On December 04, 2025 (GLOBE NEWSWIRE) — Crescent Biopharma, Inc. ("Crescent" or the "Company") (Nasdaq: CBIO), a biotechnology company dedicated to rapidly advancing the next wave of therapies for cancer patients, reported an exclusive partnership with Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech") and a comprehensive pipeline update, as well as a $185 million private placement, which is expected to close on or about December 8, 2025, subject to satisfaction of customary closing conditions.

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"We’re excited to share the tremendous progress we’ve made executing on our strategy of building a robust portfolio of next generation oncology therapeutics," said Joshua Brumm, chief executive officer of Crescent. "CR-001, our PD-1 x VEGF bispecific antibody, has the potential to be a foundational immuno-oncology backbone and the partnership we announced with Kelun-Biotech today has enhanced our pipeline of ADCs and accelerated our efforts to deliver potentially best-in-class novel combination therapies. Crescent is now poised to have three distinct programs entering the clinic in 2026 and multiple data readouts anticipated from both monotherapy and novel combination therapy studies by the end of 2027. Additionally, the financing we announced today with leading healthcare investors strengthens our balance sheet, providing anticipated cash runway through multiple key inflection points. Our comprehensive update today underscores Crescent’s commitment to deliver on our vision of building the next leading biotech oncology company."

Kelun-Biotech and Crescent Strategic Partnership

In a separate release today, Kelun-Biotech and Crescent announced a strategic partnership to develop and commercialize next generation oncology therapeutics, including novel combinations. The partnership involves Crescent’s CR-001, a PD-1 x VEGF bispecific antibody, and Kelun-Biotech’s SKB105 (also known as CR-003), an integrin beta-6 (ITGB6)-directed antibody-drug conjugate (ADC) with a topoisomerase payload.

Under the terms of the collaboration, Crescent has granted Kelun-Biotech exclusive rights to research, develop, and commercialize CR-001 in Greater China (including mainland China, Hong Kong, Macau and Taiwan). In addition, Kelun-Biotech has granted Crescent exclusive rights to research, develop, and commercialize SKB105 (CR-003) in the United States, Europe and all markets outside of Greater China. The partnership includes the development of these candidates as monotherapies, and also the evaluation of CR-001 in combination with SKB105 (CR-003). Both Crescent and Kelun-Biotech have the right to independently develop CR-001 in additional combinations, including combinations of CR-001 with proprietary ADC pipeline assets.

Key Pipeline Updates

New details on Crescent’s portfolio, including the clinical development plan for CR-001 as well as supporting preclinical data and plans for its ADC programs, will be shared during today’s conference call and webcast.

CR-001, a PD-1 x VEGF bispecific antibody

CR-001 is a tetravalent bispecific antibody being developed for the treatment of solid tumors that combines two complementary, validated mechanisms in oncology via a blockade of PD-1 and VEGF. It was intentionally designed to replicate the cooperative pharmacology of ivonescimab, which demonstrated superior efficacy results compared to the current market leader, pembrolizumab, in a large, third-party Phase 3 trial in non-small cell lung cancer.1 Because of this similar cooperativity, there is the opportunity for rapid and efficient clinical development for CR-001 as Crescent pursues both first-in-class and fast-follower solid tumor indications.
Crescent is on track to initiate a global Phase 1/2 clinical trial of CR-001 in patients with solid tumors in the first quarter of 2026. The trial is designed to enroll both treatment-naïve and previously-treated patients with multiple solid tumor types, including non-small cell lung cancer and various gastrointestinal and gynecological tumors. The trial plans to include dose-escalation, back-fill and dose-optimization cohorts to enable robust assessment of the clinical profile of CR-001. Crescent anticipates reporting proof-of-concept clinical data from the Phase 1/2 trial of CR-001 in the first quarter of 2027, including safety, pharmacokinetic, pharmacodynamic and early anti-tumor activity.
CR-001’s anti-VEGF activity may normalize the vasculature at the tumor site, which has the potential to improve the localization and effectiveness of combination therapies, such as the planned administration of CR-001 with ADCs. The partnership with Kelun-Biotech accelerates the scope and number of combination studies planned with CR-001 as a potential foundational immuno-oncology backbone. Crescent plans to evaluate CR-001 in combination with multiple ADCs, including CR-002 and CR-003 (SKB105), with initial combination data expected by year-end 2027.
CR-002, topoisomerase inhibitor ADC targeting PD-L1

CR-002 is a topoisomerase inhibitor ADC directed to PD-L1, a validated target known to have high expression in multiple solid tumors. CR-002 incorporates a PD-L1 antibody selected for high internalization to facilitate payload release in target cells and a linker designed for intracellular cleavage and high stability in circulation.
Crescent is on track to submit an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration for CR-002 in mid-2026 to support the initiation of a Phase 1/2 trial in solid tumors in the second half of 2026, with proof-of-concept data expected in the second half of 2027.
CR-003 (SKB105), topoisomerase inhibitor ADC targeting Integrin beta-6

CR-003 (SKB105), discovered by Kelun-Biotech, is a topoisomerase inhibitor ADC directed to integrin beta-6 (ITGB6), which is overexpressed in many solid tumors with minimal expression in most normal tissues. CR-003 (SKB105) consists of an anti-ITGB6 fully human IgG1 monoclonal antibody conjugated via a stable, clinically validated cleavable linker. CR-003 (SKB105) demonstrated a favorable efficacy, safety, and pharmacokinetic (PK) profile in preclinical models.
Kelun-Biotech plans to initiate a Phase 1/2 trial of CR-003 (SKB105) in Greater China in the first quarter of 2026, with proof-of-concept data expected in the first quarter of 2027. A combination study of CR-003 and CR-001 is planned to initiate in the first half of 2027 with initial data anticipated by year-end 2027.
Pipeline Expansion Opportunities

Crescent also continues to pursue opportunities to advance its strategy in immuno-oncology and best-in-class ADC combinations through internal efforts and with leading partners, including Kelun-Biotech and Paragon Therapeutics.
Anticipated Milestones

First Quarter of 2026

Initiation of Phase 1/2 trial of CR-001
Initiation of Phase 1/2 trial of CR-003 (SKB105)
Second Half of 2026

Initiation of Phase 1/2 trial of CR-002
Initiation of the first Phase 1/2 ADC combination trial with CR-001
First Quarter of 2027

Proof-of-concept clinical data from Phase 1/2 trial of CR-001
Proof-of-concept clinical data from Phase 1/2 trial of CR-003 (SKB105)
First Half of 2027

Initiation of Phase 1/2 trial of CR-001 in combination with CR-003 (SKB105)
Second Half of 2027

Proof-of-concept clinical data from Phase 1/2 trial of CR-002
By Year-End 2027

Initial clinical data from first ADC combination Phase 1/2 trial with CR-001
Initial clinical data from Phase 1/2 trial of CR-001 in combination with CR-003 (SKB105)
Private Placement Financing

Crescent also announced today that it entered into a securities purchase agreement for a private investment of securities to institutional and other accredited investors that is expected to result in gross proceeds of approximately $185 million to the Company, before placement agent fees and offering expenses. The private placement included participation from both new and existing investors, including Forbion, Fairmount, Vestal Point Capital, BVF Partners, ADAR1, Balyasny Asset Management and Venrock Healthcare Capital Partners.

Pursuant to the terms of the securities purchase agreement, the investors agreed to purchase an aggregate of 13,795,685 ordinary shares of Crescent ("Ordinary Shares") at a purchase price of $13.41 per share (or, for certain investors in lieu of Ordinary Shares, pre-funded warrants to purchase Ordinary Shares). The pre-funded warrants are to be issued for a purchase price equating to $13.409 per pre-funded warrant share (which is the per share purchase price for the Ordinary Shares less the $0.001 per share unfunded exercise price for each pre-funded warrant share) and have an exercise price of $0.001 per share. Following the transaction, there will be approximately 33.3 million Ordinary Shares and Ordinary Share equivalents issued and outstanding, including Ordinary Shares underlying pre-funded warrants and Series A non-voting convertible preferred stock. The PIPE financing is expected to close on or about December 8, 2025, subject to satisfaction of customary closing conditions.

Jefferies, TD Cowen, Guggenheim Securities, Cantor and Wedbush & Co. served as placement agents to Crescent and Piper Sandler served as financial advisor.

The Company intends to use the net proceeds from the private placement, together with the Company’s existing cash and cash equivalents, to advance the preclinical and clinical development of the Company’s product candidates and for working capital and other general corporate purposes. Based on Crescent’s current plans, Crescent believes its existing cash and cash equivalents, together with the net proceeds from the private placement, will be sufficient to fund the Company’s operations and capital expenditure requirements into 2028.

(Press release, Crescent Biopharma, DEC 4, 2025, View Source [SID1234663681])

The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and the securities have not been registered under the Securities Act of 1933, as amended, and may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements. Concurrently with the execution of the securities purchase agreement, Crescent and the investors entered into a registration rights agreement pursuant to which the Company has agreed to file a registration statement with the Securities and Exchange Commission (the "SEC") registering the resale of the Ordinary Shares and the Ordinary Shares issuable upon exercise of the pre-funded warrants, in each case sold in the private placement.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

Investor Conference Call and Webcast

Crescent will host a conference call and webcast today, December 4, 2025, at 8:00 a.m. ET. To access the conference call, please dial (877)-346-6112 (U.S. & Canada) or +1 (848)-280-6350 (international) at least 10 minutes prior to the start time and ask to be joined into the Crescent Biopharma conference call. A live webcast will be available in the Investors section of Crescent’s website at View Source, and a replay will be accessible for at least 90 days. An accompanying slide presentation will also be available on Crescent’s website at the start of the presentation.

On December 4, 2025 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, reported three positive clinical data update presentations at the World Federation of Neuro-Oncology Societies/Society for Neuro-Oncology (WFNOS/SNO) Annual Meeting, November 19-23, 2025 in Honolulu, Hawaii. The World Federation of Neuro-Oncology Societies (WFNOS) and Society for Neuro-Oncology (SNO) advance research, education, and clinical care for patients with tumors of the central nervous system.

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"Real world clinical experience with REYOBIQ in both primary and metastatic CNS cancers continues to show a promising safety profile and signs of efficacy," said Marc H. Hedrick, M.D., Plus Therapeutics President and Chief Executive Officer. "This expanding clinical data set around REYOBIQ coupled with substantial progress bringing our CNSide diagnostic portfolio to market provides our team at Plus with growing confidence that we can achieve our goal of materially improving survival rates for patients with CNS cancers."

KEY HIGHLIGHTS:

Phase 1 Multicenter Study of Multiple Doses of Rhenium (186Re) Obisbemeda (Reyobiq) for Leptomeningeal Metastases: Rationale, Design, and Preliminary Cohort 1 Data

Overview:

Completed ReSPECT-LM single dose trial showed REYOBIQ was well-tolerated up to a maximum tolerated dose of 66mCi, with a recommended phase 2 dose of 44.1 mCi, and absorbed doses delivered of >300 Gy observed
ReSPECT-LM open label, multidose Phase 1/2 trial initiated to identify maximum tolerated dose across varying dosing intervals and to characterize efficacy of multiple doses at optimal dose selected by assessing response using CNSide CSF tumor cell enumeration test

Response:

Enrollment in Cohort 1 has begun with delivery of 13.2 mCi at 3 intervals
Three patients enrolled as of data cutoff: one patient has received all doses without dose limiting toxicity

Next Steps:

Phase 1b/2a dose optimization trial is enrolling with the ultimate goal of improving outcomes for LM patients

Phase 1/2 ReSPECT-GBM Trial of Rhenium (186Re) Obisbemeda in Recurrent Glioblastoma: Safety and Efficacy from the Phase 1 and Update on Phase 2

Overview:

Phase 1 dose-escalation study completed, with patients dosed from 1.0 mCi to 41.5 mCi, achieving a maximum absorbed tumor dose of 739.5 Gy. Dose 22.3 mCi was selected as the recommended Phase 2 dose due to its favorable safety profile
Ongoing Phase 2 study has enrolled 24 of planned 34 patients as of data cutoff; study continues to evaluate safety and efficacy at the Phase 2 recommended dose

Safety:

Across all patients treated in both Phase 1 and 2, most treatment-related adverse events were Grade 1 or 2, including lymphopenia (7.9%), cognitive disorder (7.0%), and headache (7.0%), with no treatment-related deaths or study discontinuations due to serious adverse reactions (SARs)

Response:

Efficacy data from Phase 1 cohorts 1 to 6 showed a median overall survival of 17 months for patients receiving ≥100 Gy, compared to 6 months for those receiving <100 Gy, surpassing historical bevacizumab monotherapy outcomes
SPECT/CT imaging continues to confirm high tumor-specific radiation retention, with minimal systemic exposure

Next Steps:

Phase 2 continues to enroll
REYOBIQ has demonstrated promising safety and efficacy profile, supporting continued investigation as a novel therapeutic for recurrent GBM

Assessment of rhenium-186 obisbemeda (186RNL) therapy for recurrent glioblastoma (rGBM) using MRI and SPECT imaging biomarkers

Overview:

Phase 1 ReSPECT-GBM showed promising improvements in overall survival
REYOBIQ efficacy also evaluated using MRI and SPECT imaging biomarkers

Response:

REYOBIQ dose positively correlates with treatment coverage ratio, time to peak, and progression free survival; negatively correlates with mean transit time and tumor volume
Based on a Wilcoxon Signed Rank test on 23 patients receiving REYOBIQ, untreated tumor volume was significantly increased relative to treated tumor volume. Overall survival negatively associated with tumor volume

Conclusion:

MRI combined with SPECT imaging biomarkers effectively evaluate REYOBIQ in recurrent GBM treatment, guiding patient specific planning

Plus Therapeutics and its wholly owned subsidiary, CNSide Diagnostics focused on central nervous system metastases management, each hosted a booth at the WFNOS/SNO Annual Meeting exhibit hall.

About LM
Leptomeningeal metastases (LM) are a rare but severe complication of advanced cancer, affecting the fluid-lined structures of the central nervous system. LM occurs in approximately 5% of patients with metastatic cancer, with breast cancer, lung cancer, and melanoma being the most common sources. Median survival is typically 2-6 months, and effective treatment options are limited, highlighting the urgent need for novel therapies.

About REYOBIQ (rhenium Re186 obisbemeda)
REYOBIQ (rhenium Re186 obisbemeda) is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. REYOBIQ has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. REYOBIQ is being evaluated for the treatment of recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancer in the ReSPECT-GBM, ReSPECT-LM, and ReSPECT-PBC clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT). The Company’s ReSPECT-PBC clinical trial for pediatric brain cancer is supported by a $3 million grant from the U.S. Department of Defense’s Peer Reviewed Cancer Research Program.

(Press release, Plus Therapeutics, DEC 4, 2025, View Source [SID1234661129])

On December 4, 2025 J & D Pharmaceuticals LLC reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the company’s investigational therapy for the treatment of Hepatocellular Carcinoma (HCC) a rare and life-threatening disorder that is estimated to occur in approximately 73,000 individuals in the United States in 2025.

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HCC is a devastating disorder that has a very poor prognosis. With FDA approved medications the amount of time extended in patient with HCC is only 2.5 months. There is a need for a safer and more effective medication for HCC.

"Receiving Orphan Drug Designation is yet another significant milestone for J & D Pharmaceuticals," said Lenard Lichtenberger, PhD, Chief Scientific Officer. "This designation adds to the two previous orphan drug designations we received and continues to underscore the urgent need for innovative therapies for HCC patients and strengthens our commitment to developing solutions that we expect to transform the lives of those affected by this debilitating condition not just by adding years to their lives but life to those years."

The FDA’s Orphan Drug Designation program provides incentives to encourage the development of treatments for rare diseases, including tax credits for qualified clinical testing, exemption from certain FDA fees, and the potential for seven years of market exclusivity upon regulatory approval.

J & D Pharmaceuticals plans to advance its HCC program into clinical development and will continue working closely with the FDA and the HCC community to accelerate progress toward delivering a novel treatment option to patients in need.

(Press release, J & D Pharmaceuticals, DEC 4, 2025, View Source;d-pharmaceuticals-llc-receives-orphan-drug-designation-for-treatment-of-hepatocellular-carcinoma-hcc-302632020.html [SID1234661142])

On December 4, 2025 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech", 6990.HK), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs, and Crescent Biopharma, Inc. ("Crescent") (Nasdaq: CBIO), a biotechnology company dedicated to rapidly advancing the next wave of therapies for cancer patients, reported that the companies have entered into a strategic partnership to develop and commercialize oncology therapeutics, including novel combinations.

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The partnership involves Crescent’s CR-001, a PD-1 x VEGF bispecific antibody, and Kelun-Biotech’s SKB105, an integrin beta-6 (ITGB6)-directed antibody-drug conjugate (ADC) with a topoisomerase payload. Both candidates are being developed for the treatment of solid tumors and are expected to enter Phase 1/2 monotherapy clinical trials in the first quarter of 2026.

Under the terms of the collaboration, Crescent has granted Kelun-Biotech exclusive rights to research, develop, manufacture and commercialize CR-001 in Greater China (including mainland China, Hong Kong, Macau and Taiwan). In addition, Kelun-Biotech has granted Crescent exclusive rights to research, develop, manufacture and commercialize SKB105 in the United States, Europe and all other markets outside of Greater China. The partnership includes the development of these candidates as monotherapies, and also the evaluation of CR-001 in combination with SKB105. Both Crescent and Kelun-Biotech have the right to independently develop CR-001 in additional combinations, including combinations of CR-001 with proprietary ADC pipeline assets.

Dr. Michael Ge, chief executive officer of Kelun-Biotech, said, "We are pleased to have entered into a partnership with Crescent for two innovative assets, CR-001 and SKB105. This collaboration complements and strengthens our differentiated oncology pipeline by the addition of CR-001 and also enables us to advance the development of SKB105 in the global market, bolstering its potential commercial value and our global collaboration network. Our creative global partnership combines the capabilities of both companies to explore novel monotherapies and combination strategies for tumor treatments with SKB105 and CR-001. By leveraging China’s abundant clinical resources and execution efficiency, we aim to expedite clinical development while rigorously maintaining the highest global standards. We believe this partnership creates a powerful synergy to maximize the potential of these two drug candidates for the treatment of patients in both China and the rest of the world."

"We are thrilled to be partnering with Kelun-Biotech, an established leader in the development and commercialization of ADCs who shares our commitment to bringing next generation therapeutics that can improve outcomes for people living with cancer," said Joshua Brumm, chief executive officer of Crescent. "This collaboration expands our pipeline with the addition of SKB105, furthers our strategy of advancing multiple modalities across our portfolio, and accelerates our efforts to deliver synergistic combinations with CR-001, which has the potential to be a foundational backbone therapy. We look forward to working with Kelun-Biotech to drive innovative therapeutics with the potential to address multiple tumor types and transform cancer care."

Under the collaboration, Kelun-Biotech will receive an upfront payment of US$80 million from Crescent and is also eligible to receive additional milestones of up to US$1.25 billion, plus tiered middle single-digit to low double-digit royalties on net sales of SKB105. Kelun-Biotech is also eligible to receive additional payment from Crescent if Crescent undergoes a near-term change of control or enters into a sublicense agreement with a third party. Crescent will receive an upfront payment of US$20 million from Kelun-Biotech and is also eligible to receive additional milestones of up to US$30 million, plus tiered low to middle single digit royalties on net sales of CR-001.

About CR-001 (also known as SKB118)

CR-001 is a tetravalent bispecific antibody being developed for the treatment of solid tumors that combines two complementary, validated mechanisms in oncology via a blockade of PD-1 and VEGF. PD-1 checkpoint inhibition is aimed at restoring T cells’ ability to recognize and destroy tumor cells, and blocking VEGF is intended for reducing blood supply to tumor cells and inhibiting tumor growth. In preclinical studies, CR-001 demonstrated cooperative pharmacology with increased binding to PD-1 and signal blockade in the presence of VEGF as well as robust anti-tumor activity. CR-001’s anti-VEGF activity may also normalize the vasculature at the tumor site, which has the potential to improve the localization and effectiveness of combination therapies, such as the administration of CR-001 with antibody-drug conjugates (ADCs). A global Phase 1/2 trial of CR-001 in patients with solid tumors is anticipated to commence in the first quarter of 2026.

About SKB105 (also known as CR-003)

SKB105 is a differentiated ADC targeting integrin beta-6 (ITGB6) with a topoisomerase 1 inhibitor payload. ITGB6 is overexpressed in many solid tumors, but shows minimal to no expression in most normal tissues, thereby potentially reducing the risk of systemic toxicity and off-target effects. SKB105 consists of an anti-ITGB6 fully human IgG1 monoclonal antibody conjugated via a stable, clinically validated cleavable linker. The molecule incorporates proprietary Kthiol irreversible conjugation technology, designed to enhance stability and tumor-specific payload delivery while reducing adverse effects. SKB105 demonstrated a favorable efficacy, safety, and pharmacokinetic (PK) profile in preclinical models. A Phase 1/2 clinical trial of SKB105 in patients with solid tumors is anticipated to commence in the first quarter of 2026.

On December 4, 2025 Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that seek to overcome tumor immune evasion and drug resistance, reported that it will present new preclinical data from its CAPTN-3 platform of conditionally activated tri-specific antibodies at the upcoming European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Immuno-Oncology (ESMO-IO) 2025 Annual Congress being held from December 10-12, 2025, in London, United Kingdom.

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Presentation Details:

• Conference: ESMO (Free ESMO Whitepaper) Immuno-Oncology (ESMO-IO) 2025 Annual Congress
• Title: CAPTN-3 unique design demonstrated by 2 novel platform compounds
• Presenter: Dr. Hadas Reuveni
• Presentation Number: FPN# 287P
• Session Title: Poster Presentation
• Date/Time: Wednesday, December 10, 2025, 17:15
• Location: London, UK

"Our CAPTN-3 platform can produce novel tri-specific antibodies that engage T cells, NK cells and bind to tumor associated antigens. The powerful synergy we have seen in preclinical studies strengthens our conviction in not only the platform, but also in this novel structure to overcome tumor evasion and drug resistance. We look forward to showcasing new data from our lead CAPTN-3 program, IM1240, in multiple PD-1 resistant models, and new data demonstrating the platform versatility with multiple tri-specific antibodies" said Gil Efron, Chief Executive Officer of Purple Biotech, Ltd.

The poster will be accessible under the Publications section of the Purple Biotech website following the congress.

(Press release, Purple Biotech, DEC 4, 2025, View Source;id=374459&p=2412439&I=1206939-c7Z3G6f3m8 [SID1234661130])