On September 15, 2026 Amplia Therapeutics Limited (ASX:ATX; OTCQB:INNMF), ("Amplia" or the "Company"), and the Australia New Zealand Gynaecological Oncology Group (ANZGOG) reported that the clinical trial protocol for the planned PRROSE Phase 2 ovarian cancer study has been finalised, marking an important milestone toward study commencement.

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 ANZGOG and Amplia teams have worked collaboratively over the last three months to finalise the PRROSE trial protocol. With this completed, submission for ethics and site governance approvals will be undertaken, with site activation and patient recruitment planned before the end of 2026.

The PRROSE trial will explore the combination of Amplia’s FAK inhibitor, narmafotinib, in combination with standard-of-care chemotherapy, in women with high-grade serous ovarian cancer (HGSOC). The study will focus on patients whose tumours demonstrate a poor response to chemotherapy prior to planned interval debulking surgery, a group with a significant unmet medical need.

The study will be led by Dr Gwo Yaw Ho of Monash Health and Monash University and will be sponsored and coordinated by ANZGOG. Approximately 26 patients across selected clinical sites in Australia and New Zealand are expected to be enrolled into the trial.

Dr Chris Burns, CEO and Managing Director of Amplia, commented: "This is an important study for a patient population who currently have limited treatment options. We are grateful to the ANZGOG team, working closely with our clinical team at Amplia, for their diligent efforts to complete the trial protocol. We now look forward to finalising ethics submissions with the goal of opening trial sites before the end of the year."

Dr Gwo Yaw Ho, Lead Investigator, said: "Completion of the study protocol enables us to move towards evaluating this promising therapeutic approach in patients with high-grade serous ovarian cancer who are at increased risk of poor outcomes. We look forward to initiating the study and exploring the potential clinical benefit of combining narmafotinib with chemotherapy."

The PRROSE study was first announced in May 20261 and is designed to explore the potential role of FAK inhibition in improving outcomes for patients with ovarian cancer.

(Press release, Amplia Therapeutics, SEP 15, 2026, View Source [SID1234670856])

On September 15, 2026 Akeso, Inc. (9926.HK) reported the presentation of positive overall survival (OS) results from the randomized, double-blind, multicenter, registrational Phase III HARMONi-2 study (AK112-303) at the 2026 World Conference on Lung Cancer (WCLC), organized by the International Association for the Study of Lung Cancer (IASLC). The study evaluated the company’s first-in-class next-generation immuno-oncology therapy, ivonescimab, versus pembrolizumab as first-line treatment for patients with PD-L1-positive (PD-L1 TPS ≥1%) locally advanced or metastatic non-small cell lung cancer (NSCLC).

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!

Professor Caicun Zhou, Principal Investigator of HARMONi-2, IASLC President, and Director of the Department of Oncology at Shanghai East Hospital, delivered an oral presentation in the session titled "The Breakthrough Immunotherapy for Advanced NSCLC," where he shared the complete results of the study.

As of the data cutoff on August 20, 2026, the median follow-up was 36 months, and a total of 234 overall survival (OS) events had occurred. For this OS analysis, a prespecified O’Brien-Fleming spending function was used, with a one-sided alpha of 0.0141.

Results showed that, compared with pembrolizumab, first-line treatment with ivonescimab significantly prolonged OS in patients with PD-L1-positive advanced NSCLC. This finding met the prespecified statistical significance threshold and demonstrated clear clinical benefit. The overall survival benefit was generally consistent across prespecified subgroups, with particularly pronounced benefit observed in the PD-L1-high population.

1. Intention-to-Treat (ITT) Population: Median OS of 30.8 Months with Ivonescimab, 27% Reduction in Risk of Death, with a Significant and Widening Long-Term Survival Advantage

In the ITT population, ivonescimab monotherapy significantly prolonged OS versus pembrolizumab, with median OS of 30.8 months versus 22.6 months (HR=0.73; 95% CI: 0.57–0.95; P=0.009), corresponding to a 27% reduction in the risk of death.
Ivonescimab demonstrated a clear long-term survival advantage over pembrolizumab, which further widened with longer follow-up: 2-year OS rates were 57.9% versus 48.0%, and 3-year OS rates were 45.0% versus 33.1%.
After treatment discontinuation, 46.0% of patients in the pembrolizumab arm received subsequent systemic therapy, compared with 36.4% in the ivonescimab arm.
2. Overcoming Traditional Anti-VEGF Treatment Restrictions: No Significant Increase in Bleeding Risk Observed in High-Risk Squamous Patients

Squamous NSCLC patients accounted for 45.5% of the HARMONi-2 population, and non-squamous patients for 54.5%. Among squamous patients treated with ivonescimab, 72.2% had central tumors, 10.0% had tumor cavitation or necrosis, and 6.7% had tumors encasing major vessels.

These populations are traditionally considered contraindicated or high-risk for anti-VEGF therapies and have long lacked effective treatment options. However, no apparent increase in bleeding risk was observed with ivonescimab, and these patients showed favorable benefit.

3. Significant OS Benefit Across PD-L1 Expression Levels, with Outstanding Benefit in the TPS ≥50% Subgroup

In the PD-L1 TPS ≥50% subgroup, median OS was not reached (NR) with ivonescimab versus 23.2 months with pembrolizumab (HR=0.58; 95% CI: 0.38–0.89).
In the PD-L1 TPS 1–49% subgroup, median OS was 28.5 months with ivonescimab versus 22.1 months with pembrolizumab (HR=0.85; 95% CI: 0.61–1.18).
4. Consistent OS Benefit by Histology, with Greater Advantage in Squamous Cell Carcinoma

In the squamous cell carcinoma subgroup, median OS was 30.5 months with ivonescimab versus 19.3 months with pembrolizumab (HR=0.65; 95% CI: 0.45–0.95).
In the non-squamous subgroup, median OS was 33.6 months with ivonescimab versus 25.6 months with pembrolizumab (HR=0.79; 95% CI: 0.55–1.14).
5. Favorable Overall Safety Profile with No New Safety Signals; Safety Characteristics Generally Consistent Between Arms

In May 2024, a prespecified interim analysis of progression-free survival (PFS) assessed by the Independent Data Monitoring Committee (IDMC) confirmed that HARMONi-2 met its primary PFS endpoint with statistically significant and clinically meaningful results. Median PFS was 11.14 months with ivonescimab versus 5.82 months with pembrolizumab (HR=0.51, P<0.0001). This indication was approved in China in 2025.

HARMONi-2 is the first randomized, double-blind, controlled Phase III clinical study globally to demonstrate statistically significant positive OS and PFS results versus pembrolizumab.

An international multicenter Phase III clinical study evaluating ivonescimab monotherapy versus pembrolizumab as first-line treatment for PD-L1-high NSCLC (HARMONi-7/AK112-3007) is currently progressing efficiently.

To date, ivonescimab has consistently achieved dual-positive OS and PFS results across multiple Phase III head-to-head trials against PD-1/L1 therapies and continues to expand into major solid tumors beyond lung cancer. The synergistic antitumor effects of ivonescimab’s dual "immuno-oncology + anti-angiogenesis" mechanism continue to be validated in both clinical research and real-world settings. Ivonescimab has the potential to provide a more effective treatment option with a manageable safety profile for cancer patients worldwide and to drive continued progress in oncology care.

(Press release, Akeso Biopharma, SEP 15, 2026, View Source [SID1234670837])

On September 14, 2026 Shanghai Allink Biotherapeutics Co.,Ltd ("Allink"), a clinical-stage biotechnology company dedicated to developing next-generation antibody-drug conjugates (ADCs) and multispecific antibodies for oncology and immunology, reported the presentation of initial data from the first-in-human Phase I clinical trial (NCT06707610) of ALK202, its internally discovered and potential best-in-class EGFR/c-MET bispecific ADC.The data were featured in a poster tour presentation (Abstract #PT2.01.03) on September 14, 2026, at the International Association for the Study of Lung Cancer (IASLC) 2026 World Conference on Lung Cancer (WCLC 2026) in Seoul, South Korea.

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 study is led by Principal Investigator Professor Caicun Zhou of Shanghai East Hospital, Tongji University School of Medicine, with Professor Fei Zhou as first author, and is being conducted across multiple clinical sites in China, Australia and the United States.

Study Design and Patient Baseline

ALK202 is under investigation in an open-label, international, multicenter Phase I study in patients with advanced solid tumors refractory to standard therapy. The dose-escalation stage (Part A) evaluated ALK202 administered every three weeks (Q3W; 1.5–6.4 mg/kg) and on Days 1 and 8 of every three-week cycle (D1/D8 Q3W; 3.2–3.6 mg/kg). The dose-expansion stage (Part B) is further evaluating the safety and efficacy profile of selected doses (2.8 or 3.2 mg/kg D1/D8 Q3W) in patients with EGFR-mutant non-small cell lung cancer (NSCLC), EGFR wild-type c-MET–positive NSCLC, c-MET–positive colorectal cancer and other solid tumors.
At the June 24, 2026 data cutoff, 71 patients had received dosing. The enrolled group represented a heavily pretreated, refractory advanced population: the median age was 61 years (range, 33–80), 90% had metastatic disease and 82% had received two or more prior lines of therapy (including 54% with three or more).
Manageable Safety Profile
Safety analysis of the 71 patients showed that treatment-related adverse events (TRAEs) occurred in 96% of patients, with Grade ≥3 TRAEs in 31%. The most common adverse events were hematologic and gastrointestinal toxicities, which were generally manageable. Notably, EGFR target-associated toxicities were infrequent, with low rates of rash (4%) and pruritus (7%). Overall, the treatment demonstrated a favorable tolerability profile, only 3% of patients discontinued treatment due to TRAEs, and no treatment-related deaths or interstitial lung disease (ILD) events were reported.

Encouraging Efficacy Data
EGFR-mutant NSCLC population (n=20): The best objective response rate (ORR) was 40% and the disease control rate (DCR) was 85%. In the D1/D8 Q3W dose groups, the ORR reached 71% (5/7) .

c-MET–positive (IHC 2+/3+ ≥50%) solid tumor population (n=20): The ORR was 40% and the DCR was 95%. In the D1/D8 Q3W dose groups, the ORR reached 83% (5/6) .

"The Phase I data for ALK202 have demonstrated clear efficacy signals in patients with c-MET–positive solid tumors and EGFR-mutant NSCLC," said Dr. Hui Feng, Founder and Chief Executive Officer of Allink Biotherapeutics. "We will accelerate enrollment in the dose-expansion stage to further explore c-MET as a biomarker-driven population across EGFR wild-type NSCLC, colorectal cancer and additional solid tumors. At the same time, these monotherapy results in late-line NSCLC provide a stronger data foundation for advancing combination treatment strategies into first-line setting. We believe that, with its differentiated molecular design and growing body of international multicenter clinical evidence, ALK202 has the potential to become a best-in-class EGFR/c-MET bispecific ADC, bringing meaningful benefit to patients in China and around the world as early as possible."

About ALK202

ALK202 is Allink’s internally discovered first-in-class EGFR/c-MET bispecific antibody-drug conjugate, comprising the topoisomerase I inhibitor exatecan conjugated via a cleavable, highly hydrophilic linker. Its antitumor activity is mediated through multiple mechanisms: dual blockade of the EGFR and c-MET pathways, antibody-dependent cellular cytotoxicity (ADCC), targeted payload delivery, and a bystander killing effect. EGFR and c-MET are key oncogenic drivers and resistance-associated targets in NSCLC and multiple other solid tumors. ALK202 has the potential to offer a new treatment option for patients with EGFR-mutant NSCLC and solid tumors with high c-MET expression. A Phase I clinical study of ALK202 in advanced solid tumors (NCT06707610) is actively advancing, and a Phase II clinical study in lung cancer (NCT07603791) is also underway.

(Press release, Shanghai Allink Biotherapeutics, SEP 14, 2026, View Source [SID1234670857])

On September 14, 2026 Bionano Genomics, Inc. (Nasdaq: BNGO) reported three new independently authored, peer-reviewed publications demonstrating the clinical utility of OGM in high-risk hematologic malignancies — myelodysplastic syndromes (MDS), acute myeloid leukemia (AML), and therapy-related myeloid neoplasms (t-MN). The studies, published in Modern Pathology, the International Journal of Cancer, and npj Precision Oncology, reinforce a growing body of evidence that OGM can detect prognostically important structural genomic alterations that elude standard karyotyping, FISH, and targeted sequencing panels.

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!

MD Anderson Cancer Center: Chromoanagenesis by OGM defines an ultra-high-risk MDS subset.

Researchers at The University of Texas MD Anderson Cancer Center, led by Guilin Tang, PhD, used OGM to study 332 samples from subjects with MDS, identifying chromoanagenesis (CAG), a catastrophic single-event genomic restructuring process, in 15.9% of cases overall and 17.6% of newly diagnosed subjects. The study, published in Modern Pathology (Wei et al., 2026), found that:

CAG-positive by OGM subjects had a median overall survival of just 9.9 months, significantly shorter than non-CAG subjects where median survival was not reached.
CAG by OGM showed the potential to confer prognostic information beyond existing risk-stratification systems, potentially enabling the identification of patients for early allogeneic transplantation or TP53-targeted clinical trials.

University of Oulu: Cryptic structural variants uncovered in "normal karyotype" AML.

A separate study from the University of Oulu and collaborators, led by Tuomo Mantere, PhD, used OGM to analyze 48 samples of cytogenetically normal AML (CN-AML) — a subgroup that appears unremarkable on standard karyotyping but is clinically heterogeneous. Published in the International Journal of Cancer (Turtinen et al., 2026), the study found that:

OGM detected clinically relevant structural variants or copy-neutral loss-of-heterozygosity in 46% of cases classified as "normal" by conventional karyotyping.
Recurrent alterations included KMT2A partial tandem duplications (10% of cases), RUNX1 disruptions, NF1 deletions, and a novel putative FOXP1:EYA2 fusion not previously reported in the literature.
Subjects with OGM-detected abnormalities had significantly worse overall survival than those without (p = 0.005).

Josep Carreras Leukaemia Research Institute: OGM refines risk in therapy-related neoplasms and younger MDS.

A multicenter Spanish study led by Mar Mallo, PhD, and Francesc Solé, PhD, at the Josep Carreras Leukaemia Research Institute in collaboration with a Spanish hospital network applied OGM to two clinically distinct: 48 subjects with therapy-related myeloid neoplasms (t-MN) and 65 subjects with younger-onset MDS (yMDS, age ≤60). Published in npj Precision Oncology (Mestre et al., 2026), the study found that:

OGM was interpretable in 100% of samples, including all 8 cases where conventional banding analysis (CBA) failed due to lack of dividing cells, and identified 134 additional genomic alterations.
OGM refined cytogenetic classification in 52.0% of karyotypically abnormal cases and detected clinically relevant structural alterations in 9.8% of cases with a normal karyotype, including reclassification of subjects into the therapeutically relevant MDS with isolated 5q- category.
OGM-defined genomic complexity was independently associated with overall survival; chromoanagenesis emerged as the strongest independent predictor of inferior survival in multivariable analysis (HR 9.26), exceeding even TP53 mutation status.
Integrating OGM findings into IPSS-R and IPSS-M scoring shifted 16.7% of t-MN and up to 12.8% of yMDS subjects into higher-risk prognostic categories, which could have implications for treatment planning, including identification of biallelic TP53 inactivation.

Key highlights across all three studies:

Three independent academic centers, spanning the U.S., Finland, and Spain, each show the potential for OGM to identify clinically actionable genomic complexity that conventional cytogenetic workups miss.
All three studies link OGM findings directly to overall and/or disease-specific survival.
Findings support a potential role for OGM in refining prognostication beyond IPSS-R/IPSS-M and ELN2022 classification systems, including in patients who otherwise appear lower-risk by standard testing, and in cases where conventional karyotyping fails outright due to lack of dividing cells.
Across all three cohorts, chromoanagenesis and TP53 disruption consistently emerge as markers of a biologically distinct, ultra-high-risk disease subset best captured by genome-wide structural variant detection.

"These three independent studies, spanning MDS, AML, and therapy-related myeloid neoplasms, all point to the same conclusion: a meaningful fraction of high-risk genomic complexity in myeloid malignancies is simply invisible to conventional karyotyping," said Al Luderer, PhD, chairman and interim chief executive officer of Bionano. "As OGM adoption continues to expand, we expect to see more of this kind of evidence connecting structural variant detection directly to potential patient outcomes and treatment decisions."

(Press release, Bionano Genomics, SEP 14, 2026, View Source [SID1234670855])

On September 14, 2026 Asimov, the company building an AI-native synthetic biology platform to advance therapeutic development, reported a cell line development partnership with Sidewinder Therapeutics, a biopharmaceutical company pioneering the development of next-generation bispecific ADCs (antibody-drug conjugates) for the treatment of cancer. As part of a broader collaboration across multiple products, Asimov successfully delivered a cell line for Sidewinder’s bispecific antibody candidate for solid tumors.

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 excited to be partnering with Sidewinder Therapeutics to advance their novel bispecific, which represents a powerful approach to targeting and treating solid tumors," said Alec Nielsen, co-founder and CEO at Asimov. "Complex molecules such as Sidewinder’s 4-chain bispecific can be challenging to express, and achieving such high titers for this molecule is a testament to the strength of both our team and our CHO Edge System."

Asimov has worked closely with the Sidewinder team on a custom cell line development program for this 4-chain bispecific antibody. In order to achieve the required expression levels and quality attributes, Sidewinder relied on Asimov’s CHO Edge system, which combines a GS knock-out CHO host, hyperactive transposase, genetic parts library, and Kernel, Asimov’s AI-driven genetic design software.

"With a pipeline of first-in-class bispecific ADCs, we needed to find a cell line development partner with the technical capabilities required to deliver high expression levels while simultaneously achieving consistent product quality," said Eric Murphy, Ph.D., co-founder and CEO at Sidewinder. "The team at Asimov has exceeded expectations, and we’re excited to be progressing toward the clinic with such a high performing cell line."

(Press release, Sidewinder Therapeutics, SEP 14, 2026, View Source [SID1234670854])