therapeutic areas, including oncology, immunology, and autoimmunity. With the capital from this financing, we plan to advance our lead program in oncology into the clinic within two years and advance several of our other product candidates through pre-clinical development."

As part of the financing, Christoph Westphal, M.D., Ph.D., Founding Executive Chairman, Solu Therapeutics, and Founding Partner, Longwood Fund; Omar Khalil, Partner, Santé Ventures; John Hamer, Ph.D., Managing Director, DCVC Bio; Satoshi Konagai, Astellas Venture Management; and Peter Hutt have joined Solu Therapeutics’ Board of Directors. In return for the license, GSK received equity in Solu and will receive milestones and royalties on products derived from the CyTaC platform.

"Antibody therapeutics have had tremendous success across multiple disease areas, however, there is still tremendous untapped potential," commented Dr. Westphal. "We believe that the novel technology and world-class team recruited to build out Solu Therapeutics will unlock this potential to create a new generation of precision medicines."

"I believe the CyTaC platform opens a vast array of opportunities by combining the pharmacology and efficacy of antibodies with the binding capacity and dose control of small molecules," commented Mr. Khalil. "We’re excited to partner with the Solu team as they develop new medicines for patients who otherwise have limited therapeutic options."

Personalis to Participate at Upcoming Investor Conferences

On August 1, 2023 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported that its management team will participate at the following investor conferences (Press release, Personalis, AUG 1, 2023, View Source [SID1234633612]):

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8th Annual Needham Virtual MedTech & Diagnostics 1×1 Conference
Participating on Monday, August 14, 2023

Sidoti Virtual Micro Cap Conference
Presenting on Wednesday, August 16, 2023 at 12:15 p.m. Eastern Time

Chinese Patent Granted for A*STAR Spinoff, CytoMed Therapeutics’ Licensed Allogeneic CAR-Gamma Delta T Cell Technology

On August 1, 2023 CytoMed Therapeutics Limited (NASDAQ: GDTC) ("CytoMed" or "Company"), a Singapore-based biopharmaceutical company focused on harnessing its proprietary technologies to develop novel donor-derived cell-based immunotherapies for the treatment of various cancers, reported that the chimeric antigen receptor gamma delta T cell (CAR-γδ T cell) technology, which is exclusively licensed from the Agency for Science, Technology and Research (A*STAR), has been granted a patent by the China National Intellectual Property Administration (CNIPA) (Press release, Cytomed Therapeutics, AUG 1, 2023, View Source [SID1234633611]).

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"With our first-in-human trial for CAR-γδ T cells set to begin in Singapore in the second half of 2023, and the recent successful recruitment of our first blood donor for the trial, we are especially thrilled to learn that our technology has received a Chinese patent," said Peter Choo, Chairman of CytoMed. "We have also started to seek partnerships in the vast China market."

The patent titled "Gamma Delta T Cells and a Method of Augmenting the Tumoricidal Activity of the Same" covers technologies for the clinical-scale expansion of γδ T cells from a small amount of donor peripheral blood cells, as well as the modification of the expanded γδ T cells to incorporate a CAR that enables the modified cells to recognize a wide range of cancers, including both solid and hematologic cancers.

Patent No. ZL201880023646.8, published as CN 110494558 B, is owned by A*STAR and exclusively licensed to the Company. The Company holds an exclusive, worldwide license, for use in immunotherapy, including stem cell therapy, until the expiration of the patent covering technology.

The Company received approval in January 2023 from the Health Sciences Authority (HSA) in Singapore to conduct a Phase I clinical trial. The clinical trial, in partnership with the National University Hospital (NUH), Singapore has recruited its first blood donor. The donor blood will be used to manufacture allogeneic CAR-γδ T cells for the study. The cells will be processed in CytoMed’s current PIC/S Good Manufacturing Practice (GMP) facility in Malaysia. The Phase I trial is expected to initiate in the second half of 2023.

CytoMed’s CAR-γδ T cell technology has been developed as an investigational cancer therapy to target NKG2D ligands, a type of stress-induced cancer antigens. The risk of "on-target-off-cancer" side effects may be reduced by targeting stress-induced antigens that are mainly expressed on cancer cells such as NKG2D ligands.

The Company’s other licensed technology from A*STAR is an induced pluripotent stem cell (iPSC)-based technology to derive a novel synthetic γδ NKT cells for the treatment of various types of cancers. A patent for this proprietary technology has already been granted in Japan, and this asset is under preclinical development.

IDEAYA Biosciences to Participate in Upcoming August 2023 Investor Relations Event

On August 1, 2023 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported its participation in an upcoming investor relations event (Press release, Ideaya Biosciences, AUG 1, 2023, View Source [SID1234633610]).

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BTIG Virtual Biotechnology Conference 2023
Tuesday, August 8th, 2023 at 3:00 PM ET

Fireside chat with Yujiro S. Hata, Chief Executive Officer, hosted by Justin Zelin, Director, Biotechnology Research Analyst
A live audio webcast of the conference event will be available through the conference host.

Coeptis Therapeutics Files FDA 513(g) Submission for CD38 In Vitro Companion Diagnostic

On August 1, 2023 Coeptis Therapeutics Holdings, Inc. (NASDAQ: COEP) ("Coeptis" or "the Company"), a biopharmaceutical company developing innovative cell therapy platforms for cancer, reported that it has submitted a 513(g) request to the U.S. Food and Drug Administration (FDA) for an in vitro companion diagnostic test designed to be used with anti-CD38 monoclonal antibody therapies (Press release, Coeptis Therapeutics, AUG 1, 2023, View Source [SID1234633609]). The 513(g) request serves to introduce Coeptis’ diagnostic technology to the FDA and to request guidance in determining the appropriate classification and regulatory pathway.

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The companion diagnostic test is intended to guide clinicians’ decisions in difficult to treat oncology indications. Treatments for complicated oncology indications that target CD38 can have significant impact on the immune system including increased risk for infectious complications, autoimmune disorders, and secondary malignancies, so in vitro companion diagnostics could be a valuable tool in guiding treatment decisions.

"With this 513(g) submission, we now look forward to initiating a dialogue with the FDA to advance the regulatory development of our CD38 diagnostics technology, which we believe has potential to significantly improve the treatment of severe and complicated oncology indications," said Dave Mehalick, President and CEO of Coeptis Therapeutics. "For patients living with these very severe and difficult to treat conditions, this companion diagnostic could potentially relieve substantial burdens and cost of treatments to those individuals who likely won’t respond to treatment. Importantly, predicting treatment could provide clinicians with the opportunity to choose a different, possibly more effective treatment plan, rather than losing time with an ineffective therapy as the disease progresses."