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 Ensem Therapeutics, Inc. (ENSEM), a clinical-stage, oncology-focused biopharmaceutical company, reported that the first patient has been dosed with ETX-636 in China at Fudan University Shanghai Cancer Center as part of its ongoing global Phase 1/2 clinical trial, marking a significant advancement in ENSEM’s global development strategy.

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ETX-636 is a potential first-in-class and best-in-class allosteric pan-mutant-selective PI3Kα dual inhibitor and degrader. The rapid study initiation of ETX-636 in China follows the November 19th approval of the Investigational New Drug (IND) application by China’s National Medical Products Administration (NMPA).

"ENSEM is committed to advancing innovative precision oncology medicines for patients worldwide," said Shengfang Jin, PhD, Co-Founder and Chief Executive Officer of ENSEM. "The expansion of the ETX-636 clinical trial into China represents a significant milestone that strengthens our global clinical presence. We are pleased that several leading oncology centers in China are joining the study, which has the potential to accelerate enrollment, expand access to a broader and underserved patient population, and further strengthen the global clinical data package supporting ETX-636."

Hongxia Wang, MD, Principal Investigator in China at Fudan University Shanghai Cancer Center, added, "Mutant PI3Kα is a frequent and critical oncogenic driver across many cancers, including nearly half of hormone receptor-positive, HER2-negative advanced breast cancers. While first-generation PI3Kα inhibitors have clinically validated the target, their limitations – particularly toxicities associated with wild-type PI3Kα inhibition – underscore the need for improved therapies. ETX-636 employs a novel allosteric mechanism-of-action to selectively inhibit and degrade mutant PI3Kα while sparing wild-type PI3Kα, potentially offering superior tolerability with robust anti-tumor activity. We are excited to collaborate with ENSEM to evaluate ETX-636’s clinical potential and bring new treatment options to patients in China."

The ongoing first-in-human, global Phase 1/2 study is evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of ETX-636 in patients with advanced solid tumors harboring PI3Kα mutations (NCT06993844). Since the first patient was dosed in the United States in June 2025, multiple leading U.S. cancer centers have joined the study. ETX-636 is being evaluated both as monotherapy and in combination with fulvestrant, an approved selective estrogen receptor degrader, for the treatment of advanced HR+/HER2- breast cancer. Dose escalation in the United States is progressing as planned, and ETX-636 has been well tolerated to date, with no observed hyperglycemia or dose-limiting toxicities. ENSEM expects to disclose preliminary clinical data supporting proof of concept in the second half of 2026.

About ETX-636

ETX-636 was rationally designed to optimally bind a specific allosteric pocket in p110α, the catalytic subunit of PI3Kα. ETX-636 allosteric binding enables selective inhibition of all activating mutant forms of PI3Kα, including hotspot kinase- and helical-domain mutations, while sparing wild-type PI3Kα. The high selectivity of ETX-636 for mutant PI3Kα is expected to reduce the risk of hyperglycemia and other wild-type PI3Kα-related adverse events compared with non-mutant-selective PI3Kα inhibitors. In preclinical toxicology studies, ETX-636 did not disrupt glucose homeostasis at predicted human efficacious doses.

In addition to potent catalytic inhibition, ETX-636 uniquely induces proteasome-dependent degradation of mutant PI3Kα while preserving wild-type protein – a feature not observed with other allosteric PI3Kα inhibitors. This dual mechanism of action drives deep and durable pathway suppression and has demonstrated robust tumor regression in kinase- and helical-domain PI3Kα-mutant breast cancer xenograft models, both as monotherapy and in combination with fulvestrant, with or without a CDK4/6 inhibitor.

(Press release, ENSEM Therapeutics, FEB 2, 2026, View Source [SID1234662412])

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.

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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 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported the publication of a new study in npj Precision Oncology highlighting the power of its ultrasensitive molecular residual disease (MRD) assay, NeXT Personal, in monitoring immunotherapy response across a broad range of advanced cancers.

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The study, titled "Ultrasensitive ctDNA monitoring reveals early predictors of immunotherapy response in advanced cancer," was led by oncology researchers at UC San Diego Moores Cancer Center.

The findings reinforce the NeXT Personal test’s ability to detect circulating tumor DNA (ctDNA) at ultrasensitive levels, providing a window for earlier clinical intervention that other approaches may miss. The NeXT Personal test achieves ultrasensitive detection of small traces of ctDNA from a patient’s blood sample using a personalized approach that tracks up to ~1,800 tumor-specific variants unique to each patient’s tumor.

While immunotherapy has transformed cancer care, only ~10-40% of patients achieve durable benefit, making it critical to monitor how patients are responding to therapy. This interim analysis of the ongoing study includes 39 patients with advanced solid tumors—across nine different cancer types—treated with immune checkpoint inhibitors alone or in combination with other therapies. Key findings include:

Early identification of therapy response: Molecular response—defined by ctDNA dynamics—was detectable early, a median of 23 days after starting immunotherapy. Patients achieving an early molecular response had significantly longer progression-free survival.
Lead time over imaging: For patients whose disease progressed, NeXT Personal identified molecular progression a median of 161 days (over five months) before imaging.
Criticality of the ultrasensitive range in advanced tumors: The study found that even in advanced tumors where ctDNA shedding can be higher, 33% of positive ctDNA detections occurred in the ultrasensitive range (below 100 PPM). These are detections that could be missed with a less sensitive test.
Strong correlation with outcomes: Patients who achieved molecular complete response (ctDNA clearance) had seven times higher overall survival than patients who did not achieve ctDNA clearance.
"We continue to expand the clinical evidence that NeXT Personal can be used to monitor therapy response in advanced cancer patients on immunotherapy," said Richard Chen, M.D., M.S., Chief Medical Officer and Executive Vice President of R&D at Personalis. "This pan-cancer study builds on our recent publication in Clinical Cancer Research, similarly showing the impact of ultrasensitive ctDNA testing in late-stage cancers. With immunotherapy, an important pillar of cancer treatment in advanced cancer patients, the need for better tools to evaluate patient response is increasingly important. These findings show how NeXT Personal and ultrasensitive ctDNA testing can potentially play an important role in impacting care across a broad spectrum of solid tumors."

(Press release, Personalis, FEB 2, 2026, View Source [SID1234662413])

On February 2, 2026 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported the submission of its premarket approval (PMA) to the U.S. Food and Drug Administration (FDA) for Signatera CDx for detection of molecular residual disease (MRD) in patients with muscle-invasive bladder cancer (MIBC) who may benefit from treatment with atezolizumab (Tecentriq).

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This submission is supported by data from the randomized, double-blind, phase 3 IMvigor011 clinical trial, which met its primary endpoint and demonstrated the benefits of Signatera-guided therapy in MIBC. In the study, Signatera-positive patients treated with atezolizumab (Tecentriq) had statistically significant and clinically meaningful improvements in disease-free survival and overall survival, compared with placebo. The trial also showed that Signatera-negative patients had a low risk of recurrence without adjuvant immunotherapy. Results were featured in a Presidential Symposium at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress on October 20, 2025, with a concurrent publication in The New England Journal of Medicine.

Bladder cancer is the sixth most common cancer in the United States1 and MIBC represents 20-25% of the newly diagnosed cases.2 Radical cystectomy (with or without neoadjuvant therapy) is curative for approximately half of these patients, but until now it has been very challenging to identify which patients are likely to recur and to offer them effective, personalized therapy while sparing the others from unnecessary treatment.3,4 The IMvigor011 trial, sponsored by Genentech, a member of the Roche Group, was designed to address that challenge.

"Submitting this PMA represents an important step toward making MRD-guided treatment a reality for patients with muscle-invasive bladder cancer," said Alexey Aleshin, M.D., general manager of oncology and corporate chief medical officer at Natera. "If approved, we believe Signatera CDx has the potential to be the first companion diagnostic MRD test that helps guide treatment decisions and improve outcomes for patients."

(Press release, Natera, FEB 2, 2026, View Source [SID1234662414])