Alligator to present 24-month OPTIMIZE-1 data at ESMO GI 2025

On July 1, 2025 Alligator Bioscience (Nasdaq Stockholm: ATORX) Alligator Bioscience (Nasdaq Stockholm: ATORX), a clinical-stage biotechnology company developing tumor-directed immunotherapies, reported that new data from the ongoing OPTIMIZE-1 study, evaluating the CD40 agonist mitazalimab in combination with mFOLFIRINOX in metastatic pancreatic cancer, will be presented at the ESMO (Free ESMO Whitepaper) Gastrointestinal Cancers Congress 2025, taking place in Barcelona on 2–5 July (Press release, Alligator Bioscience, JUL 1, 2025, View Source [SID1234654190]).

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The poster includes 24-month efficacy results and dose characterization data from OPTIMIZE-1 (NCT04888312), a Phase 1b/2 trial in patients with previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC). Patients receiving 900 μg/kg mitazalimab showed a median overall survival of 14.9 months and a median progression-free survival of 7.8 months, supporting a sustained clinical benefit. The survival rate at 24 months was 29.4%, triple that of chemotherapy alone.

A comparison between the 900 μg/kg and 450 μg/kg cohorts revealed a higher response rate for 900 μg/kg of 54.4% versus 22.7%. This indicates a dose-response relationship further supporting mitazalimab’s contribution to the positive clinical response data observed in OPTIMIZE-1, reinforcing the candidate’s favorable safety profile and supporting 900 μg/kg as the recommended Phase 3 dose — a decision recently endorsed by the FDA.

Poster presentation details
Title: CD40 agonist mitazalimab + mFOLFIRINOX in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC): 24-month follow up and dose characterization from the OPTIMIZE-1 study
Topic: Upper digestive – Biliary, ampullary and pancreatic cancer
Presentation number: 265P
Session: Poster display session 1 and coffee break
Date: Thursday, 3 July 2025
Time: 15:30–16:30 CEST
Location: Foyer
Presenter: Dr. Aurélien Lambert

Adagene announces up to $25 million strategic investment from Sanofi

On July 1, 2025 Adagene Inc. ("Adagene or the Company") (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, reported strategic investment and option exercise by Sanofi (Euronext: SAN FP) (Press release, Adagene, JUL 1, 2025, View Source [SID1234654189]).

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Sanofi has agreed to make strategic investment of up to US$25 million in Adagene. The Company plans to use the proceeds to fund its research and development activities, including clinical development of muzastotug (ADG126), an anti-CTLA-4 SAFEbody, through a randomized phase 2 trial in microsatellite stable colorectal cancer (MSS CRC).

To further explore the clinical potential of muzastotug, Adagene will supply Sanofi with muzastotug to evaluate the safety, efficacy, pharmacokinetics and biomarker data in combination with other anticancer therapies in over 100 patients in a phase 1/2 clinical trial in advanced solid tumors. Adagene continues to own worldwide commercial rights to muzastotug.

Sanofi has also exercised its option to select a third SAFEbody discovery program, utilizing Adagene’s proprietary masking technology and antibody engineering expertise. The bispecific therapeutic, with undisclosed targets, will be engineered by Adagene and induces an option exercise fee, as well as milestones and royalties as per the 2022 partnership agreement with Adagene.

"Expanding our partnership with Sanofi highlights the potential of our SAFEbody platform and the clinical proof of concept for ADG126, our masked anti-CTLA-4 program and the most advanced of its kind," said Peter Luo, Chairman, CEO and President of R&D at Adagene. "This strategic partnership reinforces our shared vision of ADG126’s promise in advanced solid tumors, including MSS CRC, where dose-limiting challenges have hindered anti-CTLA-4 therapies. We value our trusted relationship with Sanofi."

As of December 31, 2024, the Company had audited cash and cash equivalents of US$85.2 million. The proceeds from the investment of Sanofi, together with the current cash and cash equivalents, are expected to be sufficient to fund planned operations into 2027.

Following the equity investment and strategic collaborations, a Sanofi representative will join Adagene’s Scientific Advisory Board (SAB), which provides strategic advice on the scientific and clinical aspects of the Company’s activities.

Abeona Therapeutics® Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

On July 1, 2025 Abeona Therapeutics Inc. (Nasdaq: ABEO) reported it has granted equity awards to new non-executive employees who joined the Company (Press release, Abeona Therapeutics, JUL 1, 2025, View Source [SID1234654188]). The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4).

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On June 30, 2025, the Compensation Committee of Abeona’s Board of Directors granted restricted stock equity awards as a material inducement to employment to 21 individuals hired by Abeona, which equity awards relate to, in the aggregate, up to 48,715 restricted shares of Abeona common stock. One-third of the shares subject to such restricted stock awards will vest yearly on each anniversary of the Grant Date, such that the shares subject to such restricted stock awards granted to each employee will be fully vested on the third anniversary of the Grant Date, in each case, subject to each employee’s continued employment with Abeona on the applicable vesting dates.

MonTa announces completion of phase I does-escalation

On July 1, 2025 MonTa reported completion of its phase I dose-escalation study with completion of the last cohort of patients after treating 85 patients in total. We look forward to design the expansion phase also called phase IB to move towards patients with less advanced cancer with unmed medical need (Press release, MonTa Biosciences, JUL 1, 2025, View Source [SID1234654187]).

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Medicus Pharma Ltd Announces a Definitive Agreement to Acquire Antev Ltd. UK

On June 30, 2025 Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus") and Antev Ltd. ("Antev"), a UK-based clinical-stage drug development company, reported that they have entered into a definitive agreement dated June 29, 2025 (the "Definitive Agreement") pursuant to which Medicus has agreed to acquire all of the issued and outstanding shares of Antev (the "Antev Shares") on a share exchange basis (the "Transaction").

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Subject to the closing conditions noted in the Definitive Agreement, Medicus will acquire all issued and outstanding Antev Shares, on a fully diluted basis, in exchange for 2,666,600 (or approximately 17% in aggregate) of the issued and outstanding Medicus common shares (the "Consideration Shares").

In addition to resale restrictions prescribed under applicable securities law, the Consideration Shares issuable to Antev shareholders will be subject to a 9-month staggered lock-up and an agreement granting certain voting rights in favor of Medicus management for a period of 36 months.

Antev shareholders will be entitled to receive up to approximately US$65 million in additional contingent consideration tied to potential future FDA Phase 2 and New Drug Application approvals, as more particularly described in the Definitive Agreement.

The Transaction is expected to close before the end of August 2025, subject to the fulfillment of certain closing conditions, including obtaining Antev shareholder approval and other applicable corporate, regulatory and third-party approvals. No assurances can be given that the parties will successfully close the Transaction on the terms or timeframe currently contemplated or at all.

Antev is a clinical stage biotech company, developing Teverelix, a next generation GnRH antagonist, as first in market product for cardiovascular high-risk prostate cancer patients and patients with first acute urinary retention (AURr) episodes due to enlarged prostate.

Antev Acute Urinary Retention (AUR) Indication:
Teverelix is aiming to be the first-in-class indication product for preventing recurrence of acute urinary retention (AURr) in males 45 years or older, who suffer from prostate enlargement. Antev has a US Food and Drug Administration (FDA) approved phase 2b study designed to randomize 390 men after a successful trial without catheterization (TWOC). 85% of nearly one million (1M) annual AUR episodes in the US occur in Men 60+ who suffer from enlarged prostate that manifests with age and frequently is followed by a recurrent episode within 6 months for approximately 30% of men, presenting a potential market opportunity of more than US $2B annually.

Antev planned Phase 2b Study Design in Acute Urinary Retention:

Randomized controlled double blinded study in 390 men after a successful TWOC in 60-70 sites in United States (US) and European Union (EU). The participants shall receive either single intramuscular (IM) or subcutaneous (SC) injection (90mg or 120mg) or placebo in addition to standard therapy. Primary endpoint is a composite of AURr, need for surgery or poor urinary flow metrics in the first 28 weeks plus 24 weeks follow up.

Antev High Cardiovascular (CV) Risk Advanced Prostate Cancer (APC) indication:
Teverelix is aiming to be the best-in-class indication product for hormone therapy for advanced prostate cancer (APC) patients with increased CV risk. Antev has a US Food and Drug Administration (FDA) approved phase 2b open label study designed to recruit 40 men with advanced prostate cancer. Antev is targeting a niche in patients with increased CV risk, aiming to provide an androgen deprivation therapy (ADT) option with potentially lower cardiac toxicity than conventional GnRH agonists. If approved, Teverelix could become the first hormone therapy labeled specifically for treating prostate cancer in patients with a history of cardiovascular disease. 300,000 to 500,000 men in the US are living with advanced stage prostate cancer presenting a potential market opportunity of more than US $4B annually.

Antev planned Phase 2b Study Design in Advanced Prostate Cancer

Open label study in 40 men with advanced prostate cancer suitable for ADT. The participants shall receive a loading dose of 180mg IM plus x2 180mg SC (total 540mg), followed by x2 180mg (360mg) SC day 29 and every 6 weeks. The total duration of the treatment is 22 weeks. Primary endpoint is to confirm castration rate by day 29, sustaining to day 155, probability greater than 90%.

(Press release, Medicus Pharma, JUN 30, 2025, View Source [SID1234671208])