Akari Therapeutics ASCO Abstract Acceptance Highlights Potential for AKTX-101 ADC to Treat KRAS Mutant Tumors

On April 21, 2026 Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing antibody drug conjugates (ADCs) with novel RNA splicing modulating payloads, reported that its abstract has been accepted for online publication at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2026.

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This marks Akari’s first abstract acceptance at ASCO (Free ASCO Whitepaper), one of the most highly regarded forums in clinical oncology research, and represents a significant milestone for the Company as it continues to advance its AKTX-101 ADC into Phase 1 clinical development by late 2026/early 2027.
Details are as follows:

Abstract Title: Combination synergy of spliceosome modulator ADC with a K-Ras inhibitor in KRAS–mutated pancreatic cancers

Date and Time: The full publication will be made available on May 21, 2026, at 5:00 PM ET on the ASCO (Free ASCO Whitepaper) website.

"This first ASCO (Free ASCO Whitepaper) acceptance for Akari is continued validation of our novel RNA splicing modulator payload platform for ADCs, and its broad potential in treating a wide range of cancer tumors, including those with KRAS mutations, a rapidly expanding therapeutic category moving forward," said Abizer Gaslightwala, President and Chief Executive Officer of Akari Therapeutics. "We believe this data highlights a growing body of evidence demonstrating that targeting RNA splicing in cancer cells could be a powerful way to attack even the most difficult cancers."

Additional details will be disclosed in accordance with ASCO (Free ASCO Whitepaper) embargo policies.

For more information about the ASCO (Free ASCO Whitepaper) Annual Meeting 2026, please visit asco.org.

(Press release, Akari Therapeutics, APR 21, 2026, View Source [SID1234664594])

Genprex Signs Sponsored Research Agreement to Study Biomarkers that May Predict Patient Response to Reqorsa® Gene Therapy

On April 21, 2026 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported the Company has entered into a new Sponsored Research Agreement (SRA) with The University of Texas MD Anderson Cancer Center (UT MD Anderson) to study biomarkers that may predict patient response to Reqorsa Gene Therapy (quaratusugene ozeplasmid), the Company’s lead drug candidate that is in development for the treatment of non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC).

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Shortly after it was founded, Genprex entered its first SRA with UT MD Anderson in 2010, and the two parties have completed several subsequent SRAs. These efforts demonstrate Genprex’s commitment to innovative cancer treatments and improving outcomes for patients through the continued research and development of its oncology pipeline.

In preclinical studies, research collaborators have identified TROP2 and PTEN as two potential biomarkers that may increase the likelihood of patient response to REQORSA. TROP2 (trophoblast cell-surface antigen 2) is a transmembrane glycoprotein that functions as a cell surface receptor. TROP2 overexpression in adult tissues is a hallmark of many solid tumors, making it a major target for modern cancer therapies. PTEN (phosphatase and tensin homolog) is a tumor suppressor gene that serves as a multi-functional cancer biomarker for risk assessment, diagnosis and treatment planning in a number of cancers.

"We are very excited to expand our research of TROP2 and PTEN to better understand how these biomarkers might predict and improve outcomes in patients treated with REQORSA," said Ryan Confer, President and Chief Executive Officer at Genprex. "We believe this research agreement demonstrates Genprex’s commitment to developing tailored treatment options for lung cancer patients who have unmet medical need, and we believe this research sets Genprex at the forefront of precision oncology treatment."

Research with TROP2 and PTEN may provide insights that could refine Genprex’s patient selection strategies for its Acclaim-1 and Acclaim-3 clinical trials and optimize clinical outcomes.

Acclaim-1 is a Phase 1/2 clinical trial that uses a combination of REQORSA and AstraZeneca’s Tagrisso (osimertinib) in patients with late-stage NSCLC that has activating epidermal growth factor receptor (EGFR) mutations and progression on treatment with Tagrisso or Tagrisso-containing regimens. Genprex is currently enrolling and treating patients in the Phase 2a expansion portion of the Acclaim-1 clinical trial following the successful completion of the Phase 1 dose escalation portion of the study. The Phase 1 portion showed REQORSA was generally well tolerated with no dose limiting toxicities (DLTs) despite doubling the starting dose. Importantly, the results showed early signs of efficacy with some patients experiencing prolonged progression free survival and one patient having a partial response. There were three patients out of the twelve originally enrolled in the Phase 1 dose escalation portion of the study who had prolonged progression-free survival (PFS). One patient attained a partial remission after the second course of REQORSA and Tagrisso and has maintained this response through 60 courses of treatment (approximately 42 months), and this patient continues to receive REQORSA and Tagrisso treatment to date.

Acclaim-3 is a Phase 1/2 clinical trial that uses a combination of REQORSA and Genentech, Inc.’s Tecentriq (atezolizumab) as maintenance therapy for patients with extensive stage small cell lung cancer (ES-SCLC) who did not develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment. Patients are treated with REQORSA and Tecentriq until disease progression or unacceptable toxicity is experienced. Genprex is currently enrolling and treating patients in the Phase 2 expansion portion of the Acclaim-3 clinical trial following the successful completion of the Phase 1 dose escalation portion of the study, which showed no DLTs. One patient in the Phase 1 portion of the study achieved an unconfirmed partial remission after 24 cycles of therapy and continues to receive study treatment in the trial after more than 18 months.

"We have seen in our Acclaim clinical trials that there are some patients whose cancer progresses after a short number of cycles of treatment, but we have also seen that some patients benefit from REQORSA for a very long time, in one case for more than three years," said Mark Berger, Chief Medical Officer at Genprex. "It is important to understand why some patients are responding very well to REQORSA, and we believe that the identification of biomarkers will allow us to predict which future patients may have these similar, positive responses. This meaningful research will not only benefit patients, but we believe it will allow for better prediction of those likely to benefit in the future."

(Press release, Genprex, APR 21, 2026, View Source [SID1234664610])

Aktis Oncology Announces Presentation of First Clinical Imaging and Dosimetry Data for AKY-2519 at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting

On April 21, 2026 Aktis Oncology, Inc. (NASDAQ:AKTS) (the "Company"), a clinical-stage oncology company focused on expanding the breakthrough potential of targeted radiopharmaceuticals to large populations, including those not addressed by existing platform technologies, reported that clinical imaging and dosimetry data of AKY-2519 in patients with various B7-H3 expressing solid tumors will be presented in two poster presentations at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held May 29 – June 2, 2026, in Chicago.

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AKY-2519 is a miniprotein radioconjugate targeting B7-H3, which is expressed in several solid tumors, including prostate and lung cancers. In March 2026, the U.S. Food and Drug Administration (FDA) cleared Investigational New Drug (IND) applications for Aktis to proceed to a Phase 1b clinical trial with AKY-25191. AKY-2519 is the second clinical-stage miniprotein radioconjugate discovered using Aktis’ proprietary platform. The Company’s lead miniprotein radioconjugate, AKY-1189, targeting Nectin-4, is currently enrolling patients in a Phase 1b clinical trial. Aktis’ miniprotein radioconjugates are designed to selectively deliver actinium-225 (225Ac), a highly potent alpha-emitting radioisotope, to target-expressing tumors.

Details of the ASCO (Free ASCO Whitepaper) presentations on AKY-2519 are as follows:

Presentation Title: AKY-2519, a novel B7-H3–targeted radioconjugate, and its biodistribution profile in patients with mCRPC*
Date and Time: May 30, 1:30 p.m.- 4:30 p.m. CDT
Poster Session: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Poster #: 234
Abstract #: 3097
*This normal tissue biodistribution and tumor uptake assessment through PET/CT imaging and normal tissues and tumor dosimetry analyses through sequential SPECT/CT imaging of patients with mCRPC was conducted at the Nuclear Medicine Research Infrastructure (NuMeRI), University of Pretoria and Steve Biko Academic Hospital, South Africa.

Presentation Title: First-in-human PET/CT imaging with 68Ga-AKY-2519, a B7-H3 targeted miniprotein radioconjugate, to demonstrate tumor uptake and normal tissue exposure across various advanced solid tumors**
Date and Time: May 30, 1:30 p.m.- 4:30 p.m. CDT
Poster Session: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Poster #: 235
Abstract #: 3098
**This normal tissue biodistribution and tumor uptake assessment through PET/CT imaging in various solid tumors was conducted at the Department of Nuclear Medicine, University of Duisburg-Essen and German Cancer Consortium (DKTK), Universitätsklinikum Essen (University Hospital Essen), Essen, Germany.

About Aktis’ miniprotein radioconjugate platform
Aktis has developed a proprietary, isotope-agnostic miniprotein radioconjugate platform to selectively deliver the tumor-killing properties of radioisotopes to targeted tumors. Aktis’ therapeutic miniprotein radioconjugates are designed to maximize anti-cancer activity through high tumor penetration coupled with internalization and retention in cancer cells, while rapidly clearing from normal organs and tissues. The Aktis platform further enables clinicians to visualize and verify target engagement with imaging isotopes prior to exposure to therapeutic radioisotopes. Leveraging this platform, and its patient-first end-to-end supply chain, Aktis is advancing a pipeline of next-generation targeted radiopharmaceuticals to address the unmet needs of patients across a broad spectrum of solid tumors.

(Press release, Aktis Oncology, APR 21, 2026, View Source [SID1234664626])

Assertio Provides Update on Garda Therapeutics Tender Process

On April 21, 2026 Assertio Holdings, Inc. ("Assertio" or the "Company") (Nasdaq: ASRT), reported an update that Garda Therapeutics, Inc. ("Garda") intends to commence the tender offer to acquire all outstanding shares of Assertio on April 29, 2026 – the day following the expiration of the 20-day "window-shop" period.

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As previously announced on April 8, 2026, Assertio has entered into a definitive agreement (the "Garda Agreement") to be acquired by Garda for $18.00 per share in cash, or a total cash consideration of $125.1 million, plus a contingent value right. The Garda Agreement includes a 20-day "window-shop" period. Under the terms of the window-shop provision, Assertio is free to engage with other parties who may provide superior value to shareholders. In the event the Board terminates the Garda Agreement in favor of a superior bid during the window-shop period, a reduced breakup fee would apply.

(Press release, Assertio Holdings, APR 21, 2026, View Source [SID1234664642])

CytoDyn Completes Enrollment in Phase 2 Metastatic Colorectal Cancer Study

On April 21, 2026 CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a clinical-stage oncology company advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor with therapeutic potential across multiple indications, including metastatic triple-negative breast cancer ("mTNBC") and colorectal cancer ("mCRC")," reported the completion of enrollment in its Phase 2 clinical study (ClinicalTrials.gov Identifier: NCT06699836) evaluating leronlimab in combination with trifluridine and tipiracil (TAS-102) plus bevacizumab in patients with CCR5-positive, microsatellite stable (MSS), relapsed/refractory metastatic colorectal cancer (mCRC), also known as CLOVER – CCR5-targeting Leronlimab With Oral Chemotherapy and VEGF-inhibitor Enriched Regimen.

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The open-label, randomized, two-arm, multi-center study is evaluating leronlimab in combination with trifluridine and tipiracil (TAS-102) plus bevacizumab in patients who have progressed following prior standard therapies. With enrollment now complete, CytoDyn will advance the study through treatment and follow-up, with resulting data expected to inform the program’s development strategy and potential next steps.

"Completing enrollment in this Phase 2 study marks an important milestone for CytoDyn and for the continued development of leronlimab in oncology," said Dr. Jacob Lalezari, Chief Executive Officer of CytoDyn. "We are grateful to the patients, investigators, and clinical sites whose commitment made completion of enrollment possible and look forward to evaluating the study results."

"CLOVER is designed to prospectively assess the activity of leronlimab in combination with an established regimen in a difficult to treat and highly refractory patient population with microsatellite stable (MSS) metastatic colorectal cancer, " said Pashtoon M. Kasi, M.D., M.S., Principal Investigator of the study and Medical Director of GI Oncology, City of Hope Orange County, Irvine, California. "With enrollment now complete, the study is well positioned to generate meaningful insights in this patient population with a high unmet need."

The CLOVER study builds on emerging clinical and translational findings from CytoDyn’s ongoing Phase 2 mCRC program, including data being presented at the AACR (Free AACR Whitepaper) Annual Meeting 2026. Preliminary results demonstrated early signals of clinical and biomarker activity with leronlimab in combination with TAS-102 and bevacizumab, including rapid reductions in circulating tumor DNA and modulation of immune-related markers. These findings support further evaluation of CCR5 inhibition as a strategy to enhance anti-tumor activity in metastatic colorectal cancer.

Leronlimab is a monoclonal antibody targeting CCR5, a receptor involved in immune cell trafficking and tumor biology. By blocking CCR5, leronlimab may help modulate the tumor microenvironment and enhance the activity of existing therapies in difficult-to-treat cancers.

CytoDyn plans to share topline data from the study as they become available.

About the Phase 2 mCRC Study (NCT06699836)
This Phase 2 clinical study is an open-label, randomized, two-arm, multi-center study evaluating leronlimab in combination with trifluridine and tipiracil (TAS-102) plus bevacizumab in patients with CCR5-positive, microsatellite stable (MSS), relapsed/refractory metastatic colorectal cancer (mCRC), also known as CLOVER – CCR5-targeting Leronlimab With Oral Chemotherapy and VEGF-inhibitor Enriched Regimen.

Approximately 60 patients were enrolled and randomized 1:1 to receive either 350 mg or 700 mg of leronlimab in combination with standard-of-care therapy. Eligible participants are adults with histologically confirmed mCRC who have progressed following prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, anti-VEGF therapy, and, where appropriate, anti-EGFR therapy.

The primary endpoint of the study is objective response rate (ORR), as defined by RECIST v1.1 criteria. Secondary endpoints include safety and tolerability, duration of response, and overall survival. Patients will be followed for up to 12 months.

(Press release, CytoDyn, APR 21, 2026, View Source [SID1234664658])