1stOncology™: Cancer Intelligence Service – Page 460 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Candel Therapeutics Enters into $130 Million Term Loan Facility with Trinity Capital Inc.

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").

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

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])

Results of Operations and Financial Condition

On October 14, 2025 Biogen Inc. (Biogen) reported that its GAAP and non-GAAP results for the third quarter of 2025 will include acquired in-process research and development, upfront and milestone expense of approximately $2 million on a pre-tax basis (Press release, Biogen, OCT 14, 2025, View Source [SID1234656631]). The estimated charge is expected to impact GAAP and non-GAAP net income per diluted share for the third quarter 2025 by approximately ($0.01) per share.

During the first quarter of 2025 we began presenting acquired in-process research and development, upfront and milestone expense as a separate line item in our condensed consolidated statements of income. Acquired in-process research and development, upfront and milestone expense includes costs incurred in connection with collaboration and license agreements such as upfront and milestone payments and, when applicable, premiums on equity securities and asset acquisitions of acquired in-process research and development. Biogen does not forecast such acquired in-process research and development, upfront and milestone expense due to the uncertainty of the future occurrence, magnitude and timing of these transactions in any given period.

Results for the quarter ended September 30, 2025, have not been finalized and are subject to our financial statement closing procedures. There can be no assurance that our final results will not differ from the preliminary unaudited estimates described herein.

Aprea Therapeutics Announces Presentations at EORTC-NCI-AACR International Conference on Molecular Targets and Cancer Therapeutics

On October 14, 2025 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea", or the "Company"), a clinical-stage biopharmaceutical company developing innovative treatments that exploit specific cancer cell vulnerabilities while minimizing damage to healthy cells, reported that two abstracts on its clinical programs, APR-1051 amd ATRN-119, have been accepted for poster presentation at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) 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), taking place October 22 – 26, 2025 at the Hynes Convention Center in Boston, Massachusetts.

Poster Details

Title: Early safety and efficacy of APR-1051, a novel WEE1 inhibitor, in patients with cancer-associated gene alterations: Updated data from ACESOT-1051 phase 1 trial
Lead author: Anthony Tolcher MD, FRCPC
Presenter: Philippe Pultar, MD
Session: Poster Session B
Session date/ time: Friday, October 24th, 12:30 – 16:00 ET
Location: Exhibit Hall D, Hynes Convention Center

Title: Updated data from ABOYA-119: A phase 1/2a trial of ATRN-119, a novel macrocyclic ATR inhibitor, in patients with advanced solid tumors harboring DNA damage
Lead author: Amit Mahipal MD
Presenter: Oren Gilad, PhD
Session: Poster Session B
Session date/ time: Friday, October 24th, 12:30 – 16:00 ET
Location: Exhibit Hall D, Hynes Convention Center

Copies of the posters will be available on the "Investor Resources" page of the Aprea corporate website on the day of the presentations.

(Press release, Aprea, OCT 14, 2025, View Source [SID1234656630])

Actithera Secures Exclusive Rights to Innovative Covalent Chemistry Technologies from Weizmann Institute for Targeted Radiopharmaceutical Applications

On October 14, 2025 Actithera, a biotechnology company pioneering next-generation radiopharmaceutical therapies, reported an exclusive license agreement with Yeda, the commercial arm of the Weizmann Institute of Science, for two patent families covering breakthrough covalent chemistry technologies (Press release, Actithera, OCT 14, 2025, View Source [SID1234656629]). Actithera will apply these innovations to advance its proprietary platform for radiopharmaceutical drug discovery and development.

The licensed technologies were developed in the laboratory of Professor Nir London, an internationally recognized leader in covalent drug design. These approaches enable a highly differentiated way to introduce radioactivity selectively and durably onto tumor-specific proteins, offering the potential to redefine how radiopharmaceuticals are conceived, optimized, and deployed in the clinic.

"This agreement represents an important step forward for Actithera," said Andreas Goutopoulos, PhD, Founder and Chief Executive Officer of Actithera. "By adding Professor London’s pioneering chemistry to our toolkit of proprietary covalent and non-covalent approaches, we are uniquely positioned to unlock new opportunities in cancer treatment. This innovation from the Weizmann Institute enables us to introduce radioactivity directly into tumor cells by irreversibly and tracelessly radiolabeling tumor-specific proteins while keeping them in their native state. We believe that this combination of irreversibility and tracelessness can translate into prolonged retention of radiation within tumors and ultimately improve therapeutic outcomes."

Elik Chapnik, PhD, Chief Executive Officer of Yeda, commented: "We are pleased to partner with Actithera in bringing Professor London’s groundbreaking covalent chemistry technologies into the radiopharmaceutical field. Actithera’s vision and expertise make them an ideal partner to translate these scientific advances into impactful cancer therapies that can benefit patients worldwide."

The technologies will be integrated into Actithera’s existing discovery platform as the company advances its lead FAP-targeting radioligand candidate toward clinical development in multiple indications. This strategic expansion is supported by Actithera’s recent oversubscribed $75.5 million Series A financing completed in July 2025, which is enabling the continued development of the Company’s proprietary RLT discovery platform and preclinical pipeline.

Professor Nir London, Associate Professor, Department of Chemical and Structural Biology, Weizmann Institute of Science, added: "My lab has long been dedicated to expanding the possibilities of covalent drug design. Seeing our work translated into the radiopharmaceutical space through Actithera’s innovative platform is particularly exciting given the field’s potential to deliver targeted radiation directly to tumors while sparing healthy tissue. I look forward to supporting their progress as they advance these technologies toward clinical validation."
The covalent chemistry technologies from the Weizmann Institute represent one of several cutting-edge approaches integrated into Actithera’s discovery engine, expanding the Company’s toolkit for building a pipeline of precision therapies addressing areas of high unmet need in oncology.

AB Science will hold a virtual conference on Thursday, October 16, 2025 from 2pm to 3pm CET to provide an update on the Phase 1 study with AB8939

On October 14, 2025 AB Science SA (Euronext – FR0010557264 – AB) reported an update on the Phase 1 study of the molecule AB8939 and, in particular, on the initial clinical data for the combination of AB8939 + Venetoclax in the first three patients with acute myeloid leukemia (AML) associated with a very unfavorable genetic profile.

AB8939 is a drug candidate that jointly targets cancer cells by destabilizing microtubules, which are essential for cell division, and also targeting cancer stem cells by inhibiting enzymes (ALDH1A1 and ALDH2) that are essential for maintaining their physiological state and survival.

AB8939 is currently being evaluated in a Phase 1 clinical trial (study AB18001, NCT05211570) in patients with refractory and relapsed AML.

The Phase 1 clinical trial of AB8939 has completed its first two stages, which consisted of determining the maximum tolerated dose (MTD) after 3 and 14 consecutive days of monotherapy, respectively. In both cases, the MTD was 21.3 mg/m².

The third stage, currently underway, involves evaluating the combination of AB8939 + Venetoclax. Three patients were evaluated at the first dose level (AB8939 14 days at a dose of 16 mg/m² + Venetoclax 14 days).

Nicholas J. Short, MD, Associate Professor and Co-Lead of Section of Developmental Therapeutics, Department of Leukemia, MD Anderson Cancer Center, said, "The results observed in these high-risk AML patients are impressive, particularly in the two patients whose leukemia had progressed on venetoclax. These initial results are very encouraging and justify the continuation of patient treatment with additional cycles, particularly in view of the mechanism of AB8939 on cancerous hematopoietic stem cells."

At the end of this third stage, an AB8939 + venetoclax expansion phase will be initiated in a group of about 15 patients with a more homogeneous profile than in the previous stages of phase 1, namely patients in their second- or third-line of treatment and with a poor prognosis (TP53 mutant, MECOM, NRAS mutant) in order to confirm the initial promising clinical data before initiating a registration clinical trial.

Virtual conference

AB Science will hold a virtual conference on Thursday, October 16, 2025, from 2pm to 3pm CET.

ZOOM link to the conference (audio + presentation): Access to the conference.

The purpose of this virtual conference will be to present in more detail the initial clinical data on the combination of AB8939 + venetoclax in the first three patients with refractory and relapsed AML associated with a very unfavorable genetic profile.

The following individuals will participate in the virtual conference:

Nicholas J. Short, MD, Associate Professor and Co-Lead of Section of Developmental Therapeutics, Department of Leukemia, MD Anderson Cancer Center

Professor Short is a clinical and translational investigator in adult acute leukemias, with a particular emphasis on the development of phase I and II investigator-initiated clinical trials of novel agents and combinations for patients with acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). His major contributions to leukemia research include: developing new immunotherapy-based frontline regimens in Philadelphia chromosome-negative B-cell ALL, developing chemotherapy-free regimens in Philadelphia chromosome-positive ALL, establishing the clinical utility of high-sensitivity next-generation sequencing-based MRD assays in ALL, developing novel MRD-directed therapies in AML and ALL, and developing novel regimens for older adults with FLT3-mutated AML. He serves as principal investigator or co-principal investigator on over a dozen phase I and II clinical trials and has authored over 250 peer-reviewed manuscripts in the field of leukemia. For his clinical and translational accomplishments in the field of leukemia, he has been awarded the ASCO (Free ASCO Whitepaper) Young Investigator Award and the ASH (Free ASH Whitepaper) Junior Faculty Scholar in Clinical Research.

Olivier Hermine, MD, PhD, Head of the Hematology Department at Necker-Enfants Malades Hospital, Paris, France

Olivier Hermine is Professor of Hematology at Paris Descartes University, Head of the Hematology Department at Necker-Enfants Malades Hospital, member of LYSA, and Director of the CALYM team "Cellular and Molecular Mechanisms of Hematological Disorders and Therapeutic Implications" at the IMAGINE Inserm U 116 CNRS ERL 8654 institute. He is also coordinator of the Reference Center for Mastocytosis (CeReMast), co-founder and director of the scientific committee of AB Science.

His research topics include lymphoproliferative disorders linked to the hepatitis C virus, mantle cell lymphomas, and the regulation of erythropoiesis. He is the author or co-author of more than 900 scientific publications.

Christian Auclair, PharmD, PhD, Emeritus Professor

Professor Auclair holds a doctorate in pharmaceutical sciences. He is co-founder and former director of the doctoral school of oncology at the Faculty of Medicine of Paris-Saclay University. He is former director of the biology department at the École Normale Supérieure de Cachan (now ENS Paris-Saclay) and director of UMR 8113 at the CNRS. He was also deputy scientific director of the CNRS’s life sciences department. He is the author of more than 120 publications in the field of antitumor pharmacology and virology. He is co-founder and scientific advisor to AB Science.

Orphan Drug Status

In April 2025, AB Science announced that the molecule AB8939 had been granted orphan drug designation by the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) for the treatment of acute myeloid leukemia (AML).

The molecule AB8939 had already obtained orphan drug designation from the US Food and Drug Administration (FDA) for AML.

About AB8939
AB8939 is a new synthetic molecule which jointly targets cancer cells, by destabilizing the microtubules essential for cell division, and cancer stem cells, by inhibiting enzymes (ALDH1A1 and ALDH2) essential for maintaining their physiological state and survival. The molecule ‘1-{4-[2-(5-ethoxymethyl-2-methylphenylamino)-oxazol-5-yl]phenyl}imidazolidin-2-one’ is the chemical name of AB8939. The intellectual property of AB8939 is 100% owned by AB Science.

(Press release, AB Science, OCT 14, 2025, View Source [SID1234656628])