1stOncology™: Cancer Intelligence Service – Page 606 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

CytoDyn to Present on Leronlimab Induction of PD-L1 and Immune Checkpoint Inhibitor Responses in Metastatic Triple-Negative Breast Cancer at the AACR Special Conference: Mechanisms of Cancer Immunity and Cancer-related Autoimmunity

On September 25, 2025 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 triple-negative breast cancer (TNBC) and colorectal cancer (CRC), reported it will present a poster and an oral presentation at the AACR (Free AACR Whitepaper) Special Conference in Cancer Research: Mechanisms of Cancer Immunity and Cancer-related Autoimmunity, taking place September 24, to September 27, 2025, in Montreal, Canada (Press release, CytoDyn, SEP 25, 2025, View Source [SID1234656235]).

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!

Metastatic triple-negative breast cancer (mTNBC) is associated with a very poor prognosis. The efficacy of a class of drugs called immune checkpoint inhibitors (ICIs) is reduced in patients with mTNBC who have low levels of PD-L1[1]. An immune cell receptor called CCR5 has been observed in up to 95% of patients with TNBC. A recent review of CytoDyn’s prior oncology trials suggests that treatment with leronlimab, a humanized monoclonal antibody targeting CCR5, combined with an ICI, may improve survival in patients with mTNBC [2]. This retrospective analysis of 28 patients demonstrated that leronlimab induced PD-L1 expression on circulating tumor cells in 88% of patients treated at leronlimab doses of > 525mg/week. Moreover, 5/5 patients who induced PD-L1, and received treatment with both leronlimab and an ICI, remain alive after a median of ~60 months since starting leronlimab.

Key Findings:

CCR5 inhibition combined with ICI therapy increased overall survival in patients with mTNBC, with 18% of heavily pretreated mTNBC patients alive after a median of ~60 months.
Inhibition of CCR5 by leronlimab induced PD-L1 expression on patient circulating tumor cells.
Expression levels of CCR5 correlate with T cell infiltration in TNBC.

"These impressive findings on how leronlimab can serve to make metastatic triple-negative breast cancer cells more responsive to checkpoint inhibitors are of great value as we move this asset forward for oncology indications," said Jacob Lalezari, M.D., CEO of CytoDyn. "Understanding this immune-modulating mechanism not only deepens insight into how leronlimab works, but also supports its potential as a broadly applicable therapy for a range of solid tumors that historically have had limited treatment options."

"The substantial increases in PD-L1 expression, observed in liquid biopsies of patients treated with leronlimab, may be the key to unlocking the effectiveness of immune checkpoint inhibitors for patient populations previously deemed resistant to such approaches," said Richard Pestell, M.D., Ph.D., FRCP, AO, Presenter and Lead Consultant in Preclinical and Clinical Oncology at CytoDyn. "These results suggest leronlimab may remodel the tumor immune environment in metastatic triple-negative breast cancer, a particularly challenging form of the disease."

Details of the oral and poster presentations are as follows:

Abstract Title:
CCR5 inhibition with leronlimab is associated with enhanced PD-L1 expression, ICI response, and long‑term survival in metastatic TNBC

Poster presentation:
September 26, 2025, 6:30 p.m. – 8:30 p.m. EDT

Podium/speaking presentation:
September 27, 2025, 10:25 a.m. – 10:40 a.m. EDT

Circle Pharma Announces Poster Presentation Highlighting the Potential of CID-078, a First-in-class Oral Cyclin A/B RxL Inhibitor, at the American Association for Cancer Research Special Conference on Discovery and Innovation in Pediatric Cancer

On September 25, 2025 Circle Pharma, Inc., a clinical-stage biopharmaceutical company pioneering next-generation targeted macrocycle therapeutics for cancer, reported an upcoming poster presentation highlighting the potential of CID-078 as a novel therapeutic option in pediatric cancers at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference on Pediatric Cancer, taking place from September 25-28 in Boston, MA (Press release, Circle Pharma, SEP 25, 2025, View Source [SID1234656234]). CID-078 is a first-in-class, orally bioavailable macrocyclic cyclin A/B RxL inhibitor that is currently being evaluated in a Phase 1 clinical trial for patients with advanced solid tumors.

The presentation, based on a collaboration between Circle Pharma and Children’s Cancer Institute (Sydney, Australia), will focus on the novel mechanism of action of CID-078 for cancers driven by high E2F activity including those with alterations in the tumor suppressor genes RB1 or CDKN2A/B, as well as the prevalence of these biomarkers across a diverse range of pediatric cancer types. In addition, the presentation will outline new preclinical data on the correlation between CID-078 sensitivity and RB1 and E2F biomarker status in a database of pediatric tumor samples from The ZERO Childhood Cancer Precision Medicine Program.

"We believe CID-078 may represent a promising new therapeutic option for pediatric cancers with certain defined molecular drivers," said Michael C. Cox, PharmD, MHSc, BCOP, senior vice president and head of early development at Circle Pharma. "These findings may inform strategies for real-time patient identification and stratification in potential future pediatric studies of CID-078. Presenting these data generated in collaboration with Children’s Cancer Institute during Childhood Cancer Awareness Month reinforces our commitment to advancing the development of our therapies for patients who urgently need new options."

Details of the presentation are as follows:

Title: Investigating the Cyclin A/B RxL Inhibitor CID-078 in Pediatric Cancers with RB1 Loss and High E2F1

Abstract Number: B021

Session: Poster Session B

Date & Time: Friday, September 26, 5:00-7:00 p.m. ET

Presenting Author: Chelsea Mayoh, Children’s Cancer Institute, Lowy Cancer Centre, UNSW Sydney, Kensington, Australia

About CID-078, Circle Pharma’s Oral Cyclin A/B RxL Inhibitor Program

CID-078 is an orally bioavailable macrocycle with dual activity blocking protein-protein interactions between both cyclins A and B and key substrates that bind to them via conserved RxL motifs. CID-078 selectively targets tumor cells with oncogenic alterations that cause cell cycle dysregulation, including alterations in the tumor suppressor RB1. In pre-clinical studies, Circle Pharma’s cyclin A/B RxL inhibitors have been shown to potently and selectively disrupt the protein-to-protein interaction between cyclins A and B and their key substrates and modulators, including E2F (a substrate of cyclin A) and MYT1 (a modulator of cyclin B). Preclinical studies have demonstrated the ability of these cyclin A/B RxL inhibitors to cause single-agent tumor regressions in multiple in vivo models. A multi-center Phase 1 clinical trial (NCT06577987) is currently enrolling patients with advanced solid tumors harboring RB1 alterations.

Celyad Oncology reports first half year 2025 financial results

On September 25, 2025 Celyad Oncology (Euronext: CYAD) (the "Company"), reported its financial results for the first half year 2025 ended June 30, 2025 (Press release, Celyad, SEP 25, 2025, View Source [SID1234656232]).

First Half 2025 financial review

As of June 30, 2025, the Company’s Treasury position amounted to €0.8 million.

After due consideration of detailed budgets and estimated cash flow forecasts for the years 2025 and 2026, the Company projects that its existing cash and cash equivalents will be sufficient to fund its estimated operating and capital expenditures into the fourth quarter of 2025.

Key financial figures for first half 2025, compared with the first half of 2024 and full year 2024, are summarized below:

Selected key financial figures (€ millions) Half Year 30 June 2025 Half Year 30 June 2024 Full Year 31 December 2024
Revenue – – 0.2
Research and development expenses (2.1) (1.5) (3.2)
General and administrative expenses (1.7) (1.7) (3.2)
Other income/(expenses) 0.1 0.2 0.4
Operating loss (3.7) (3.1) (5.9)
Loss for the period/year (3.7) (3.0) (5.9)
Net cash used in operations (3.3) (2.8) (5.7)
Cash and cash equivalents 0.8 6.2 4.2

Research and Development (R&D) expenses were €2.1 million in June 2025 as compared to €1.5 million during the same period in 2024, an increase of €0.6 million. The increase in the Company’s R&D expenses was primarily driven by the increase of the IP costs related to the licensing activities as well as the increase of the expenses linked to the redevelopment of the catheter.

General and Administrative (G&A) expenses remained stable with €1.7 million in June 2025 as in June 2024.

Net loss for the first half of 2025, was €3.7 million, or €(0.09) per share, compared to a net loss of €3.0 million, or €(0.07) per share, for the same period in 2024.

Net cash used in operations was €3.3 million for the first half of 2025 compared to €2.8 million for the first half of 2024. The increase of €0.5 million was primarily driven by the global increase of IP activities and catheter development costs.

As of June 30, 2025, the Company had cash and cash equivalents of €0.8 million. No capital increase occurred in the first half of 2025. The total number of basic shares outstanding was 41.4 million like in December 31, 2024.

The interim financial report for first half 2025 of the Company can be found on our website: View Source

AIM ImmunoTech Secures Patent in Japan Through 2039 for Novel Cancer Therapy Combining Ampligen® (Rintatolimod) with Checkpoint Inhibitors

On September 25, 2025 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported that the Japan Patent Office has issued a patent covering the Company’s proprietary use of Ampligen (Rintatolimod) in combination with checkpoint inhibitors (anti-PD-1 or anti-PD-L1 antibodies) for the treatment of cancer (Press release, AIM ImmunoTech, SEP 25, 2025, View Source [SID1234656229]).

"We remain committed to strengthening our global intellectual property protection for Ampligen as we continue to advance its clinical development. This Japan patent – which does not expire until December 20, 2039 – further strengthens our intellectual property portfolio in one of the world’s largest oncology markets and enhances exclusivity around combination therapies that address high-need cancer indications. Importantly, this patent further reinforces our ability to advance our clinical pipeline, secure strategic collaborations, and capture value in the growing global immuno-oncology sector. The scope of this patent enhances the value for any future strategic oncology transactions," AIM ImmunoTech CEO Thomas K. Equels stated.

The allowed claims in Japan cover an agent for treating cancer consisting of Ampligen in combination with a checkpoint inhibitor. The claims are broad, encompassing multiple cancer types, including pancreatic cancer, skin cancer, colorectal cancer, ovarian cancer, melanoma, breast cancer/triple negative breast cancer, head and neck tumors, bladder cancer, renal cell carcinoma, and lung cancer. The claims also capture specific dosing regimens, administration routes, and synergistic therapeutic effects observed when Ampligen is combined with checkpoint inhibitors.

AIM also holds a U.S. patent (expires August 9, 2039) for methods involving use of Ampligen as part of a combination oncology therapy when paired with an anti-PD-L1 antibody and a patent in the Netherlands (expires December 19, 2039) for the use of Ampligen as a combination cancer therapy with checkpoint blockade inhibitors, such as Keytruda (pembrolizumab), Opdivo (nivolumab) and Imfinzi (durvalumab).

The combination of these compounds is designed to work synergistically to enhance the effectiveness of the treatment. AIM believes this novel approach could revolutionize the treatment landscape for cancers that have historically been challenging to treat, such as pancreatic cancer and advanced recurrent ovarian cancer. In fact, in collaboration with AstraZeneca, Ampligen is in a Phase 2 clinical trial combined with AstraZeneca’s durvalumab (an anti-PD-L1) for the treatment of metastatic pancreatic cancer. AIM recently released a DURIPANC Mid-Year Interim Clinical Progress Update showing promising signs of superior Progression-Free Survival and Overall Survival, as well as no significant toxicity.

Similarly, a Phase 2 study in collaboration with Merck Sharp & Dohme LLC in advanced recurrent ovarian cancer combing Ampligen with Keytruda has been completed and we expect the final data report within the next two months.

Lantheus and GE HealthCare Announce Exclusive Licensing Agreement for Prostate Cancer Imaging Agent PYLARIFY® (Piflufolastat F 18) in Japan

On September 24, 2025 Lantheus Holdings, Inc. (NASDAQ: LNTH) and GE HealthCare (NASDAQ: GEHC) reported an exclusive licensing agreement for GE HealthCare to develop, manufacture, and commercialize Lantheus’ piflufolastat F18 (PYLARIFY in U.S. market) in Japan for prostate cancer diagnostics and companion diagnostic use. PYLARIFY is used for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer.

The agreement includes the transfer of regulatory dossiers, manufacturing competencies and technical support to enable GE HealthCare to drive clinical development in Japan, towards potential regulatory submissions and commercial launch. GE HealthCare will draw on its extensive manufacturing network and R&D expertise following its acquisition in March 2025 of Nihon Medi-Physics Co., Ltd. (NMP), a leading radiopharmaceutical company in Japan.

Prostate cancer is the fourth most common cancer worldwide, with Japan recording the third highest number of cases in the world in 2022, after the U.S. and China.1

"This partnership is expected to meaningfully extend the reach of our diagnostic imaging agent in key international markets," said Brian Markison, CEO of Lantheus. "GE HealthCare and NMP’s deep regional expertise will enable us to advance the detection and care of prostate cancer and drive significant impact in an important market."

"Bringing targeted PET imaging agents to new geographies supports Lantheus’ Purpose to Find, Fight and Follow disease to deliver better patient outcomes," added Jean-Claude Provost, Chief Science Officer at Lantheus. "By aligning with GE HealthCare, we’re addressing a critical clinical need in Japan, and helping to lay the foundation for a more personalized approach to prostate cancer detection, diagnosis and monitoring."

"This collaboration represents a strategic advancement for GE HealthCare as we expand our pipeline of radiopharmaceuticals and continue to deliver on our commitment to improving patient access to innovative diagnostics," said Kevin O’Neill, President & CEO of the Pharmaceutical Diagnostics (PDx) segment of GE HealthCare and President of NMP. "Working alongside Lantheus gives us access to one of the best-in-class PET imaging agents that is already approved in the U.S. and in Europe, and if approved locally, could provide clinicians and their patients with a powerful new option for detecting and monitoring prostate cancer."

Under the terms of the agreement, GE HealthCare will pay Lantheus an upfront license fee, development milestones and tiered royalties based on product sales in Japan. The companies will also establish a Joint Steering Committee to oversee development and commercialization activities.

Piflufolastat F 18 (also known as 18F-DCFPyL, PYLARIFY or PYLCLARI) was FDA-approved in 2021 and is marketed as PYLARIFY. PYLARIFY has made a profound impact on the lives of patients battling prostate cancer and is the number one utilized PSMA PET imaging agent in the U.S. It is a proven diagnostic backed by real-world experience, including in over 500,000 scans across 48 states. In 2023, it was approved in the European Union and is marketed there as PYLCLARI. The European rights were licensed to Curium from Progenics Pharmaceuticals, Inc., a Lantheus company.

About PYLARIFY (piflufolastat F 18) Injection
PYLARIFY (piflufolastat F 18) injection (also known as 18F-DCFPyL or PYLCLARI) is a fluorinated small molecule PSMA-targeted PET imaging agent that enables visualization of lymph nodes, bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer. For men with prostate cancer, PYLARIFY PET combines the accuracy of PET imaging, the precision of PSMA targeting and the clarity of an F 18 radioisotope for superior diagnostic performance. The recommended PYLARIFY dose is 333 MBq (9 mCi) with an acceptable range of 296 MBq to 370 MBq (8 mCi to 10 mCi), administered as a bolus intravenous injection.

PYLARIFY (piflufolastat F 18) Injection in the U.S.

Indication

PYLARIFY (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:

with suspected metastasis who are candidates for initial definitive therapy.
with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.

Important Safety Information

Contraindications
None.

Warnings and Precautions

Risk of Image Misinterpretation
Imaging interpretation errors can occur with PYLARIFY imaging. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of PYLARIFY for imaging of patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. The performance of PYLARIFY for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by risk factors such as Gleason score and tumor stage. PYLARIFY uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes and in normal tissues. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.

Hypersensitivity Reactions
Monitor patients for hypersensitivity reactions, particularly patients with a history of allergy to other drugs and foods. Reactions may be delayed. Always have trained staff and resuscitation equipment available.

Radiation Risks
Diagnostic radiopharmaceuticals, including PYLARIFY, expose patients to radiation. Radiation exposure is associated with a dose-dependent increased risk of cancer. Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration.

Adverse Reactions
The most frequently reported adverse reactions were headaches, dysgeusia and fatigue, occurring at rate of ≤2% during clinical studies with PYLARIFY. In addition, a delayed hypersensitivity reaction was reported in one patient (0.2%) with a history of allergic reactions.

Drug interactions
Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of PYLARIFY in prostate cancer. The effect of these therapies on performance of PYLARIFY PET has not been established.

To report suspected adverse reactions for PYLARIFY, call 1-800-362-2668 or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Please read the accompanying full Prescribing Information also available at PYLARIFY.com.

(Press release, Lantheus, SEP 24, 2025, View Source [SID1234662958])