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 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.

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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.

On June 27, 2025 Imugene Limited (ASX: IMU), a clinical-stage immuno-oncology company, reported the first patient dosed in Australia, as part of the investigator sponsored Phase II Neo-POLEM clinical trial (Press release, Imugene, JUN 27, 2025, https://mcusercontent.com/e38c43331936a9627acb6427c/files/4621b5ea-5e19-3f10-0982-51c3e3f18e9e/1st_Patient_Dosed_in_Australia_PD1_Vaxx_neo_POLEM_PhII_Trial.pdf [SID1234654143]).

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Neo-POLEM is a Phase II study investigating the potential of PD1-Vaxx, a neoadjuvant PD-1 vaccine, to improve treatment outcomes for patients with mismatch repair-deficient / microsatellite instability high (dMMR/MSI-high) colorectal cancer. Approximately 15% of patients with colorectal cancer have the dMMR/MSI-high subtype.

The trial is an IST being conducted by Cancer Research UK Southampton Clinical Trials Unit in collaboration with Royal Surrey Hospital NHS Foundation Trust and the Australasian Gastro-Intestinal Trial Group (AGITG).

The primary objective of the study is to determine major pathological response rates, a measure of tumour size reduction post-treatment with PD1-Vaxx before surgery, with secondary objectives to assess the safety of PD1-Vaxx, evaluate biomarkers, and evaluate the objective response rates and overall survival.

This trial builds upon compelling early evidence that immunotherapy can deliver significant benefits in this patient population. The trial will recruit patients in both Australia and the United Kingdom.

Imugene’s CEO and Managing Director Leslie Chong said: "Dosing the first patient in the Neo-POLEM study represents hopeful treatment options for those suffering from these subtypes of colorectal cancer. We are encouraged by the potential of PD1-Vaxx to activate the body’s own immune system to fight cancer in this earliest stage of disease. Our focus remains firmly on improving outcomes for people living with this disease, and we’re grateful to the patients and clinical teams in Australia and the UK who are making this progress possible."

Colorectal cancer (CRC), also known as bowel cancer, is the third most common cancer, with a worldwide annual incidence of more than 1.2 million cases and a mortality rate of approximately 50%. About 80% of patients with colon cancer have localised and resectable disease at diagnosis.