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).

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."

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.

On August 2, 2023 Grünenthal GmbH (CEO: Gabriel Baertschi), a global, science-based, privately-owned pharmaceutical company and Kyowa Kirin Co., Ltd., (TSE:4151, President and CEO: Masashi Miyamoto, Kyowa Kirin), a Japan-based global specialty pharmaceutical company, reported the successful completion of a deal to enter into a Joint Venture Collaboration for Kyowa Kirin International’s established medicines portfolio (Press release, Gruenenthal, AUG 2, 2023, View Source [SID1234633676]).

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The portfolio comprises 13 brands across six therapeutic areas primarily focused on pain management, including Abstral and PecFent for breakthrough cancer pain, Moventig for opioid-induced constipation, and Adcal-D3 for osteoporosis. All products will continue to be marketed through affiliates in seven major European countries and through a network of partners in various additional territories worldwide.

"Grünenthal is a global leader in pain management. With the addition of this strong portfolio, we will be able to help more patients who suffer from various forms of pain," said Gabriel Baertschi, Chief Executive Officer, Grünenthal.

"The established medicines portfolio has a proud history of delivering life-changing value for patients. Today’s announcement now means even more patients, for many years to come, will continue to benefit from the portfolio. We are enormously grateful and proud of our colleagues who have worked tirelessly to make this Joint Venture Collaboration a reality," said Jeremy Morgan, President, Kyowa Kirin International.

Grünenthal owns a 51 percent majority share in the Joint Venture Collaboration, while Kyowa Kirin owns a 49 percent share. Grünenthal intends to fully acquire the remaining 49 percent share via exercising an option at the beginning of 2026.

On August 2, 2023 ABM Therapeutics (ABM) reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ABM-1310, a novel small molecule BRAF inhibitor developed by the company, for the treatment of patients with glioblastoma (GBM) bearing BRAF V600 mutation (Press release, ABM Therapeutics, AUG 2, 2023, View Source [SID1234633675]).

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Orphan Drug Designation is a significant recognition bestowed by the FDA to the drugs used in the treatment of rare diseases. This designation intends to encourage and support the development of drugs that are vital to patients with rare medical conditions. ODD could provide the drug developer various regulatory support and financial incentives. Obtaining Orphan Drug Designation is a prestigious recognition from the FDA, which encourages ABM to accelerate the development of ABM-1310 for treating patients with GBM.

ABM-1310 is an orally administered medicine with high BRAF-mutation selectivity, high water solubility, and high blood-brain barrier permeability. It is one of innovative drugs independently developed by ABM. ABM-1310 is in Phase I studies at multiple clinical sites in the U.S. and China for BRAF V600-mutant advanced solid tumors. The interim result from its U.S. Phase 1 study was presented in June 2023 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, demonstrating ABM-1310’s promising anticancer activity and good safety profile in patients with advanced BRAF V600 mutant solid tumors including primary brain tumors such as GBM and other gliomas. A new Phase I clinical trial specifically targeting GBM has recently been initiated in China.

GBM is a hard-to-treat, highly aggressive brain tumor. Due to the complexity in tumorigenesis and resistance to the therapy, the treatment of GBM remains significant challenges. Conventional treatments, including surgical resection, radiation therapy, and chemotherapy, are still suboptimal. As of the fact that very few treatment options are available after disease progression, development of more effective therapies is with a high demand.

ABM is dedicated to the development of novel medicines to provide patients with more effective treatment options. The FDA-granted Orphan Drug Designation marks another important milestone for the company. ABM is highly encouraged and will continue its endeavors in developing more innovative drugs, and bringing new hope and more choices to patients with cancers.