On September 26, 2025 Novartis reported it will present new data from 34 abstracts across its oncology portfolio at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025 in Berlin (October 17-21, 2025) (Press release, Novartis, SEP 26, 2025, View Source [SID1234656245]).

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"We look forward to sharing new clinical data that underscores how we are reimagining treatment for breast and prostate cancer, advancing highly effective therapies designed to improve quality of life, enable more personalized care and ultimately provide more time for cancer patients," said Dushen Chetty, PhD, Global Head of Oncology Development, Novartis, Ad Interim. "Our ambition is to set new standards of care in some of the most prevalent cancers by pioneering novel technologies like radioligand therapy."

Key highlights of data accepted by ESMO (Free ESMO Whitepaper) include:

Medicine Abstract title Abstract Number/
Presentation Details
Pluvicto (lutetium (177Lu) vipivotide tetraxetan) Phase 3 trial of [177Lu]Lu-PSMA-617 combined with ADT + ARPI in patients with PSMA-positive metastatic hormone-sensitive prostate cancer (PSMAddition) #LBA6
Presidential Symposium 2 (Proffered Paper session)
October 19, 2025
16:30 – 18:15 CEST
Pluvicto (lutetium (177Lu) vipivotide tetraxetan) Associations between quantitative baseline 68Ga-PSMA-11 PET parameters and 177Lu-PSMA-617 efficacy in the PSMAfore Study #2390P
Poster Presentation
October 18, 2025
09:00 – 17:00 CEST
Pluvicto (lutetium (177Lu) vipivotide tetraxetan) Final analysis of patients treated with [177Lu]Lu-PSMA-617 in early access program in metastatic castration-resistant prostate cancer (mCRPC) in France #2389P
Poster Presentation
October 18, 2025
09:00 – 17:00 CEST
[225Ac]-PSMA-617 PSMAcTION trial-in-progress: a phase 2/3 randomized trial of [225Ac]Ac-PSMA-617 (225Ac-PSMA-617) versus standard of care in patients with PSMA-positive metastatic castration-resistant prostate cancer who progressed on or after [177Lu]Lu-PSMA therapy #2516TiP
Poster Presentation
October 18, 2025
09:00 – 17:00 CEST
Kisqali (ribociclib) Adjuvant ribociclib (RIB) plus nonsteroidal aromatase inhibitor (NSAI) in patients (pts) with HR+/HER2− early breast cancer (EBC): NATALEE 5-year outcomes #LBA14
Proffered Paper session
October 17, 2025
14:00 – 15:30 CEST
Kisqali (ribociclib) Impact of neoadjuvant chemotherapy (NACT) response on clinical outcomes with ribociclib (RIB) in HR+/HER2− EBC: a subgroup analysis from the phase 3 NATALEE trial #366P
Poster Presentation
October 20, 2025
09:00 – 17:00 CEST
Kisqali (ribociclib) A NATALEE data–based machine learning (ML) model to predict distant recurrence (DR) and treatment (tx) effect in real-world (RW) patients (pts) with HR+/HER2– early breast cancer (EBC) without CDK4/6 inhibitor (CDK4/6i) tx #372P
Poster Presentation
October 20, 2025
09:00 – 17:00 CEST
Kisqali (ribociclib) Real-world characteristics, treatments and outcomes of NATALEE and monarchE-eligible HR+/HER2- early breast cancer patients in the hospital district of Helsinki and Uusimaa (HUS), Finland #360P
Poster Presentation
October 20, 2025
09:00 – 17:00 CEST
Kisqali (ribociclib) Risk of Recurrence (ROR) After Neoadjuvant Ribociclib Plus ET in Clinically High-Risk ER+/HER2− BC: Preliminary Analysis of the SOLTI-RIBOLARIS Trial #296O
Proffered Paper session
October 17, 2025
14:00 – 15:30 CEST

On September 25, 2025 Leap Therapeutics, Inc. (Nasdaq: LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported it will present the final clinical results from Part B of the DeFianCe study (NCT05480306), a Phase 2 study of sirexatamab (DKN-01), an anti-DKK1 monoclonal antibody, in combination with bevacizumab and chemotherapy (Sirexatamab Arm) compared to bevacizumab and chemotherapy (Control Arm) in patients with advanced microsatellite stable (MSS) colorectal cancer (CRC) who have received one prior systemic therapy for advanced disease (Press release, Leap Therapeutics, SEP 25, 2025, View Source [SID1234656244]). The final results will be presented in a Mini Oral Session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, taking place October 17-21 in Berlin, Germany.

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Mini Oral Session Details:

Title: DeFianCe Trial: A randomized phase 2 trial of sirexatamab (DKN-01) plus bevacizumab and chemotherapy versus bevacizumab and chemotherapy as second-line therapy in advanced microsatellite stable (MSS) colorectal cancer (CRC)
Presenter: Zev A. Wainberg, M.D., Professor of Medicine and Co-Director of the GI Oncology Program at UCLA
Session Type: Mini Oral Session
Session Category: GI Tumours, Lower Digestive
Date and Time: Sunday, October 19, 2025, 4:05 p.m. CEST
Location: Cologne Auditorium – CityCube A
Abstract Number: LBA34

On September 25, 2025 Theratechnologies Inc. ("Theratechnologies" or the "Company") (TSX: TH) (NASDAQ: THTX), a commercial-stage biopharmaceutical company, reported the completion of the previously-announced plan of arrangement under Chapter XVI – Division II of the Business Corporations Act (Québec) involving CB Biotechnology, LLC (the "Purchaser"), an affiliate of Future Pak, LLC ("Future Pak"), pursuant to which the Purchaser has acquired all the issued and outstanding common shares of the Company (the "Shares") for US$3.01 per Share in cash plus one contingent value right ("CVR") per Share for additional aggregate cash payments of up to US$1.19 per CVR if certain milestones are achieved by the Company (the "Arrangement") (Press release, Theratechnologies, SEP 25, 2025, View Source [SID1234656243]).

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Consideration for the Shares has been remitted by the Purchaser to Computershare Investor Services Inc., as depositary under the Arrangement, and will be paid to former shareholders of Theratechnologies as soon as reasonably practicable after the date hereof (or, in the case of registered shareholders, as soon as reasonably practicable after a properly completed and signed letter of transmittal is received by the depositary together with the share certificate(s) and/or DRS Advice(s) representing Shares formerly held by them).

Each CVR is a contractual right that entitles the holder thereof to aggregate payments from the Purchaser of up to US$1.19 per CVR if certain milestones are achieved by the Company, the whole in accordance with the agreement entered into on the day hereof among the Purchaser, Future Pak and Computershare Trust Company of Canada as CVR agent. The CVRs are recorded in a register kept by the CVR agent and are not evidenced by a certificate or any other instrument. Based on a report prepared by an independent third-party valuator, the Company and the Purchaser have determined the fair market value of each CVR to be US$0.80 as at September 24, 2025.

As a result of the completion of the Arrangement, it is expected that the Shares will be de-listed from the Toronto Stock Exchange on or about September 26, 2025 and from the Nasdaq Capital Market on or about September 25, 2025. The Company shall apply to cease to be a reporting issuer under Canadian securities laws in all provinces of Canada. The Company will also deregister the Shares under the U.S. Securities Exchange Act of 1934, as amended.

Early Warning Reporting

Immediately prior to the effective date of the Arrangement, the Purchaser and its affiliates did not own any Shares. An early warning report will be filed on SEDAR+ at www.sedarplus.ca under the Company’s profile. Further information and/or a copy of the early warning report may be obtained from the contacts below. The Purchaser’s head office is located at CB Biotechnology, LLC c/o Honigman LLP, 2290 First National Building, 660 Woodward Avenue, Detroit, MI 48226-3506.

On September 25, 2025 Synaffix B.V. ("Synaffix"), a Lonza company (SWX:LONN) focused on commercializing its clinical-stage platform technology for the development of antibody-drug conjugates (ADCs) with potential best-in-class therapeutic index, reported that it has entered into a licensing agreement with Qurient Co., Ltd., a clinical-stage biopharmaceutical company based in South Korea, for the development of a dual-payload ADC (Press release, Synaffix, SEP 25, 2025, View Source [SID1234656242]).

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Dual-payload ADCs are designed to deliver two separate cytotoxic agents with distinct mechanisms of action to target cancer cells, aiming to enhance therapeutic efficacy and mitigate payload resistance. Their therapeutic promise can potentially expand the current range of effective treatments while minimizing toxicity to healthy tissues, especially in refractory cancer cases.

The collaboration aims to develop a dual-payload ADC consisting of Synaffix’s exatecan-based technology and Qurient’s CDK7 inhibitor, aiming to target unmet medical needs in solid tumors. Under the terms of the agreement, Qurient will gain access to Lonza’s clinical-stage, site-specific ADC technology platform powered by Synaffix services including GlycoConnect antibody conjugation, HydraSpace polar spacer, and exatecan-based linker-payload technologies, as well as Lonza’s market-leading expertise and experience in developing and manufacturing bioconjugates.

Lonza will manufacture components related to its proprietary Synaffix technologies, and Qurient will perform the research, development, manufacturing and commercialization of the ADC, and manufacturing of Qurient’s CDK7 inhibitor.

Peter van de Sande, Head of Synaffix, said: "This licensing collaboration with Qurient signifies the versatility of our industry-leading ADC platform technology. Enabling the development of a dual- payload ADC built with Synaffix technology reflects our drive to continue pioneering innovation in the field."

Kiyean Nam, CEO at Qurient, said: "Dual-payload ADCs represent the next frontier in targeted antibody therapeutics, and we look forward to advancing this novel combination of our CDK7 inhibitor and Synaffix’s SYNtecan linker-payload. The combination of our proprietary technology with Synaffix’s industry-leading platform has the potential to be applicable to a wider range of targets and antibodies, and we look forward to exploring those possibilities in the future."

On September 25, 2025 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat cancers and viral infections, reported that the Canadian Intellectual Property Office (CIPO) has issued a notice of allowance for Patent Application No. 3,142,510 titled, "PREPARATION OF PRELIPOSOMAL ANNAMYCIN LYOPHILIZATE." A patent from the application is expected to be issued in the coming months (Press release, Moleculin, SEP 25, 2025, https://moleculin.com/moleculin-announces-notice-of-allowance-for-canadian-patent-covering-annamycin/ [SID1234656241]).

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When issued, the patent claims will cover methods of making a preliposomal Annamycin lyophilizate with improved stability and high purity, with a base patent term currently extending until June 2040, subject to extension to account for time required to fulfill requirements for regulatory approval. Moleculin’s novel drug candidate is being positioned to become the first ever non-cardiotoxic anthracycline to be approved and is currently being developed for the treatment of acute myeloid leukemia (AML) and soft tissue sarcoma lung metastases (STS lung mets). Additional preclinical studies performed at a world-renowned cancer center indicate Annamycin may be a potential treatment for many other types of cancers. The new chemical entity uses a unique lipid-based delivery technology and has shown the potential to be used in a wide range of cancers. In addition to the newly expected Canadian patent and previously issued U.S. and allowed European patents, Moleculin has additional patent applications related to Annamycin pending in the U.S., Europe and in major jurisdictions worldwide.

Walter Klemp, Chairman and CEO of Moleculin, commented, "We remain committed to bolstering our global intellectual property portfolio for Annamycin. This Canadian patent further strengthens our current IP portfolio which includes claims to methods of making our preliposomal Annamycin, in yet another key territory. As we continue to advance our development of Annamycin as a potentially transformative therapeutic candidate for hard-to-treat tumors, building on our global patent protection remains a focus."

Annamycin, also known by its non-proprietary name of naxtarubicin, currently has Fast Track Status and Orphan Drug Designation from the FDA for the treatment of relapsed or refractory AML, in addition to Orphan Drug Designation for the treatment of STS lung mets. Furthermore, Annamycin has Orphan Drug Designation for the treatment of relapsed or refractory AML from the EMA.