Innovent Biologics Announces U.S. FDA IND Approval for the First Global MRCT Phase 3 Study (MarsLight-11) of IBI363 (PD-1/IL-2α-bias) in Squamous Non-Small Cell Lung Cancer

On August 24, 2025 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company committed to developing, manufacturing and commercializing high-quality medicines in oncology, cardiovascular and metabolic diseases, autoimmune, ophthalmology and other major therapeutic areas, reported that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application to initiate a global Phase 3 clinical trial (MarsLight-11) of IBI363 in immunotherapy(IO)-resistant squamous non-small cell lung cancer (NSCLC) (Press release, Innovent Biologics, AUG 24, 2025, View Source [SID1234655447]). IBI363 is Innovent’s self-discovered novel PD-1/IL-2α-bias bispecific antibody fusion protein. The upcoming study will be the first global Phase 3 trial of IBI363 and represents a significant milestone in advancing a first-in-class, dual-immune activation immunotherapy for this large patient population. Besides, the pivotal trial of IBI363 head-to-head against pembrolizumab (Keytruda) in the treatment of melanoma is underway in China.

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IBI363 as a Next-generation IO therapy Set for First Global Phase 3 Lung Cancer Trial

This IND clearance follows recent positive feedback from the U.S. FDA at the End-of-Phase 2 (EOP2) meeting. Major alignments of the Phase 3 program were reached regarding the dose selection, study design, and other critical considerations. Innovent has also received IND approval from China’s National Medical Products Administration (NMPA) for this program. In parallel, Innovent has initiated communications and submissions to other major Health authorities. IBI363 has also received Fast Track Designation (FTD) from the FDA and Breakthrough Therapy Designation (BTD) from the National Medical Products Administration (NMPA) in China for this indication.

The multi-regional, randomized, controlled Phase 3 trial will enroll approximately 600 patients globally including China, U.S., Canada, EU, UK, and Japan, etc. The study will evaluate the efficacy and safety of IBI363 3 mg/kg monotherapy compared with docetaxel in patients with unresectable, locally advanced or metastatic squamous NSCLC who have experienced disease progression following platinum-based chemotherapy and anti-PD-1/PD-L1 immunotherapy. The primary endpoint is overall survival.

IBI363’s Breakthrough Data Validates its Dual-immune Activation Mechanism, Stepwise Development in Multiple Tumor Types

At ASCO (Free ASCO Whitepaper) 2025, Phase 1b/2 results demonstrated meaningful and durable clinical activity in areas of high unmet need, including IO-resistant lung cancer, traditionally "cold tumors" such as acral and mucosal melanoma, and microsatellite stable (MSS) colorectal cancer.

These promising data position IBI363 as a potential first-in-class dual-immune activation therapy with broad applicability across difficult-to-treat cancers. Innovent is rapidly progressing IBI363 into registrational studies, with a pivotal program in melanoma already ongoing, a global Phase 3 trial in squamous NSCLC expected to start shortly, and a registration strategy in colorectal cancer in planning.

In parallel, multiple Phase 1b/2 trials are evaluating IBI363 both as monotherapy and in combinations in first-line NSCLC, first-line CRC, and additional tumor types, including platinum-resistant ovarian cancer (PROC), EGFR+ NSCLC, and neoadjuvant therapy for non-squamous NSCLC. This comprehensive development strategy is designed to maximize the value of IBI363 and expand its potential to address multiple large global oncology markets and improve patient outcomes.

Roy S. Herbst, MD, PhD, Deputy Director and Chief of Medical Oncology and Hematology for Yale Cancer Center and Smilow Cancer Hospital, Ensign Professor of Medicine (Medical Oncology) and Professor of Pharmacology at Yale School of Medicine, shared, "Lung cancer remains the most prevalent malignant tumor worldwide, with particularly high incidence and mortality rates globally. Non-small cell lung cancer constitutes the majority of these cases. Although immunotherapy has significantly improved survival outcomes for some patients, those who do not respond to such treatments and lack driver gene mutations have limited therapeutic options, underscoring the urgent need for enhanced clinical interventions.

Clinical research of the PD-1/IL-2α-biased bispecific molecule IBI363 has revealed encouraging findings. Preliminary trials have demonstrated that IBI363 not only induces tumor remission in a subset of patients but also achieves disease stability in the majority of patients, indicating durable anti-tumor activity. In comparison to traditional chemotherapy, IBI363 appears to offer potential advantages in both objective response rate (ORR) and progression-free survival (PFS), providing new hope for patients diagnosed with lung cancer."

Professor Shun Lu from the Oncology Department of Shanghai Chest Hospital, stated: "As a first-in-class PD-1/IL-2α-biased bispecific antibody fusion protein, IBI363 acts by simultaneously blocking the PD-1/PD-L1 pathway and activating the IL-2 pathway. The IL-2 arm of IBI363 is engineered to retain its affinity for IL-2Rα while reducing binding to IL-2Rβ and IL-2Rγ, thereby minimizing toxicity. The PD-1 binding arm not only blocks PD-1 but also selectively delivers IL-2. This dual mechanism targets and activates tumor-specific T cells co-expressing PD-1 and IL-2α, enabling more precise and effective stimulation of this T-cell subpopulation. IBI363 has demonstrated robust antitumor activity across multiple tumor models and has shown remarkable efficacy in IO-resistant, PD-L1 low expression, and cold tumor settings.

The promising data associated with IBI363 offers a novel treatment avenue for patients with non-small cell lung cancer who have not responded to immunotherapy. As research progresses, this innovative therapy holds the potential to bridge clinical gaps and provide the possibility of long-term survival for a greater number of patients."

Dr. Hui Zhou, Chief R&D Officer for Oncology Pipeline at Innovent Biologics, said, "Today’s IND clearance marks a significant milestone as we initiate the first global Phase 3 trial of our next-generation IO therapy, IBI363 (PD-1/IL-2α-bias). If successful, this trial could bring a potentially transformative treatment to patients with squamous NSCLC worldwide, who currently have limited options after checkpoint inhibitor therapy. Concurrently, we are exploring IBI363 in a broad global clinical program and look forward to more data and continued development in the future.

This achievement also signifies a milestone for Innovent’s global innovation strategy, rooted in our mission to ’empower patients worldwide with affordable, high-quality biopharmaceuticals’ and our vision to ‘build a global premier biopharmaceutical leader.’ Having developed a highly competitive pipeline aligned with our globalization strategy, we have prioritized the global R&D of our assets, alongside expanding our international team and footprint to accelerate the development and access of innovative therapies worldwide.

In addition to IBI363, Innovent is advancing a broader pipeline for global development, including next-generation ADC programs such as bispecific and dual-payload ADCs. We believe our robust pipeline and ongoing R&D efforts will continue to expand our impact in oncology on a global scale."

Defence Therapeutics Announces Debenture Units Financing

On August 22, 2025 Defence Therapeutics Inc. ("Defence" or the "Company"), a leading biotechnology company specialized in drug delivery technologies, reported a non-brokered private placement of debenture units (the "Units") at a price of $1,000 per Unit for aggregate gross proceeds of up to $1,200,000 (the "Offering"). Each Unit will consist of (i) one $1,000 principal amount of 8.0% convertible debenture (a "Debenture"), and (ii) 1,666 common share purchase warrants (the "Warrants") (Press release, Defence Therapeutics, AUG 22, 2025, View Source;utm_medium=rss&utm_campaign=defence-therapeutics-announces-debenture-units-financing [SID1234655455]).

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The Debentures will bear interest at 8.0% per annum and will mature two years following the issue date. The Debentures are unsecured and will rank pari passu in right of payment of principal and interest with all the existing and future unsecured indebtedness of the Company. The principal amount of each Debenture will be convertible at the option of the holder into common shares in the capital of the Company (a "Common Share") at the conversion price of $0.60 per Common Share (the "Conversion Price"). The accrued interest of the Debentures will be paid annually in Shares at the Conversion Price or in cash at the Company’s election.

Each Warrant will be exercisable to acquire one Common Share (a "Warrant Share") at an exercise price of $0.75 per Warrant Share for a period of two years from the issue date.

All securities issued in connection with the Offering will be subject to a statutory hold period of four months and one day following the closing date of the Offering in accordance with applicable securities legislation. Completion of the Offering is subject to a number of conditions, including, but not limited to, the receipt of all regulatory approvals. The Company may pay a finder’s fee in connection with the Offering to eligible arm’s length finders in accordance with the policies of the Canadian Securities Exchange.

This news release does not constitute an offer to sell or the solicitation of any offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful. The Debentures and the Shares which may be issued on exercise thereof have not been and will not be registered under the United States Securities Act of 1933, as amended (the "U.S. Securities Act") and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the U.S. Securities Act and applicable state securities laws.

Tvardi Therapeutics to Participate in the Cantor Global Healthcare Conference

On August 22, 2025 Tvardi Therapeutics, Inc. ("Tvardi") (NASDAQ: TVRD), a clinical-stage biopharmaceutical company focused on the development of novel, oral, small molecule therapies targeting STAT3 to treat fibrosis-driven diseases, reported that the Company’s Management will participate in a fireside chat at the Cantor Global Healthcare Conference on Thursday, September 4, 2025 at 2:10 PM EDT and participate in one-on-one investor meetings (Press release, Tvardi Therapeutics, AUG 22, 2025, View Source [SID1234655440]).

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The webcast of the fireside chat will be accessible on the Tvardi Investors’ website. A replay of the webcast will be available for approximately 90 days following the conference.

Tempus Announces the Acquisition of Paige

On August 22, 2025 Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine, reported the acquisition of Paige, an AI company specializing in digital pathology (Press release, Tempus, AUG 22, 2025, View Source [SID1234655439]). The acquisition allows Tempus to grow its dataset, expand its experienced technical team, and establish a strong footprint in digital pathology with an industry leading technology portfolio.

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Founded in 2017, Paige has developed and deployed several AI applications, including the first FDA-cleared AI application in pathology, allowing researchers and pathologists to better detect cancer, which enables care teams to make more precise and informed treatment decisions. Paige has developed and refined its products through a dataset that includes almost 7 million digitized pathology slide images and associated clinical and molecular data, stripped of patient identifiers to protect privacy. Leveraging a dataset of de-identified data and images that spans 45 countries and diverse genders, races, ethnicities, and regions, Paige has also developed the first million-slide foundation model for cancer, empowering researchers and life sciences companies to better understand pathology data, and enabling the advancement of drug discovery and development.

"As we embark upon building the largest foundation model that’s ever been built in oncology, the acquisition of Paige substantially accelerates our efforts," said Eric Lefkofsky, Founder and CEO of Tempus. "Paige is a leader in digital pathology and has amassed one of the most comprehensive digital pathology datasets in the world through its relationship with Memorial Sloan Kettering Cancer Center. We believe both the Paige team, with their deep generative AI experience, and the dataset they have built, will be catalytic across all of our AI efforts."

"We’ve always believed that the future of cancer care and precision medicine lies in harnessing the full potential of AI to redefine what’s possible in digital pathology and transform how cancer is detected, understood, and treated," said Razik Yousfi, CEO and CTO of Paige. "By joining forces with Tempus, a company already making remarkable strides in oncology diagnostics, we can bring our innovations to a broader patient population and deliver even greater impact. We are confident this partnership is uniquely positioned to maximize and expand the reach of our technology, ensuring it fulfills our mission of delivering powerful, data-driven insights."

Tempus is acquiring Paige for $81.25 million, which is being paid predominantly in Tempus common stock, as well as Tempus’ assumption of Paige’s remaining commitment under its existing Microsoft Azure cloud services agreement.

Antengene Announces 2025 Interim Financial Results Highlighting Encouraging Data from Mid/Late-Stage Clinical Programs and Its Innovative TCE Technology Platform

On August 22, 2025 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) reported its interim results for the period ending June 30, 2025, along with an update highlighting some of its recent achievements (Press release, Antengene, AUG 22, 2025, View Source [SID1234655436]).

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Dr. Jay Mei, Antengene’s Founder, Chairman, and CEO, said, "In the first half of 2025, Antengene delivered a series of milestone achievements. Our core mid/late-stage clinical asset, ATG-022, was granted a Breakthrough Therapy designation by the NMPA based on its outstanding clinical data that demonstrated efficacy across all CLDN18.2 expression levels. This underscores ATG-022’s distinctive characteristics as a potential backbone therapy for the treatment of gastric cancer. Moreover, ATG-037 has also exhibited compelling best-in-class potential in clinical studies, with encouraging efficacy data in patients with CPI-resistant melanoma and NSCLC. During the reporting period, we disclosed the preclinical data of ATG-201 (CD19 x CD3 TCE with masking via steric hindrance) in NHP models. ATG-201 is being developed for the treatment of autoimmune diseases and is expected to enter clinical development in Q4 2025. On the commercialization and operational front, XPOVIO delivered a robust 70.6% period-over-period revenue growth, while sales and administrative expenses declined significantly year-over-year, validating the effectiveness of our two-pronged strategy that centers around innovation and operational efficiency. Looking ahead, we will strive to accelerate the development and commercialization of our key assets, in efforts to deliver breakthrough therapies to patients worldwide and generate sustainable long-term value for our investors."

【Business Updates】

1. Key Clinical Assets

ATG-022 (CLDN18.2 Antibody-Drug Conjugate)

Updated Data from the Ongoing Phase I/II CLINCH Study: ATG-022 demonstrated significant clinical efficacy and a favorable safety profile in patients with gastric/gastro-esophageal junction adenocarcinoma across high, low, and ultra-low CLDN18.2 expression levels. 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), including 1 complete response (CR), with a disease control rate (DCR) of 90% (27/30), a median progression-free survival (mPFS) of 6.97 months, a 6-month PFS rate of 51.1%, a 9-month overall survival (OS) rate of 82.7%, and a 12-month OS rate of 66.2%. The 1.8 mg/kg dose cohort achieved an ORR of 40% (10/25), including 1 CR, and a DCR of 84% (21/25). Low and ultra-low CLDN18.2 expressors (IHC 2+ ≤ 20%) who were treated at the efficacious dose range of 1.8-2.4 mg/kg achieved an ORR of 33.3% (6/18), including 1 CR, and a DCR of 50% (9/18). To date, three patients in the study have achieved CR during treatment, with one case of CR observed in each of the three cohorts (i.e., both dose levels in the CLDN18.2 moderate-to-high expressor cohorts and the CLDN18.2 low and ultra-low expressor cohort).
Breakthrough Therapy Designation: ATG-022 was granted a Breakthrough Therapy designation by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for the treatment of patients with CLDN18.2-positive, HER2-negative unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma who have received at least two prior lines of therapy.
Advancing Clinical Development in Gastric Cancer Across First- to Third-Line Settings: Antengene is currently conducting a Phase II dose-expansion study of ATG-022 in the Mainland of China and Australia. The company will continue to advance the clinical development of ATG-022 in gastric cancer in first- to third-line settings, including first-line treatment with ATG-022 in combination with pembrolizumab and chemotherapy (CAPOX/FOLFOX); second-line treatment with ATG-022 in combination with pembrolizumab; and third-line treatment with ATG-022 monotherapy. This strategy covers patients with a wide spectrum of CLDN18.2 expression levels, including moderate-to-high expressors (2+ >20%) and low and ultra-low expressors (2+ ≤20%). In addition, the ongoing clinical study includes a basket trial cohort including multiple tumor types. In preliminary data from patients with a certain subtype of gynecologic tumor, all 7 evaluable patients achieved tumor shrinkage, indicating significant clinical potential of ATG-022 in other CLDN18.2-positive tumors. Currently, this cohort continues to enroll patients.
ATG-037 (Oral CD73 Small Molecule Inhibitor)

Updated Data from the Ongoing Phase I/II STAMINA Study: Following the initiation of a global clinical collaboration with MSD, Antengene is evaluating ATG-037 in combination with the anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with checkpoint inhibitor (CPI)-resistant melanoma and non-small cell lung cancer (NSCLC). As of July 24, 2025, data from 25 evaluable patients (11 with melanoma and 14 with NSCLC) showed an ORR of 28% (7/25) and a DCR of 84% (21/25). The melanoma subgroup with majority of patients with double resistance to both anti-PD-1 and anti-CTLA-4 antibodies demonstrated particularly notable efficacy, with an ORR of 36.4%, a DCR of 100%, including 1 CR and 3 partial responses (PRs). In the NSCLC subgroup, the ORR was 21.4%, the DCR was 71.4%, including 3 PRs. It is worth noting that the responses demonstrated impressive durability, with 1 patient in CR demonstrated durable response and has been on the trial for over 32 months, 2 patients with durable PR and has been on the trial for over 15 months, and 1 patient with stable disease (SD) has been on the trial for over 28 months. These data highlight the durable antitumor activity of this combination regimen in CPI-resistant patients. The Phase II STAMINA dose optimization and dose expansion study is currently progressing smoothly in China and Australia.
ATG-031 (CD24-targeting macrophage activator)

Ongoing PERFORM study: ATG-031 is the first-in-class humanized anti-CD24 monoclonal antibody that has entered clinical trials for cancer treatment in the U.S. ATG-031 works by blocking the CD24-Siglec10 pathway and enhancing macrophage-mediated phagocytosis of cancer cells. Key study sites of ATG-031 include MD Anderson Cancer Center at the University of Texas, University of California, San Francisco (UCSF), University of Colorado, and Yale Cancer Center, four renowned cancer centers in the U.S. The Phase I PERFORM study is progressing in the U.S.
2. The TCE Platform and Preclinical/Pre-IND Assets

A TCE Platform Featuring Steric Hindrance Masking: AnTenGager TCE is a proprietary "2+1" 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 cytokine release syndrome (CRS) and enhance efficacy. These characteristics support the platform’s broad applicability across autoimmune diseases, solid tumors and hematological malignancies indications. Antengene is seeking a range of collaborations with its global partners for AnTenGager TCE, through platform access, co-development, and out-licensing to accelerate the development of TCE therapeutics and maximize the value of the technology platform.
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 autoimmune diseases. Preclinical data showed that in NHP models, the repeated dosing of ATG-201 surrogate at 1mpk, 3mpk, and 6mpk dose levels was well tolerated and associated with very low cytokine release. Furthermore, this surrogate antibody can mediate complete B cell depletion in peripheral blood, spleen and lymph nodes. ATG-201 is poised to enter clinical development in the second half of 2025.
Antengene will continue to advance the development of other preclinical programs, including ATG-106 (CDH6 x CD3 TCE) for the treatment of ovarian cancer and kidney cancer, ATG-110 (LY6G6D x CD3 TCE) for the treatment of microsatellite stable (MSS) colorectal cancer, and ATG-112 (ALPPL2 x CD3 TCE) for the treatment of gynecologic tumors and lung cancer.
3. Commercialized Product

Mainland of China: In July 2025, XPOVIO received approval for its third indication in the Mainland of China, bringing a new treatment option to patients with multiple myeloma (MM) who have received at least one prior therapy. Among the three approved indications of XPOVIO, two have already been included in China’s National Reimbursement Drug List (NRDL), including XPOVIO monotherapy for the treatment of relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) and XPOVIO in combination with dexamethasone for the treatment of R/R MM.
Taiwan Market: In February 2025, XPOVIO received national reimbursement approval in Taiwan market, making it the fifth APAC market to secure reimbursement coverage after mainland of China, South Korea, Australia, and Singapore.
ASEAN Markets: In March 2025, XPOVIO was approved in Indonesia. To date, XPOVIO has been approved for multiple indications in ten countries and regions across the APAC region.
【Highlights of Financial Results】

1. Revenue From Product Sales Rose Sharply by 70.6% Period-over-Period

With the steady expansion of its commercial footprint across the Asia-Pacific markets, XPOVIO generated a sales revenue of RMB 53.2 million in the first half of 2025, which rose sharply by 70.6% period-over-period. Along with the rapid revenue growth, the company’s operational efficiency continued to improve, with sales and administrative expenses declining by 34.0% and 32.8% year-over-year, respectively, demonstrating excellent cost control.

2. Strong Cash Reserves Securing the Execution of Long-Term Strategies

As of the end of the reporting period, the company held RMB 794 million in cash and bank balances, which is sufficient to support existing key programs to the proof-of-clinical-concept stage, securing the execution of the company’s long-term strategies.

To learn more about the 2025 interim financial results, please see the full announcement in the "Investor Relations" section on the company’s website.