On June 27, 2025 Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, reported its wholly-owned subsidiary T-mab has entered into an agreement with Qilu Pharmaceutical for Albipagrastim alfa for Injection (R&D code: 8MW0511). Under the terms of the agreement, Mabwell will grant Qilu Pharmaceutical exclusive rights to develop, manufacture, improve, utilize and commercialize the licensed product in the Greater China (including Chinese Mainland, Hong Kong, Macau and Taiwan) (Press release, Mabwell Biotech, JUN 27, 2025, View Source [SID1234654161]). T-mab can obtain a total of up to RMB 500 million of upfront payment and sales milestone payment, and the royalty of up to double-digit percentage of net sales of licensed product.

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Albipagrastim alfa for Injection is a recombinant (yeast-secreted) human serum albumin/human granulocyte-colony stimulating factor (I) fusion protein for Injection. It is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

Albipagrastim alfa is a new generation of long-acting G-CSF (highly active modified cytokine) with intellectual property rights of Mabwell, which was developed with albumin fusion platform technology by fusing highly active recombinant G-CSF with human serum albumin (HSA). The modification increases the molecular weight, significantly inhibits the elimination pathway mediated by G-CSF receptor and prolongs the half-life of the drug in vivo, which improves the treatment adherence by reducing the frequency of administration in clinical practice. Compared to PEG-G-CSF, Albipagrastim alfa uses HSA as its natural carrier protein via a Pichia pastoris expression system. This approach offers a simpler production process and superior product homogeneity.

On June 27, 2025 TransThera Sciences Inc. ("TransThera") reported that the translational studies of tinengotinib in CCA with acquired resistance to FGFR inhibitors were published in Annals of Oncology (IF 56.7). Dr. Peng Peng, Vice President at TransThera, serves as the co-first author (Press release, TransThera Biosciences, JUN 27, 2025, View Source [SID1234654162]).

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CCA is an aggressive bile duct cancer often driven by FGFR2 fusion and rearrangement, which are targetable with inhibitors like pemigatinib and futibatinib. However, resistance frequently develops due to acquired FGFR2 mutations. In this paper, multimodal analyses led to a model characterizing the biology of acquired resistance, informing the rational design of next-generation FGFR inhibitors. Novel FGFR inhibitors should be small, high-affinity, and capable of binding to active form of FGFR. The article discloses for the first time the co-crystal structure of tinengotinib with the FGFR2 kinase domain of its unique binding mode, in addition to kinetic studies to illustrate its higher affinity compared to first-generation FGFR inhibitors, in vitro and in vivo activities against clinically acquired FGFR2 resistance mutations, as well as a case report to demonstrate its clinical efficacy. These data demonstrated that tinengotinib is a second-generation FGFR inhibitor meeting all the aforementioned criteria.

Dr. Lipika Goyal, the Director of Gastrointestinal Oncology at the Stanford Cancer Center, who is the principal investigator of the study and correspondence author of the paper, stated, "The study represents a comprehensive analysis of acquired resistance to FGFR inhibitors using circulating tumor DNA, biopsy, rapid autopsy, pharmacokinetic, and in vitro and in vivo data, It represents the largest collection of primary patient data on acquired FGFR resistance, with analysis of nearly 500 clinical samples. Research in rare cancers like CCA relies on the collective efforts of numerous teams working together, and we highly appreciated the translational studies of tinengotinib by TransThera, which validated the principles of developing next-generation FGFR inhibitors highlighted in this publication. We believe this study will be a substantial contribution to the field that will advance our understanding of acquired resistance to FGFR inhibitors."

"We are delighted that TransThera’s discovery be part of the fundamental research in the field of overcoming FGFR refractory. Currently tinengotnib is undergoing a pivotal phase 3 study globally and we hope to bring novel treatment option to CCA patients", commented by Dr. Peng from TransThera.

About Tinengotinib

Tinengotinib is an internally discovered, global phase III multi-kinase inhibitor that exerts antitumor effects by targeting FGFRs and VEGFRs, mitotic kinases Aurora A/B and Janus kinases (JAK). Ongoing clinical trials in the US and China have revealed the potential of tinengotinib to be efficacious in various solid tumors. It was granted the Orphan Drug Designation(ODD) and Fast Track Designation(FTD) by the FDA for the treatment of CCA, the Breakthrough Therapy Designation (BTD) by NMPA in China, the Orphan Drug Designation(ODD) for the treatment of biliary tract cancer by EMA.

On June 27, 2025 Schrödinger, Inc. (Nasdaq: SDGR) reported that SGR-1505, its clinical stage MALT1 inhibitor, was designated as a Fast Track product by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with Waldenström macroglobulinemia that have failed at least two lines of therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor (Press release, Schrodinger, JUN 27, 2025, View Source [SID1234654163]).

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"We are excited to receive Fast Track designation for SGR-1505, which underscores the significant need in patients with Waldenström macroglobulinemia," said Karen Akinsanya, Ph.D., president, head of therapeutics R&D and chief strategy officer, partnerships at Schrödinger. "Despite the continued therapeutic advances in the treatment of hematologic malignancies, treatment failure and disease progression due to BTK resistance remains a challenge for a growing number of patients. This unmet need represents an opportunity for novel mechanisms such as MALT1 as monotherapy and as part of new combination regimens."

"We believe this Fast Track designation in Waldenström macroglobulinemia, combined with our encouraging Phase 1 data across a broad range of relapsed/refractory B-cell malignancies such as chronic lymphocytic leukemia, diffuse large B-cell lymphoma, and marginal zone lymphoma, reinforce the potential of SGR-1505 as a future therapeutic option for patients," said Margaret Dugan, chief medical officer at Schrödinger. "We look forward to discussing our Phase 1 study results and recommended Phase 2 dose with the FDA later this year."

The FDA Fast Track program is designed to facilitate the development and expedite the review of drug candidates to treat serious conditions and fill an unmet medical need. A drug granted Fast Track designation is eligible for multiple benefits, including more frequent meetings and written communications with the FDA, as well as eligibility for Accelerated Approval, Priority Review or Rolling Review, if relevant criteria are met.

SGR-1505 is currently being evaluated in a Phase 1 clinical study as a treatment for patients with relapsed/refractory B-cell malignancies. Initial data were recently presented at the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress and International Conference on Malignant Lymphoma where SGR-1505 was observed to have a favorable safety profile and was well tolerated. Encouraging signs of preliminary efficacy were observed in multiple B-cell malignancy subtypes, including Waldenström macroglobulinemia patients, previously treated with a BTK inhibitor prior to starting SGR-1505.

On August 11, 2023, the FDA granted orphan drug designation to SGR-1505 for Mantle Cell Lymphoma (MCL) based on preclinical data.

About SGR-1505
SGR-1505 is an oral investigational MALT1 inhibitor being evaluated for the treatment of relapsed/refractory B-cell malignancies. MALT1 plays a central role in key signaling pathways that drive cancer cell survival and proliferation, making its location downstream of BTK in the NF-κB signaling pathway an attractive target for the development of novel therapeutics for a potentially broad range of B-cell malignancies. In preclinical studies, SGR-1505 was observed to be highly potent and selective, and has demonstrated anti-tumor activity in preclinical models both as a monotherapy and in combination with BTK and BCL-2 inhibitors. There is also emerging therapeutic rationale supporting MALT1 inhibition as a potential treatment for inflammatory and autoimmune disorders.

SGR-1505 was designed using Schrödinger’s computational platform at scale and was discovered approximately 10 months after the company started its MALT1 program. A Phase 1 study in patients with relapsed/refractory B-cell malignancies is ongoing (NCT05544019).

On June 27, 2025 Sona Nanotech Inc. (CSE: SONA) (OTCQB: SNANF) (the "Company", "Sona"), an oncology-focused life sciences company developing innovative therapies based on its uniquely biocompatible gold nanorod technology, reported that it has received ethics committee approval to proceed with its previously announced early feasibility study of its Targeted Hyperthermia Therapy ("THT") cancer treatment (Press release, Sona Nanotech, JUN 27, 2025, View Source [SID1234654155]).

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Sona CEO David Regan commented, "This ethics committee approval gives us the green light we’ve been waiting for to begin enrolling patients suffering from late-stage melanoma, for whom no other therapy has worked, to participate in our first-in-human clinical trial. Our clinical trial partner will now begin enrolling patients, and we will advise when a first dosing of our THT treatment has occurred. Sona’s CMO, Dr. Carman Giacomantonio, will provide clinical training and will observe the application of THT in the first patients enrolled."

The study is designed to assess safety, tolerability, and preliminary efficacy and will include two treatments of Sona’s THT, one week apart, for patients with advanced melanoma who are on, but have failed to respond to, a standard of care immunotherapy protocol. The study is anticipated to be conducted this summer with an initial read-out of final results expected by September, subject to enrollment rates.

On June 26, 2025 Cidara Therapeutics, Inc. ("Cidara") (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) therapeutics, reported the closing of its underwritten public offering of 9,147,727 shares of its common stock, including the exercise in full by the underwriters of their option to purchase an additional 1,193,181 shares, at a price to the public of $44.00 per share (Press release, Cidara Therapeutics, JUN 26, 2025, View Source [SID1234654141]). The gross proceeds to Cidara from the offering, before deducting underwriting discounts and commissions and offering expenses, were $402.5 million. All of the shares in the offering were sold by Cidara.

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J.P. Morgan, Morgan Stanley, Guggenheim Securities and Cantor acted as joint book-running managers for the offering.

The offering was made pursuant to a shelf registration statement on Form S-3 that was filed with the U.S. Securities and Exchange Commission (the "SEC") on May 8, 2025, and declared effective by the SEC on May 15, 2025. A final prospectus supplement and accompanying prospectus relating to the offering were filed with the SEC and are available for free on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from: J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014, or by email at [email protected]; Guggenheim Securities, LLC Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017 or by telephone at (212) 518-9544, or by email at [email protected]; or Cantor Fitzgerald & Co. by mail at Attention: Capital Markets, 110 East 59th Street, New York 10022 or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, 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.