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])

On April 21, 2026 Rgenta Therapeutics, a clinical-stage biotechnology company pioneering the development of a new class of oral small molecules targeting RNA and RNA regulation for oncology and neurological disorders, reported that an abstract highlighting clinical data from the ongoing Phase 1a/b study of RGT-61159, an oral MYB splicing modulator, in patients with adenoid cystic carcinoma (ACC) or colorectal cancer (CRC) has been accepted for poster presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place May 29 – June 2, 2026 in Chicago, IL.

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Poster presentation details:

Title: A Phase 1a/b Study of RGT-61159, An Oral MYB Splicing Modulator, in
Patients with Advanced Adenoid Cystic Carcinoma and Colorectal Cancer.
Abstract #: 3089
Session Title: Poster Session – Developmental Therapeutics—Molecularly Targeted
Agents and Tumor Biology
Poster Board: 226
Date and Time: May 30, 2026, 1:30 – 4:30 p.m. CDT

About RGT-61159
RGT-61159 is an orally available small molecule designed to specifically modulate splicing of the transcription factor MYB resulting in the inhibition of the oncogenic MYB protein and potential cell death of the cancer cells that overexpress the MYB protein. MYB acts as a master regulator of cell proliferation, self-renewal, and differentiation processes and its aberrant expression has been demonstrated in multiple forms of human cancer including adenoid cystic carcinoma (ACC), acute myeloid leukemia (AML), T-cell acute lymphoblastic leukemia (T-ALL), colorectal cancer (CRC), small cell lung cancer (SCLC) and breast cancer. Rgenta is evaluating RGT-61159 in an ongoing multi-center, open-label Phase 1a/b clinical trial in patients with advanced relapsed or refractory ACC or CRC. The Phase 1a/b study is designed to evaluate safety, tolerability, pharmacokinetics, target engagement, and clinical efficacy of RGT-61159 in patients with ACC or CRC. Additional information about the Phase 1a/b clinical trial can be accessed at ClinicalTrials.gov (NCT06462183).

(Press release, Rgenta Therapeutics, APR 21, 2026, View Source [SID1234664657])

On April 21, 2026 Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company, reported that four abstracts evaluating PEDMARK (sodium thiosulfate injection) were accepted as part of the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting program, taking place May 29-June 2, 2026 in Chicago, IL.

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PEDMARK is currently approved for pediatric patients one month of age and older with localized, non-metastatic solid tumors, and is also recognized by the National Comprehensive Cancer Network with a 2A recommendation for use in adolescent and young adult patients.

Poster Presentation Details:

Title: Effects of Delayed Sodium Thiosulfate on Cisplatin-Induced Ototoxicity in Pediatric and Adolescent Patients with Cancer: Results from the Japanese Children’s Cancer Group STS-J01 Study
Poster Session: Pediatric Oncology
Date and Time: June 1, 2026, 1:30 PM – 4:30 PM CT
Abstract Number: 10052
Lead Author: Eiso Hiyama, MD, professor in the Department of Pediatric Surgery at Hiroshima University Hospital in Hiroshima, Japan

Title: Randomized Phase 1 Trial of Cisplatin-Based Chemotherapy With or Without Sodium Thiosulfate for Men with Metastatic Germ Cell Tumor (GCT)
Poster Session: Genitourinary Cancer—Prostate, Testicular, and Penile
Date and Time: May 31, 2026, 9:00 AM – 12:00 PM CT
Abstract Number: TPS5131
Lead Author: Koral Shah, MD, Hematology/Oncology chief fellow, City of Hope

Abstract-Only Publication Details:

Title: Real-World Feasibility and Tolerability of PEDMARK for Otoprotection in Young Adults Receiving Cisplatin for Solid Tumors.
Abstract Number: e24189
Lead Author: Veronica Alana Vestal, MD, Comprehensive Cancer Center of University of Puerto Rico

Title: Audiometric Outcomes for Intravenous Sodium Thiosulfate for Cisplatin-Induced Ototoxicity Prevention in Adults with Head and Neck Cancer
Abstract Number: e18110
Lead Author: James Johns, MD, Icahn School of Medicine at Mount Sinai, New York

The full abstracts will be available on the ASCO (Free ASCO Whitepaper) website on May 21, 2026, at 5:00 p.m. ET.

About Cisplatin-Induced Ototoxicity
Cisplatin and other platinum-based chemotherapies are widely used to treat solid tumors and have been vital in improving survival rates. Unfortunately, these life-saving treatments often result in permanent, irreversible hearing loss, also known as ototoxicity.1

Hearing loss from cisplatin treatment is not rare. Studies show that between 60-90% of patients treated with cisplatin may develop hearing loss, depending upon the dose and duration of chemotherapy2. Many of those treated with cisplatin will require lifelong hearing aids or cochlear implants, which can be helpful for some, but do not reverse the hearing loss and can be costly over time.3 Treatment-induced hearing loss can reduce quality of survivorship as it impacts many aspects of life, such as speech and language skills, academic performance, social-emotional development, career potential and the ability to live independently.4,5 While audiologic monitoring is recommended to help manage ototoxicity, it is currently underutilized in certain cancer patient populations.

PEDMARK (sodium thiosulfate injection)
PEDMARK is the first and only U.S. Food and Drug Administration (FDA) approved therapy indicated to reduce the risk of ototoxicity associated with cisplatin treatment in pediatric patients 1 month of age and older with localized, non-metastatic, solid tumors. It is a unique formulation of sodium thiosulfate in single-dose, ready-to-use vials for intravenous use in pediatric patients. PEDMARK is also the first and only therapeutic agent with proven efficacy and safety data with an established dosing regimen, across two open-label, randomized Phase 3 clinical studies, the Children’s Oncology Group (COG) Protocol ACCL0431 and SIOPEL 6.

Additionally, PEDMARK is recommended for the adolescent and young adult (AYA) population by the National Comprehensive Cancer Network, or NCCN, with a 2A endorsement.

Approximately 500,000 patients in the U.S. are diagnosed annually with cancers that could be treated with a platinum-based chemotherapy.6,7 The incidence of ototoxicity depends upon the dose and duration of chemotherapy, and many of those treated will require lifelong hearing aids. Until the FDA approval of PEDMARK, there were no preventative agents for this hearing loss. Patients with hearing loss resulting from cancer treatment have a statistically significant worse quality of life compared with peers who have no hearing loss.89

PEDMARK has been studied by co-operative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity, COG ACCL0431 and SIOPEL 6. Both studies have been completed. The COG ACCL0431 protocol enrolled childhood cancers typically treated with intensive cisplatin therapy for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, medulloblastoma, and other solid tumors. SIOPEL 6 enrolled only hepatoblastoma patients with localized tumors.

Indications and Usage
PEDMARK (sodium thiosulfate injection) is indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors.

Limitations of Use
The safety and efficacy of PEDMARK have not been established when administered following cisplatin infusions longer than 6 hours. PEDMARK may not reduce the risk of ototoxicity when administered following longer cisplatin infusions, because irreversible ototoxicity may have already occurred.

Important Safety Information
PEDMARK is contraindicated in patients with history of a severe hypersensitivity to sodium thiosulfate or any of its components.

Hypersensitivity reactions occurred in 8% to 13% of patients in clinical trials. Monitor patients for hypersensitivity reactions. Immediately discontinue PEDMARK and institute appropriate care if a hypersensitivity reaction occurs. Administer antihistamines or glucocorticoids (if appropriate) before each subsequent administration of PEDMARK. PEDMARK may contain sodium sulfite; patients with sulfite sensitivity may have hypersensitivity reactions, including anaphylactic symptoms and life-threatening or severe asthma episodes. Sulfite sensitivity is seen more frequently in people with asthma.

PEDMARK is not indicated for use in pediatric patients less than 1 month of age due to the increased risk of hypernatremia or in pediatric patients with metastatic cancers.

Hypernatremia occurred in 12% to 26% of patients in clinical trials, including a single Grade 3 case. Hypokalemia occurred in 15% to 27% of patients in clinical trials, with Grade 3 or 4 occurring in 9% to 27% of patients. Monitor serum sodium and potassium levels at baseline and as clinically indicated. Withhold PEDMARK in patients with baseline serum sodium greater than 145 mmol/L.

Monitor for signs and symptoms of hypernatremia and hypokalemia more closely if the glomerular filtration rate (GFR) falls below 60 mL/min/1.73m2.

Administer antiemetics prior to each PEDMARK administration. Provide additional antiemetics and supportive care as appropriate.

The most common adverse reactions (≥25% with difference between arms of >5% compared to cisplatin alone) in SIOPEL 6 were vomiting, nausea, decreased hemoglobin, and hypernatremia. The most common adverse reaction (≥25% with difference between arms of >5% compared to cisplatin alone) in COG ACCL0431 was hypokalemia.

Please see full Prescribing Information for PEDMARK at: www.PEDMARK.com.

(Press release, Fennec Pharmaceuticals, APR 21, 2026, View Source [SID1234664656])

On April 21, 2026 Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") reported that safety and tolerability data from the ProstACT Global Phase 3 study (Part 1) will be presented as a late-breaking oral presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 29 – June 2, 2026, in Chicago, IL.

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ProstACT Global is an international, multi-center, Phase 3 trial evaluating Telix’s lead prostate-specific membrane antigen (PSMA) targeted lutetium radio antibody-drug conjugate (rADC) therapy, TLX591-Tx (lutetium-177 (¹⁷⁷Lu) rosopatamab tetraxetan), in combination with standard of care (SoC) versus SoC alone. The study is designed to reflect real-world global clinical practice with the aim to support broad geographic adoption in the evolving prostate cancer treatment landscape.

Part 1 of the trial is a safety and dosimetry lead-in, assessing the tolerability, biodistribution, and radiation dose profile of TLX591-Tx when administered in combination with SoC in patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC).

The selection of this abstract as a late-breaking oral presentation at ASCO (Free ASCO Whitepaper) underscores the potential clinical significance of the ProstACT Global study and Telix’s continued leadership in advancing next-generation radiopharmaceutical therapies for prostate cancer.

Presentation details are as follows:

Title: Safety and dosimetry of 177Lu-rosopatamab tetraxetan plus SoC in patients with metastatic castration-resistant prostate cancer: Preliminary results from Part 1 of Phase 3 ProstACT Global study.

Presenting Author: Pedro C. Barata, MD, MSc, University Hospitals Seidman Cancer Center, Cleveland, OH.

Abstract Number: LBA5009.

Date, Time and Location: June 1, 2026, 3:12 p.m. – 3:24 p.m. CDT, Arie Crown Theater

Session Type and Title: Clinical Science Symposium – Radiation Re-Imagined: Radioligand Innovation in Prostate Cancer

Late-breaking abstracts will be made publicly available at 7:00 a.m. CDT (8:00 a.m. EDT) on the day of presentation. Additional information can be found at www.asco.org

About ProstAct Global

ProstACT Global (ClinicalTrials.gov ID: NCT06520345) is an international, multi-center trial in two parts: Part 1, safety and dosimetry lead-in with 36 patients (complete); and Part 2, 2:1 randomized global expansion with an overall target enrollment of approximately 490 patients. Eligible patients must have confirmed progressive mCRPC assessed with a 68Ga-PSMA-11 PET1 imaging agent (such as Illuccix, kit for the preparation of gallium-68 (68Ga) gozetotide injection, or Gozellix, kit for the preparation of gallium-68 (68Ga) gozetotide injection) following prior treatment with one androgen receptor pathway inhibitor (ARPI).

The antibody approach demonstrates different targeting and pharmacology to that observed in other PSMA-targeted small molecule radioligand therapies (RLT). In contrast to these therapies2, collective long-term follow-up of patients administered with TLX591-Tx has not observed significant acute or delayed kidney toxicity, as the agent is primarily cleared through the liver, a comparatively radioresistant organ, instead of the kidneys3. Due to its large molecular weight, TLX591-Tx also demonstrates minimal salivary and lacrimal gland uptake, reducing dry mouth and dry eyes, common adverse effects of existing PSMA-targeted RLTs4.

Additional information on the Phase 3 ProstACT Global study can be found at: View Source

TLX591-Tx has not received a marketing authorization in any jurisdiction.

(Press release, Telix Pharmaceuticals, APR 21, 2026, View Source [SID1234664655])

On April 21, 2026 BridgeBio Oncology Therapeutics, Inc. ("BBOT") (Nasdaq: BBOT), a clinical-stage biopharmaceutical company focused on RAS-pathway malignancies, reported new preclinical data in an oral presentation for BBO-10203, a first-in-class covalent small molecule RAS:PI3Kα breaker that selectively blocks the physical interaction between RAS and PI3Kα resulting in the inhibition of RAS-driven PI3Kα-AKT signaling in tumors with no observed hyperglycemia. The data were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026.

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"The interaction between RAS and PI3Kα plays a critical role in malignant cells," said Pedro J. Beltran, PhD, Chief Scientific Officer of BBOT. "BBO-10203 physically disrupts the interaction between RAS and PI3Kα, leading to signaling inhibition and tumor regressions. Importantly, unlike competing approaches, no hyperglycemia has been observed to date. In addition, BBO-10203’s ability to block RAS-mediated activation of PI3Kα is independent of the mutational status of either RAS or PI3Kα, which may enable treatment of a broader patient population. These data suggest that non-canonical RAS proteins play a key role in PI3Kα activation in HER2AMP cell lines. Furthermore, BBO-10203 demonstrates strong in vivo combination activity with HER2-targeted therapies, including tucatinib and trastuzumab, in HER2 AMP models."

Highlights from the oral presentation include:

BBO-10203 physically and allosterically disrupts the interaction between RAS and PI3Kα, leading to signaling inhibition without inhibiting the kinase activity of PI3Kα
BBO-10203 induces tumor regressions at 30 mg/kg QD and no hyperglycemia observed at 100 mg/kg QD
BBO-10203 shows that PI3Kα activity in HER2AMP cells is RAS-dependent
RAS RBD mutations recapitulate the pAKT and viability effects of breaker activity in HER2AMP cell lines
Non-canonical RAS signaling appears to be the dominant driver of pAKT in HER2AMP cell lines
BBO-10203 displays strong in vivo combination effects with HER2 inhibitors tucatinib or trastuzumab in HER2AMP models

The oral presentation is titled "The RAS:PI3Kα breaker BBO-10203 inhibits PI3Kα/AKT activity in HER2AMP models through non-canonical RAS signaling blockade." A copy of the presentation will be available on the "Publications" page of the BBOT website following the conference.

About BBO-10203
BBO-10203 is an orally bioavailable small molecule with a novel mechanism of action designed to inhibit the physical interaction between RAS and PI3Kα, inhibiting RAS-driven PI3Kα-AKT signaling in tumors. BBO-10203 binds directly and covalently to the RAS-binding domain of PI3Kα, preventing its activation by KRAS, HRAS and NRAS, reducing downstream signaling and tumor growth. It is a protein-protein inhibitor and not a kinase inhibitor, enabling inhibition of RAS-driven PI3Kα-AKT signaling in tumors without the risk of hyperglycemia. Importantly, BBO-10203’s ability to block RAS activation of PI3Kα is agnostic to the mutational status of either RAS or PI3Kα. In addition to a potentially differentiated safety profile, BBO-10203 could be combined with direct KRAS inhibitors, such as BBO-8520 and BBO-11818, or drugs that target HER2 or ER receptors. BBO-10203 is being evaluated in the Phase 1 BREAKER-101 trial (NCT06625775) for patients with locally advanced or metastatic HER2+ breast cancer, HR+/HER2- breast cancer, KRAS-mutant colorectal cancer, and KRAS-mutant non-small cell lung cancer. Updated Phase 1 clinical data are expected in the second half of 2026.

(Press release, BridgeBio Oncology Therapeutics, APR 21, 2026, View Source [SID1234664654])