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.

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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.

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"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.

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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.

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"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])

Excalipoint Therapeutics Launches with $68.7 Million to Develop Next-Generation T-Cell Engager Therapies

On March 18, 2026 Excalipoint Therapeutics, a biotechnology company developing next-generation T-cell engager (TCE) therapies for cancer and autoimmune diseases, reported an oversubscribed $68.7 million seed financing round to support advancement of its proprietary technology platforms and pipeline of differentiated T-cell engager programs.

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The financing includes $41 million in seed funding completed at the company’s inception in August 2025, co-led by HSG, Apricot Capital, and Yuanbio Venture Capital, with participation from 5Y Capital, Co-Win Ventures, Med-Fine Capital and Hony Capital. The seed round represents one of the largest early-stage financings for a Chinese biotechnology company.

After ramping up to full operational status and achieving significant clinical progress in just six months, the company secured a $27.7 million extension round co-led by MPCi (formerly Matrix Partners China) and Centurium Capital. The round also included significant participation from global investors LAV (Lilly Asia Ventures) and Eisai Innovation Inc, the venture arm of Eisai Co., Ltd. Existing investors Apricot Capital and 5Y Capital also participated in the extension round.

Excalipoint was co-founded by Lei Fang, Ph.D., Co-Founder, Chairman and Chief Executive Officer, and Jielun Zhu, MBA, CFA, Co-Founder, Chief Financial Officer and Chief Business Officer. Dr. Fang previously held leadership roles at Lepu Biopharma and I-Mab Biopharma, while Mr. Zhu brings over 20 years of healthcare and capital markets experience, including leadership roles at I-Mab Biopharma, Fapon Group, and Jefferies.

The new funding will support advancement of Excalipoint’s proprietary platforms – TOPAbody, T-Cell Immune Shield, and TCE Probody – as well as a pipeline of six differentiated programs with first- or best-in-class potential. These programs are designed to improve the efficacy, safety, and durability of T-cell immunotherapies for solid tumors and other difficult-to-treat cancers.

Excalipoint’s next-generation platforms are designed to overcome key biological barriers that have historically limited T-cell engager therapies, including converting "cold" tumors into "hot" tumors, addressing the tumor microenvironment, and enabling targeting of difficult-to-drug tumor antigens. Supported by these proprietary platforms, the company is building a diversified pipeline to reduce single-asset risk and drive value through strategic partnerships and out-licensing.

Excalipoint’s pipeline includes the following programs:

EXP011 (CTM012) – A tri-specific antibody targeting DLL3, CD3, and 4-1BB, being developed for small cell lung cancer, neuroendocrine tumors, and other DLL3-expressing malignancies. The company initiated a Phase I/II clinical trial with the first patient dosed in October 2025.
EXP012 (CTM013) – A tri-specific antibody targeting CDH17, CD3, and 4-1BB, being developed to treat colorectal, gastric, and pancreatic cancers.
EXP016 – A tri-specific antibody leveraging the TOPAbody platform designed to target solid tumors with high unmet medical need.
EXP017 – A multi-specific antibody developed using the Immune Shield platform aimed at addressing key limitations of the tumor microenvironment.
EP101 – A molecule enhanced with the Pro-TCE platform technology designed to enable targeting of challenging tumor-associated antigens.
EXP015 – A tri-specific antibody derived from the TOPAbody platform targeting IgG-associated diseases in immunology.
"Excalipoint is developing a proprietary pipeline and three powerful technology platforms to position our company as a true innovation powerhouse and developer of T-cell engagers," said Lei Fang, Ph.D., Co-Founder, Chairman and Chief Executive Officer, Excalipoint Therapeutics. "By combining science and capital with China’s clinical development efficiency and access to large patient populations, we can rapidly generate clinical data while advancing a pipeline of differentiated therapies. Our progress reflects the strength and maturity of China’s biotech ecosystem, which has become an essential part of the global innovation value chain. The strong support from top-tier investors validates both our science and this new approach to building a globally competitive biotechnology company."

"Our successful launch and backing from top-tier investors highlight Excalipoint’s strong growth potential. In just six months, we added two technology platforms and expanded our pipeline to six differentiated programs," said Jielun Zhu, MBA, CFA, Co-Founder, Chief Financial Officer and Chief Business Officer of Excalipoint Therapeutics. "Built on a NewCo model, we are combining disciplined capital deployment, focused execution, and cross-border partnerships to efficiently translate our science into clinical progress and long-term value."

Founded under a pioneering China NewCo model that integrates experienced founders, pipeline assets, and venture capital to accelerate drug development, Excalipoint has rapidly evolved into a multi-platform clinical-stage biotechnology company focused on next-generation T-cell engager therapeutics.

"MPCi is deeply engaged in healthcare, focusing on science-driven innovative enterprises with core technological barriers. Excalipoint is our highly recognized next-generation TCE innovation powerhouse," said David Su, Founding Managing Partner, MPCi. "With three independent and cutting-edge technology platforms, it has the potential to break down traditional TCE treatment bottlenecks. It boasts 6 highly differentiated pipelines and the rapid clinical progress of EXP011, the lead asset, reflects the team’s exceptional competence and flawless execution. As its long-term partner, MPCi will empower Excalipoint to unlock the enormous value of T-cell immunotherapy and become a global innovation benchmark."

"Centurium Capital’s investment thesis focuses on identifying companies capable of driving transformative innovation, and we believe Excalipoint is among the most promising next-generation TCE companies globally," said Vicky Li, Executive Director at Centurium Capital. "Led by Dr. Lei Fang and Mr. Jielun Zhu, the company combines strong scientific leadership, a differentiated pipeline, and an impressive track record of execution. We are proud to co-lead this financing and support Excalipoint’s continued growth."

(Press release, Excalipoint Therapeutics, MAR 18, 2026, View Source [SID1234663724])