On November 19, 2025 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biotech company dedicated to discovering, developing and commercialising first-in-class and/or best-in-class medicines for autoimmune disease, solid tumors and hematological malignancies indications, reported that at the R&D Day taking place today, it will present the latest data and future plans for three mid/late-stage clinical programs, including ATG-022 (CLDN18.2 antibody-drug conjugate [ADC]), ATG-037 (oral CD73 small molecule inhibitor), and ATG-101 (PD-L1/4-1BB bispecific antibody). The company will also share the latest progress on ATG-125 (B7H3 x PD-L1 bispecific ADC): A B7H3 x PD-L1 targeted therapy featuring "IO + ADC" dual-effect molecules for the treatment of solid tumors and its AnTenGager T-cell engager (TCE) technology platform which incorporates steric hindrance masking, along with updates on several key preclinical programs. In addition, guest expert Prof. Xin Wang, Chief Physician, Drug Clinical Trial Center, National Cancer Center / Cancer Hospital of the Chinese Academy of Medical Sciences, will deliver a keynote session sharing her insights on ATG-022.

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The event will be held today at 14:00 (Beijing Time), both in-person at the Antengene Shanghai office and online via webcast. For further information on how to join the event, please refer to: View Source

1. Building a pipeline of first/best-in-class innovative therapies with strategic focus on four areas

To address major unmet medical needs in the APAC region and globally amid the rapidly evolving innovative drug landscape, Antengene has adopted a forward-looking strategy to build a diverse portfolio covering four major areas – ADCs, immuno-oncology (IO), autoimmune diseases, and TCEs.

ADCs: ATG-022 (CLDN18.2 ADC) is advancing smoothly through clinical development and has generated a steady stream of promising data. In addition, two "IO + ADC" dual-mechanism candidates targeting B7-H3 x PD-L1 and CD24 are progressing well in preclinical development.
IO: ATG-037 (oral CD73 small molecule inhibitor) and ATG-101 (PD-L1/4-1BB bispecific antibody) are progressing smoothly through clinical studies.
Autoimmune diseases: ATG-201 (CD19×CD3 TCE), which is advancing toward clinical studies for the treatment of autoimmune diseases, can mediate complete B cell depletion with reduced risk of cytokine release syndrome (CRS). ATG-207 (undisclosed bifunctional biologics), is a first-in-class preclinical program being developed for T-cell driven autoimmune diseases.
TCEs: Antengene has built a robust portfolio of first/best-in-class programs targeting CD19×CD3, CDH6×CD3, ALPPL2×CD3, LY6G6D×CD3, GPRC5D×CD3, LILRB4×CD3, and FLT3×CD3, offering a wide therapeutic window for addressing unmet clinical needs across autoimmune diseases, solid tumors, and hematologic malignancies.
2. Encouraging data set a solid foundation for further advancement in clinical development

▶ ATG-022 (CLDN18.2 ADC)

Latest data from the Phase I/II CLINCH study: As of November 10, 2025, in patients with moderate to high CLDN18.2 expression (IHC 2+ > 20%), the 2.4 mg/kg dose cohort achieved an objective response rate (ORR) of 40% (12/30), a disease control rate (DCR) of 90% (27/30), and a median overall survival (mOS) of 14.72 months; while the 1.8 mg/kg dose cohort achieved an ORR of 40% (12/30), a DCR of 86.7% (26/30), and a median progression-free survival (mPFS) of 5.45 months. Among patients with low/ultra-low CLDN18.2 expression (IHC 2+ ≤ 20%), those treated at the efficacious dose range of 1.8-2.4 mg/kg achieved an ORR of 28.6% (6/21) and a DCR of 52.4% (11/21). In these results, ATG-022 demonstrated potent antitumor activity in patients with a broad range of CLDN18.2 expression levels.
Broad combinatory potential for front-line treatment: the 1.8 mg/kg cohort demonstrated promising efficacy with only 16.1% of patients experienced grade 3 or higher treatment-related adverse events (TRAEs). This differentiated safety profile uniquely positions ATG-022 as an ADC with best-in-class safety profile and potential to transform first-line standard of care in combination with both immune checkpoint inhibitors (CPIs) and chemotherapy.
Three clinical development pathways: To fully realize the therapeutic potential of its CLDN18.2-targeted therapy ATG-022, Antengene has outlined a clear clinical development roadmap designed to achieve regulatory approval, maximize therapeutic reach, and broaden tumor-type coverage. The strategy includes a near-term approval path through a pivotal Phase III in third and later line gastric cancer patients with moderate to high CLDN18.2 expression; a front-line proof-of-concept Phase II study evaluating ATG-022 in combination with a CPI and the CAPOX regimen, which, if supported by positive results, is expected to advance into a Phase III trial; and A broad indication-expansion effort through the ongoing Phase II study that builds on encouraging activity signals, extending beyond gynecologic tumors to further assess ATG-022 across a wider range of solid tumor types.
▶ ATG-037 (oral CD73 small molecule inhibitor)

Latest data from the Phase I/Ib STAMINA-01 study: As of October 24, 2025, in the subgroup of patients with CPI-resistant melanoma who received the combination regimen (12 patients), the ORR was 33.3%, the DCR was 100%, including 1 complete response (CR) and 3 partial responses (PRs). One of these patients had maintained CR and reported no safety issues despite having been on the treatment for more than two years. In the subgroup of patients with CPI-resistant non-small cell lung cancer (14 patients), the ORR was 21.4%, the DCR was 71.4%, including 3 PRs. These findings suggest that ATG-037 has clinically meaningful therapeutic potential in multiple tumor types, particularly in patients who are CPI-resistant.
Clinical development pathways: existing data show that ATG-037 holds enormous therapeutic potential for the treatment of first-line or CPI-resistant melanoma, with promising potential for expansion into other tumor types. Antengene’s clinical development roadmap for ATG-037 has four main components: 1. combination with CPI for the treatment of CPI-resistant unresectable and metastatic melanoma (second-line treatment); 2. combination with CPI for the first-line treatment of unresectable or metastatic melanoma; 3. active expansion into other tumor types supported by the encouraging proof-of-concept data in CPI-resistant non-small cell lung cancer; 4. explore potential combinations with next-generation CPIs such as PD-1×VEGF bispecific antibody.
▶ ATG-101 (PD-L1/4-1BB bispecific antibody): dose-escalation study of ATG-101 is currently underway in China, the U.S., and Australia, and has already observed favorable safety in varies dosing regimens, thus laying a solid foundation for the future clinical development. One study evaluating ATG-101 in extrapulmonary neuroendocrine carcinoma (EP-NEC) patients will be initiated soon.

3. AnTenGager technology platform: a key driver of innovation

▶ A TCE platform featuring steric hindrance masking: AnTenGager is a proprietary "2+1" second-generation TCE technology platform featuring "2+1" bivalent binding for low-expressing targets, steric hindrance masking, and proprietary CD3 sequences with fast on/off kinetics to minimize 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 AnTenGagerTM 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.
ATG-110（LY6G6D x CD3 TCE): A potential global best-in-class LY6G6D x CD3 targeted TCE being developed for the treatment of microsatellite stable colorectal cancer.
ATG-112 (ALPPL2 x CD3 TCE): A global first-in-class ALPPL2 x CD3 targeted TCE being developed for the treatment of gynecologic tumors and lung cancer.
ATG-125 (B7H3 x PD-L1 bispecific ADC): A B7H3 x PD-L1 targeted therapy featuring "IO + ADC" dual-effect molecules for the treatment of solid tumors.
ATG-207 (undisclosed bifunctional biologics): a global first-in-class bifunctional biologic agent being developed for the treatment of T-cell driven autoimmune diseases, a therapeutic area representing a huge unmet clinical need.
Antengene will strive to further accelerate these highly promising clinical and preclinical programs. The company plans to report additional progress of these innovative programs and update the medical community, patients, and investors on future developmental milestones at a series of upcoming top international conferences.

(Press release, Antengene, NOV 19, 2025, View Source [SID1234660099])

On November 19, 2025 Defence Therapeutics Inc. ("Defence" or the "Company"), a leading biotechnology company pioneering next-generation antibody-drug conjugate ("ADC"), reported a major step forward in the fight against cancer that goes beyond the ADCs current limitations.

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Following successful presentations and meetings at the World ADC Conference in San Diego with ADC companies as well as with industry leaders and pioneers at CPHI in Frankfurt, Defence is moving forward with the strategy to become a supplier of its Accum platform technology to ADC companies struggling with dosing and toxicity as well as to improve the drug delivery precision to cancer cells more effectively for the benefit of cancer patients.

"Many pharmaceuticals and biotech companies have ADCs on the market or in development. A lot of these companies are facing the same challenge, their ADC being toxic for the patients at therapeutic dose. Defence’s Accum technology can universally enhance the potency of any ADCs, reducing their toxicity, while retaining their epitope selectivity and tumor targeting" said Dr. Maxime Parisotto, Chief Scientific Officer at Defence Therapeutics.

Defence has completed studies confirming its ability to enhance ADCs potency. The most recent comparative study, in mouse xenograft models of HER2-positive breast cancer (JIMT-1 cells), demonstrated a ~20-fold higher anti-tumor efficacy with Accum-Kadcyla than Kadcyla alone when administered at the same dose (0.5 mg/kg). The tumor growth significantly halted in the Accum-Kadcyla-treated group, resulting in a consistent and near-complete response in 90% of the mice while Kadcyla alone at the same dose (0.5 mg/kg) had no effective results on inhibiting tumor growth (see November 4, 2025 press release).

Defence is engaging with ADC companies to transform the ADC cancer therapies with its unique proprietary Accum technology platform to be used with any antibodies and on any indications. Defence’s technology and team are in place to deliver the strategy and build an ADC drug delivery powerhouse.

(Press release, Defence Therapeutics, NOV 19, 2025, View Source;utm_medium=rss&utm_campaign=defence-therapeutics-to-build-adc-drug-delivery-powerhouse-using-its-proprietary-accum-technology [SID1234660863])

On November 19, 2025 FibroBiologics, Inc. (Nasdaq: FBLG) ("FibroBiologics" or the "Company"), a clinical-stage biotechnology company with 270+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, reported it has entered into a definitive purchase agreement for the issuance and sale to an existing shareholder of 3,540,000 shares of its common stock and pre-funded warrants to purchase 8,570,203 shares of its common stock at a purchase price of $0.3303 per share or pre-funded warrant (less $0.00001 for each pre-funded warrant), in a registered direct offering priced at-the-market under Nasdaq rules. The pre-funded warrants are exercisable at any time at an exercise price of $0.00001 per share and do not expire.

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"We’re grateful for the continued support from one of our major shareholders. Their commitment gives us the flexibility to strengthen our capital structure and stay focused on building the future. This kind of long-term alignment allows us to move faster, innovate more aggressively, and fully pursue the opportunities in our pipeline," said Pete O’Heeron, Founder and Chief Executive Officer.

The purchase price for the shares or prefunded warrants will be paid not in cash but with sovereign-issued .9999 fine gold coins valued at $4,069.18 per oz. based on the spot price of gold at the time of signing of the purchase agreement, delivered to the Company’s depository. The Company intends to liquidate the purchase price into United States dollars in the near term.

In addition, in a concurrent private placement, the Company will issue and sell unregistered warrants to purchase one share of its common stock for each share of common stock or pre-funded warrant purchased in the registered direct offering, for up to 12,110,203 shares of common stock. The unregistered warrants have an exercise price of $0.3303 per share of common stock, will be exercisable beginning on the effective date of, and subject to, approval by our stockholders of the issuance of the shares of common stock upon exercise of the unregistered warrants (the "Stockholder Approval") and will expire five years following the date of the Stockholder Approval. The Company has agreed to file a registration statement with the Securities and Exchange Commission ("SEC") to register the resale of the shares of common stock underlying the unregistered warrants. If at the time of exercise of such warrants there is no effective registration statement registering the shares issuable upon exercise of such warrants, or the prospectus contained therein is not available for the resale of such shares by the warrant holder, then such warrants may also be exercised, in whole or in part, by cashless (net) exercise.

The offering is expected to close on or about November 19, 2025, subject to the satisfaction of customary closing conditions. The gross proceeds to the Company from the offering are expected to be approximately $4.0 million, before deducting offering expenses payable by FibroBiologics. FibroBiologics intends to use the net proceeds from the offering for general corporate purposes, including the satisfaction of debt. In addition, if the holders of the unregistered warrants exercise such warrants in full for cash following the Stockholder Approval, the Company would receive additional gross proceeds of approximately $4.0 million. The Company cannot predict when or if the unregistered warrants will be exercised for cash or exercised at all. It is possible that the unregistered warrants may expire and may never be exercised.

The shares of common stock, pre-funded warrants and shares of common stock issuable upon exercise of the pre-funded warrants offered in the registered direct offering (but not the unregistered warrants issued in the concurrent private placement or the shares issuable upon exercise of such unregistered warrants) are being offered pursuant to a shelf registration statement on Form S-3 (File No. 333-284663) previously filed and declared effective by the SEC on February 10, 2025. The offering of the shares of common stock and pre-funded warrants in the registered direct offering is being made only by means of a prospectus supplement that forms a part of the registration statement. The final prospectus supplement relating to the securities offered in the registered direct offering will be filed by FibroBiologics with the SEC. When available, copies of the final prospectus supplement relating to the registered direct offering, together with the accompanying prospectus, can be obtained from the SEC’s website at www.sec.gov.

The unregistered warrants issued in the concurrent private placement and the shares issuable upon exercise of such warrants were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and/or Regulation D promulgated thereunder, have not been registered under the Act or applicable state securities laws and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.

(Press release, FibroBiologics, NOV 19, 2025, View Source [SID1234660083])

On November 19, 2025 Dialectic Therapeutics, Inc., a clinical-stage biotechnology company developing innovative anti-cancer drugs, reported that patient dosing is underway in a clinical trial led by the renowned Drs. Elizabeth Stover, Joyce Liu, and Ursula Matulonis from the Dana-Farber Cancer Institute. Dr. Matulonis previously served as the Principal Investigator for the study that led to a recent FDA approval in platinum-resistant ovarian cancer (PROC).

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Dr. Stover, the principal investigator and IND-holder of the study, has recruited the first two patients, with more now being considered for eligibility in this extraordinarily exciting trial. For more information about the trial, including eligibility criteria, call 877-338-7425 or visit: View Source

"The advance of DT2216 to this Phase 1b/2 trial represents a critical milestone, driven by compelling data from our Phase 1a and preclinical studies. We have a remarkable opportunity to impact patients’ lives and are grateful for the leadership of our world-class collaborators at Harvard and Dana-Farber," said John D. Harkey Jr., Executive Chairman of Dialectic Therapeutics, Inc.

"New therapeutic options are very much needed for our patients with platinum-resistant ovarian cancer. The preclinical data is extremely compelling in terms of the likelihood of translating to the clinical setting, and we are very excited to test weekly paclitaxel and DT2216 for ovarian cancer," stated Dr. Ursula Matulonis, Chief of the Division of Gynecologic Oncology at the Dana-Farber Cancer Institute and professor of Medicine at Harvard Medical School.

Dr. Stover’s trial builds on the Phase 1a clinical data and the preclinical results, generated by Dialectic and Harvard School of Public Health, which demonstrate complete tumor eradication in both in vivo and in vitro ovarian cancer models.

"The preclinical efficacy observed with DT2216 and paclitaxel is among the strongest results we have seen in preclinical models of high-grade serous ovarian cancer. It’s exciting to be able to bring a new potential treatment option to the clinic for our patients," said Dr. Elizabeth Stover, Assistant Professor of Medicine at Harvard Medical School and a medical oncologist in the Division of Gynecologic Oncology.

DT2216 is a novel therapeutic designed to potently and selectively degrade BCL-XL, a key protein used by cancer cells to evade death.

The company’s completed Phase 1a trial enrolled and treated 20 patients across six dose-escalating cohorts. This study established a recommended Phase 2 dose (RP2D) demonstrating a favorable safety and tolerability profile. Biomarkers from patients receiving the RP2D showed that DT2216 degraded the intended BCL-XL target protein in all patients within this dosing cohort, demonstrating powerful and precise target engagement.

In collaboration with Dr. Kristopher Sarosiek at Harvard School of Public Health, the effects of DT2216 were evaluated in cancer cell line and patient-derived xenograft (PDX) models of high-grade serous ovarian carcinoma (HGSOC), including OVCAR3 and the highly chemo-resistant DF83 PDX model. The combination of paclitaxel and DT2216 induced rapid tumor regressions and eradicated the tumors completely. Notably, tumors showed no evidence of regrowth after DT2216 treatment was discontinued.

"As a lab that investigates how tumor cells commit to cell death, we’re encouraged by how cleanly the biology matches the pharmacology. DT2216 selectively engages the target – BCL-XL – and potently initiates tumor cell death in combination with paclitaxel. It’s exactly the trajectory we hope to replicate in patients," stated Dr. Sarosiek, Director of the Cell Death Laboratory at Harvard School of Public Health. "We’ve long sought to develop innovative therapies that directly target the proteins responsible for making tumor cells resistant to treatment, and DT2216 offers us the opportunity to finally achieve this in patients."

(Press release, Dialectic Therapeutics, NOV 19, 2025, View Source [SID1234660100])

On November 19, 2025 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported the Company has added Gabrail Cancer Center in Canton, Ohio, as a new clinical trial site for the Acclaim-1 and Acclaim-3 clinical trials studying its lead drug candidate, Reqorsa Gene Therapy (quaratusugene ozeplasmid), in lung cancer. In addition, the Company expects to add and open additional clinical trial sites for its Acclaim clinical trials over the coming months in an effort to expand its reach to additional patients and expedite enrollment.

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"We are pleased to collaborate with Gabrial Cancer Center, an established patient-focused cancer treatment center, in order to expand the number of trial sites available and to provide access to a greater number of patients who may be able to participate in our lung cancer trials," said Ryan Confer, President and Chief Executive Officer at Genprex. "We believe this partnership may accelerate patient enrollment, allowing more patients to receive our innovative gene therapy treatment and for Genprex to more expeditiously advance our clinical trials."

About Acclaim-1

Acclaim-1 is a Phase 1/2 clinical trial evaluating the combination of REQORSA and AstraZeneca’s Tagrisso (osimertinib) to treat patients with late-stage non-small cell lung cancer (NSCLC) who have activating EGFR mutations and disease progression after treatment with Tagrisso.

The Phase 2a expansion study follows the successful completion of the Phase 1 dose escalation portion of the study, which showed REQORSA was generally well tolerated with no dose limiting toxicities despite doubling the starting dose. Importantly, the results showed early signs of efficacy with some patients experiencing prolonged progression free survival and one patient having a partial response.

The Phase 2a expansion portion of the trial is expected to enroll approximately 33 patients who have previously received Tagrisso treatment and will determine the safety profile and evaluate efficacy, as well as several other exploratory endpoints. Genprex’s team plans to conduct an interim analysis following the treatment of 19 patients, which the Company currently expects to complete enrollment of the first 19 patients in the first half of 2026. The Acclaim-1 clinical trial has received U.S. Food and Drug Administration (FDA) Fast Track Designation.

About Acclaim-3

Acclaim-3 is a Phase 1/2 clinical trial evaluating the combination of REQORSA and Genentech’s Tecentriq (atezolizumab) as maintenance therapy in patients with extensive stage small cell lung cancer (ES-SCLC) who are candidates for maintenance therapy after receiving Tecentriq and chemotherapy as standard of care initial treatment. In this study, patients will be treated with REQORSA and Tecentriq until disease progression or unacceptable toxicity is experienced.

The Phase 2 expansion study follows the successful completion of the Phase 1 dose escalation portion of the study, which showed REQORSA was generally well tolerated. There were no dose limiting toxicities, and in Acclaim-3, the Phase 2 patients are receiving the same dose of REQORSA as patients in the Phase 2 portion of Acclaim-1.

The Phase 2 expansion portion is expected to enroll approximately 50 patients. The primary endpoint of the Phase 2 portion is to determine the 18-week progression-free survival rate from the time of the start of maintenance therapy with REQORSA and Tecentriq in patients with ES-SCLC. Patients will also be followed for survival. Genprex’s team plans to conduct an interim analysis after the 25th patient enrolled and treated reaches 18 weeks of follow up. The Company expects to complete enrollment of the first 25 patients for interim analysis in the Phase 2 expansion portion of the study in the first half of 2026. The Acclaim-3 clinical trial is supported by FDA Fast Track Designation and Orphan Drug Designation.

(Press release, Genprex, NOV 19, 2025, View Source [SID1234660084])