Adicet Bio to Participate in a Fireside Chat at the Canaccord Genuity 43rd Annual Growth Conference

On August 2, 2023 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer, reported that Chen Schor, President and Chief Executive Officer, will participate in a fireside chat at the Canaccord Genuity 43rd Annual Growth Conference being held from August 7-10, 2023 in Boston (Press release, Adicet Bio, AUG 2, 2023, View Source [SID1234633681]).

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Details of the event are as follows:
Date: Wednesday, August 9, 2023
Time: 1:00 p.m. ET

The live audio webcast can be accessed on the Investors section of Adicet Bio’s website at View Source An archived replay will be available for 30 days following the presentation.

Molecular Targeting Technologies, Inc. and Molecular Theranostics Center of Singapore Receive HSA Approval for Clinical Trial Authorization for EBTATE® in Nasopharyngeal Cancer

On August 2, 2023 Molecular Targeting Technologies, Inc. (MTTI), and its wholly owned subsidiary, Molecular Theranostic Center of Singapore (MTCS) reported the approval of a Clinical Trial Authorization (CTA) application by the Health Sciences Authority (HSA) of Singapore (Press release, Molecular Targeting Technologies, AUG 2, 2023, View Source [SID1234633680]). The CTA enables a Phase IB/II, open-label study of the safety and efficacy of a 3-dose regimen of 177Lu-DOTA-EB-TATE (EBTATE) in patients with nasopharyngeal cancer (NPC) to be conducted at the National University Cancer Institute Singapore (NCIS) and the National University of Singapore (NUS).

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Somatostatin receptor 2 (SSTR2) is found in 81% of primary, recurrent, and metastatic NPC patients. EBTATE, the first patented and only long-acting peptide receptor radionuclide therapy (PRRT) targeting SSTR2 receptors, binds reversibly to serum albumin, resulting in prolonged circulation half-life, increased tumor uptake and retention, and improved therapeutic outcome by delivering an 8-fold greater dose to the tumor compared to 177Lu-Dotatate. A recent three-year clinical trial follow-up* showed EBTATE was effective at controlling tumor and well tolerated without serious adverse events or nephrotoxicity.

NPC has a high prevalence with 133,354 new cases and 80,008 deaths in 2020**. While treatment options include surgery, chemotherapy and radiation therapy, there are no approved molecularly targeted therapies for NPC.

Professor Goh Boon Cher, MD, Deputy Director of NICS and NUS, stated "We are pleased to be collaborating with MTTI/MTCS to evaluate this novel treatment for SSTR2 expressing NPC. The study which will be conducted at our hospital will bring new hope for nasopharyngeal cancer patients."

Dr. Chris Pak, President & CEO of MTTI and Chairman of MTCS, remarked: "The Evans Blue (EB)-albumin binding motif of EBTATE prolongs its circulation half-life and enhances tumor targeting. In preclinical and early clinical studies, EBTATE provided several advantages such as 8-fold uptake in tumor and lower administered radioactive dose versus first generation 177Lu-Dotatate in many cancers. We hope this groundbreaking treatment will be beneficial for nasopharyngeal cancer patients."

CG Oncology Announces $105 Million Oversubscribed Crossover Financing to Advance Clinical-Stage Bladder Cancer Pipeline

On August 2, 2023 CG Oncology reported the close of an oversubscribed $105 million crossover financing round, co-led by new investors Foresite Capital and TCGX, with participation from Avidity Partners, BVF Partners and Janus Henderson Investors, as well as existing investors including Acorn Bioventures, Ally Bridge Group, Decheng Capital, Longitude Capital, Malin Corporation and RA Capital Management (Press release, CG Oncology, AUG 2, 2023, View Source [SID1234633679]).

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"We are excited to welcome leading life science investors who share our vision of developing cutting-edge therapeutics addressing unmet medical needs in bladder cancer," said Arthur Kuan, Chief Executive Officer, CG Oncology. "Our lead asset, cretostimogene grenadenorepvec, continues to make significant clinical progress in bladder cancer in both monotherapy and in combination studies and we are encouraged to see our treatments get closer to being available to bladder cancer patients worldwide."

"We have been impressed and encouraged by the significant progress the team at CG Oncology has made to demonstrate the efficacy of oncolytic immunotherapy cretostimogene grenadenorepvec, which has shown clear signals of activity as a single agent and in combination," said Michael Rome, Ph.D., Managing Director, Foresite Capital. "A significant unmet need remains in bladder cancer, and the CG team is moving with great urgency and focus to deliver potential new treatment options that could elevate the standard of care in this difficult-to-treat patient population."

The proceeds will support the continued advancement of clinical programs in bladder cancer towards FDA approval including BOND-003, a fully enrolled, single-arm, Phase 3, monotherapy study for cretostimogene grenadenorepvec as a potential treatment for high-risk non-muscle invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG).

"Cretostimogene grenadenorepvec has the potential to address resistance mechanisms to approved immunotherapies and substantially improve outcomes for bladder cancer patients," said Giuliano Marostica, Principal, TCGX. "We are excited to partner with CG Oncology to develop this transformational therapy that addresses a high unmet medical need in bladder cancer."

About Cretostimogene Grenadenorepvec

Cretostimogene grenadenorepvec is an intravesically delivered oncolytic immunotherapy agent in a Phase 3 trial for the treatment of BCG-unresponsive non-muscle invasive bladder cancer. Cretostimogene grenadenorepvec is also in a Phase 2 study in combination with KEYTRUDA (pembrolizumab) in the same indication. Other types of bladder cancer are being evaluated with cretostimogene grenadenorepvec in combination with OPDIVO (nivolumab).

Horizon Technology Finance Provides $15 Million Venture Loan Facility to Tallac Therapeutics

On August 2, 2023 Horizon Technology Finance Corporation (NASDAQ: HRZN) ("Horizon"), a leading specialty finance company that provides capital in the form of secured loans to venture capital backed companies in the technology, life science, healthcare information and services, and sustainability industries, reported that it has provided a $15 million venture loan facility to Tallac Therapeutics, Inc. ("Tallac"), of which $5 million has been initially funded (Press release, Tallac Therapeutics, AUG 2, 2023, View Source [SID1234633678]).

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Tallac is developing multiple novel immunotherapies to fight cancer. Tallac’s innovative Toll-like Receptor Agonist Antibody Conjugate (TRAAC) platform enables systemic delivery of differentiated TLR9 agonists to activate a specific anti-cancer immune response for various solid tumor malignancies. Tallac is backed by premier investors including venBio, Lightstone Ventures, Morningside and MRL Ventures Fund. The company will use the loan proceeds for general growth and working capital purposes.

"Tallac is advancing new immunotherapies that may make a tremendous difference in the ongoing fight against cancer," said Gerald A. Michaud, President of Horizon. "Through the development of antibody conjugate-based therapeutics, Tallac’s best-in-class therapies attempt to trigger innate and adaptive immune responses to best address the needs of patients. We are pleased to support Tallac’s continued work and its vital mission."

"We are pleased to have Horizon’s support as we continue to make excellent progress in our TRAAC platform and programs," said Hong I. Wan, Ph.D., president, CEO and co-founder of Tallac Therapeutics. "We are excited to further progress our lead program, TAC-001, in the clinic and to advance additional agents to find difficult-to-treat cancers."

IDEAYA and Amgen Achieve First-Patient-In for Clinical Evaluation of IDE397 (MAT2A) and AMG 193 (PRMT5(MTA)) Combination in MTAP(-/-) Tumors

On August 2, 2023 IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported achievement of First-Patient-In for the Amgen-sponsored Phase 1/2 clinical trial evaluating the combination of IDE397, the IDEAYA investigational MAT2A inhibitor, and AMG 193, the Amgen investigational MTA-cooperative PRMT5 inhibitor, in patients having tumors with MTAP deletion, with an expansion focus in NSCLC (Press release, Ideaya Biosciences, AUG 2, 2023, View Source;tumors-301891206.html [SID1234633677]).

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"We are excited to pursue this potential first-in-class synthetic lethality combination therapy targeting mechanistically complementary nodes of the MTAP methylation pathway – MAT2A and PRMT5. The clinical strategy is supported by preliminary signals of monotherapy activity and by compelling preclinical efficacy, tolerability and selectivity for the combination," said Dr. Darrin M. Beaupre, M.D., Ph.D., Chief Medical Officer, IDEAYA Biosciences.

IDE397 is IDEAYA’s potent and selective small molecule inhibitor targeting methionine adenosyltransferase 2a (MAT2A). IDEAYA observed clinical efficacy for IDE397 as monotherapy in multiple MTAP-deletion high-priority tumor types based on its experience across several patients in early dose expansion, including an earlier-reported unconfirmed partial response which has confirmed by RECIST 1.1 (~47% tumor reduction).

AMG 193 is the Amgen investigational methylthioadenosine- (MTA-) cooperative protein arginine methyltransferase 5 (PRMT5) inhibitor.

IDEAYA and Amgen are collaborating to clinically evaluate the IDE397 and AMG 193 combination in patients having tumors with MTAP deletion in an Amgen-sponsored clinical trial pursuant to a Clinical Trial Collaboration and Supply Agreement, or CTCSA. The global Phase 1/2 clinical trial will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of IDE397 in combination with AMG 193, with an initial expansion focus in NSCLC patients with MTAP-deletion.

Pursuant to the mutually non-exclusive CTCSA, Amgen is the sponsor of the IDE397 and AMG 193 combination clinical trial and each of IDEAYA and Amgen will supply their respective compounds, IDE397 and AMG 193. Each party will pay fifty percent (50%) of the external third-party costs for conducting the clinical trial and be wholly responsible for their respective own internal costs and expenses in support of the clinical trial. The companies will jointly own clinical data and all intellectual property, if any, relating to the combined use of IDE397 and AMG 193 from the clinical trial. Each party retains commercial rights to its respective compounds, including with respect to use as a monotherapy or combination agent. The companies have formed a joint oversight committee responsible for coordinating all regulatory and other activities in support of the clinical trial.