On May 19, 2025 Pfizer Inc. (NYSE: PFE) reported it has entered into an exclusive global, ex-China, licensing agreement with 3SBio, Inc. (01530.HK), a leading Chinese biopharmaceutical company, for the development, manufacturing and commercialization of SSGJ-707, a bispecific antibody targeting PD-1 and VEGF, currently undergoing several clinical trials in China for non-small cell lung cancer, metastatic colorectal cancer, and gynecological tumors (Press release, Pfizer, MAY 19, 2025, View Source [SID1234653236]). SSGJ-707 has shown initial efficacy and safety data in a promising class of cancer medicines. 3SBio plans to initiate the first Phase 3 study in China in 2025.

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Under the terms of the agreement, 3SBio and its subsidiaries Shenyang Sunshine Pharmaceutical Co., Ltd. and 3S Guojian Pharmaceutical (Shanghai) Co., Ltd. will grant Pfizer an exclusive global license to develop, manufacture and commercialize SSGJ-707 worldwide, excluding China. The agreement also provides Pfizer the option of commercialization rights in China. 3SBio will receive an upfront payment of $1.25 billion and is eligible to receive milestone payments associated with certain development, regulatory and commercial milestones up to $4.8 billion as well as tiered double-digit royalties on sales of SSGJ-707, if approved.

The transaction is expected to close in the third quarter subject to fulfillment of customary closing conditions, including receipt of required regulatory approvals and 3SBio shareholder approval. Upon close, Pfizer will make a $100 million equity investment in 3SBio subject to an agreed upon securities subscription agreement between the parties. Pfizer plans to manufacture drug substance for SSGJ-707 in Sanford, North Carolina, and drug product in McPherson, Kansas.

On May 19, 2025 Alpha Tau Medical Ltd. ("Alpha Tau", or the "Company") (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported first quarter 2025 financial results and provided a corporate update (Press release, Alpha Tau Medical, MAY 19, 2025, View Source [SID1234653221]).

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"2025 has started off with a bang at Alpha Tau, with a flurry of important milestones as we continue to evaluate Alpha DaRT in treating internal organ tumors, expand our manufacturing capabilities, and prepare for commercial activities," said Alpha Tau Chief Executive Officer Uzi Sofer. "With four active U.S. IDEs approved by the FDA, and U.S. trials expected to begin soon in patients with newly-diagnosed pancreatic cancer and recurrent GBM, construction of the first phase of our Hudson, NH facility nearing completion, and our ambitions for the continued expansion of our clinical trial program, our recently completed financing came at the perfect time to ensure that our momentum continues to accelerate throughout the course of the year."

Recent Corporate Highlights:

● In April, Alpha Tau announced the completion of a $36.9 million registered direct financing from, and strategic marketing alliance with, an affiliate of Oramed Pharmaceuticals, Inc. (Oramed). Oramed CEO, President and Chairman Nadav Kidron has also joined the Alpha Tau Board of Directors, bringing years of public company biotech experience.

● In April, Alpha Tau announced receipt of an IDE from the FDA to conduct a U.S. pilot study of Alpha DaRT in patients with recurrent glioblastoma multiforme (GBM). The clinical trial is expected to enroll up to ten U.S. patients with recurrent glioblastoma not amenable for surgical resection who have undergone a prior course of central nervous system radiation.

● In February, Alpha Tau announced achievement of Medical Device Single Audit Program (MDSAP) certification for the Company’s manufacturing facility in Jerusalem. MDSAP was established by a coalition of international medical device regulatory authorities from Australia, Brazil, Canada, Japan and the U.S., to enable medical device manufacturers to be audited once for compliance with ISO 13485 and the standards of these five different markets. MDSAP certification may also speed the timetable to commercialization within these participating geographies, as it allows for a streamlined auditing process, providing manufacturers with a comprehensive approach to meet international regulatory standards efficiently.

● In January, Alpha Tau hosted a virtual R&D Update Day to present interim results from multiple trials as well as more information regarding the expected regulatory path forward in internal organs. Principal investigators presented data showing high disease control rate and strong interim safety results observed across three trials exploring the use of Alpha DaRT in pancreatic cancer patients, following a subset of the data presented by investigators at Hadassah Medical Center on a poster at the prestigious 2025 ASCO (Free ASCO Whitepaper) GI Symposium. Principal investigators also reported strong interim results in median survival of patients treated with Alpha DaRT after prior therapy as compared to previously published studies of alternative monotherapies, across all analyzed subgroups.

● At the R&D Update Day, positive interim results were also reported for the first eight patients recruited in a combination trial of Alpha DaRT with pembrolizumab (Keytruda), a checkpoint inhibitor, in treating patients with recurrent unresectable or metastatic head and neck squamous cell carcinoma (HNSCC). A reported systemic objective response rate of 75% and complete response rate of 37.5% were observed, compared to historical benchmarks of 19% and 5%, respectively, for pembrolizumab on its own in the KEYNOTE-048 trial.

● Approvals for two forthcoming clinical trials exploring the use of Alpha DaRT in treating pancreatic cancer were also announced during the R&D Update Day:

o IDE received from the FDA to conduct a U.S. pilot study of Alpha DaRT together with first-line chemotherapy in patients with newly diagnosed pancreatic cancer, the first step toward regulatory approval in the U.S. The trial was initially approved for 12 patients with metastatic cancer and was then expanded to 30 patients in two cohorts of 15 patients each, one cohort of patients with newly diagnosed locally advanced cancer and the other of patients with newly diagnosed metastatic cancer.

o Approval from France’s Ministry of Health to commence a French multicenter clinical trial of Alpha DaRT alongside capecitabine for patients with locally advanced pancreatic cancer, as well as a second study at a single center in France examining the use of Alpha DaRT delivered via Fine Needle System, or FNS, in the treatment of locally advanced pancreatic cancer.

Expected Upcoming Milestone Targets:

● First patient enrolled in pancreatic cancer pilot study in the U.S. in Q3 2025. For more information, please see here: View Source

● First patient treated in Israel for brain cancer in Q2 or Q3 2025.

● Completion of patient recruitment in the ReSTART pivotal U.S. multi-center trial in recurrent cutaneous squamous cell carcinoma in Q3 2025. For more information, please see here: View Source

About Alpha DaRT

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.

● First patient treated in U.S. GBM pilot study in H2 2025. For more information, please see here: View Source

● Response from Japan’s PMDA in H2 2025 to application for pre-market approval of Alpha DaRT in patients with recurrent head & neck cancer.

Financial results for quarter ended March 31, 2025

R&D expenses for the three months ended March 31, 2025 were $7.2 million, compared to $6.4 million for the same period in 2024, due to increased employee compensation and benefits, increased production expenses and reduced government grants, offset by lower share-based compensation expenses.

Marketing expenses for the three months ended March 31, 2025 were $0.5 million, compared to $0.5 million for the same period in 2024.

G&A expenses for the three months ended March 31, 2025 were $1.7 million, compared to $1.4 million for the same period in 2024, primarily due to increased employee compensation and benefits, including share-based compensation, and increased professional fees (including legal expenses).

Financial income, net, for the three months ended March 31, 2025 was $0.7 million, compared to $0.4 million for the same period in 2024, due to a decrease in expense from remeasurement of warrants, offset by a decrease in interest from bank deposits.

For the three months ended March 31, 2025, the Company had a net loss of $8.7 million, or $0.12 per share, compared to a net loss of $8.0 million, or $0.11 per share, in the three months ending March 31, 2024.

Balance Sheet Highlights

As of March 31, 2025, the Company had cash and cash equivalents, short-term deposits and restricted deposits in the amount of $54.8 million, compared to $62.9 million at December 31, 2024. In April 2025, Alpha Tau raised $36.9 million through a registered direct financing transaction.

On May 19, 2025 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ZL-1310, the Company’s potential first-in-class Delta-like ligand (DLL3) antibody-drug conjugate (ADC), for the treatment of extensive-stage small cell lung cancer (ES-SCLC) (Press release, Zai Laboratory, MAY 19, 2025, View Source [SID1234653237]). ZL-1310, which is being evaluated in an ongoing global Phase 1a/1b clinical trial (NCT06179069), previously received an Orphan Drug designation for SCLC from the FDA. The company will present updated data at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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"The FDA’s decision to grant Fast Track designation to ZL-1310 highlights the significant need for expanded treatment options for patients with SCLC and represents an important step in our efforts to advance a novel therapeutic option as quickly as possible," said Rafael G. Amado, M.D., President, Head of Global Research and Development, Zai Lab. "This designation reinforces the clinical progress we have achieved for ZL-1310 to-date, and we remain on track to initiate a pivotal study in small cell lung cancer later this year, positioning us for a potential accelerated approval in 2027."

Fast Track designation facilitates the expedited development and review of new drugs to address an unmet medical need or treat serious or life-threatening diseases. Benefits of this designation include more frequent engagements with the FDA to discuss the drug’s clinical development plan and eligibility for Accelerated Approval and Priority Review if relevant criteria are met. More information on the Fast Track process is available here.

Zai Lab will hold an investor conference call and webcast to highlight updated ZL-1310 data at ASCO (Free ASCO Whitepaper) and outline the next steps in clinical development.

Details regarding upcoming ZL-1310 webcast and conference call are as follows:

Date/Time: Monday, June 2, 2025, at 7:00 a.m. CT / 8:00 a.m. ET / 8:00 p.m. HKT., please register at:
Webcast presentation (preferred): View Source;
Dial-in: View Source
Presenter: Rafael G. Amado, M.D., President, Head of Global Research and Development, Zai Lab

About Small Cell Lung Cancer and ZL-1310

SCLC is one of the most aggressive and lethal solid tumors, accounting for approximately 5% of the approximately 2.5 million patients diagnosed with lung cancer worldwide each year. 1,2 Additionally, two-thirds of all SCLC patients are diagnosed at extensive stage. 3

DLL3 is an antigen overexpressed in many neuroendocrine tumors, such as SCLC, and is often associated with poor clinical outcomes. ZL-1310 comprises a humanized anti-DLL3 monoclonal antibody connected via a cleavable linker to a novel camptothecin derivative (a topoisomerase 1 inhibitor) as its payload. The compound was designed with a novel ADC technology platform called TMALIN, which leverages the tumor microenvironment to overcome challenges associated with first-generation ADC therapies.

On May 19, 2025 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") reported it will present 16 abstracts featuring new data across its approved cancer therapies at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (May 30 – June 3) (Press release, Astellas, MAY 19, 2025, View Source [SID1234653222]). The research underscores Astellas’ dedication as a pioneer in oncology and focus on clinical outcomes that matter to patients.

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The abstracts include new post hoc analyses of long-term overall survival (OS) data for XTANDI (enzalutamide) and two analyses for PADCEV (enfortumab vedotin), which demonstrate how these standard-of-care medicines can continue to treat patients in metastatic, non-metastatic, castration-resistant, or hormone-sensitive prostate cancer patients and unresectable, locally advanced or metastatic urothelial cancer patients, respectively.

Moitreyee Chatterjee-Kishore, Ph.D., M.B.A., Head of Oncology Development, Astellas
"At Astellas, we are dedicated to transforming cancer care through innovative treatment approaches. The data we will present at ASCO (Free ASCO Whitepaper) this year, including new long-term follow-up data for advanced prostate and bladder cancers, reflect the pioneering role we continue to play in delivering outcomes that matter to patients. We continue to push the boundaries of cancer treatment with our growing pipeline, using novel modalities and precision medicine approaches, to benefit all eligible patients now and in the future."

Highlights from Astellas at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting will include a strong focus on Overall Survival (OS) data updates, confirming the value that these therapies bring to patients:

Enzalutamide:

The ARCHES five-year follow-up OS analysis of enzalutamide plus androgen-deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) will be featured in an oral presentation

In addition to the ARCHES five-year follow-up presentation, Astellas is supporting investigator-sponsored studies. Eight-year data assessing outcomes of enzalutamide vs non-steroidal anti-androgen (NSAA) in mHSPC will be presented from an independent, investigator-sponsored trial (ENZAMET) led by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP).

Enfortumab vedotin
Urothelial carcinoma

Two analyses of the phase 3 EV-302 study of enfortumab vedotin in combination with pembrolizumab vs chemotherapy in previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC)
Exploratory analysis of responders will be presented in an oral presentation
Poster presentation featuring long-term subgroup analysis
Bladder cancer

A systematic review and meta-analysis of surrogate endpoints in muscle-invasive bladder cancer trials will be featured in a poster presentation.

Shontelle Dodson, Executive Vice President, Head of Medical Affairs, Astellas
"Long-term overall survival is the gold standard endpoint in cancer research. New post hoc analysis data from the ARCHES enzalutamide trial demonstrates our mission to help patients live longer, healthier lives. We are committed to maximizing the impact of our therapies as we continue to pioneer the oncology medicines of tomorrow."

Astellas Presentations at 2025 ASCO (Free ASCO Whitepaper) Annual Meeting

Enzalutamide

Presentation Title

Lead Author

Presentation Details

ARCHES 5-year follow-up overall survival analysis of enzalutamide plus androgen deprivation therapy in patients with metastatic hormone-sensitive prostate cancer

A. Armstrong

Type: Oral Presentation

Abstract Number: 5005

Date: June 3, 2025, 9:45am – 12:45pm CDT

Cardiovascular event risk in patients with metastatic castration-resistant prostate cancer treated with enzalutamide or abiraterone acetate in the United States

A. Bryce

Type: Poster Presentation

Abstract Number: 5041

Date: June 2, 2025, 9:00am – 12:00pm CDT

Secondary outcomes by prior definitive treatment in patients with high-risk biochemically recurrent prostate cancer treated with enzalutamide monotherapy: EMBARK post hoc analysis

S. Freedland

Type: Poster Presentation

Abstract Number: 5103

Date: June 2, 2025, 9:00am – 12:00pm CDT

How low do you need to go? Association between various prostate-specific antigen response measures and clinical outcomes in metastatic castration‑sensitive prostate cancer in the Veteran Health Administration data

S. Freedland

Type: Poster Presentation

Abstract Number: 5092

Date: June 2, 2025, 9:00am – 12:00pm CDT

Abiraterone acetate is associated with shorter overall survival than enzalutamide in patients with chemotherapy naïve metastatic castration-resistant prostate cancer: Real world data from the Flatiron electronic health records database

D. George

Type: E-Publication Only

Abstract Number for Publication: e17033

Secondary outcomes by prior definitive treatment in patients with high-risk biochemically recurrent prostate cancer (treated with enzalutamide plus leuprolide (combo): EMBARK post hoc analysis

N. Shore

Type: E-Publication Only

Abstract Number for Publication: e17127

Corticosteroid Use and Risk of Adverse Events in Patients Treated for Metastatic Hormone-Sensitive Prostate Cancer

U. Swami

Type: E-Publication Only

Abstract Number for Publication: e17097

Enfortumab vedotin

Presentation Title

Lead Author

Presentation Details

EV-302: Long-term subgroup analysis from the phase 3 global study of enfortumab vedotin in combination with pembrolizumab vs chemotherapy in previously untreated locally advanced or metastatic urothelial carcinoma

J. Bedke

Type: Poster Presentation

Abstract Number: 4571

Date: June 2, 2025, 9:00am – 12:00pm CDT

Exploratory analysis of responders from the phase 3 EV-302 trial of enfortumab vedotin plus pembrolizumab vs chemotherapy (chemo) in previously untreated locally advanced or metastatic urothelial carcinoma

S. Gupta

Type: Oral Presentation

Abstract Number: 4502

Date: June 1, 2025, 9:45am – 12:45pm CDT

Evaluation of surrogate endpoints in muscle-invasive bladder cancer: A systematic review and meta-analysis

M. Galsky

Type: Poster Presentation

Abstract Number: 4580

Date: June 2, 2025, 9:00am – 12:00pm CDT

Study EV-103 Cohort H: Neoadjuvant treatment with enfortumab vedotin monotherapy in cisplatin-ineligible patients with muscle-invasive bladder cancer: 3-year efficacy results

N. Mar

Type: Poster Presentation

Abstract Number: 4583

Date: June 2, 2025, 9:00am – 12:00pm CDT

Recent trends in US real-world first-line treatment patterns for patients with locally advanced or metastatic urothelial carcinoma

G. Sonpavde

Type: E-Publication Only

Abstract Number for Publication: e16556

Patient and clinician expert perspectives on the impactful symptoms of head and neck squamous cell carcinoma and its treatment

E. Theodorou

Type: E-Publication Only

Abstract Number for Publication: e18001

Zolbetuximab

Presentation Title

Lead Author

Presentation Details

A real-world study on epidemiology, biomarker test results, clinical characteristics, and treatment patterns of unresectable locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma in China

Y. Chen

Type: E-Publication Only

Abstract Number for Publication: e16013

Gilteritinib

Presentation Title

Lead Author

Presentation Details

Real-world adherence and tolerability of FLT3 inhibitors s post-allogeneic transplant maintenance therapy in
older adults with AML: A Medicare claims cohort study

V. Kennedy

Type: E-Publication Only

Abstract Number: e18505

Pipeline

Presentation Title

Lead Author

Presentation Details

Trial in progress: Phase 1 study of the selective protein degrader ASP4396 in patients with locally advanced or metastatic solid tumors with KRAS G12D mutation

Shiraj Sen

Type: Poster Presentation

Abstract Number: TPS3178

Date: June 2, 2025, 1:30 – 4:30pm CDT

On May 19, 2025 FUJIFILM Corporation reported the successful validation of the cancer cell-targeting potential of its peptide-oligonucleotide conjugates (Press release, Fujifilm, MAY 19, 2025, View Source [SID1234653238]). This validation resulted from combining oligonucleotides with cyclic peptides developed from Fujifilm’s proprietary peptide library, which contains trillions of variants. This research achievement will be presented at TIDES USA, an exhibition to be held from May 19 to 22, 2025, in San Diego (poster number: 35).

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Cyclic peptides, including those containing unnatural amino acids, are emerging as a promising new modality in drug discovery due to their unique and favorable properties, including high binding affinity and specificity, improved tissue permeability, and synthetic versatility. Peptide-oligonucleotide conjugation addresses delivery challenges associated with oligonucleotide-based therapies by utilizing the excellent delivery properties of peptides and have been actively researched.

Leveraging its large peptide library constructed with mRNA display technology, and structural optimization techniques, Fujifilm has developed a proprietary cyclic peptide that binds strongly to integrins overexpressed on the surface of cancer cells, with a low dissociation constant (KD) of 1.6 nM. Utilizing chemical modification methods Fujifilm can successfully synthesize the peptide-oligonucleotide conjugate at high yield. Uptake of these peptide-oligonucleotide conjugates by cancer cells is higher compared to uptake of the non-conjugated oligonucleotide, demonstrating the peptide-oligonucleotide conjugate’s ability to selectively accumulate in cancer cells.

Fujifilm is expanding its drug discovery services for peptide therapeutics globally, providing a wide range of contract research services focusing on peptide discovery, high-throughput screening, and structural optimization. Fujifilm’s one-stop comprehensive service includes peptide chemical synthesis and target protein expression and purification to meet diverse research demands. Fujifilm is committed to driving research and development that fosters technological innovation in the healthcare field, leveraging the ability of cyclic peptides to regulate cellular functions and their specific molecular recognition capabilities, contributing to the advancement of pharmaceutical development of peptide therapeutics.