On March 18, 2026 Biotheryx, Inc., a biopharmaceutical company focused on the discovery and development of first-in-class protein degraders for cancer and inflammatory diseases, reported that the first patient has been dosed in the dose expansion phase of its clinical trial evaluating BTX-9341, a potent and selective CDK4/6 degrader, in combination with fulvestrant for the treatment of HR+/HER2- breast cancer in patients who have previously received CDK4/6 inhibitor therapy in the advanced and/or metastatic setting.

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The dose expansion portion of the trial is a randomized study designed to evaluate the efficacy and safety of BTX-9341 in combination with fulvestrant. The trial is being conducted at multiple sites in the United States and is expected to enroll approximately 80 patients across two treatment arms based on the recommended dose identified in the earlier dose escalation phase. This dose expansion study builds on the recently completed dose escalation phase that evaluated the safety, tolerability, pharmacokinetics and pharmacodynamic activity of BTX-9341. The primary endpoint of this study is the Overall Response Rate (ORR), with key secondary endpoints including the measurement of investigator-assessed Clinical Benefit Rate (CBR) and Progression Free Survival (PFS).

"We are pleased to have dosed the first patient in the dose expansion portion of our clinical trial evaluating BTX-9341 in combination with fulvestrant." said Dr. Leah Fung, Chief Executive Officer of Biotheryx. "The encouraging safety, pharmacokinetics, and preliminary activity observed in the earlier dose escalation portion of the study support advancing BTX-9341 into this next stage of clinical evaluation. We believe the differentiated mechanism of targeted CDK4/6 degradation has the potential to address resistance seen with currently available CDK4/6 inhibitors, and we look forward to further assessing BTX-9341 in combination with fulvestrant to improve outcomes for patients with HR+/HER2- breast cancer who have previously received CDK4/6 inhibitor therapy."

About BTX-9341

BTX-9341 is a first-in-class, oral degrader of CDK4/6, important targets for a range of cancers and clinically validated in HR+/HER2- breast cancer. In preclinical breast cancer models, BTX-9341 demonstrated superiority to CDK4/6 inhibitors through potent and highly selective catalytic degradation of CDK4 and CDK6, robust inhibition of CDK2 and Cyclin E transcription, cell cycle arrest, and ultimately superior in vivo efficacy in breast cancer xenografts. Beyond this increased efficacy potential, BTX-9341 is differentiated from CDK4/6 inhibitor approaches through the ability to overcome key resistance mechanisms that limit the impact of inhibitors in second line HR+/HER2- metastatic breast cancer.

(Press release, BioTheryX, MAR 18, 2026, View Source;breast-cancer-302716705.html [SID1234663712])

On March 18, 2026 Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, reported that they will present three posters from their ongoing Phase 2 clinical trial with spevatamig (PT886), a first-in-class bispecific antibody targeting CLDN18.2 and CD47, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) held on April 17-22 in San Diego, CA. All three posters will be presented under the Phase II and Phase III Clinical Trials Session. Details of each presentation are below:

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Title: Pharmacokinetics of spevatamig (PT886), a bispecific antibody targeting CLDN18.2 and CD47, in patients with advanced gastrointestinal cancers as monotherapy or combination therapy

Date/Time: 4/20/2026 | 2:00-5:00 PM PST
Location: Poster Section 52
Poster Board Number: 8
Abstract Presentation Number: CT144
First Author: Anwaar Saeed, MD, University of Pittsburgh Medical Center

Title: Reducing nausea and vomiting while maintaining the full potential for efficacy with spevatamig, a CLDN18.2xCD47 bispecific antibody

Date/Time: 4/20/2026 | 2:00-5:00 PM PST
Location: Poster Section 52
Poster Board Number: 6
Abstract Presentation Number: CT142
First Author: Michael Overman, MD, University of Texas MD Anderson Cancer Center

Title: Resolved hematological toxicities associated with anti-CD47 agents using a bispecific design involving an optimized anti-CD47 arm: A clinical proof of concept study

Date/Time: 4/20/2026 | 2:00-5:00 PM PST
Location: Poster Section 52
Poster Board Number: 7
Abstract Presentation Number: CT143
First Author: Harshabad Singh, MD, Mass General Brigham

ABOUT SPEVATAMIG
Spevatamig is a first-in-class native IgG-like bispecific antibody (bsAb) targeting claudin 18.2 and CD47. It was granted orphan drug designation (ODD) for the treatment of pancreatic cancer by the FDA in 2022 and was granted Fast Track designation for the treatment of patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma in 2024. In 2023, Phanes entered into a clinical collaboration agreement with Merck (known as MSD outside the US and Canada) to study spevatamig in combination with Merck’s anti-PD-1 therapy, pembrolizumab.

The US multi-center Phase 1/2 clinical trial of spevatamig (NCT05482893) is evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of spevatamig in patients with advanced gastric, gastroesophageal junction, pancreatic ductal or biliary tract adenocarcinomas. The Phase 2 study of spevatamig has begun in China (CTR20241655).

(Press release, Phanes Therapeutics, MAR 18, 2026, View Source [SID1234663711])

On March 18, 2026 Illumina, Inc. (NASDAQ: ILMN) and Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, reported an expanded collaboration to advance precision oncology through innovative applications of next-generation sequencing (NGS) solutions across the healthcare ecosystem. Projects are expected to include promoting equitable access to cancer biomarker testing by bringing it closer to patients through new distributed test offerings; generating evidence to facilitate payer coverage; and developing new tests to address areas of unmet need.

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"By deepening our collaboration, we’ll continue to leverage the strengths of our respective teams to innovate and improve access to critical biomarker testing for patients with cancer," said Traci Pawlowski, vice president of Clinical Product Development at Illumina. "Our longstanding collaboration is rooted in a shared vision to advance precision oncology through groundbreaking research and leading-edge technologies."

New test development is expected to span advanced oncology research and in vitro diagnostic (IVD) tests for comprehensive genomic profiling (CGP) and whole-genome sequencing (WGS). These solutions will aim to address areas of unmet needs in precision oncology and help bridge existing testing gaps.

As part of the collaboration, the companies will explore co-commercializing Labcorp’s FDA-authorized liquid biopsy assay PGDx elio plasma focus Dx alongside Illumina’s FDA-approved TruSight Oncology Comprehensive for solid tumor profiling. Together, these distributed IVD test kits are intended to expand access to both tissue and liquid biopsy testing for hospitals and community health systems—bringing advanced biomarker testing closer to patients and helping to provide more specific diagnoses and identify eligibility for targeted treatments and clinical trials. This distributed offering also aims to provide pharmaceutical companies with differentiated opportunities for companion diagnostic (CDx) development, supporting both tissue and liquid biopsy needs for targeted therapy approvals.

"This collaboration reflects Labcorp and Illumina’s shared commitment to improving cancer care through innovation and access," said Shakti Ramkissoon, MD, PhD, MBA, vice president and medical lead for oncology at Labcorp. "Building on our longstanding medical and scientific collaborations and our ongoing efforts to generate clinical evidence and expand access to advanced genomics, we are combining our expertise to deliver transformative testing solutions that support more timely, equitable cancer care."

Illumina and Labcorp will also continue joint efforts to demonstrate the clinical utility of CGP and promote its adoption. In a collaborative study published in Frontiers of Oncology, researchers evaluated more than 7,600 non-small cell lung cancer (NSCLC) tumor samples. The study applied Illumina CGP to demonstrate its coverage and utility in detecting known and novel genomic features of NSCLC. Results showed that CGP detected variants with a current targeted therapy or clinical trial in more than 72% of patient tumors.

This is one of eight joint publications in oncology between Illumina and Labcorp since 2022, along with 18 posters and presentations made at industry conferences.

"Expanding access to advanced genomic testing is essential to delivering personalized cancer care," said Pawlowski. "Together with Labcorp, we are accelerating innovation to bring critical insights closer to patients and enable better outcomes across diverse care settings."

(Press release, Illumina, MAR 18, 2026, View Source [SID1234663710])

On March 18, 2026 Diakonos Oncology Corp., a clinical-stage biotechnology company developing a new generation of immunotherapies to treat challenging and aggressive cancers, reported that the Company will present new clinical trial data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, to be held April 17-22 in San Diego, California, and at the American Academy of Neurology (AAN) Annual Meeting, to be held April 18-22 in Chicago, Illinois. Both conferences will feature clinical data on DOC1021 (dubodencel), a first-in-class, patient-derived double-loaded dendritic cell investigational therapy, with AACR (Free AACR Whitepaper) focusing on pancreatic ductal adenocarcinoma and AAN on glioblastoma.

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"Presenting data at both of these conferences underscores the breadth and potential impact of DOC1021 across some of the most challenging cancers," said Jay Hartenbach, President and COO of Diakonos Oncology. "The AACR (Free AACR Whitepaper) presentation provides updated data from our ongoing pancreatic cancer study, and the AAN presentation will mark the first report of results from our expanded access program in glioblastoma. These clinical data continue to validate DOC1021’s novel mechanism, which leverages a patient’s full complement of tumor antigens to drive robust immune responses against malignancy. We look forward to sharing these new results and advancing this first‑in‑class therapy to improve outcomes for patients with pancreatic cancer and glioblastoma, both of which are marked by poor prognosis and significant unmet need."

Details on the AACR (Free AACR Whitepaper) poster presentation are outlined below:

Title: Clinical and Immunologic Assessment of DOC1021 Dendritic Cell Therapy in Resectable or Borderline Resectable Pancreatic Cancer
Authors: Konduri, V., Trivedi, A., Liu, W., Namekar, M., Ernste, K., Wilson, G. G., Duus, E. M., Armaghany, T., Makawita, S. U., Camp, E. R., Van Buren, G., Aguilar, L. K., Musher, B. L., and Decker, W. K.
Abstract Number/Poster Number: abstract #CT093 / poster #24 in Poster Section 51
Session Name: Phase I Clinical Trials in Progress
Presentation Date/Time: Monday, April 20, from 9:00 AM–12:00 PM PT.

Details on the AAN poster presentation are outlined below:

Title: DOC1021 Cell-based Immunotherapy in Combination with Standard Chemoradiation for Adjuvant Therapy of Glioblastoma: Early Results from an Expanded Access Protocol of a Phase I Trial
Authors: Zhu, J‑J., Esquenazi‑Levy, Y., Hsu, S., Vu, M., Zvavanjanja, R. C., Trivedi, A., Liu, W., Namekar, M., Ernste, K., Tandon, N., Schumann, E. H., Duus, E. M., Aguilar, L. K., Georges, J. F., Konduri, V., and Decker, W. K.
Abstract Number/Poster Number: abstract #3099 / poster #010 in Neighborhood 6
Session Name: P11: Neuro-oncology: Neurosurgery and Immunotherapy Trials
Presentation Date/Time: Wednesday, April 22, from 11:45 AM–12:45 PM CT.

About DOC1021
DOC1021 is a first-in-class, patient-derived double-loaded dendritic cell therapy that combines tumor lysate and amplified tumor-derived mRNA. The immunotherapy is made with a patient’s dendritic cells combined with mRNA and proteins prepared from freshly obtained patient tumor specimens.

The unique double-loading approach, a physiologic mimic of viral infection, unlocks a synergistic and exponentially more powerful tumor killing response that permits complete targeting of the total cancer antigen pool. Moreover, the approach does not require any molecular modification or genetic engineering of the patient’s immune cells and does not require preconditioning chemotherapy or high dose IL-2 for administration. DOC1021 is designed for outpatient administration and broad access via community cancer centers.

Diakonos currently has two actively enrolling clinical trials with DOC1021, a Phase 1 pancreatic cancer study (NCT04157127) and a Phase 2 glioblastoma (GBM) study (NCT06805305). Diakonos received Fast Track designation from the FDA for both the GBM and pancreatic cancer programs in October 2023 and May 2024, respectively. The company also received Orphan Drug Designation for the GBM program in January 2024. A refractory melanoma Phase 1/2 study with DOC1021 (NCT07288112) will be initiated early this year with the facilitation and support of the Cancer Prevention and Research Institute of Texas (CPRIT).

(Press release, Diakonos Oncology, MAR 18, 2026, View Source [SID1234663709])

On March 18, 2026 Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) ("Tonix" or the "Company"), a fully integrated, commercial biotechnology company, reported that Seth Lederman, MD, Chief Executive Officer, will deliver a company presentation at BIO-Europe Spring 2026, being held March 23-25, 2026, in Lisbon, Portugal.

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Company Presentation Details

Date and Time: Tuesday, March 24, 2026, 1:30-1:45 p.m. WET
Location: Presentation Theatre A
Presenter: Seth Lederman, MD, Chief Executive Officer

(Press release, TONIX Pharmaceuticals, MAR 18, 2026, View Source [SID1234663705])