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.

On June 16, 2025 Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence (AI) company developing targeted cancer therapies using its proprietary RADR AI platform, reported remarkable clinical observations for a patient in Lantern’s Phase 2 HARMONIC clinical trial (Press release, Lantern Pharma, JUN 16, 2025, View Source [SID1234653937]). A 70-year-old never-smoker with advanced non-small cell lung cancer (NSCLC) has achieved a durable complete response in their target cancer lesions following treatment with LP-300 in combination with standard-of-care chemotherapy. Importantly, the patient continues to show sustained survival benefits after nearly two years.

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The patient, who had previously failed three lines of prior therapy including Keytruda (pembrolizumab) with chemotherapy, radiation therapy, and the EGFR inhibitor Tagrisso (osimertinib), initially demonstrated a partial response with a 57% reduction in tumor volume after completion of the HARMONIC lead-in cohort enrollment in Q3 of 2024. The patient subsequently demonstrated a complete response in the target cancer lesions, specifically the lung and adrenal gland lesions by Q1 of 2025. This type of complete response in the target cancer lesions is atypical for this advanced and recurrent NSCLC after multiple rounds of therapy.

"This remarkable case exemplifies several of the things we have hoped to observe with LP-300 in the HARMONIC trial," said Panna Sharma, President and CEO of Lantern Pharma. "To see a heavily pre-treated patient not only achieve a complete response in their target cancer lesions but maintain that response with excellent quality of life is truly extraordinary. This outcome provides important confirmation of our data and AI-driven approach to drug development and gives us growing confidence as we advance toward potential future registration-enabling studies for this underserved patient population that has no approved treatment options after failing targeted kinase therapies."

Notably, the patient has shown no clinically significant adverse drug reactions or dose-limiting toxicities (DLTs) over 21 cycles of treatment. By February 2025, imaging showed continued complete response in the primary target lesions with only scar tissue remaining at the site of the lung cancer lesions, and the disappearance of the adrenal gland cancer lesion, demonstrating the profound and durable nature of the therapeutic response.

Growing Global Cancer Type with No Approved Options After Kinase Therapy Failure
The proportion of never-smoking patients with non-small cell lung cancer (NSCLC) has been significantly increasing globally over the past 30 years, from 15% in the 1970s to 33% in the 2000s. Lung cancer in never smokers is the fifth leading cause of cancer-related deaths globally, according to the International Agency for Research on Cancer (IARC). Never-smokers represent a distinct subset of lung cancer patients1 with unique genetic profiles and limited treatment options, estimated to represent a $4+ billion annual market opportunity globally. The HARMONIC trial is evaluating LP-300, advanced with Lantern’s proprietary RADR AI platform, in combination with pemetrexed and carboplatin in never-smokers with advanced NSCLC who have progressed after treatment with tyrosine kinase inhibitors (TKIs).

Exceptional Clinical Observations in a Challenging Patient Population With Significant Unmet Needs
This case represents a particularly significant observation given the patient’s extensive treatment history, including with both immuno-oncology agents and targeted kinase therapies, and the challenging nature of advanced NSCLC in non-responsive never-smokers. The sustained response over nearly two years, combined with excellent tolerability, underscore LP-300’s potential to be a transformative treatment option for this underserved patient population and is demonstrative of the mechanistic rationale for this drug-candidate.

"The sustained response we’re observing in this patient, particularly after three lines of prior standard of care treatments, is remarkable and provides strong support for LP-300’s therapeutic potential," said Dr. Reggie Ewesuedo, Vice President of Clinical Development at Lantern Pharma. "The fact that this patient has tolerated 21 cycles of treatment without clinically significant adverse drug reactions and has achieved meaningful durable response reinforces our confidence in the promise of this drug-candidate in this patient population."

About Lantern Pharma’s HARMONIC Trial
The HARMONIC clinical trial is a Phase 2 study (NCT05456256) evaluating LP-300 in combination with standard chemotherapy (pemetrexed/carboplatin) for never-smokers with advanced lung adenocarcinoma who have experienced progression or intolerance to prior tyrosine kinase inhibitor (TKI) therapy. The trial is designed to assess whether LP-300, when added to chemotherapy, improves progression-free survival (PFS) and overall survival (OS) compared to the current standard-of-care chemotherapy doublet alone.

The multicenter, open-label, randomized study has planned enrollment of approximately 90 patients across sites in the United States, Japan, and Taiwan. The trial compares LP-300 in combination with standard-of-care chemotherapy versus chemotherapy alone in a 2:1 randomization, with co-primary endpoints of progression-free survival (PFS) and overall survival (OS).

Upcoming Milestones and Clinical Development
Lantern expects to continue reporting clinical updates from the HARMONIC trial throughout 2025 as enrollment progresses across multiple sites. The company anticipates providing an additional data update from the randomized expansion phase in the second half of 2025.

The never-smoker NSCLC population represents a significant and growing unmet medical need, with no therapies specifically approved for this patient subset. Approximately 15-20% of all lung cancer patients in the U.S. are never-smokers, with significantly higher rates in Asian populations, where up to 50% of new lung cancer diagnoses occur in never-smokers.

About LP-300
LP-300 was advanced with Lantern’s proprietary RADR AI platform to aid in the confirmation of combination synergies and the proposed mechanism of action. The lead-in cohort of the Phase 2 HARMONIC trial demonstrated an initial 86% clinical benefit rate and 43% objective response rate, leading to the current randomized expansion phase.

On June 16, 2025 Imbrium Therapeutics L.P. ("Imbrium"), a clinical-stage biopharmaceutical company, reported pipeline developments at the BIO International Convention on Wednesday, June 18, at 9:15 a.m. in Room 153B (Press release, Imbrium Therapeutics, JUN 16, 2025, View Source [SID1234653936]). Imbrium is actively seeking partnerships to advance the development of investigational therapeutics for multiple indications across several disease areas including genitourinary disorders, substance use disorders, and cancerous malignancies.

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Imbrium is discussing two investigational agents, sunobinop and tinostamustine, both of which could present substantial revenue opportunities*.

Sunobinop is a novel, first-in-class, nociceptin receptor partial agonist. The orally active investigational drug is in Phase 1b/2a clinical development for multiple indications, including alcohol use disorder (AUD), interstitial cystitis/bladder pain syndrome (IC/BPS), and overactive bladder (OAB). Related to AUD, sunobinop’s pharmacological properties offer a unique approach under investigation for alcohol craving, consumption and sleep issues; it has the potential to be the first new modality in AUD in almost 20 years. Related to OAB and IC/BPS, sunobinop has been shown in early studies to target the sensory nerves in the bladder to affect urination, pain, and nocturia. Global or regional rights are available for partnership.

Tinostamustine is a novel, first-in-class, investigational drug combining DNA alkylating activity and histone deacetylase inhibition in a single molecule. It has the potential to be a first-line agent to treat patients with glioblastoma multiforme (GBM), a highly aggressive form of brain cancer. In Phase 1 studies as an adjuvant to standard chemoradiation, tinostamustine was shown to improve survival in difficult-to-treat newly diagnosed patients and is on track for accelerated development. It has the potential to be the first new chemotherapeutic to treat GBM in more than 20 years. Tinostamustine has also shown promise in early clinical studies in other solid and hematological tumors. U.S. rights are available for partnership.

"We are committed to securing partnerships that further advance promising novel therapies," said David Saussy, Head of Licensing & Business Development. "We look forward to presenting these pipeline highlights at BIO and moving our research programs forward to help address unmet patient needs."

Tinostamustine and all proposed indications for sunobinop are open to partnering. For more information, e-mail [email protected]. For more information about our pipeline, click here.

*This release discusses investigational uses of agents in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that sunobinop or tinostamustine will successfully complete development or gain FDA approval.