On February 2, 2026 MAA Laboratories, Inc. reported that it has completed early regulatory engagement with the Therapeutic Goods Administration (TGA) of Australia for its Dasatinib Nanoparticle Tablets, developed using the Company’s proprietary NanoCont platform technology.

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The engagement provides procedural clarity on the applicable regulatory pathway for the program in Australia. The product is being developed under a Category 1, Type F regulatory framework, consistent with global regulatory precedents for differentiated, suprabioavailable formulations of approved drug substances.

MAA’s Dasatinib Nanoparticle Tablets are designed to achieve equivalent systemic exposure at lower doses through enhanced bioavailability, enabling a development strategy centered on bioavailability and bioequivalence (BA/BE) studies. Under this pathway, regulatory evaluation is conducted at the time of submission.

Importantly, this approach is aligned with scientific advice previously received in Europe and Canada, as well as IND clearance by the U.S. Food and Drug Administration, where a BA/BE-based development strategy without additional clinical efficacy, safety, or toxicology studies was considered appropriate for this differentiated formulation.

"We view Australia as an important market for innovative, patient-focused therapies," said Dr. Anjani Jha, Founder and CEO of MAA Laboratories. "Our engagement with the TGA provides clarity on the appropriate regulatory framework and is consistent with the global development strategy we are executing across the U.S., Europe, and Canada."

MAA Laboratories’ NanoCont platform enables the development of differentiated, branded products that retain the regulatory efficiencies of established molecules while offering the potential benefits of improved bioavailability, optimized dosing, and enhanced tolerability. The Company continues to advance its dasatinib program and broader oncology pipeline toward global registration and commercialization.

(Press release, MAA Laboratories, FEB 2, 2026, View Source [SID1234662396])

On February 2, 2026 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported that the Company granted an aggregate of 1,799 restricted stock units (RSUs) to four newly-hired employees. These RSU awards were granted as of January 31, 2026 (the "Grant Date") pursuant to the Company’s 2022 Inducement Stock Incentive Plan, as amended, as inducements material to the new employees entering into employment with Karyopharm in accordance with Nasdaq Listing Rule 5635(c)(4).

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Each RSU award will vest over three years, with 33 1/3% of the shares underlying the RSU award vesting on each of the three consecutive anniversaries of the Grant Date. The vesting of each RSU award is subject to the employee’s continued service as an employee of, or other service provider to, Karyopharm through the applicable vesting dates.

(Press release, Karyopharm, FEB 2, 2026, View Source [SID1234662395])

On February 2, 2026 ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, reported the launch of ResQ215B, a Phase 2 clinical study evaluating a novel chemotherapy-free and lymphodepletion-free combination immunotherapy in patients with indolent B-cell non-Hodgkin lymphoma (iNHL), including Waldenström’s Macroglobulinemia.

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The outpatient study evaluates ImmunityBio’s novel, off-the-shelf CD19-targeted high-affinity natural killer (NK) cell therapy (CD19 t-haNK) in combination with nogapendekin-alfa inbakicept (NAI; ANKTIVA), an IL-15 superagonist, and the anti-CD20 monoclonal antibody rituximab. Notably, the regimen does not require any lymphodepleting chemotherapy, distinguishing it from conventional CAR-T cell therapies.

ResQ215B builds on promising results from the Phase 1 QUILT-106 study (NCT06334991), which evaluated CD19 CAR-NK cell therapy in combination with the anti-CD20 rituximab (without ANKTIVA). In that study, durable complete responses were observed in heavily pretreated patients with iNHL, including Waldenström’s Macroglobulinemia.

In an initial chemotherapy-free cohort of patients with Waldenström’s Macroglobulinemia treated with CD19 CAR-NK cells plus rituximab without any lymphodepletion, all four patients achieved clinical disease control. Two patients achieved rapid complete remissions (CR) that remain ongoing at 7 and 15 months of follow-up, respectively, without additional therapy beyond the planned treatment courses. The other two patients achieved stable disease, including one patient with declining IgM levels. These early findings demonstrated a 100% disease control in this small cohort using an outpatient, off-the-shelf CAR-NK cell therapy plus antibody combination without chemotherapy or inpatient hospitalization.

With the addition of ANKTIVA, ResQ215B is designed to evaluate whether further stimulation of innate and adaptive immune responses may enhance the depth and durability of anti-tumor activity. ANKTIVA is designed to promote the proliferation and activation of NK cells and CD8* T cells, potentially augmenting CAR-NK-mediated cytotoxicity and rituximab-driven ADCC.

Preclinical and clinical data suggests that IL-15 agonists may help restore immune function in the face of antibody resistance. In a previously published Phase 1 study (NCT02384954) Foltz et al. reported that combining an IL-15 superagonist with rituximab achieved a 78% complete response rate in patients with relapsed iNHL who had previously failed rituximab therapy.

"Our BioShield platform, which combines cell therapy, our IL-15 superagonist, and a monoclonal antibody in an outpatient, chemotherapy-free setting, represents our vision for Immunotherapy 2.0," said Patrick Soon-Shiong, M.D., Founder, Executive Chairman, and Global Chief Medical and Scientific Officer of ImmunityBio. "Building on the durable complete remissions observed with our CD19 CAR-NK cell therapy plus rituximab in Waldenström’s Macroglobulinemia, we are now adding ANKTIVA to further arm the immune system. We believe this off-the-shelf immunotherapy platform can trigger powerful anti-tumor activity without the toxicities of traditional treatments, potentially transforming the treatment paradigm for patients with indolent B-cell malignancies."

"A therapy that does not require apheresis, individualized manufacturing, chemotherapy, or inpatient hospitalization would represent an important advance for patients with iNHL, who are regarded as having incurable lymphomas," said Lennie Sender, M.D., Chief Medical Officer for Cell Therapy and Liquid Tumors at ImmunityBio. "To date, all treated patients have received the therapy in an outpatient setting without significant immune-related toxicities, demonstrating the feasibility of delivering potent cellular therapy without hospital admission. With ResQ215B, we will evaluate whether adding ANKTIVA can further improve response rates and durability while maintaining this favorable safety profile. This could open the door to a more patient-friendly immunotherapy option for follicular lymphoma, Waldenström’s, and other indolent NHL subtypes that currently rely on more aggressive or continuous treatments. Indolent B-cell lymphomas, such as Waldenström’s Macroglobulinemia, remain an area of high unmet medical need."

About the ResQ215B Study

ResQ315B is a Phase 2, open-label study designed to evaluate whether the addition of ANKTIVA can enhance immune-mediated tumor control when combined with CD19 CAR-NK cells and rituximab. The study will enroll adults with CD19⁺/CD20⁺ indolent NHL, including Waldenström’s Macroglobulinemia, who are relapsed or are refractory after at least two prior lines of therapy. Treatment will be administered in 21-day outpatient cycles without preconditioning chemotherapy.

About CD19 t-haNK

ImmunityBio’s CD19 t-haNK is an off-the-shelf, allogeneic NK-92-based cell therapy genetically engineered to express a CD19-specific chimeric antigen receptor (CAR) and a high-affinity CD16 (FcγRIIIa 158V) receptor. This dual-engineered design enables two complementary mechanisms of action: direct CAR-mediated cytotoxicity against CD19-expressing malignant B cells, and augmented antibody-dependent cellular cytotoxicity (ADCC) when paired with an anti-CD20 antibody such as rituximab. By targeting both CD19 and CD20, the combination is designed to reduce immune escape and improve overall response rates.

(Press release, ImmunityBio, FEB 2, 2026, View Source [SID1234662394])

On February 2, 2026 Exelixis, Inc. (Nasdaq: EXEL) reported that its New Drug Application (NDA) for zanzalintinib, in combination with atezolizumab (Tecentriq), has been accepted for review in the U.S. for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, and, if RAS wild-type, an anti-epidermal growth factor receptor (EGFR) therapy. The Food and Drug Administration (FDA) assigned a standard review with a Prescription Drug User Fee Act target action date of December 3, 2026.

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"We are encouraged by this meaningful progress toward addressing the needs of patients with previously treated metastatic colorectal cancer, for whom effective therapies have been limited and treatment outcomes remain poor," said Dana T. Aftab, Ph.D., Executive Vice President, Research and Development, Exelixis. "Zanzalintinib has the potential to become an important advancement in a challenging treatment landscape, and if approved, zanzalintinib in combination with atezolizumab would provide a novel mechanism of action for patients with previously treated metastatic colorectal cancer. We are deeply grateful to the patients, caregivers and investigators contributing to the clinical research in support of this application, and we look forward to collaborating with the FDA during the review process for our first NDA for zanzalintinib."

The NDA is based on the results of the phase 3 STELLAR-303 pivotal trial, in which zanzalintinib in combination with atezolizumab demonstrated a statistically significant improvement in overall survival (OS) versus regorafenib in the intention-to-treat (ITT) population of patients with previously treated CRC. Detailed results, including OS and progression-free survival (PFS) in the ITT population and in the subset of patients without liver metastases (non-liver metastases, NLM), were presented at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress and published in The Lancet. Data pertaining to the other dual primary endpoint, OS in patients without active liver metastases, were immature at the data cutoff, and the trial is proceeding to the planned final analysis for this endpoint, which is expected in mid-2026, based on current event rates.

About STELLAR-303
STELLAR-303 (NCT05425940) is a global, multicenter, randomized, phase 3, open-label study that randomized patients 1:1 to either zanzalintinib in combination with atezolizumab (n=451) or regorafenib (n=450). The study includes patients with previously treated non-MSI-high metastatic CRC. The dual primary endpoints of the study are OS in the ITT population and in the NLM subgroup of patients. The ITT population consisted of all randomized patients, regardless of the presence of liver metastases. The NLM subgroup consisted of patients who did not have active liver metastases at baseline as determined by investigator assessment. Secondary endpoints include PFS, objective response rate and duration of response in the ITT population and in the NLM subgroup of patients. More information about the trial is available at ClinicalTrials.gov.

About Zanzalintinib
Zanzalintinib is a novel oral kinase inhibitor that inhibits the activity of the TAM kinases (TYRO3, AXL, MER), MET and VEGF receptors. These kinases play important roles in oncogenic processes, including tumor cell proliferation, metastasis, angiogenesis, drug resistance and evasion of antitumor immunity. With zanzalintinib, Exelixis sought to build upon its extensive experience with the target profile of cabozantinib, the company’s flagship medicine, while improving key characteristics, including pharmacokinetic half-life. Zanzalintinib is currently being developed for the treatment of advanced solid tumors, including colorectal cancer, kidney cancer and neuroendocrine tumors.

Zanzalintinib is an investigational agent that is not approved for any use and is the subject of ongoing clinical trials.

About CRC
CRC is the third most common cancer and a leading cause of cancer-related deaths in the U.S.1 Approximately 159,000 new cases will be diagnosed in the U.S. in 2026, with around 55,000 expected deaths from the disease.1 CRC is most frequently diagnosed among people aged 65-74 and is more common in men and in people of non-Hispanic American Indian/Alaska Native descent.2 Nearly a quarter of CRC cases are diagnosed at the metastatic stage, at which point the five-year survival rate is around just 15%.1,2 The liver is the most common site for CRC metastasis. Liver metastases significantly impact survival, with a median five-year survival rate of less than 14% when treated with palliative chemotherapy.

(Press release, Exelixis, FEB 2, 2026, View Source [SID1234662393])

On February 2, 2026 AstraZeneca reported Imfinzi (durvalumab) in combination with standard-of-care FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel) has been recommended for approval in the European Union (EU) for the treatment of adult patients with resectable, early-stage and locally advanced (Stages II, III, IVA) gastric and gastroesophageal junction (GEJ) cancers. The regimen includes neoadjuvant Imfinzi in combination with chemotherapy before surgery, followed by adjuvant Imfinzi in combination with chemotherapy, then Imfinzi monotherapy.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on event-free survival (EFS) and overall survival (OS) data from the MATTERHORN Phase III trial. The EFS results were presented during the Plenary Session at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and simultaneously published in The New England Journal of Medicine.

In a planned interim analysis, patients treated with the Imfinzi-based perioperative regimen showed a 29% reduction in the risk of disease progression, recurrence or death versus chemotherapy alone (based on an EFS hazard ratio [HR] of 0.71; 95% confidence interval [CI] 0.58-0.86; p<0.001). Estimated median EFS was not yet reached for the Imfinzi arm versus 32.8 months for the comparator arm. An estimated 78.2% of patients treated with the Imfinzi-based perioperative regimen were event-free at one year, compared to 74.0% in the comparator arm; the estimated 24-month EFS rate was 67.4% versus 58.5%, respectively.

In the final OS analysis, results showed the Imfinzi and FLOT perioperative regimen demonstrated a statistically significant and clinically meaningful survival improvement, reducing the risk of death by 22% compared to chemotherapy alone (based on a HR of 0.78; 95% CI 0.63-0.96; p=0.021). An estimated 69% of patients treated with the Imfinzi-based regimen were alive at three years compared with 62% in the comparator arm. At each subsequent prespecified OS landmark, the survival curves indicated increasing separation, signaling a greater magnitude of benefit over time for the Imfinzi-based regimen. An OS benefit was observed regardless of PD-L1 status. OS results from MATTERHORN were presented in a Proffered Paper session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025.

Josep Tabernero, MD, PhD, head of the Medical Oncology Department at Vall d’Hebron University Hospital and director of the Vall d’Hebron Institute of Oncology (VHIO) in Barcelona, Spain, and principal investigator in the MATTERHORN trial, said: This recommendation signals a major step forward for patients in the EU with early gastric and gastroesophageal junction cancers, who have historically faced high rates of recurrence and poor long-term outcomes despite curative-intent surgery and chemotherapy. This durvalumab-based perioperative regimen is the first immunotherapy approach to significantly extend survival in this setting, and if approved, should set a new standard of care."

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "Imfinzi plus FLOT demonstrated a durable, increasing long-term survival benefit in the MATTERHORN trial, with more than two-thirds of patients alive at three years. The CHMP recommendation marks further progress toward our goal to offer novel approaches in early-stage cancers where there is the greatest chance for cure and brings us closer to providing the third perioperative Imfinzi-based regimen in the EU."

Gastric cancer is the fifth leading cause of cancer death globally, with nearly one million people diagnosed each year.1 In 2024, there were roughly 43,000 drug-treated patients in the US, EU and Japan in early-stage and locally advanced gastric or GEJ cancer.2 Approximately 62,000 patients in these regions are expected to be newly diagnosed in this setting by 2030.3

The safety profile for Imfinzi and FLOT chemotherapy was consistent with the known profiles of each medicine, and the percentage of patients that completed surgery was similar compared to chemotherapy alone. Grade 3 or higher adverse events due to any cause were similar between the two arms (71.6% for Imfinzi and FLOT arm; 71.2% for comparator arm).

Imfinzi is approved in the US and other countries in this same indication based on the MATTERHORN results. Regulatory applications are currently under review in Japan and several other countries.

Notes

Gastric and gastroesophageal junction cancers
Gastric (stomach) cancer is the fifth most common cancer worldwide and the fifth-highest leading cause of cancer mortality.1 Nearly one million new patients were diagnosed with gastric cancer in 2022, with approximately 660,000 deaths reported globally.1 In many regions, its incidence has been increasing in patients younger than 50 years old, along with other gastrointestinal (GI) malignancies.4

GEJ cancer is a type of gastric cancer that arises from and spans the area where the oesophagus connects to the stomach.5

Disease recurrence is common in patients with resectable gastric cancer despite undergoing surgery with curative intent and treatment with neoadjuvant/adjuvant chemotherapy.6 Approximately one in four patients with gastric cancer who undergo surgery develop recurrent disease within one year, and the five-year survival rate remains poor, with less than half of patients alive at five years.6-7

MATTERHORN
MATTERHORN is a randomised, double-blind, placebo-controlled, multi-centre, global Phase III trial evaluating Imfinzi as perioperative treatment for patients with resectable Stage II-IVA gastric and GEJ cancers. Perioperative therapy includes treatment before and after surgery, also known as neoadjuvant/adjuvant therapy. In the trial, 948 patients were randomised to receive a 1500mg fixed dose of Imfinzi plus FLOT chemotherapy or placebo plus FLOT chemotherapy every four weeks for two cycles prior to surgery. This was followed by Imfinzi or placebo every four weeks for up to 12 cycles after surgery (including two cycles of Imfinzi or placebo plus FLOT chemotherapy and 10 additional cycles of Imfinzi or placebo monotherapy).

In the MATTERHORN trial, the primary endpoint is EFS, defined as time from randomisation until the date of one of the following events (whichever occurred first): RECIST (version 1.1, per blinded independent central review assessment) progression that precludes surgery or requires non-protocol therapy during the neoadjuvant period; RECIST progression/recurrence during the adjuvant period; non-RECIST progression that precludes surgery or requires non-protocol therapy during the neoadjuvant period or discovered during surgery; progression/recurrence confirmed by biopsy post-surgery; or death due to any cause. Key secondary endpoints include pathologic complete response rate, defined as the proportion of patients who have no detectable cancer cells in resected tumour tissue following neoadjuvant therapy, and OS. The trial enrolled participants in 176 centres in 20 countries, including in the US, Canada, Europe, South America and Asia.

Imfinzi
Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

In GI cancer, Imfinzi is approved in combination with chemotherapy in locally advanced or metastatic biliary tract cancer (BTC) and in combination with Imjudo (tremelimumab) in unresectable hepatocellular carcinoma (HCC). Imfinzi is also approved as a monotherapy in unresectable HCC in Japan and the EU.

In addition to its indications in GI cancers, Imfinzi is the global standard of care based on OS in the curative-intent setting of unresectable, Stage III non-small cell lung cancer (NSCLC) in patients whose disease has not progressed after chemoradiotherapy (CRT). Additionally, Imfinzi is approved as a perioperative treatment in combination with neoadjuvant chemotherapy in resectable NSCLC, and in combination with a short course of Imjudo and chemotherapy for the treatment of metastatic NSCLC. Imfinzi is also approved for limited-stage small cell lung cancer (SCLC) in patients whose disease has not progressed following concurrent platinum-based CRT; and in combination with chemotherapy for the treatment of extensive-stage SCLC.

Perioperative Imfinzi in combination with neoadjuvant chemotherapy is approved in the US, EU, Japan and other countries for patients with muscle-invasive bladder cancer based on results from the NIAGARA Phase III trial. Additionally, in May 2025, Imfinzi added to Bacillus Calmette-Guérin induction and maintenance therapy met the primary endpoint of disease-free survival for patients with high-risk non-muscle-invasive bladder cancer in the POTOMAC Phase III trial.

Imfinzi in combination with chemotherapy followed by Imfinzi monotherapy is approved as a 1st-line treatment for primary advanced or recurrent endometrial cancer (mismatch repair deficient disease only in the US and EU). Imfinzi in combination with chemotherapy followed by Lynparza (olaparib) and Imfinzi is approved for patients with mismatch repair proficient advanced or recurrent endometrial cancer in the EU and Japan.

Since the first approval in May 2017, more than 414,000 patients have been treated with Imfinzi. As part of a broad development programme, Imfinzi is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with NSCLC, bladder cancer, breast cancer, ovarian cancer and several GI cancers.

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(Press release, AstraZeneca, FEB 2, 2026, View Source [SID1234662392])