On December 11, 2025 NanOlogy, LLC, a private clinical-stage oncology company, reported its drug development program aimed at transforming the treatment of diffuse intrinsic pontine glioma (DIPG), an aggressive highly lethal pediatric brainstem tumor. The company is developing Large Surface Area Microparticle (LSAM) Cisplatin for stereotactic intratumoral (IT) administration in this initial indication.

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Plans for Pediatric Clinical Trials

NanOlogy is completing Investigational New Drug (IND) enabling studies required by the U.S. Food and Drug Administration (FDA). Upon completion of these studies, the company plans to submit an IND application for LSAM-Cisplatin to treat malignant neoplasms of the brain including DIPG. Subject to FDA allowance to proceed, NanOlogy aims to initiate a clinical trial in late 2026 to evaluate the safety and response of stereotactic IT administration of LSAM-Cisplatin in children diagnosed with DIPG. According to DIPG.org, DIPG afflicts 150 – 300 children annually in the United States, with median survival of less than one year. Current treatments, like radiation therapy, may delay progression but almost always fail to deliver long term survival. NanOlogy is also assessing future opportunities to extend the use of LSAM-Cisplatin to treat other brain and solid tumors.

The Promise of LSAM-Cisplatin in DIPG

In laboratory research studies, cisplatin has been shown to kill DIPG tumors by binding to DNA and disrupting cell replication, leading to cell death. Unfortunately, current systemically administered cisplatin formulations are associated with numerous severe side effects throughout the body. In addition, cisplatin does not cross the blood brain barrier well, limiting its efficacy in brain tumors, making systemically administered cisplatin a suboptimal treatment for DIPG.

"We believe NanOlogy’s innovative LSAM-Cisplatin investigational drug designed for intratumoral administration can overcome the limitations of current treatment options with highly targeted delivery of drug into the tumor, continuous drug release, and minimal systemic toxicity," said H. Paul Dorman, founder and chairman of NanOlogy. "Advancements in minimally invasive surgical procedures and imaging now allow local delivery of LSAMs to solid tumors virtually anywhere in the body, including the brain. We are excited to advance IT LSAM-Cisplatin for DIPG and explore the promise it may hold for children and families facing this devastating disease."

(Press release, NanOlogy, DEC 11, 2025, View Source [SID1234661381])

On December 11, 2025 Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics, reported the appointment of Rick Fair as Chief Executive Officer and member of the Board of Directors of Enliven, effective December 11, 2025. Sam Kintz, Co-Founder and former Chief Executive Officer of Enliven, will assume a new role as Head of Pipeline, also effective December 11, 2025. The transition plan reflects Enliven’s commitment to the next phase of the Company, including a pivotal Phase 3 trial for ELVN-001 in patients with chronic myeloid leukemia (CML) and its commercialization. Additionally, this transition enables a dedicated focus to develop and potentially advance Enliven’s existing early pipeline assets to the clinic.

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"I am pleased to announce the appointment of Rick Fair as Enliven’s new CEO. Rick has substantial experience bringing late-stage oncology and hematology assets to commercialization. He joins us at a critical time as we plan to initiate a pivotal Phase 3 clinical trial of ELVN-001 in 2026. His expertise adds to Enliven’s ability to design and execute a successful Phase 3 trial and commercialize ELVN-001 to deliver long-term value to our stockholders," said Richard Heyman, Ph.D., Chairman of the Board of Directors.

Mr. Fair has more than 25 years of experience in product development and commercialization, including 20 years with large pharmaceutical companies. He most recently served as President and Chief Executive Officer of Bellicum Pharmaceuticals, a clinical-stage biopharmaceutical company researching novel, controllable cellular immunotherapies for cancers. Prior to leading Bellicum, Mr. Fair served over 10 years with Roche/Genentech in commercial leadership positions of increasing responsibility. Over his last four years at Roche/Genentech, he led the Global Product Strategy Oncology/Hematology group responsible for developing and implementing lifecycle plans for its late-stage and in-market portfolio. During this time, he oversaw the launch of five new therapies and numerous new indications across solid and hematologic tumors, and the commercialization plans for a $23 billion business. Prior to Roche/Genentech, Mr. Fair spent nearly 10 years with Johnson & Johnson where he served in leadership positions in market access and marketing. He holds a B.S. from the University of Michigan and an M.B.A. from Columbia Business School.

"I am very excited to join Enliven as CEO at this important phase and look forward to working with this team to bring ELVN-001 through its Phase 3 trial and to market," said Mr. Fair. "The data generated to date demonstrate that ELVN-001 has the potential to be the best-in-class ATP-competitive inhibitor for the treatment of CML and provide patients with CML a treatment with better efficacy, tolerability and convenience than currently approved therapies."

Dr. Heyman added, "We are extremely grateful to Sam for his significant contributions to Enliven and look forward to his continued work leading our early-stage research programs. As a co-founder and CEO of Enliven, Sam has been instrumental in the early development of ELVN-001 and advancing the program into clinical trials. The Board is excited that Sam will remain engaged with Enliven to lead our existing early pipeline initiatives. Thanks to Sam and the team, we remain well positioned clinically and financially to execute on our next phase of growth."

"We welcome Rick and his deep product development and commercialization experience during this incredibly exciting time," said Mr. Kintz. "I am proud of the team’s achievements to date and remain committed to the long-term success of Enliven and ELVN-001. I am also excited to return to my roots to lead our early pipeline efforts. I started my career as a medicinal chemist, and I am most passionate about the discovery through proof-of-concept stage of drug development. We have ongoing efforts that I believe could further transform Enliven and provide long-term value to our stockholders. I truly believe these leadership changes are best for Enliven’s future. It has been a pleasure serving as Enliven’s CEO, and I am confident that Rick is the right person to lead us through our next chapter."

(Press release, Enliven Therapeutics, DEC 11, 2025, View Source [SID1234661380])

ON December 11, 2025 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported FDA approval to initiate COMPASSION-37/AK104-311 trial, a global multicenter Phase III trial in gastric cancer evaluating cadonilimab, a first-in-class PD-1/CTLA-4 bispecific antibody. The study will compare cadonilimab plus chemotherapy against chemotherapy with or without nivolumab as first-line treatment for HER2-negative, unresectable or metastatic gastric/gastroesophageal junction adenocarcinoma.

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This is the second international registrational study for cadonilimab, following the ongoing trial in immunotherapy-resistant hepatocellular carcinoma. COMPASSION-37 represents a pivotal advancement in cadonilimab’s global development and a concrete step in Akeso’s worldwide strategy, reinforcing its leadership in next-generation immuno-oncology. The company remains committed to its dual-track approach of proprietary development and strategic collaboration, leveraging global resources to accelerate cadonilimab’s international availability and expand accessible treatment options for patients worldwide.

Chemotherapy with or without PD-1 inhibitors, such as nivolumab, represents the international standard of care for advanced gastric cancer. However, the disease exhibits significant heterogeneity. While PD-1 treatment in combination with chemotherapy remains an effective treatment in many gastric cancer patients with high PD-L1 expression (CPS >5), its efficacy is markedly limited in gastric cancer patients with low PD-L1 expression (CPS <5) or negative PD-L1 expression (CPS <1). These low and negative PD-L1 patients constitute well more than half of the total gastric cancer patient population.

In 2024, the FDA narrowed the indication for all approved PD-1 inhibitors in the first-line treatment of advanced gastric cancer, restricting their use to PD-L1-positive patients. Authoritative guidelines, including those from the National Comprehensive Cancer Network (NCCN) and the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper), also prioritize recommending nivolumab-based regimens for patients with PD-L1 CPS ≥5. This underscores that treating advanced gastric cancer in PD-L1 low-expressing and negative patients has become a globally recognized clinical challenge.

In 2024, based on the COMPASSION-15 study results, cadonilimab in combination with chemotherapy was approved in China for the first-line treatment of gastric cancer, demonstrating benefit across all patient populations, including both PD-L1 positive and negative subgroups.

COMPASSION-15 is the only global Phase III clinical study in first-line advanced gastric cancer to have demonstrated survival benefit across all patient populations, irrespective of PD-L1 expression status. In this trial, patients with low PD-L1 expression and those who were PD-L1-negative accounted for as high as 49.8% and 23% of the enrolled population, respectively, significantly exceeding proportions observed in historical studies of its kind. The robust representation of low and negative PD-L1 patients in the study and the effective treatment of these patients validates cadonilimab’s broad-spectrum antitumor efficacy beyond PD-L1 dependency in gastric cancer.

Long-term follow-up data showed that cadonilimab plus chemotherapy significantly reduced the risk of death by 39% in the overall population compared to the control group (OS HR 0.61), regardless of PD-L1 status. In the PD-L1 CPS ≥5 subgroup, the reduction in mortality risk reached 51% (OS HR 0.49). Importantly, even among patients with low PD-L1 expression (CPS <5), a statistically significant 24% reduction in mortality risk was maintained (OS HR 0.76). These results were presented as an oral report at ESMO (Free ESMO Whitepaper) 2025. Earlier interim analysis data from the COMPASSION-15 study had been released as a prominent oral presentation at AACR (Free AACR Whitepaper) 2024, with the full manuscript subsequently published in the Nature Medicine. These results highlight cadonilimab’s potential to elevate the current standard of tumor immunotherapy and address clinical challenges unmet by single-target agents.

(Press release, Akeso Biopharma, DEC 11, 2025, View Source [SID1234661379])

On December 11, 2025 Biohaven Ltd. (NYSE: BHVN) reported that it presented clinical safety and efficacy data for BHV-1510 at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Immuno-Oncology Congress, taking place from December 10-12, 2025, in London, United Kingdom. The presentation highlights Biohaven’s novel next-generation trophoblast cell surface antigen 2 (Trop2) directed antibody drug conjugate (ADC), BHV-1510, in combination with Regeneron’s anti-PD-1 cemiplimab demonstrating efficacy and manageable safety across several tumors.

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At the BHV-1510 dose of 2.5 mg/kg Q3W in combination with cemiplimab, confirmed ORR was 72.7%. Confirmed responses were observed in 3/5 (60%) in NSCLC, 4/4 (100%) in endometrial cancer, which included a complete response, and 1/2 (50%) in urothelial cancer (Fig.1). In all 23 efficacy evaluable participants treated with BHV-1510 in combination with cemiplimab across dose levels, as of the clinical cutoff date (October 10, 2025) the confirmed objective response rate (ORR) was 52.2%, with confirmed objective responses in 6/14 (42.9%) in NSCLC, 4/6 (66.7%) in endometrial cancer, and 1/2 (50%) in urothelial cancer (Fig. 2). A confirmed response was reported in the participant with triple negative breast cancer. The majority of participants had tumor reduction on their first scan, with a median time to response of 11.1 weeks. Participants remain on study at 6 months and beyond, 18 participants continue on the study treatment at time of the clinical cutoff date (Fig.3).

Ida Micaily, M.D., M.S., Principal Investigator and Assistant Professor at Sidney Kimmel Comprehensive Cancer Center at Jefferson stated, "We are excited by this emerging data and the potential synergy of BHV-1510 with cemiplimab. The early responses we are observing in these difficult-to-treat tumors—despite patients having received prior therapies, including other PD-1/PD-L1 agents—are particularly encouraging. We also have patients remaining on therapy beyond six months, suggesting the potential for durable disease control."

In the population studied, the median prior lines of therapy for advanced/metastatic disease were two and the majority (87.1%) had prior PD-(L)1 exposure with 16 participants (51.6%) receiving a PD-(L)1 as the most recent treatment prior to receiving study treatment. The maximum tolerated dose was not reached and only one participant had a dose limiting toxicity of stomatitis (Grade 3) at the 2.75 mg/kg Q3W dose. As of the clinical cutoff date, a total of 31 participants were treated with the combination of BHV-1510 and cemiplimab, with BHV-1510 doses ranging from 2-2.75 mg/kg Q3W and 1.25-1.5 mg/kg D1D8Q3W. Cemiplimab was given at 350 mg Q3W.

Across all doses BHV-1510, was generally well tolerated with a safety profile differentiated from other Trop-2 ADCs. The rate of neutrophil count decrease was low and manageable; all Grade (Grade ≥3), 12.9% (6.5%). Similarly, the rates of treatment emergent diarrhea and alopecia were low; all Grade (Grade ≥3), 6.5% (0) and 9.7% respectively. The most frequent toxicity observed was oral mucositis/stomatitis all Grade (Grade ≥3), 59.1% (22.7%) in the Q3W regimen and all Grade (Grade ≥3), 33.3% (11.1%) in the D1D8Q3W regimen. This is a well-known class effect which is manageable. Importantly, there were no cases of interstitial lung disease, and no participants discontinued treatment due to an adverse event. Treatment emergent SAEs were reported in 4 participants, none of which were related to the study treatment. The pharmacokinetic profile for BHV-1510 was favorable, the unconjugated payload concentration was low with a payload-to-ADC molar ratio < 1%, indicating that ADC was highly stable in the circulation.

Nushmia Khokhar, M.D., Chief Medical Officer of Oncology at Biohaven, commented, "Continued preliminary clinical data with BHV-1510 in patients who have received and progressed on standard-of-care treatment, including prior anti-PD1/PDL1 therapy, are highly encouraging. These findings—together with the early promising efficacy, differentiated safety profile, lack of payload-related toxicity, enabled by our novel TopoIx payload and stable linker technology—underscores the potential for BHV-1510 to move into earlier lines of therapy, in particular with checkpoint inhibitor combinations, for these challenging tumor types."

Poster Presentation Information:

Poster 252P: Phase 1 clinical trial of BHV-1510, a next generation Trop2 ADC, in combination with the PD-1 monoclonal antibody, cemiplimab in patients with advanced solid tumors.
Date/Time: Wednesday, December 10, 2025, 5:15-6:30 pm GMT

The poster will be available on the Posters and Presentations page after the conference at www.biohaven.com.

(Press release, Biohaven Pharmaceutical, DEC 11, 2025, View Source [SID1234661378])

On December 11, 2025 TransCode Therapeutics, Inc. (NASDAQ: RNAZ) and Quantum Leap Healthcare Collaborative ("Quantum Leap") reported a new collaboration to evaluate TransCode’s lead therapeutic candidate TTX-MC138 as part of the Quantum Leap PRE-I-SPY clinical trial platform.

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The PRE-I-SPY program will incorporate TTX-MC138 in a Phase 2a dose-expansion clinical trial enrolling up to 45 patients with colorectal cancer who have completed standard curative-intent therapy and are ctDNA positive. The Phase 2a portion of the trial is planned to begin in the first half of 2026 and will be led by Principal Investigator Dr. Paula Pohlmann of MD Anderson Cancer Center.

This clinical trial aims to evaluate the biological and clinical activity of TTX-MC138 in the Minimal Residual Disease (MRD) setting, where the therapeutic intervention may have the greatest opportunity to improve long-term outcomes. The decision to test TTX-MC138 in patients who have demonstrated a pathological complete response following standard-of-care therapy but have evidence of circulating tumor DNA (ctDNA) is based on the high degree of recurrence in those patients and the lack of effective therapies in that setting. TTX-MC138 offers a therapeutic option in that setting because of the drug’s mechanism of action specifically targeting metastatic disease combined with an excellent safety profile.

"The safety and durable clinical benefit observed in TransCode’s Phase 1a trial with TTX-MC138 provide the basis for TransCode’s decision to proceed with Phase 2a clinical testing", noted Daniel Vlock, MD, TransCode’s Consulting Clinician. "The observed safety profile, coupled with the durability of TTX-MC138’s anti-tumor effects, is particularly encouraging. These findings are consistent with the drug’s mechanism of action and provide a basis for a more rigorous efficacy evaluation. This positions us to potentially intervene earlier in the patient’s disease, offering a new therapeutic option for patients at risk of developing metastatic disease."

"Detecting and treating micrometastatic disease before it becomes visible is one of the biggest unmet challenges in cancer," said Laura Esserman, M.D., co-founder of Quantum Leap, and Professor of Surgery and Radiology at the University of California, San Francisco. "The PRE-ISPY Trial is uniquely positioned to rapidly evaluate agents like TTX-MC138 that may eradicate minimal residual disease and prevent recurrence in colorectal and eventually other cancer. We are excited to collaborate with TransCode to accelerate this program, with the goal of advancing effective, less toxic precision therapies into Phase 2 and beyond—where the potential to truly cure patients exists."

About TTX-MC138

TTX-MC138 is a first-in-class therapeutic candidate designed to inhibit microRNA-10b, or miR-10b, a microRNA widely believed to be critical to the emergence and progression of many metastatic cancers. TransCode’s Phase 1a first-in-human clinical trial achieved its primary safety endpoint and established a recommended Phase 2 dose, as announced at ESMO (Free ESMO Whitepaper) 2025.

(Press release, TransCode Therapeutics, DEC 11, 2025, View Source [SID1234661375])