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.

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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.

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]).

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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

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]).

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"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.

On September 24, 2025 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, and TerThera BV, a leading provider of GMP-grade Terbium-161, reported a supply agreement for non-carrier-added (n.c.a.) Terbium-161 (Tb-161), a novel medical radioisotope with distinct chemical properties and emerging potential in radiopharmaceutical therapy. Under the terms of the agreement, TerThera will supply Good Manufacturing Practice (GMP)-compliant n.c.a. Tb-161 to ITM to support the development of its Terbium-based pipeline candidates, complementing ITM’s established manufacturing capabilities in cooperation with the Paul Scherrer Institute (PSI).

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"Driving innovation across isotopes, targeting molecules and cancer indications keeps ITM at the forefront of the rapidly evolving radiopharmaceutical industry," said Dr. Andrew Cavey, CEO of ITM. "We see strong potential in Terbium-161 as a critical new isotope for targeted radiopharmaceutical therapy, and our partnership with TerThera will allow us to advance its use in our pipeline. With supply of Terbium-161, we are well-positioned to harness its radiation properties to deliver meaningful advances for people living with cancer."

Currently, Tb-161-based radiopharmaceuticals are being clinically investigated for various types of cancers. Tb-161 is gaining attention in the radiopharmaceutical field for its unique emission profile. Like Lu-177, it emits medium-range beta particles and has a similar half-life. However, Tb-161 also emits low-energy Auger and internal conversion electrons, delivering highly localized radiation that can effectively target isolated cancer cells and micro-metastases with minimal off-target effects.

"As industry interest in Terbium-161 grows, a safe and sustainable supply of this radionuclide is crucial to support the development of new treatment options and strategies and we see this as our core mission," added Philippe van Overeem, CEO of TerThera. "ITM is a true innovator in the dynamic radiopharmaceutical field and we look forward to supplying them with our GMP-grade Terbium-161 as they advance their pipeline candidates and make progress in bringing the benefit of this valuable isotope to patients."

(Press release, ITM Isotopen Technologien Munchen, SEP 24, 2025, View Source [SID1234661163])

On September 24, 2025 Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing novel payload antibody drug conjugates (ADCs), reported key preclinical data demonstrating the potential of its novel antibody drug conjugate (ADC) spliceosome modulating payload, PH1, for the treatment of tumors fueled by alternative splicing-drivers, such as the Androgen Receptor splice variant 7 (AR-V7) in prostate cancer (Press release, Akari Therapeutics, SEP 24, 2025, View Source [SID1234656230]).

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AR-V7 is a key driver for progression of metastatic castration resistant prostate cancer (mCRPC). During progression of hormone-sensitive prostate cancer, many patients fail to respond to current first-line therapies known as Androgen Receptor Pathway Inhibitors (ARPIs), which include enzalutamide (Xtandi, $6B/annual sales), apalutamide (Erleada, $3B/annual sales) and darolutamide (Nubeqa, $1.6B/annual sales). Importantly, as patients lose ARPI response, their tumors transform and significantly increase in AR-V7 expression. As a result, there is an increasing and significant unmet need for targeted therapy options in ARPI-resistant hormone refractory patients, where there are currently limited options such as traditional chemotherapy like taxanes.

As referenced in the Company’s recent patent filing, preclinical data demonstrated that Akari’s ADC payloadPH1 is able to suppress the expression levels of the AR-V7 receptor in a hormone-refractory mCRPC model called 22Rv1. As a control, ARPIs had no effect on AR-V7 receptor expression in these experiments, which was expected given the refractory nature of these prostate cancer cell lines.

Surprisingly, in a different model, of hormone-sensitive LnCAP cells that express high levels of normal Androgen Receptor (i.e. ARPI sensitive) and lack AR-V7, PH1 demonstrated a benefit as a single agent, and additive effect when combined with either Xtandi or Erleada. The Company believes this combined efficacy data may potentially lead to the development of robust first-line combination regimens of Xtandi or Erleada with a PH1 payload conjugated ADC (PH1 ADC) to target prostate cancer that is sensitive to ARPIs. As progression is often linked to AR-V7 expression, and PH1 reduces AR-V7 expression, it is hypothesized that the combination of ARPI plus PH1 ADCs may slow the development of resistance and AR-V7-driven tumor progression which typically occurs after patients progress on Xtandi or Erleada. Akari has plans to test this hypothesis using PH1 ADCs against different prostate cancer targets in future research.

Abizer Gaslightwala, President and Chief Executive Officer of Akari Therapeutics commented, "We believe these compelling preclinical data support the rationale for Akari to develop a novel ADC with our PH1 spliceosome-modulating payload targeting prostate cancer either alone or in partnership with potential partners. Our goal is to develop the first ADC therapeutic in prostate cancer, either as a first-line combination therapy with ARPIs or a second-line therapy post ARPI failures in tumors driven by AR-V7. We are excited to continue to advance this novel spliceosome modulating payload to drive robust anti-cancer biological mechanisms to treat difficult alternative splicing-driven tumors, for which there are currently no effective treatment options today."

The Company plans to present the preclinical data at an upcoming scientific conference.