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Aptose’s Tuspetinib Exceeds Expectations When Combined with Standard of Care Treatment Across Diverse Populations of Newly Diagnosed AML

On October 16, 2025 Aptose Biosciences Inc. ("Aptose" or the "Company") (OTC: APTOF, TSX: APS), a clinical-stage precision oncology company developing the tuspetinib (TUS)-based triple drug frontline therapy to treat patients with newly diagnosed AML, reported that data from the ongoing TUSCANY trial of tuspetinib in combination with venetoclax and azacitidine (TUS+VEN+AZA) are being presented in a poster presentation, "TUSCANY Study of Safety and Efficacy of Tuspetinib plus Standard of Care Venetoclax and Azacitidine in Study Participants with Newly Diagnosed AML Ineligible for Induction Chemotherapy," at the European School of Haematology (ESH) 7th International Conference on Acute Myeloid Leukemia "Molecular and Translational": Advances in Biology and Treatment, being held from October 16-18, 2025 in Estoril, Portugal. Data to date from 10 patients in the TUSCANY trial across all three cohorts, 40 mg, 80 mg or 120 mg TUS dose in TUS+VEN+AZA, reveal promising clinical safety and antileukemic activity and support the use of TUS with standard of care treatment across a broad range of AML populations, including those carrying adverse mutations regardless of FLT3 mutation status.

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The TUS+VEN+AZA triplet is being developed as a safe and well-tolerated, mutation agnostic frontline therapy to treat large, mutationally diverse populations of newly diagnosed AML patients who are ineligible to receive induction chemotherapy. Across all dose cohorts to date, no significant safety concerns or dose limiting toxicities (DLTs) have been observed in the TUSCANY trial, including no prolonged myelosuppression in Cycle 1 of subjects in remission, no reports of drug-related QTc prolongation or differentiation syndrome (DS), no CPK elevation and no treatment-related deaths. Dosing has begun at the 160 mg TUS dose level.

"We have observed that TUS can be safely added to a backbone VEN+AZA without needing to reduce the dose of these standard-of-care drugs. The activity we have observed with the TUS triplet in the first 10 patients has exceeded our expectations with 9 achieving complete remissions and 7 demonstrating MRD-negativity by central flow cytometry," said Rafael Bejar, M.D., Ph.D., Chief Medical Officer of Aptose. "In addition, these remissions are happening in diverse genetic subtypes including those with unmutated FLT3, FLT3-ITD, NPM1c, biallelic TP53 with complex karyotype, RAS, or myelodysplasia related mutations, making this a truly mutation agnostic therapy."

Data highlights:

TUS in combination with standard dosing of VEN+AZA has been well tolerated with no DLT, no treatment-related deaths, no differentiation syndrome, no QTc prolongation, no prolonged myelosuppression after remission in Cycle 1, and no CPK elevations reported at any dose levels to date in these newly diagnosed AML patients.
Addition of TUS to VEN+AZA achieved CR/CRh responses in 6/6 (100%) patients treated at the higher dose levels of 80 mg and 120 mg TUS, exceeding the 66% rate expected from VEN+AZA alone.
Overall, TUS+VEN+AZA CR/CRh responses were observed in 9/10 (90%) patients.
7 of 8 (88%) CR/CRh responses in FLT3 wildtype AML, representing 70% of AML population.
TUS+VEN+AZA MRD-negativity noted in 7/9 (78%) responding patients by central flow cytometry.
CR/CRh responses achieved across diverse mutational subtypes including: unmutated FLT3, FLT3-ITD, NPM1c, biallelic TP53 with complex karyotype, RAS, and myelodysplasia related mutations.
Dosing at the TUS 160 mg dose level is now ongoing.
See the ESH poster presentation here.

TUSCANY: TUS+VEN+AZA Triplet Phase 1/2 Study

The tuspetinib-based TUS+VEN+AZA triplet therapy is being advanced in the TUSCANY Phase 1/2 trial with the goal of creating an improved frontline therapy for newly diagnosed AML patients that is active across diverse AML populations, durable, and well tolerated.

The TUSCANY triplet Phase 1/2 study, being conducted at 10 leading U.S. clinical sites by elite clinical investigators, is designed to test various doses and schedules of TUS in combination with standard dosing of AZA and VEN for patients with AML who are ineligible to receive induction chemotherapy. A convenient, once daily oral agent, TUS is being administered in 28-day cycles. Multiple U.S. sites are enrolling in the TUSCANY trial with anticipated enrollment of 18-24 patients by the end of 2025. Data will be released as it becomes available.

More information on the TUSCANY Phase 1/2 study can be found on www.clinicaltrials.gov.

(Press release, Aptose Biosciences, OCT 16, 2025, View Source [SID1234656696])

Clarity signs copper-67 Supply Agreement with Nusano

On October 16, 2025 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, reported the signing of a Supply Agreement for copper-67 with Nusano, Inc. ("Nusano").

Nusano’s 190,000 square foot state-of-the-art facility in West Valley City, Utah is expected to begin operations in late 2025 with copper-67 isotope supply planned to commence in mid-2026. The proprietary accelerator-based technologies employed by Nusano are particularly well suited for high-volume mass production of copper-67. Nusano is uniquely positioned to regularly supply this therapeutic isotope for both Clarity’s clinical trials and commercial use based on the ease of production and readily available target material. Importantly, Nusano is setting up its own enriched stable isotope production for copper-67 starting materials in the near future, further reducing supply chain risks while allowing for a fully integrated production process in the United States.

The copper-67 supply from Nusano further expands Clarity’s growing network of US-based suppliers, including NorthStar Medical Radioisotopes, LLC ("NorthStar") and Idaho State University Idaho Accelerator Center (IAC).

Dr Alan Taylor, Executive Chairperson of Clarity Pharmaceuticals, commented: "We are excited to continue growing our supply network for copper-67 in preparation for a registrational Phase III clinical trial with 67Cu-SAR-bisPSMA, our lead product aimed at improving the treatment paradigm for men suffering with prostate cancer. With outstanding preliminary clinical trial data generated to date from our Phase I/IIa SECuRE trial and a Fast Track Designation in the US for this optimised product, we look forward to progressing our theranostic program, pending final study findings.

"Building reliable, abundant, sustainable and cost-effective supply goes hand-in-hand with our clinical development to allow us to swiftly scale manufacturing when needed. We have seen in the past the challenges associated with growing isotope supply with lutetium-177, which relies heavily on an ageing fleet of nuclear reactors, ultimately affecting care for oncology patients waiting for their treatments. We believe, the shift away from limited nuclear reactor-based supply to more easily scalable accelerator-based methods is a prerequisite for radiopharmaceuticals to grow sustainably into the large oncology sector. By employing copper-67, we can avoid many of the drawbacks of other therapeutic isotopes. Its production requires only electricity and readily available starting materials. With Nusano’s alternative production methods, we are further differentiating our supply and look forward to having numerous pathways to producing large quantities of copper-67."

Nusano’s Chief Executive Officer, Chris Lowe, commented: "Nusano is commercialising a breakthrough radioisotope production platform in 2025 capable of producing more than 25 radioisotopes for life science applications. We are excited to deepen our relationship with Clarity through the signing of this Supply Agreement for copper-67 to enable their clinical and commercial efforts with a dependable supply of radioisotopes from our world-class production facility in Utah.

"Clarity is in a unique position with their copper-67 program, being the only radiopharmaceutical company with ongoing clinical trials utilising this important isotope, and we look forward to working together as they continue to progress their program toward registrational trials and commercialisation."

Additional Disclosure
The Supply Agreement is effective as of 16 October 2025 and is for an initial period of 3 years with automatic renewal for successive 2-year periods. Cancellation provisions are aligned with industry standard rates.

(Press release, Clarity Pharmaceuticals, OCT 16, 2025, View Source [SID1234656673])

OSE Immunotherapeutics Reports First Half 2025 Financial Results

On October 15, 2025 OSE Immunotherapeutics reported its consolidated financial results for the first half of 2025.

(Press release, OSE Immunotherapeutics, OCT 15, 2025, View Source [SID1234661838])

Boehringer Ingelheim advances cancer antibody-drug conjugate portfolio with asset from AimedBio

On October 15, 2025 Boehringer Ingelheim and AimedBio, a biotechnology company specializing in the development of antibody-based therapeutics, reported a global collaboration and licensing agreement to develop a novel antibody-drug conjugate (ADC) therapy for a broad range of cancers. The agreement further strengthens Boehringer’s growing ADC portfolio, driven by its subsidiary, NBE Therapeutics, to achieve the company’s aim of transforming the lives of people with cancer.

"ADCs are a powerful therapeutic approach that combines biological precision with chemical potency," said Vittoria Zinzalla, Global Head of Experimental Medicine at Boehringer Ingelheim. "Targeting the specific cancer surface marker with AimedBio’s ADC may expand precision medicine treatment options for currently hard to treat cancers and potentially deliver meaningful benefit to patients. We are proud to move this program into the clinic as part of our mission to transform cancer care."

ADCs harness the specificity of monoclonal antibodies and the potency of cytotoxic agents – in this case a derivative of exatecan – to selectively target and eliminate cancer cells while minimizing damage to healthy tissue. The ADC developed by AimedBio targets a protein that is highly expressed across a broad spectrum of cancers, minimally present in normal tissues, and plays a significant role in tumor growth, metastasis and resistance to therapy. Targeting this protein with an ADC is expected to enable highly specific cytotoxic action against the tumor cells, enhancing efficacy and supporting better outcomes for patients.

"We believe this program has the potential to transform the treatment landscape for many cancers that currently lack effective options. Partnering with Boehringer will help advance this program with the speed, scale, and expertise needed to validate this novel target and approach," said Do-Hyun Nam, CTO of AimedBio. "Boehringer’s strong commitment to next-generation cancer therapies makes them the ideal partner to carry this program forward into the clinic and beyond."

Under the terms of the agreement, AimedBio is entitled to receive up to $991 million in total, including an upfront payment, development and regulatory milestones, and commercial milestones, as well as separate royalty payments on net sales.

(Press release, Boehringer Ingelheim, OCT 15, 2025, View Source [SID1234656704])

Tubulis Raises €308 Million Series C to Accelerate Clinical Development of Lead ADC Candidate TUB-040 and Expand Pipeline

On October 15, 2025 Tubulis reported the successful closing of a €308 million (USD 361 million) financing. The round was led by Venrock Healthcare Capital Partners with participation from additional new investors Wellington Management and Ascenta Capital. Existing investors who supported the Series C include Nextech Invest, EQT Life Sciences, Frazier Life Sciences, Andera Partners, Deep Track Capital, Bayern Kapital, Fund+, High-Tech Gründerfonds (HTGF), OCCIDENT, and Seventure Partners.

The proceeds from the Series C financing will be used to expand the clinical development of TUB-040, Tubulis’ lead antibody-drug conjugate (ADC) candidate, into earlier lines of therapy and additional tumor indications. TUB-040 targets NaPi2b, an antigen that is overexpressed in ovarian cancer and lung adenocarcinomas. TUB-040 is currently being evaluated in a Phase I/IIa study (NAPISTAR1-01, NCT06303505) in patients with platinum-resistant ovarian cancer (PROC) as well as relapsed or refractory non-small cell lung cancer and was granted Fast Track designation by the U.S. FDA in June 2024. The capital will also advance Tubulis’ pipeline, including the clinical-stage ADC candidate TUB-030, several preclinical programs, and expand its proprietary ADC platform technologies to bring ADCs into novel applications.

"This landmark financing round reflects the deep conviction these global healthcare investors have in Tubulis and the disruptive potential of our ADC platforms," said Dr. Dominik Schumacher, CEO and Co-founder of Tubulis. "With TUB-040 progressing in the clinic and first data to be shared in a late-breaking oral presentation at ESMO (Free ESMO Whitepaper), we are ready to expand into earlier treatment lines, while continuing to innovate across our pipeline and technology platforms. The new funding empowers us to execute on our vision of creating truly differentiated antibody-drug conjugates that are tailored to the biology of solid tumors and can deliver superior therapeutic value to patients."

"Tubulis has distinguished itself in the ADC field with a forward-looking vision consistently backed by strong scientific data," said Nimish Shah, Partner at Venrock Healthcare Capital Partners. "The company is now positioned to translate an exceptional preclinical foundation into meaningful clinical results, with several important readouts on the horizon. As Tubulis continues to expand its pipeline and build momentum, I’m excited to partner with the leadership team and Board to advance a new generation of ADC medicines for patients."

In conjunction with the financing, Dr. Lorence Kim, Co-founder and Managing Partner at Ascenta Capital and Patrick Heron, Managing Partner at Frazier Life Sciences, will join Tubulis’ Supervisory Board. An overview of all Supervisory Board members and their biographies can be found here.

"This milestone financing is a testament to the scientific strength and executional track-record of the Tubulis team," added Dr. Christian Grøndahl, Chair of the Supervisory Board of Tubulis. "The company has built a unique ADC platform and is now working on demonstrating its clinical impact. With the backing of experienced biotech investors, Tubulis is on a path towards solidifying its position as a global leader in the ADC landscape."

(Press release, Tubulis, OCT 15, 2025, View Source [SID1234656690])