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.

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!

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])

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.

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!

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])

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.

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 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])

On April 21, 2026 Amphista Therapeutics ("the Company" or "Amphista"), a leader in the discovery and development of non-cereblon/non-VHL Targeted Glue degraders, reported the first public disclosure of the chemical structure of its lead Targeted Glue AMX-883, a novel DCAF16-dependent protein degrader of BRD9, during the New Drugs on the Horizon session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026 in San Diego, California yesterday.

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 oral presentation titled "Discovery of AMX-883: an orally bioavailable, novel degrader of BRD9 as a karyotype-independent pro-differentiation agent for the potential treatment of acute myeloid leukaemia", detailed the discovery and optimisation of a series of DCAF16-recruiting BRD9 degraders which yielded AMX-883, an orally bioavailable clinical candidate with picomolar potency and exquisite selectivity over the related bromodomain proteins BRD4 and BRD7. The DCAF16-dependent mechanism of action of AMX-883 was structurally confirmed by high-resolution cryo-EM of the ternary complex, revealing true glue-like interactions that stabilize the complex.

Amphista nominated AMX-883 as its first clinical development candidate in October 2025, based on a preclinical data package which expands the growing evidence base defining a critical role for BRD9 in maintaining acute myeloid leukaemia (AML) blast stemness and survival.

Martin Pass, Chief Development Officer at Amphista Therapeutics, said: "I’m delighted to be able to share the preclinical characterization data for AMX-883, our BRD9 Targeted Glue degrader, for the first time at AACR (Free AACR Whitepaper). Not only does it showcase the ability of our Eclipsys platform to deliver truly differentiated and high-quality molecules, but it also brings new insight and mechanistic understanding to BRD9’s role in AML and the hope that targeted removal from AML blasts may bring profound benefit to patients".

The data presented demonstrate that by degrading BRD9, AMX-883 relieves the differentiation block characteristic of AML, inducing expression of myeloid differentiation genes and repressing pro-proliferative programmes. AMX-883 increases markers of myeloid maturation across a range of AML cell lines representing diverse cytogenetic backgrounds, including TP53-mutant disease. This underlines its potential as a broad-acting, pro-differentiation agent and karyotype-independent therapeutic with the potential to benefit a wider population of AML patients than current treatments.

Critically, through BRD9 degradation, AMX-883 blocks patient-derived tumour growth in vivo as a monotherapy and demonstrated synergistic efficacy while in combination with venetoclax and prevented the emergence of resistance to venetoclax in vitro, addressing a major clinical challenge in AML.

Patrick Kelly, Chief Medical Officer at Amphista Therapeutics, added: "AML is a devastating disease with a poor prognosis, and most patients will relapse or become refractory to current treatments within a matter of months. As a karyotype-independent, pro-differentiation agent, AMX-883 has the potential to address a critical unmet need in AML by offering a broadly applicable treatment option. We are excited to advance this highly differentiated molecule into clinical trials in the second half of this year bringing new hope to patients facing this serious disease."

The Company is advancing AMX-883 into a Phase I clinical trial for AML in H2 2026.

(Press release, Amphista Therapeutics, APR 21, 2026, View Source [SID1234664674])

On April 21, 2026 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, reported that regulatory authorities in South Korea and Australia have cleared the Company to expand its pivotal Phase 2 ALPHA3 study evaluating cemacabtagene ansegedleucel (cema-cel) in first-line (1L) consolidation treatment for patients with large B-cell lymphoma (LBCL).

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 study, currently enrolling across more than 60 sites in North America, will expand to over 80 global sites with the addition of South Korea and Australia. This growing trial footprint reflects strong interest in ALPHA3 from clinical trial sites.

"Expanding into South Korea and Australia allows us to leverage regions with established clinical research infrastructure and experienced investigators," said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. "These countries provide high-quality trial environments and efficient healthcare delivery systems. These regulatory approvals, follow our recent interim futility analysis, and we expect this expansion to support the continued enrollment and global development of cema-cel."

The Company recently announced findings from a planned interim futility analysis of the ALPHA3 trial from the first 24 patients enrolled. In this analysis, cema-cel demonstrated a 58.3% (7/12) minimal residual disease (MRD) clearance versus 16.7% (2/12) in the standard-of-care (SOC) observation arm in the 1L consolidation setting. Cema-cel was generally well-tolerated, with no serious treatment-related adverse events and no cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS). There were no hospitalizations for treatment-related adverse events, suggesting consolidation of MRD+ remission with cema-cel may be suitable for a fully outpatient regimen. The ALPHA3 study is expected to enroll approximately 220 patients by the end of 2027. An interim analysis of event-free survival (EFS) is anticipated in mid-2027, followed by the primary EFS analysis in mid-2028. If positive, results could support a Biologics License Application (BLA) submission.

About Cemacabtagene Ansegedleucel (cema-cel)
Cemacabtagene ansegedleucel, or cema-cel, is a next generation anti-CD19 AlloCAR T investigational product for the treatment of large B cell lymphoma (LBCL). In June 2022, the U.S. Food and Drug Administration granted Regenerative Medicine Advanced Therapy (RMAT) designation to cema-cel in r/r LBCL. Allogene has oncology rights to cema-cel in the US, EU and UK with options for rights in China and Japan.

About the ALPHA3 Trial
Over 60,000 patients are expected to be treated for LBCL annually in the US, the EU and the UK. While first line (1L) R-CHOP or other chemoimmunotherapy is effective for most patients, approximately 30% will relapse and require subsequent treatment. The current standard of care after 1L treatment has been simply to "watch and wait" to see if the disease relapses. The pivotal Phase 2 ALPHA3 study takes advantage of cema-cel as a one-time, off-the-shelf treatment that can be administered immediately upon discovery of MRD following six cycles of R-CHOP or other chemoimmunotherapy, positioning it to become the standard "7th cycle" of frontline treatment available to all eligible patients with MRD.

(Press release, Allogene, APR 21, 2026, View Source [SID1234664595])