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Zymeworks Receives U.S. FDA Fast Track Designation for ZW191, an FRα-Targeting Antibody-Drug Conjugate

On March 30, 2026 Zymeworks Inc. (Nasdaq: ZYME), a biotechnology company managing a portfolio of licensed healthcare assets, while developing a diverse pipeline of novel, multifunctional biotherapeutics, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ZW191, an antibody-drug conjugate (ADC) targeting folate receptor-α (FRα), for the treatment of patients with advanced or metastatic platinum-resistant ovarian cancer (PROC).

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ZW191 is an ADC engineered to target FRα, a protein expressed in several tumor types, including approximately 75% of high-grade serous ovarian carcinomas1, over 50% of endometrial cancers,2,3 and ~70% of lung adenocarcinomas4. ZW191’s differentiated design strongly supports its ability to internalize into FR⍺-expressing cells with the potential to release bystander active topoisomerase-1 inhibitor (ZD06519), a novel proprietary payload developed by Zymeworks to kill tumor cells.

The FDA’s Fast Track designation program is designed to expedite the development and review timelines of drugs that demonstrate the potential to treat serious conditions, aiming to deliver therapeutics to patients more quickly in areas of unmet need.

"Receiving Fast Track Designation for ZW191 highlights the potential of this program to address significant unmet medical needs for patients with previously treated advanced ovarian cancer. Notably, the designation was granted irrespective of FRα expression highlighting ZW191’s potential of extending treatment benefits to a broad group of patients without need for biomarker selection," said Sabeen Mekan, M.D., Senior Vice President and Chief Medical Officer at Zymeworks. "This designation also further reinforces our expertise in ADC development, and we look forward to working closely with the FDA to advance this program for patients with difficult-to-treat cancers."

Zymeworks is currently evaluating ZW191 in a Phase 1 clinical study (NCT06555744) designed to assess safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity in patients with advanced solid tumors. The study is designed to further characterize ZW191’s clinical activity and safety to inform its future development strategy.

(Press release, Zymeworks, MAR 30, 2026, View Source [SID1234664050])

BeyondSpring Announces Plinabulin and ADC Combination Poster Presentation at AACR Annual Meeting 2026

On March 30, 2026 BeyondSpring Inc. (NASDAQ: BYSI) ("BeyondSpring" or the "Company"), a clinical-stage company developing transformative therapies for the treatment of cancer and other diseases, reported that the Company will have a poster presentation at the 2026 Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) ("AACR"), taking place on April 17 through 22, 2026 in San Diego, California.

Presentation Details:

Title: Plinabulin Boosts Antitumor Efficacy of Topoisomerase Inhibitor-based Antibody-drug Conjugates Without or With Immune Checkpoint Inhibitor
Presenter / Authors: Yingjuan June Lu, Xiaoyan He, Weiwei Cheng, Zhengyan Zhang, James Tonra, Lan Huang
Presentation Time: April 21, 2026, 2PM to 5PM PT
Location: Poster Section 8 at San Diego Convention Center
Session Category: Immunology
Session Title: T Cell Engagers 2 / Antibody-Drug Conjugates 1
Poster Board Number: 16
Poster Number: 5597

(Press release, BeyondSpring Pharmaceuticals, MAR 30, 2026, View Source [SID1234664049])

CERo Therapeutics Doses Second Patient in Cohort 2 of Phase 1 CER-1236 Trial

On March 30, 2026 CERo Therapeutics Holdings, Inc., (OTCQB: CERO) ("CERo" or the "Company") an innovative cellular immunotherapy company seeking to advance the next generation of engineered T cell therapeutics that employ phagocytic mechanisms, reported it has dosed the second patient in the second cohort (fifth patient overall) in its Phase 1 CER-1236 clinical trial in hematologic malignancies, including acute myeloid leukemia (AML), with planned expansion into myelodysplastic syndromes (MDS) and myelofibrosis (MF). With more than seven days of follow-up completed after the second patient’s infusion, protocol-defined monitoring of safety, pharmacokinetic, pharmacodynamic, and clinical activity endpoints is ongoing.

As previously presented at the February Tandem Meetings in Salt Lake City, investigators reported no cases of cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) of any grade, no dose-limiting toxicities during the 28-day assessment window, and in vivo cell expansion with peak levels observed between days 10 and 14 following infusion. In the same presentation, the Company reported observations from a single patient with inv(3) AML who received four CER-1236 infusions over five months at the lowest dose level and experienced 72 consecutive days of platelet transfusion independence. These data informed the protocol amendment expanding enrollment into patients with MDS and MF.

Robert Sikorski, M.D., Ph.D., CERo Chief Medical Officer, stated, "The study is progressing according to protocol, with ongoing evaluation of safety, pharmacokinetics, pharmacodynamics, and clinical activity. The data generated to date support continued dose escalation and planned expansion of enrollment into patients with advanced myelodysplastic syndrome (MDS) and myelofibrosis (MF). These are patient populations with substantial unmet need, and we are committed to continuing the clinical evaluation of CER-1236 as a potential new cell therapy approach for patients with these diseases."

The first-in-human, multi-center, open-label, Phase 1/1b study was initially designed to evaluate the safety and preliminary efficacy of CER-1236 in patients with AML that is either relapsed/refractory, or in remission with measurable residual disease, or newly diagnosed patients with TP53 mutated AML. The two-part study initiated with dose escalation to determine the highest tolerated dose and recommended dose for subsequent expansion, followed by an expansion phase to evaluate safety and efficacy. Primary outcome measures include incidence of adverse events (AEs) and serious adverse events (SAEs), incidence of dose-limiting toxicities and estimation of overall response rate (ORR), complete response (CR), composite complete response (cCR), and measurable residual disease (MRD). Secondary outcome measures include pharmacokinetics (PK). Based on emerging safety data and clinical observations, the trial has recently been amended to include transfusion-dependent myelodysplastic syndromes (TD-MDS), high-risk MDS (HR-MDS), or post-JAK-inhibitor myelofibrosis (MF).

CERo CEO Chris Ehrlich added, "CERo continues to execute the CERTAIN-T trial, with completion of the second cohort approaching. The study data continue to reinforce ongoing dose escalation and planned expansion into additional patient populations. We are grateful to the patients, investigators, study sites, and the CERo team for their contributions, and we look forward to sharing additional data as the study progresses."

(Press release, Cero Therapeutics, MAR 30, 2026, View Source [SID1234664048])

AP Biosciences and Tasly Finalize Amended Collaboration Agreement to Support Global Out-Licensing of AP505 (B1962)

On March 30, 2026 AP Biosciences, a clinical-stage biopharmaceutical company dedicated to transforming cancer therapy through development of innovative bispecific antibodies, reported the finalization of an amendment to its development collaboration with Tasly Pharmaceutical Group Co.LTD., establishing a supplementary framework for the anticipated out-licensing of AP505 (B1962) outside the original agreement’s designated Territory (which includes PRC, Hong Kong and Macau under the original License Development and Commercialization Agreement).

AP505 (B1962) has completed a Phase 1 clinical study and is currently being evaluated in Phase 2 trials led by Tasly in-Territory for advanced solid tumors, further supporting its translational potential and advancement toward later-stage development. The amended deal around AP505 (B1962) pairs Tasly’s proven clinical development efficiency in-Territory with AP Biosciences’ global development and partnering strategy, a collaboration structure designed to accelerate AP505 (B1962)’s continued advancement while maximizing its value both in- and ex-Territory, in international markets.

"This amendment reflects the shared commitment between AP Biosciences and Tasly to accelerate the development and commercialization of AP505 (B1962) for patients globally," said Jeng Her, Ph.D., Founder and Chief Executive Officer of AP Biosciences. "By establishing clear and rapid pathways for technology transfer, clinical data sharing, and clinical supply, this agreement enhances our readiness to engage potential partners and progress AP505 (B1962) toward ex-Territory clinical development."

Under the amended terms, Tasly will support AP Biosciences’ global development and partnering efforts by providing relevant clinical data, regulatory materials, and clinical supply for ex-Territory studies, on a revenue-sharing basis. The agreement also establishes a framework for technology transfer and collaboration with potential third-party partners in ex-Territory.

Locust Walk Partners, LLC, served as the lead financial advisor of the collaboration agreement amendment.

For more information about AP Biosciences and its bispecific antibody pipeline, please visit: View Source

About AP505 (B1962)

AP505 (B1962) is a bispecific antibody engineered to target two critical and complementary pathways in cancer biology. By simultaneously binding programmed cell death ligand-1 (PD-L1) and vascular endothelial growth factor (VEGF), AP505 (B1962) aims to both release immune suppression on T cells and inhibit tumor-driven angiogenesis, thereby enhancing anti-tumor activity compared to conventional monotherapies. Its symmetric IgG-based fusion protein structure increases manufacturability and stability, and enables purification using standard monoclonal antibody processes, while its dual-pathway mechanism is poised to address major unmet needs in indications such as hepatocellular carcinoma and pMMR colorectal cancer, where single-agent immunotherapies have shown limited efficacy.

(Press release, AP Biosciences, MAR 30, 2026, View Source [SID1234664047])

Bicara Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update

On March 30, 2026 Bicara Therapeutics Inc. (Nasdaq: BCAX) reported financial results for the fourth quarter and full year ended December 31, 2025 and provided a business update.

"Bicara enters the year with exceptional momentum across our clinical, regulatory, and corporate priorities," said Claire Mazumdar, Ph.D., Chief Executive Officer at Bicara Therapeutics. "The continued advancement of our pivotal FORTIFI-HN01 study, the robust body of clinical data supporting ficerafusp alfa’s differentiated profile, and the alternate dosing option for ficerafusp alfa all underscore the significant progress we’ve made toward transforming outcomes for patients with HPV-negative head and neck cancer. Coupled with our fortified financial position from our recent financing, we are well positioned to execute on our milestones, scale our organization for potential commercialization, if approved, and deliver meaningful value for patients and shareholders throughout the year."

Fourth Quarter 2025 Highlights and Recent Progress

FORTIFI-HN01: Pivotal Phase 2/3 Clinical Trial of Ficerafusp Alfa in First Line (1L) Recurrent or Metastatic (R/M) HPV-Negative Head and Neck Squamous Cell Carcinoma (HNSCC)

Selected 1500mg of ficerafusp alfa as the optimal dose for the treatment of 1L HPV-negative R/M HNSCC in Phase 3 of the FORTIFI-HN01 pivotal trial.
Initiated Phase 3 of the FORTIFI-HN01 study, and expect to be substantially enrolled by the end of the year.
Announced plans to develop ficerafusp alfa with a loading and every-three-week (Q3W) maintenance schedule, with the goal of achieving regulatory alignment to enable data generation for potential U.S. approval.
Phase 1b Data of Ficerafusp Alfa in 1L R/M HPV-Negative HNSCC

Presented Phase 1b data at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Asia Congress 2025 demonstrating that ficerafusp alfa 750mg QW plus pembrolizumab was generally well-tolerated with an ORR comparable to 1500mg QW. Read the full presentation here. Biomarker analyses demonstrated that the 1500mg dose achieved greater TGF-β inhibition, stronger immune activation, and deeper clinical responses, supporting higher dose selection and further derisking the ORR interim analysis for the FORTIFI-HN01 pivotal study.
Presented Phase 1b data at the 2026 Multidisciplinary Head and Neck Cancers Symposium (MHNCS) showing that ficerafusp alfa 2000mg Q2W plus pembrolizumab was generally well‑tolerated and produced rapid, deep, and durable responses. Read the full presentation here. Updated biomarker analyses confirmed that the 2000mg Q2W regimen maintains TGF‑β inhibition and immune activation consistent with the differentiated profile of 1500mg QW, supporting development of a loading and Q3W maintenance schedule that maintains efficacy and safety while providing additional convenience.
Development of Ficerafusp Alfa Across Other Solid Tumor Types

Continued to enroll a Phase 1b expansion cohort evaluating ficerafusp alfa both as monotherapy and in combination with pembrolizumab in patients with 3L+ metastatic colorectal cancer (mCRC) (RAS/BRAF wild type MSS).
Corporate Highlights

Raised net proceeds of $161.8 million through an oversubscribed public offering. Net proceeds from the offering will be used to further invest in and build Bicara’s medical and commercial infrastructure to support a planned regulatory filing and commercial launch for ficerafusp alfa, if approved, in the U.S.; to further accelerate the development of ficerafusp alfa in 1L R/M HPV-negative HNSCC, including a less frequent dosing schedule; to fund manufacturing costs for ficerafusp alfa for ongoing and anticipated drug development efforts; to fund early signal-finding to support future indication expansion for ficerafusp alfa; and for other general corporate purposes.
Key Anticipated Upcoming Milestones

HNSCC

Present long-term follow-up data from Phase 1b study of ficerafusp alfa in combination with pembrolizumab in 1L R/M HPV-negative HNSCC at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which will be held from May 29-June 2, 2026 in Chicago, IL.
Achieve substantial enrollment in FORTIFI-HN01 pivotal study by the end of 2026 to enable interim analysis readout in the middle of 2027.
Make critical commercial hires, including a Chief Commercial Officer, by the end of 2026 to advance organizational preparation for launch readiness.
Other Solid Tumors, Including mCRC

Present data from Phase 1b expansion cohort evaluating ficerafusp alfa both as monotherapy and in combination with pembrolizumab in patients with 3L+ mCRC (RAS/BRAF wild type MSS) in the second half of 2026.
Fourth Quarter 2025 Financial Results

Cash, Cash Equivalents and Marketable Securities: As of December 31, 2025, Bicara had cash, cash equivalents and marketable securities of $414.8 million, compared to $489.7 million in cash and cash equivalents as of December 31, 2024. An additional $161.8 million in net proceeds was raised via an oversubscribed public offering in the first quarter of 2026. Based on its current operating and development plans, the Company expects that its existing cash, cash equivalents and marketable securities will fund operations into the first half of 2029.
Research and Development Expenses: Research and development expenses were $33.0 million for the fourth quarter of 2025 as compared to $19.9 million for the fourth quarter of 2024, and $125.1 million for the full year 2025 as compared to $63.6 million for the full year 2024. The increase was primarily due to costs associated with ongoing pivotal Phase 2/3 clinical trial, FORTIFI-HN01, as well as the Company’s ongoing Phase 1/1b dose expansion cohorts, and an increase in personnel costs.
General and Administrative Expenses: General and administrative expenses were $8.1 million for the fourth quarter of 2025 as compared to $6.8 million for the fourth quarter of 2024, and $30.5 million for the full year 2025 as compared to $18.8 million for the full year 2024. The increase was primarily due to additional personnel costs and professional fees to support advancement of our clinical trials and operations as a public company.
Net Loss: Net loss totaled $37.4 million and $138.0 million for the fourth quarter and full year ended December 31, 2025, respectively, as compared to $21.0 million and $68.0 million for the fourth quarter and full year ended December 31, 2024, respectively.
Upcoming Investor Conferences

Bicara Therapeutics will participate in one upcoming investor conference:

BofA Securities Health Care Conference 2026 on Wednesday, May 13, 2026 at 9:20 a.m. PT.
A live webcast of the fireside chat will be accessible through the Investor Relations section of Bicara’s website under Events and Presentations. A replay of the webcast will be archived and available for 30 days following the event.

Conference Call Information

Bicara will host a live conference call and webcast at 8:30 a.m. ET today to discuss fourth quarter and full year 2025 financial results and recent business activities. Individuals may register for the conference call by clicking the link here. Once registered, participants will receive dial-in details and a unique PIN that will allow them to access the call. An audio webcast will be accessible through the Investor Relations section of Bicara’s website under Events and Presentations. An archived replay will also be available for 30 days following the event.

(Press release, Bicara Therapeutics, MAR 30, 2026, View Source [SID1234664046])