On January 15, 2026 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, reported a number of updates on the SECuRE trial following an SRC meeting. The SRC has recommended that the trial continue with the Cohort Expansion Phase (Phase II) as planned with no modifications to the protocol. The interim results assessed by the SRC were collected from nine participants enrolled in the cohort that had evaluable data by the cut-off date of the 25th of November 2025 and continue to show promising efficacy and a favourable safety profile of 67Cu-SAR-bisPSMA.

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The majority of the nine participants had bone metastasis at enrolment (66.7%) and received multiple lines of previous treatments (more than 5 previous anti-cancer regimens, 55.6%). Median PSA prior to 67Cu-SAR-bisPSMA treatment was 18.9 ng/mL (range 1.5-30.2 ng/mL). Six out of these nine participants received at least 2 cycles of 8 GBq of 67Cu-SAR-bisPSMA each, with two of them also receiving concomitant enzalutamide.

Of the nine participants included in this SRC analysis, six had at least two PSA results following their 67Cu-SAR-bisPSMA treatment by the data cut-off date. Of these six participants, thus far four (66.7%) showed reductions in PSA of 50% or more (PSA50) and two (33.3%) showed reductions of 80% or more (PSA80).

The safety profile of 67Cu-SAR-bisPSMA remains favourable in the Cohort Expansion, with the majority of related AEs being Grade 1 or 2. The most common related AEs were nausea and lymphopenia (observed in three out of nine participants [33.3%], for each AE). The only AE that was Grade 3 or above was lymphopenia observed in three participants, some of whom had bone metastasis at baseline and/or had received multiple lines of therapy, including taxane and an investigational agent, prior to enrolment in the SECuRE study. There have been no overall renal toxicity or electrocardiogram (ECG) changes observed in these participants. In the combination enzalutamide arm, no new AEs (or worsening of AEs) related to 67Cu-SAR-bisPSMA have been observed to date.

Trial participant with no detectable disease after 3 cycles of 67Cu-SAR-bisPSMA

One of the participants in the Cohort Expansion was a 64-year-old man with bone metastases and baseline PSA of 5.4 ng/mL prior to entering the SECuRE study. Following his first cycle of 67Cu-SAR-bisPSMA, this participant showed a dramatic 95.2% reduction in PSA. He went on to receive 2 more cycles of 67Cu-SAR-bisPSMA and achieved undetectable PSA levels. In a follow-up bone scan and CT no metastatic disease was observed. This participant only exhibited mild (Grade 1) related AEs, most of which were gastrointestinal events, with no haematological or renal AEs observed. The participant reported having excellent quality of life following the treatment.

The interim data from this Phase II continues to confirm the favourable safety profile and promising efficacy seen in previous cohorts of the SECuRE trial1 and supports the continuation of the trial with the aim to progress to a registrational Phase III study.

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "SAR-bisPSMA continues generating world-class data in both theranostic and diagnostic trials. The combination of the optimised dimer "bis" structure with the benefits of copper isotopes, enabled by the proprietary sarcophagine technology, is proving to have created a product that is here to challenge the current treatment and diagnostic paradigms in radiopharmaceuticals.

"We have already seen a glimpse of the effects of 67Cu-SAR-bisPSMA through our Dose Escalation cohorts with additional and similar data being generated in the Cohort Expansion phase, demonstrating once again excellent efficacy and safety results of 67Cu-SAR-bisPSMA.

"All of the participants with evaluable data treated in the Phase II to date have shown declines in PSA, with the majority showing PSA decreases of more than 50% and mostly having only mild or moderate AEs. Most of these patients have been treated with more than 5 systemic treatment regiments and had bone metastasis prior to entering the SECuRE study. Although the number of participants with evaluable data to date is small, it is incredible to see yet another extraordinary case where a patient who had bone metastasis prior to entering the study achieved undetectable PSA following 67Cu-SAR-bisPSMA treatment, with no disease observed by anatomical and molecular imaging at the last assessments. This participant only experienced mild, transient AEs, most being gastrointestinal, and has reported having excellent quality of life following the treatment.

"Importantly, the work we have undertaken during the Dose Escalation Phase is now continuing to provide a strong foundation for us as we look ahead at protocol development and dosing for our Phase III clinical trial and commercialisation. As the participant numbers continue to increase with the trial enrollment, we continue to see very promising responses over and over again, giving us more confidence about the future of this product and its potential for commercialisation in metastatic castration-resistant prostate cancer (mCRPC). With three Fast Track Designations for the SAR-bisPSMA product and positive interactions with the US Food and Drug Administration (FDA) to date, we are working towards bringing this agent to clinicians and their patients around the world through the entirety of the prostate cancer journey, from first diagnosis to late-stage disease. All of these indications, being imaging in pre-definitive therapy and biochemical recurrence, as well as therapy in mCRPC, are blockbuster markets individually for prostate-specific membrane antigen (PSMA) targeted products, with an estimated combined market value of approximately US$10-15 billion by 2030. We are committed to continuing the development of this product, aiming to bring improved diagnostic and treatment options for prostate cancer in various stages of their disease."

About the SECuRE trial
The SECuRE trial (NCT04868604)2 is a Phase I/IIa theranostic trial for identification and treatment of participants with PSMA-expressing mCRPC using 64Cu/67Cu-SAR-bisPSMA. 64Cu-SAR-bisPSMA is used to visualise PSMA-expressing lesions and select candidates for subsequent 67Cu-SAR-bisPSMA therapy. The trial is a multi-centre, single arm, dose escalation study with a cohort expansion involving approximately 54 participants in the US. The overall aim of the trial is to determine the safety and efficacy of 67Cu-SAR-bisPSMA for the treatment of prostate cancer.

The SECuRE trial consists of the Dose Escalation (Phase I) and Cohort Expansion (Phase II) Phases. Based on the data from the Dose Escalation Phase, which demonstrated a favourable safety profile and efficacy of 67Cu-SAR-bisPSMA, the SECuRE trial progressed to the Cohort Expansion (Phase II) at an 8 GBq dose level as per the SRC recommendation (up to 6 cycles per patient in total)3.

Cohort 2 of the Dose Escalation phase of the trial, where participants were dosed with 8 GBq of 67Cu-SAR-bisPSMA, demonstrated a very low rate of related AEs while all three participants achieved PSA declines of 80% or more (PSA80)1. The Dose Escalation Phase also showed high PSA response rates of the mCRPC in the pre-chemotherapy setting with a favourable safety profile: 92% of pre-chemotherapy participants (12/13) demonstrated PSA drops greater than 35%, PSA reductions greater than 50% were reached in 61.5% (8/13) of participants, and reductions of 80% or more were achieved in 46.2% (6/13) of participants1. These results supported the progress of the trial to its Cohort Expansion Phase using 8 GBq multi-dose in participants who had not received chemotherapy in the mCRPC setting.

Recruitment is currently ongoing into the Cohort Expansion Phase which will include 24 participants. A subset of participants will be treated with the combination of 8 GBq of 67Cu-SAR-bisPSMA with enzalutamide (androgen receptor pathway inhibitor [ARPI]), in line with the positive results from the Enza-p trial4 and previous discussions with and advice from key global medical experts in the field of prostate cancer, including the Company’s Clinical Advisory Board members, Prof Louise Emmett and Prof Oliver Sartor, as well as the SRC.

About SAR-bisPSMA
SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two PSMA-targeting agents to Clarity’s proprietary sarcophagine (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a Targeted Copper Theranostic (TCT) that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.

About Prostate Cancer
Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death in men worldwide5. Prostate cancer is the second-leading causes of cancer death in American men. The American Cancer Institute estimates in 2025 there will be about 313,780 new cases of prostate cancer in the US and around 35,770 deaths from the disease.

(Press release, Clarity Pharmaceuticals, JAN 15, 2026, View Source [SID1234662039])

On January 15, 2026 Oxford Vacmedix (OVM), the UK-based biotech company developing novel immunotherapies to treat cancer reported the publication of the Phase 1a results in eClinical Medicine, a journal of the Lancet group. The Phase 1 clinical trial of OVM-200, which is now nearing completion, is a multicentre, open‑label, first‑in‑human evaluation of OVM‑200, an immunotherapy developed using Oxford Vacmedix’s Recombinant Overlapping Peptide (ROP) therapeutic platform. Patients with advanced non‑small cell lung cancer, ovarian cancer, or prostate cancer are being treated in the trial. In Phase 1a 12 patients received three subcutaneous doses (250, 500, 1,000, or 2,000μg) of OVM‑200 at 2‑week intervals.

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The results demonstrate very good progress toward the primary and secondary endpoints for the trial;

Excellent Safety Profile (primary endpoint): OVM‑200 is very well tolerated at all dose levels. There have been no serious adverse drug reactions and no dose‑limiting toxicities. The only adverse effects were Grade 1 injection‑site reactions.
Very strong Immunogenicity (secondary endpoint): the immune response for both antibodies and T cells has been measured. Both measurements showed a very strong immune response with the antibody response being sustained over 6 months. The 2,000μg cohort generated the strongest immune response.
Therapeutic Dose established for Phase 1b: based on the immune response seen the 2,000μg dose was chosen for the Phase 1b continuation of the trial. Patients could receive up to 11 doses of 2,000μg in Phase 1b.
Professor Shisong Jiang, founder and Chief Scientific Officer of Oxford Vacmedix, said:

We are very pleased to have this publication of the first clinical results for immunotherapies developed using our ROP technology – our first step toward providing accessible immunotherapy for all patient types. This progress has only been possible through the hard work of many people in the labs and in the clinic.

William Finch, Chief Executive Officer of Oxford Vacmedix, said:

This publication marks an important milestone for the company and shows the potential of the ROP technology. We are very pleased with the results and with the trial now nearing completion are already in discussion with potential Series B investors to fund Phase 2 trials for OVM-200.

(Press release, Oxford Vacmedix, JAN 15, 2026, View Source;utm_medium=rss&utm_campaign=publication-of-ovm-200-phase-1a-results [SID1234662057])

On January 15, 2026 Propanc Biopharma, Inc. (Nasdaq: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company focused on developing novel treatments for chronic diseases, including recurrent and metastatic cancer, reported the latest update on pancreatic cancer research. Pancreatic cancer remains one of the most lethal human malignancies: median survival after diagnosis is typically measured in months, and the five-year survival rate is below 10 %. Traditional therapies such as surgery, chemotherapy and radiation often fail to achieve durable remission, especially in metastatic or chemoresistant disease. This high unmet need has drawn interest to novel mechanisms of action — including Propanc Biopharma’s pancreatic proenzyme formulation known as PRP.

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What Is PRP and Its Biological Rationale?

Propanc’s lead clinical candidate, PRP, is a proprietary mixture of two pancreatic proenzymes — trypsinogen and chymotrypsinogen — formulated in a synergistic 1:6 ratio and administered intravenously. These proenzymes are hypothesized to target cancer stem cells (CSCs) and modulate malignant cellular programs such as the epithelial to mesenchymal transition (EMT), a process linked to metastasis and drug resistance.

Key Mechanistic Findings from Preclinical Studies include:

Suppression of metastatic processes: PRP reduced angiogenesis (formation of blood vessels that feed tumors) and cell migration in pancreatic cancer models and appeared to reverse EMT markers that contribute to invasiveness.
Enhanced chemosensitivity: Laboratory data suggest PRP makes resistant pancreatic tumor cells more responsive to standard chemotherapies and alters the tumor microenvironment — including reduced fibrosis and dampened TGF-β pathway signaling.
Tumor growth inhibition: In vivo studies in animal models showed significant reduction in pancreatic tumor weight, with >85 % growth inhibition at certain PRP doses versus controls.

Importantly, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to PRP in 2017 for the treatment of pancreatic cancer, recognizing the severe unmet need and small patient population.

Clinical Development Status

Propanc has progressed its PRP candidate toward human studies. Following an initial public offering and Nasdaq listing, the company is advancing plans to initiate Phase I/II clinical trials in 2026, starting with dose-finding studies and moving to proof-of-concept studies in pancreatic and other cancers. (MedPath)

Pancreatic Cancer Market: Size and Growth

Pancreatic cancer therapeutics represent a rapidly expanding global market as incidence rises and new treatments emerge. Recent market research provides the following context:

Global Market Projections:

Global pancreatic cancer treatment market: Forecast to grow from ~USD 2.9 billion in 2024 to ~USD 5.8 billion by 2030, representing a CAGR of ~12.3 %. (Grand View Research)
Pancreatic cancer market overall: Some industry projections put the broader pancreatic cancer market (including therapies and diagnostics) from ~$3.25 billion in 2025 to over $10.25 billion by 2034 at ~13.6 % CAGR. (Precedence Research)
Other reports estimate the pancreatic cancer therapeutics and diagnostics market growing toward ~$13.8 billion by 2035 at ~9.9 % CAGR. (Market Research Future)

Propanc’s Market Addressable Opportunity

According to Propanc and external research estimates, the pancreatic cancer segment targeted by PRP is forecast to reach roughly $6.93 billion by 2030.
Combined with ovarian cancer, which is also a focus for PRP, the total addressable market over the coming decade has been cited in the $14 – 18 billion range.
North America — particularly the United States — constitutes one of the largest revenue sectors in this market. (Precedence Research)

Financial Metrics and Propanc’s Position

Propanc Biopharma is a pre-revenue biotechnology company focused on early-stage clinical development:

The company has no product revenues to date and remains development and research oriented. Significant annual net losses have been reported due in large part to non-cash stock-based compensation expenses rather than major R&D outlays. (Reddit)
A recent IPO and Nasdaq listing raised approximately $4 million in gross proceeds, with Propanc positioning itself for clinical advancement of PRP and a recombinant follow-on candidate (Rec-PRP). (Stock Titan)
Despite limited cash flow from operations, the company has entered structural financing arrangements, including a potential $100 million private placement facility to fund further development. (Santé log)

Challenges and Outlook

While the scientific rationale for PRP is compelling, pancreatic cancer remains biologically complex, with historical challenges in translating early preclinical signals to clinical success. Challenges include:

Designing robust clinical trials that show meaningful overall survival benefits.
Demonstrating PRP’s effects on the tumor microenvironment and chemosensitivity translate into improved outcomes for patients.
Navigating competitive therapeutic landscapes with new targeted therapies, immunotherapies, and combination regimens.

Yet, if PRP proves safe and effective, its mechanism of targeting cancer stem cells and modulating EMT could offer a distinct therapeutic option in a market desperate for innovation. Combining that potential with a significant and growing addressable pancreatic cancer market underscores why PRP’s clinical success could have both medical and financial implications in the years ahead.

(Press release, Propanc, JAN 15, 2026, View Source [SID1234662058])

On January 15, 2026 Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL gene silencing technology to eliminate cancer, reported that Mr. Robert Bitterman, CEO and Chairman of the Board, Phio Pharmaceuticals will present an update on the company’s proprietary INTASYL siRNA technology and progress on the on-going clinical trial with lead compound PH-762 for treatment of skin cancers.

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"All stakeholders and investors are invited to join the presentation and register for one-on-one meetings to learn more about Phio Pharmaceuticals in our continuing pursuit of innovative pathways towards a cancer free future using our INTASYL technology," stated Robert Bitterman, CEO and Chairman of Phio Pharmaceuticals.

Phio’s presentation will begin at 1:45 PM ET on January 22, 2026 and can be accessed live here: WEBCAST LINK FOR PHIO’S PRESENTATION: Webinar Registration – Zoom

Mr. Bitterman will also host one-on-one meetings with investors at the conference, taking place on Wednesday Jan 21, 2026 8:30 AM ET through Thursday Jan 22, 2026 at 5:00 PM ET. Registration is free and you don’t need to be a Sidoti client. REGISTRATION LINK FOR ONE-ON-ONE MEETINGS:  www.sidoti.com/events.

About Sidoti Events, LLC ("Events") and Sidoti & Company, LLC ("Sidoti")

In 2023, Sidoti & Company, LLC , Sidoti & Company, LLC (www.sidoti.com) formed an affiliate company, Sidoti Events, LLC in order to focus exclusively on its rapidly growing conference business and to more directly serve the needs of presenters and attendees.  The relationship allows Events to draw on the 25 years of experience Sidoti has as a premier provider of independent securities research focused specifically on small and microcap companies and the institutions that invest in their securities, with most of its coverage in the $200 million-$5 billion market cap range. Sidoti’s coverage universe comprises approximately 160 equities, of which 50 percent participate in the firm’s rapidly growing Company Sponsored Research ("CSR") program.  Events is a leading provider of corporate access through the eight investor conferences it hosts each year. By virtue of its direct ties to Sidoti, Events benefits from Sidoti’s small- and microcap-focused nationwide sales force, which has connections with approximately 2,500 institutional relationships in North America.  This enables Events to provide multiple forums for meaningful interaction for small and microcap issuers and investors specifically interested in companies in the sector.

(Press release, Phio Pharmaceuticals, JAN 15, 2026, View Source [SID1234662059])

On January 15, 2026 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biotech company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for autoimmune disease, solid tumors and hematological malignancies indications, reported that it recently presented at the 44th Annual J.P. Morgan Healthcare Conference held in San Francisco. At the conference, Antengene shared the latest data and clinical development plans for its core clinical asset, ATG-022 (a CLDN18.2 antibody-drug conjugate [ADC]), as well as R&D progress on ATG-125 (a B7-H3 x PD-L1 bispecific ADC), its steric hindrance masking AnTenGager T cell engager (TCE) platform, and other key preclinical programs.

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1. Core Clinical Program: ATG-022

Latest data from the Phase I/II CLINCH study: As of December 25, 2025, among patients with moderate to high CLDN18.2 expression (IHC 2+ > 20%) in the 2.4 mg/kg dose cohort, the objective response rate (ORR) was 40% (12/30) and the disease control rate (DCR) was 90% (27/30), with a median progression-free survival (mPFS) of 5.09 months and a median overall survival (mOS) of 14.72 months. In the 1.8 mg/kg dose cohort, the ORR was 46.7% (14/30), the DCR was 86.7% (26/30), the mPFS was 6.97 months, and the mOS has not yet been reached. Among patients with low/ultra-low CLDN18.2 expression (IHC 2+ ≤ 20%) treated at the efficacious dose range of 1.8-2.4 mg/kg, the ORR was 28.6% (6/21). In addition, one patient in each of the three dose groups achieved a complete response (CR). These results demonstrated the potent anti-tumor activity of ATG-022 across all levels of CLDN18.2 expression.
Promising frontline combination potential: Compared with the data presented at the Company’s R&D Day in November last year, the 1.8 mg/kg dose group demonstrated a further improvement in ORR and a meaningful prolongation in mPFS, while maintaining a favorable safety profile. The incidence of Grade 3 or higher treatment-related adverse events (TRAEs) was only 19.4%. This differentiated safety profile positions ATG-022 as a potentially best-in-class ADC in terms of safety, with the potential to be combined with checkpoint inhibitors (CPIs) and chemotherapy to transform the current frontline standard-of-care regimen.
First Disclosure of Positive Clinical Signals of ATG-022 in Non-Gastrointestinal Tumors: As of January 6, 2025, among 9 efficacy evaluable patients, the ORR was 22.2% (2/9), and DCR was 88.9% (8/9). These data suggest that ATG-022 may have the potential to treat CLDN18.2-positive non-gastrointestinal tumors, which could expand the treatable patient population beyond gastrointestinal cancers. The efficacy observed to date also supports further exploration of CLDN18.2 as a pan-tumor therapeutic target.
Advancing clinical development across 1L to 3L gastric cancer: Antengene is currently conducting the Phase I/II CLINCH study and the Phase Ib/II CLINCH-2 study of ATG-022 in Mainland of China and Australia. The Company continues to advance the clinical development of ATG-022 across different lines of gastric cancer treatment, including first-line therapy in combination with checkpoint inhibitors (CPIs) and chemotherapy (CAPOX/FOLFOX); second-line therapy in combination with CPIs; and third-line therapy as monotherapy, covering patients with varying levels of CLDN18.2 expression. In addition, the CLINCH study of ATG-022 includes a basket trial cohort evaluating multiple tumor types, with the majority of patients continuing to receive treatment.
2. Next-Generation ADCs and Proprietary TCEs

ATG-125 (B7-H3 × PD-L1 bispecific ADC): ATG-125 is an "IO+ADC " dual-function molecule targeting B7-H3 and PD-L1, integrating the direct cytotoxic activity of an ADC with the durable immune activation of immuno-oncology (IO) therapies. By simultaneously blocking B7-H3- and PD-L1-mediated immunosuppressive signaling, ATG-125 effectively activates T cells and induces immunological memory. Preclinical studies demonstrate that the bispecific ADC delivers superior in vivo efficacy compared with single-target B7-H3-ADC or PD-L1-ADC approaches. The Company plans to submit an IND for ATG-125 in Q1 2027.

TCE platform with steric hindrance masking technology: AnTenGager is Antengene’s proprietary, second-generation T cell engager (TCE) platform featuring "2+1" bivalent binding for low-expressing targets, steric hindrance masking, and proprietary CD3 sequences with fast on/off kinetics to minimize cytokine release syndrome (CRS) and enhance efficacy. These characteristics support the platform’s broad applicability across autoimmune diseases, solid tumors and hematological malignancies indications. Leveraging this platform, Antengene has discovered multiple investigational programs:

ATG-201 (CD19 x CD3 TCE): ATG-201 is a novel "2+1" CD19-targeted T-cell engager developed on the AnTenGager TCE platform for the treatment of B cell related autoimmune diseases. Preclinical data presented at the 2025 American College of Rheumatology (ACR) Annual Meeting showed that in non-human primate (NHP) models, the monkey surrogate of ATG-201 achieved deep and durable depletion of naïve B cells with a favorable safety profile, characterized by only a very mild and transient increase in cytokine levels. The IND-enabling study of ATG-201 has been completed and the IND-submission is under preparation.
ATG-106 (CDH6 x CD3 TCE): A global first-in-class CDH6 x CD3 targeted TCE being developed for the treatment of ovarian cancer and kidney cancer. The Company plans to submit an IND for ATG-106 in the first half of 2027.
ATG-112 (ALPPL2 x CD3 TCE): A global first-in-class ALPPL2 x CD3 targeted TCE being developed for the treatment of gynecologic tumor, non-small cell lung cancer, and pancreatic ductal adenocarcinoma. The Company has nominated a preclinical candidate (PCC) in January 2026.
Additional TCE programs for solid tumors: Antengene plans to submit an IND for ATG-110 (LY6G6D × CD3 TCE) in the first half of 2027 for the treatment of microsatellite-stable colorectal cancer. In addition, ATG-115 (an undisclosed bispecific antibody) and two undisclosed trispecific antibody programs are currently in preclinical development.
3. Innovative Treatment for Autoimmune Diseases: Globally First-in-Class ATG-207

ATG-207 is a globally first-in-class dual-function biologic being developed for the treatment of T cell–mediated autoimmune diseases. The Company plans to present the preclinical data for ATG-207 for the first time at an international scientific conference in 2026.

(Press release, Antengene, JAN 15, 2026, View Source [SID1234662060])