On February 2, 2026 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a novel class of custom-built protein drugs known as DARPin therapeutics ("Molecular Partners" or the "Company"), reported the presentation of first patient imaging and dosimetry data of MP0712, its DLL3-targeted Radio-DARPin candidate co-developed with strategic partner Orano Med, at the 8th Theranostics World Congress (TWC), taking place in Cape Town, South Africa on January 29-February 1.

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!

The data, presented in two posters and an oral presentation, are highly supportive of the clinical development plans of MP0712 carrying the therapeutic isotope 212Pb for patients with small cell lung cancer (SCLC) and other DLL3-expressing neuroendocrine cancers. The data from five evaluable patients were generated with MP0712 carrying the diagnostic isotope 203Pb under the leadership of Dr. Mike Sathekge as part of a Named Patient Access Program under the legal framework for compassionate care in South Africa (also referred to as Section 21 of the Medicines and Related Substances Act).

"I am highly encouraged by the data generated in my group suggesting a favorable distribution profile of MP0712, a DLL3-targeted radiopharmaceutical for patients with SCLC and NEC cancers," said Dr. Mike Sathekge, Professor and Head of Nuclear Medicine at the University of Pretoria and Steve Biko Academic Hospital, and President and CEO of the Nuclear Medicine Research Infrastructure (NuMeRI). During the imaging step with 203Pb, we observed in our patients a promising tumor uptake, paired with a clean profile in healthy organs indicating a therapeutic potential for MP0712. I look forward to seeing this confirmed in the upcoming Phase 1 study."

The images show specific uptake as well as robust accumulation of MP0712 in tumor lesions, with limited uptake in healthy tissues, as intended. MP0712 is half-life engineered to promote tumor uptake over time via the DLL3 internalization and replenishment mechanism. Biodistribution of MP0712 in patients with various DLL3-expressing cancers, including small cell lung, urothelial, and other neuroendocrine cancers, provides a strong rationale for broad clinical development of MP0712 in SCLC and neuroendocrine cancers. The dosimetry extrapolations support the Phase 1/2a study design of MP0712 with 212Pb as therapeutic radioactive payload.

"The clinical data presented at TWC 2026 validate our assumptions and support the ongoing U.S. Phase 1/2a study, enabling us to initiate dosing of MP0712 within a potentially therapeutic range," said Patrick Amstutz, Ph.D., CEO of Molecular Partners. "These encouraging results reinforce our ambition to become a leader in alpha‑targeted therapies for patients with small cell lung cancer and other neuroendocrine malignancies. We thank the NuMeRi team for the strong collaboration and look forward to continuing our work together across our emerging pipeline. The biodistribution and dosimetry data demonstrate exactly what we aim to achieve with Radio‑DARPins — strong tumor accumulation with rapid clearance from healthy tissues. We look forward to sharing initial Phase 1 safety and activity data in 2026 as we advance our Radio-DARPin platform to deliver potent alpha‑emitting radioisotopes to solid tumors across multiple indications."

The Phase 1/2a study of MP0712 (ClinicalTrials.gov: NCT07278479) is a multi-center study in the U.S., with the objectives to assess safety and determine a recommended phase 2 dose for MP0712 carrying the potent therapeutic isotope 212Pb. The study, which contains an imaging and dosimetry step with 203Pb-labeled MP0712, is ongoing with initial clinical data expected in 2026.

Details of the presentations at TWC 2026

Two Poster Presentations:

Abstract 207: First-in-human evaluation of DLL3-Targeting 203Pb/212Pb DARPin MP0712 SPECT/CT in high-grade neuroendocrine malignancies: safety, biodistribution, and optimal imaging windows
Abstract 260: First-in-human dosimetry of the DLL3-targeting 203Pb/212Pb theranostic DARPin MP0712 in patients with small cell lung cancer and high-grade neuroendocrine tumours
Time & Presenters: Friday January 30, 2026, 17:30-18:30 SAST, by the NuMeRI team of Dr. Mike Sathekge.

Oral Presentation:
Title: From DARPins to Radio-DARPin Therapeutics – Progressing the first Radio-DARPin Therapeutic MP0712 (212Pb x DLL3) for SCLC into the clinic

Time: Saturday January 31, 2026; 10:30-12:00 SAST;
Session: "Antibody Drug Conjugates and Diversification of the Mechanisms of Action"
Presented by Molecular Partners

Webcast to be held on Monday February 2 at 8:00 ET (14:00 CET):
In addition to the presentations at TWC, Molecular Partners will host a webcast to discuss the new clinical data. Prof. Ken Herrmann, Chairman of the Scientific Advisory Board at Molecular Partners, will comment on the clinical data in the webcast.

Details as follows:
For Participants who want to listen and view slides: Please register here.

For Participants who may want to ask a question following the presentation: Please register here. These participants will be provided with additional dial-in instructions to join the live conference call and will have the ability to "raise their hand" and ask a verbal question during the Q&A.

(Press release, Molecular Partners, FEB 2, 2026, View Source [SID1234662397])

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.

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!

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).

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!

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.

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!

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.

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!

"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])