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])

On October 12, 2026 Citius Pharmaceuticals, Inc. ("Citius Pharma" or the "Company") (Nasdaq: CTXR), a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, reported that Chairman and Chief Executive Officer Leonard Mazur will present and host one-on-one investor meetings at two upcoming investor conferences in New York City.

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Mr. Mazur will provide an overview of the Company’s business and recent developments, including the ongoing commercialization of LYMPHIR (denileukin diftitox-cxdl) by the Company’s majority-owned subsidiary, Citius Oncology, Inc. (Nasdaq: CTOR).

Maxim Growth Summit:

Conference: 2026 Maxim Growth Summit
Dates: October 12–14, 2026
Location: Hard Rock Hotel New York, New York, NY
Investors interested in scheduling a one-on-one meeting with management should contact their conference representative or the Company’s investor relations team.

ThinkEquity Conference:

Conference: ThinkEquity Conference
Date: October 15, 2026
Location: Mandarin Oriental, New York, NY
Presentation Date & Time: Thursday, October 15, 2026, 3:00-3:30pm ET
Please note that the presentation date and time is subject to change. Participants should refer to the final program agenda for up-to-date information.

Investors interested in scheduling a one-on-one meeting with management should contact their conference representative or the Company’s investor relations team.

(Press release, Citius Pharmaceuticals, OCT 12, 2026, View Source [SID1234673331])

On October 12, 2026 Geron Corporation (Nasdaq: GERN), a hematology-focused biopharmaceutical company pursuing more meaningful moments for people living with blood cancer, reported two oral presentations and one poster presentation highlighting imetelstat in patients with lower-risk myelodysplastic syndromes (LR-MDS) at the 88th Annual Meeting of the Japanese Society of Hematology and the 2026 Annual Meeting of the German, Austrian and Swiss Societies for Hematology and Medical Oncology. These presentations will feature real-world evidence and findings from the Phase 3 IMerge trial.

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"We’re encouraged by the growing interest in imetelstat across the global hematology community, supported by both the clinical evidence from IMerge and an expanding body of real-world evidence in lower-risk MDS," said Joseph E. Eid, M.D., Executive Vice President, Research and Development and Chief Medical Officer of Geron. "These presentations provide an important opportunity to share evidence relevant to patient populations across regions and engage with clinicians as we evaluate opportunities to bring imetelstat’s potential to more people living with LR-MDS around the world."

Key takeaways from the presentations:

88th Annual Meeting of the Japanese Society of Hematology 2026

Real-World Experience With Imetelstat in Lower-Risk Myelodysplastic Syndromes: Insights From United States Claims Data (Eid, et al. Oral #O1-11C-4)
The retrospective study used closed medical and pharmacy claims with linked enrollment and laboratory data from the Komodo Health database and included adults with MDS who initiated imetelstat between June 2024 and August 2025, representing the first 14 months after the launch of imetelstat in the U.S.
In this real-world U.S. cohort (N=58), with a mean age of 75 years at diagnosis, most patients (71%) initiated imetelstat in the third line or later, with considerable anemia and a mean Charleson Comorbidity Index of 2.6 at the time of initiation.
Despite substantial comorbidity burden, most patients remained on therapy through the early months when cytopenias typically emerge (~67% at 6 months; Kaplan-Meier [KM] estimate).
Durable Clinical Outcomes With Imetelstat in Korean Patients With LR-MDS (Eid, et al. Poster #P3-12-5)
This post-hoc study explores characteristics of two Korean patients with LR-MDS who had over one year of red blood cell transfusion independence (RBC-TI) with imetelstat, and explores the relationship between cytopenias and treatment outcomes with imetelstat in 13 Korean patients from the Phase 2/3 and heart rate-corrected QT interval (QTc) substudy of IMerge.
Both patients who achieved long-term response with imetelstat experienced grade 3/4 neutropenia and grade 3/4 thrombocytopenia events early during treatment; most resolved to grade ≤2 in <4 weeks, consistent with the broader IMerge data.
Durable efficacy and manageable safety with imetelstat was exhibited in Korean patients across a range of patient and disease characteristics (sex, RS status, baseline erythropoietin [EPO], and baseline platelet levels).
In the 13 Korean patients, early cytopenias with imetelstat were associated with better clinical outcomes, as previously reported in IMerge.

2026 Annual Meeting of the German, Austrian and Swiss Societies for Hematology and Medical Oncology

Telomerase Inhibition With Imetelstat in Patients With Lower-Risk Myelodysplastic Syndromes: Integrating Molecular Findings, Cytopenias, and Clinical Outcomes (Brauer, et al. Oral #V755)
This presentation integrates key evidence from the Phase 2/3 and QTc substudy of IMerge to support clinical practice, reporting on molecular changes, cytopenias and clinical outcomes with imetelstat in LR-MDS, including emerging evidence suggesting treatment may potentially alter the underlying biology of the disease.
Transient cytopenias observed early in treatment may be the result of an on-target effect of imetelstat and may be predictive of a better therapeutic response.
Certain patients with LR-MDS and transfusion-dependent (TD) anemia who experience sustained RBC-TI (≥8-week, ≥24-week, or ≥1-year) with imetelstat may experience improved health-related outcomes, including fatigue, QUALMS Total, QUALMS-P, and QUALMS-E scores.
The presentations are available on the "Publications & Presentations" page of the Geron website.

About RYTELO (imetelstat)
RYTELO (imetelstat) is an oligonucleotide telomerase inhibitor approved in the U.S. for the treatment of adult patients with lower-risk myelodysplastic syndromes (LR-MDS) with transfusion-dependent anemia requiring four or more red blood cell units over eight weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESAs). It is indicated to be administered as an intravenous infusion over two hours every four weeks.

In addition, RYTELO is approved in the European Union as a monotherapy for the treatment of adult patients with transfusion-dependent anemia due to very low, low or intermediate risk myelodysplastic syndromes without an isolated deletion 5q cytogenetic (non-del 5q) abnormality and who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy.

RYTELO is a first-in-class treatment that works by inhibiting telomerase enzymatic activity. Telomeres are protective caps at the end of chromosomes that naturally shorten each time a cell divides. In LR-MDS, abnormal bone marrow cells often express the enzyme telomerase, which rebuilds those telomeres, allowing for uncontrolled cell division. Developed and exclusively owned by Geron, RYTELO is the first and only telomerase inhibitor approved by the U.S. Food and Drug Administration and the European Commission.

Please see RYTELO (imetelstat) full Prescribing Information, including Medication Guide, available at View Source

(Press release, Geron, OCT 12, 2026, View Source [SID1234673330])

On October 12, 2026 Lonza, the world’s leading contract development and manufacturing organization (CDMO), and Qurient Co. Ltd., a clinical-stage biopharmaceutical company, reported an exclusive license agreement for the use of Qurient’s cyclin-dependent kinase 7 (CDK7) inhibitors for dual-payload antibody-drug conjugate (ADC) applications.

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Dual-payload ADCs carry two different cytotoxic payloads on a single antibody, allowing them to attack each tumor cell through multiple mechanisms at the same time. The agreement includes Qurient’s highly selective and potent clinical stage CDK7 inhibitor designed to target multiple hallmarks of cancer.

Christian Seufert, Head of Advanced Synthesis, Lonza, commented: "Dual-payload ADCs are among the most promising areas of innovation for customers developing differentiated cancer therapies. This agreement adds a differentiated CDK7 inhibitor payload technology to Lonza’s ADC toolbox and further strengthens our ability to support customers from early technology evaluation through development, manufacturing and commercialization. With SYN-duo CC and customizable dual-payload formats, we can offer customers more choice and flexibility as they design and advance the next-generation of ADC programs."

Kiyean Nam, CEO, Qurient, added: "We believe CDK7 inhibition offers significant potential as part of the next generation of dual-payload ADCs. This agreement expands the opportunity to apply our CDK7 inhibitors across a broader range of ADC programs by combining Qurient’s CDK7 expertise with Lonza’s established ADC technology and development capabilities. We look forward to seeing SYN-duo CC and future customized formats support the exploration of new approaches for patients with unmet medical needs."

Through the agreement, Lonza will expand its ADC technology offering with SYN-duo CC, a new dual-payload that combines a topoisomerase 1 inhibitor, a camptothecin derivative and a specific CDK7 inhibitor. The novel format is intended to provide ADC developers with an additional option for designing dual-payload ADCs where the CDK7 inhibitor potentiates the activity of the topoisomerase 1 inhibitor within a single targeted therapeutic approach.

Beyond the combination of exatecan and Qurient’s CDK7 inhibitor contained within SYN-duo CC, under this agreement Lonza can leverage its existing proprietary platform to derive additional, novel combinations of Qurient’s CDK7 inhibitor with any other payload in the dual-payload ADC setting.

The agreement supports Lonza’s strategy to expand proprietary technologies that complement its integrated CDMO services. By adding access to Qurient’s CDK7 inhibitors for dual-payload ADC applications, Lonza is broadening its technology offering in ADCs, a strategically important modality where customers are seeking more flexible approaches to molecule design, development and manufacturing.

(Press release, Lonza, OCT 12, 2026, View Source [SID1234673329])