On February 20, 2025 ReCerise Therapeutics Inc. ("ReCerise"), a company committed to research and development of first-in-class therapeutics in oncology, reported to have entered into a research partnership with the National Cancer Centre Singapore ("NCCS") to develop innovative treatments utilizing multi-omics data analyses in hepatocellular carcinoma (HCC) (Press release, ReCerise Therapeutics, FEB 20, 2025, View Source [SID1234650438]).

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This collaboration will be conducted under the PLANet programme (Precision Medicine in Liver Cancer across an Asia-Pacific Network), which was conceptualized and led by NCCS based on the intra-tumoral heterogeneity of liver tumors and its highly dynamic tumor microenvironment (TME). The longitudinal study performs comprehensive multi-omics profiling of tumor and blood samples from liver cancer patients. This collaboration will leverage the processed multi-omics data collected under the PLANet programme, and will be led by Prof. Pierce Chow Kah Hoe, a prominent global expert in the field of HCC. Prof Chow is a Senior Consultant Surgeon in the Division of Surgery and Surgical Oncology at Singapore General Hospital (SGH) and NCCS, and principal investigator of the PLANet programme.

HCC is a highly prevalent cancer with a poor prognosis due to late diagnosis and low response to existing immunotherapeutic treatment options. ReCerise was established with the purpose of investigating and developing new therapeutic modalities to address such unmet medical needs. So far, basic research and proof-of-concept studies on a liver specific protein have demonstrated promise as a potential solution. ReCerise hopes to expand upon this background knowledge by utilizing real-life evidence in collaboration with NCCS to investigate an HCC patient cohort and confirm the target’s expression and its effect on the liver microenvironment.

"We are excited to collaborate with NCCS to accelerate the development of an innovative new drug for the treatment of liver cancer that ReCerise has been working toward," said Yong-Bae Kim, CEO of ReCerise Therapeutics. "Through this joint research, we plan to conduct multi-faceted studies on the development potential of RCT1213, a hepatocellular carcinoma treatment candidate currently under development, by utilizing the various omics data and research database of Asian HCC patients at NCCS."

The research collaboration between these two parties is a research and development project funded by the Korean government and is subject to the management and supervision of the Korea Evaluation Institute of Industrial Technology (KEIT).

On February 20, 2025 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported expansion of its oncology pipeline portfolio through the acquisition of assets relating to a next-generation oncolytic virus ICVB-1042 from IconOVir Bio, Inc. (IconOVir) (Press release, UroGen Pharma, FEB 20, 2025, View Source [SID1234650421]). In addition, UroGen also announced that it has entered into multiple strategic research collaborations to explore the potential of its proprietary RTGel technology to enhance clinical effectiveness of multiple immunotherapies, including optimizing dwell time to improve treatment outcomes.

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"UroGen’s long-term growth strategy is built on advancing our uro-oncology pipeline, expanding our portfolio, and driving innovation in cancer treatment," said Liz Barrett, President and Chief Executive Officer of UroGen. "The acquisition of ICVB-1042, a next-generation investigational oncolytic virus, marks a significant milestone in our plan to develop novel, locally administered therapies for bladder cancer and other specialty cancers. This strategic investment underscores our commitment to identifying and advancing high-impact therapies that address critical unmet needs. Through targeted acquisitions and research collaborations, we are strengthening UroGen’s leadership in oncology and laying the foundation for sustained innovation and growth."

The use of biological agents to treat bladder cancer has its roots in the development of Bacillus Calmette-Guérin (BCG) therapy. Much like BCG therapy, ICVB-1042 is being developed to activate the immune system within the tumor microenvironment, but unlike BCG therapy, ICVB-1042 has the potential to selectively destroy cancer cells while retaining potency and trigger a robust immune response. A fusion of potency and cancer cell destruction would mark a groundbreaking step forward, unlocking new possibilities in the fight against cancer.

"The treatment of bladder cancer has long been shaped by immunological approaches such as BCG therapy. UroGen now seeks to advance bladder cancer treatment with highly targeted, next-generation viral immunotherapies like ICVB-1042," said Mark Schoenberg, M.D., Chief Medical Officer of UroGen. "ICVB-1042 may represent an exciting leap forward, with several attributes we believe differentiate this asset from other oncolytic viruses. Supported by a robust non-clinical data package, we are eager to develop this investigational therapy as a potential new treatment in localized cancer."

Asset Purchase

On February 14, 2025, UroGen acquired certain assets of IconOVir, including product candidate ICVB-1042, and assumed certain liabilities and obligations of IconOVir arising under certain acquired contracts. As consideration for the assets, UroGen issued IconOVir 374,843 of its ordinary shares (representing a value of approximately $4.0 million based on 30-day VWAP), agreed to pay IconOVir a one-time payment of $15.0 million in cash upon the achievement of a cumulative aggregate worldwide net sales milestone for all products, including combination products, that incorporate or comprise ICVB-1042 (ICVB Products), and agreed to pay IconOVir a certain low, single-digit percentage royalty on a ICVB Product-by-ICVB Product basis on annual worldwide net sales of such ICVB Product.

Conference Call & Webcast Information

Members of UroGen’s management team will host a live conference call and webcast today at 12:00 PM ET to discuss the Company’s long-term growth strategy. The live webcast can be accessed by visiting the Investors section of the Company’s website at View Source Please connect at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast.

On February 20, 2025 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, reported multiple oral and poster presentations, including an oral presentation of additional analyses from the ongoing Phase 2 RAMP 201 (ENGOT-ov60/GOG-3052) trial evaluating the investigational combination of avutometinib plus defactinib in patients with recurrent low-grade serous ovarian cancer (LGSOC), at the Society of Gynecologic Oncology (SGO) 2025 Annual Meeting on Women’s Cancer, to be held on March 14-17 in Seattle, Washington (Press release, Verastem, FEB 20, 2025, View Source [SID1234650424]). Verastem will also have an exhibition booth (#622) at the meeting where it will be available to discuss its ongoing cancer research.

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"The presentation of the RAMP 201 primary analysis, which served as the basis of the acceptance of our NDA that is under Priority Review with the FDA, includes additional subgroup analysis by KRAS mutational status," said Dan Paterson, president, and chief executive officer of Verastem Oncology. "We look forward to sharing these learnings with many of the world’s leading gynecologic oncologists at SGO as part of our continued commitment to people living with recurrent low-grade serous ovarian cancer. We also recognize the importance of these findings to the broader cancer community as part of our growing pool of data reinforcing the potential to change expectations in managing RAS/MAPK pathway-driven cancers."

Oral Presentation:

Abstract Title: Avutometinib + Defactinib in Recurrent Low-Grade Serous Ovarian Cancer (ENGOT-ov60/GOG-3052/RAMP 201): Dose Intensity and Subgroup Analysis
Presenter: Rachel Grisham, M.D.
Session: Focused Forum XV: Ongoing IMPACT
Date/Time: Monday, March 17, 2025, 9:15 am PST
Oral Presentation​ – Investigator-Sponsored Trial:

Abstract Title: A Phase II Study of Avutometinib and Defactinib in Advanced or Recurrent Gynecologic Mesonephric Cancer: Interim Results
Presenter: Rachel Grisham, M.D.
Session: Focused Forum IV: Finding IMPACT: The Needle in the Haystack​
Date and Time: Saturday, March 15, 2025, 4:15 pm PST
Preclinical Virtual Poster​:

Abstract Title: Preclinical Efficacy of the Estrogen Receptor Degrader Fulvestrant in Combination with RAF/MEK clamp Avutometinib and FAK Inhibitor in Low-Grade Serous Ovarian Cancer with Acquired Resistance to Chemotherapy and Aromatase Inhibitor
Study Author: Cem Demirkiran, M.D.
About the Avutometinib and Defactinib ​​Combination

Avutometinib is an oral RAF/MEK clamp that potently inhibits MEK1/2 kinase activities and induces inactive complexes of MEK with ARAF, BRAF, and CRAF, potentially creating a more complete and durable anti-tumor response through maximal RAS/MAPK pathway inhibition. In contrast to currently available MEK-only inhibitors, avutometinib blocks both MEK kinase activity and the ability of RAF to phosphorylate MEK. This unique mechanism allows avutometinib to block MEK signaling without the compensatory activation of MEK that appears to limit the efficacy of the MEK-only inhibitors.

Defactinib is an oral, selective inhibitor of focal adhesion kinase (FAK) and proline-rich tyrosine kinase-2 (Pyk2), the two members of the focal adhesion kinase family of non-receptor protein tyrosine kinases. FAK and Pyk2 integrate signals from integrin and growth factor receptors to regulate cell proliferation, survival, migration, and invasion. FAK activation has been shown to mediate resistance to multiple anti-cancer agents, including RAF and MEK inhibitors.

Verastem Oncology is currently conducting clinical trials with avutometinib with and without defactinib in RAS/MAPK-driven tumors as part of its Raf And Mek Program or RAMP. Verastem is currently enrolling patients and activating sites for RAMP 301 (GOG-3097/ENGOT-ov81/NCRI) (NCT06072781), an international Phase 3 confirmatory trial evaluating the combination of avutometinib and defactinib versus standard chemotherapy or hormonal therapy for the treatment of recurrent low-grade serous ovarian cancer (LGSOC).

Verastem was granted Priority Review and a Prescription Drug User Fee Act (PDUFA) date of June 30, 2025, for its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), for the investigational combination of avutometinib and defactinib in adults with recurrent KRAS mutant LGSOC who received at least one prior systemic therapy. Verastem initiated a rolling NDA in May 2024 to the FDA and completed its NDA submission in October 2024. The FDA granted Breakthrough Therapy Designation for the treatment of patients with recurrent LGSOC after one or more prior lines of therapy, including platinum-based chemotherapy, in May 2021. Avutometinib alone or in combination with defactinib was also granted Orphan Drug Designation by the FDA for the treatment of LGSOC.

Verastem Oncology has established a clinical collaboration with Amgen to evaluate LUMAKRAS (sotorasib) in combination with avutometinib and defactinib in both treatment-naïve patients and in patients whose KRAS G12C mutant non-small cell lung cancer progressed on a G12C inhibitor as part of the RAMP 203 trial (NCT05074810). Verastem has received Fast Track Designation from the FDA for the triplet combination in April 2024. RAMP 205 (NCT05669482), a Phase 1b/2 clinical trial evaluating avutometinib and defactinib with gemcitabine/nab-paclitaxel in patients with front-line metastatic pancreatic cancer, is supported by the PanCAN Therapeutic Accelerator Award. FDA granted Orphan Drug Designation to the avutometinib and defactinib combination for the treatment of pancreatic cancer.

On February 19, 2025 AnaptysBio presented tis corporate presentation (Presentation, AnaptysBio, FEB 19, 2025, View Source [SID1234650385]).

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On February 19, 2025 Gilead Sciences, Inc. (Nasdaq: GILD) reported that its executives will be speaking at the following investor conferences (Press release, Gilead Sciences, FEB 19, 2025, View Source [SID1234650386]):

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TD Cowen Annual Health Care Conference on Tuesday, March 4 at 11:10 AM Eastern Time
Leerink Partners Global Healthcare Conference on Tuesday, March 11 at 10:40 AM Eastern Time

The live webcasts can be accessed at the company’s investors page at investors.gilead.com. The replays will be available for at least 30 days following the presentation.