On June 17, 2025 Alligator Bioscience (Nasdaq Stockholm: ATORX), a clinical-stage biotechnology company developing tumor-directed immunotherapies, reported that the European Medicines Agency (EMA) has provided positive scientific advice supporting the overall design of the planned Phase 3 study of mitazalimab in metastatic pancreatic cancer (Press release, Alligator Bioscience, JUN 17, 2025, View Source [SID1234653942]).

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The advice confirms that the proposed Phase 3 study of mitazalimab in combination with mFOLFIRINOX is appropriately designed to support future marketing authorization application. The guidance confirms that the information submitted supports mitazalimab advancement to registrational trials, and Alligator is continuing preparations for trial initiation in line with regulatory input.

This regulatory feedback represents another key milestone in the late-stage development of mitazalimab and complements the recently announced confirmation by the U.S. Food and Drug Administration (FDA) of the Phase 3 dose.

"We are very pleased with EMA’s endorsement of our Phase 3 trial design and mitazalimab’s Phase 3 readiness, confirming its path to regulatory approval in Europe," said Søren Bregenholt, CEO of Alligator Bioscience. "This advice from EMA aligns very well with previous input from FDA thus enabling a single global Phase 3 study leading to mitazalimab’s potential registration as a new treatment for patients with metastatic pancreatic cancer in these major territories."

On June 16, 2025 Biosceptre reported that lead scientists Alex Joechner and Dr. Cindy Li from the Biosceptre Laboratory were honoured with an invitational oral presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) 2025 Annual Congress, held this week in Milan (Press release, Biosceptre, JUN 16, 2025, View Source;utm_medium=rss&utm_campaign=biosceptre-presenting-our-aml-modular-car-t-program-at-the-prestigious-european-hematological-congress [SID1234654004]).

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With more than 14,000 delegates in attendance, EHA (Free EHA Whitepaper) is one of the world’s premier events for hematological research. Of the more than 3,500 abstracts submitted last year, only 235 were selected for oral presentation—highlighting the exceptional quality and impact of the work presented by our team.

The 15-minute oral presentation showcased compelling new data on Biosceptre’s modular CAR-T platform, focusing on its function and therapeutic potential in treating Acute Myeloid Leukemia (AML). This recognition reflects the scientific strength of our BRiDGECAR program and the dedication of our team in advancing next-generation cell therapies for challenging blood cancers.

We congratulate Alex and Dr. Li on this achievement and thank the EHA (Free EHA Whitepaper) for the opportunity to present on the global stage.

On June 16, 2025 Crescent Biopharma, Inc. ("Crescent" or the "Company"), a biotechnology company dedicated to rapidly advancing the next wave of therapies for cancer patients, reported the completion of its previously announced merger with GlycoMimetics, Inc. ("GlycoMimetics") (Press release, Crescent Biopharma, JUN 16, 2025, View Source [SID1234653974]). The combined company will operate under the name Crescent Biopharma, Inc., and its shares are expected to begin trading on the Nasdaq Capital Market today, June 16, 2025, under the ticker symbol "CBIO."

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Immediately prior to the closing of the merger, Crescent completed a previously announced private financing of $200 million in gross proceeds led by Fairmount, Venrock Healthcare Capital Partners, BVF Partners, and a large institutional investor, with participation from a broad syndicate of healthcare-focused investors. Notable participants include Paradigm BioCapital, RTW Investments, Blackstone Multi-Asset Investing, Frazier Life Sciences, Commodore Capital, Perceptive Advisors, Deep Track Capital, Boxer Capital Management, Soleus, Logos Capital, Driehaus Capital Management, Braidwell LP, and Wellington Management. The proceeds include the conversion of $37.5 million in previously issued convertible notes, plus accrued interest thereon. This financing, together with existing cash, is expected to support the Company’s operations through 2027, including multiple anticipated pipeline milestones.

Pursuant to the terms of the previously disclosed merger agreement, each outstanding share of Crescent common stock was converted into 0.1445 shares of common stock of the combined company, as adjusted for the reverse stock split of GlycoMimetics common stock at a ratio of 1-for-100 shares, effected immediately prior to the merger. The new CUSIP number for the combined company following the reverse stock split and merger is 38000Q201. Following the completion of the merger, there are approximately 19.5 million shares of the combined company’s common stock and common stock equivalents outstanding, including shares of common stock underlying pre-funded warrants and Series A convertible preferred stock, and excluding shares underlying equity awards.

"With our seasoned team, promising pipeline, and solid financial foundation supported by leading biotechnology investors, Crescent is well-positioned to lead the next wave of therapeutic innovation for people living with cancer," said Joshua Brumm, chief executive officer of Crescent. "We anticipate dosing patients in early 2026 in our global Phase 1 trial for CR-001, a PD-1 x VEGF bispecific antibody. Based on the intentional design of CR-001 to replicate a clinically validated approach, we expect the data we generate in patients with solid tumors to be meaningful. We are also advancing two novel ADCs, starting with our CR-002 program which we anticipate entering the clinic in the middle of next year. Our hope is to rapidly bring new treatment options for cancer patients that could truly make a difference in their lives."

Crescent remains on track to submit an Investigational New Drug (IND) application in the fourth quarter of 2025 for its lead program, CR-001, a tetravalent PD-1 x VEGF bispecific antibody intentionally designed to replicate the cooperative pharmacology of ivonescimab, which demonstrated superior efficacy compared to the current market leader, pembrolizumab, in a large third party Phase 3 trial in non-small cell lung cancer.1 Crescent expects to report proof-of-concept clinical data from a Phase 1 trial of CR-001 in patients with solid tumors in the second half of 2026. CR-002 and CR-003, novel antibody-drug conjugates (ADCs) with topoisomerase inhibitor payloads, are being developed as single agents and in combination with CR-001, with an IND submission for CR-002 anticipated in mid-2026.

On June 16, 2025 HekaBio K.K. (Headquarters: Chuo-ku, Tokyo; President & CEO: Robert E. Claar; hereinafter "HekaBio") reported the signing of a strategic partnership agreement with Alfresa Holdings Corporation (Headquarters: Chiyoda-ku, Tokyo; Representative Director & President: Ryuji Arakawa; hereinafter "Alfresa Holdings"), the leading pharmaceutical wholesaler group in Japan (Press release, HekaBio, JUN 16, 2025, View Source [SID1234653939]). As part of this agreement, Alfresa Holdings has also made a capital investment in HekaBio. The partnership aims to accelerate the commercialization of innovative medical products in Japan.

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Background and Purpose

In recent years, Japan has implemented policy reforms to address the growing access gap, where innovative therapies approved overseas are slow to come to the Japanese market.

In response to these developments, HekaBio has focused on introducing cutting-edge pharmaceuticals, medical devices, and regenerative medicine products from global markets into Japan and the Asia-Pacific markets. Leveraging a proprietary global network and partnership model, HekaBio evaluates over 200 assets annually across oncology, cardiology and CNS, and supports end-to-end commercialization from licensing to clinical and regulatory development, manufacturing and sales.

This partnership with Alfresa Group will enable HekaBio to advance and expand its portfolio and impact, particularly in CNS and regenerative medicine where Alfresa Group has strengths in manufacturing and in sales, including various other aspects of sales-related operations across the supply chain.

Outlook

Through this partnership, HekaBio and Alfresa Group aim to accelerate the introduction of high-impact, potential blockbuster therapies into the Japanese market, expanding treatment options for patients. The companies also plan to explore commercialization strategies across the Asia-Pacific region and beyond.

On June 16, 2025 Debiopharm (www.debiopharm.com), a privately-owned, Swiss-based biopharmaceutical company aiming to establish tomorrow’s standards of care to cure cancer and infectious diseases, reported that the first patient has been dosed in the first-in-human clinical trial evaluating the safety, tolerability, and antileukemic activity of Debio 1562M monotherapy in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) (Press release, Debiopharm, JUN 16, 2025, View Source [SID1234653938]). This phase 1/2 trial (NCT06969430) will lay the groundwork for further development as it will allow the characterization of the safety and tolerability of the drug, dose optimization, and define the product’s activity.

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AML remains a significant unmet need in oncology, particularly for older adults who account for the majority of cases. Despite advances in our understanding of AML biology and the introduction of new therapies, outcomes remain dismal for many patients—especially those who are not candidates for intensive treatments such as traditional chemotherapy or stem cell transplantation. While intensive chemotherapy and targeted therapies are available, they have not substantially improved long-term outcomes across all patient populations. The 5-year overall survival (OS) rate remains at just 32%1, with a median OS as low as 7 months in certain populations.2 This stark therapeutic gap leaves thousands of patients without viable treatment options each year, highlighting an urgent need for innovative interventions capable of extending survival. Transformative solutions are critical to improving both prognosis and quality of life for this underserved population within the AML treatment landscape.

"It’s time for AML research to advance with more precise therapeutic options," expressed Marianna Muller, Senior Medical Director, Oncology, Debiopharm. "This study will help us better understand the potential of Debio 1562M and how it could provide an effective new treatment while minimizing tolerability challenges for patients facing this very difficult disease with high unmet medical need."

CD37, a cell-surface antigen, has been shown to be a relevant ADC target in AML due to its broad expression on blasts and leukemic stem cells along with efficient internalization.3 Research reveals that this increased expression is restricted to malignant cells compared to healthy hematopoietic stem cells and is correlated with poor patient outcomes.3 Debio 1562M is a next generation ADC targeting CD37 with 1st-in-class potential. The compound was designed using Debiopharm’s Trifecta approach optimizing 3 key components: naratuximab – an anti-CD37 monoclonal antibody, Multilink proprietary linker technology, and a microtubule inhibitor as cytotoxic payload. In pre-clinical studies, Debio 1562M showed anti-leukemic activity across all AML subtypes as well as superior activity vs. the current standard-of-care and targeted therapies in AML models.

Debiopharm has been involved in targeted drug delivery for more than a decade, developing MultiLink—our unique and versatile proprietary ADC technology suite, key components of which are integrated into this product. We recognize how critical the need is for AML patients and remain dedicated to addressing it through our ADC expertise. As our pre-clinical results have shown promising antitumor activity and tolerability in this hard-to-treat leukemia, we’re looking forward to seeing what this clinical stage research with Debio 1562M could reveal," mentioned Bertrand Ducrey, CEO of Debiopharm.