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AVEO Oncology, an LG Chem company, and HiberCell Enter Into an Exclusive Development and Option Agreement for First-in-Human Compound

On November 4, 2025 AVEO Oncology, an LG Chem company (AVEO), and HiberCell, Inc. (HiberCell) reported that the companies have entered into an exclusive development and option agreement to develop HiberCell’s first-in-human human protein kinase RNA-like endoplasmic reticulum kinase (PERK) inhibitor, HC-5404, alone and in combination with AVEO’s potent and selective vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI), FOTIVDA (tivozanib). FOTIVDA is an anti-angiogenic agent approved by the U.S. Food and Drug Administration in March of 2021 for the treatment of adult patients with relapsed or refractory renal cell carcinoma (RCC) following two or more prior systemic therapies. Pre-clinical studies of HC-5404 in multiple solid tumor models, including gastric cancer and RCC, suggest the potential for enhanced anti-tumor efficacy when combined with an anti-angiogenic agent.

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Under the terms of the agreement, AVEO is responsible for conducting initial stage clinical development. During the Phase 2 clinical trial, AVEO will have the option to obtain an exclusive license for the development, manufacturing, and commercialization of HC-5404 in all therapeutic indications worldwide for an undisclosed option fee. In addition, if AVEO exercises its option, HiberCell will be eligible to receive milestone payments and royalties for global net sales of HC-5404, contingent upon successful development and commercialization.

"AVEO and LG Chem are excited to enter into this collaboration with HiberCell to advance the development of this first-in-human PERK inhibitor and to expand on our commitment to RCC patients," said Michael P. Bailey, President and CEO of AVEO. "HC-5404 has shown promising activity combined with VEGFR TKIs which makes pairing it with tivozanib in RCC a logical first phase of development. The combinability with our current portfolio in RCC, coupled with the opportunity to expand to other oncology indications, make this collaboration an important step in our vision to become a global leader in oncology."

"We are excited to be partnering with AVEO to help us explore the combination activity of HC-5404 and tivozanib in metastatic renal cell carcinoma," said Steven Gillis, Ph.D., Chairman and acting Chief Executive Officer at HiberCell. "AVEO brings considerable scientific and clinical development capabilities across oncology, including significant expertise in renal cell carcinoma. This collaboration is an important step in assessing the combination of HC-5404 and tivozanib in RCC and may inform broader development across multiple tumor types."

About FOTIVDA (tivozanib)
FOTIVDA (tivozanib) is an oral, next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI). It is a potent, selective inhibitor of VEGFRs 1, 2, and 3 with a long half-life designed to improve efficacy and tolerability. AVEO received U.S. Food and Drug Administration (FDA) approval for FOTIVDA on March 10, 2021, for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies, based on data from the TIVO-3 trial comparing FOTIVDA to sorafenib. FOTIVDA was approved in August 2017 in the European Union and other countries in the territory of its partner Recordati UK Ltd. for the treatment of adult patients with advanced RCC. FOTIVDA was discovered by Kyowa Kirin.

IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTION

Hypertension was reported in 45% of patients (22% ≥ Grade 3). Hypertensive crises were reported in 0.8% of patients. Do not initiate FOTIVDA in patients with uncontrolled hypertension. Monitor for hypertension and treat as needed. Reduce the FOTIVDA dose for persistent hypertension not controlled by anti-hypertensive medications. Discontinue FOTIVDA for severe hypertension that cannot be controlled with anti-hypertensive therapy or for hypertensive crisis.

Cardiac failures were reported in 1.6% of patients (1% ≥ Grade 3); 0.6% of events were fatal. Monitor for signs or symptoms of cardiac failure during treatment with FOTIVDA. Manage with dose interruption, dose reduction, or discontinuation.

Cardiac ischemia were reported in 3.2% of patients; 0.4% of events were fatal. Arterial thromboembolic events were reported in 2.0% of patients, including death due to ischemic stroke (0.1%). Closely monitor patients at risk for, or who have a history of these events. Discontinue FOTIVDA in patients who develop severe arterial thromboembolic events, such as myocardial infarction and stroke.

Venous Thrombotic Events (VTE) were reported in 2.4% of patients, including 0.3% fatal events. Closely monitor patients who are at increased risk for these events. Discontinue in patients who develop serious VTEs.

Hemorrhagic Events were reported in 11% of patients; 0.2% of events were fatal. Use FOTIVDA with caution in patients who are at risk for or who have a history of bleeding.

Proteinuria was reported in 8% of patients (2% = Grade 3). Monitor during treatment with FOTIVDA. For moderate to severe proteinuria, reduce the dose or interrupt treatment. Discontinue in patients who develop nephrotic syndrome.

Gastrointestinal (GI) Perforation including fatal cases, has been reported in patients receiving FOTIVDA. Monitor for symptoms of GI perforation or fistula formation periodically throughout treatment with FOTIVDA. Permanently discontinue FOTIVDA in patients who develop severe or life-threatening GI perforation.

Thyroid Dysfunction events were reported in 11% of patients (0.3% ≥ Grade 3). Monitor thyroid function before and during treatment with FOTIVDA.

Wound Healing Complications: Withhold FOTIVDA for at least 24 days prior to elective surgery and do not administer for at least 2 weeks after major surgery and until adequate wound healing is observed.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS) can occur with FOTIVDA. Evaluate for RPLS in patients presenting with seizures, headache, visual disturbances, confusion, or altered mental function. Discontinue if signs or symptoms of RPLS occur.

Embryo-fetal Toxicity: FOTIVDA can cause fetal harm. Advise patients of the potential risk to a fetus, to avoid becoming pregnant and to use contraception during treatment and for one month after the last dose of FOTIVDA. Advise males with female partners of reproductive potential to use effective contraception during treatment and for one month after the last dose of FOTIVDA.

Allergic Reaction to Tartrazine: FOTIVDA 0.89 mg capsule contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible patients.

ADVERSE REACTIONS

Common adverse reactions include fatigue/asthenia, hypertension, diarrhea, decreased appetite, nausea, dysphonia, hypothyroidism, cough, and stomatitis.

Serious adverse reactions include bleeding (3.5%), venous thromboembolism (3.5%), arterial thromboembolism (2.9%), acute kidney injury (2.3%), and hepatobiliary disorders (2.3%).

DRUG INTERACTIONS

Avoid coadministration with strong CYP3A4 inducers.

USE IN SPECIFIC POPULATIONS

Advise women not to breastfeed during treatment and for at least 1 month after the last dose.

The recommended dosage for patients with end-stage renal disease has not been established.

Reduce the FOTIVDA dose for patients with moderate hepatic impairment. The recommended dosage in patients with severe hepatic impairment has not been established.

To report SUSPECTED ADVERSE REACTIONS, contact AVEO Pharmaceuticals, Inc. at 1-833-FOTIVDA (1-833-368-4832) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information for FOTIVDA (tivozanib).

(Press release, AVEO, NOV 4, 2025, View Source [SID1234659391])

OmniAb Reports Third Quarter 2025 Financial Results and Business Highlights

On November 4, 2025 OmniAb, Inc. (NASDAQ: OABI) reported financial results for the three and nine months ended September 30, 2025, and provided operating and partner program updates.

"Throughout the third quarter we continued to execute on our strategic initiatives while further demonstrating the value of our proprietary technology platform to a growing base of partners. The number of new program additions so far this year has significantly outpaced last year, bolstering our partnered pipeline and creating potential sources of enduring value within our portfolio. Importantly, OmniAb’s innovative technology platform and operational model allow for partner and program additions within an increasingly efficient and lean cost structure," said Matt Foehr, Chief Executive Officer of OmniAb. "In August we completed a private placement and strengthened our balance sheet while continuing to expand our suite of leading-edge technologies. We look forward to next month’s launch of OmniUltra, an important new technology that we expect will expand our platform and open new business opportunities."

Third Quarter 2025 Financial Results

Revenue for the third quarter of 2025 was $2.2 million, compared with $4.2 million for the same period in 2024, with the decrease primarily related to lower milestone revenue and a decline in service revenue associated with the completion of work on certain small molecule ion channel programs earlier this year.

Research and development expense was $10.4 million for the third quarter of 2025, compared with $13.3 million for the same period in 2024, with the decrease primarily due to lower personnel expenses related to reduced share-based compensation expense and headcount, and lower external expenses associated with small molecule ion channel programs. General and administrative expense was $6.8 million for the third quarter of 2025, compared with $7.1 million for the same period in 2024, with the decrease primarily due to lower legal fees and share-based compensation expense.

Net loss for the third quarter of 2025 was $16.5 million, or $0.14 per share, compared with a net loss of $16.4 million, or $0.16 per share, for the same period in 2024.

Nine Months Ended September 30, 2025 Financial Results

Revenue for the nine months ended September 30, 2025 was $10.3 million, compared with $15.6 million for the same period in 2024. The decline in license and milestone revenue was primarily due to lower milestone revenue, and service revenue declined primarily as a result of the completion or discontinuation of certain small molecule ion channel programs and the acceleration of revenue in the prior-year period from one of the discontinued programs. These decreases were offset by $0.7 million in xPloration revenue reflecting the sale of an instrument and related consumables.

Cost of xPloration revenue was $0.3 million for the nine months ended September 30, 2025 and consisted of direct costs associated with the sale of the xPloration instrument and associated consumables. Research and development expense was $33.8 million for the nine months ended September 30, 2025, compared with $41.8 million for the same period in 2024, primarily due to lower personnel expenses and lower external expenses associated with ion channel programs and contract research costs. General and administrative expense was $22.4 million for the nine months ended September 30, 2025, compared with $23.4 million for the same period in 2024 with the decrease primarily due to lower legal fees and share-based compensation expense. Other operating income, net for the nine months ended September 30, 2025 was $2.7 million and reflected a gain of $3.0 million from the sale of a small molecule Kv7.2 program to Angelini and a $0.9 million reduction in contingent liabilities attributed to changes in certain ion channel programs, partially offset by the $1.0 million contingent liability adjustment associated with the Angelini program. Other operating income, net during the nine months ended September 30, 2024 was $2.3 million and included a $2.4 million reduction in contingent liabilities primarily attributed to changes in ion channel programs.

Net loss for the nine months ended September 30, 2025 was $50.6 million, or $0.46 per share, compared with a net loss of $49.0 million, or $0.48 per share, for the same period in 2024.

As of September 30, 2025, OmniAb had cash, cash equivalents and short-term investments of $59.5 million. In August, OmniAb raised $30 million from a private placement of common stock, with net proceeds to the Company of approximately $28 million.

2025 Financial Guidance

OmniAb now expects 2025 revenue to be in the range of $18 million to $22 million, and operating expense to be in the range of $82 million to $86 million. In addition, OmniAb continues to expect 2025 cash use to be lower than cash use in 2024, excluding financings. The Company expects to end the year with cash between $52 million and $56 million. The 2025 full year effective tax rate is expected to be approximately 0%.

Third Quarter 2025 and Recent Business Highlights

During the third quarter of 2025, OmniAb entered into new license agreements, including with A*Star and University of Leeds, and recently with Dana-Farber Cancer Institute, Inc. As of September 30, 2025, the Company had 104 active partners and 399 active programs, including 32 OmniAb-derived programs in clinical development or being commercialized.

OmniAb continued to expand its intellectual property portfolio with the issuance of a U.S. patent related to its new OmniUltra technology, a transgenic chicken that produces a cow-like antibody with an exceptionally long third heavy-chain complementarity-determining region (CDRH3). The Company plans to launch this new proprietary discovery platform in December 2025 at the Antibody Engineering & Therapeutics (AET) conference in San Diego.

In addition, OmniAb and GSK published a paper titled "Voltage sensor interaction site for a selective small molecule Nav1.1 sodium channel potentiator that enhances firing of fast-spiking interneurons" in the October 2025 edition of Molecular Pharmacology. The paper highlights the potential for Nav1.1 as a therapeutic target for seizure disorders.

Business and partner highlights from the third quarter of 2025 and recent weeks included the following:

Batoclimab & IMVT-1402

In September, Immunovant presented an abstract at the 2025 Annual Meeting of the American Thyroid Association with six-month off-treatment data in uncontrolled Graves’ disease (GD) patients treated with batoclimab for 24 weeks. Of the 21 patients who entered the six-month off-treatment follow-up period, ~80% (17/21) demonstrated response, resulting in normal thyroid function (T3 and T4 less than the upper limit of normal) at the end of the six-month follow-up period. Of the 17 responders to therapy, ~50% (8/17) achieved anti-thyroid drug free remission at six months following the end of batoclimab treatment. Safety and tolerability were observed to be consistent with prior batoclimab studies.
Immunovant’s lead compound IMVT-1402 has two ongoing potentially registrational trials in GD and are currently enrolling patients, with topline readouts expected in 2027.
Zimberelimab

Arcus Biosciences presented the first overall survival (OS) results from Arm A1 of the Phase 2 EDGE-Gastric study at the European Society for Medical Oncology 2025 Congress. Anti-TIGIT domvanalimab plus anti-PD-1 zimberelimab and chemotherapy demonstrated 26.7 months of median OS as first-line treatment of unresectable or advanced gastroesophageal adenocarcinomas.
SAL003

China’s National Medical Products Administration accepted Shenzhen Salubris Pharmaceuticals’ SAL003 New Drug Application as a Class 1 therapeutic biological. SAL003 is a recombinant fully‑human anti‑PCSK9 monoclonal antibody designed for the treatment of hypercholesterolemia and mixed dyslipidemia.
Mipletamig

Aptevo Therapeutics announced a 100% remission rate in Cohort 3 of its Phase 1b/2 RAINIER trial evaluating mipletamig, a first-in-class CD123 x CD3 bispecific antibody, in combination with venetoclax + azacitidine for newly diagnosed patients with acute myeloid leukemia unfit for intensive chemotherapy. Aptevo also reported that no dose-limiting toxicities or cytokine release syndrome have been observed in the RAINIER trial, or among any frontline patients treated with mipletamig to date.
Sugemalimab

CStone Pharmaceuticals and Istituto Gentili entered into an exclusive partnership to commercialize sugemalimab across 23 countries in Western Europe and the United Kingdom.
CStone also announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion, recommending the approval of sugemalimab as monotherapy for the treatment of unresectable stage III non-small cell lung cancer in adults with PD-L1 expression on ≥1% of tumor cells and no sensitizing EGFR mutations, or ALK, ROS1 genomic aberrations and whose disease has not progressed following platinum-based chemotherapy.
RNDO-564

Rondo Therapeutics’ abstract titled "Comprehensive Characterization of RNDO-564, a First-in-Class CD28 x Nectin-4 Bispecific Antibody for the Treatment of Solid Tumors" was accepted for presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) on November 7, 2025.
Conference Call and Webcast

OmniAb management will host a conference call with accompanying slides today beginning at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss this announcement and answer questions. To participate via telephone, please dial (800) 549 8228 using the conference ID 92631. Slides, as well as the live and replay webcast, are available at View Source

(Press release, OmniAb, NOV 4, 2025, View Source [SID1234659390])

Transgene Provides Business and Financial Update for Q3 2025

On November 4, 2025 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported a business update on its lead asset TG4050 developed from its myvac platform, upcoming plans, and its financial position as of September 30, 2025.

TG4050 – INTV: New Data presented at SITC (Free SITC Whitepaper) supports TG4050’s potential role in preventing cancer relapse

Transgene and its partner NEC1 will jointly present a poster on additional immunological data profiling the neoantigen-specific T-cell response after treatment with TG4050 in head and neck cancer at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting.

Comprehensive immunogenicity data confirm the ability of TG4050 monotherapy to induce neoantigen-specific cytotoxic CD8+ T-cell responses capable of targeting and eliminating tumor cells – see press release. These CD8+ T cells target multiple neoantigens encoded in the vaccine, have tissue resident cytosignature, and are still detectable up to two years after the start of TG4050 treatment. Overall, these data support the TG4050 mechanism of action that resulted in the reduction of risk of relapse observed in the randomized Phase I study.

These data have been generated from the randomized Phase I part of the ongoing Phase I/II trial evaluating TG4050 as a single agent in the adjuvant treatment of HPV-negative HNSCC, in patients that are in complete response following surgery and adjuvant (chemo-)radiotherapy.

These results follow the positive randomized Phase I data presented in a rapid oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (ASCO Annual Meeting – see press release).

The SITC (Free SITC Whitepaper) abstract is available both on the SITC (Free SITC Whitepaper) and Transgene websites. The poster presentation will take place on November 8 at the Conference and will be available on Transgene’s website following the presentation.

Transgene will host a webcast (in English) to discuss the SITC (Free SITC Whitepaper) data on November 14, 2025, from 10:00 a.m. to 11:00 a.m. ET (16:00 to 17:00 CET). The webcast and the replay will be available here and on Transgene‘s website.

Transgene expects to complete the randomization of patients with operable HNSCC in the Phase II part of the trial by early 2026. First immunogenicity data from this Phase II part are expected to be available in H2 2026. The first efficacy data (2-year disease-free survival, DFS) will become available as soon as all patients are evaluable for two-year DFS with either an event (relapse or death) or 2-year follow-up whichever occurs first.

Transgene is currently evaluating the most efficient regulatory pathway to accelerate the development of its lead asset, TG4050, with the goal of bringing it to patients with operable HNSCC as quickly as possible.

myvac platform: Potential to reduce the risk of relapse across multiple operable solid tumors

Transgene’s INTV platform, myvac, could be applied across a range of solid tumors where in many cases a significant unmet medical need remains. In parallel, Transgene is initiating start-up activities for a potential new Phase I trial in a second indication in an early treatment setting, with the aim of initiating once all conditions are met.

BT-001 (oncolytic virus – intratumoral administration): Updated Phase I/II data presented at ESMO (Free ESMO Whitepaper) 2025 demonstrated positive antitumoral activity

Transgene and BioInvent presented a poster on updated clinical results showing the positive antitumoral activity of BT-001 in patients with advanced refractory tumors at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting – see press release.

These updated data from the Phase I trial (NCT04725331) evaluating BT-001 in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA (pembrolizumab)2 showed positive local, abscopal and sustained antitumoral activity in injected and non-injected lesions. Immune-mediated tumor shrinkage is consistent with the mechanistic hypothesis that BT-001, in combination with pembrolizumab, turns "cold" tumors into immunologically active ones.

The poster is available on Transgene’s website.

Transgene and BioInvent are exploring clinical development opportunities for intratumoral administration of BT-001 in collaboration with clinicians.

Key financial elements

In millions of euros Q3
2025 2024
Research Tax Credit 5.8 4.8
Revenue from collaborative and licensing agreements 0.1 -
Other income 0.3 0.2
Operating income 6.13 5.0

During the third quarter of 2025, the Research Tax Credit increased to €5.8 million compared to €4.8 million for the same period in 2024, reflecting the progress of the ongoing Phase II part of the clinical trial evaluating TG4050 in head and neck cancer, with sustained patient enrollment and related expenses, including the manufacturing of individualized batches.

As of September 30, 2025, Transgene had €12.8 million in cash, compared to €16.7 million as of December 31, 2024.

Over the first nine months of 2025, Transgene’s net cash burn4 was €28.8 million (including the prefinancing of the 2024 Research Tax Credit for €5.2 million in June 2025) compared to €31.3 million for the same period in 2024.

Business funded until the end of December 2026

In March 2025, the Company signed a new amendment to the current account advance agreement with its major shareholder TSGH (Institut Mérieux), which increased the total amount of the facility by €15 million to €48 million. As of September 30, 2025, the Company has drawn down €35.5 million from this facility.

With this credit facility and the support of TSGH (Institut Mérieux), Transgene is able to fund its business until the end of December 2026, enabling the Company to deliver significant news flow on its myvac platform over the next 12 months.

(Press release, Transgene, NOV 4, 2025, View Source [SID1234659389])

New Phase I Immunological Data Presented at SITC 2025 Support TG4050’s Potential Role in Preventing Cancer Relapse

On November 4, 2025 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, and NEC Corporation (NEC; TSE: 6701), a leader in IT, network and AI technologies, reported it will jointly present additional immunological data profiling the immune response after treatment with the individualized neoantigen therapeutic vaccine (INTV) TG4050 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. The conference will be held in National Harbor, Maryland, USA, from November 5 to 9, 2025.

Comprehensive immunogenicity data confirm TG4050’s ability to induce neoantigen-specific cytotoxic CD8+ T cell responses capable of targeting and eliminating tumor cells, thereby contributing to the prevention of cancer relapse, when used as monotherapy.

Prof. Le Tourneau, MD, PhD, Medical Oncologist at Gustave Roussy, and Principal Investigator, commented: "These new immunological data provide compelling evidence confirming TG4050’s mechanism of action. They also offer a clear rationale for the sustained prevention of relapses, which is a critical outcome for long-term patient benefit."

Data presented at SITC (Free SITC Whitepaper) demonstrate that TG4050 in monotherapy induces a potent CD8+ T cell response consistent with durable anti-tumor immunity:

Vaccine-induced cytotoxic CD8+ T cells display effector phenotype biomarkers even one year after the end of treatment, suggesting potential long-term effector functions.
CD8+ T cells express high levels of cytotoxic and tissue-resident biomarkers, suggesting that these cells are effective at killing cancer cells and likely to be found not only in the blood but also in tissues, where they are designed to be able to scout for and eliminate tumor cells.
The abstract is available on both the new windowSITC and PDFTransgene websites. The poster presentation will take place on November 8 and will be available that day on both the SITC (Free SITC Whitepaper) and Transgene’s websites.

Dr. Emmanuelle Dochy, MD, Chief Medical Officer of Transgene, said: "We are extremely proud to present new immunological data that further characterize the CD8+ T cell responses against the selected neoantigens. These translational data confirm that the vaccine selected neoantigens that induce an efficient immune response. TG4050 is currently being evaluated in the Phase II part of our ongoing Phase I/II study. The first immunogenicity data from this Phase II part are expected to be available in the second half of 2026."

Motoo Nishihara, Corporate EVP and CTO, at NEC, added: "These findings highlight the strong potential of NEC’s AI-driven platform in enabling the development of individualized neoantigen therapeutic vaccines. The confirmation of the mechanism of action and evidence of durable relapse prevention mark important milestones that reinforce our dedication to revolutionizing cancer treatment through cutting-edge AI innovation."

Transgene and NEC previously shared data (see PDFpress release) illustrating that CD8+ T cells specific to tumor neoantigens have been detected in patients treated with TG4050. These cells target multiple neoantigens encoded in the vaccine and their responses persist for up to two years after the start of the treatment.

New data provide key mechanistic insights into how TG4050 induces and sustains potent, CD8+ T cell responses in operable HNSCC* patients

Comprehensive immunogenicity data demonstrate TG4050’s ability to induce neoantigen-specific cytotoxic CD8+ T cell responses capable of targeting and eliminating tumor cells, supporting its potential to reduce risk of relapse

Conference call scheduled on November 14 at 4 p.m. CET (in English). See details below.

Strasbourg, France & Tokyo, Japan, November 4, 2025, 5:45 p.m. CET – Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, and NEC Corporation (NEC; TSE: 6701), a leader in IT, network and AI technologies, will jointly present additional immunological data profiling the immune response after treatment with the individualized neoantigen therapeutic vaccine (INTV) TG4050 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. The conference will be held in National Harbor, Maryland, USA, from November 5 to 9, 2025.

Data presented at SITC (Free SITC Whitepaper) demonstrate that TG4050 in monotherapy induces a potent CD8+ T cell response consistent with durable anti-tumor immunity:

Transgene will host a webcast (in English) to discuss the SITC (Free SITC Whitepaper) data on November 14, 2025, from 10:00 a.m. to 11:00 a.m. ET (4 p.m. to 5 p.m. CET).

Webcast link to English language conference call:
new windowView Source

(Press release, Transgene, NOV 4, 2025, View Source [SID1234659388])

Candel Therapeutics Showcases Immunotherapy Leadership at SITC 2025, Demonstrating Integration of Clinical Innovation, Multi-Omics, and Artificial Intelligence to Advance Next-Generation Immunotherapies in Solid Tumors

On November 4, 2025 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company developing multimodal biological immunotherapies to help patients fight cancer, reported it will deliver three presentations at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 40th Anniversary Annual Meeting, taking place November 5–9, 2025, in National Harbor, Maryland.

Together, these presentations underscore Candel’s leadership in the development of novel therapeutics, harnessing multi-omics insights and artificial intelligence (AI) to define therapeutic strategies based on a deeper understanding of the tumor microenvironment and biomarkers of response in multiple solid tumors.

"Candel’s presentations at SITC (Free SITC Whitepaper) 2025 exemplify our innovative approach to the discovery and development of novel immunotherapies," said Paul Peter Tak, M.D., Ph.D., FMedSci, President and Chief Executive Officer of Candel Therapeutics. "By leveraging next-generation research tools we are working to generate deep biological insights that inform every stage of drug development, from bench to bedside and back. This iterative process allows us to refine how we develop a novel class of immunotherapies that have the potential to improve clinical outcome in patients with difficult-to-treat solid tumors."

Invited Faculty Presentation and Panel Discussion:

Paul Peter Tak, M.D., Ph.D., FMedSci, will present Candel’s positive phase 3 clinical trial data of CAN-2409 in patients with newly diagnosed, localized prostate cancer and discuss the next wave of innovation in immunotherapy during an invited faculty presentation and subsequent panel discussion. The Company plans to submit a Biologics License Application (BLA) for CAN-2409 in prostate cancer in the fourth quarter of 2026.

Title: Phase 3, Randomized, Placebo-Controlled Clinical Trial of CAN-2409 + Prodrug in Combination with Standard of Care Radiation Therapy for Newly Diagnosed, Localized Prostate Cancer with Curative Intent

Presenter: Paul Peter Tak, M.D., Ph.D., FMedSci, President and CEO of Candel Therapeutics
Session: The Next Wave: Viruses, Cells and Next-gen PD-1 Bispecifics
Date/Time: Friday, Nov. 7, 2025, 3:55 – 5:35 p.m.
Location: Potomac Ballroom – Gaylord National Resort and Convention

CAN-2409 in NSCLC Clinical Data:

Daniel Sterman M.D., Thomas and Suzanne Murphy Professor of Medicine and Cardiothoracic Surgery, NYU Langone Health and Principal Investigator, will present a poster based on integration of clinical and biomarker data from the phase 2a open-label clinical trial of CAN-2409 in patients with stage III/IV NSCLC who had progressed, despite immune checkpoint inhibitor (ICI) treatment (NCT04495153). Patients received two courses of intratumoral CAN-2409 combined with valacyclovir prodrug along with continued ICI treatment. Leveraging previously reported clinical data,1,2,3 Multi-Omics Factor Analysis (MOFA) was applied to integrate over 3,000 data points from flow cytometry and proteomics analysis of serial samples to provide a deeper understanding of the relationship between clinical and biological responses to CAN-2409.

Key findings include:

Patients with non-squamous (NSQ) histology exhibited greater expansion of effector and memory T cell populations following CAN-2409 treatment compared to patients with squamous (SQ) histology; latent immune signatures were associated with lack of response and poor outcome in patients with SQ histology
Robust systemic immune activation in NSQ patients was observed after the second CAN-2409 course, with increased CD8+ central memory T cells and elevated soluble granzymes associated with long-term survival
Improved immune activation after CAN-2409 administration was observed in patients with NSQ histology compared to those with SQ histology, and this was associated with prolonged overall survival
"The enhanced immune activation and improved survival observed after CAN-2409 administration in patients with non-squamous disease, support the rationale for a phase 3 clinical of CAN-2409 in this subgroup of patients," said Dr. Sterman.

enLIGHTEN Discovery Platform Preclinical Data:

Anne Diers, Ph.D., Vice President of Research at Candel Therapeutics, will present a poster on the third preclinical candidate based on the enLIGHTEN Discovery Platform. An AI approach was used to interrogate The Cancer Genome Atlas (TCGA) RNA sequencing data and identify potential therapeutic payloads to be deployed in the tumor microenvironment to treat specific indications. The resulting therapeutic candidate consists of the Alpha-201 vector expressing IL-12 and IL-15 and has been designed for the treatment of breast cancer.

Key findings include:

Evidence of infection and payload-dependent PBMC-mediated tumor cell killing in vitro, showing that the engineered virus can trigger immune cells to attack cancer cells
Significant tumor growth suppression (60.0% ± 12.6 vs. vehicle) in the EMT6 mouse model of breast cancer
Evidence of a synergistic interaction between IL-12 and IL-15 payloads, with the combination producing nominally greater effects than either cytokine alone
Increased frequency of circulating Ki67+ CD8+ T cells, natural killer cells, and conventional dendritic cells type 2, as well as upregulation of inflammatory response pathways, including IFN-gamma/alpha responses, upon treatment with Alpha-201 IL-12-15
"The enLIGHTEN platform provides a new, systematic approach to cancer immunotherapy development," said Francesca Barone, M.D., Ph.D., Chief Scientific Officer at Candel. "By rationally identifying optimal combinations of immune targets for specific tumor types and validating them using our viral vector engineering capabilities, we can design multimodal therapies with the potential to overcome the immunosuppressive tumor microenvironment."

About CAN-2409

CAN-2409 (aglatimagene besadenovec), Candel’s most advanced multimodal biological immunotherapy candidate, is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to a patient’s tumor. After intratumoral administration, HSV-tk enzyme activity results in conversion of prodrug (valacyclovir) into deoxyribonucleic acid (DNA)-incorporating nucleotide analogs, leading to immunogenic cell death in cells exhibiting DNA damage and proliferating cells, with subsequent release of a variety of tumor (neo)antigens in the tumor microenvironment. At the same time, the adenoviral serotype 5 capsid proteins promote inflammation through the induction of expression of pro-inflammatory cytokines, chemokines, and adhesion molecules. Together, this regimen is designed to induce an individualized and specific CD8+ T cell-mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity, based on in situ immunization against a variety of tumor antigens. CAN-2409 has the potential to treat a broad range of solid tumors. Encouraging monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several preclinical and clinical settings. More than 1,000 patients have been dosed with CAN-2409 in clinical trials with a favorable tolerability profile to date, supporting the potential for combination with standard of care, when indicated.

(Press release, Candel Therapeutics, NOV 4, 2025, View Source [SID1234659387])