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.

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"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])

On March 10, 2026 Alligator Bioscience (Nasdaq Stockholm: ATORX), a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs, reported that the United States Patent and Trademark Office (USPTO) has granted a patent covering Alligator’s proprietary bispecific antibody format. The granted patent provides protection for the structural design of tetravalent bispecific antibodies capable of dual antigen binding.

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The patent covers a versatile antibody architecture designed to enable stable and efficient assembly of bispecific antibodies, including configurations targeting immune modulators and tumor-associated antigens. This platform is intended to support the development of next-generation immunotherapies across a range of oncology indications and combination strategies.

The bispecific antibody format covered by the patent underpins multiple programs within Alligator’s research platform and has already demonstrated external validation. In September 2025, Alligator entered into an evaluation and option agreement covering the RUBY antibody format, highlighting the commercial and strategic interest in Alligator’s antibody engineering capabilities.

"This patent grant strengthens the intellectual property foundation around our bispecific antibody platform and highlights the value of our technology beyond mitazalimab," said Søren Bregenholt, CEO of Alligator Bioscience. "It supports our strategy to build long-term value through our innovative antibody formats, both within our own pipeline and through partnerships, as exemplified by the RUBY agreement."

(Press release, Alligator Bioscience, MAR 10, 2026, View Source [SID1234663408])

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.

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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])

On March 10, 2026 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on non-invasive diagnostics and early cancer detection, reported initiation of the Company’s planned large-scale, longitudinal clinical study for CyPath Lung, its noninvasive diagnostic test for the detection of early-stage lung cancer.

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The 2,000-patient longitudinal study is designed to evaluate the clinical performance of the CyPath Lung flow cytometry test as a noninvasive diagnostic that uses sputum samples to detect the presence of lung cancer in high-risk individuals with existing lung nodules six millimeters (mm) to less than 30 mm in diameter identified by lung cancer screening. In an earlier clinical trial, CyPath Lung showed 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients with small pulmonary nodules less than 20mm. Several recent patient case studies demonstrate the test’s ability to detect lung cancer at its curative Stage 1A.

bioAffinity Technologies expects up to 20 clinical study sites, including a dozen Department of Veterans Affairs (VA) medical centers and two of the nation’s largest military hospitals, will participate in the study. Michael J. Morris, MD, pulmonology and critical care physician at Brooke Army Medical Center, is the national Principal Investigator for the study (NCT07168993). The John P. Murtha Cancer Center Research Program (MCCRP), a research program within the Department of Surgery at the Uniformed Services University of the Health Sciences in Bethesda, Maryland, is providing support and funding associated with the trial at several federal facilities.

Physicians currently order CyPath Lung, a laboratory developed test (LDT) offered by bioAffinity Technologies’ subsidiary Precision Pathology Laboratory Services, for their patients with indeterminate lung nodules to determine next steps in patient care.

The longitudinal clinical trial announced today will evaluate FlowPath Lung, a research-use test that uses the same technology and follows the same procedures as CyPath Lung. The different name is simply used to distinguish the investigational assay from the commercially available test.

"As more indeterminate pulmonary nodules are found either incidentally or by routine lung cancer screening, CyPath Lung can fill the diagnostic gap between ‘watchful waiting’ and invasive procedures that carry risk," said Gordon Downie, MD, PhD, Chief Medical Officer of bioAffinity Technologies. "As a result, we see growing adoption and use of CyPath Lung by physicians and expect this longitudinal trial to provide additional evidence to support inclusion of our noninvasive test as part of the standard of care for lung cancer screening and diagnosis."

"Initiating this study represents an important milestone for CyPath Lung," said Maria Zannes, President and CEO of bioAffinity Technologies. "By following patients longitudinally across multiple sites, we expect to acquire robust, real-world data that reflects how CyPath Lung may be used to support risk assessment and clinical decision-making aligned with our objective to establish CyPath Lung as a standard of care for evaluating patients at high-risk for early-stage lung cancer."

The study includes participation from several federal facilities to examine the test’s performance in diverse patient populations, including military service members and veterans. Patient enrollment is expected to take up to 18 months with patients followed for up to 24 months or until a definitive diagnosis of cancer or no cancer is determined.

About CyPath Lung

CyPath Lung is a non-invasive test designed to improve the early detection of lung cancer in patients at high risk for the disease. CyPath Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. CyPath Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters.

(Press release, BioAffinity Technologies, MAR 10, 2026, View Source [SID1234663409])

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.

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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])