On January 10, 2025 Verismo Therapeutics, a clinical-stage CAR T company developing novel KIR-CAR platform technology, reported that it has dosed the first patient in its CELESTIAL-301 Phase 1 clinical trial (Press release, Verismo Therapeutics, JAN 10, 2025, View Source [SID1234649610]). The patient was infused at Sarah Cannon Research Institute (SCRI) at Colorado Blood Cancer Institute (CBCI) in Denver, Colorado.

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CELESTIAL-301 aims to assess safety, tolerability, and preliminary efficacy of SynKIR-310 in patients with relapsed/refractory (r/r) B cell Non-Hodgkin Lymphomas (B cell NHL), including Diffuse Large B Cell lymphoma (DLBCL), Follicular Lymphoma (FL), Mantle Cell Lymphoma (MCL), and Marginal Zone Lymphoma (MZL). The Phase 1 multicenter clinical trial is enrolling patients who previously received CAR T therapy but who have since relapsed or become refractory to it as well as patients who never received CAR T therapy.

CELESTIAL-301 trial seeks to address several areas of high unmet medical need. Commercially approved CAR T cell therapies have shown impressive high initial response rates in blood cancers. Over time, however, these therapies result in relapse in an estimated 40-50% of patients1. Such relapses are due in part to lack of long-term T cell effector function and persistence. There are currently very limited treatment options for patients with r/r DLBCL who relapse following treatment with commercial CAR T cell therapies.

SynKIR-310 relies on Verismo’s unique KIR-CAR platform and proprietary CD19 binder (DS191). SynKIR-310 targets CD19, similarly to the commercially approved CAR T therapies, with the added potential of prolonged anti-tumor T cell function and persistence. These KIR-CAR improvements may prevent early disease relapse in patients with advanced B cell lymphomas.

"The initiation of patient dosing in the CELESTIAL-301 trial marks an exciting milestone for Verismo Therapeutics as we advance our mission to develop transformative therapies for patients facing advanced lymphomas. CBCI’s commitment to patients and to conducting novel early-stage clinical trials has allowed us to reach this milestone earlier than expected," according to Dr. Laura Johnson, Chief Operations Officer and Chief Scientific Officer at Verismo Therapeutics. "SynKIR-310 is uniquely designed to prolong T cell functional persistence and combat the challenges of disease relapse, offering a potentially life-saving option for these patients."

"We are thrilled to administer this promising therapy," said Michael Tees, MD, the principal investigator at SCRI at Colorado Blood Cancer Institute (CBCI), where the first patient was dosed. "Emerging treatments like SynKIR-310 have potential to reshape care for patients with advanced lymphomas, offering new hope. This milestone showcases the impact of CBCI and other expert research centers in advancing early-stage clinical trials."

Verismo achieved IND clearance from the FDA in May 2024 to proceed with this multicenter Phase 1 clinical trial investigating SynKIR-310. SynKIR-310 is Verismo’s second clinical pipeline following SynKIR-110 targeting aggressive mesothelin-expressing solid tumors. For more information about the CELESTIAL-301 clinical trial, please visit ClinicalTrials.gov: NCT06544265.

On January 10, 2025 Diakonos Oncology, a clinical-stage biotechnology company leveraging proprietary dendritic cell technology to address critical and unmet therapeutic needs in late-stage and aggressive cancers, reported that it will present its latest developments at the Biotech Showcase in San Francisco, CA from January 13-15, 2025 (Press release, Diakonos Oncology, JAN 10, 2025, View Source [SID1234649609]). Biotech Showcase is a premier event for private and micro-mid-cap biotechnology companies to highlight their innovation and connect with global investors and engage with executives from prominent biopharmaceutical interests.

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Diakonos Oncology will be represented by President and Chief Operating Officer Jay Hartenbach, who will be presenting on recent corporate milestones and research developments, including lead product DOC1021, a unique autologous dendritic cell vaccine (DCV), which will begin enrolling patients in its Phase 2 clinical trial for glioblastoma (GBM) in H1 2025 at leading treatment centers across the US.

Details of the presentation are as follows:

Event: Biotech Showcase 2025
Date: January 15, 2025, at 11:15 a.m. Pacific Standard Time
Location: Hilton San Francisco – Union Square, San Francisco, CA
Track: Yosemite C (Ballroom Level)

"Our unique cellular vaccine product targets the complete tumor antigen profile and induces powerful memory T cell responses against some of the most aggressive cancers," said Mr. Hartenbach. "We are excited to share the latest clinical data, which continues to exceed expectations with ongoing patient survival, and to present our plans for future trials in new indications."

To learn more about the event, please visit https://informaconnect.com/biotech-showcase/ or to schedule one-on-one meetings, please email [email protected].

About DOC1021

DOC1021 is a novel autologous dendritic cell vaccine (DCV) that initiates a potent cytotoxic TH1 immune response against a patient’s cancer through the company’s proprietary double loading technology. This unique approach unlocks a synergistic tumor killing response driven by dual protein and RNA antigen sourcing, and it allows targeting of the complete cancer antigen profile. This approach has demonstrated an excellent safety profile and does not require myelosuppressive preconditioning chemotherapy or high dose IL-2 administration.

In addition to the lead GBM study, DOC1021 is being studied in an ongoing Phase 1 clinical trial for pancreatic ductal adenocarcinoma (PDAC) that will complete enrollment later this year. Diakonos has received Fast Track designations from the FDA for both the GBM and PDAC programs. The company has also received Orphan Drug Designation for the GBM program.

On January 10, 2025 Kazia Therapeutics Limited (NASDAQ: KZIA) ("Kazia" or the "Company"), an oncology-focused drug development company, reported that it has entered into a definitive agreement for the purchase and sale of up to an aggregate of 1,333,333 of the Company’s American Depositary Shares ("ADSs") (or ADS equivalents in lieu thereof), each ADS representing 100 ordinary shares of the Company, at a purchase price of $1.50 per ADS (or ADS equivalent in lieu thereof), in a registered direct offering (Press release, Kazia Therapeutics, JAN 10, 2025, View Source [SID1234649608]). The Company has also agreed to issue, in a concurrent private placement, unregistered warrants to purchase up to an aggregate of 1,333,333 ADSs. The warrants will have an exercise price of $1.50 per ADS, will be immediately exercisable upon issuance, and will expire five and one-half years from the date of issuance. The closing of the offering is expected to occur on or about January 13, 2025, subject to the satisfaction of customary closing conditions.

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Maxim Group LLC is acting as the exclusive placement agent for the registered direct offering and concurrent private placement.

The gross proceeds to the Company from the offering are expected to be approximately $2.0 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering for general corporate purposes, which may include working capital, expenses related to research, clinical development and commercial efforts, and general and administrative expenses.

The securities described above (excluding the warrants and ADSs underlying the warrants) are being offered and sold by the Company in a registered direct offering pursuant to a "shelf" registration statement on Form F-3 (File No. 333-281937) that was originally filed with the Securities and Exchange Commission (the "SEC") on September 5, 2024, and declared effective on September 12, 2024. The offering of such securities in the registered direct offering is being made only by means of a prospectus supplement that forms a part of the effective registration statement. A final prospectus supplement and the accompanying base prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying base prospectus may also be obtained, when available, from Maxim Group LLC at 300 Park Avenue, New York, NY 10022, by phone at (212) 895-3500 or e-mail at [email protected].

The unregistered warrants described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the ADSs representing ordinary shares underlying such warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and the underlying ADSs may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

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

On January 10, 2025 The Menarini Group ("Menarini"), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc. ("Stemline"), a wholly-owned subsidiary of the Menarini Group focused on bringing transformational oncology treatments to cancer patients, and Insilico Medicine ("Insilico"), a clinical stage generative artificial intelligence (AI)-driven biotechnology company, reported that the companies have entered into an exclusive licensing agreement granting Stemline the global rights to develop and commercialize a preclinical small molecule targeting high unmet needs in oncology (Press release, Menarini, JAN 10, 2025, View Source [SID1234649607]).

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The asset is a highly selective and potentially best-in-class small molecule inhibitor targeting a broad range of solid tumor cancers, devel oped with the help of Chemistry42, Insilico’s generative chemistry engine, and Insilico’s drug discovery team. The asset has successfully completed preclinical development and has demonstrated broad anti-tumor activity in selected cancers.

"We are thrilled to enter our second collaboration with Insilico Medicine, a leader in the field of generative AI, for a highly selective and potentially best-in-class small molecule targeting a broad range of cancers," said Elcin Barker Ergun, CEO of the Menarini Group. "This asset will help us enter into new areas of high unmet need, expanding the tumor areas where we can help cancer patients with ground-breaking therapies."

"Our previous experience with Menarini Stemline proved that the company is efficient, agile, strategic, and committed to rapidly delivering the best novel therapeutic solutions to patients with cancer, maximizing the probability of success of the program," said Alex Zhavoronkov, PhD, Founder and CEO of Insilico Medicine. "Menarini Stemline’s strategic visionary management is rapidly re-shaping the field of oncology, and we are very happy to take part in their quest to extend patients’ lives around the world."

Under the terms of the agreement, Stemline will provide a $20 million upfront payment to Insilico. The combined value of the deal, including all development, regulatory, and commercial milestones, is over $550 million, followed by tiered royalties.

Prior to this collaboration, the Menarini Group and Insilico entered an exclusive licensing agreement in January 2024 for MEN2312, an innovative small molecule for breast cancer treatment and other oncology indications.

About MEN2312

MEN2312 was designed by Insilico’s R&D team with the help of its end-to-end Pharma Generative AI platform to inhibit KAT6 and block endocrine receptor (ER) at the transcriptional level, giving it the potential to overcome resistance to endocrine therapies due to mutation or ligand-independent constitutive activation of ER. In preclinical studies, the molecule has demonstrated potent inhibition against KAT6 in multiple CDX and PDX models with good efficacy and safety.

On January 10, 2025 Harbour BioMed (HKEX: 02142, the "Company"), a global biopharmaceutical company committed to the discovery, development and commercialization of novel antibody therapeutics focusing on immune-oncology and immunology, reported that the Company and Sichuan Kelun Biotech BioPharmaceutical (HKEX: 06990, "Kelun-Biotech") have entered into a license agreement with Windward Bio AG ("Windward Bio") for HBM9378/SKB378, an anti-thymic stromal lymphopoietin (TSLP) fully human monoclonal antibody co-developed by Harbour BioMed and Kelun-Biotech (Press release, Harbour BioMed, JAN 10, 2025, View Source [SID1234649606]).

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Under the terms of the agreement, Windward Bio is granted an exclusive license to research, develop, manufacture, and commercialize HBM9378/SKB378 globally, excluding Greater China and several Southeast and West Asian countries. In return, Harbour BioMed and Kelun-Biotech are eligible to receive a total of up to $970 million upfront and milestone payments, as well as tiered royalties ranging from single to double digits on net sales. The $45 million upfront and near-term milestone payments include both cash payment and an equity interest in Windward Bio’s parent company. Furthermore, Harbour BioMed and Kelun-Biotech are eligible to receive additional payments if Windward Bio undergoes a near-term change of control or enters into a sublicense agreement with a third party. All payments under the license agreement shall be paid in equal amounts to Harbour BioMed and Kelun-Biotech.

In connection with the license agreement, Windward Bio announced a $200 million Series A financing round led by OrbiMed, Novo Holdings, and Blue Owl Healthcare Opportunities, along with co-investors SR One, Omega Funds, RTW Investments, Qiming Venture Partners, Quan Capital, and Pivotal bioVenture Partners.

"We are delighted to partner with Windward Bio to advance the development of HBM9378/SKB378, a promising TSLP-targeted fully human antibody with significant potential to address immunological diseases," said Dr. Jingsong Wang, Founder, Chairman & CEO of Harbour BioMed. "This collaboration demonstrates the value of our Harbour Mice technology platform and reflects our commitment to bring transformative treatments to patients worldwide."

About HBM9378/SKB378

HBM9378/SKB378 (now also known as WIN378) is a co-development project jointly conducted by Harbour BioMed and Kelun-Biotech, with both parties equally sharing the global rights. It is a fully human monoclonal antibody targeting TSLP, generated from the two heavy chains and two light chains (H2L2) Harbour Mice platform. It inhibits the TSLP-mediated signaling pathway by blocking the interaction between TSLP and its receptor, which is a well-validated cytokine plays a key role in the development and progression of various immunological conditions, including asthma and chronic obstructive pulmonary disease (COPD). Inhibition of this pathway has shown benefits across multiple inflammatory phenotypes. The antibody’s long half-life optimization and outstanding biophysical properties provide a favorable dosing advantage.

Prior to the execution of the license agreement, Harbour BioMed submitted an Investigational New Drug (IND) application to the Centre for Drug Evaluation of the National Medical Products Administration (NMPA) in China for HBM9378/SKB378 for the treatment of COPD in November 2024. The company has also completed a phase I clinical trial in China under an IND for the treatment of moderate-to-severe asthma.