Novastra Therapeutics to Present Initial Phase 1 Data for OAP-101 in Anti–PD-1–Refractory Advanced Melanoma at ESMO Congress 2026

On October 13, 2026 Novastra Therapeutics, a clinical-stage biotechnology company developing a novel category of cancer immune therapy, reported that initial clinical data from an ongoing investigator-initiated Phase 1 study of its candidate OAP-101 in anti-PD-1-refractory advanced melanoma will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026, taking place October 23-27, 2026, in Madrid, Spain.

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Novastra’s OmniAntigen Platform (OAP) enables systematic immune reprogramming therapy (XIRT), with off-the-shelf in situ and autologous approaches designed to coordinate tumor-antigen presentation with innate immune activation, priming tumor-directed immunity. These approaches aim to overcome resistance of cold solid tumors to checkpoint inhibition and to act as an immune amplification companion for antibody-drug conjugates (ADCs), chemotherapy, and radiotherapy.

Presentation details:
Presentation type: Poster
Session: Investigational Immunotherapy
Title: OAP-101 autologous whole-tumor antigen system-level immune reprogramming therapy in anti–PD-1–refractory advanced melanoma
Presenting author: Junling Guo, PhD, Chief Executive Officer, Novastra Therapeutics
Presentation number: 2000P
Date and time: Saturday, October 24, 2026, at 12:00 – 12:45 CEST

The poster will feature the first clinical data for Novastra’s OAP/XIRT approach in a setting designed to overcome checkpoint-inhibitor resistance in immunologically cold solid tumors. The Phase 1 study investigates OAP-101 in patients with advanced metastatic melanoma refractory to multiple lines of currently available therapy, including anti-PD-1 checkpoint inhibition.

The full abstract will be available as of 12:05 a.m. CEST on October 19, 2026, through the ESMO (Free ESMO Whitepaper) Congress 2026 online programme and the Annals of Oncology Abstract Book supplement.

Reaching more patients with cold solid tumors who are currently left behind
Despite advances in checkpoint inhibition and ADCs, many patients with solid tumors still experience treatment resistance. For immunotherapy, a key challenge is the absence of an effective anti-tumor immune response because the tumor hides from immune recognition.1-3

Built on OAP, XIRT is designed to overcome this challenge by priming the immune system. OAP enables rapid antigen encapsulation with a supramolecular nanocloak for effective presentation to the immune system. The nanocloak is designed to combine antigen delivery with innate immune stimulation, including activation of the cGAS-STING pathway, connecting the innate and adaptive immune systems.4 OAP enables the preservation of a broad repertoire of tumor-cell antigens in autologous settings. For in vivo applications, Novastra is designing an in-situ approach where the nanocloak self-assembles within the tumor, capturing tumor-derived antigens released by ADCs, chemotherapy, or radiotherapy.

(Press release, Novastra Therapeutics, OCT 13, 2026, View Source [SID1234673377])

Zelluna ASA: Invitation to Third Quarter 2026 Results Webcast Including ZIMA-101 Clinical Progress Update

On October 13, 2026 Zelluna (OSE: ZLNA), a clinical-stage biotechnology Company pioneering allogeneic, off-the-shelf T-cell receptor-based natural killer (TCR-NK) cell therapies for solid cancers, reported it will publish its financial results for the third quarter of 2026 on Thursday, 5 November 2026.

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In connection with the third quarter results, the Company will provide an update on its activities during the quarter, including progress in the ongoing Phase 1 ZIMA-101 study of ZI-MA4-1, Zelluna’s first-in-class MAGE-A4-targeting TCR-NK cell therapy for advanced solid tumours.

The presentation will be available via a live webcast on www.zelluna.com at 09:00 CET on Thursday, 5 November 2026, and participants will be able to submit questions during the presentation. The webcast recording will remain available on the Company’s website after the event.

The quarterly report and presentation materials will be published on the Company’s website at 07:00 CET on Thursday, 5 November 2026, ahead of the webcast.

(Press release, Zelluna Immunotherapy, OCT 13, 2026, View Source [SID1234673376])

Biodexa announces another Serenta milestone with 100 patients enrolled in its registrational Phase 3 trial in FAP

On October 13, 2026 Biodexa Pharmaceuticals PLC (Nasdaq: BDRX) ("Biodexa" or "the Company"), a clinical stage biopharmaceutical company developing innovative products focused on the treatment or prevention of gastrointestinal cancers reported that it has enrolled 100 patients in its registrational Phase 3 trial of eRapa in Familial Adenomatous Polyposis (FAP), NCT06950385. The trial, branded "Serenta" is recruiting at 29 clinical sites across the US and five countries in Europe with a further two sites in Canada expected to be initiated shortly.

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The Serenta protocol provides for a pre-specified futility analysis after 25 Progression Free Survival (PFS) events and database lock after 75 PFS events in the Serenta trial. The Serenta protocol includes a composite endpoint which defines the nature of the PFS events.

Commenting, Stephen Stamp, Chief Executive Officer of Biodexa said "Enrolment of the 100th patient represents an important milestone for Serenta and reflects the continued strong recruitment performance across our participating sites. Based on the current rate of PFS event accrual, the pre-specified futility analysis could take place early next year with database lock potentially occurring around the end of next year, both significantly sooner than originally anticipated".

About Familial Adenomatous Polyposis

FAP is characterized by the proliferation of polyps in the colon, duodenum and/or rectum, usually occurring in mid-teens. There is no approved therapeutic option for treating FAP patients, for whom active surveillance and surgical resection of the colon and/or rectum remain the standard of care. If untreated, FAP typically leads to colorectal cancer. There is a significant hereditary component to FAP with a reported incidence of one in 5,000 to 10,000 in the US and one in 11,300 to 37,600 in Europe. eRapa has received Orphan Drug Designation in the US and in Europe. Importantly, mTOR has been shown to be over-expressed in FAP polyps – thereby underscoring the rationale for using a potent and generally safe mTOR inhibitor like eRapa to treat FAP.

About eRapa
eRapa is a proprietary oral capsule formulation of rapamycin, also known as sirolimus. Rapamycin is an mTOR (mammalian Target Of Rapamycin) inhibitor. mTOR has been shown to have a significant role in the signalling pathway that regulates cellular metabolism, growth and proliferation and is activated during tumorigenesis. Data from an open label Phase 2 trial were presented at Digestive Disease Week and InSIGHT 2024 in May and June 2024, respectively. Based on those data, Biodexa initiated a double-blind, placebo-controlled Phase 3 registrational trial in the US and Europe and plans to enrol 168 subjects randomized 2:1, drug: placebo. The Phase 3 program is supported by a $20 million grant from the Cancer Prevention and Research Institute of Texas.

(Press release, Biodexa Pharmaceuticals, OCT 13, 2026, View Source [SID1234673375])

VERAXA Biotech Presents in vivo Proof-of-Concept Data for BiTAC®-ADC Technology at World ADC Congress

On October 13, 2026 VERAXA Biotech AG (NASDAQ: VRXA; "VERAXA"), an emerging leader in designing novel cancer therapies, reported first in vivo proof-of-concept data and additional in vitro data validating its novel BiTAC-ADC technology platform at the 17th World ADC Congress in San Diego, CA, USA. The in vivo data demonstrate that a systemically applied, single dose of the two-component BiTAC-ADC selectively triggered a tumor-specific response resulting in a significant reduction in tumor volume, while continuing to show differentiated safety features and the potential to overcome systemic toxicity, the primary limitation of current ADCs.

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The in vivo data presented at the World ADC Congress showed that treatment with BiTAC-ADCs resulted in strong tumor regression in a xenograft breast cancer model even at a single dose of 3 mg/kg. As intended, BiTAC-ADCs utilizing one non-targeted component, thereby only delivering one component to the tumor, showed no significant effect. A control ADC, engineered by VERAXA using the same conjugation and linker-payload technology and with the same drug-antibody ratio (DAR) as its BiTAC-ADC counterpart, performed similarly. In the BiTAC-ADC treatment arm, no decrease in body weight could be observed.

"These novel datasets on the BiTAC-ADC platform underline the rapid progress our team has made in demonstrating the potentially transformative safety benefits of BiTAC-ADCs compared to conventional ADCs," said Christoph Erkel, Ph.D., Chief Scientific Officer at VERAXA. "While BiTAC-TCEs remain our priority, the rapid validation of our BiTAC-ADC concept bodes well for establishing a second pillar in our R&D and partnering strategy towards safer drugs for solid tumor patients."

"Demonstrating that BiTAC-ADCs can reach the tumor site following intravenous administration, induce a specific effect only upon arrival of both BiTAC components, and shrink the tumor in a living organism is a significant platform milestone and validates its underlying concept," added Paul Sauter, Ph.D., Senior Director and Department Head ADC Tech & Chemistry at VERAXA.

The poster presented at the World ADC congress also expanded on previously published in vitro studies and shows that BiTAC-ADCs can discriminate between cancer and healthy cells, require both BiTAC-ADC constructs to be co-targeted to the tumor site and do not release active toxins in the periphery. The BiTAC-ADC concept was also successfully evaluated across a wide range of cancer cell lines and against several validated ADC targets. Taken together, the data sets underline the potential for this novel therapeutic concept with comparable efficacy to a conventional ADC, but a mechanistically highly differentiated safety profile.

The BiTAC therapeutic strategy is designed to unlock a new level of precision in cancer treatment via dual-targeting using two complementary precursors and enabling a tumor-restricted activation of the desired therapeutic effect. Applied to the development of antibody drug conjugates (ADCs), the technology delivers a systemically inactive prodrug and a cell-impermeable proactivator through two separate antibodies, each addressing a defined tumor-associated antigen. While the single BiTAC-ADC precursors are therefore not toxic by design, the selective internalization of both components into the same cancer cell leads to dose-dependent cytotoxicity.

(Press release, Veraxa Biotech, OCT 13, 2026, View Source [SID1234673374])

Prelude Announces Clinical Trial Collaboration and Supply Agreement with Lilly to Evaluate KAT6A Selective Degrader PRT13722 in Combination with Verzenio® and Inluriyo® in Patients with HR+/HER2- Breast Cancer

On October 13, 2026 Prelude Therapeutics Incorporated (Nasdaq: PRLD), a precision oncology company, reported a clinical trial collaboration and supply agreement with Eli Lilly and Company ("Lilly") for supply of its CDK4/6 kinase inhibitor, abemaciclib and its oral estrogen receptor antagonist, imlunestrant. The agreement supports the evaluation of Prelude’s clinical development candidate PRT13722, an oral KAT6A selective degrader, in combinations with abemaciclib and imlunestrant in a Phase 1 trial in patients with HR+/HER2- breast cancer.

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The U.S. Food and Drug Administration (FDA) recently cleared the Company to proceed with the Phase 1 study under its Investigational New Drug (IND) Application for PRT13722. The Company expects to begin enrolling patients in the fourth quarter of 2026 beginning with monotherapy dose escalation and rapidly advancing to various combination cohorts.

"This collaboration with Lilly enables us to evaluate the potential of PRT13722 in combinations with abemaciclib and imlunestrant in patients with HR+ breast cancer," stated Sean Brusky, Chief Business & Strategy Officer of Prelude. "We are taking a highly differentiated approach to this clinically validated target. Our preclinical data demonstrate that selectively degrading KAT6A has the potential to improve upon the efficacy and hematologic toxicity seen with dual KAT6A/B inhibitors, thereby enabling combination approaches that could advance the standard of care in earlier lines of therapy. We are pleased to be partnering with Lilly, recognized global leaders in breast cancer, to generate these important data for patients."

At the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2026 Annual Meeting in April of this year, Prelude presented preclinical data that demonstrated PRT13722, by selectively degrading KAT6A, drives more complete disruption of the KAT6A regulatory pathways than dual KAT6A/B inhibitors, resulting in more robust depth and breadth of efficacy across HR+/HER2- breast cancer models. Additionally, PRT13722 drove durable complete tumor regressions in HR+/HER2- CDX and PDX xenograft models (both endocrine therapy naive and experienced) at well tolerated doses, as a monotherapy. In combinations with endocrine therapy, CDK4/6 inhibitors and PI3K inhibitors, PRT13722 demonstrated synergy while maintaining monotherapy and combination activity across HR+ breast cancer models, including ESR1 mutated and acquired therapy-resistant cancer cells. PRT13722 also demonstrated preclinically an improved hematological safety profile compared to the KAT6A/B dual inhibitor prifetrastat, which may enable combinations with standard of care agents used in the frontline treatment of metastatic and early-stage HR+/HER2- breast cancer.

Prelude maintains full global development and commercial rights to PRT13722 as a wholly owned program.

Highly selective KAT6A oral degrader program
KAT6 is an emerging and clinically validated target in the treatment of HR+ breast cancer. Prelude discovered and is developing first-in-class, highly potent, highly selective and orally bioavailable KAT6A degraders. Prelude believes that selectively degrading KAT6A and sparing KAT6B has the potential for improved efficacy, tolerability and combinability with other agents relative to dual inhibitors of KAT6A/B.

(Press release, Prelude Therapeutics, OCT 13, 2026, View Source [SID1234673373])