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CancerVax Reports Successful Initial Mouse Study with Breakthrough Results

On March 31, 2026 CancerVax, Inc., the developer of a breakthrough universal cancer treatment platform that uses the body’s immune system to treat cancer, reported that the initial biodistribution study of its targeted lipid nanoparticle ("LNP") in mice was successful.

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Most conventional LNPs get trapped in the liver and cause liver toxicity. This is a major reason why many LNP therapies fail in clinical trials. In this study, a large proportion of CancerVax LNPs did not appear to accumulate in the liver compared to the base conventional LNP formulation. This may indicate systemic circulation and distribution to organs and tissues where cancer might occur.

The CancerVax platform is designed to harness the body’s existing immunity to detect, mark, and kill cancer cells with precision. At the core of the platform are customizable nanoparticles that use a novel two-step precision cancer targeting mechanism.

Detection: The nanoparticles first bind to surface proteins highly associated with the target cancer cells ("Marker1").
Activation: Once inside the cancer cell, the nanoparticles release proprietary "Smart mRNA" payloads that are only activated in the presence of cancer-specific genetic signatures ("Marker2"). These Smart mRNAs instruct the cancer cells to produce proteins associated with well-immunized diseases like measles. This effectively "tricks" the immune system into killing cancer cells as if they were common diseases.
Marker1 delivers the nanoparticles to cells expressing the corresponding surface protein and Marker2 selects only cancerous cells from that group to activate the mRNA therapeutic payload. Using different combinations of Marker1 and Marker2 will target different cancers to disguise them as known diseases and trick the body into attacking them with strength.

Recently, the Company completed its animal-grade Marker1-LNP and was able to proceed with its much-anticipated mouse studies. The Marker1-LNP was designed to specifically target the previously announced indications of pancreatic cancer and liver cancer.

The first mouse study was a biodistribution study where Marker1-LNPs were injected and tracked across numerous tissues. The results exceeded the Company’s expectations.

Some breakthrough results included the following and demonstrated the power and versatility of the CancerVax platform:

Systemic Circulation of the LNPs: This will allow the CancerVax therapy to reach many tissues and organs and avoid the common problem of LNP liver accumulation that causes liver damage and liver failure.

Distribution Noted in Many Organs: Spleen, Lung, Liver, Kidney, Intestines, Pancreas, Bladder, Heart, Stomach, Ovaries/Testes. This encouraging datapoint will allow the Company to expand its research program to include many more cancer indications for its universal cancer treatment platform.

Dosage Response: A clear dose response was observed in this study of 24 mice, with signal intensity increasing alongside administered dose levels. Importantly, all animals remained healthy and active during the study, suggesting strong tolerability of the Marker1-LNP formulation.

Dr. Adam Grant, Principal Scientist, commented, "We leveraged artificial intelligence to identify an optimal Marker1 for targeting pancreatic and liver cancers. The observed systemic distribution of our Marker1-LNP beyond the target tissues represents an important validation of our platform. While early, these results have exceeded our expectations and support advancement of our dual-marker strategy, where Marker1 and Marker2 are designed to enhance targeting precision and reduce off-target exposure to healthy tissues."

"This initial success also expands the potential of our platform across multiple indications. By reducing liver accumulation, our targeted LNP approach may enable flexible substitution of Marker1 while maintaining consistent delivery characteristics. I believe one of our current Marker1+Marker2 LNP constructs may already be primed to target colorectal cancers, highlighting the universality of the CancerVax platform."

"This is a very exciting time for CancerVax," said Dr. George Katibah, Chief Scientific Officer. "We have worked diligently to reach this milestone, and we now have high-quality reagents to support the extensive in vivo studies ahead."

Dr. Katibah continued, "This study demonstrated several important advances. First, conjugation of our Marker1 to the LNP preserved the integrity of the core formulation while improving performance. Second, we observed a significant reduction in liver accumulation—a major limitation of conventional LNP therapies. Third, these results further validate our targeted LNP platform as a foundation for precision cancer therapeutics. As we advance through the in vivo phase of our development program, we will conduct additional animal studies to systematically evaluate the safety and efficacy of our novel therapy. These data will be used to support and strengthen our planned Investigational New Drug (IND) application to the FDA for human clinical trials."

Byron Elton, CEO of CancerVax added, "We would not be here without the work of our amazing science team and the help of our world-class scientific advisors. Over the past year, we have made tremendous progress developing a revolutionary way to treat cancer. The cancer immunotherapy space is very hot right now. In 2025, AbbVie acquired Capstan Therapeutics, a targeted LNP CAR-T therapy company, for $2.1 billion in Phase 1 clinical stage. In 2026, Eli Lilly acquired Orna Therapeutics, a circular RNA and targeted LNP company, for $2.4 billion in preclinical stage. CancerVax is in the targeted LNP, mRNA, cancer immunotherapy and cancer vaccine space. We hope to share our exciting progress with interested strategic partners soon."

(Press release, CancerVax, MAR 31, 2026, View Source [SID1234664108])

Tvardi Therapeutics Announces Fourth Quarter and Full-Year 2025 Results and Provides Business Update

On March 31, 2026 Tvardi Therapeutics, Inc. ("Tvardi") (NASDAQ: TVRD), a clinical-stage biopharmaceutical company focused on the development of novel, oral, small molecule therapies targeting STAT3 to treat inflammatory and proliferative diseases, reported its ﬁnancial and operating results for the fourth quarter and full-year ended December 31, 2025, and provided a business update.

Recent Highlights:

Additional analysis from the REVERT IPF Phase 2 trial demonstrated that TTI-101 was associated with a 9.4% baseline-weighted reduction in fibrosis score compared to 2.4% for placebo, as well as a 4.5-fold greater decline in IL-6, a central STAT3-driven inflammatory cytokine. These findings are consistent with preclinical data demonstrating reductions in established fibrosis and inflammatory signaling across multiple validated disease models.
The healthy volunteer study of its next-generation STAT3 inhibitor, TTI-109, is ongoing, with topline data anticipated in the second quarter of 2026.
The ongoing Phase 1b/2 REVERT LIVER CANCER trial will report topline results in the second half of 2026 to allow the data additional time to mature. This timing adjustment is intended to enhance the depth of insights gleaned from the program, including longitudinal and translational assessments, characterization of durability and dose optimization (including the addition of up to 15 participants in the monotherapy arm to explore once-a-day dosing), to better inform subsequent development and regulatory strategy.
Imran Alibhai, Ph.D., Chief Executive Officer of Tvardi, stated, "We entered 2026 with line-of-site to two significant clinical milestones: 1) healthy volunteer data from our next-generation STAT3 inhibitor, TTI-109, in the second quarter of this year, and 2) topline data from our ongoing Phase 2 trial of TTI-101 in HCC, which we anticipate in the second half."

"Further analysis of data from our Phase 2 IPF trial of TTI-101 that we announced in October revealed compelling trends. These data give us optimism for TTI-109, which has been developed to enhance TTI-101’s ability to target STAT3 as a more efficient delivery vehicle with the potential to improve tolerability."

"At the same time, we eagerly await data from our ongoing Phase 2 REVERT LIVER CANCER trial, with a data readout expected in the second half of this year to allow for further data maturation. Interim results from this study have already shown clinically meaningful activity of TTI-101 both as monotherapy and in combination with established anti-cancer agents across treatment lines, and we believe the broader dataset will better position us to define the optimal development path and regulatory strategy for this important program."

"I believe we are well positioned to continue to advance these promising molecules, potentially offering new hope to patients requiring new, more effective treatment options while creating enduring value for our company," Dr. Alibhai concluded.

Upcoming Milestones:

Preliminary topline data from a healthy volunteer study of the company’s next-generation STAT3 inhibitor, TTI-109, anticipated in the second quarter of 2026
Preliminary topline data from the company’s ongoing REVERT LIVER CANCER Phase 1b/2 clinical trial of TTI-101, anticipated in the second half of 2026
Fourth Quarter and Full-Year 2025 Financial Results

Research and development expenses for the three months ended December 31, 2025, were $5.5 million as compared to $8.6 million for the comparable period in 2024. For the full year 2025, research and development expenses were $18.0 million, as compared to $23.7 million for the full year 2024. The decrease was primarily driven by declining clinical costs associated with TTI-101 offset by an increase in TTI-109 developmental costs.

General and administrative expenses were $2.1 million for the three months ended December 31, 2025, as compared to $2.2 million for the three months ended December 31, 2024. For the full year 2025, general and administrative expenses were $8.7 million, as compared to $4.5 million for the full year 2024. The increase was primarily driven by increases in professional fees, attributable to increased legal, accounting and audit fees incurred as a result of the merger with Cara Therapeutics and subsequent filings as a public company.

Net loss for the three months ended December 31, 2025, was $7.3 million, as compared to a net loss of $12.7 million for the comparable period in 2024. For the full year 2025, net loss was $18.2 million, as compared to a net loss of $29.4 million for the full year 2024.

Basic and diluted net loss per share attributable to common shareholders for the three months ended December 31, 2025, were a net loss of $(0.78) on a basic and diluted basis, compared to a net loss of $(4.94) on a basic and diluted basis for the comparable period in 2024. For the full year 2025, basic and diluted net loss attributable to common stockholders were $(2.46) and $(3.26), respectively, as compared to basic and diluted loss attributable to common stockholders of $(11.42) for the full year 2024.

Cash, cash equivalents and short-term investments as of December 31, 2025, were $30.8 million, as compared to $31.6 million as of December 31, 2024. Tvardi anticipates that its current cash runway is sufficient to fund operations, as currently planned, through clinical readouts and into the fourth quarter of 2026.

(Press release, Tvardi Therapeutics, MAR 31, 2026, View Source [SID1234664107])

Galapagos and Gilead Enter into Binding Agreement to Collaborate on Advancing First in Class T Cell Engager Program for Autoimmune Diseases

On March 31, 2026 Galapagos NV (Euronext & NASDAQ: GLPG) ("Galapagos" or the "Company") reported that it has entered into a binding agreement (the "Framework Agreement") with Gilead Sciences, Inc. ("Gilead") in connection with Gilead’s definitive agreement to acquire all of the outstanding equity interests of US-based Ouro Medicines, LLC ("Ouro"), a privately held biotechnology company focused on developing T cell engager therapies for autoimmune diseases.

Gamgertamig (OM336) is a clinical‑stage BCMAxCD3 T cell engager designed to enable rapid and deep plasma and B‑cell depletion following a short duration, subcutaneously administered treatment course. In ongoing Phase 1/2 clinical studies, gamgertamig has demonstrated transformative efficacy and a differentiated safety profile after a single treatment cycle in severe antibody-mediated orphan diseases, including autoimmune hemolytic anemia (AIHA) and immune thrombocytopenia (ITP). Gamgertamig has been granted both Fast Track and Orphan Drug Designation by the U.S. FDA for the treatment of AIHA and ITP and is expected to enter registrational studies as early as 2027.

BCMA‑targeted T cell engagers are being investigated as a precision approach for severe inflammatory and autoimmune diseases by eliminating pathogenic B cells and plasma cells. By redirecting a patient’s own T cells toward BCMA‑expressing plasma cells, clinical data suggest these agents can reduce inflammation, improve organ‑level disease, and in some cases enable durable, drug‑free remission without ongoing immunosuppression.

"Today marks an important milestone in the transformation of Galapagos as we are executing on our strategy," said Henry Gosebruch, Chief Executive Officer of Galapagos. "This collaboration brings a clinically meaningful, high‑potential asset into our portfolio, while preserving the majority of our cash for future opportunities. Additionally, the risk-adjusted potential financial return from this collaboration is attractive and leverages our partner’s capabilities. We are pleased to have a cash pool of $500 million that provides greater standalone flexibility, enabling additional strategic transactions and supporting a possible return of up to $150 million capital to shareholders."

Gosebruch continued, "We look forward to welcoming the talented and accomplished Ouro Medicines team to Galapagos and sharing several value enhancing catalysts this year for gamgertamig, as we further advance this potential first-in-class, best-in-class program for patients in indications with high unmet medical need."

"From the outset, we saw the potential for gamgertamig to redefine the standard of care for immune-mediated diseases," said Jaideep Dudani, PhD, Co-Founder and Chief Executive Officer of Ouro Medicines. "Since then, we’ve taken meaningful steps to advance that vision, with multiple trials now underway. With support from Gilead and Galapagos, we can build on the strong early foundation—leveraging its proven track record in late-stage development, launch, and commercialization to accelerate our programs and help deliver on the promise gamgertamig holds for patients with immune-mediated diseases, following our initial collaboration with Keymed Biosciences."

"We are excited about partnering with Galapagos to maintain the momentum that has been generated by the nimble and agile biotech approach to rapidly advance gamgertamig, while leveraging our global commercial capabilities," said Andrew Dickinson, Chief Financial Officer of Gilead.

Terms of the Framework Agreement with Gilead
On March 23, 2026, Gilead announced that it had entered into a definitive agreement to acquire all of the outstanding equity interests of Ouro for a total upfront cash consideration of $1.675 billion, subject to customary adjustments, and up to $500 million in contingent milestone payments (the "Acquisition"). In connection with the Acquisition, the Company has entered into the Framework Agreement with Gilead, which comprises the following components:

relief under the Option, License and Collaboration Agreement dated July 14, 2019 between the Company and Gilead (the "OLCA"), to enable the Company to deploy at least $500 million of its available cash independently from Gilead and outside the scope of the OLCA and the Ouro transaction, including up to $150 million for share buybacks (the "OLCA Waiver");
a binding term sheet granting the Company licenses to certain intellectual property rights relating to Ouro’s research programs, including Ouro’s lead program of gamgertamig for development purposes, and to the BCMAxCD19xCD3 T cell engager program and other preclinical programs for development and commercialization purposes (the "Licensing Term Sheet"); and
a binding term sheet pursuant to which the Company would acquire substantially all Ouro’s operational assets in connection with the Acquisition, including facilities and personnel, such that the Company would obtain an operating business (the "Asset Acquisition Term Sheet").

The Framework Agreement will only come into effect as from the completion of the Acquisition. The parties have agreed to enter into a collaboration agreement consistent with the terms of the binding term sheet.

Financial details of the Framework Agreement
Under the Framework Agreement, the Company’s share of the total consideration for the Acquisition amounts to 50% of the upfront consideration of $1.675 billion and 50% of any contingent milestone payments, which also includes the consideration under the Asset Acquisition Term Sheet.

Under the Licensing Term Sheet, the Company is required to fund its share of payments owed to KeyMed Biosciences Chengdu Co., Ltd ("KeyMed") under the head license agreement between KeyMed and Ouro (the "KeyMed Agreement"), comprising 25% of the milestone payments and 50% of the royalty payments that become due to KeyMed with respect to gamgertamig products. The Company will also bear all costs of development prior to registrational studies for gamgertamig pursuant to agreed-upon research plans and budgets, including Ouro’s current clinical trials, while costs of registration-enabling clinical development would be shared equally between the parties, with execution leadership divided by indication.

Galapagos is also eligible for up to $100 million milestones payments upon Gilead’s initiation of the first registrational trials for gamgertamig in certain other indications.

Gilead will be responsible for commercialization, including all related costs, globally outside of Keymed’s territories. Upon commercialization, Gilead will pay the Company tiered royalties between 20-23% on net sales of gamgertamig.

In addition, Galapagos will gain a preclinical portfolio of three additional autoimmune focused programs originally from Ouro, on which Gilead had the option to opt into a 50/50 profit split post clinical proof-of-concept for $75 million per program.

The OLCA Waiver allows the Company to spend $500 million of cash (and any additional cash generated from that amount) to acquire or develop research programs independently from Gilead and not subject to Gilead’s rights under the OLCA. In addition, the Company can elect to use up to $150 million of that $500 million for potential share repurchases, dividend payments and other distributions of Company’s capital stock, subject to certain limitations.

Related party procedure
Gilead, the counterparty to the Framework Agreement, is a related party to the Company within the meaning of IAS 24. As of December 31, 2025, Gilead Therapeutics A1 Unlimited Company, an indirect wholly-owned subsidiary of Gilead, owned 25.35% of the Company’s shares. Therefore, the Transaction has been subject to the procedure set out in Article 7:97 of the Belgian Code of Companies and Associations ("BCCA").

A committee of three independent members of Galapagos’ Board of Directors (the "Committee") has reviewed the terms and conditions of the Framework Agreement in accordance with the provisions of Article 7:97 of the BCCA and has issued a written, reasoned advice to the Board of Directors. In its advice, the Committee concluded that: "Having regard to the foregoing considerations, the Committee is of the view that the Transaction is not manifestly unlawful in nature and that it is unlikely that the Transaction would result in disadvantages to the Company that are not outweighed by benefits to the Company. The Committee therefore advises favorably on the Transaction." The Board of Directors has, in its decision-making, not deviated from the conclusion of the Committee.

The Company’s statutory auditor has carried out its assessment in accordance with Article 7:97, §4 of the BCCA, the conclusion of which reads as follows: "Based on our review, nothing has come to our attention that causes us to believe that the financial and accounting data reported in the advice of the Committee of independent directors dated on March 30, 2026 and in the minutes of the Board of Directors dated on March 30, 2026, which justify the proposed transaction, are not consistent, in all material respects, compared to the information we possess in the context of our mission. Our mission is solely executed for the purposes described in article 7:97 CCA and therefore our report may not be used for any other purpose."

Advisors
Morgan Stanley & Co., LLC is acting as financial advisor to Galapagos. Paul, Weiss, Rifkind, Wharton & Garrison LLP and Linklaters LLP are serving as legal counsel to Galapagos. The Committee has been assisted by MTS Health Partners, L.P. as independent financial expert to the Committee in connection with the Transaction.

Conference call and webcast presentation:
We will host a conference call and webcast presentation today, March 31, 2026, at 14:00 CET / 8:00 am ET. To participate in the conference call, please register in advance using this link. Dial-in numbers will be provided upon registration. The conference call can be accessed 10 minutes prior to the start of the call by using the conference access information provided in the email received after registration, or by selecting the "call me" feature. The live webcast is available on www.glpg.com or via the following link. The archived webcast will be available for replay shortly after the close of the call on the investor section of the website.

About gamgertamig
Gamgertamig (OM336) is an investigational BCMAxCD3 bispecific T-cell engager for the treatment of autoantibody driven autoimmune diseases. It has been granted both Orphan Drug Designation and Fast Track Designation by the U.S. Food and Drug Administration for the treatment of autoimmune hemolytic anemia and immune thrombocytopenia purpura. The program is currently under an open Investigational New Drug (IND) in the U.S. and is expected to enter registrational studies in 2027. Gamgertamig is in-licensed by Ouro Medicines from Keymed Biosciences, which owns the rights to develop the program in Greater China.

(Press release, Galapagos, MAR 31, 2026, View Source [SID1234664106])

Pheast Therapeutics Advances PHST001, an IgG4 Anti-CD24 Monoclonal Antibody, into Phase 1b Combination Cohorts

On March 31, 2026 Pheast Therapeutics, a clinical-stage biotechnology company advancing macrophage-directed immunotherapies for cancer, reported that the first patient has been dosed in the Phase 1b portion of its ongoing Phase 1 study of PHST001, an IgG4 anti-CD24 macrophage checkpoint inhibitor.

"The initiation of the Phase 1b combination cohorts marks an important step forward for PHST001 and reflects the progress of our Phase 1 program," said Roy Maute, Ph.D., Co-founder and Chief Executive Officer of Pheast Therapeutics. "The safety and biological signals we have seen to-date support advancing PHST001 into combination cohorts with established therapies. Together with the preliminary data we will be presenting at AACR (Free AACR Whitepaper), we are building a strong foundation as we work toward our goal of bringing new options to patients facing cancers with significant unmet need."

The Phase 1b portion of the study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of PHST001 in combination with established chemotherapy regimens using a suitable dose identified by the Phase 1a portion. To date, the observed safety profile supports continued monotherapy escalation and advancement into combination regimens. Preliminary clinical and translational findings from the Phase 1a portion of the study, along with supporting preclinical data, will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, taking place April 17–22 in San Diego (see company announcement dated March 17, 2026).

Initial expansion cohorts are actively enrolling patients with advanced ovarian cancer, endometrial cancer, and cholangiocarcinoma. Additional tumor types and combination strategies may be explored as the study progresses.

"Advancing into combination therapy allows us to explore how macrophage activation may enhance the activity of existing treatment approaches," said Raphaël Rousseau, M.D., Ph.D., Chief Medical Officer of Pheast Therapeutics. "With a dose established for combination evaluation, Phase 1b enables us to further define the potential role of PHST001 across multiple tumor settings."

PHST001 is designed to block CD24, a macrophage checkpoint that enables tumor cells to evade innate immune clearance through engagement of Siglec-10. By targeting this pathway, PHST001 is intended to promote macrophage-mediated phagocytosis of cancer cells and support anti-tumor immune responses.

About CD24

CD24 is a cell surface protein that plays a key role in tumor immune evasion by engaging Siglec-10, an inhibitory receptor on macrophages. This interaction suppresses macrophage-mediated clearance of cancer cells, allowing tumors to escape destruction by the innate immune system. CD24 was identified as a novel macrophage checkpoint through foundational work by Dr. Amira Barkal, principal founder of Pheast. Along with other co-founders, Drs. Irving Weissman, Ravi Majeti, and Roy Maute, Pheast’s research opened the door to therapeutic strategies targeting CD24 to drive innate immune responses against cancer.

About PHST001

PHST001 is an anti-CD24 macrophage checkpoint inhibitor designed to overcome immune suppression in the tumor microenvironment. CD24 is highly expressed by many human cancers, and high expression of CD24 is a negative prognostic factor in multiple cancer indications. Pheast has engineered PHST001 to be a potential best-in-class antibody designed to induce macrophages to phagocytose cancer cells and initiate a powerful immune response. PHST001-101 is an open-label, multicenter Phase 1 study in patients with advanced solid tumors (ClinicalTrials.gov Identifier: NCT06840886). Primary objectives include safety, tolerability, and dose optimization, with secondary objectives evaluating pharmacokinetics and preliminary anti-tumor activity. PHST001 received FDA Fast Track Designation for the treatment of ovarian cancer in June 2025.

(Press release, Pheast Therapeutics, MAR 31, 2026, View Source [SID1234664105])

Nuvectis Pharma Announces Upcoming Presentations for NXP900 at the 2026 American Association for Cancer Research Meeting

On March 31, 2026 Nuvectis Pharma, Inc. (NASDAQ: NVCT) ("Nuvectis" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, reported upcoming presentations for NXP900 at the upcoming 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Meeting (2026 AACR (Free AACR Whitepaper)), taking place from April 17th to April 22nd in San Diego, CA.

Abstract Title Poster Presentation Details
NXP900, a Phase 1b, first-in-class YES1/SRC inhibitor demonstrates potent synergy with KRAS inhibitors in KRASi sensitive and resistant NSCLC models Session Title
Combination Targeted Therapy

Session Date / Time
April 21st, 2:00 PM – 5:00 PM PT
Resistance to the SFK inhibitor NXP900 in cholangiocarcinoma is characterized by IL13RA2-AKT signaling and can be overcome by combination therapy Session Title
Novel Strategies to Reverse Drug Resistance

Session Date / Time
April 22nd, 9:00 AM – 12:00 PM PT
Targeting myeloid-derived suppressor cells (MDSCs) to restore antitumor immunity in non-small cell lung cancer (NSCLC) via SRC family kinase Inhibition with NXP900 Session Title
Tyrosine Kinase, Phosphatase, and Other Inhibitors

Session Date / Time
April 21st, 2:00 PM – 5:00 PM PT

(Press release, Nuvectis Pharma, MAR 31, 2026, View Source [SID1234664104])