On October 12, 2026 Amphista Therapeutics Limited (‘Amphista’ or ‘the Company’), a leader in the discovery and development of non-cereblon / VHL targeted protein degradation (TPD) medicines, reported dosing of the first patient in a Phase 1 trial for its lead candidate, AMX-883. Initiated following authorization from the U.S. Food and Drug Administration in June 2026, the BRAMLIE trial will investigate the safety, pharmacokinetics, and preliminary efficacy of AMX-883 monotherapy in participants with AML and high-risk MDS1.

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BRAMLIE is expected to enroll approximately 54 patients across multiple sites. After establishing the monotherapy profile, a multi-center dose-escalation study would evaluate AMX-883 in combination with current standards of care in participants with relapsed/refractory AML as well as in earlier lines of therapy.

AML is an aggressive blood cancer causing ~130,000 deaths globally each year, with most patients receiving traditional cytotoxic chemotherapy. Although novel targeted agents can be effective, the use of these is restricted to specific mutations – and therefore target only a subset of AML patients – highlighting a need for broad-acting therapeutics.

Acting via a targeted protein degradation (TPD) mechanism, Amphista’s Targeted Glue degraders are highly selective small molecule therapeutics with properties optimized for human medicines. AMX-883 is a potent, selective, orally bioavailable Targeted Glue for BRD9 – a subunit of the chromatin remodeling complex involved in maintaining leukemic stemness and blocking of myeloid cell differentiation. Rapid BRD9 degradation is induced via AMX-883’s novel mechanism of action by which it recruits the E3 ligase DCAF16, enabling exceptional selectivity. Preclinically, AMX-883 has demonstrated activity across diverse AML subtypes, independent of mutation status2.

Dr Eytan Stein, Director, Program for Drug Development in Leukemia, Division of Hematologic Malignancies at Memorial Sloan Kettering Cancer Center, and Lead Investigator for this trial, said: "With a five-year survival rate of just 33%, and emerging resistance to standard-of-care treatments like venetoclax, AML is one of the most devastating blood cancers, and there is an urgent need for innovative new therapeutics. AMX-883 is the only BRD9 degrader currently in development, and I look forward to seeing what this clinical stage research will reveal."

Dr Louise Modis, Chief Executive Officer at Amphista, said: "The progression of our lead asset into the clinic marks a significant milestone for Amphista in our mission to transform the lives of patients with severe diseases. This study will help us better understand the potential of AMX-883, our lead Targeted Glue, and how it could establish an important new treatment pathway for patients facing this very difficult disease with high unmet medical need."

(Press release, Amphista Therapeutics, OCT 12, 2026, View Source [SID1234673336])

On October 12, 2026 Foresee Pharmaceuticals (TPEx: 6576), ("Foresee") reported that it was notified by its licensing partner, Changchun GeneScience Pharmaceutical Co., Ltd. ("GenSci"), that China’s National Medical Products Administration (NMPA) has approved the Marketing Authorization Application (MAA) for CAMCEVI 42 mg, a ready-to-use 6-month subcutaneous depot formulation of leuprolide mesylate, for the treatment of adult patients with advanced prostate cancer.

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Dr. Ben Chien, Ph.D., Chairman and Chief Executive Officer of Foresee Pharmaceuticals stated: "We are pleased that our partner GenSci will be launching CAMCEVI 42 mg in China. These efforts will significantly contribute to the growth of our global CAMCEVI franchise."

CAMCEVI is exclusively licensed to GenSci for commercialization in China across all current and pipeline indications, including advanced prostate cancer, central precocious puberty (CPP), and premenopausal breast cancer.

In addition to the NMPA’s approval of CAMCEVI 42 mg for advanced prostate cancer described above, GenSci submitted a supplemental New Drug Application (sNDA) in May 2026 for leuprolide mesylate injectable emulsion for the additional indication of premenopausal breast cancer, which has been accepted by the NMPA for substantive review.

About CAMCEVI 42 mg

CAMCEVI 42 mg is a sustained-release, ready-to-use, 6-month subcutaneous formulation of leuprolide mesylate, a gonadotropin-releasing hormone (GnRH) agonist, offering a less-frequent, ready-to-use dosing alternative to existing therapies.

It is approved for the treatment of adult patients with advanced prostate cancer in the United States (since May 2021), the European Union (since May 2022), and other markets, and, as announced today, in China. Product labeling may differ by country; please refer to the locally approved prescribing information.

(Press release, Foresee Pharmaceuticals, OCT 12, 2026, View Source [SID1234673335])

On October 12, 2026 Lunit (KRX: 328130), a leading provider of AI for cancer diagnostics and precision oncology, reported a strategic collaboration with Discovery Life Sciences (Discovery), a global leader in biospecimens and specialty laboratory services, to expand the adoption of the Lunit SCOPE suite, the company’s AI-powered pathology platform, across biopharmaceutical research.

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Discovery brings more than 25 years of assay expertise and has delivered biomarker services for more than 2,000 clinical trial programs while currently supporting over 350 active trial programs through its end-to-end specialty laboratory services across the drug development lifecycle.

Through the collaboration, Discovery and Lunit will work together with biopharma clients to apply the Lunit SCOPE suite within Discovery’s biomarker and tissue analysis workflows, tailoring AI-powered pathology to each program’s design. By pairing Discovery’s global biospecimen network and specialty laboratory expertise with Lunit’s AI-powered image analysis on client programs, the companies aim to provide pharmaceutical and biotechnology companies with standardized, quantitative tissue insights that support clinical research, translational studies, and drug development. The collaboration is expected to broaden global access to Lunit’s AI-powered pathology platform for biopharmaceutical researchers and organizations.

The companies also plan to expand AI-enabled tissue analysis services that help researchers generate deeper biological insights, improve the reproducibility of tissue-based analysis, and accelerate evidence generation throughout the drug development process.

In addition, Lunit will participate in Discovery Life Sciences’ Bridging Biomarker Breakthroughs to Bedsides (B4 Tour) on October 14 in South San Francisco. Yoojoo Lim, Medical Director at Lunit Oncology, will speak in an expert session and join the panel discussion, "AI in Biomarkers: What’s Working, What’s Next."

"AI-powered pathology only delivers on its promise when the tissue and the workflow behind it are consistent. Because we source the biospecimens and perform the tissue processing and pathology in our own laboratories, we can apply the Lunit SCOPE suite to reliably prepared samples and give our biopharma partners tissue data they can trust across their programs," said Anna Juncker-Jensen, PhD, Vice President of Scientific Affairs, Discovery Life Sciences.

"As biopharmaceutical companies increasingly seek quantitative and reproducible biomarkers to guide drug development, AI-powered pathology is becoming an essential part of modern translational research," said Brandon Suh, CEO of Lunit. "Through our collaboration with Discovery Life Sciences, we aim to bring the Lunit SCOPE suite to more biopharma researchers worldwide, enabling standardized tissue analysis that accelerates biomarker research and ultimately supports the development of next-generation therapies."

Through this collaboration, biopharma partners gain access to the Lunit SCOPE suite within Discovery’s end-to-end tissue workflows, from specimen sourcing through molecular pathology and quantitative readout, all performed in Discovery’s own laboratories. Integrating AI at the point of analysis gives researchers standardized, reproducible tissue data across their biomarker and translational programs.

(Press release, Lunit, OCT 12, 2026, View Source [SID1234673334])

On October 12, 2026 T-MAXIMUM PHARMACEUTICAL ("T-MAXIMUM") reported that the U.S. Food and Drug Administration (FDA) has cleared the company to initiate a Phase 2 clinical study of MT027, its internally developed, B7-H3-targeted universal (allogeneic) CAR-T therapy, for the treatment of patients with brain metastases from lung cancer and breast cancer.

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This is the second Phase 2 study of MT027 to receive FDA clearance. MT027 was previously cleared by the FDA to proceed with a Phase 2 study in recurrent glioblastoma, and has been granted Orphan Drug Designation (ODD) and Fast Track Designation (FTD). With two FDA-cleared Phase 2 programs, T-MAXIMUM has established a dual-indication portfolio for universal CAR-T therapy covering both primary and metastatic intracranial solid tumors.

Brain Metastases: An Unanswered Clinical Question Despite Advances in Systemic Therapy

Brain metastases commonly arise in patients with lung cancer, breast cancer, melanoma, renal cell carcinoma, and colorectal cancer. International studies estimate that approximately 20% of cancer patients may develop brain metastases over the course of their disease, a proportion that can reach 20% to 40% among patients with advanced solid tumors.[1][2] For patients, this means far more than an additional lesion on imaging: brain metastases may be accompanied by headaches, seizures, and cognitive and motor impairment, directly affecting daily life and subsequent treatment options.

This is a truly global clinical challenge. In 2022, there were nearly 20 million new cancer cases worldwide, including nearly 2.5 million new cases of lung cancer and approximately 2.3 million new cases of female breast cancer – the two leading primary tumor types giving rise to brain metastases.[3] Asia accounts for roughly half of all new cancer cases globally;[4] in the United States, an estimated 200,000 to 300,000 patients are newly diagnosed with brain metastases each year.[2] This large patient population means brain metastasis is not a niche need, but a question that oncology worldwide must continue to answer.

Systemic therapies can help control disease throughout the body, but treatment of intracranial lesions often remains constrained by multiple factors, including the blood-brain barrier, tumor heterogeneity, and the need to preserve neurological function. This is especially true for patients who experience intracranial progression after prior therapy, for whom there remains a need for more treatment options that are validated intracranially while balancing safety and accessibility.

Consecutive Clinical Milestones Built on Long-Term Product and Translational Groundwork

MT027’s recent series of regulatory milestones is no coincidence. It reflects an integrated capability across product, manufacturing, clinical development, and regulatory affairs built around intracranial solid tumors – one that is now advancing from early exploration toward more systematic clinical validation.

First, a foundation of clinical data. The company has accumulated sustained clinical experience in local delivery, repeat dosing, and safety monitoring for intracranial solid tumors. Years of clinical experience and data with MT027 have already led to two FDA-cleared Phase 2 programs. Data from an investigator-initiated trial (IIT) of MT026, a program built on the same platform, were published in Nature Communications in 2026: among 5 patients with recurrent high-grade glioma, 1 complete response and 3 partial responses were observed, for an objective response rate (ORR) of 80%, with no treatment-related Grade 3 or higher adverse events.

Early clinical data for MT027 in patients with refractory brain metastases from lung cancer were previously presented at the IASLC 2026 World Conference on Lung Cancer (WCLC 2026). Five heavily pretreated patients with no guideline-recommended subsequent treatment options completed treatment; among the 3 evaluable patients, 2 partial responses were observed. The safety profile was favorable, with no Grade 3 or higher adverse events and no graft-versus-host disease (GvHD). These rigorous exploratory clinical studies provide an important basis for the clinical translation of allogeneic, locally delivered CAR-T therapy in intracranial solid tumors.

Second, a well-defined manufacturing process. MT027 is manufactured using a fully non-viral gene-editing process – a generational departure from the industry’s mainstream lentiviral vector approach – offering potential advantages in product safety, batch-to-batch consistency, and cost control. The manufacturing process was established and locked prior to entering Phase 2 clinical development.

Third, leadership measured not only by getting there first, but by advancing systematically. For an innovative cell therapy company, leadership in regulatory progress comes from coordinated advancement across product, manufacturing, clinical development, and regulatory strategy. MT027’s consecutive entry into FDA-cleared Phase 2 clinical development demonstrates T-MAXIMUM’s ability to translate its prior groundwork into a repeatable and scalable clinical development capability.

Management Commentary

"Receiving FDA clearance for two consecutive Phase 2 studies of MT027 marks a pivotal step built on our sustained work in intracranial solid tumors. From glioma to brain metastases, we have always let the data speak and put clinical value first. Going forward, we will continue to rigorously evaluate the product’s safety and potential clinical value through well-designed clinical studies, steadily advancing product supply, clinical execution, and the generation of key data, as we explore new possibilities for patients who lack effective treatment options."

About MT027

MT027 is an investigational, B7-H3-targeted universal (allogeneic) CAR-T cell therapy developed by T-MAXIMUM using a fully non-viral gene-editing process and administered via local intracranial delivery. MT027 has received FDA Orphan Drug Designation and Fast Track Designation and is being evaluated in FDA-cleared Phase 2 studies in recurrent glioblastoma and in brain metastases from lung cancer and breast cancer.

(Press release, T-MAXIMUM Pharmaceutical, OCT 12, 2026, View Source [SID1234673333])

On October 12, 2026 Racura Oncology Limited (ASX: RAC), a late clinical-stage biopharmaceutical company developing new small molecule-based approaches to cancer treatment focused on silencing MYC gene expression, reported that the Safety Review Committee (SRC) for HARNESS-1 has cleared its lead oncology drug, RC220 to escalate to the next planned dose level of 100 mg/m2. HARNESS-1 (RAC-020) is a Phase 1a/b clinical trial evaluating RC220 in combination with osimertinib in patients with epidermal growth factor receptor-mutant (EGFR-mutant) non-small cell lung cancer (NSCLC).

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The SRC reviewed all safety data from both Cohort 1 patients, who received RC220 at 50 mg/m2 by intravenous infusion in combination with osimertinib at 80 mg daily. No dose-limiting toxicities or treatment-related safety concerns were identified in either patient during the safety observation period. The second Cohort 1 patient has now received three doses of RC220, administered 21 days apart, without any dose-limiting toxicities or treatment-related safety concerns.

Cohort 1 enrolled two patients after the SRC requested that a second patient receive RC220 at 50 mg/m2. This followed an observation of Grade 2 colitis in the first patient outside the trial safety period. Although the cause was undetermined, a contribution from RC220 could not be excluded. The second patient has reported no colitis or other dose limiting symptoms after three separate RC220 doses.

Pre-screening is now underway to enroll the single patient in Cohort 2, who is expected to receive RC220 at 100 mg/m2 with osimertinib at 80 mg daily. SRC clearance relates to safety and dose escalation only; this announcement does not include data on the clinical activity of RC220 in this indication.

Daniel Tillett, Ph.D., Chief Executive Officer of Racura Oncology, said: "We are pleased with the SRC’s clearance, which allows RC220 to progress to the next dose level in the HARNESS-1 trial. This is an important early milestone for the trial and reflects the disciplined execution of our clinical development plan. The Cohort 1 safety review identified no dose-limiting toxicities or treatment-related safety concerns in either patient during the safety observation period. We thank the patients and their families for supporting this study and acknowledge Principal Investigator, Associate Professor Surein Arulananda and the Monash Health team for their ongoing contribution."

Scientific Rationale

EGFR-mutant NSCLC is a molecularly stratified lung adenocarcinoma subtype driven by constitutive EGFR kinase signaling and initial sensitivity to EGFR inhibition. However, responses to EGFR tyrosine kinase inhibitors (TKIs), including osimertinib (Tagrisso; AstraZeneca), are typically limited by acquired resistance, arising through heterogeneous mechanisms such as secondary EGFR alterations, bypass receptor tyrosine kinase activation, MAPK/PI3K pathway reactivation, oncogenic fusions, lineage plasticity, epithelial-to-mesenchymal transition and histologic transformation.

RC220 is being clinically developed to target non-canonical G-quadruplex DNA and RNA structures enriched in oncogenic regulatory regions, including promoters, untranslated regions and highly transcribed loci. Stabilization of these structures can disrupt transcriptional and post-transcriptional control networks that sustain malignant proliferation, including the silencing of MYC-driven growth and survival pathways.

HARNESS-1 Trial Design

HARNESS-1 is a multicenter Phase 1a/b clinical study in patients with EGFR-mutant NSCLC receiving osimertinib. The study includes an observational screening stage using circulating tumor DNA (ctDNA) to help identify eligible patients and characterize tumor molecular status before treatment.

The Phase 1a dose-escalation stage evaluates RC220 administered by intravenous infusion on Day 1 of each 21-day cycle, in combination with standard-of-care maintenance osimertinib. It uses an accelerated titration design, in which the first three dose levels of 50 mg/m2, 100 mg/m2 and 150 mg/m2 are each evaluated in a single-patient cohort. Each patient is monitored through a 21-day safety observation period, and the SRC reviews all available safety data before the trial moves to the next dose level. This approach allows the trial to move efficiently through lower dose levels that may sit below the expected active range, while limiting patient exposure to higher doses before safety data have been reviewed.

Subject to the protocol and safety outcomes, the trial is expected to transition after the 150 mg/m2 cohort to a Bayesian Optimal Interval (BOIN) design, starting at 200 mg/m2 with at least three patients at each dose level, to identify the maximum tolerated dose and an appropriate dose for further study. Between 12 and 40 patients are expected to participate in the dose-escalation stage.

Following review of available safety and pharmacokinetic data, the study is expected to advance into a double-blind, randomized Phase 1b expansion stage. In this dose expansion stage, 40 patients will receive one of two RC220 dose levels in combination with osimertinib. Patients will be monitored for safety, pharmacokinetics and early signals of clinical activity, including progression-free survival, overall survival, ctDNA dynamics and changes in cancer-specific mutations.

Clinical Trial Information

Further details about HARNESS-1, including open and recruiting sites, are available through the Australian New Zealand Clinical Trials Registry at www.anzctr.org.au under trial code ACTRN12626000325303. Clinical trial enquiries may be directed to Racura Oncology at [email protected].

About RC220 & (E,E)-bisantrene

RC220 is a proprietary formulation of (E,E)-bisantrene designed to overcome drug solubility issues that prevent safe peripheral intravenous infusion. (E,E)-bisantrene is a clinically validated small molecule anticancer agent that primarily functions via G4-DNA and RNA binding, leading to potent transcriptional silencing of the important cancer growth regulator MYC and downstream pathways.

(Press release, Racura Oncology, OCT 12, 2026, View Source [SID1234673332])