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BioNTech Highlights Late-Stage Lung Cancer Pipeline Momentum and First Global Data for Pumitamig/Elfetabart Drozuntecan
Novel-Novel Combination at WCLC 2026

On August 20, 2026 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported it will present new clinical data from its diversified development program in lung cancer treatment at the IASLC 2026 World Conference on Lung Cancer ("WCLC") in Seoul, Republic of Korea, from September 12-15, 2026.

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The breadth of data highlights the latest progress across key strategic assets, pumitamig (BNT327/BMS986545) and gotistobart (BNT316/ONC-392), as well as BioNTech’s mRNA-based immunotherapy approaches, highlighting the strength of BioNTech’s lung cancer treatment pipeline. Additionally, a late breaking oral presentation will detail data from the novel-novel combination trial of pumitamig with the investigational B7H3-targeted antibody-drug conjugate ("ADC") elfetabart drozuntecan (elfe-D or BNT324/DB-1311), representing the first combination data for any PD-(L)1xVEGF bispecific immunomodulator and an ADC in lung cancer.

"Progress in lung cancer care means both improving treatment outcomes for patients and, importantly, finding better options for more patients who still do not sufficiently benefit from current standard therapies," said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. "The data we are presenting at this year’s WCLC provide further clinical evidence for our late-stage assets, gotistobart and pumitamig, and help to define the role of next-generation immunomodulators in addressing unmet medical needs in lung cancer. We are also presenting the first clinical evidence from a novel-novel treatment combination in lung cancer as part of our evaluation of pumitamig as a potential backbone for combination strategies of complementary mechanisms. Taken together, these data will inform the next steps in our clinical development programs and our broader efforts to expand treatment options for patients."

Highlights from BioNTech’s presentations at WCLC 2026:

Novel-novel combination trial of pumitamig, developed in collaboration with Bristol Myers Squibb Company ("BMS"), and elfetabart drozuntecan, developed in collaboration with Duality Biologics (Suzhou) Co. Ltd. ("DualityBio"):
•Advanced/metastatic SCLC and NSCLC: First data from the global Phase 1/2 trial (NCT06892548) evaluating pumitamig in combination with the B7H3-targeting ADC elfetabart drozuntecan in patients with advanced or metastatic small cell lung cancer ("SCLC") and NSCLC will be presented for this novel-novel treatment combination approach, underlining BioNTech’s leadership in novel-novel combination treatment strategies.

Gotistobart – a tumor microenvironment-selective regulatory T cell depletion candidate targeting CTLA-4, developed in collaboration with OncoC4, Inc. ("OncoC4"):

•2L+ squamous NSCLC: Updated overall survival data from stage 1 of the PRESERVE-003 Phase 3 clinical trial (NCT05671510) of gotistobart in patients with squamous non-small cell lung cancer ("NSCLC") who progressed on prior PD-(L)1 inhibitor treatment will be presented. The results further contribute to the growing body of evidence for this chemotherapy-free treatment approach. The pivotal stage 2 part of the trial is ongoing.

All abstracts are available through the WCLC website. Further information on BioNTech’s lung cancer pipeline can be accessed here.

Full presentation details:

Candidate
Abstract Title
Abstract Number/Presentation Details
Pumitamig + elfetabart drozuntecan
Pumitamig (PD-L1 x VEGF-A bsAb) + Elfetabart Drozuntecan (Elfe-D, B7H3 ADC) in Patients with Advanced/Metastatic Lung Cancer (NSCLC or SCLC)
Abstract # OA14.01
Oral Presentation
The Breakthrough Immunotherapy for Advanced NSCLC
Sep 15, 2026: 12:30 – 01:45pm KST
Pumitamig
First-line Pumitamig (PD-L1 × VEGF-A bsAb) Plus Chemotherapy in Unresectable Malignant Mesothelioma: Long-term PFS and OS
Abstract #MO04.09
Mini Oral
Novel Therapeutics and Molecular Insights in Thymic Malignancies and Pleural Mesothelioma
Sep 13, 2026: 4:45 – 6:00pm KST
ROSETTA Lung‑201: A Phase 3 Trial of Pumitamig Monotherapy vs Durvalumab in Unresectable Stage III NSCLC Post-Chemoradiation
Abstract #P2.330
Poster
Clinical Trials in Progress
Sep 14, 2026: 10:30am – 12:00pm KST
ROSETTA Lung-202: A Phase 3 trial of first-line pumitamig monotherapy vs pembrolizumab in locally advanced/metastatic NSCLC
Abstract #P2.355
Poster
Clinical Trials in Progress
Sep 14, 2026: 10:30am – 12:00pm KST
Gotistobart
Gotistobart vs Docetaxel in Metastatic Squamous NSCLC After PD-(L)1 Progression: Updated Overall Survival of the stage 1 of PRESERVE-003
Abstract #MO07.04
Mini Oral
Novel Immunotherapeutic Strategies in mNSCLC
Sep 14, 2026: 5:00 – 6:15pm KST
BNT116
Neoadjuvant BNT116 + Cemiplimab + Carboplatin + Paclitaxel in Resectable NSCLC: Preliminary Results From a Phase I Trial
Abstract #MO06.03
Mini Oral
Emerging Precision Approaches in Perioperative Therapy for Resectable NSCLC Integrating Targeted Therapy, Immunotherapy, Biomarkers, and Multimodal Strategies
Sep 14, 2026: 3:30 – 4:45pm KST

About BioNTech in Lung Cancer Treatment
Lung cancer is one of BioNTech’s key focus areas. Through a diversified portfolio of investigational next-generation immunomodulators, ADCs and mRNA-based cancer immunotherapies, the Company is pursuing multiple approaches designed to address significant unmet needs for patients across lung cancer subtypes, histologies and treatment settings. BioNTech’s clinical pipeline encompasses both monotherapies and combinations with standard of care treatments, as well as novel-novel combination regimens aimed at delivering differentiated therapeutic profiles for the treatment of patients with lung cancer. With 16 ongoing lung cancer trials, including five pivotal Phase 3 and two novel-novel combination trials, BioNTech is advancing a comprehensive development strategy with the aim of improving outcomes for patients across the continuum of lung cancer.

(Press release, BioNTech, AUG 20, 2026, View Source [SID1234670248])

Akiram Therapeutics and ITM Sign Lutetium-177 Supply Agreement to Support Development of AKIR001 for the Treatment of Solid Tumors

On August 20, 2026 Akiram Therapeutics, a Swedish clinical-stage biotech company specializing in molecular radiotherapy, and ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, reported a supply agreement for non-carrier-added (n.c.a.) Lutetium-177 (Lu-177 or 177Lu) to support the development of 177Lu-AKIR001 (AKIR001), a targeted antibody-radionuclide conjugate with first-in-class potential, currently in clinical testing for the treatment of CD44v6-expressing solid tumors.

Under the terms of the agreement, ITM will provide its high-quality n.c.a. Lu-177 for use in Akiram’s ongoing clinical trial for AKIR001, the company’s lead radiopharmaceutical candidate. Lu-177 is one of the most widely used medical radioisotopes in targeted radionuclide therapy and serves as the active payload in AKIR001. Reliable access to this isotope is essential for clinical development, and ITM’s position as a leading global supplier will support the continued advancement of the program. Additional details of the agreement have not been disclosed.

"We are pleased to partner with ITM, a leading global producer and supplier of n.c.a. Lu-177, as we continue advancing AKIR001 through clinical development," said Marika Nestor, chief executive officer of Akiram Therapeutics. "This agreement helps secure an important component for the continued development of AKIR001 and marks a significant step in advancing the program designed to address a primary driver of aggressive cancers."

AKIR001 is a targeted radiopharmaceutical drug candidate that combines the therapeutic radioisotope n.c.a. Lu-177 with a proprietary antibody targeting CD44v6, a cancer marker associated with several aggressive tumor types. The approach is designed to deliver radiation selectively to tumor cells while limiting exposure to healthy tissue. The candidate is currently being evaluated in a Phase I clinical trial (NCT06639191) at Stockholm’s Karolinska University Hospital in patients with irresectable or metastatic CD44v6-positive solid tumors, including lung, head and neck, thyroid, and gynecological cancers.

"At ITM, we remain committed to advancing and enabling the development of innovative radiopharmaceuticals for hard-to-treat cancers. This agreement with Akiram allows us to provide a dependable, high-quality source of n.c.a. Lu-177 for their clinical trials and research that may, in time, prove genuinely transformative," added Dr. Andrew Cavey, chief executive officer at ITM. "We are pleased to support the continued clinical development of AKIR001 through our manufacturing expertise and consistency of supply, and we wish Akiram every success as they advance this promising therapy."

(Press release, Akiram Therapeutics, AUG 20, 2026, View Source [SID1234670247])

Zelluna ASA: Second Quarter 2026 results

On August 20, 2026 Zelluna (OSE: ZLNA), a clinical-stage company pioneering allogeneic "off-the-shelf" T Cell Receptor-based Natural Killer (TCR-NK) cell therapies for the treatment of solid cancers, reported its results for the second quarter 2026.

Webcast scheduled for 20 August 2026 at 09:00 (CEST). Link to webcast here.

Operational Highlights:

First patient dosed with ZI-MA4-1: On 13 July 2026, Zelluna announced the dosing of the first patient in the Phase 1 ZIMA-101 study, marking the first clinical evaluation of the Company’s proprietary TCR-NK platform. ZI-MA4-1 is the world’s first MAGE-A4-targeting TCR-NK therapy to enter clinical testing. Patient recruitment is ongoing at two clinical sites in the UK.
Favourable initial safety observations support continued enrolment: On 17 August 2026, the Independent Data Monitoring Committee (IDMC) completed its planned safety review of the first patient. ZI-MA4-1 was well tolerated during the protocol-defined safety observation period, with no dose-limiting toxicities observed. The IDMC recommended recruitment of the remaining two patients at Dose Level 1. These observations represent the first clinical data from ZIMA-101.
The Royal Marsden activated as second clinical site: On 29 June 2026, Zelluna announced that The Royal Marsden NHS Foundation Trust had been activated as the second clinical site in the ZIMA-101 Phase 1 clinical trial. Together with The Christie NHS Foundation Trust, the two sites provide a strong clinical foundation for patient recruitment and execution of the ZIMA-101 study.
Private placement and retail offering successfully completed: In June 2026, Zelluna successfully completed a private placement and retail offering, raising gross proceeds of approximately NOK 58.2 million through the issuance of 3,143,958 new shares at a subscription price of NOK 18.50 per share. The financing strengthens Zelluna’s position as the Company approaches initial clinical data, supports the continued execution of the ZIMA-101 clinical trial, and enhances financial flexibility to pursue future strategic opportunities.
NOK 16 million grant awarded by the Research Council of Norway: In June 2026, the Research Council of Norway approved a NOK 16 million grant to Zelluna under the Innovation Project for the Industrial Sector (IPN) scheme. The funding will support the ongoing Phase 1 ZIMA-101 clinical study.
ZIMA-101 to be presented at ESMO (Free ESMO Whitepaper) 2026: In July 2026, an abstract describing the ongoing ZIMA-101 Phase 1 study of ZI-MA4-1 was accepted for poster presentation at the ESMO (Free ESMO Whitepaper) Congress 2026 in Madrid on 23–27 October 2026. The poster will be presented by Professor Fiona Thistlethwaite, Chief Investigator of the study at The Christie NHS Foundation Trust.
Notice of EGM – election of new Board member: On 17 August 2026, the Board called for an Extraordinary General Meeting regarding election of a new member of the Board. The Nomination Committee has proposed Martin Welschof for election as a new member of the Board, whilst Hans Ivar Robinson, who has served on the Board since its foundation, has decided to step down from the Board in line with Birk Venture’s approach of transitioning out of board positions within a reasonable period following a listing.
Financial Highlights Q2 2026:

Total operating expenses: MNOK 19.9 in Q2 2026 and MNOK 40.2 YTD
Total loss: MNOK 19.7 in Q2 2026 and MNOK 40.1 YTD
Cash and cash equivalents: MNOK 86.2 as of 30 June 2026
Financial runway: Into Q3 2027
"The second quarter and the period immediately following it have been defining for Zelluna. We set out to establish the clinical infrastructure for ZIMA-101, bring ZI-MA4-1 into the clinic and begin generating the first clinical data from our TCR-NK platform, and we have delivered on those objectives.

The first patient has now been treated, and we have reported favourable initial safety observations, with the independent monitoring committee recommending continued enrolment. I am incredibly proud of what our team has achieved. Our focus now is on continuing to execute ZIMA-101, generating the clinical data that will begin to define the potential of our TCR-NK platform, and continuing to build the pipeline that can extend that potential beyond ZI-MA4-1," says CEO Namir Hassan.

Outlook

Zelluna enters the second half of 2026 with strong momentum following the initiation of the ZIMA-101 first-in-human Phase 1 study and the Independent Data Monitoring Committee’s recommendation to continue enrolment after its review of the first patient’s safety data. With both clinical sites now activated, patient recruitment is ongoing and ZIMA-101 is progressing as planned. In parallel, Zelluna continues to strengthen its manufacturing capabilities to support the future development of ZI-MA4-1 and the broader TCR-NK platform. The Company remains focused on disciplined execution and the generation of high-quality clinical data to advance ZI-MA4-1 and its broader TCR-NK platform. Zelluna’s cash position is expected to fund planned operations into the third quarter of 2027, providing a solid foundation to execute its strategy and pursue future value-creating opportunities.

The quarterly report and presentation materials will be made publicly available on the Zelluna website at 07:00 CEST on 20 August 2026. The Company will host a webcast on 20 August at 09:00 CEST, and questions can be submitted during the event. The webcast recording will remain available on the Company’s website after the event.

(Press release, Zelluna Immunotherapy, AUG 20, 2026, View Source [SID1234670229])

Regeneron Announces Investor Conference Presentations

On August 19, 2026 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported it will webcast management participation as follows:

2026 Wells Fargo Healthcare Conference at 8:45 a.m. ET on Wednesday, September 9, 2026
Morgan Stanley 24th Annual Global Healthcare Conference at 1:05 p.m. ET on Monday, September 14, 2026
Bernstein Insights: Healthcare Leaders and Disruptors – 3rd Annual Healthcare Forum at 10:30 a.m. ET on Wednesday, September 23, 2026

The sessions may be accessed from the "Investors & Media" page of Regeneron’s website at View Source Replays and transcripts of the webcasts will be archived on the Company’s website for at least 30 days.

(Press release, Regeneron, AUG 19, 2026, View Source [SID1234670244])

Biodexa announces major milestone for its Serenta registrational Phase 3 trial in FAP

On August 19, 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 exceeded the half-way point in the recruitment of subjects in its registrational Phase 3 trial of eRapa in Familial Adenomatous Polyposis (FAP), NCT06950385. As of today, 87 of a planned 168 subjects have been recruited into the Serenta trial. The trial is recruiting at 29 clinical sites across the US and five countries in Europe with a further three sites in Canada expected to be initiated shortly.

The Company is planning a 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 "I should like to thank our collaborators at the leading FAP treatment centers who have helped drive recruitment in Serenta and put us ahead of any competition."

About Familial Adenomatous Polyposis

FAP is characterized by the proliferation of polyps in the colon 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 cancer of the colon and/or rectum. 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 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. Importantly, mTOR has been shown to be over-expressed in FAP polyps – thereby underscoring the rationale for using a potent and safe mTOR inhibitor like eRapa to treat FAP. 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 which is planned to initiate 30 clinical sites across the US and Europe and 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, AUG 19, 2026, View Source [SID1234670243])