1stOncology™: Cancer Intelligence Service – Page 335 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Artiva Biotherapeutics Reports Full Year 2025 Financial Results and Recent Business Highlights

On March 10, 2026 Artiva Biotherapeutics, Inc. (Nasdaq: ARTV) (Artiva), a clinical-stage biotechnology company whose mission is to develop effective, safe and accessible cell therapies for patients with devastating autoimmune diseases and cancers, reported financial results for the full year ended December 31, 2025, and highlighted recent progress.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

"2025 was a year of strong execution as we advanced our AlloNK program, successfully enrolling patients in community settings across autoimmune indications and prioritizing refractory RA as our lead indication," said Fred Aslan, M.D., president and chief executive officer of Artiva Biotherapeutics. "AlloNK has the potential to redefine the treatment paradigm for refractory RA by combining the durable efficacy of deep B-cell depletion with an outpatient-ready profile suitable for community rheumatology practices."

Dr. Aslan continued, "In 2026, our focus is to advance AlloNK from an early clinical program in the deep B-cell depletion space to what could become the first therapy in this class to initiate a registrational trial in RA, the autoimmune disease with the largest refractory population. We look forward to sharing initial clinical response data and engaging with the FDA on a potential pivotal trial design in refractory RA in the first half of 2026."

Recent Business Highlights

Prioritized refractory RA as lead indication: Received FDA Fast Track designation for AlloNK in refractory RA and prioritized RA as the program’s lead autoimmune indication.
Despite multiple approved biologic and targeted synthetic disease-modifying anti-rheumatic drugs (b/tsDMARDs), there are more than 150,000 RA patients in the U.S. who have failed at least two prior therapies. Real-world data suggest ACR50 response rates at six months are typically in the 10 – 20% range, underscoring the significant unmet need and opportunity for AlloNK plus rituximab to drive deeper and more durable responses with a single treatment cycle.
Artiva has successfully enrolled refractory RA patients across dose levels and will provide initial clinical response data from at least 15 patients, most of whom are expected to have six or more months of follow-up, in the first half of 2026.
Demonstrated deep and consistent B-cell depletion supporting intended mechanism of action: Across patients analyzed, AlloNK plus rituximab resulted in non-quantifiable peripheral CD19+ B-cell levels by Day 13. These findings were confirmed using a high-sensitivity assay with 10- to 50-fold greater sensitivity than standard assays. Early reconstitution data demonstrated predominantly naïve and transitional B cells, consistent with immune reconstitution patterns observed with CD19-directed autologous CAR-T therapies.
Established favorable safety and outpatient feasibility profile in autoimmune disease, leading to strong enrollment: As of the Oct. 1, 2025 data cutoff, 32 patients were treated with AlloNK plus rituximab across refractory RA, Sjögren’s disease, systemic lupus erythematosus (SLE), lupus nephritis and systemic sclerosis, entirely in the outpatient setting, with the majority treated in community rheumatology clinics. The regimen was well tolerated, with no reported cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), graft-versus-host disease or hypogammaglobulinemia.
Reported continued durability in Phase 1/2 oncology trial: Presented longer-term data from the completed Phase 1/2 trial of AlloNK plus rituximab in relapsed/refractory B-cell non-Hodgkin lymphoma demonstrating a 64% complete response rate and a median duration of response not yet reached, exceeding 19.4 months at data cutoff, in line with commercially approved auto-CAR-T results in a comparable patient population.
Enhanced executive leadership to support late-stage development and capital strategy: Appointed Subhashis Banerjee, M.D. as chief medical officer and Thad Huston as chief financial officer, adding deep rheumatology development expertise, regulatory experience and global financial leadership as AlloNK advances toward potential registrational development.
Strengthened board leadership with deep immunology and commercial expertise: Appointed Dan Baker, M.D. and Elaine Sorg to the board of directors, adding extensive experience in autoimmune drug development, regulatory strategy and large-scale immunology commercialization, including leadership roles supporting major therapies for rheumatoid arthritis and other immune-mediated diseases in multibillion dollar franchises.

Upcoming Milestones

Initial clinical response data in refractory RA expected in the first half of 2026: Artiva expects to report initial clinical response data in at least 15 patients, most of whom are expected to have six or more months of follow-up.
Planned FDA interaction in the first half of 2026 to discuss potential pivotal trial design in refractory RA: Subject to feedback and alignment with the FDA, AlloNK has the potential to become the first deep B-cell depleting therapy to initiate a pivotal trial in patients with refractory RA.

Full Year 2025 Financial Results

Cash, Cash Equivalents and Investments. As of December 31, 2025, Artiva had cash, cash equivalents, and investments of $108.0 million, which is expected to fund operations into Q2 2027.
License and Development Support Revenue. License and development support revenue was zero for the year ended December 31, 2025, compared to $0.3 million for the year ended December 31, 2024.
Research and Development Expenses. Research and development expenses were $69.5 million for the year ended December 31, 2025, compared to $50.3 million for the year ended December 31, 2024.
General and Administrative Expenses. General and administrative expenses were $20.3 million for the year ended December 31, 2025, compared to $17.2 million for the year ended December 31, 2024.
Other Income, net. Other income, net, was $5.9 million for the year ended December 31, 2025, compared to other income, net, of $1.9 million for the year ended December 31, 2024.
Net Loss. Net loss totaled $83.9 million for the year ended December 31, 2025, as compared to net loss of $65.4 million for the year ended December 31, 2024, with non-cash stock-based compensation expense of $6.8 million and $7.0 million for the years ended December 31, 2025 and 2024, respectively.

(Press release, Artiva Biotherapeutics, MAR 10, 2026, View Source [SID1234663428])

C-Further Unveils First Therapeutic Programmes Dedicated to Paediatric Oncology

On March 10, 2026 C-Further, an international consortium committed to creating new therapeutics for childhood cancers, reported the first early-stage therapeutic programmes for its pipeline, dedicated to paediatric oncology indications. Through its collaborative model, C-Further has partnered with investigators at UVA Comprehensive Cancer Center, Dana-Farber Cancer Institute and Mass General Brigham to advance CF-012 for the potential treatment of Ewing sarcoma. In parallel, the consortium has partnered with investigators at MiNK Therapeutics (Nasdaq: INKT) to advance CF-033, leveraging MiNK’s proprietary platform with translational support by investigators at the University of Southampton, for the potential treatment of multiple children’s cancers, including bone sarcoma, medulloblastoma and acute myeloid leukaemia.

Enabled by C-Further’s core partners, Cancer Research Horizons, LifeArc and Great Ormond Street Hospital Charity (GOSH Charity), the consortium will support the progression of CF-012 and CF-033 up to preclinical candidate nomination, subject to completion of scientific milestones. Together, these projects form the foundation of C-Further’s expanding pipeline which is supported by an initial $40m (£30m) budget.

Lone Friis, PhD, C-Further Programme Co-lead said: "By combining the pioneering approaches of our scientific collaborators with industry-standard drug discovery capabilities, expertise of our core partners and reach into critical paediatric-focused networks, C-Further is advancing a pipeline of potential first-in-class therapies for childhood cancers. Guided by an indication-agnostic but child-first approach, we believe the initial CF-012 and CF-033 programmes have the potential to address a profound unmet need across multiple children’s cancers."

The selected research partners represent top academic and industry investigators from across the globe, underscoring the international reach and ambition of C-Further.

CF-012 targets ETV6, a newly identified and critical transcriptional dependency that is essential for tumour growth and metastasis. The aim is to develop a potential first-in-class inhibitor with a precise mechanism to disrupt tumour growth and metastasis in young patients.

John Bushweller, PhD, Professor at the University of Virginia School of Medicine and a member of UVA Comprehensive Cancer Center, investigator for CF-012, said: "We’re excited to partner with C-Further to progress CF-012. Children and young people have historically lacked effective, targeted cancer treatments and CF-012 has the potential to address an urgent unmet need in relapsed and metastatic Ewing sarcoma – a rare, aggressive bone tumour that most commonly occurs in young people. With C-Further’s collaborative, child-first drug discovery model, we believe we have the power to bring these medicines to market."

Other key investigators for the CF-012 therapeutic programme include Kimberly Stegmaier, MD, Chair of the Department of Pediatric Oncology at Dana-Farber Cancer Institute, and Miguel Rivera, MD, Assistant Molecular Pathologist at Massachusetts General Hospital.
CF-033 is a potential first-in-class allogeneic iNKT cell therapy engineered with a specific T-cell receptor targeting PRAME, which bridges innate and adaptive immunity and is designed to enable both direct tumour cell killing and broader immune activation within the tumour microenvironment. As an allogeneic, off-the-shelf approach without the need for toxic lymphodepletion, CF-033 has the potential to support more timely treatment delivery and improved tolerability, which are important considerations in paediatric oncology, where new therapeutic approaches are urgently needed.

Marco Purbhoo, PhD, Head of Translational Medicine at MiNK Therapeutics, investigator for CF-033, said: "CF-033 is a PRAME-targeted invariant NKT (iNKT) cell therapy developed to address the urgent needs of children with high-risk cancers, which are often marked by treatment resistance and a weakened immune response that cannot sustain tumour control. Unlike conventional CAR-T or TCR-T therapies, CF-033 harnesses the unique biology of iNKT cells — immune cells that can both directly kill cancer and help coordinate a broader, longer-lasting anti-tumour response. Importantly, this approach is designed to be delivered without the need for HLA matching or toxic lymphodepletion, which is particularly meaningful for this vulnerable paediatric population."

Ali Roghanian, PhD, Associate Professor at the University of Southampton, is the other key investigator leading the CF-033 therapeutic programme.
C‑Further welcomes expressions of interest from researchers, innovators and partners who share its mission to accelerate new tailored and well-tolerated treatments for children and young people with cancer. The deadline to be considered for the next round of submissions is 13 March 2026.

C-Further has also commenced preliminary research on a third, undisclosed project. Additional programmes are expected to be announced in 2026.

(Press release, C-Further, MAR 10, 2026, View Source [SID1234663427])

Jacobio Announces 2025 Annual Results

On March 10, 2026 Jacobio Pharma(HKEX: 1167) reported its annual results for the year ended Dec. 31, 2025, and provided updates on its key pipeline programs.

During 2025, the company achieved several key advancements in KRAS-targeted therapy and innovative ADC platforms, including the approval and inclusion of the KRAS G12C inhibitor glecirasib in China into the National Reimbursement Drug List, a collaboration agreement with AstraZeneca for the pan-KRAS inhibitor JAB-23E73 worth a total of US$2.015 billion (including an upfront payment of US$100 million), and the entry of EGFR-KRAS G12Di tADC and HER2-STINGa iADC into the IND preparation stage.

Dr. Yinxiang Wang, Chairman and Co-Chief Executive Officer of Jacobio, said:
"2025 marked the tenth anniversary of Jacobio and a milestone year of value for the Company. The approval of glecirasib and its reimbursement inclusion in China marked Jacobio’s entry into commercialization. At the same time, JAB-23E73 achieved steady progress over the past year, including completion of the Phase I dose escalation phase of daily dosing in China, generation of preliminary promising clinical data, and the IND approval of its first-line pancreatic cancer combination study. Looking ahead, we will continue to focus on KRAS-targeted therapies and innovative functional-payload ADC platforms, including tADC and iADC, with the goal of bringing more treatment options to patients worldwide."

Pipeline Highlights

Glecirasib (KRAS G12C inhibitor)

In 2025, glecirasib was approved in China for the treatment of patients with KRAS G12C-mutated non-small cell lung cancer who had received at least one prior systemic therapy, and was subsequently included in the National Reimbursement Drug List. From June to December 2025, Jacobio recognized revenue of RMB 8.55 million.

A registrational Phase III trial evaluating glecirasib in combination with the SHP2 inhibitor sitneprotafib for the first-line treatment of non-small cell lung cancer is ongoing in China. Results from the Phase I/II study of this combination were published in The Lancet Respiratory Medicine, demonstrating a 71% objective response rate and a median progression-free survival of 12.2 months in the first-line setting.

Over the past year, multiple clinical studies of glecirasib were published in leading international journals, including Nature Medicine, The Lancet Respiratory Medicine, The Lancet Gastroenterology & Hepatology, and Cancer Communication.

pan-KRAS inhibitor JAB-23E73

JAB-23E73 is an oral small-molecule pan-KRAS inhibitor currently undergoing clinical development in China and the United States.

As of Jan. 15, 2026, a total of 42 patients had been enrolled in the Phase I study in China. Grade 3 treatment-related adverse events were reported in 11.9% of patients, and no Grade 4 or Grade 5 treatment-related adverse events were observed. Among 13 pancreatic cancer patients treated within the predicted efficacious dose range — including two second-line and eleven third-line or later patients — the objective response rate (ORR), including both confirmed and unconfirmed responses, was 38.5%, and the disease control rate (DCR) was 84.6%.

In February 2026, China’s Center for Drug Evaluation approved a Phase I/III clinical trial evaluating JAB-23E73 in combination with nab-paclitaxel and gemcitabine as a first-line treatment for KRAS-mutant pancreatic ductal adenocarcinoma.

ADC Programs

Jacobio continues to advance its xADC platform built around functional payloads.

JAB-BX600 (EGFR-KRAS G12D tADC) combines an EGFR-targeting antibody with a KRAS G12D inhibitor payload, enabling targeted delivery and a dual-mechanism approach that may overcome feedback resistance associated with KRAS inhibitor monotherapy. An IND submission is expected in the second half of 2026.

JAB-BX467 (HER2-STING iADC) uses a HER2-targeting antibody linked to a STING agonist payload designed to recruit lymphocytes in the tumor microenvironment and potentially convert "cold" tumors into "hot" tumors. An IND submission is expected in the second half of 2026.

Financial Update

As of the end of 2025, the Company had approximately RMB1.53 billion in cash, cash equivalents and available bank credit facilities. This balance is expected to exceed RMB2.0 billion in the first quarter of 2026, and the Company anticipates achieving profitability in 2026.

(Press release, Jacobio Pharmaceuticals, MAR 10, 2026, View Source [SID1234663426])

Agenus Triggers First $20M Contingent Payment Under Zydus Life Sciences Collaboration to Support BOT+BAL Manufacturing Needs

On March 10, 2026 Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, reported that it has triggered the first $20 million contingent payment under its previously disclosed strategic collaboration with Zydus Lifesciences Ltd.

The payment was triggered by contracted work orders for critical chemistry, manufacturing and controls (CMC) and production activities related to botensilimab (BOT) and balstilimab (BAL). These activities will allow Zydus to perform the initiation of its commercial supply of Agenus’ lead programs. They also include additional manufacturing work to satisfy regulatory requirements for BLA and MAA readiness, to build upon existing inventory in anticipation of increasing demand across clinical development programs, authorized early access pathways, and to support potential global commercialization.

This milestone marks the first operational activities between Agenus and Zylidac Bio LLC, the U.S.-based biologics manufacturing subsidiary of Zydus Life Sciences.

"This milestone reflects our commitment to progressing BOT and BAL to regulatory approval readiness, and to support our ongoing clinical development and paid compassionate access program needs," said Garo H. Armen, Ph.D., Chairman and Chief Executive Officer of Agenus. "As reimbursed access continues in France under the AAC framework and named patient programs expand in permitted countries and enrollment advances in the global BATTMAN Phase 3 trial, it is essential that we proactively align manufacturing capacity with anticipated demand. Our partnership with Zydus enables us to scale thoughtfully while maintaining capital discipline."

Agenus currently maintains sufficient cGMP clinical-grade BOT and BAL drug product inventory to support the ongoing BATTMAN Phase 3 trial, the ANSM-authorized French access program (AAC) program, paid named patient programs in select countries where permitted, and ongoing investigator-sponsored trials. The newly initiated manufacturing activities are designed to supplement existing supply and position the company to meet expanding demand across paid compassionate access, development and potential future commercial settings.

Under the collaboration agreement, up to $50 million in contingent payments may be triggered by BOT and BAL production orders. The $20 million payment announced today is contractually allocated specifically for production and CMC-related activities. This structure enables Agenus to execute critical manufacturing work in support of its development and access programs without additional capital expenditures impacting its cash position.

The strategic collaboration between Agenus and Zydus, originally announced in June 2025 and closed in January 2026, provides Agenus with long-term U.S.-based biologics manufacturing capacity to support BOT+BAL’s global development and potential commercialization.

(Press release, Agenus, MAR 10, 2026, View Source [SID1234663425])

Mipletamig Delivers Compelling 86% Clinical Benefit Rate and No CRS as Evaluable AML Patient Data increases by Nearly 50%

On March 10, 2026 Aptevo Therapeutics Inc. (Nasdaq:APVO), a clinical-stage biotechnology company developing novel immune-oncology therapeutics based on its proprietary ADAPTIR and ADAPTIR-FLEX platform technologies, reported new interim data for mipletamig in combination with venetoclax and azacitidine in newly diagnosed acute myeloid leukemia (AML) patients who are either elderly or unfit for intensive chemotherapy. In data from two trials, the combination has demonstrated robust clinical activity, delivering an 86% clinical benefit rate (CR/CRi/PR*)with zero patients experiencing the common symptom of cytokine release syndrome (CRS). These data support an emerging efficacy profile coupled with differentiated patient safety and tolerability that is additive to the current AML standard-of-care therapy.

"The emerging mipletamig data in frontline AML are highly encouraging and highlight the differentiated profile we believe is needed to advance treatment in frontline AML," said Dirk Huebner, M.D., Chief Medical Officer of Aptevo Therapeutics. "In this study we are observing strong remission rates in a growing number of evaluable patients together with a consistently favorable safety and tolerability profile, including the absence of cytokine release syndrome. Achieving meaningful clinical activity while maintaining this level of safety and tolerability is essential in the frontline AML setting, where therapies must be compatible with established regimens. These results reinforce our belief that mipletamig can be successfully combined with venetoclax and azacitidine, with the potential to enhance outcomes for older and/or unfit AML patients who continue to face poor prognosis and limited treatment options."

Huebner continued, "Importantly, four of the patients treated to date have proceeded to allogeneic stem cell transplant, which represents the best possible outcome in AML treatment and is rarely achieved in the older or unfit frontline patient population."

Data Highlights Include:

Among the evaluable frontline patient population treated to date (N=28), including 24 patients from the RAINIER trial and 4 patients from the completed dose expansion trial, mipletamig in combination with venetoclax and azacitidine has demonstrated:

100% of frontline patients have remained free of cytokine release syndrome (CRS)

86% clinical benefit rate

79% achieved CR or CRi

61% achieved CR

55% of patients who achieved CR/CRi had blast reductions that reached the important measurable residual disease-negative level, a result that is typically associated with stronger, more durable responses

35% of patients with remissions had the TP53 genetic mutation, a high-risk biomarker typically associated with poor prognosis in AML and for which most treatment options frequently fail

Collectively, these data demonstrate mipletamig’s potential to meaningfully enhance frontline AML treatment in older and/or unfit patients, by improving efficacy outcomes without materially increasing toxicity.

"Our frontline data show that mipletamig has the potential to play a meaningful role in the future frontline AML treatment," said Marvin White, President and Chief Executive Officer of Aptevo Therapeutics. "From the outset, our objective has been to develop an AML drug capable of integrating into the current standard-of-care and improving outcomes for patients who continue to face poor prognoses. The data reported reinforces our conviction that mipletamig may represent a differentiated approach with the potential to complement existing frontline therapies in a practical and impactful way. As enrollment continues, we remain focused on advancing our RAINIER trial and generating the data needed to support mipletamig’s long-term role in AML treatment."

*(Clinical Benefit Rate: CR = complete remission; CRi = complete remission with incomplete blood marker recovery; PR = partial remission.)

Consistent Safety and Tolerability Profile Maintained Across Patients Treated to Date

In frontline patients treated to date, no cytokine release syndrome (CRS) has been observed. Together with strong efficacy outcomes, this outcome underscores mipletamig’s safety and combinability, potentially offering a superior treatment in the future. This safety profile is particularly important in frontline AML, where tolerability and combinability are essential for treating older patients and/or those with comorbidities.

About the RAINIER Trial

RAINIER, a frontline AML study, is a Phase 1b/2 dose optimization, multi-center, multi-cohort, open label study. Subjects are adults aged 18 or older, newly diagnosed with AML who are not eligible for intensive induction chemotherapy. RAINIER will be conducted in two parts. First, a Phase 1b dose optimization study in frontline AML patients followed by a Phase 2 study. The Phase 1b trial consists of 28-day cycles of treatment across multiple, sequential cohorts.

About Mipletamig

Aptevo’s wholly owned lead proprietary drug candidate, mipletamig, being evaluated for the treatment of AML, is differentiated by design to redirect the immune system of the patient to destroy leukemic cells and leukemic stem cells expressing the target antigen CD123, which is a compelling target for AML due to its overexpression on leukemic stem cells and AML blasts. This antibody-like recombinant protein therapeutic is designed to engage both leukemic cells and T cells of the immune system and bring them closely together to trigger the destruction of leukemic cells. Mipletamig is purposefully designed to reduce the likelihood and severity of CRS by use of the CRIS-7-derived CD3 binding pathway, an approach that differentiates Aptevo from competitors. Mipletamig has received orphan drug designation ("orphan status") for AML according to the Orphan Drug Act. Orphan drug designation provides key advantages-including the opportunity to seek U.S. market exclusivity for a specific period of time upon approval, FDA fee reductions, and access to development and tax credits. Mipletamig has been evaluated in more than 120 patients over three trials to date.

(Press release, Aptevo Therapeutics, MAR 10, 2026, View Source [SID1234663424])