On September 13, 2024 Senhwa Biosciences, Inc. (TPEx: 6492), a new drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and infectious diseases, reported that its new drug Silmitasertib (CX-4945) was granted a rare pediatric disease designation (RPDD) by US FDA for the treatment of neuroblastoma (Press release, Senhwa Biosciences, SEP 13, 2024, View Source [SID1234646581]). This is the recognition obtained again after Silmitasertib (CX-4945) received RPDD in medulloblastoma from the FDA in July 2020, demonstrating the great potential of Silmitasertib (CX-4945) in the development of treatments for rare pediatric cancers.

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Silmitasertib is a first-in-class small molecule drug that targets the CK2 protein and acts as a CK2 inhibitor that exhibited antitumor activity in pre-clinical study of neuroblastoma. The RPD designation will qualify the drug for the priority review voucher (PRV) program meant to encourage development of novel therapies for rare pediatric diseases. Silmitasetib has previously granted 1 RPD and 3 orphan drug designations (ODD) by the FDA.

"The RPD designation offers sponsors the additional incentive by requesting priority review vouchers (PRVs) for their future marketing applications, and this approach encourages the drug development for the treatment of rare pediatric diseases," said Jin-Ding Huang, PhD, CEO of Senhwa Biosciences, Inc.

Neuroblastoma, an embryonic tumor of the peripheral sympathetic nervous system, is the third most common pediatric cancer and the most common cancer in infants. It is mostly diagnosed in infancy at an average of 1 to 2 years old. There are an estimated 700 to 800 new cases of neuroblastoma each year in the United States.

While low and intermediate-risk neuroblastoma have a very high rate of survival, high-risk neuroblastoma has a 5-year survival rate of about 50%, and it has a high likelihood of recurrence even with intense multimodal treatments. There is currently no standard treatment for patients with relapsed/refractory neuroblastoma.

On September 13, 2024 Massive Bio, a cutting-edge AI driven clinical trial matching platform provider, and Foundation Medicine, Inc. reported a strategic collaboration to increase patient access to cutting edge clinical trials (Press release, Foundation Medicine, SEP 13, 2024, View Source [SID1234646597]). This collaboration unites Massive Bio’s patient matching technology and last-mile solutions with Foundation Medicine’s global expertise and leadership in next generation sequencing (NGS) and network of healthcare providers.

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This partnership seeks to improve the low rate of patient enrollment in oncology clinical trials, which sees only about 8% of eligible patients participating in clinical trials1. As potential new therapies increasingly address rare cancers, approximately 80% of clinical studies globally fail to enroll enough patients with a biopharmaceutical company’s desired timeline, according to a 2020 report published in Perspectives in Clinical Research2. The cornerstone of this partnership lies in integrated solutions that enhance service delivery for both Massive Bio’s and Foundation Medicine’s customers through shared data and AI analytics focused on patient matching.

"The application of real-time AI and our comprehensive data significantly boosts the speed and accuracy of clinical trial matching," said Dr. Arturo Loaiza-Bonilla, MD MSEd, Co-founder and Chief Medical Officer at Massive Bio. "This capability allows us to provide individualized treatments more quickly and accurately, enhancing patient outcomes across the globe. Joining forces with Foundation Medicine is pivotal as it will allow us to develop solutions to the cancer clinical trial enrollment paradox."

Massive Bio is building the largest global oncology/hematology network to transform patient recruitment at scale with more than 132,000 patients, 5,000 physicians, 40 pharma and CRO customers and 50 partners. Massive Bio’s real-time, AI-driven platform, Synergy-AI, can analyze and summarize extensive medical records, including biomarker data from multiple sources, to match patients with over 16,000 clinical trials instantly. Massive Bio’s predictive analytics maximizes trial enrollment potential and significantly reduces screen failures.

Through this partnership, Massive Bio and Foundation Medicine hope to increase clinical trial enrollment with their extensive networks and capabilities across the healthcare landscape, employing advanced AI techniques and a robust digital health platform to refine clinical trial processes and enhance precision oncology.

"Beyond providing high quality genomic profiling to support informed decision making, Foundation Medicine is committed to empowering practitioners to act on those decisions by identifying personalized treatment options including clinical trials," said Heather Jorajuria, Senior Vice President, Clinical & Scientific Operations at Foundation Medicine. "Through this partnership with Massive Bio, we have the patient at the forefront, leveraging our combined assets and expertise to improve access to clinical trials for patients."

On September 10, 2024 Centessa Pharmaceuticals plc, a clinical-stage pharmaceutical company that aims to discover and develop medicines that are transformational for patients, reported that it has commenced an underwritten public offering of $150 million of American Depositary Shares ("ADSs"), each representing one ordinary share (Press release, Centessa Pharmaceuticals, SEP 13, 2024, View Source [SID1234646564]). All of the ADSs are being offered by Centessa. In addition, Centessa intends to grant the underwriters a 30-day option to purchase up to an additional $22.5 million of ADSs offered in the public offering. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Goldman Sachs & Co. LLC, Leerink Partners, Evercore ISI, Guggenheim Securities and BMO Capital Markets are acting as joint book-running managers for the offering.

The ADSs are being offered pursuant to a registration statement on Form S-3 that was filed with the Securities and Exchange Commission ("SEC") on September 11, 2024 and became automatically effective upon filing. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at View Source Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from: Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, telephone: (866) 471-2526, email: [email protected]; Leerink Partners LLC, Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, telephone: (800) 808-7525 ext. 6105, email: [email protected]; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, telephone: (888) 474-0200, email: [email protected]; Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, telephone: (212) 518-9544, email: [email protected]; or BMO Capital Markets Corp., Attention: Equity Syndicate Department, 151 W 42nd Street, 32nd Floor, New York, NY 10036, email: [email protected].

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

On September 13, 2024 Marengo Therapeutics, Inc., a clinical-stage biotech company pioneering a new way to activate T cells targeting the Vβ chain of the T cell receptor to select the optimal T cell subsets against cancer, reported that it has entered into a clinical study collaboration and supply agreement with Gilead Sciences, Inc. to study the combination of STAR0602 (Invikafusp alfa) with Trodelvy (sacituzumab govitecan-hziy), a Trop-2-directed antibody-drug conjugate (ADC), as a potential treatment for adult patients with metastatic hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer and metastatic triple-negative breast cancer (TNBC) (Press release, Marengo Therapeutics, SEP 13, 2024, View Source;breast-cancers-302247091.html [SID1234646582]).

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The planned combination trial, sponsored by Marengo, is expected to commence soon. This study will evaluate the safety, tolerability, and preliminary efficacy of STAR0602 (Invikafusp alfa) in combination with Trodelvy in patients with metastatic TNBC or metastatic HR+/HER2- breast cancer, aiming to explore a novel therapeutic strategy that could offer new treatment options for patients.

"We are excited about the clinical potential of combining our novel selective dual T cell activator with Gilead’s antibody-drug conjugate, Trodelvy," said Kevin Chin, M.D., Chief Medical Officer of Marengo Therapeutics. "This innovative approach leverages the strengths of two unique modalities to target and potentially eradicate cancer cells more effectively. With the possibility to deliver target cytotoxic agents directly to tumors, which release more tumor antigens for selectively activated and expanded Vβ6/10 T cells to recognize and build long-term immune memory, we believe this combination may have the potential to improve cancer patient outcomes."

Under the clinical study collaboration and supply agreement, Gilead will provide Trodelvy to Marengo, who will conduct and sponsor the combination study. Marengo and Gilead will retain all development and commercial rights to their respective compounds, including as monotherapy or as combination therapies.

The combination of invikafusp alfa and sacituzumab govitecan-hziy is investigational and not approved by any health authority globally. The safety and efficacy of this combination has not been established.

On September 13, 2024 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company, reported the Company will share new data from Module 1 of its ongoing Phase 1/2 TRESR clinical trial during an oral presentation on September 14 at the European Society for Medical Oncology Congress (ESMO) (Free ESMO Whitepaper), held in Barcelona, Spain (Press release, Repare Therapeutics, SEP 13, 2024, View Source [SID1234646598]).

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TRESR (NCT04497116) is a first-in-human, multi-center, open-label Phase 1/2 dose-escalation and expansion study designed to establish the recommended Phase 2 dose (RP2D) and schedule. The study evaluated safety, pharmacokinetics and identify preliminary anti-tumor activity associated with camonsertib monotherapy in patients with solid tumors (Module 1).

Oral Presentation Details:

Title: Camonsertib (cam) monotherapy in patients (pts) with advanced cancers harboring ATM loss-of-function (LoF)
Presenter: Benedito A. Carneiro, MD, Legorreta Cancer Center, Division of Hematology/Oncology, The Warren Alpert Medical School, Brown University, Providence, RI
Presentation number: 619MO
Session: Mini Oral Session: Developmental Therapeutics
Session date and time: Saturday, September 14 | 8:45 a.m. – 10:15 a.m. ET
Session location: Oviedo Auditorium, Hall 3