Zymeworks Announces Presentations for Ziihera® (zanidatamab-hrii) at 2026 AACR Annual Meeting

On March 18, 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 company’s partner, Jazz Pharmaceuticals, will present four abstracts featuring data from clinical trials evaluating Ziihera (zanidatamab-hrii) at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, being held April 17-22, 2026 in San Diego, CA.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are pleased to see the continued clinical progress of zanidatamab reflected in multiple presentations at AACR (Free AACR Whitepaper)," said Ken Galbraith, Chair, Chief Executive Officer, and Interim Chief Financial Officer of Zymeworks. "These studies highlight emerging data evaluating zanidatamab across tumor types beyond biliary tract cancer and gastroesophageal adenocarcinoma, and contribute to the growing body of evidence supporting its potential across HER2-expressing cancers."

Highlights at the AACR (Free AACR Whitepaper) Annual Meeting include:

An oral presentation with results from the Phase 2 single-arm, open-label NeoZanHER trial (NCT05035836) evaluating zanidatamab for the investigational use as neoadjuvant monotherapy in patients with early-stage HER2+ breast cancer. At six weeks, zanidatamab treatment resulted in a statistically significant decrease in tumor size and volume from baseline, and 30% of patients (n=6) achieved pathologic complete response (pCR). Treatment with zanidatamab was manageable with no new safety signals.
A poster presentation detailing mechanistic and multi-omics analyses characterizing zanidatamab’s differentiated HER2 biology, including dual, domain-specific binding and downstream effects on key cellular signaling pathways, with insights into activity in models following progression on trastuzumab deruxtecan (T-DXd).
Additional presentations further explore zanidatamab’s utility across HER2-expressing solid tumors and within innovative biomarker-driven clinical trial designs, including adaptive organ-preservation strategies in gastroesophageal adenocarcinoma.

Oral Presentation

Title: A Phase 2 Single-Arm Open-Label Trial Evaluating Zanidatamab in Patients with Early Stage HER2 positive Breast Cancer: The NeoZanHER Study
Presentation Number: CT012
Session: Clinical Trials Minisymposium: Aiming for Cure: Perioperative Clinical Trials
Date/Time: Saturday, April 18, 2026 at 12:30 – 2:30 pm Pacific Standard Time (PST)

Poster Presentations

Title: Zanidatamab Modulates Multiple Pathways Involved in Tumor Growth and Survival is Efficacious Post-T-DXd
Abstract: 452
Session: Experimental and Molecular Therapeutics: Next-Generation Targeted Therapies Directed Against Tumor Surface Antigens
Date/Time: Tuesday, April 21, 2026 at 9:00 am – 12:00 pm PST

Title: DiscovHER PAN-206: Phase 2 Tumor-Agnostic Study of Zanidatamab in Patients With Previously Treated Human Epidermal Growth Factor Receptor 2–Overexpressing Solid Tumors
Abstract: CT209
Session: Phase II and Phase III Clinical Trials in Progress
Date/Time: Tuesday, April 21, 2026 at 9:00 am – 12:00 pm PST

Title: AACR (Free AACR Whitepaper) Adaptive Biomarker-Driven Organ Preservation Trial in GE Adenocarcinomas (AACR-ADOPT-GEA)
Abstract: CT223
Session: Phase II and Phase III Clinical Trials in Progress
Date/Time: Tuesday, April 21, 2026 at 9:00 am – 12:00 pm PST

The AACR (Free AACR Whitepaper) abstracts are available at View Source!/21436.

About Ziihera (zanidatamab-hrii)

Ziihera (zanidatamab-hrii) is a bispecific HER2-directed antibody that binds to two extracellular sites on HER2. Binding of zanidatamab-hrii with HER2 results in internalization leading to a reduction in HER2 expression of the receptor on the tumor cell surface. Zanidatamab-hrii induces complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC), and antibody-dependent cellular phagocytosis (ADCP). These mechanisms result in tumor growth inhibition and cell death in vitro and in vivo. In the United States, Ziihera is indicated for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test.1 The FDA granted accelerated approval for this indication based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).1

Zanidatamab is being developed in multiple clinical trials as a targeted treatment option for patients with solid tumors that express HER2. Zanidatamab is being developed by Jazz and BeOne under license agreements from Zymeworks, which first developed the molecule.

The FDA granted two Breakthrough Therapy designations for zanidatamab’s development: one as a single agent for previously treated HER2 gene-amplified BTC, and one in combination with standard-of-care chemotherapy for first-line HER2+ locally advanced or metastatic GEA. The FDA also granted two Fast Track designations for zanidatamab: one as a single agent for refractory BTC and one in combination with standard-of-care chemotherapy for first-line GEA. Additionally, zanidatamab has received Orphan Drug designations from the FDA for the treatment of BTC, gastric (including gastroesophageal junction) cancer, and esophageal cancer, as well as Orphan Drug designations from the European Medicines Agency for the treatment of BTC, gastric/gastroesophageal junction cancer and oesophageal cancer.

The full U.S. Prescribing Information for Ziihera, including BOXED Warning, is available at: View Source

(Press release, Zymeworks, MAR 18, 2026, View Source [SID1234663730])

Pliant Therapeutics Announces Upcoming Presentation of Phase 1 Clinical Trial of PLN-101095 in Patients with Solid Tumors at the 2026 AACR Annual Meeting

On March 18, 2026 Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical-stage biotechnology company focused on the discovery and development of integrin-based therapeutics, reported the presentation of data from the Phase 1 trial of PLN-101095 at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place in San Diego, California from April 17-22, 2026.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The abstract was selected for oral presentation as part of the Clinical Trials Mini Symposium.

Oral Presentation

Title: First-in-human phase I study of PLN-101095, a first-in-class dual αvβ8/αvβ1integrin inhibitor, as monotherapy and in combination with pembrolizumab in patients with advanced solid tumors refractory to immune checkpoint inhibitors (ICI)

Presenter: Timothy A. Yap, M.D., Ph.D., University of Texas, M.D. Anderson Cancer Center
Session: CTMS01: Updates in Anticancer Immunotherapies
Date: Saturday, April 18, 2026
Presentation Time: 10:21 a.m. – 10:31 a.m. Pacific Time
Location: Ballroom 6A – Upper Level – San Diego Convention Center

Oncology Program

PLN-101095 is an oral, small molecule, dual selective inhibitor of αvβ8 and αvβ1 integrins designed to overcome checkpoint resistance by blocking TGF-β activation in the tumor microenvironment. Pliant is currently conducting a Phase 1a/1b open-label, dose-escalation and indication expansion trial to evaluate the safety, tolerability, pharmacokinetics, and preliminary evidence of antitumor activity of PLN-101095, as monotherapy and in combination with pembrolizumab, in patients with immune checkpoint inhibitor (ICI)-refractory advanced or metastatic solid tumors.

(Press release, Pliant Therapeutics, MAR 18, 2026, View Source [SID1234663729])

Totus Medicines Presents Phase 1a Clinical Data for TOS-358, a Covalent PI3Ka Inhibitor, at ESMO TAT 2026

On March 18, 2026 Totus Medicines, a clinical stage, precision medicine company leveraging a novel covalent DNA-encoded library + AI-powered small molecule drug discovery platform to advance a differentiated pipeline of therapeutics against high-value, historically difficult to drug targets in multiple therapeutic areas, reported the presentation by Dr. Antonio Giordano of Dana Farber Cancer Center of new clinical data for TOS-358, its lead oral covalent PI3Ka inhibitor, in an oral presentation at the European Society for Medical Oncology Targeted Anticancer Therapies (ESMO TAT) Congress in Paris, France.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"TOS-358 was designed to overcome the limitations of currently available PI3Ka inhibitors by delivering sustained and specific, >90% covalent inhibition of the target combined with a best-in-class safety profile," said Zelanna Goldberg, M.D., Chief Medical Officer of Totus Medicines. "We are very encouraged by the early clinical efficacy data, which demonstrate durable tumor control and class-leading tolerability in heavily pretreated patients, including those who had previously progressed on other PI3K pathway therapies.

"TOS-358 is amongst the most interesting agents in this class to emerge. It appears to be a well-tolerated and straightforward drug to give for PI3Ka mutant disease with early data suggesting the potential for meaningfully durable tumor control. This may help inhibit tumor growth and maintain quality of life, which is a promising combination for our patients" said Dr. Antonio Giordano.

TOS-358 is an oral, highly selective, pan-mutant, covalent PI3Ka inhibitor that achieves >95% continuous target engagement for deep and durable inhibition of PI3K-AKT signaling which is required for optimal efficacy and durability.

Phase 1a Key Clinical Findings:

Clinical results from the efficacy cohort demonstrated encouraging anti-tumor activity and durability of response:

Overall efficacy profile:

CBR: 50%
DCR: 75%
ORR: 15%
≥20% tumor shrinkage: 40%
Patients on therapy for ≥24 weeks: 45%

Clinically meaningful disease control in heavily pre-treated patients:

DCR in PAM-resistant patients: 67%
DCR in PAM-intolerant patients: 100%

Class-leading Safety & Tolerability Profile:

TOS-358 demonstrated a favorable and differentiated safety profile, with minimal gastrointestinal or epithelial toxicities.

Key observations included:

No bone marrow toxicity
No hepatic toxicity
No renal toxicity
No ocular symptoms
No rash
No stomatitis or mucositis
<5% of patients required medication for nausea or diarrhea

Hyperglycemia, an expected on-target effect of PI3Ka inhibition, was primarily low grade and manageable with oral medications. Only 3.6% (2/54 pts) required ongoing insulin, which is similar to, or lower than, other PI3Ka inhibitors in development including mutant selective and/or allosteric compounds.

Phase 1b study design:

TOS-358 is currently being evaluated in an ongoing Ph1b study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary antitumor activity of TOS-358 in combination with fulvestrant and in combination with fulvestrant and CDK inhibitors in patients with PI3Ka-mutated, HR+/HER2- metastatic breast cancer. Initial data from these combination cohorts are expected to be presented at future medical and scientific conferences.

(Press release, Totus Medicines, MAR 18, 2026, View Source [SID1234663728])

BBOT Announces Multiple Presentations at the American Association for Cancer Research (AACR) Annual Meeting 2026

On March 18, 2026 BridgeBio Oncology Therapeutics, Inc. ("BBOT") (Nasdaq: BBOT), a clinical-stage biopharmaceutical company focused on RAS-pathway malignancies, reported multiple presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026 being held on April 17-22, 2026, in San Diego, California. The abstracts released today can be found on the AACR (Free AACR Whitepaper) website here.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Details on the presentations are as follows:

Title: The RAS: PI3Kα breaker BBO-10203 inhibits PI3Kα/AKT activity in HER2+ models through non-canonical RAS signaling blockade
Session Category: Experimental and Molecular Therapeutics
Session Title: Targeted Protein Degradation and Non-cannonical Oncogenic Signaling
Session Type: Oral Presentation
Session Date/Time: Tuesday, April 21, 2:30 p.m. – 4:30 p.m. PT
Location: Upper Level Ballroom 6DE
Abstract Number: 6780
Presenter: James Stice, PhD, Director, BBOT

Title: BBO-11818: an orally bioavailable, highly potent and selective non-covalent pan-KRAS (ON) and (OFF) inhibitor with robust anti-tumor activity in KRAS-mutant preclinical models
Session Category: Experimental and Molecular Therapeutics
Session Title: Novel Antitumor Agents 3
Session Type: Poster Presentation
Session Date/Time: Wednesday, April 22, 9:00 a.m. – 12:00 p.m. PT
Location: Poster Section 13
Poster Board Number: 24
Poster Number: 7104
Presenter: Carlos Stahlhut, PhD, Associate Director, BBOT

About BBO-11818
BBO-11818 is a selective, orally bioavailable non-covalent inhibitor that targets KRAS in both the ON and OFF states, has high selectivity over HRAS and NRAS, and displays strong activity in KRAS-mutant preclinical models, including KRASG12D and KRASG12V. BBO-11818 potently suppresses MAPK signaling and inhibits cell proliferation in KRAS-mutant cell lines and mouse models. BBO-11818 is currently being evaluated in the Phase 1 KONQUER-101 trial in subjects with locally advanced unresectable or metastatic KRAS-mutant solid tumors.

About BBO-10203
BBO-10203 is a first-in-class small molecule which breaks the protein-protein interaction between RAS and PI3Kα and inhibits RAS-mediated activation of the PI3Kα pathway. It selectively disrupts oncogenic RAS-PI3Kα signaling while sparing insulin-mediated glucose uptake, potentially maintaining efficacy with reduced risk of hyperglycemia or hyperinsulinemia. BBO-10203 is currently being evaluated in the Phase 1 BREAKER-101 trial for patients with locally advanced or metastatic HER2+ breast cancer, HR+/HER2- breast cancer, KRAS-mutant colorectal cancer, and KRAS-mutant non-small cell lung cancer.

(Press release, BridgeBio Oncology Therapeutics, MAR 18, 2026, View Source [SID1234663727])

Marker Therapeutics Reports Year-End 2025 Corporate and Financial Results

On March 18, 2026 Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company developing next-generation T cell-based immunotherapies for hematological malignancies and solid tumors, reported corporate updates and financial results for the year ended December 31, 2025.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"In 2025, we continued to advance MT-601, our lead Multi-Antigen Recognizing (MAR)-T cell therapy, and generated highly encouraging clinical data from our ongoing Phase 1 APOLLO study," said Juan Vera, M.D., President and Chief Executive Officer of Marker Therapeutics. "Updated results reported last August demonstrated a 66% objective response rate in relapsed non-Hodgkin lymphoma, including durable complete responses, with a favorable safety profile across evaluated doses. During the year we also reported immunomonitoring data indicating that lymphodepletion enhances the expansion and persistence of MT-601, and we advanced the APOLLO study into dose expansion in patients with relapsed Diffuse Large B Cell Lymphoma (DLBCL). We anticipate providing a data update from the APOLLO study in the second quarter of 2026."

Dr. Vera continued, "Beyond lymphoma, we made important progress expanding our MAR-T platform across hematologic and solid tumors. Recent research from Baylor College of Medicine published in Nature Medicine in early 2026 showed promising results in pancreatic cancer using MAR-T cells and received national coverage on Good Morning America."

"Looking ahead, we expect continued clinical execution across our programs, including additional APOLLO data updates and initiation of our company-sponsored pancreatic cancer clinical program, which we believe positions the next 12 to 18 months as an important value-creating period for Marker," concluded Dr. Vera.

2025 PROGRAM UPDATES & OPERATIONAL HIGHLIGHTS

MT-601 (Lymphoma)

MT-601, Marker’s lead MAR-T cell therapy, is being evaluated in the nationwide multicenter APOLLO study (clinicaltrials.gov identifier: NCT05798897) in patients with lymphoma who have relapsed after anti-CD19 CAR-T cell therapy or for whom CAR-T therapy is not an option.
The Company provided an update on the Phase 1 study in August 2025 (Press Release, Aug 26, 2025) highlighting encouraging overall response rates. These data were also presented at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2025. Key findings from the update included:
66% objective response rate (8/12) in patients with relapsed non-Hodgkin lymphoma, including 50% complete responses. Durable responses were observed (range 3-24 months).
78% objective response rate (7/9) observed in patients with Hodgkin lymphoma.
Favorable safety profile across all dose levels (100×10⁶–400×10⁶ cells), with no dose-limiting toxicities (DLTs) and no ICANS reported.
The dose expansion phase of the study is enrolling patients with anti-CD19 CAR-relapsed Diffuse Large B Cell Lymphoma (DLBCL) at the maximum dose level (400×10⁶ cells).
Additional patient data and FDA feedback on study design are expected in the second quarter of 2026.
MT-601 (Pancreatic Cancer)

Marker continues to advance MT-601 in pancreatic cancer, supported by non-dilutive funding from the National Institutes of Health (NIH), Small Business Innovation Research (SBIR) program and the Cancer Prevention and Research Institute of Texas (CPRIT).
Nature Medicine publication (January 2026): Researchers at Baylor College of Medicine reported encouraging results evaluating multi-antigen targeted T cells in pancreatic cancer, demonstrating a favorable safety profile and up to 84.6% disease control rate when combined with frontline chemotherapy (Press Release, Jan 5, 2026).
Marker expects to initiate its company-sponsored pancreatic cancer program in the second quarter of 2026, incorporating learnings from prior studies.
MT-401 Off-the-Shelf Program (AML/MDS)

Marker is evaluating MT-401, a MAR-T cell therapy targeting four antigens, as an Off-the-Shelf (OTS) product in the Phase 1 RAPID study in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
The study is supported by non-dilutive grant funds from National Cancer Institute (NCI), the Food and Drug Administration (FDA) and the Cancer Prevention and Research Institute of Texas (CPRIT).
ADDITIONAL 2025 CORPORATE HIGHLIGHTS

Manufacturing collaboration with Cellipont Bioservices to advance cGMP production of MT-601. Technical transfer expected to be completed in Q2 2026.
Kathryn Penkus Corzo, R.Ph., MBA joined the Board of Directors (November 1, 2025).
FISCAL YEAR 2025 FINANCIAL HIGHLIGHTS
Cash Position and Guidance: At December 31, 2025, Marker had cash, cash equivalents and restricted cash of $17 million. The Company believes that its existing cash and cash equivalents will fund its operating expenses through the fourth quarter of 2026, assuming no additional grant funds are received, either from new grants or from existing awarded grants.

R&D Expenses: Research and development expenses were $11.8 million for the year ended December 31, 2025, compared to $13.5 million for the year ended December 31, 2024.

G&A Expenses: General and administrative expenses were $4.2 million for the year ended December 31, 2025, compared to $4.2 million for the year ended December 31, 2024.

Net Loss: Marker reported a net loss of $12.2 million for the year ended December 31, 2025, compared to a net loss of $10.7 million for the year ended December 31, 2024.

About MAR-T cells
The multi-antigen recognizing (MAR) T cell platform (formerly known as multiTAA-specific T cells) is a novel, non-genetically modified cell therapy approach that selectively expands tumor-specific T cells from a patient’s/donor’s blood capable of recognizing a broad range of tumor antigens. Unlike other T cell therapies, MAR-T cells allow the recognition of hundreds of different epitopes within up to six tumor-specific antigens, thereby reducing the possibility of tumor escape. Since MAR-T cells are not genetically engineered, Marker believes that its product candidates will be easier and less expensive to manufacture, with an improved safety profile compared to current engineered T cell approaches and may provide patients with meaningful clinical benefits.

(Press release, Marker Therapeutics, MAR 18, 2026, View Source [SID1234663726])