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TransThera Publishes Translational Studies of Tinengotinib (TT-00420) against Cholangiocarcinoma on Annals of Oncology

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.

Mabwell Announces Novel Drug Technology License Agreement with Qilu Pharmaceutical for Albipagrastim alfa for Injection

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.

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.

Allarity Therapeutics Announces Dosing of Second Patient in New Phase 2 Trial of Stenoparib in Advanced Ovarian Cancer

On June 27, 2025 Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib—a differentiated, dual PARP and WNT pathway inhibitor reported that the second patient has been dosed in its new Phase 2 clinical trial protocol evaluating stenoparib in patients with advanced, recurrent, platinum-resistant or platinum-ineligible ovarian cancer (Press release, Allarity Therapeutics, JUN 27, 2025, View Source [SID1234654160]).

Commenting on the development, Thomas Jensen, Chief Executive Officer of Allarity Therapeutics, stated:

"We are pleased to see the second patient enrolled so soon after the trial’s launch. This pace of enrollment suggests a strong level of engagement from our investigators, who appear highly attuned to the opportunity to explore stenoparib’s potential for patients with few or no remaining treatment options."

This new trial builds on earlier Phase 2 data demonstrating durable clinical benefit and favorable tolerability with twice-daily dosing of stenoparib. It focuses on the platinum resistant patient population for whom current treatment options are extremely limited. Stenoparib may represent a novel, targeted and better-tolerated treatment option for these patients who are typically offered only marginally effective, toxic chemotherapies.

In parallel, this trial will serve to advance Allarity’s proprietary Drug Response Predictor (DRP) companion diagnostic and further evaluate the WNT-modulating mechanism of action unique to stenoparib.

About Stenoparib
Stenoparib is an orally available, small-molecule dual-targeted inhibitor of PARP1/2 and tankyrase 1/2. At present, tankyrases are attracting significant attention as emerging therapeutic targets for cancer, principally due to their role in regulating the WNT signaling pathway. Aberrant WNT/β-catenin signaling has been implicated in the development and progression of numerous cancers. By inhibiting PARP and blocking WNT pathway activation, stenoparib’s unique therapeutic action shows potential as a promising therapeutic for many cancer types, including ovarian cancer. Allarity has secured exclusive global rights for the development and commercialization of stenoparib, which was originally developed by Eisai Co. Ltd. and was formerly known under the names E7449 and 2X-121.

About the Drug Response Predictor – DRP Companion Diagnostic
Allarity uses its drug-specific DRP to select those patients who, by the gene expression signature of their cancer, may have a high likelihood of benefiting from a specific drug. By screening patients before treatment, and only treating those patients with a sufficiently high, drug-specific DRP score, the therapeutic benefit rate may be enhanced. The DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including transcriptomic information from cell lines, combined with clinical tumor biology filters and prior clinical trial outcomes. DRP is based on messenger RNA expression profiles from patient biopsies. The DRP platform has shown an ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients across dozens of clinical studies (both retrospective and prospective). The DRP platform, which may be useful in all cancer types and is patented for dozens of anti-cancer drugs, has been extensively published in the peer-reviewed literature.

Turnstone Biologics Corp. Enters into Agreement to be Acquired by XOMA Royalty
Corporation for $0.34 in Cash Per Share Plus a Contingent Value Right

On June 27, 2025 XOMA Royalty Corporation ("XOMA Royalty") (Nasdaq: XOMA) and Turnstone Biologics Corp. ("Turnstone" or the "Company") (Nasdaq-CM: TSBX) reported that they have entered into a definitive merger agreement ("the Merger Agreement"), whereby XOMA Royalty will acquire Turnstone for $0.34 in cash per share of Turnstone common stock ("Turnstone common stock") plus one non-transferable contingent value right ("CVR") (Press release, Turnstone Biologics, JUN 27, 2025, View Source [SID1234654159]).

Following a thorough review process conducted with the assistance of its legal and financial advisors, the Turnstone Board of Directors has unanimously determined that the acquisition by XOMA Royalty is in the best interests of all Turnstone stockholders and has approved the Merger Agreement and related transactions.

Terms

Pursuant and subject to the terms of the Merger Agreement, XOMA Royalty will commence a tender offer (the "Offer") by July 11, 2025, to acquire all outstanding shares of Turnstone common stock. The closing of the Offer is subject to certain conditions, including the tender of Turnstone common stock representing at least a majority of the total number of outstanding shares, a minimum cash balance at closing, and other customary closing conditions. Immediately following the closing of the tender offer, Turnstone will be acquired by XOMA Royalty, and all remaining shares not tendered in the offer, other than shares validly subject to appraisal, will be converted into the right to receive the same cash and CVR consideration per share as is provided in the tender offer. Turnstone stockholders holding approximately 25.2% of Turnstone common stock have signed support agreements under which such stockholders have agreed to tender their shares in the Offer and support the merger transaction. The merger transaction is expected to close in August 2025.

Advisors

Leerink Partners is acting as exclusive financial advisor and Cooley LLP is acting as legal counsel to Turnstone. Gibson, Dunn & Crutcher LLP is acting as legal counsel to XOMA Royalty.

Titan Pharmaceuticals Announces $600,000 Private Placement of Convertible Preferred Stock

On June 27, 2025 Titan Pharmaceuticals, Inc. (NASDAQ: TTNP) ("Titan" or the "Company") reported that, pursuant to a securities purchase agreement (the "Purchase Agreement") with Blue Harbour Asset Management L.L.C-FZ ("Blue Harbour"), it has completed a private placement of the Company’s newly designated Series C Convertible Preferred Stock (the "Preferred Stock") (Press release, Titan Pharmaceuticals, JUN 27, 2025, View Source [SID1234654158]). Pursuant to the Purchase Agreement, Blue Harbour purchased 60,000 shares of Preferred Stock for an aggregate purchase price of $600,000. The shares have a conversion price of $3.40.

The Certificate of Designations authorizing the Preferred Stock contains a beneficial ownership conversion "blocker" that prevents Blue Harbour from acquiring the lower of either (i) the maximum percentage of common stock permissible under Nasdaq rules and regulations without first obtaining shareholder approval or (ii) 19.99% of the Company’s outstanding common stock.

The shares being sold in this transaction do not involve a public offering and have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), in reliance on Regulation S thereunder. Titan and Blue Harbour have concurrently entered into a registration rights agreement (the "Registration Rights Agreement") pursuant to which Titan has agreed to provide certain registration rights upon the occurrence of certain events set forth in the Registration Rights Agreement. Additional information regarding the agreement can be found in an 8-K that was filed with the SEC: View Source

ARC Group Ltd. served as sole financial advisor to Titan in the private placement.