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 that it has entered into a five-year, $130 million term loan facility with Trinity Capital Inc. (Nasdaq: TRIN) ("Trinity Capital").

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The loan facility consists of four tranches, with the first tranche of $50 million drawn upon closing of the agreement. The second and third tranches totaling $50 million in the aggregate are available to be drawn subject to the achievement of certain regulatory, clinical and operational milestones, subject to certain conditions precedent described in the agreement, and the fourth tranche of $30 million is available at the lender’s discretion. Interest is payable on the outstanding principal amount at a fixed or floating rate at the Company’s option, initially 10.25% per annum. The loan facility has a five-year term with an interest-only period of 36 months, which is extendable for an additional 12 months upon achievement of a certain commercial milestone. The loan facility contains customary representations, warranties, covenants, and events of default.

"This strategic financing, combined with our cash and cash equivalents of $87.2 million, as of September 30, 2025, significantly strengthens our balance sheet, positioning the Company for the initiation of a pivotal phase 3 clinical trial of CAN-2409 in NSCLC in Q2’26, and supporting the Company through its potential launch in early localized prostate cancer and into commercialization," commented Charles Schoch, CFO of Candel Therapeutics. "This transaction and use of proceeds reflects our disciplined capital allocation approach."

"We believe Candel’s strong clinical data and innovative approach positions them well to make a real impact for patients facing prostate cancer and NSCLC – conditions with large commercial opportunities and a continued unmet need," said Rob Lake, Senior Managing Director of Life Sciences at Trinity Capital. "Our investment underscores Trinity’s commitment to provide flexible capital solutions to innovative life sciences companies that are working on bringing important therapies to patients and providers worldwide."

Paul Peter Tak, M.D., Ph.D., FMedSci, highlighted, "In parallel to this transaction, the Company has also made further portfolio prioritization decisions, and will seek externally funded partnerships for the clinical development of CAN-2409 in pancreatic ductal adenocarcinoma (PDAC). While we have compelling phase 2a data, successfully conducted enabling work for a phase 2b/3 clinical trial in this indication, had a positive Scientific Advisory Board meeting, and were awarded Orphan Designation by the EMA, we decided to completely focus our resources and capital for CAN-2409 on early localized prostate cancer and NSCLC, reinforcing our commitment to advancing breakthrough therapies for patients in two of the largest oncology indications, while delivering sustainable value to shareholders. Furthermore, based on the positive interim data for multiple injections of CAN-3110 in recurrent glioblastoma, from the ongoing phase 1b clinical trial that is funded by the Break Through Cancer foundation, we will conduct enabling work for the design of a small randomized controlled phase 2 clinical trial in this indication, which is within the current budget."

Proceeds from this facility will be used (i) with respect to the first tranche, solely to refinance that certain Loan and Security Agreement, dated as of February 24, 2022, by and between First-Citizens Bank & Trust Company (as successor to Silicon Valley Bank) and the Company, on the closing date and as working capital and to fund its general corporate purposes, initiation of a pivotal phase 3 clinical trial of CAN-2409 in NSCLC, while preparing for expected submission of a Biologics License Application for CAN-2409 in prostate cancer in the fourth quarter of 2026, and (ii) with respect to any subsequent tranche of loans, solely as working capital and to fund its general corporate purposes, completion of critical launch readiness, medical affairs and pre-commercialization activities, funding for potential commercial launch, upon the potential approval from the U.S. Food and Drug Administration (FDA), as well as ongoing costs from the potential phase 3 clinical trial for NSCLC.

Jefferies LLC acted as the Company’s exclusive financial advisor on this transaction.

(Press release, Candel Therapeutics, OCT 14, 2025, View Source [SID1234656632])

On October 14, 2025 Iksuda Therapeutics (Iksuda), the developer of class-leading antibody drug conjugates (ADCs), reported it will present new data from its Phase 1 study of IKS014, a human epidermal growth factor receptor 2 (HER2) ADC, in patients with advanced HER2+ solid tumours, at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in Berlin, Germany (17-21 October).

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Poster Presentation details:

Abstract Title:

A Phase 1 Dose Escalation Trial of IKS014, a HER2-Targeting Antibody Drug Conjugate (ADC), in Participants with Advanced HER2+ Solid Tumors

Session Title:

Developmental Therapeutics

Date/Time:

19 October 2025/12:00-12:45 CET

Location:

Level 2, Hall 25

Poster Number:

936P

The Phase 1 study (NCT05872295) is a non-randomised, open-label, multicentre trial evaluating IKS014 in patients with locally advanced or metastatic solid tumours that express HER2. Data will be presented from the dose escalation portion of the trial conducted in Australia, which was designed to establish the Maximum-tolerated dose and/or Recommended Phase 2 Dose for IKS014 as monotherapy and to provide initial safety, tolerability, efficacy, PK, PD, and immunogenicity characteristics of the ADC.

About IKS014

IKS014 is a potential best-in-class antibody drug conjugate, benefiting from tumour selective activation and release of the cytotoxic agent monomethyl auristatin F (MMAF). In preclinical trials, it displayed impressive activity in high- and low-HER2 expressing tumours with a favourable Therapeutic Index compared with other HER2-directed drugs. Iksuda gained exclusive world-wide rights (excluding Greater China and South Korea) to IKS014 from LigaChem Biosciences (View Source).

(Press release, Iksuda Therapeutics, OCT 14, 2025, View Source [SID1234656664])

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])