1stOncology™: Cancer Intelligence Service – Page 503 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Candel Therapeutics Presents Phase 3 Clinical Trial of CAN-2409 in Localized Prostate Cancer at ASTRO 2025

On September 29, 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 subgroup analyses focused on the radiation regimen from the Company’s positive phase 3 clinical trial of CAN-2409 (aglatimagene besadenovec) in patients with intermediate-to-high-risk localized prostate cancer at the 2025 Annual Meeting of the American Society for Radiation Oncology (ASTRO) (Press release, Candel Therapeutics, SEP 29, 2025, View Source [SID1234656327]).

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!

Current standard-of-care radiation therapy for intermediate-to-high-risk localized prostate cancer has remained largely unchanged, with a significant unmet medical need, as approximately ~30% of patients experience disease recurrence within 10 years.

The Company has previously presented data from a randomized phase 3 clinical trial of CAN-2409 plus valacyclovir vs. placebo added to standard of care radiotherapy with curative intent in patients with localized prostate cancer. The press release is posted on the investor relations section of our website, available here. The randomized, double-blind, placebo-controlled, multicenter phase 3 trial (NCT01436968) enrolled 745 patients with intermediate-to-high-risk localized prostate cancer randomized 2:1 to either CAN-2409 plus valacyclovir in combination with standard of care or standard of care alone, with experimental treatment administered before and during radiation therapy. The trial achieved its primary endpoint with a 30% improvement in disease-free survival (HR 0.7, p=0.0155) and demonstrated a 38% improvement in prostate cancer-specific disease-free survival (HR 0.62, p=0.0046). At two years, pathological complete response rates were 80.4% as compared to 63.6% observed in the control arm (p=0.0015).

This study represents the first potential advancement in localized, non-metastatic prostate cancer in more than 20 years. The Company today released additional information from its subgroup analysis of the phase 3 data showing that CAN-2409’s activity was independent of the radiation modality used in the trial.

Key Highlights from ASTRO 2025 Presentation:

CAN-2409 significantly improved prostate cancer-specific outcomes (HR 0.62; p=0.0046). Effects observed in both moderate hypofractionated EBRT (HR 0.52, CI 0.30 – 0.93, p=0.0236) and conventional EBRT (HR 0.76, CI 0.53 – 1.07, p=0.1131)
Demonstrated safety and compatibility across radiation therapy modalities, with both conventional radiation therapy (~78 Gy in 2 Gy fractions, ~72% of patients) and moderate hypofractionated radiation therapy (60 Gy in 3 Gy fractions, ~25% of patients) showing similar tolerability profiles
Grade ≥ 3 treatment related adverse events were similar in the CAN-2409 plus valacyclovir and control arms with both hypofractionated (1.6% vs. 1.9%) and standard EBRT (1.8% vs. 1.1%), respectively
"These additional analyses suggest that the efficacy of CAN-2409 is independent of the modality of radiation used. Most importantly, the activity of CAN-2409 was maintained with moderate hypofractionated radiation, which is more convenient for patients," said Glen Gejerman, M.D., M.B.A., Co-Director of Urologic Oncology at Hackensack Meridian Health and one of the principal investigators of the study.

Paul Peter Tak, M.D., Ph.D., FMedSci, President and Chief Executive Officer of Candel said, "These new insights presented at ASTRO further support the broad therapeutic potential of CAN-2409 in localized prostate cancer treated with curative intent. Previously, we have shown the benefit of CAN-2409 compared to placebo in patients treated with standard of care radiotherapy, independent of the use of short-term androgen deprivation therapy. The consistency of benefit, across radiation therapy modalities, supports the therapy’s potential as the first major advancement in localized prostate cancer treatment in over 20 years. Our regulatory strategy remains on track with Biologics License Application submission expected in the fourth quarter of 2026."

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.

PATENT ALLOWANCE FOR KEY NARMAFOTINIB PATENT IN US

On September 29, 2025 Amplia Therapeutics Limited (ASX: ATX), ("Amplia" or the "Company"), reported that the US Patent and Trademark Office (USPTO) has notified the Company that a key patent protecting the Company’s best-in-class FAK inhibitor narmafotinib has been allowed in the US (Press release, Amplia Therapeutics, SEP 29, 2025, View Source [SID1234656325]). The patent, titled A salt and crystal form of a FAK Inhibitor, describes the specific chemical form of narmafotinib being utilised in currently ongoing clinical trials.

The patent allowance precedes a formal ‘Notification of Grant’ of the patent, which is expected in the coming months. The Company has previously announced that this key patent has already been granted in Japan and Europe1, and it has also been granted in Australia, India, Korea, Singapore, and New Zealand. Granting of this patent extends protection of narmafotinib out to a least 2040 in these jurisdictions. Protection in other regions is under review by the respective patent offices.

This patent describes a stable, manufacturable form of narmafotinib that provides improved drug levels upon dosing. Importantly, it is this specific form of the drug that is being developed clinically by the Company, including in the current ACCENT and AMPLICITY trials in advanced pancreatic cancer.

Amplia’s CEO and Managing Director Dr Chris Burns comments: "We continue to build a patent portfolio around narmafotinib to ensure the Company’s key intellectual property is protected and thus commercially valuable, for as long as possible."

Soligenix Announces Closing of $7.5 Million Public Offering

On September 29, 2025 Soligenix, Inc. (Nasdaq: SNGX) ("Soligenix" or the "Company"), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported the closing of its previously announced "reasonable best efforts" public offering with participation from existing and certain healthcare focused institutional investors for the purchase and sale of 5,555,560 shares of common stock of the Company (or common stock equivalents in lieu thereof) and warrants to purchase up to 5,555,560 shares of common stock at a combined purchase price of $1.35 per share and accompanying warrant (the "Offering") (Press release, Soligenix, SEP 29, 2025, View Source [SID1234656324]). The warrants have an exercise price of $1.35 per share, are exercisable immediately and will expire five years from the issuance date. The Company received aggregate gross proceeds of approximately $7.5 million, before deducting placement agent fees and other Offering expenses.

The Company agreed that certain existing May 2023, April 2024 and July 2024 warrants (together, the "Existing Warrants") to purchase an aggregate of 1,162,064 shares of common stock will be amended such that the Existing Warrants will have a reduced exercise price of $1.35 per share and shall expire commensurate with the warrants sold in the Offering.

This funding extends the Company’s cash runway through the end of 2026, providing sufficient funds for anticipated key inflection points. The Company intends to use the net proceeds of this Offering to fund research and development and commercialization activities, working capital and general corporate purposes.

A.G.P./Alliance Global Partners acted as the sole placement agent in connection with the Offering.

The securities described above were offered pursuant to a registration statement on Form S-1 (File No. 333-290413), previously filed with the Securities and Exchange Commission ("SEC") on September 19, 2025, which became effective on September 25, 2025. This Offering was made only by means of a prospectus forming part of the effective registration statement. Copies of the final prospectus relating to the Offering may be obtained on the SEC’s website located at View Source Electronic copies of the final prospectus relating to the Offering may be obtained from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

ReCode Therapeutics Announces Over $29 Million in Additional Financing to Advance Genetic Medicines Pipeline and Provides Corporate Update

On September 29, 2025 ReCode Therapeutics, a clinical-stage genetic medicines company using tissue-specific delivery to power the next wave of mRNA and gene correction therapeutics, reported the close of over $29 million in additional financing (Press release, ReCode Therapeutics, SEP 29, 2025, View Source;utm_medium=rss&utm_campaign=recode-therapeutics-announces-over-29-million-in-additional-financing-to-advance-genetic-medicines-pipeline-and-provides-corporate-update [SID1234656323]). The company also reported expanded support from the Cystic Fibrosis Foundation (CF Foundation) and a new research collaboration with Praxis Precision Medicines, Inc. (NASDAQ: PRAX).

"With continued support from organizations like the CF Foundation and our collaboration with Praxis, we are building on our momentum to deliver on the promise of genetic medicines for people living with genetic diseases who currently have limited or no effective treatments," said Shehnaaz Suliman, M.D., MBA, M.Phil., chief executive officer of ReCode Therapeutics.

Key Updates

Over $29 Million Raised in New Financing: ReCode has raised more than $29 million to advance its pipeline of genetic medicines, including investigational therapies for cystic fibrosis (CF). The funding strengthens the company’s financial foundation as it progresses its clinical and preclinical programs.
Expanded Support from the CF Foundation: The CF Foundation, which previously invested $15 million to support the development of and early-stage clinical trials for RCT2100, an inhaled mRNA therapy, is committing an additional $3 million to support the company’s ongoing Phase 2 clinical trial of RCT2100. RCT2100 is designed to provide functional CFTR protein by delivering a correct copy of CFTR mRNA to lung cells, offering potential benefits to all people with CF, including those with rare and nonsense mutations who do not benefit from existing modulator therapies. In total, the Foundation has agreed to invest up to $33 million in ReCode’s mRNA and gene editing research programs. For more information, please visit www.CF-Clinical-Studies.com.
Partnership with Praxis Precision Medicines for ASO Delivery: ReCode has entered into a research collaboration with Praxis Precision Medicines, Inc., a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal excitation-inhibition imbalance, to identify a well-tolerated lipid nanoparticle (LNP) formulation that enhances the delivery of antisense oligonucleotides (ASOs) to underexposed brain regions.
ERS and NACFC Attendance: ReCode leadership will attend the European Respiratory Society (ERS) Congress in Amsterdam, the Netherlands, from September 27 to October 1, and the North American Cystic Fibrosis Conference (NACFC) in Seattle from October 22 to 25.

Oncolytics Biotech® Announces Update for Potential First-Line Pancreatic Cancer Registration Study

On September 29, 2025 Oncolytics Biotech Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, reported an update on the proposed design of its planned registration-directed clinical trial in first-line pancreatic ductal adenocarcinoma (PDAC) (Press release, Oncolytics Biotech, SEP 29, 2025, View Source [SID1234656322]). The Company is currently scheduled to meet with the U.S. Food and Drug Administration (FDA) in mid-November 2025 to advance study details.

Key Elements of the Proposed Registration Study
•Three-arm design – patients will be randomized to receive:
1.Gemcitabine + nab-paclitaxel (GnP) control arm.
2.GnP + pelareorep.
3.GnP + pelareorep + checkpoint inhibitor (CPI).
•Primary endpoint: Overall Survival (OS).
•Statistical rigor: The trial will be powered to detect statistical significance between the investigational arms and the control arm.
•Planned interim analysis: An interim efficacy analysis will be incorporated to enable early assessment of potential clinical benefit.

This proposed design builds on a post-hoc, pooled clinical analysis, which found that the addition of pelareorep to chemotherapy achieved an approximate 22% two-year survival rate, compared to just 9% for patients treated with chemotherapy alone, as in historical, third-party benchmarks (link to the PR).

"We are excited to advance this potential registration-directed study in first-line pancreatic cancer with a well-powered, three-arm design," said Jared Kelly, Chief Executive Officer of Oncolytics. "By evaluating pelareorep with chemotherapy and in combination with checkpoint inhibition, we expect to position this program to deliver meaningful data for patients and regulators alike. We believe that potential partners will recognize the possibility this trial design presents to establish pelareorep as the first approved immunotherapy in first-line pancreatic cancer – a transformative milestone in oncology."