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.

On May 19, 2025 Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, reported financial results for the first quarter of 2025 and provided a corporate update (Press release, Compugen, MAY 19, 2025, View Source [SID1234653223]).

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"We continued to advance our diverse innovative clinical and early-stage pipeline," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "We initiated and activated the first site in our randomized placebo-controlled trial evaluating single agent COM701 maintenance therapy in patients with relapsed platinum sensitive ovarian cancer (sub-trial 1). We are working diligently to dose the first patient and activate additional sites. In addition, we continue to advance our Phase 1 trial for GS-0321 a potential first-in-class anti-IL18BP antibody licensed to Gilead."

Dr. Cohen-Dayag continued, "We are encouraged by the progress our partner AstraZeneca is making with its rilvegostomig program which is notably the largest ongoing Phase 3 program in the TIGIT space. Rilvegostomig is a PD-1/TIGIT bispecific antibody, the TIGIT component of which is derived from COM902. AstraZeneca has increased the number of its Phase 3 trials with rilvegostomig to ten trials across lung, gastrointestinal and endometrial cancers. At the upcoming ASCO (Free ASCO Whitepaper) 2025 conference, as part of poster presentations, AstraZeneca plans to share early data for rilvegostomig in combination with the ADC Datroway in first-line advanced non-small-cell-lung cancer and in combination with chemotherapy in first-line advanced biliary tract cancer. AstraZeneca’s broad development strategy for rilvegostomig to replace existing PD(L)-1 inhibitors represents a significant potential revenue source for Compugen as we are eligible for both future milestone payments and mid-single digit tiered royalties on future sales."

Dr. Cohen-Dayag added, "Our solid financial position with a cash runway expected to fund our operations into 2027 allows us to advance our innovative clinical and early-stage pipeline. Additionally, it enables us to continue to leverage our AI/ML powered predictive computational discovery platform, UnigenTM, to accelerate our research efforts supporting our early-stage pipeline. We are also excited about the upcoming leadership changes which will come into effect in September 2025. I will assume the newly created role of Executive Chair of the Board of Directors, and Dr. Eran Ophir, currently Chief Scientific Officer, will become President and Chief Executive Officer and will join the Board of Directors. We believe this combination of leadership ensures a solid foundation for the Company’s next phase of growth."

Next Planned Milestones
•
ASCO 2025: Compugen’s partner, AstraZeneca, plans to present early data as poster presentations from two ongoing Phase 2 rilvegostomig trials:

o
First-line Dato-DXd + rilvegostomig in advanced or metastatic non-small cell lung cancer: Results from TROPION-Lung04 (cohort 5)

o
First-line rilvegostomig plus chemotherapy in advanced biliary tract cancer: Primary analysis of GEMINI-Hepatobiliary sub-study 2 (cohort A)
•
H2 2026: data from projected interim analysis of single agent COM701 sub-trial 1 as maintenance therapy in relapsed platinum sensitive ovarian cancer

First Quarter 2025 Financial Highlights
Cash: As of March 31, 2025, Compugen had approximately $103.7 million in cash, cash equivalents, short-term bank deposits, and investment in marketable securities. The cash balance includes the previously reported proceeds raised through the Company’s ATM, in January and February 2025.

Compugen expects that its cash and cash-related balances will be sufficient to fund its operating plans into 2027. This does not include any additional cash inflows. The Company has no debt.

Revenue: Compugen reported approximately $2.3 million in revenues for the first quarter ended March 31, 2025, compared to approximately $2.6 million in revenues for the comparable period in 2024. The revenues reported in the first quarter of 2025 reflect recognition of portions of both the upfront payment and the IND milestone payment from the license agreement with Gilead. The revenues reported in the first quarter of 2024 reflect recognition of portions of the upfront payment from the license agreement with Gilead.

R&D expenses for the first quarter of 2025 were approximately $5.8 million compared with approximately $6.4 million for the comparable period in 2024.

G&A expenses were approximately $2.4 million for the first quarters of 2025 and 2024.

Net loss for the first quarter of 2025 was approximately $7.2 million, or $0.08 per basic and diluted share, compared with a net loss of approximately $7.3 million, or $0.08 per basic and diluted share, in the first quarter of 2024.

Full financial tables are included below.

Conference Call and Webcast Information
The Company will hold a conference call today, May 19, 2025, at 8:30 AM ET to review its first quarter 2025 results. To access the conference call by telephone, please dial 1-866-744-5399 from the United States, or +972-3-918-0644 internationally. The call will also be available via live webcast through Compugen’s website, located at the following link. Following the live audio webcast, a replay will be available on the Company’s website.

On May 19, 2025 CRISPR Therapeutics (NASDAQ: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, and Sirius Therapeutics, a clinical stage biotech company developing innovative small interfering RNA (siRNA) therapies for global markets, reported a strategic partnership to develop and commercialize siRNA therapies (Press release, CRISPR Therapeutics, MAY 19, 2025, View Source [SID1234653224]).

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"We are excited to partner with Sirius, and broaden our cardiovascular medicine portfolio, on the heels of promising top-line data that we recently shared for CTX310, which targets ANGPTL3," said Samarth Kulkarni, Ph.D., Chairman and Chief Executive Officer of CRISPR Therapeutics. "Coagulation Factor XI represents an innovative and highly compelling target for treating thrombotic diseases that affect millions worldwide. SRSD107, which targets Factor XI, has the potential to be a best-in-class therapy, offering infrequent dosing and improved patient outcomes. Sirius’ siRNA platform complements our existing capabilities and expands our therapeutic toolkit, enabling us to develop a broader range of transformative gene-based medicines."

"We are pleased to collaborate with CRISPR Therapeutics, a recognized leader in the development of gene-based medicines," said Qunsheng Ji, MD, Ph.D. Chief Executive Officer of Sirius Therapeutics. "Thrombotic diseases represent a significant unmet need, and our promising Phase 1 data highlights the potential of SRSD107 as a best-in-class Factor XI-targeted therapy. Sirius is committed to addressing the needs of these patients, as we work with CRISPR Therapeutics to advance novel siRNA therapies globally."

"There is a large population of patients who are at risk for potentially life-threatening thromboembolic events due to underlying co-morbid diseases such as malignancy, cardiovascular disease, and hyper-coagulability. A significant percentage of these patients are inadequately treated due to concerns for bleeding risk, or challenges with compliance," said Christian T. Ruff, M.D., M.P.H., senior investigator of TIMI Group, director General Cardiology, Brigham and Women’s Hospital, and associate professor, Harvard Medical School. "SRSD107 offers the potential for a therapy with lower bleeding risk, infrequent dosing for better compliance, without concerns for renal clearance or drug interactions, and reversibility to further mitigate bleeding risks that could be differentiated from currently available therapies and other Factor XI modalities."

SRSD107 is a next generation, long-acting siRNA designed to selectively inhibit Factor XI (FXI), a key driver of pathological thrombosis with minimal impact on normal hemostasis. By targeting FXI, SRSD107 aims to reduce thrombotic events while minimizing the risk of bleeding – representing a differentiated approach compared to Factor Xa inhibitors. In addition, SRSD107 may offer the potential for reversibility not observed with other anti-Factor XI modalities. The addressable population includes patients with atrial fibrillation, venous thromboembolism (VTE), cancer-associated thrombosis, chronic Coronary Artery Disease (CAD), chronic Peripheral Vascular Disease (PVD), end-stage renal disease requiring hemodialysis, and patients undergoing major orthopedic surgery, where bleeding risk limits existing therapies.

The clinical program for SRSD107 includes two promising Phase 1 clinical trials, where single doses of SRSD107 were found to be safe and well tolerated. In addition, SRSD107 demonstrated robust pharmacodynamic effects, including reductions of over 93% in FXI levels and FXI activity (FXIa), along with more than a twofold increase in activated partial thromboplastin time (aPTT) relative to baseline. These effects were sustained, with responses maintained for up to 6 months post-dosing. SRSD107 has the potential to be a best-in-class FXI inhibitor, showing deep reductions in FXI via semi-annual subcutaneous injection. Results from the Phase 1 trials were presented at both the 2025 Annual Scientific Sessions of the American College of Cardiology and the 2024 Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper).

A Phase 2 clinical trial of SRSD107 is being initiated to evaluate its safety and efficacy for the prevention of VTE in patients undergoing total knee arthroplasty. The trial aims to confirm the anticoagulant benefits of SRSD107 and to inform dose selection for future pivotal trials.

Collaboration Details
Under the terms of the agreement, CRISPR Therapeutics will make an upfront payment of $25 million in cash and $70 million in equity to Sirius Therapeutics. The companies will jointly develop SRSD107 under a 50-50 cost and profit-sharing structure. CRISPR Therapeutics will lead commercialization in the U.S., while Sirius will be responsible for commercialization in Greater China.

Additionally, CRISPR Therapeutics will have the option to nominate up to two siRNA targets for research and development. For each target, CRISPR Therapeutics will fund research and retain opt-in rights to lead clinical development and commercialization. Sirius will be eligible to receive milestone payments, as well as tiered royalties ranging from high single to low-double digits.

On May 19, 2025 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, reported that the first patient has been dosed with CX-801 in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in the ongoing Phase 1 dose escalation study (NCT06462794) evaluating safety and initial clinical activity in patients with metastatic melanoma (Press release, CytomX Therapeutics, MAY 19, 2025, View Source [SID1234653225]).

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CX-801 is a dually masked interferon (IFN) alpha-2b PROBODY cytokine. CX-801 has been intentionally designed by CytomX to harness the power of Interferon alpha-2b’s immune stimulating properties in combination with checkpoint inhibition. Interferon alpha-2b has well known single agent anti-cancer activity in multiple tumor types, including in melanoma. However, its use has been limited due to its poor tolerability arising from systemic toxicities. CX-801 is designed to localize the potency of IFN alpha-2b to tumors and reduce systemic toxicities, enabling combination strategies.

CytomX is conducting a focused Phase 1 dose escalation study of CX-801 in metastatic melanoma. The combination arm of the study evaluating CX-801 in combination with KEYTRUDA has been initiated following successful the clearance of the first three CX-801 monotherapy dose escalation cohorts.

"We are excited to begin evaluating this combination therapy that has the potential to provide significant clinical benefit to patients with PD-1 refractory melanoma, which remains an area of high unmet need," said Dr. Wayne Chu, M.D., chief medical officer of CytomX Therapeutics. "Utilizing CytomX’s proprietary conditional activation platform to maintain potency and widen interferon’s therapeutic index, CX-801 is well suited to combine with KEYTRUDA and could become an important component of combination immuno-oncology therapy. We look forward to initial Phase 1a translational and biomarker data in advanced melanoma in the second half of 2025."