On June 22, 2025 Harbour BioMed (HKEX: 02142), a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology and oncology, reported a global strategic collaboration with Otsuka Pharmaceutical Co., Ltd. ("Otsuka") to advance BCMAxCD3 bispecific T-cell engagers for the treatment of autoimmune diseases (Press release, Harbour BioMed, JUN 22, 2025, View Source [SID1234654042]).

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Under the terms of the agreement, Otsuka is granted an exclusive license to develop, manufacture, and commercialize HBM7020, a BCMAxCD3 bispecific T-cell engager globally, excluding Greater China (Mainland China, Hong Kong, Macau and Taiwan). In return, Harbour BioMed will receive a total of $47 million in upfront and near-term payments. The company is also eligible for additional payments of up to $623 million upon the achievement of specified development and commercial milestones, as well as tiered royalties on future net sales. This strategic collaboration establishes a foundation for potential future partnerships between the two companies in the T-cell engager area.

"We are delighted to collaborate with Otsuka, a global healthcare leader renowned for its innovative approach to addressing unmet medical needs," said Dr. Jingsong Wang, Founder, Chairman, and CEO of Harbour BioMed. "This collaboration underscores the strength of Harbour BioMed’s proprietary Harbour Mice and HBICE technology platforms, which enable the rapid development of fully human bispecific antibodies with optimized safety and efficacy profiles. By leveraging our unique capabilities, we are well-positioned to advance next-generation biotherapeutics that can make a meaningful difference in patients’ lives worldwide."

Makoto Inoue, President and Representative Director of Otsuka Pharmaceutical, noted, "Otsuka is expanding our development pipeline in the autoimmune disease field by leveraging the antibody drug platform of our subsidiary Visterra, and the small molecule drug discovery platform of our subsidiary Jnana. HBM7020 is expected to demonstrate efficacy in a broad range of autoimmune diseases in which B cells play a major role in disease pathogenesis, and we hope to contribute further to the field of specialized autoimmune diseases and thereby benefit patients."

About HBM7020

HBM7020 is a BCMAxCD3 bispecific antibody generated using Harbour BioMed’s fully human HBICE bispecific technology and Harbour Mice platform. It is designed to crosslink target cells and T cells by binding to BCMA and CD3 on the cell surface, leading to potent T cell activation and targeted cell elimination. By incorporating dual anti-BCMA binding sites for enhanced cell targeting and monovalent-optimized CD3 activity to minimize cytokine release syndrome (CRS), HBM7020 has demonstrated potent cytotoxicity with broad therapeutic potential in both immunological and oncological diseases. In August 2023, HBM7020 obtained IND clearance from the National Medical Products Administration (NMPA) to commence a Phase I trial for cancer in China.

On June 22, 2025 Exelixis, Inc. (Nasdaq: EXEL) reported positive topline results from the STELLAR-303 phase 3 pivotal trial in which zanzalintinib in combination with atezolizumab (Tecentriq) demonstrated a statistically significant improvement in overall survival (OS) versus regorafenib in the intent-to-treat (ITT) population of patients with previously treated non-microsatellite instability (MSI)-high metastatic colorectal cancer (CRC) (Press release, Exelixis, JUN 22, 2025, View Source [SID1234654040]). These topline findings are from the final analysis conducted by the Independent Data Monitoring Committee of one of the dual primary endpoints of the STELLAR-303 phase 3 trial. The trial will proceed to the planned final analysis for the other dual primary endpoint of OS in patients without liver metastases (non-liver metastases, NLM).

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The safety profiles of zanzalintinib in combination with atezolizumab and of regorafenib were generally consistent with what has been previously observed, and no new safety signals were identified.

The ITT population consisted of all randomized patients, regardless of the presence of liver metastases. The NLM subgroup consisted of patients who did not have active liver metastases at baseline as determined by investigator assessment.

"The STELLAR-303 results, which showed a survival benefit with the combination of zanzalintinib and atezolizumab versus regorafenib across all randomized patients with previously treated metastatic colorectal cancer, marks an important first milestone for our zanzalintinib pivotal development program," said Amy Peterson, M.D., Executive Vice President, Product Development & Medical Affairs, and Chief Medical Officer, Exelixis. "We look forward to discussing the findings with regulatory authorities and presenting the detailed results at an upcoming medical conference."

Secondary endpoints of STELLAR-303 include progression-free survival, objective response rate and duration of response in the ITT population and in the NLM subgroup of patients. Exelixis plans to submit detailed results of STELLAR-303 for presentation at an upcoming medical conference.

About STELLAR-303
STELLAR-303 (NCT05425940) is a global, multicenter, randomized, phase 3, open-label study that randomized 901 patients 1:1 to either zanzalintinib (100 mg) in combination with atezolizumab or regorafenib. The study includes patients with previously treated non-MSI-high metastatic CRC. The dual primary endpoints of the study are OS in the ITT population and in the NLM subgroup of patients. Presence of liver metastases at baseline for all enrolled patients was determined by investigator assessment. Secondary endpoints include progression-free survival, objective response rate and duration of response in the ITT population and in the NLM subgroup of patients. More information about the trial is available at ClinicalTrials.gov.

About Zanzalintinib
Zanzalintinib is a third-generation oral tyrosine kinase inhibitor that inhibits the activity of receptor tyrosine kinases implicated in cancer growth and spread, including VEGF receptors, MET, AXL and MER. These receptor tyrosine kinases are involved in both normal cellular function and in pathologic processes such as oncogenesis, metastasis, tumor angiogenesis and resistance to multiple therapies, including immune checkpoint inhibitors. With zanzalintinib, Exelixis sought to build upon its extensive experience with the target profile of cabozantinib, the company’s flagship medicine, while improving key characteristics, including pharmacokinetic half-life. Zanzalintinib is currently being developed for the treatment of advanced solid tumors, including colorectal cancer, kidney cancer, head and neck cancer and neuroendocrine tumors.

Zanzalintinib is an investigational agent that is not approved for any use and is the subject of ongoing clinical trials.

About CRC
CRC is the third most common cancer and the second leading cause of cancer-related deaths in the U.S.1 Approximately 154,000 new cases will be diagnosed in the U.S. with around 53,000 expected deaths from the disease in 2025.1 CRC is most frequently diagnosed among people aged 65-74 and is more common in men and in people of non-Hispanic American Indian/Alaska Native descent.2 Nearly a quarter of CRC cases are diagnosed at the metastatic stage, at which point the five-year survival rate is just 16.2%.2 The liver is the most common site for CRC metastasis. Liver metastases significantly impact survival, with a median five-year survival rate of less than 14% when treated with palliative chemotherapy.

On June 22, 2025 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics ("Molecular Partners" or the "Company") and Orano Med, a clinical-stage radiopharmaceutical company and a pioneer in the development of targeted alpha-particle therapies (TAT) with 212Pb (lead-212), reported the debut of MP0726, its Radio-DARPin candidate targeting mesothelin (MSLN) and will present preclinical data in an oral presentation at the 2025 Annual Meeting of the Society of Nuclear Medicine and Molecular Imaging (SNMMI), taking place June 21-24 in New Orleans, LA, USA (Press release, Molecular Partners, JUN 22, 2025, View Source [SID1234654039]).

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The oral presentation outlines encouraging early preclinical proof-of-concept data showing that MP0726 binds with high affinity and selectivity to the membrane-proximal domain of MSLN without being impacted by shed MSLN. In vivo results in a MSLN tumor model show a favorable biodistribution with substantial uptake of the Radio-DARPin in MSLN-positive tumors, while other organs showed limited accumulation. At 24 hours post injection, tumor accumulation was up to 34%, resulting in a tumor to kidney ratio of up to 4.5.

MP0726 leverages the unique properties of DARPins to selectively bind membrane-bound MSLN, a promising target for ovarian cancer due to its differentiated expression profiles – high in tumor, and lower in healthy tissues. High levels of shed MSLN can act as a decoy receptor and have historically hampered the development of MSLN-targeted therapeutics. MP0726 is being co-developed under Molecular Partners’ strategic partnership with Orano Med.

"Our collaboration with Molecular Partners has been delivering substantial progress in a short time, reflecting the skills, passion and strong complementarity of our teams. This progress highlights the effectiveness of our joint R&D efforts, enabling us to identify and advance differentiated clinical candidates that address important unmet medical needs. With its world-class R&D capabilities, the ownership of a virtually unlimited supply of the starting isotope, and fully-integrated manufacturing supply chain, Orano Med is uniquely positioned to support the development of these important potential new medicines", said Arnaud Lesegretain, CEO of Orano Med.

"We are proud to advance our second Radio-DARPin candidate into development, together with our partner Orano Med, for patients with MSLN expressing cancers. The promising preclinical data indicate a favorable biodistribution profile and highlight the unique approach to targeting MSLN with MP0726," said Patrick Amstutz, Ph.D., CEO of Molecular Partners.

MP0726 represents the second Radio-DARPin program to move into pre-clinical development. The first Radio-DARPin program, MP0712 targeting DLL3, is on track to dosing the 1st patient in a Phase 1 study in the US in the second half of 2025.

Details of the presentation:

Preclinical characterization of a Lead-212 Radio-DARPin Therapeutic to selectively target membrane-bound mesothelin in solid tumors
Date & Time: 24 June 2025; 2:50-3:00 pm CST
Session: SS38 Radiopharmaceutical Oncology – Preclinical and Early Phase (2:30-3:45 pm CST)

About 212Pb-based Radio-DARPins
Molecular Partners’ Radio-DARPin platform is being developed to provide a unique and innovative delivery system for radioactive payloads, with exquisite targeting capabilities of DARPins combined with the optimally balanced safety and tumor killing of 212Pb. DARPins are ideal vectors for efficient delivery of therapeutic radionuclides to solid tumors, while overcoming some historic limitations of radioligand therapy approaches, thanks to their small size as well as high specificity and affinity. Molecular Partners and Orano Med are developing targeted alpha radio-therapeutics against up to ten targets, including the tumor-associated protein Delta-like ligand 3 (DLL3) and mesothelin (MSLN).

On June 20, 2025, Alaunos Therapeutics, Inc. (the "Company") reported to have entered in a securities purchase agreement (the "Securities Purchase Agreement") with certain purchasers identified therein, pursuant to which the Company agreed to issue and sell (i) 338,725 shares of common stock (the "Shares"), par value $0.001 per share of the Company ("Common Stock"), at a purchase price of $3.36 per share; and (ii) 271,674 pre-funded warrants to purchase Common Stock, at a purchase price of $3.359 per share, in a registered direct offering (the "Offering") (Filing, 8-K, Alaunos Therapeutics, JUN 20, 2025, View Source [SID1234654140]).

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The Offering was made pursuant to the Company’s currently effective shelf registration statement on Form S-3 (Registration File No. 333- 266841), which was initially filed with the U.S. Securities and Exchange Commission (the "Commission") on August 12, 2022, as amended by Amendment No. 1 thereto, which was filed with the Commission on August 31, 2025, and was declared effective on September 7, 2022.

The Offering closed on June 24, 2025. The Company intends to use the net proceeds from the Offering for general corporate purposes, which may include among other things, capital expenditures and working capital.

The Securities Purchase Agreement contains customary representations, warranties, covenants, and other agreements by the Company. The foregoing description of the Securities Purchase Agreement is only a summary and is qualified in its entirety by reference to the full text of the Securities Purchase Agreement, which is filed as Exhibit 10.1 to this Current Report on Form 8-K and incorporated by reference in this Item 1.01.

A copy of the opinion and consent of Norton Rose Fulbright US LLP, as legal counsel to the Company, regarding the legality of the issuance and sale of the Offering Shares is attached hereto as Exhibit 5.1 and Exhibit 23.1 to this Current Report on Form 8-K.

This Current Report on Form 8-K is not an offer to sell any securities of the Company and is not soliciting an offer to buy such securities in any state where such offer and sale is not permitted.

On June 20, 2025, Aptose Biosciences Inc., as borrower (the "Company"), reported that it had entered into a loan agreement (the "Loan Agreement") with Hanmi Pharmaceutical Co. Ltd., as lender ("Hanmi") (Filing, 8-K, Aptose Biosciences, JUN 20, 2025, View Source [SID1234654132]). The Loan Agreement is an uncommitted facility for up to US$8.5 million (the "Facility"), administered through multiple advances for the purpose of continued clinical development of a Tuspetinib ("TUS") based triple drug frontline therapy to treat patients with newly diagnosed acute myeloid leukemia (AML), accounts payable with respect of the Company’s TUS related business operations, and general corporate purposes reasonably related to the Company’s TUS related business operations.

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The Facility may be advanced in one or more (but not more than five (5) advances) until December 31, 2025. The Facility is a non-revolving facility, and amounts repaid thereunder may not be reborrowed. No single advance shall be for an amount in excess of US$2,500,000.

The aggregate principal amount of all advances and all accrued and unpaid interest and fees together with all other obligations under the Loan Agreement will be repayable by the Company in full on August 31, 2028. Any unpaid principal amount with respect to each advance shall accrue interest a six percent (6%) per annum.

The proceeds from borrowings under the Loan Agreement will be used by the Company to fund its: (a) TUS related business operations, (b) accounts payable with respect of the Company’s TUS related business operations, and (c) general corporate purposes reasonably related to the Company’s TUS related business operations, in each case, unless the Company has obtained the prior written approval of Hanmi.

The Loan Agreement also contains customary affirmative and negative covenants with respect to the Company, including, among other things, compliance with laws, no change of business, no merger and maintenance of corporate existence, maintenance of insurance, restrictions on the incurrence of loans and guarantees, and other customary covenants. These covenants are subject to a number of limitations and exceptions as provided in the Loan Agreement.

The Company’s obligations under the Loan Agreement are secured by a first ranking security interest over all present and after acquired personal property of the Company and unlimited guarantees by, and first ranking security over all present and after acquired personal property of each of Aptose’s subsidiaries.

Additionally, the Loan Agreement contains customary events of default, insolvency, cessation of production, material adverse effect as well as remedies for credit facilities of this nature.

The description of the Loan Agreement contained in this Item 1.01 is qualified in its entirety by reference to the complete text of the Loan Agreement, a copy of which is filed herewith as Exhibit 10.1, to this Current Report on Form 8-K.