On September 13, 2024 OS Therapies, a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, reported the development and in vitro concept data for two novel ADC therapeutic candidates leveraging the Company’s proprietary SiLinker technology (Press release, OS Therapies, SEP 13, 2024, View Source;Based-Therapeutic-Candidates [SID1234646596]). The Company has completed target engagement tests for both therapeutic candidates and confirmed their therapeutic potential. These new constructs will target Breast, Lung and Gastric Cancer; and Ovarian, Fallopian Tube and Primary Peritoneal Cancer, respectively.

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The Company is advancing its tADC platform through successive product development de-risking milestones and intends to out-license certain therapeutic candidates and components that are strategic to potential partners’ pipelines – particularly the ph-sensitive SiLinker. The Company’s first tADC asset OST-tADC-FRα-H has achieved proof of concept in animal models of ovarian cancer. With the additional two constructs now added to the pipeline, the Company is positioning itself to become a key provider of intellectual property for new therapeutic product development to partners. All while continuing to focus its internal resources on bringing to market the OST-HER2 off-the-shelf immunotherapy cancer vaccine platform for canines with osteosarcoma, and for humans with osteosarcoma and other HER2 positive cancers such as breast cancer and colorectal cancer.

On September 13, 2024 Aurinia Pharmaceuticals Inc. reported that the Company’s management team will attend the 2024 Cantor Fitzgerald Global Healthcare Conference in New York City, September 17-19, 2024 (Press release, Aurinia Pharmaceuticals, SEP 13, 2024, View Source [SID1234646563]).

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Aurinia management will host one-on-one meetings with investors and will participate in a fireside chat and Q&A session on Tuesday, September 17th, at 3:05 PM EDT. A live webcast of the session will be available on the Investor section of Aurinia’s website, which can be found here.

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.