On February 23, 2026 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Vir Biotechnology, Inc. (Nasdaq: VIR) reported they have entered into a global strategic collaboration to advance VIR-5500, an investigational PRO-XTEN dual-masked CD3 T-cell engager (TCE) targeting PSMA for the treatment of prostate cancer. The collaboration aims to accelerate the development of VIR-5500 and further strengthen Astellas’ oncology pipeline and prostate cancer leadership.

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Adam Pearson, Chief Strategy Officer, Astellas
"Astellas is proud to have helped 1.5 million patients with prostate cancer, and we are dedicated to expanding our impact as part of our R&D strategy. Our deep expertise in this disease area, combined with a growing immuno-oncology (IO) pipeline of biologics, including T-cell engagers, uniquely positions us to help advance VIR-5500, a potentially best-in-class T-cell engager for prostate cancer. This strategic collaboration allows Astellas and Vir Biotechnology to combine our expertise and reaffirms our commitment to improving the lives of people with prostate cancer."

Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer, Vir Biotechnology
"Astellas is an ideal collaborator for the VIR-5500 program given the company’s successful track record advancing therapies across the treatment continuum, building blockbuster franchises and delivering value to patients through strategic development alliances with other biotech partners. This collaboration will enable more rapid advancement of VIR-5500 to potentially benefit more people living with prostate cancer. We believe this collaboration reflects confidence in our PRO-XTEN platform, which has broad potential across multiple solid tumor indications."

Despite recent advances in treatment, prostate cancer, especially metastatic castration-resistant prostate cancer (mCRPC), remains an aggressive and difficult cancer to treat; mCRPC has a 5-year survival rate of approximately 30%.i Patients who progress to mCRPC develop therapeutic resistance and currently have limited treatment options.

VIR-5500 is a potential best-in-class dual-masked Prostate-Specific Membrane Antigen (PSMA)-targeting TCE and is currently in Phase 1 development for people with advanced, metastatic prostate cancer (NCT05997615). VIR-5500 combines a bispecific PSMA and CD3 binding TCE with the PRO-XTEN masking technology, which is designed to keep the TCEs masked (or inactive) until they reach the tumor microenvironment, reducing off-target effects and improving the therapeutic index.

Under the terms of the agreement, Vir Biotechnology will receive $335 million in upfront and near-term payments, including $240 million in cash, $75 million in equity investment at a 50% premium,ii and a near-term $20 million milestone. Global development costs for VIR-5500 will be shared, with Astellas responsible for 60% and Vir Biotechnology responsible for 40% of all costs. Vir Biotechnology will continue the ongoing Phase 1 trial, until responsibility is transitioned to Astellas, after which Astellas will be responsible for all development activities. In the U.S., Vir Biotechnology will have the option to co-promote VIR-5500 with Astellas, and profit/loss will be shared equally. Outside the U.S., Astellas will be exclusively responsible for commercialization of VIR-5500. In addition, Vir Biotechnology is eligible to receive up to $1.37 billion in development, regulatory and sales milestones, along with tiered, double-digit royalties on ex-U.S. net sales. Under the terms of Vir Biotechnology’s licensing agreement with Sanofi, a portion of certain collaboration proceeds will be shared with Sanofi.

Lazard acted as Vir Biotechnology’s exclusive financial advisor. Closing of the transaction is contingent on customary closing conditions, including clearance under the Hart-Scott-Rodino (HSR) Act.

(Press release, Astellas, FEB 23, 2026, View Source [SID1234662874])

On February 23, 2026 Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, reported that two abstracts have been accepted for presentation at the 2026 ASCO (Free ASCO Whitepaper) Genitourinary (GU) Cancers Symposium (ASCO GU). The meeting is being held February 26-28, 2026, in San Francisco, California.

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Details of the poster presentations are below:

Title: "ctDNA monitoring of FGFR3-altered metastatic urothelial cancer treated with dabogratinib (formerly TYRA-300) in the SURF301 trial"

Abstract Number: 809
Session: Poster Session B: Prostate Cancer and Urothelial Carcinoma
Date and Time: February 27, 2026, 11:30 AM–12:45 PM PST
Presenting Author: Andrew J. Murtha, BSc, University of British Columbia, Vancouver, BC, Canada
Title: "A phase 2 multicenter, open-label study evaluating the efficacy and safety of dabogratinib (formerly TYRA-300) in participants with FGFR3-altered low-grade, intermediate risk non-muscle invasive bladder cancer (SURF302)"

Abstract Number: TPS886
Session: Trials in Progress Poster Session B: Urothelial Carcinoma
Date and Time: February 27, 2026, 11:30 AM–12:45 PM PST
Presenting Author: Gautam Jayram, MD, Urology Associates, Nashville, TN
More information can be found at the ASCO (Free ASCO Whitepaper) GU website. The posters will be available on the IR page of TYRA’s website following presentation at ASCO (Free ASCO Whitepaper) GU: View Source

(Press release, Tyra Biosciences, FEB 23, 2026, View Source [SID1234662873])

On February 23, 2026 Biogen Inc. (Nasdaq: BIIB) reported that Christopher A. Viehbacher, President and Chief Executive Officer, will participate in a fireside chat during the TD Cowen 46th Annual Health Care Conference. The webcast will be live on Monday, March 2, 2026, at 9:10 a.m. ET. To access the live webcast, please visit the Investors section of Biogen’s website at investors.biogen.com. An archived version of the webcast will be available for at least 30 days following the presentation.

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(Press release, Biogen, FEB 23, 2026, View Source [SID1234662872])

On February 23, 2026 Kyntra Bio (Nasdaq: KYNB), formerly FibroGen (Nasdaq: FGEN), reported that the data on anti-tumor activity of FG-3246 in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) from the investigator-sponsored Phase 1b/2 study will be presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU), taking place February 26-28, 2026 in San Francisco, CA.

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"The results from this Phase 1b/2 investigator-initiated study demonstrate encouraging preliminary anti-tumor activity of FG-3246 in combination with enzalutamide in patients with mCRPC. Notably, the 10.1 months of rPFS in patients with only one prior ARPI underscores the potential of FG-3246 in earlier lines of therapy," commented Dr. Rahul Aggarwal, Professor of Medicine at the University of California San Francisco, and Principal Investigator of the study. "The positive trend observed in the association between tumor uptake of FG-3180 (CD46-targeting PET) and PSA50 response, though from a small number of patients, is especially intriguing and I’m excited to see the potential utility of this biomarker further explored in the Phase 2 monotherapy study."

"These data from the investigator sponsored trial expand on the clinically meaningful results previously observed with FG-3246," said Thane Wettig, Chief Executive Officer of Kyntra Bio. "The 10.1 months of median rPFS observed in patients progressing on only one prior ARPI, and the mitigation of neutropenia related adverse events with prophylactic G-CSF are especially encouraging as they further validate our Phase 2 monotherapy trial design. We look forward to sharing the interim analysis of the Phase 2 monotherapy trial in the second half of 2026 as well as further characterizing the potential utility of FG-3180 as a patient selection biomarker."

The presentation includes data from 44 biomarker unselected patients with progressive metastatic castration-resistant prostate cancer, 17 of which were enrolled in the Phase 1b dose escalation portion of the study. Eligibility criteria for the trial included patients who progressed on at least one prior ARPI while patients who were treated with prior chemotherapy in the castration-resistant setting were excluded. Over 60% of the patients progressed on two or more prior ARPIs, which included prior enzalutamide treatment. The primary endpoint of the escalation phase was assessment of dose-limiting toxicities (DLT) and determination of the maximum tolerated dose and recommended dose for the Phase 2 portion of the study – which was determined to be 2.1 mg/kg of FG-3246 and 160 mg/day of enzalutamide. The primary endpoint of the Phase 2 expansion portion of the study was composite response rate (PSA50 response and/or objective response per RECIST v1.1). Secondary endpoints were PSA50 response rate, objective response rate, radiographic progression free survival (rPFS), overall survival, and treatment-related adverse events (TRAEs).

FG-3246 combined with enzalutamide demonstrated anti-tumor activity with a composite response rate of 21% in the overall cohort and 40% in patients who had progressed on only one prior ARPI. Median rPFS of 7.0 months was observed in the overall cohort. Notably, median rPFS of 10.1 months was observed in patients who had progressed on only one prior ARPI, a result which was consistent across the different prior ARPIs administered. Additionally, higher tumor uptake of FG-3180 demonstrated a trend towards higher probability of PSA50 response (p=0.053), highlighting the potential of FG-3180 as a biomarker for patient selection.

Combination therapy of FG-3246 and enzalutamide demonstrated a similar safety profile as was observed in the previous Phase 1 monotherapy trial of FG-3246. Neutropenia risk was successfully mitigated with use of G-CSF prophylaxis. The most frequent TRAEs with the combination therapy included fatigue, peripheral neuropathy, anorexia, and dysgeusia. Cumulative toxicities, including peripheral neuropathy, led to treatment discontinuation for some patients.

The poster presentation, titled "A phase 1b/2 study of FOR46 (FG-3246) in combination with enzalutamide (enza) in patients with metastatic castration resistant prostate cancer (mCRPC)", is scheduled for the poster session taking place on February 26, 2026 from 11:30 AM to 12:45 PM PT.

FG-3246 is currently being evaluated in a Phase 2 monotherapy trial with interim data expected in the second half of 2026. The trial also includes treatment with FG-3180, a CD46-directed PET imaging agent, which will measure expression levels of CD46 positive lesions. This will enable further assessment of the correlation between CD46 expression and response to FG-3246 and the potential of FG-3180 to serve as a biomarker to aid in patient selection in future trials of FG-3246.

About FG-3246 and FG-3180
FG-3246 (FOR46) is a potential first-in-class fully human antibody-drug conjugate (ADC), exclusively in-licensed from Fortis Therapeutics, and is being developed by Kyntra Bio for metastatic castration-resistant prostate cancer and potentially other tumor types. FG-3246 binds to an epitope of CD46, a cell receptor target, that induces internalization upon antibody binding, is present at high levels in prostate cancer and other tumor types and demonstrates very limited expression in most normal tissues. FG-3246 is comprised of an anti-CD46 antibody, YS5, linked to the anti-mitotic agent, MMAE, which is a clinically and commercially validated ADC payload. FG-3246 has demonstrated anti-tumor activity in both preclinical and clinical studies. FG-3180 is a companion diagnostic PET imaging agent, using the same CD46-targeting antibody together with an 89Zr tracker. To date, FG-3180 demonstrated specific uptake in CD46 positive tumors and is currently being evaluated as a biomarker for its potential to inform patient selection.

About the Phase 1b/2 Study of FG-3246 in Combination with Enzalutamide
This Phase 1b/2 study is an investigator-sponsored trial being conducted at the University of California San Francisco to evaluate FG-3246 (FOR46) in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) after prior progression on at least one androgen receptor pathway inhibitor. The primary objective for the Phase 1b portion of the study is to determine the maximally tolerated dose (MTD) and recommended Phase 2 dose of FG-3246 in combination with enzalutamide in patients with mCRPC. The objectives of the Phase 2 portion of the study are to determine the composite response rate (CRR), proportion of participants with a greater than or equal to 50% change in prostate specific antigen (PSA50), objective response rate (ORR), median duration of response, median radiographic progression free survival (rPFS), and median overall survival (OS) of patients treated with FG-3246 in combination with enzalutamide. For more information about this study, which is currently enrolling, please visit www.clinicaltrials.gov (NCT05011188).

(Press release, Kyntra Bio, FEB 23, 2026, View Source [SID1234662871])

On February 23, 2026 BridgeBio Pharma, Inc. (Nasdaq: BBIO) ("BridgeBio" or the "Company"), a biopharmaceutical company focused on developing medicines for genetic conditions, reported that members of its management team will participate in the following healthcare investor conferences:

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TD Cowen 46th Annual Healthcare Conference, Boston, MA: Fireside Chat on Monday, March 2 at 3:50 pm EST
Leerink Partners Global Healthcare Conference, Miami, FL: Fireside Chat on Tuesday, March 10 at 1:00 pm EDT
Barclays 28th Annual Global Healthcare Conference, Miami FL: Fireside Chat on Wednesday, March 11 at 12:30 pm EDT

To access the live webcast of BridgeBio’s presentations, please visit the "Events and Presentations" page within the Investors section of the BridgeBio website at View Source A replay of the webcasts will be available on the BridgeBio website for 90 days following the event.

(Press release, BridgeBio, FEB 23, 2026, View Source [SID1234662870])