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Poster Presentation Demonstrating Combination Benefit of Narmafotinib in Preclinical Kras-Mutated Cancer Models

On March 9, 2026 Amplia Therapeutics Limited (ASX:ATX; OTCQB:INNMF), ("Amplia" or the "Company"), reported that compelling data describing new clinical opportunities for its lead drug narmafotinib was presented at the AACR (Free AACR Whitepaper) Special Conference in Cancer Research: RAS Oncogenesis and Therapeutics in Los Angeles, California on Friday March 6.

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The poster presentation discloses preclinical data demonstrating that the Company’s best-in-class FAK inhibitor narmafotinib enhances the activity of a new class of drugs called kRAS inhibitors in various models of cancer. In particular, the data indicates that narmafotinib blocks resistance pathways that can emerge with kRAS inhibitor treatment, thereby enhancing efficacy and durability of response.

A copy of the poster is available on the Company’s website.

Inhibitors of mutant kRAS proteins are an exciting new class of drug in development for the treatment of lung, colon and pancreatic cancer, amongst others. There are currently over 50 different kRAS inhibitors undergoing clinical studies across the globe. Despite promising mid-stage clinical data, however, side-effects of these drugs can be significant and treatment-emergent resistance is commonplace.

Dr Chris Burns, CEO of Amplia, commented, "We are excited to present our research findings at this specialist conference focused on RAS inhibition in cancer. We believe there is significant clinical potential in combining narmafotinib with kRAS inhibitors and will be discussing our findings with pharma and biotech companies actively working in this space."

(Press release, Amplia Therapeutics, MAR 9, 2026, View Source [SID1234663397])

Junshi Biosciences Announces NMPA Acceptance of New Drug Applications for Toripalimab Injection (Subcutaneous) Across 12 Indications

On March 9, 2026 Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, reported that the new drug applications (the "NDAs") for the company’s product, toripalimab injection (subcutaneous injection [code: JS001sc]), for 12 indications in the treatment of tumors has been accepted by the National Medical Products Administration ("NMPA"). JS001sc is the first domestic anti-PD-1 monoclonal antibody in a subcutaneous formulation to enter the marketing application stage.

According to data released by GLOBOCAN 2022, in 2022, there were 4.8247 million new cancer cases and 2.5742 million cancer-related deaths in China. Immunotherapy (I-O), represented by anti-PD-1 monoclonal antibodies, has become a cornerstone treatment for various malignant tumors, including lung cancer, breast cancer, liver cancer, esophageal cancer, and nasopharyngeal carcinoma. Now, immunotherapy covers nearly all stages of treatment for cancer patients, encompassing adjuvant/neoadjuvant treatment for early-stage tumors, consolidation treatment after radical chemoradiation for locally advanced tumors, and first-line to last-line treatments for advanced tumors. Currently, most immunotherapy drugs in China are administered intravenously, and this not only requires lengthy infusion times, but also imposes significant inconveniences on patients. There is an urgent clinical need for more convenient administration methods for immunotherapy.

Independently developed by Junshi Biosciences, JS001sc injection is a subcutaneous injection based on the marketed product toripalimab injection (code: JS001) that is expected to enhance convenience for patients. The 12 indications in the JS001sc NDAs cover all currently approved indications of toripalimab injection in the Chinese Mainland.

The NDA is mainly based on the JS001sc-002-III-NSCLC Study (NCT06505837), a multi-center, open-label, randomized phase 3 clinical study led by principal investigator Professor Lin WU from Hunan Cancer Hospital. The study aimed to compare the exposure, efficacy and safety of JS001sc plus chemotherapy versus JS001 plus chemotherapy for the first-line treatment of recurrent or metastatic non-squamous non-small-cell lung cancer ("NSCLC"). The results showed that JS001sc’s exposure was non-inferior to that of JS001 with comparable efficacy and safety profiles. JS001sc-002-III-NSCLC was the first phase 3 clinical study of domestic anti-PD-1 monoclonal antibody in a subcutaneous formulation. Further details will be presented at an upcoming international academic conference.

Professor Lin WU said, "The JS001sc-002-III-NSCLC study, as China’s first Phase 3 clinical trial of a domestically developed PD-1 monoclonal antibody in a subcutaneous formulation, confirmed that the subcutaneous administration method achieved statistical non-inferiority in drug exposure compared with intravenous administration, while demonstrating comparable efficacy and safety. This milestone not only validates the scientific rationale behind the pharmaceutical development of the subcutaneous formulation, but also provides a novel administration pathway for cancer immunotherapy at the clinical level. In the current era of holistic cancer management, treatment convenience and improved quality of life have become critical clinical priorities. The development and application of subcutaneous injection formulations are expected to significantly reduce dosing time, optimize healthcare resource allocation, and offer new technical support for advancing hierarchical medical systems and home-based treatment management. We anticipate the early approval of the subcutaneous formulation of toripalimab, which will further enrich China’s cancer immunotherapy landscape and ultimately benefit a broader population of cancer patients."

Dr. Jianjun ZOU, General Manager and CEO of Junshi Biosciences, said, "We are excited that the NMPA has formally accepted the NDA for JS001sc covering all approved indications of TUOYI (toripalimab). This signifies JS001sc’s potential to address multiple tumor types, including NSCLC, nasopharyngeal carcinoma, esophageal cancer, renal cancer, and liver cancer. It also marks another critical milestone in expanding toripalimab’s innovative and clinical value. As a subcutaneous formulation, JS001sc will substantially enhance dosing convenience, optimize patient treatment experiences, and improve long-term therapy adherence. Moving forward, we will actively advance the regulatory review process, consistently centering patient needs. Using our clinical evidence, we hope to leverage evidence-based medicine to advance high-quality development of China’s cancer therapies, ultimately delivering more accessible, convenient, and high-quality treatment options to patients."

About JS001sc

JS001sc is a subcutaneous injection formulation developed by Junshi Biosciences based on the marketed product toripalimab injection (code: JS001). It is the first domestic anti-PD-1 monoclonal antibody in a subcutaneous formulation to enter the marketing application stage and is expected to bring convenient administration to patients. The 12 indications in the NDAs of JS001sc covers all currently approved indications of toripalimab injection in the Chinese Mainland.

(Press release, Shanghai Junshi Bioscience, MAR 9, 2026, View Source [SID1234663396])

ProstACT Global Phase 3 Study (Part 1) Achieves Primary Objectives

On March 9, 2026 Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") reported that Part 1 of the ProstACT Global Phase 3 study, the safety and dosimetry lead-in for its therapeutic candidate – TLX591-Tx (lutetium-177 (177Lu) rosopatamab tetraxetan) – has achieved its primary objectives, demonstrating an acceptable safety and tolerability profile with no new safety signals observed.

Key findings include:

Tolerability profile supported by dosimetry and low-grade non-hematologic events.
Lesion dosimetry indicates no difference in absorbed dose profile across cohorts.
No adverse drug-drug interactions observed in TLX591-Tx combinations.
Hematologic events are in line with expectations and transient and manageable, with similar rates of recovery across all patient cohorts.
The results from Part 1 are consistent with prior clinical studies of this first-in-class lutetium radio antibody-drug conjugate (rADC) therapy.
Part 1 of the study confirmed the safety profile, biodistribution and dosimetry of TLX591-Tx administered in two doses, 14 days apart, in combination with one of three standard of care (SOC) therapies: abiraterone, enzalutamide or docetaxel. The patient population comprised prostate-specific membrane antigen (PSMA) positive metastatic castration resistant prostate cancer (mCRPC) patients previously treated with one androgen receptor pathway inhibitor (ARPI).

ProstACT Global is a differentiated Phase 3 trial comparing PSMA-targeted 177Lu-rADC therapy administered with SOC versus SOC alone, a trial design intended to reflect current global clinical practice1. Telix has already advanced the study into Part 2 – a 2:1 randomized treatment expansion – in jurisdictions where the clinical trial has obtained approval from health authorities2. Part 1 data will be presented to the United States (U.S.) Food and Drug Administration (FDA) to seek an Investigational New Drug (IND) amendment to progress Part 2 in the U.S.

Neeraj Agarwal, MD, Professor of Medicine and Presidential Endowed Chair of Cancer Research at Huntsman Cancer Institute, Salt Lake City, and ProstACT Global Principal Investigator and Steering Committee member, commented, "These results reinforce the feasibility of integrating TLX591-Tx with current standard of care therapies for mCRPC, including ARPIs such as enzalutamide or abiraterone, or docetaxel. Hematologic events align with those typically seen in this patient population and therapeutic class, and these cases resolved quickly. The dosimetry profile, along with the low-grade nature of non-hematologic adverse events, further supports the tolerability profile of this investigational therapy."

David N. Cade, MD, Group Chief Medical Officer, Telix added, "Despite advances in clinical practice, men with advanced prostate cancer still need improved first and second line treatment options. These results build on prior findings and highlight the potential for TLX591-Tx in combination with contemporary standard of care, to become a new first-line option for patients facing this aggressive disease. We are encouraged by the data and look forward to engaging with the FDA at the earliest opportunity, while continuing to advance enrollment in Part 2 in regions where clinical trial initiation has already been approved."

Summary results

ProstACT Global Part 1 dosed 36 patients, allocated across 3 cohorts:

Cohort 1 (11 patients): TLX591-Tx + enzalutamide.
Cohort 2 (11 patients): TLX591-Tx + abiraterone.
Cohort 3 (14 patients): TLX591-Tx followed by docetaxel.
Safety and tolerability

An acceptable safety profile was observed across combination cohorts and tolerability of TLX591-Tx was consistent with prior studies.
All 36 patients received both doses of TLX591-Tx per protocol, no new safety signals were observed.
Almost all treatment-emergent non-hematologic events were Grade 1 or Grade 2. The most prevalent were fatigue (53%), nausea (28%) and dry mouth (25%).
Hematologic events were transient and manageable.
Grade 3 thrombocytopenia (14%) and neutropenia (22%), and Grade 4 thrombocytopenia (31%) and neutropenia (25%) events were in line with the profile expected for this class of therapy and extent of disease.
Dosimetry and biodistribution

Radiation exposure to key organs was well below established safety limits3.
Limited dose to salivary glands and kidneys.
Lesion dosimetry demonstrated uptake across tumor sites and across all cohorts.
Pharmacokinetics demonstrated sustained activity at 15 days, corroborated by imaging which demonstrated prolonged tumor retention.
No evidence of drug-drug interactions impacting TLX591-Tx targeting, distribution or clearance.
About ProstACT Global

ProstACT Global (ClinicalTrials.gov ID: NCT06520345) is an international, multicenter trial in two parts: Part 1, safety and dosimetry lead-in with 36 patients (complete); and Part 2, 2:1 randomized global expansion with an overall target enrollment of approximately 490 patients. Eligible patients must have confirmed progressive mCRPC assessed with a 68Ga-PSMA-11 PET4 imaging agent (such as Illuccix, kit for the preparation of gallium-68 (68Ga) gozetotide injection, or Gozellix, kit for the preparation of gallium-68 (68Ga) gozetotide injection) following prior treatment with one ARPI.

The antibody approach demonstrates different targeting and pharmacology to that observed in other PSMA-targeted small molecule radioligand therapies (RLT). In contrast to these therapies5, collective long-term follow-up of patients administered with TLX591-Tx has not observed significant acute or delayed kidney toxicity, as the agent is primarily cleared through the liver, a comparatively radioresistant organ, instead of the kidneys6. Due to its large molecular weight, TLX591-Tx also demonstrates minimal salivary and lacrimal gland uptake, reducing dry mouth and dry eyes, common adverse effects of existing PSMA-targeted RLTs7.

Additional information on the Phase 3 ProstACT Global study can be found at: View Source

(Press release, Telix Pharmaceuticals, MAR 9, 2026, View Source [SID1234663395])

kyron.bio Announces Strategic Partnership with Servier to Advance Precision Glycosylation in Antibody Therapeutics

On March 9, 2026 kyron.bio, a biotechnology company pioneering precision glycoengineering for antibody therapeutic development, reported a strategic partnership with Servier, an international pharmaceutical group governed by a Foundation.

Under the terms of the agreement, kyron.bio will use its technology to glycoengineer an antibody selected by Servier, who will fund the associated research activities. Servier will have the option to further explore antibody engineering and development opportunities based on the outcomes. Financial details are not disclosed.

kyron.bio’s proprietary glycoengineering platform can enhance therapeutic performance of antibodies by enabling precise control of the glycan structures to improve efficacy, safety, and scalability. In this partnership kyron.bio will seek to demonstrate clear glycan control on the Servier antibody of interest for a specific pre-determined N-glycoform.

To date, engineering of glycans have been under-exploited, due to technical challenges, limiting the use of glycan engineering in drug design. kyron.bio is changing that. The company has developed a scalable, proprietary method to achieve comprehensive control over glycosylation, unlocking the possibility to use precision glycosylation in next generation drug design.

Dr. Emilia McLaughlin, founder and Chief Executive Officer of kyron.bio, said,

"We are delighted that Servier has chosen to explore the potential of our glycoengineering platform. Servier has deep expertise in therapeutic development and combined with our precision glycosylation technology, this partnership provides a powerful opportunity to unlock new levels of antibody performance and deliver better outcomes for patients.

"Precision glycosylation represents a transformative approach in biologics development. By engineering defined glycan profiles, therapeutic antibodies can be optimized for improved immune engagement, pharmacokinetics, and reduced variability."

In 2024, kyron.bio was the winner of the Servier Golden Ticket award which has provided invaluable support and mentorship through the company’s early translational phase and has developed a foundation for understanding the potential of kyron.bio’s technology.

Dr. Emmanuel Nony, Director of External Innovation Europe at Servier, said,

"Meeting kyron.bio as a winner of Servier’s Golden Ticket award has enabled our scientists to develop an understanding of the kyron.bio glycan engineering technology and its exciting possibilities in antibody drug design. This collaboration is opening new frontiers for antibody derivatives as well. Together, we are exploring innovative pathways to optimize drug design and production, with a shared commitment to bringing safer and more effective therapies to patients."

kyron.bio’s strategy is to form strategic drug design partnerships with pharmaceutical and biotech companies working on next-generation antibody therapeutics, alongside in house therapeutic development programs.

A successful company creation from the French Entrepreneur First Scheme, in 2025 kyron.bio raised €5.5m in a seed round from an experienced syndicate of venture investors including HCVC, Verve Ventures, Entrepreneurs First and Saras Capital, as well as private angel investors and the European Innovation Council. It has established an R&D base at the biotech hub Paris Biotech Santé in the Cochin Hospital.

(Press release, Servier, MAR 9, 2026, View Source [SID1234663394])

European Commission approves AKEEGA® (niraparib and abiraterone acetate dual action tablet) for the treatment of patients with BRCA1/2-mutated metastatic hormone-sensitive prostate cancer (mHSPC)

On March 9, 2026 Johnson & Johnson reported that the European Commission (EC) has approved an indication extension for AKEEGA (niraparib and abiraterone acetate dual action tablet) with prednisone or prednisolone (AAP) in combination with androgen deprivation therapy (ADT), for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) and BRCA1/2 mutations (germline and/or somatic).

"Patients with BRCA-mutated metastatic prostate cancer often experience rapid progression on the current standard of care, highlighting a significant unmet need for more personalised treatment approaches that address the underlying biology of their disease," said Dr. Elena Castro, Medical Oncologist, Hospital 12 de Octubre, Madrid* "Today’s approval of niraparib in combination with abiraterone acetate introduces a new precision-based treatment option for these patients, with the potential to delay progression."

AMPLITUDE efficacy results

The approval is supported by data from the Phase 3 AMPLITUDE study, which evaluated the efficacy and safety of the niraparib/AAP combination compared with placebo plus AAP in 696 patients with mHSPC and homologous recombination repair (HRR) gene alterations.1 The primary analysis of the study demonstrated clinically meaningful and statistically significant improvements in its primary endpoint of radiographic progression-free survival (rPFS).1 Patients with BRCA1/2 mutations showed the greatest benefit of treatment with the niraparib/AAP combination (n=191), as after 30.7 months of follow-up, the median rPFS was not yet reached compared to 26 months in patients treated with the placebo plus AAP (n=196), corresponding to a reduction in the risk of radiographic progression or death by 48 percent (hazard ratio [HR] 0.52, 95 percent confidence interval [CI], 0.37-0.72, p<0.0001).1,3 Treatment with the niraparib/AAP combination also significantly prolonged the time to symptomatic progression in patients with BRCA mutations (HR 0.44, 95 percent CI, 0.29-0.68, p=0.0001).1 The second interim analysis of overall survival was consistent with the first interim analysis and favoured the niraparib/AAP combination, with a 20 percent reduction in risk of death (HR 0.80, 95 percent CI, 0.58-1.11) in patients with BRCA mutations.3 Follow-up is ongoing.4

"This expanded indication for niraparib and abiraterone acetate reflects our commitment to delivering transformative innovation across the prostate cancer continuum," said Charles Drake, M.D., Ph.D., FAAP, Vice President, Prostate Cancer and Immunotherapy Disease Area Leader, Johnson & Johnson. "Niraparib and abiraterone acetate is the first precision-medicine combination treatment approved for patients with BRCA1/2-mutated metastatic hormone-sensitive prostate cancer and is supported by strong clinical data demonstrating a clinically meaningful delay in disease progression."

AMPLITUDE safety results

The safety profile of the niraparib/AAP combination in mHSPC was consistent with that observed in metastatic castration-resistant prostate cancer (mCRPC), for which the niraparib/AAP combination is already authorised.1,5 The most common Grade 3/4 adverse events (AEs) with the niraparib/AAP combination were anaemia and hypertension; however, treatment discontinuations due to AEs remained low and adverse events were managed with dose modifications and supportive care.1

Data from the AMPLITUDE study were presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and selected for inclusion in the Best of ASCO (Free ASCO Whitepaper) and ASCO (Free ASCO Whitepaper) Press Programme.6

"Today’s EC approval shifts the treatment paradigm and brings new hope to those facing a metastatic prostate cancer diagnosis," said Henar Hevia, Ph.D., Senior Director, EMEA Therapeutic Area Head, Oncology, Johnson & Johnson. "By bringing niraparib and abiraterone acetate earlier into the treatment pathway, in the hormone-sensitive setting, we can intervene at a point where it may have the greatest impact in helping change the trajectory of the disease for patients with BRCA1/2-mutated tumours."

About AMPLITUDE
AMPLITUDE (NCT04497844) is an ongoing, Phase 3, randomised, double-blind, placebo-controlled, international, multicentre study evaluating the efficacy and safety of niraparib and abiraterone acetate in a dual action tablet (DAT) formulation with prednisone plus ADT compared to matching oral placebo/abiraterone acetate in a DAT formulation with prednisone plus ADT in patients with deleterious germline or somatic homologous recombination repair (HRR) gene-altered metastatic hormone-sensitive prostate cancer (mHSPC).4 The primary endpoint is radiographic progression-free survival (rPFS).4 The study enrolled 696 participants from 32 countries.1

About Niraparib and Abiraterone Acetate
This orally administered, DAT consists of a combination of niraparib, a highly selective poly (ADP-ribose) polymerase (PARP) inhibitor, and abiraterone acetate, a CYP17 inhibitor.3,4 Niraparib combined with abiraterone acetate and given with prednisone or prednisolone was authorised in April 2023 in the European Economic Area for the treatment of patients with BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated.5 Niraparib and abiraterone acetate is also approved in the USA, Canada, Switzerland, United Kingdom and many more countries. Additional marketing authorisation applications are under review across a number of countries globally.

In April 2016, Janssen Biotech, Inc. entered into a worldwide (except Japan) collaboration and license agreement with TESARO, Inc. (acquired by GSK in 2019), for exclusive rights to niraparib in prostate cancer.7

For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using niraparib and abiraterone acetate, please refer to the Summary of Product Characteristics.3

About Metastatic Hormone-Sensitive Prostate Cancer
Metastatic hormone-sensitive prostate cancer, also known as metastatic castration-sensitive prostate cancer (mCSPC), refers to prostate cancer that still responds to ADT and has spread to other parts of the body.

(Press release, Johnson & Johnson, MAR 9, 2026, View Source [SID1234663393])