On October 14, 2025 Circle Pharma, Inc., a clinical-stage biopharmaceutical company pioneering next-generation targeted macrocycle therapeutics for cancer, reported an upcoming poster presentation highlighting the preclinical anti-tumor potential of cyclin D1 RxL inhibition at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), being held from October 22 – 26, 2025, in Boston, MA.

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Details of the presentation are as follows:

Title: First-in-class Oral Macrocyclic Cyclin D1-selective Inhibitors Demonstrate Anti-Tumor Activity in Cyclin D1-dependent Tumors

Session: Poster Session A

Date & Time: Thursday, October 23, 12:30-4:00 p.m. ET

About Circle Pharma’s Oral Cyclin D1 RxL Inhibitor Program

Cyclin D1 is overexpressed in certain solid tumors and hematologic malignancies. In these cancers, the cyclin D1/CDK4 complex drives cell proliferation by binding to the tumor suppressor retinoblastoma protein (Rb) and promoting its phosphorylation and inactivation. Using its MXMO platform, Circle Pharma has developed oral macrocyclic inhibitors that potently and selectively disrupt the cyclin D1-Rb interaction, demonstrating robust anti-tumor activity in cyclin D1-driven cancers.

(Press release, Circle Pharma, OCT 14, 2025, View Source [SID1234656633])

On October 14, 2025 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, reported encouraging interim data from its ongoing phase 1b clinical trial of CAN-3110 (linoserpaturev) in recurrent glioblastoma, and a publication in the high-impact scientific journal Science Translational Medicine.

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The research detailed in the publication "Serial Multiomics Uncovers Anti-Glioblastoma Responses Not Evident by Routine Clinical Analyses," published on October 8, 2025 (link to abstract), was led by E. Antonio Chiocca, M.D., Ph.D., Executive Director of the Center for Tumors of the Nervous System at the Mass General Brigham Cancer Institute, as part of the multi-institutional Break Through Cancer Accelerating GBM Therapies Through Serial Biopsies TeamLab.

The publication presents findings from the comprehensive analysis of 97 serial tumor biopsies collected from two patients treated with repeated administrations of CAN-3110 in Cohort C of the ongoing phase 1b clinical trial (NCT03152318). By integrating multi-omic datasets with conventional histology and standard-of-care brain magnetic resonance imaging (MRI), the study revealed a discordance between immune biomarkers and histologic evidence of response on the one hand and imaging results on the other. Biopsy analyses demonstrated that CAN-3110 induced dynamic spatial and temporal remodeling of the tumor microenvironment, where tumor cells are replaced by immune cells. In one of the two patients, this process resulted in a complete pathological response. Interestingly, immune infiltration leads to an apparent increase in tumor size on MRI, which may be mistakenly interpreted as disease progression. These results underscore the limitations of conventional imaging in evaluating the response to viral immunotherapy and highlight the importance of overall survival (OS) data, supported by histology.

Among the key discoveries, the investigators reported the expansion of novel tissue-resident effector memory T cell clonotypes specifically targeting CAN-3110 epitopes, together with the expression of HLA-presented immunopeptides, including cancer-associated antigens. These findings provide evidence for both viral- and tumor-specific immune activation after intra-tumoral injection of CAN-3110.

"These data unveil a critical limitation in glioblastoma clinical trials, demonstrating our inability to accurately assess efficacy of immunotherapies using conventional imaging," said Dr. Chiocca, the principal investigator of the clinical trial. "Through sophisticated analysis of serial biopsy samples, we showed that CAN-3110 can transform the tumor microenvironment. For the first time, we identified T cell clonotypes, specifically reactive against oncolytic HSV viral epitopes, alongside evidence for an antitumoral response, providing support for the dual mechanism of action of CAN-3110."

The Company today also reported updated survival data for all patients enrolled in the phase 1b clinical trial of CAN-3110 in rHGG. Updated median OS (mOS) was 11.8 months (CI: 8.3–14.9) for arm A (n = 41) and 12.0 months (CI: 10.0–NA) for arm B (n = 9), respectively, after a single injection of CAN-3110, consistent with previously reported data for arms A and B. At the time of data cutoff (8/15/2025), one patient from arm A and one patient from arm B were still alive after prolonged follow-up (59.2 and 42.4 months, respectively, after CAN-3110 administration).

At the time of data cutoff, 9 patients in arm C had received multiple administrations of CAN-3110. At the 1×10⁸ PFU dose, 3 patients received 4 injections, 1 patient received 5 injections, and 2 patients received 6 injections. At the 1×10⁷ PFU dose, 1 patient received 4 injections, and 2 patients received 5 injections. Median follow-up was 8.9 months. Four out of 9 patients were alive at time of data cutoff (range 3.1-28.2 months after initiation of CAN-3110 treatment). Five patients had died, of which 3 died more than one year after initiation of CAN-3110 treatment (range 5.5-21.8 months). With a short follow up time for the most recently dosed patients and 2 additional patients still to be enrolled in arm C, we expect to present mature mOS data and an update on long-term survivors in Q4 2026. Of importance for the study design of a potential pivotal trial, there was no clear-cut evidence that > 4 injections resulted in better clinical outcomes than 4 injections, suggesting that a larger number of CAN-3110 administrations may not be required to achieve optimal efficacy.

"Glioblastoma is among the most difficult cancers to treat, with an expected median overall survival of less than 6 to 9 months in recurrent glioblastoma. The promising data presented today highlight the transformational potential of CAN-3110 in this indication, with OS in individual patients substantially exceeding historical benchmarks," said Francesca Barone, M.D., Ph.D., Chief Scientific Officer of Candel. "These results support the notion that CAN-3110 could uniquely reprogram the cold, immunosuppressive tumor microenvironment, associated with extended survival."

"The encouraging results with CAN-3110 in recurrent glioblastoma strengthen our confidence in the potential of our viral immunotherapy platform to address one of the most devastating cancers," said Paul Peter Tak, M.D., Ph.D., FMedSci, President and Chief Executive Officer of Candel. "The observed clinical benefit, together with evidence of immune activation in the tumor microenvironment, supports our plans to design a small phase 2 clinical trial of CAN-3110 in recurrent glioblastoma, working closely with investigators, the glioblastoma community, and regulators; CAN-3110 has previously received FDA Fast Track Designation and Orphan Drug Designation for the treatment of recurrent high-grade glioma."

About CAN-3110

CAN-3110 (linoserpaturev) is a first-in-class, replication-competent herpes simplex virus-1 (HSV-1) next-generation oncolytic viral immunotherapy candidate designed for dual activity for oncolysis and immune activation in a single therapeutic. CAN-3110 is being evaluated in a phase 1b clinical trial in patients with rHGG. In October 2023, the Company announced that Nature published results from this ongoing clinical trial. CAN-3110 was generally well tolerated with no dose-limiting toxicity reported. In the clinical trial, the investigators observed improved mOS compared to historical controls after a single CAN-3110 injection in this therapy-resistant condition.1 The Company and academic collaborators are currently evaluating the effects of repeat CAN-3110 injections in rHGG, supported by the Break Through Cancer foundation.

(Press release, Candel Therapeutics, OCT 14, 2025, View Source [SID1234656577])

On October 14, 2025 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that it will host an analyst and investor event focused on lacutamab, an asset with path to potential Accelerated Approval based on existing long-term follow-up data of the Phase 2 TELLOMAK study, providing both clinical perspectives and market outlook. The event will be held in person and virtually on Tuesday, October 28, 2025, from 8:00 a.m. to 10:00 a.m. ET / 1:00 p.m. to 3:00 p.m. CET, at the Park Terrace Hotel on Bryant Park in New York.

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The program will feature Pierluigi Porcu, M.D., Division Chief for Hematology and BMT at University of Kentucky, Lexington, a world expert in T-cell lymphomas, who will provide medical perspectives on results from the Phase 2 TELLOMAK trial, which evaluated lacutamab in patients with relapsed or refractory (R/R) cutaneous T-cell lymphoma (CTCL). ZS Associates, leading experts in life sciences and healthcare markets, will describe the eligible U.S. cutaneous T-cell lymphoma patient population based on real-world claims data. Finally, Innate Pharma’s management will provide updates on the planned Phase 3 trial, regulatory pathway in CTCL, including path to potential accelerated approval in Sézary syndrome, and commercial opportunity for lacutamab.

"We look forward to engaging with the investor community in New York to share the latest updates and perspectives on lacutamab, a product which has the potential to meaningfully improve outcomes and quality of life for CTCL patients with high unmet medical needs while creating significant value for shareholders," said Jonathan Dickinson, Chief Executive Officer of Innate Pharma. Supported by strong TELLOMAK Phase 2 results, lacutamab is positioned for accelerated approval in Sézary syndrome once the confirmatory study in CTCL is underway. New real-world data showing a larger eligible CTCL population in the U.S. than previously reflected in public data further reinforce our commitment to advancing lacutamab for patients, with the confirmatory Phase 3 protocol nearing completion."

About Pierluigi Porcu, M.D.

Pierluigi Porcu, M.D. is the Ewa Marciniak Endowed Chair Professor and Division Chief for Hematology and Blood and Marrow Transplantation (Hem BMT) at the University of Kentucky College of Medicine, and Associate Director for Clinical Translation for the UK Lucille P. Markey Comprehensive Cancer Center. Dr. Porcu is an NCI-funded physician scientist and an internationally recognized expert in clinical and translational research in T-cell lymphoma. He is a former President of the United State Cutaneous Lymphoma Consortium (USCLC), and a member of the board of directors of the International Society of Cutaneous Lymphomas (ISCL). Dr. Porcu has served as global coordinating investigator or chair on numerous advisory boards and clinical trial steering committees.

Dr. Porcu earned his medical degree from the University of Torino in Italy and completed a residency in internal medicine and a fellowship in hematology-oncology at Indiana University in Indianapolis. From 1999 to 2015, he was a faculty in the Division of Hematology at The Ohio State University. From 2016 to 2025 he served as Professor and Division director of Hematologic malignancies and hematopoietic stem cell transplantation in the Department of Medical Oncology at Thomas Jefferson University in Philadelphia.

About lacutamab

Lacutamab is a first-in-class anti-KIR3DL2 antibody, developed in cutaneous T-cell lymphoma (CTCL) and peripheral T-cell lymphoma (PTCL). CTCL is a group of rare non-Hodgkin lymphomas that develop in the skin and severely affect patients’ quality of life. Sezary syndrome (SS) is a rare and aggressive leukemic form with poor survival, while mycosis fungoides (MF) is the most common subtype, with advanced stages associated with poor outcomes.

Data from the Phase 2 TELLOMAK trial in CTCL demonstrated durable activity, a favorable safety profile, and improvements in patients’ quality of life. FDA provided encouraging initial feedback on Innate Pharma’s proposed regulatory pathway, which could potentially include Accelerated Approval for Sézary syndrome.

The program has received Fast Track designation from the FDA, PRIME designation from the EMA for SS, and Orphan Drug designation in both the US and EU for CTCL. More recently, it has received Breakthrough Therapy Designation for SS.

A Phase 3 in CTCL is under preparation.

(Press release, Innate Pharma, OCT 14, 2025, View Source [SID1234656665])

On October 14, 2025 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, reported it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for relacorilant to treat patients with platinum-resistant ovarian cancer.

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Corcept’s MAA submission is based on positive data from its pivotal Phase 3 ROSELLA and Phase 2 trials. In these trials, patients who received relacorilant plus nab-paclitaxel experienced improved progression-free and overall survival compared to patients who received nab-paclitaxel monotherapy, with no need for biomarker selection. Relacorilant was well-tolerated, consistent with its known safety profile. Importantly, the type, frequency and severity of adverse events in the combination arms were comparable to those in the nab-paclitaxel monotherapy arms. Relacorilant conferred its benefit without increasing the safety burden of the patients who received it.

The U.S. Food and Drug Administration (FDA) is reviewing Corcept’s application to market relacorilant in the United States to treat patients with platinum-resistant ovarian cancer. The FDA’s Prescription Drug User Fee Act (PDUFA) target action date is July 11, 2026.

"Our MAA submission brings us a step closer to our goal of delivering relacorilant to patients with platinum-resistant ovarian cancer," said Joseph Belanoff, M.D., Corcept’s Chief Executive Officer. "Better treatment options are urgently needed. Relacorilant has the potential to redefine how platinum-resistant ovarian cancer is treated."

About Relacorilant

Relacorilant, an oral therapy, is a selective glucocorticoid receptor (GR) antagonist that modulates cortisol activity by binding to the GR but not to the body’s other hormone receptors. Corcept is developing relacorilant in ovarian cancer and a variety of other serious disorders, including endogenous hypercortisolism and prostate cancer. Relacorilant is proprietary to Corcept and is protected by composition of matter, method of use and other patents. It has been designated an orphan drug by the FDA and the European Commission (EC) for the treatment of hypercortisolism and by the EC for the treatment of ovarian cancer. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of December 30, 2025 for relacorilant as a treatment for patients with hypercortisolism, and a PDUFA date of July 11, 2026 for relacorilant as a treatment for patients with platinum-resistant ovarian cancer.

About Cortisol’s Role in Oncology

Cortisol plays a role in tumor growth through several mechanisms. It helps solid tumors resist chemotherapy by inhibiting cellular apoptosis — the tumor-killing effect chemotherapy is meant to stimulate. In some cancers, cortisol promotes tumor growth by activating oncogenes in the cells to which it binds. Cortisol also suppresses the body’s immune response, which weakens its ability to fight all diseases, including cancer.

About Platinum-Resistant Ovarian Cancer

Ovarian cancer is the fifth most common cause of cancer death in women. Patients whose disease returns less than six months after receiving platinum-containing therapy have "platinum-resistant" disease. There are few treatment options for these women. Median overall survival following recurrence is approximately 12 months with single-agent chemotherapy. Approximately 20,000 women with platinum-resistant disease are candidates to start a new therapy each year in the United States, with at least an equal number in Europe.

(Press release, Corcept Therapeutics, OCT 14, 2025, https://ir.corcept.com/news-releases/news-release-details/corcept-submits-marketing-authorization-application-european [SID1234656635])

On October 14, 2025 Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), an oncology company developing innovative, full-length multispecific antibodies and antibody drug conjugates (Biclonics, Triclonics and ADClonics), reported initial interim clinical data as of an April 28, 2025 data cutoff from the ongoing phase 2 trial of the bispecific antibody petosemtamab in combination with standard of care FOLFOX/FOLFIRI in 1L, 2L metastatic CRC (mCRC) and petosemtamab monotherapy in 3L+ mCRC. Updated data will be presented in a plenary session oral presentation by Dr. Moh’d Khushman M.D., Washington University School of Medicine, St. Louis, MO at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) on Friday, October 24 at 10:20 a.m. ET.

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"We are encouraged by these early data indicating the promise of petosemtamab to combine safely with chemotherapy, and its potential to benefit a wide range of cancer patients that have metastatic colorectal cancer," said Bill Lundberg, M.D., President, Chief Executive Officer of Merus. "We look forward to providing a more mature clinical update of a larger cohort of patients from a later cutoff date in our plenary session oral presentation."

Petosemtamab (MCLA-158: EGFR x LGR5 Biclonics):

Presentation title: Petosemtamab (MCLA-158) monotherapy or with chemotherapy in metastatic colorectal cancer: Preliminary antitumor activity and safety data from a phase 2 trial

Observations in the abstract include:

As of an April 28, 2025 data cutoff date:

36 patients (pts) with left- and/or right-sided, KRAS, NRAS, and BRAF wildtype microsatellite stable mCRC received petosemtamab 1500 mg Q2W, in combination with FOLFOX/FOLFIRI or as monotherapy
Pts treated in 1L or 2L had no prior anti-EGFR therapy
Pts treated in 2L received 1 prior chemotherapy regimen in the metastatic setting
Pts treated in 3L+ received at least 2 prior regimens in the metastatic setting, including a prior anti-EGFR therapy
1L petosemtamab with FOLFOX/FOLFIRI
7 pts were treated in 1L (6 FOLFOX and 1 FOLFIRI), with 6 ongoing
3 pts were efficacy evaluable, with median follow up of 2.6 months
1 unconfirmed complete response and 2 partial responses (PR; 1 unconfirmed) observed
2L petosemtamab with FOLFOX/FOLFIRI
10 pts were treated in 2L (1 FOLFOX and 9 FOLFIRI), with 8 ongoing
8 were efficacy evaluable, with median follow up of 3.4 months
4 PRs (2 unconfirmed), 3 stable diseases (SD; all ongoing) and 1 clinical deterioration prior to first scan
All unconfirmed responses in 1L and 2L were continuing on therapy without disease progression
3L+ petosemtamab monotherapy:
19 pts were treated, with 12 pts ongoing
14 were efficacy evaluable, with median follow up 2.5 months,
1 unconfirmed PR ongoing without disease progression, 6 SDs (all ongoing), 6 progressive diseases and 1 death unrelated to treatment prior to first scan observed
Petosemtamab safety:
No fatal treatment-related TEAEs observed in each cohort
Petosemtamab plus FOLFOX:
Most frequent treatment-emergent adverse events (TEAEs) regardless of causality (all Grades [G]/G3) were dermatitis acneiform (71%/0%), constipation (43%/0%), fatigue (43%/0%), and peripheral neuropathy (43%/0%)
Petosemtamab plus FOLFIRI:
Most frequent TEAEs regardless of causality (all G/G3) were diarrhea (70%/0%), mucosal inflammation (50%/10%), and fatigue (40%/0%)
Petosemtamab monotherapy:
Most frequent TEAEs regardless of causality (all G/G3) were rash (58%/0%), and nausea (26%/0%)
Presentations:
Title: Petosemtamab (MCLA-158) monotherapy or with chemotherapy in metastatic colorectal cancer: Preliminary antitumor activity and safety data from a phase 2 trial
Session Title: Plenary Session 4: Clinical Trials Plenary Session
Date and Time: Friday, October 24, 10:20 a.m. ET
The same data will also be available in a poster:
Session Title: Poster Session B
Session Date and Time: Friday, October 24, 12:30-4:00 p.m. ET The full presentations are planned to be available on the Merus website at the start of each session.

(Press release, Merus, OCT 14, 2025, View Source [SID1234656650])