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])

On March 4, 2026 Senhwa Biosciences, Inc. (TPEx: 6492), a clinical stage company focusing on development of first-in-class therapeutics for oncology, rare diseases, and infectious diseases, reported the signing of a major strategic Memorandum of Understanding (MOU) with CellType, an AI-driven biotech company backed by Y Combinator (Winter 2026).

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Under this partnership, the two companies will integrate CellType’s proprietary AI platform to accelerate the clinical development and global commercialization strategy of Senhwa’s core asset, Silmitasertib (CX-4945).

Prior to formalizing the collaboration, the foundational research underlying CellType’s technology was conducted at Yale University in collaboration with Google DeepMind, where researchers computationally predicted and experimentally validated a novel immune-modulatory mechanism of CX-4945. This strategic alliance marks a transformative milestone for Senhwa: CX-4945 is evolving from a single-target small molecule into a platform-enabling asset—"CX-4945 2.0." Through AI-driven deep data validation, Senhwa aims to expand potential indications, significantly enhance clinical success probability, and strengthen the asset’s attractiveness for partnerships with international pharmaceutical companies for licensing discussion.

In parallel, CellType will feature CX-4945 as the flagship case study of its AI platform, showcasing real-world validation results to global investors—demonstrating how AI can fundamentally transform traditional drug development models, reduce R&D risk, and amplify therapeutic value.

Senhwa Chairman Benny T. Hu stated:

"By integrating CellType’s cutting-edge AI foundation models—capable of reasoning about biology at the cellular level, and rooted in pioneering research from Yale University and Google DeepMind—into Senhwa’s clinical-stage core asset, we are not simply accelerating development—we are redefining the strategic positioning of CX-4945. This collaboration represents Senhwa’s official entry into the next phase of AI-driven drug development. We highly recognize CellType’s scientific excellence and global vision, and we look forward to unlocking new therapeutic possibilities for cancer patients worldwide while delivering sustainable, long-term structural value growth for our shareholders."

AI-Driven Mechanistic Breakthrough

CellType was founded by computational biologist Dr. David van Dijk. The company is backed by Y Combinator (Winter 2026). Its proprietary AI platform applies large language models to single-cell gene expression—the first of its kind—enabling sophisticated decoding of complex tumor microenvironment (TME) signaling.

Through the original research collaboration with Google DeepMind at Yale University, researchers screened over 4,000 compounds and identified CX-4945 as a highly promising candidate. AI-predicted findings were subsequently validated in interdisciplinary laboratories at Yale University. Results indicate that beyond its known mechanism, CX-4945 demonstrates previously unrecognized immune-modulatory potential—including amplification of immune activation, enhancement of tumor antigen presentation, and conversion of "cold tumors" into "hot tumors." These properties may significantly improve immunotherapy efficacy and help overcome resistance challenges.

Six-Month Pilot Program and Strategic Framework

Under the MOU, the parties will initiate a six-month pilot program focused on:

Indication expansion strategies, Biomarker discovery and validation, Combination therapy synergy evaluation in the context of immuno-oncology and new targets for treating different types of cancers and Establishment of an AI-driven translational validation framework.

This collaboration not only position CX-4945 as a core immune-sensitizing molecule in immuno-oncology but also establishes Senhwa as CellType’s founding strategic partner. The agreement preserves flexibility for deeper collaboration structures in the future, including joint ventures, co-development, or licensing arrangements.

Market Opportunity and Strategic Outlook

The global cancer immunotherapy market is entering a high-growth phase, with industry forecasts projecting the market to reach approximately US$305.8 billion by 2033. Despite rapid expansion, overcoming immunotherapy resistance and optimizing the tumor microenvironment remain among the most critical and value-defining challenges in oncology.

This partnership extends beyond a technical pilot—it sends a clear signal to global capital markets: the valuation paradigm of CX-4945 is accelerating, and AI is emerging as a powerful multiplier of clinical success probability.

Looking ahead, Senhwa and CellType will continue to deepen their collaboration, advancing CX-4945 from an innovative therapeutic candidate to a core AI-enabled immunotherapy platform asset—jointly redefining the next key inflection point in cancer immunotherapy and creating enduring value for shareholders, partners, and patients worldwide.

(Press release, Senhwa Biosciences, MAR 4, 2026, View Source [SID1234663266])

On March 4, 2026 TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biotechnology company focused on the development of T cell receptor (TCR)-engineered T cell (TCR-T) therapies for the treatment of patients with cancer, reported financial results for the three months and full year ended December 31, 2025, and provided business updates.

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"The regulatory and operational progress we have made over the last several months related to our heme program is exciting. We expect the momentum to continue into the second quarter when we plan to share the initial data from patients enrolled into Cohort C in the ALLOHA study as well as initiate TScan’s first Phase 3 trial," said Gavin MacBeath, Ph.D., Chief Executive Officer. "The data we presented at ASH (Free ASH Whitepaper) in December 2025 continue to support our decision to focus the Company’s efforts on development of therapeutics for patients with heme malignancies. Additionally, the recent FDA clearance of INDs for TSC-102-A01 and TSC-102-A03 will allow us to bring our TCR-T therapies to twice as many patients who currently have limited options in the post-transplant setting."

Recent Corporate Updates: Hematologic Malignancies Program

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In December 2025, the Company presented positive updated data from the ALLOHA Phase 1 heme trial at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition.

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TSC-101 was well-tolerated with no dose-limiting toxicities observed.
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Treatment arm continues to demonstrate favorable relapse-free survival (HR=0.50; p=0.23) and overall survival (HR=0.61; p=0.52).
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3/3 (100%) of TSC-101-treated patients who reached two-year follow-up remained relapse-free compared to 1/4 (25%) in the control arm.

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In February 2026, the U.S. Food and Drug Administration (FDA) cleared the Company’s investigational new drug (IND) applications for TSC-102-A01 and TSC-102-A03. These TCR-T therapy candidates target CD45, a protein that is broadly expressed in heme cells but absent in non-heme tissues. TSC-102-A01 and TSC-102-A03 are allogeneic, donor-derived TCR-T therapy candidates designed to eliminate residual cancer and prevent relapse in patients with heme malignancies who are undergoing allogeneic hematopoietic cell transplantation (HCT) using either reduced intensity conditioning or myeloablative conditioning. TSC-102-A01 and TSC-102-A03 are designed to treat patients who are HLA-A*01:01- or HLA-A*03:01-positive, respectively, and are paired with donors who are negative for the HLA allele. The Company plans to initiate a Phase 1 study with these candidates in the second half of this year.

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In February 2026, TScan announced completion of enrollment in Cohort C of the Phase 1 ALLOHA trial, where patients are being dosed with TSC-101 manufactured using its commercial-ready manufacturing process.

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In February 2026, the Company presented a poster at the 2026 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR (Tandem Meetings). The poster can be found on the "Publications" page of the Company’s website at tscan.com.

Upcoming Anticipated Milestones: Heme Malignancies Program

TScan’s lead TCR-T therapy candidate, TSC-101, is designed to treat residual disease and prevent relapse in patients with heme malignancies undergoing allogeneic HCT (the ALLOHA trial, NCT05473910).

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Share early clinical data on patients treated in Cohort C of the ALLOHA study in the second quarter of 2026.
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Launch pivotal trial for TSC-101 in the second quarter of 2026.
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Share updated data on patients treated in Cohort C of the ALLOHA study in the second half of 2026.
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Initiate Phase 1 study of TSC-102-A01 and TSC-102-A03 in the second half of 2026.

Recent Corporate Updates: Early Pipeline

Solid Tumor Program:
·
In November 2025, the Company announced the discontinuation of the PLEXI-T trial. Clinical data on initial patients treated in the study have been disclosed in the Company’s 2025 Form 10-K filed with the Securities and Exchange Commission on March 4, 2026.
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The Company is currently developing methods to engineer TCR-T cells in vivo to treat solid tumors.

Autoimmunity Program:

The Company is leveraging their target discovery platform to identify targets for a set of T-cell-driven autoimmune disorders and is currently developing potential treatment options.
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The Company anticipates sharing preclinical proof-of-concept data for its therapeutic approach in the second half of 2026.

Financial Results

Revenue: Revenue for the fourth quarter of 2025 was $2.6 million, compared to $0.7 million for the fourth quarter of 2024, and $10.3 million for the full-year 2025, compared to $2.8 million for the full-year 2024. The increase in both periods was primarily due to timing of research activities pursuant to the Company’s collaboration agreement with Amgen.

R&D Expenses: Research and development (R&D) expenses for the fourth quarter of 2025 were $20.0 million, compared to $29.4 million for the fourth quarter of 2024, and $114.2 million for the full-year 2025, compared to $107.4 million for the full-year 2024. The year over year increase was primarily driven by increased manufacturing and clinical activities, with the quarter over quarter decrease primarily driven by timing of manufacturing activities, as well as savings in connection with the Company’s previously announced strategy to prioritize the clinical development of its heme program. R&D expenses included non-cash stock compensation expense of $0.9 million and $1.3 million for the fourth quarter of 2025 and 2024, respectively, and $6.0 million and $4.8 million for the full-year 2025 and 2024, respectively.

G&A Expenses: General and administrative (G&A) expenses for the fourth quarter of 2025 were $6.4 million, compared to $8.0 million for the fourth quarter of 2024, and $32.0 million for the full-year 2025, compared to $30.3 million for the full-year 2024. The year-over-year increase was primarily driven by personnel costs to support business activities, with the quarter-over-quarter decrease primarily driven by savings in connection with the Company’s previously announced strategy to prioritize the clinical development of its heme program. G&A expenses included non-cash stock compensation expense of $1.1 million and $1.4 million for the fourth quarter of 2025 and 2024, respectively, and $5.7 million and $4.7 million for the full-year 2025 and 2024, respectively.

Net Loss: Net loss was $23.0 million for the fourth quarter of 2025, compared to $35.8 million for the fourth quarter of 2024, and included net interest income of $0.9 million and $2.0 million, respectively. Net loss for the full-year 2025 was $129.8 million, compared to $127.5 million for the full-year 2024, and included net interest income of $6.0 million and $8.4 million, respectively. Net loss for the fourth quarter of 2024 and full-year 2024 included a $1.1 million loss on extinguishment of debt.

Cash Position: Cash and cash equivalents as of December 31, 2025 were $152.4 million, excluding $5.0 million of restricted cash. The Company believes that its existing cash resources will be sufficient to fund its current operating plan into the second half of 2027.

Share Count: As of December 31, 2025, the Company had 56,901,623 issued and outstanding shares of common stock, consisting of 52,625,035 shares of voting common stock and 4,276,588 shares of non-voting common stock, as well as 73,011,767 outstanding pre-funded warrants to purchase shares of voting common stock at an exercise price of $0.0001 per share. Pro forma outstanding shares, inclusive of both common stock and prefunded warrants, were 129,913,390 as of December 31, 2025.

(Press release, TScan Therapeutics, MAR 4, 2026, View Source [SID1234663251])