Lyell Immunopharma to Present Phase 1/2 Safety and Translational Data for Ronde-Cel in Large B-Cell Lymphoma at the European Hematology Association 2026 Congress

On June 4, 2026 Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing a pipeline of next-generation chimeric antigen receptor (CAR) T-cell therapies for patients with cancer, reported that the Company will present data from its ongoing Phase 1/2 clinical trial of rondecabtagene autoleucel (ronde-cel) in patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress, taking place in Stockholm, Sweden, June 11–14, 2026. The data will be featured in two poster presentations covering an updated ronde-cel safety analysis and translational insights.

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EHA 2026 Poster Presentations

Low-Grade CRS and ICANS with Rondecabtagene Autoleucel, a Dual-Targeting CD19/CD20 CAR T-Cell Product Candidate, in Patients with Large B-Cell Lymphoma: Updated Safety Analysis

Poster: PF962
Session: Large B-Cell Lymphomas – Clinical; Hall A
Time: Friday, June 12, 12:45 pm EDT / 6:45 pm CEST
Presenting Author: Sarah M. Larson, M.D., Associate Professor in the Division of Hematology-Oncology, David Geffen School of Medicine, UCLA
Durable Responses with Rondecabtagene Autoleucel (Dual-Targeting CD19/CD20 CAR
T-Cells) are Associated with Higher Proportion of Cytotoxic T Cells with Memory Potential in Infusion Products

Poster: PF1097
Session: Lymphoma Biology & Translational Research; Hall A
Time: Friday, June 12, 12:45 pm EDT / 6:45 pm CEST
Presenting Author: Akil Merchant, M.D., Associate Professor and Co-Director of the Lymphoma Program, Samuel Oschin Cancer Center, Cedars-Sinai Medical Center
Ronde-cel is currently being evaluated for the treatment of R/R LBCL across two pivotal clinical trials. In the 3L+ setting, the ongoing single-arm PiNACLE trial is expected to report updated data in the second half of 2026 and pivotal data by mid-2027, setting up a subsequent Biologics License Application (BLA) submission in 2027. In the 2L setting, the Phase 3 randomized PiNACLE-H2H trial is evaluating ronde-cel against investigator’s choice of axicabtagene ciloleucel or lisocabtagene maraleucel.

The posters will be available through the Science section of the Company’s website at www.lyell.com after the presentations.

(Press release, Lyell Immunopharma, JUN 4, 2026, View Source [SID1234666453])

Akari Therapeutics Releases CEO Corner Reflecting on Evolving ADC Landscape and Akari’s Differentiated PH1 Payload Platform Following ASCO 2026

On June 4, 2026 Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing antibody drug conjugates (ADCs) with novel RNA splicing modulator payloads, reported a new CEO Corner segment featuring President and Chief Executive Officer Abizer Gaslightwala discussing key themes emerging from the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and Akari’s positioning within the evolving ADC landscape.

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In the segment, Mr. Gaslightwala reflects on the accelerating pace of innovation across oncology and the growing industry focus on difficult-to-treat, genetically defined cancers, particularly KRAS-driven tumors such as pancreatic, lung and colon cancers where significant unmet need remains today.

Mr. Gaslightwala also discusses the continued momentum surrounding ADC development and what he believes represents the industry’s transition toward "ADC 2.0," driven by increasing demand for differentiated payload technologies capable of overcoming limitations associated with existing Top1 and MMAE payload classes.

The discussion highlights emerging clinical data presented at ASCO (Free ASCO Whitepaper) suggesting limited efficacy when patients receive sequential ADC therapies utilizing the same payload class following relapse, reinforcing the growing need for novel payload approaches across the ADC landscape.

As part of the CEO Corner, Mr. Gaslightwala discusses Akari’s proprietary PH1 spliceosome-modulating payload platform and why the Company believes its differentiated mechanism may potentially help address resistance challenges observed with current ADC approaches while expanding therapeutic applicability across multiple difficult-to-treat solid tumors.

The segment also highlights Akari’s first accepted ASCO (Free ASCO Whitepaper) abstract featuring preclinical data demonstrating combination synergy between the PH1 ADC payload and a KRAS inhibitor in KRAS-mutated pancreatic cancer models, further supporting the potential applicability of Akari’s novel payload platform within the rapidly evolving KRAS therapy landscape.

In addition, Mr. Gaslightwala outlined several anticipated milestones investors should monitor throughout the remainder of 2026, including continued advancement of Akari’s PH1 spliceosome-modulating payload platform and the Company’s planned initiation of its Phase 1 first-in-human clinical trial for its lead development candidate AKTX-101which is expected by mid-2027.

(Press release, Akari Therapeutics, JUN 4, 2026, View Source [SID1234666437])

MAIA Biotechnology Reports Strong Enrollment and Dosing Momentum in Pivotal Phase 3 Non-Small Cell Lung Cancer Trial

On June 4, 2026 MAIA Biotechnology, Inc. (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, reported a patient enrollment update for its ongoing pivotal Phase 3 trial, THIO-104, evaluating its novel telomere-targeting therapy as a third-line (3L) treatment for advanced non-small cell lung cancer (NSCLC). To date, 29 patients have been dosed among 34 activated trial sites in 6 foreign countries.

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Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA, commented, "Enrollment and dosing in our Phase 3 study is progressing at a strong pace. Based on this early momentum, we are targeting up to 100 patients by year-end and expect to have sufficient survival data to conduct an interim analysis in 2027."

Dr. Vitoc has previously stated that statistical assessments of MAIA’s lead therapeutic, ateganosine, suggest a high probability of technical success in the THIO-104 full approval trial if Phase 3 data is consistent with Phase 2 THIO-101 trial results. Median overall survival was 17.8 months in parts A and B of the Phase 2 trial. With chemotherapy, which is the standard utilized treatment for 3L NSCLC patients, expected survival in a heavily pre-treated population is 5.8 months.1

Ateganosine is a first-of-its-kind dual mechanism therapy designed to break down telomere structure and function in cancer cells while inducing immune activation. As a potential breakthrough therapeutic, ateganosine holds substantial commercial opportunity in a projected $70 billion global NSCLC treatment market by 2030.2

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ateganosine as a 3L NSCLC treatment.

About Ateganosine

Ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment of ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About THIO-104 Phase 3 Clinical Trial

THIO-104 is a multicenter, open-label, randomized Phase 3 clinical trial, designed to evaluate ateganosine’s telomere-targeting anti-tumor activity when followed by PD-(L)1 inhibition in patients with advanced third-line NSCLC who previously did not respond or developed resistance to treatment regimens containing checkpoint inhibitor and/or chemotherapy and have progressed. The trial has two primary objectives: (1) to assess the clinical efficacy of ateganosine compared to investigator’s choice of chemotherapy, using median Overall Survival (OS) as the primary clinical endpoint (2) to evaluate the safety and tolerability of ateganosine in sequential combination with a checkpoint inhibitor. For more information on this Phase 3 trial, please visit ClinicalTrials.gov using the identifier NCT06908304.

(Press release, MAIA Biotechnology, JUN 4, 2026, View Source [SID1234666454])

Oncovita presents promising preclinical data on MVdeltaC, a novel onco-immunotherapy at EACR, 8-11 June 2026, in Budapest

On June 4, 2026 Oncovita, a French biotech company specialized in therapeutic and prophylactic vaccines, reported that the full preclinical pharmacology package of its lead candidate MVdeltaC which supports the entry into clinics will be presented at the European Association for Cancer Research annual congress (EACR-2026) to be held in Budapest, Hungary on June 08-11, 2026.

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MVdeltaC is a genetically modified measles virus, one of the Oncovita candidates based on its proprietary technology platform Measovir, derived from the safe and highly immunogenic measles attenuated vaccine virus, a technology which has been previously used successfully for the development of several prophylactic vaccines.

Pr. Frédéric Tangy, CSO and Jean-François Le Bigot PhD, Executive President will present a poster (N° P-402) titled: « In situ cancer immunotherapy with modified MVdeltaC measles virus induces potent RIG-I dependent tumor clearance and immune memory".

This presentation will include results obtained from in vitro and in vivo models of solid tumor, including PDX models and syngeneic models in immunocompetent mice, such as mesothelioma, bladder, TNBC and neuroblastoma.

MVdeltaC exhibits a very strong immunogenic apoptosis activity resulting in tumor regression and up to total disappearance of the tumors in immunocompetent models (corresponding to RECIST CR Complete Remission). In addition, when animals which completely rejected tumor were re-challenged with tumor cells, no tumor growth was observed, demonstrating antitumor immune protection.

Detailed investigations of the biological MOA allow to conclude to the activation of RIG-I receptor by the defective viral RNA molecules massively generated by the modified measles virus which results in strong innate and adaptive immune activation against the tumors.

Finally, an investigation using IA, in collaboration with Infinitusbio.AI, concludes that MVdeltaC has more impact than MV on 70% of the 104 cancer biomarkers.

MVdeltaC has been granted the Orphan Drug Status by the US-FDA and the EMA for mesothelioma use.

"We look forward to meeting with colleagues and experts at the EACR congress and sharing the positive results gained with MVdeltaC" said Frédéric Tangy, Scientific Director.

"We are now preparing the GMP batch production of this first candidate in an internationally recognized CDMO in order to initiate clinical trial by end of 2027. With the benefit from the ODD status, we could establish a clinical development plan leading to registration while already initiating discussions with VCs and with potential pharma-biotech partners" concluded Jean-François Le Bigot, Executive Chairman of Oncovita.

(Press release, Oncovita, JUN 4, 2026, View Source [SID1234666472])

Lixte Biotechnology Holdings, Inc. Announces Closing of approximately $16.6 Million Registered Direct Offering Priced at the Market Under Nasdaq Rules

On June 4, 2026 Lixte Biotechnology Holdings, Inc. (NASDAQ: LIXT) (the "Company"), a biotech company focused on advancing cancer treatments, reported that it intends to close a registered direct offering with accredited investors for the purchase and sale of approximately $16.6 million of shares of Common Stock and pre-funded warrants at a price of (i) an offering price of $6.31 per share of common stock, and (ii) an offering price of $0.0001 per Pre-funded Warrant . The entire transaction was priced at the market under Nasdaq rules.

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The offering consisted of the sale of 2,625,362 shares of common stock and Pre-Funded Warrant entitling the holder to purchase one share of common stock (and the common stock issuable from time to time upon exercise of such pre-funded warrants). The public offering price per common stock was $6.31 (or $6.3099 for each Pre-Funded Warrant, which was equal to the public offering price per common share sold in the offering minus an exercise price of $0.0001 per Pre-Funded Warrant). The Pre-Funded Warrants are immediately exercisable and may be exercised at any time until exercised in full.

Aggregate gross proceeds to the Company from the offering were approximately $16.6 million. The transaction closed on June 4, 2026. The Company intends to use the net proceeds from the offering, together with its existing cash, for general corporate purposes and working capital.

Sichenzia Ross Ference Carmel LLP acted as counsel to the Company

The registered direct offering was made pursuant to an effective shelf registration statement on Form S-3 (No. 333-278874) previously filed with the U.S. Securities and Exchange Commission (SEC) and declared effective by the SEC on May 2, 2024. A final prospectus supplement and accompanying prospectus describing the terms of the offering have been filed with the SEC and are available on the SEC’s website located at www.sec.gov.

Interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that the Company filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about the Company and such offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy 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 registration or qualification under the securities laws of any such state or jurisdiction.

(Press release, Lixte Biotechnology, JUN 4, 2026, View Source [SID1234666438])