On March 4, 2026 Creatv Bio, a Division of Creatv MicroTech, Inc. ("Creatv") reported the initiation of a collaboration with CytoDyn Inc. of Vancouver, Washington ("CytoDyn") to provide its’ LifeTracDx liquid biopsy test to support a Phase 2 study evaluating CytoDyn’s leronlimab in combination with TAS-102 and Bevacizumab in previously treated patients with relapsed/refractory metastatic Colorectal Cancer (mCRC).

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CytoDyn’s Phase 2 study in mCRC (NCT06699836), now underway, is enrolling 60 participants who will be tested with the LifeTracDx blood test at multiple-time points over the course of the trial. Collected under the study protocol as an exploratory biomarker, Creatv Bio’s LifeTracDx Blood Test will be used to evaluate numeric increases in PD-L1 expression across the patient population. The study’s primary endpoint is objective response rate (ORR), defined as the proportion of patients achieving a confirmed complete or partial response per RECIST v1.1, evaluating the efficacy of leronlimab in combination with trifluridine and tipiracil plus bevacizumab in patients with CCR5-positive, refractory, microsatellite-stable metastatic colorectal cancer (mCRC) over a 12-month treatment period.

LifeTracDx uses both circulating tumor cells (CTCs) and Cancer Associated Macrophage-Like (CAML) cells, which are macrophages that engulf tumor cells, as sensitive and accurate markers for real-time monitoring of tumor response to all forms of treatment and provides pharmacokinetic changes of both CCR5 and PD-L1 from the tumor microenvironment.

In prior studies, leronlimab induced PD-L1 expression on CTCs and CAMLS in 88% of metastatic breast cancer patients treated at doses above 525 mg/week, reinforcing the proposed ability of CCR5 blockade to convert "cold" tumors into "hot," PD-L1–positive tumors. In addition, changes observed in circulating atypical CAMLs further support leronlimab’s role in remodeling the tumor immune microenvironment and enhancing responsiveness to checkpoint blockade.

Creatv Bio has demonstrated that monitoring the expressions of PD-L1 using the LifeTracDx blood test at baseline, followed by sequential sampling after induction of therapy, may identify patients who have upregulated PD-L1 expression in their tumors.

(Press release, CytoDyn, MAR 4, 2026, View Source [SID1234663263])

On March 4, 2026 Keros Therapeutics presented its corporate presentation.

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(Presentation, Keros Therapeutics, MAR 4, 2026, View Source [SID1234663248])

On March 4, 2026 Adela, Inc., an innovator in blood testing for molecular residual disease (MRD) monitoring and early cancer detection through a proprietary genome-wide methylome enrichment technology, reported the publication of clinical validation results in npj Precision Oncology for use of its test to monitor response to immunotherapy in patients with advanced solid tumors.

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The study demonstrated that changes in methylated circulating tumor DNA (ctDNA) measured prior to treatment initiation and before cycle 3 of therapy were strongly associated with objective response and clinical benefit. These findings validated the test’s potential to support clinical decision-making regarding continuation or discontinuation of immunotherapy early in a course of treatment.

In patients with advanced cancer receiving immunotherapy, there is a critical unmet need for sensitive, rapid turnaround tools to monitor treatment response during early treatment cycles, as using conventional imaging alone can lead to delayed recognition of non-response and missed opportunities to alter treatment. Most emerging molecular options for response monitoring require tumor tissue, which is often not available in patients with advanced cancer. A tissue-free option offers broader accessibility.

The validation study analyzed banked samples from 64 patients with advanced head & neck, breast, ovarian, melanoma, or other solid tumors who received pembrolizumab at Princess Margaret Cancer Centre, University Health Network as part of the INSPIRE Study (NCT026344369). Blood samples were collected pre-treatment and prior to every three treatment cycles starting at cycle 3 of treatment.

Compared to those with an increase in methylated ctDNA, patients with a decrease in methylated ctDNA between pre-treatment and pre-cycle 3 were more likely to achieve:

Objective response (odds ratio [OR]=31.77, 95% CI: 3.71–4173.19, P=0.0003)
Clinical benefit (OR=15.55, 95% CI: 3.31–151.52, P=0.0002)
A decrease in methylated ctDNA was also associated with significantly better:

Progression-free survival (hazard ratio [HR]=0.27, 95% CI: 0.14–0.50, P<0.0001)
Overall survival (HR=0.49, 95% CI: 0.27–0.86, P=0.01).
"The study supports the use of the test for response monitoring and the early identification of patients who are not responding to immunotherapy and could benefit from a different treatment approach. The test may thus be a useful tool to support clinical decisions regarding therapy continuation or discontinuation to optimize patient outcomes, and perhaps avoid unnecessary toxicity," said Enrique Sanz-Garcia, MD, Medical Oncologist and Clinician Investigator at Princess Margaret Cancer Centre, University Health Network.

Adela’s test has also been clinically validated for surveilling for recurrence in head and neck cancer, with results published in the Annals of Oncology.

"We are pleased to announce the publication of the clinical validation of a second application of our genome-wide methylation-based platform," said Anne-Renee Hartman, MD, Chief Medical Officer at Adela. "Because our approach captures biologically relevant information across the entire methylome, it removes the need for disease-specific panels and supports broad use across solid tumors and diverse clinical settings."

Adela’s test is currently available for use in monitoring immunotherapy response by biopharmaceutical companies and other investigators, including for biomarker discovery and drug development. Adela plans to commercialize the test later this year for use in patients with solid tumors treated with immunotherapy to monitor response and help guide treatment decision-making.

(Press release, Adela, MAR 4, 2026, View Source [SID1234663264])

On March 4, 2026 MannKind Corporation (Nasdaq: MNKD), reported its attendance at two upcoming investor conferences, at which MannKind’s Chief Executive Officer, Michael Castagna, PharmD, and Chief Financial Officer, Chris Prentiss will participate in fireside chats and in 1×1 meetings with investors.

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Leerink Partners 2026 Global Healthcare Conference in Miami
Tuesday, March 10, 3:40 p.m. ET

Barclays 28th Annual Global Healthcare Conference in Miami
Wednesday, March 11, 1:00 p.m. ET

Links to the live audio webcast of the sessions will be available on MannKind Corporation’s website at: View Source Recorded versions will also be available on the website for approximately 90 days following the conference.

(Press release, Mannkind, MAR 4, 2026, View Source [SID1234663249])

On March 4, 2026 Theolytics, a clinical-stage biotechnology company developing next-generation oncolytic immunotherapies, reported that it has been awarded, pending final negotiation, €8 million in non-dilutive grant funding from Horizon Europe 2025, the European Union’s flagship research and innovation funding programme. Horizon Europe 2025 is supporting high-impact clinical-stage projects aimed at improving patient outcomes and strengthening Europe’s scientific leadership. The grant to Theolytics will provide significant financial support to advance the company’s Phase 2 OCTOPOD-IV clinical trial evaluating THEO-260, its novel therapeutic candidate designed to address unmet needs in patients with advanced ovarian cancer.

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Positioned to tackle the complex, immune-suppressed nature of advanced solid tumours, THEO-260 is an oncolytic immunotherapy designed for effective killing of both cancer cells and cancer-associated fibroblasts (CAFs), while inducing immune activation. Platinum-resistant ovarian cancer represents a prototype of a broader category of stroma-rich solid tumours for which THEO-260 is being developed.

Margaret Duffy, CSO and Co-founder of Theolytics, said, "Our collective success with this grant award reflects the extraordinary work being done by the team at Theolytics, and the calibre of our clinical and translational partner centres. The Horizon Europe award validates both the scientific rationale behind our THEO-260 programme and the huge potential of its novel oncolytic and ‘CAF-lytic’ mechanism to address a significant unmet need in stroma-rich solid cancers. By integrating advanced translational analyses into our clinical trial design, we will clinically demonstrate the differentiated mechanism of action of THEO-260 and provide key data to advance this programme and deliver true impact for cancer patients."

This highly competitive Horizon Europe 2025 award follows a rigorous grant review process and highlights the company’s innovative science, strong technical area expertise, clear clinical development plan and the opportunity for THEO-260 to address a clear unmet patient need.

The grant application was coordinated with several major partners, expert clinical and translational centres involved in the OCTOPOD-IV study and includes the Cancer Center Clínica Universidad de Navarra, Catalan Institute of Oncology in Spain; the Princess Margaret Hospital in Toronto, Canada; and The Institute of Cancer Research (ICR) in London, UK. Two thirds of the funds will be received directly by Theolytics to advance the OCTOPOD-IV Phase 2a expansion trial, and the other third will be deployed directly to the partners in support of their work on the trial.

OCTOPOD-IV (NCT06618235) is a first-in-human, multi-centre trial to assess safety, tolerability and preliminary efficacy of THEO-260 in patients with high-grade serous ovarian or endometrioid cancer. In addition, the trial is designed to determine the recommended Phase 2 dose and demonstrate THEO-260’s differentiated cancer/cancer-associated fibroblast-lytic mechanism of action in patients through comprehensive biomarker analysis.

Prof Alan Melcher, Professor of Translational Immunotherapy at The Institute of Cancer Research, London, said, "The differentiated mechanism of action – targeting the stroma and inducing immune activity in the suppressed tumour microenvironment (TME) – of this oncolytic immunotherapy THEO-260 offers the potential to provide an important new treatment option for patients with advanced solid tumours. We are pleased to support the OCTOPOD-IV study, for which the ICR will provide important translational data to assess this novel and promising approach."

Dr Antonio González, Director of the Department of Medical Oncology and Cancer Center at the Clínica Universidad de Navarra, and President of the Spanish Cooperative Group for Gynaecological Cancer Research, added, "We see many women with advanced platinum-resistant ovarian cancer, whose life expectancy is typically only a year or less. There remains a serious lack of effective treatment options for these women, and so we are hopeful that THEO-260 may bring an advance in therapy that will improve and extend the lives of our patients."

Recruitment at UK and Spanish clinical sites for OCTOPOD-IV is ongoing and will now expand into further international centres (including additional sites in Spain and Canada). A second clinical trial (OCTOPOD-IP) in the US, which will investigate intraperitoneal (IP) delivery of THEO-260 to advanced ovarian cancer patients, has also been initiated in collaboration with The University of Texas MD Anderson Cancer Center (NCT07211659).

(Press release, Theolytics, MAR 4, 2026, View Source [SID1234663250])