Theriva™ Biologics Announces Presentation Describing Next Generation Oncolytic Adenovirus VCN-12 at the 32nd Annual Congress of the European Society of Gene & Cell Therapy (ESGCT)

On October 6, 2025 Theriva Biologics (NYSE American: TOVX), ("Theriva" or the "Company"), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, reported an upcoming presentation at the 32nd Annual Congress of the European Society of Gene & Cell Therapy (ESGCT), to be held in Seville, Spain from 7-10 October 2025 (Press release, Theriva Biologics, OCT 6, 2025, View Source [SID1234656466]).

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!

Co-founder of VCN Biosciences S.L. (now Theriva Biologics S.L.) Dr. Ramón Alemany – Head of the Immunotherapy and Virotherapy Group at the ProCURE Program of the Catalan Institute of Oncology (ICO) and the Oncobell Program of the Biomedical Research Institute of Bellvitge (IDIBELL) in Barcelona – will present new mechanistic and preclinical data for VCN-12, a next generation oncolytic adenovirus selected from Theriva’s VCN-X discovery program. VCN-12 is derived from lead clinical product VCN-01 (zabilugene almadenorepvec) and is armed with additional transgenes designed to improve tumor cell lysis, enhance stroma degradation, and augment the antitumor immune response.

Title: "Cancer Virotherapy with Armed Oncolytic Adenoviruses"
Presentation #: INV16
Date and time: Wednesday 08 October 2025, 08:30 am CEST
Session: 3b Virotherapy and Cancer Gene Therapy
Location: Room Parallel B, Seville Exhibition and Conference Centre (Fibes), Seville, Spain
In addition to the scheduled presentation on VCN-12, a recently-published pre-ESGCT meeting monograph details the results of a preclinical study conducted by investigators at the University of Navarra evaluating the intracranial administration of VCN-01 for the potential treatment of brain tumors. The authors highlight the urgent need to develop new and improved therapies for brain cancers and conclude that their findings "provide a strong rationale for its [VCN-01] further development as a therapeutic option for patients with brain tumors" (Palacios-Alonso D et al. (2025) Toxicity and Biodistribution of the Oncolytic Virus VCN-01 Following Intracranial Injection in Syrian Hamsters.

Vivoryon Therapeutics N.V. Successfully Completes Private Placement Raising EUR 5.1 Million

On October 6, 2025 Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY; NL00150002Q7) ("Vivoryon" or the"Company"), a clinical stage company developing small molecule medicines for inflammatory and fibrotic disorders, with a primary focus on kidney diseases, reported that it has completed a private placement of new shares to selected investors ("Offering") with gross proceeds in the amount of EUR 5.1 million (Press release, Vivoryon Therapeutics, OCT 6, 2025, View Source [SID1234656465]).

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!

Pursuant to the results of the Offering, the Company will issue 3,380,500new ordinary shares at an offering price of EUR 1.50 per share, amounting to gross proceeds of EUR 5.1 million. The new shares issued pursuant to the Offering represent 12.9 % of Vivoryon’s existing issued share capital and will be issued from the Company’s authorized capital under exclusion of the existing shareholders’ pre-emptive rights. As a consequence, the Company’s number of shares outstanding will increase to 29,614,337 and the Company’s share capital will increase from EUR 262,338.37 by EUR 33,805.00 to EUR 296,143.37 on completion of the Offering.

The private placement was supported by existing and new shareholders.

"This successful financing demonstrates the trust and confidence of both our longstanding and our new investors in our program and company strategy" said Frank Weber, MD, CEO of Vivoryon. "This is the first time Vivoryon has raised capital for the development of varoglutamstat in chronic kidney disease and it is an important step in moving the project forward including securing a strategic partnership. We are currently in discussions with several pharmaceutical companies, and this additional support provides us with the financial runway and financial flexibility to realize the right collaboration."

The Company intends to use the proceeds from the private placement towards realizing the immediate next steps in ongoing clinical development of its lead candidate varoglutamstat, namely securing a partnership and, if required, additional funding to enable initiation of the planned Phase 2 study in diabetic kidney disease, as well as for general corporate purposes.

The Company now expects, based on its most recent financial and business plan, that its existing cash and cash equivalents including the proceeds from the private placement will be sufficient to fund its operating plans well into Q3 2026.

Koch Wertpapierhandels GmbH supported the private placement, Girolist AG acted as Transfer Agent.

The new shares are expected to be admitted to trading on Euronext Amsterdam on October 7, 2025 with delivery to the investors on or around October 9, 2025. The new shares will rank pari passu in all respects with the existing ordinary shares in the Company.

Trogenix announces £70 million / $95 million Series A financing to drive clinical development of potentially curative therapies for aggressive cancers

On October 6, 2025 Trogenix Ltd ("Trogenix"), a pioneering biotech company dedicated to developing innovative cancer therapies, reported the completion of its Series A financing, raising £70 million / $95 million (Press release, Trogenix, OCT 6, 2025, View Source;utm_medium=rss&utm_campaign=trogenix-announces-95-million-series-a-financing [SID1234656464]). The funding will enable the rapid advancement of its robust pipeline of potentially curative cancer therapies across multiple aggressive solid tumours into the clinic.

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!

Ken Macnamara, Chief Executive Officer at Trogenix, said:

"This significant investment accelerates our lead programme in glioblastoma and follow-on programme in colorectal cancer liver metastases through the clinic, advances our pipeline in liver and lung cancers, and further enhances our Odysseus platform. We are honoured to have the support of existing and new investors who share our mission to deliver breakthrough treatments and pursue cures for the thousands of patients and families facing devastating diagnoses each year."

The Series A financing was led by IQ Capital with participation from founding investor 4BIO Capital, returning investors Cancer Research Horizons, the Brain Tumor Investment Fund, and new investors Eli Lilly and Company, Meltwind, LongeVC, and Calculus Capital, as well as undisclosed private investors. The investment underscores the transformative, curative potential of Trogenix’s precision genetic medicines driven by the Company’s Odysseus platform that identifies and targets the universal vulnerabilities of solid tumours. Trogenix’s revolutionary technology delivers highly potent combination payloads that kill cancerous cells and stimulate the immune system whilst leaving surrounding healthy tissue untouched, thereby changing the treatment paradigm for cancer patients.

Max Bautin, Co-founder and Managing Partner at lead investor, IQ Capital, said:

"Our outsized investment in Trogenix in today’s selective funding landscape reflects our confidence in the company’s world-leading science, exceptional management team and a clear roadmap for delivery both in the clinic and commercially. We are particularly excited by the potential opportunities ahead across Trogenix’s pipeline and look forward to our future collaboration."

This investment in Trogenix also represents Cancer Research Horizons’ largest investment to-date, highlighting the transformational potential of Trogenix’s breakthrough technology in cancer treatment.

Iain Foulkes, Chief Executive Officer at Cancer Research Horizons, commented:

"Trogenix’s platform technology is a powerful example of the innovation we seek to accelerate. Representing our largest investment to date, this partnership reflects our commitment to advancing science with the potential to transform cancer treatment. As they advance into clinical trials for glioblastoma, one of the hardest to treat cancers, we’re pleased to support a team whose work could reshape therapeutic approaches and improve outcomes for patients facing the greatest need."

Dima Kuzmin, Co-founder and Managing Partner at founding investor, 4BIO Capital, and Chairman of Trogenix, added:

"We are proud to have supported Trogenix through the initial incubation stage and spin-out from the University of Edinburgh, and are very happy to continue our support alongside this strong syndicate. It is exciting to see the company forge ahead with its clinical development to deliver a pioneering portfolio of cancer therapies to patients in need."

Trogenix is revolutionising cancer treatment by combining the dual power of cancer cell killing and immune stimulation, delivered via a Trojan Horse approach that reawakens the immune system to provide long-term protection against tumour recurrence. Playing a central role to Trogenix’s precision cancer treatments are its proprietary Synthetic Super Enhancers (SSEs) which are activated by targeting the unique identity of diseased cell states, rather than individual genes, to control two key payloads: a cytotoxic prodrug converting enzyme and an immune stimulating cytokine. SSEs are exquisitely designed using Trogenix’s proprietary technology platform, Odysseus, which rigorously identifies and optimises targets in cancer cells to rapidly generate candidates with manufacturable profiles for preclinical development.

Trogenix’s lead programme, in glioblastoma (GBM), one of the most aggressive and treatment-resistant brain cancers, is advancing toward clinical trials with first patient dosing anticipated in Q1 2026. Only 25% of GBM patients survive beyond one year[1] and despite decades of research and significant investment, treatment options remain severely limited. The Company’s follow-on programme is in colorectal cancer liver metastases (CRCLM). Colorectal cancer is the third most common cancer worldwide[2], with at least 25% of patients developing CRCLM[3].

In addition to its lead and follow-on programmes, Trogenix will be developing its pipeline focused on other aggressive solid cancers including hepatocellular carcinoma and non-small cell lung carcinoma.

Orca Bio Announces FDA Acceptance and Priority Review of the Biologics License Application (BLA) for Orca-T® to Treat Hematological Malignancies

On October 6, 2025 Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, reported the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) seeking approval for Orca-T, its lead investigational allogeneic T-cell immunotherapy, for the treatment of hematological malignancies including acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) and myelodysplastic syndromes (MDS) (Press release, Orca Bio, OCT 6, 2025, View Source;utm_medium=rss&utm_campaign=orca-bio-announces-fda-acceptance-and-priority-review-of-the-biologics-license-application-bla-for-orca-t-to-treat-hematological-malignancies [SID1234656463]).

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 FDA granted the BLA Priority Review with a Prescription Drug User Fee Act (PDUFA) target action date of April 6, 2026.

"A stem cell transplant has been the only potentially curative option for many people with AML, ALL or MDS, however treatment-related toxicities too often hinder patient recovery. Acceptance of the Orca-T BLA marks a pivotal moment in our ability to deliver a first-in-class therapy designed to improve survival free from complications like graft versus host disease," said Nate Fernhoff, Ph.D., co-founder and chief executive officer at Orca Bio. "Supported by positive Phase 3 clinical data, today’s regulatory milestone reflects important recognition of the transformative potential of Orca-T. We look forward to working collaboratively with the FDA on the review of our application with the goal of advancing Orca-T and making it available to patients in need."

The BLA submission for Orca-T is supported by positive results from the pivotal Phase 3 study, Precision-T (NCT04013685), a randomized, open-label multi-center study that evaluated the safety, efficacy and tolerability of Orca-T compared to conventional allogeneic hematopoietic stem cell transplant (alloHSCT) in patients with AML, ALL and MDS. The study met its primary endpoint of a statistically significant improvement in survival free of moderate-to-severe chronic graft versus host disease (cGvHD) with Orca-T versus alloHSCT.

About Orca-T
Orca-T is an investigational allogeneic T-cell immunotherapy being evaluated for the treatment of multiple hematological malignancies including acute leukemias and myelodysplastic syndromes. Orca-T is composed of highly purified regulatory T-cells, hematopoietic stem cells and conventional T-cells derived from peripheral blood from either related or unrelated matched donors. Orca-T has received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug Designation for the prevention of graft versus host disease or death in patients eligible for hematopoietic stem cell transplant from the U.S. Food and Drug Administration.

Nanoligent closes €12 million Series A financing to advance its lead oncology nanodrug

On October 6, 2025 Nanoligent reported the completion of a €12 million Series A financing round led by Inveready (Inveready Biotech IV), with participation from CDTI (through the Innvierte program), Clave Capital (Clave Innohealth), and existing investors i&i Biotech Fund I, Italian Angels for Growth / Nanolinvest, and AVANTECA Partners (Press release, Nanoligent, OCT 6, 2025, https://www.nanoligent.com/nanoligent-closes-12-million-series-a-financing-to-advance-its-lead-oncology-nanodrug/ [SID1234656462]).

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 proceeds will support completion of the regulatory preclinical package for the company’s lead candidate, NNL1524, enable manufacturing scale-up, and fund the initiation of a Phase Ia clinical study in patients with solid tumors.

NNL1524 is a multivalent cytotoxic nanoparticle designed to selectively target the chemokine receptor CXCR4, a protein involved in tumor growth, invasion, and metastasis, and frequently overexpressed in several hematologic and solid malignancies including colorectal, lung, and breast cancers. In preclinical studies, NNL1524 demonstrated significant antitumor activity as a single agent and a favorable safety profile, supporting its advancement into clinical development.

Dr. Montserrat Cano, Chief Executive Officer of Nanoligent, commented:
"This financing represents an important milestone for Nanoligent. The support of such a strong syndicate of investors will be instrumental as the company progresses toward clinical validation of its technology and first-in-human studies."

Antonio Herce, Director of Investments at Inveready, stated:
"Nanoligent’s nanodrug platform offers a distinctive approach to targeted cytotoxic therapy, combining high selectivity, internalization efficiency, and stability. We are pleased to support the company’s efforts to bring this promising technology closer to patients."

The transaction was advised by Hoffmann Eitle and VentureTech Audit.