On July 16, 2025 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, reported that Nature Medicine (IF: 58.7) has published the results of the Phase 1 clinical study of IBI343, an innovative anti-CLDN18.2 ADC, for the treatment of advanced gastric/gastroesophageal junction (G/GEJ) adenocarcinoma (Press release, Innovent Biologics, JUL 16, 2025, View Source [SID1234654412]). Publication in this leading international academic journal indicates the strong recognition of the therapy’s clinical potential and marks another significant milestone in China’s progress in developing novel anti-tumor medications. Based on the study findings, a multi-regional Phase 3 clinical trial (G-HOPE-001, NCT06238843) was launched in 2024 to further evaluate IBI343 as a safe and effective treatment option for patients with advanced G/GEJ AC.

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Gastric cancer remains one of the most common malignant tumors in the world. According to the GLOBOCAN 2022 statistics, it ranks as the fifth most common malignant tumor and the fifth leading cause of cancer-related death globally, with an estimated 970,000 new cases and 660,000 deaths annually. Each year, China reports 359,000 new cases and 260,000 deaths from gastric cancer, representing 37.0% and 39.4% of global totals, respectively, highlighting a significant unmet medical need.

CLDN 18.2 is a tight junction protein expressed in differentiated epithelial cells on the gastric mucosa under normal physiological conditions. Previous studies have revealed that Claudin18.2 is highly expressed in multiple types of cancer, including gastric cancer (60-80%), pancreatic cancer (50%), esophageal carcinoma (30-50%), and lung cancer (40-60%). Targeting CLDN18.2 with monoclonal antibodies (mAbs) and ADCs represents a promising new approach for treating gastric cancer.

This published study is a global, multicenter Phase 1 clinical trial (ClinicalTrial.gov identifier: NCT05458219) designed to evaluate the safety, tolerability and preliminary efficacy of IBI343 in patients with advanced solid tumors. Between October 26, 2022, and June 30, 2024, a total of 116 subjects with advanced G/GEJ adenocarcinoma were enrolled to receive IBI343 monotherapy (8 in escalation and 108 in expansion).

IBI343 has demonstrated encouraging tumor response and survival benefit

The study analyzed the efficacy data of evaluable subjects with high expression of CLDN18.2 (≥75% tumor cells with membranous staining intensity ≥2+ by IHC), in the two dose groups of 6 mg/kg and 8 mg/kg.

At 6 mg/kg (N=31), 15 patients had partial responses (PR) including 9 patients with confirmed PRs and 1 patient awaiting confirmation. The confirmed ORR was 29.0% (95% CI: 14.2-48.0) and the disease control rate (DCR) was 90.3% (95% CI: 74.2-98.0). In 9 patients with confirmed response, the median duration of response (DoR) was 5.6 months (95% CI: 2.8-7.0). The median follow-up was 10.6 months (95% CI: 9.7-11.5) for PFS and OS. The median PFS was 5.5 months (95% CI: 4.1-7.0). OS data was not mature with the current median OS of 10.8 months (95% CI: 6.8-NC). After data cutoff, response of the remaining 1 patient was confirmed on July 26, 2024 and the confirmed ORR was updated to 32.3% (95% CI: 16.7-51.4).
At 8 mg/kg (N=17), 17 patients with high expression of CLDN 18.2 were evaluable. Among them, 9 patients had PRs including 8 patients had confirmed PR. The confirmed ORR 47.1% (95% CI: 23.0-72.2), and the DCR was 88.2% (95% CI: 63.6-98.5). In eight patients with confirmed response, the median DoR was 5.7 months (95% CI: 2.7-NC). Of all G/GEJ adenocarcinoma patients with high CLDN18.2 expression treated at 8 mg/kg (N=19, including 1 patient from dose escalation and 18 patients from dose expansion), the median follow-up was 8.1 months (95% CI: 7.6-8.5) for PFS and OS. The median PFS was 6.8 months (95% CI: 2.8-7.5), and the median OS was not reached with events occurred in 36.8% patients.
IBI343 also demonstrated superior safety

Among all patients with G/GEJ adenocarcinoma (n=116, including 8 patients with gastric cancer from the dose escalation phase), 66.4% patients (77/116) had ≥3 grade TEAEs. The most common ≥3 grade TEAEs (≥35%) were neutrophil count decreased (28.4%), white blood cell count decreased (25.9%), and anemia (16.4%). There were very few grade ≥3 gastrointestinal adverse events, including only 1.7% of grade ≥3 nausea. No interstitial lung disease of any grade was reported. Treatment-related toxicity was alleviated with adequate supportive treatment, and the overall safety was tolerable.
Integrated pharmacokinetics (PK), exposure-response, safety, and efficacy data supported 6 mg/kg Q3W as the recommended Phase 2 dose (RP2D) of IBI343. This provides support for the conduct of subsequent Phase 3 trial, suggesting that IBI343 may become a new treatment option for patients with gastric cancer in the future.

Professor Lin Shen, Corresponding Author, Leading Principal Investigator, from Beijing Cancer Hospital, said, "Following the eras of chemotherapy, targeted therapy and immunotherapy, ADCs have opened a new frontier in the treatment of gastrointestinal tumors. IBI343 is a new generation of Fc-silent anti-CLDN18.2 ADC that has shown encouraging clinical benefits and low gastrointestinal toxicity in Phase 1 studies. We look forward to the results of the Phase 3 study comparing IBI343 with standard treatment, aiming to ultimately reshape clinical practice, transform treatment paradigms, and usher in a new chapter in precision medicine."

Dr. Hui Zhou, Chief R&D Officer for Oncology Pipeline at Innovent Biologics, said, "There is a huge unmet clinical need for the treatment of advanced gastric cancer. The Phase 1 study results of IBI343 in advanced gastric and gastroesophageal junction adenocarcinoma, now published in the top international journal, Nature Medicine, further verify the clinical value of IBI343 in this population. We will work with researchers worldwide to advance the multi-regional Phase 3 clinical trial (G-HOPE-001), with the goal of establishing a new paradigm in clinical diagnosis and treatment and ultimately benefiting gastric cancer patients around the world. We are also exploring the therapeutic potential of IBI343 in pancreatic cancer and other indications."

About Gastric/ Gastroesophageal Junction Adenocarcinoma

Gastric cancer is one of the most prevalent malignant tumors worldwide and a leading cause of cancer-related deaths globally. The 5-year survival rate of patients with metastatic gastric cancer is less than 5%[i]. China and Japan have the highest incidence rates of gastric cancer[ii]. Currently, the standard-of-care treatments for patients with advanced metastatic gastric cancer include a chemotherapy combination of fluoropyrimidine and platinum, as well as immune checkpoint inhibitor therapy. However, systemic therapy has limited efficacy in advanced gastric cancer. In particular, the prognosis for patients with third-line or higher gastric cancer is usually poor, with fewer treatment options and shorter survival expectations. The median survival time for these patients is only about 0.5 year[iii].

Claudin, a member of the tight junction molecule family, is a key structural and functional component of epithelial tight junctions. Among them, CLDN18.2 is normally buried in gastric mucosa, but the development of malignancy leads to disruption of tight junctions and exposure of CLDN18.2 epitopes on the membrane of tumor cells[iv]. CLDN18.2 is expressed in up to 80% of patients with gastric cancer.

About IBI343（Anti CLDN18.2 ADC）

IBI343 is a recombinant human anti-CLDN18.2 monoclonal antibody-drug conjugate (ADC) developed by Innovent Biologics. It specifically binds to the tumor cells expressing CLDN18.2, triggering CLDN18.2-dependent internalization of the ADC. Once inside the cell, the cytotoxic payload is released, resulting in DNA damage and ultimately apoptosis of the tumor cells. The released drug can also diffuse across the plasma membrane to reach and kill neighboring cells, resulting in a "bystander killing effect".

As an innovative TOPO1i ADC, IBI343 has demonstrated tolerable safety and encouraging efficacy signals in this Phase 1 clinical studies. The therapeutic potential of IBI343 is currently being explored in tumor types such as gastric cancer and pancreatic cancer.

The multi-regional Phase 3 clinical trial of IBI343 for advanced gastric / gastroesophageal junction adenocarcinoma is now recruiting patients (G-HOPE-001, NCT06238843). The relevant indication has been granted Breakthrough Therapy Designation (BTD) by China’s NMPA .

The multi-regional Phase 1 clinical trial of IBI343 for advanced pancreatic ductal adenocarcinoma is also enrolling patients (NCT05458219). This indication has received Fast Track Designation (FTD) from the U.S. FDA and been granted BTD by China’s NMPA.

On July 16, 2025 Citius Oncology, Inc. ("Citius Oncology" or the "Company") (Nasdaq: CTOR), a majority-owned subsidiary of Citius Pharmaceuticals, Inc. (Nasdaq: CTXR), reported the pricing of its "reasonable best-efforts" public offering of 6,818,182 shares of common stock of the Company and warrants to purchase shares of common stock at a public offering price of $1.32 per share (Press release, Citius Oncology, JUL 16, 2025, View Source [SID1234654413]). The warrants will have an exercise price of $1.32 per share, will be immediately exercisable upon issuance, and will expire five years from the date of issuance. Gross proceeds from the offering, before deducting placement agent fees and other estimated offering expenses, are expected to be approximately $9.0 million.

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Maxim Group LLC is acting as sole placement agent in connection with the offering.

The Company intends to use the net proceeds from the offering primarily to support the commercialization of LYMPHIR, including milestone, royalty, or other payments pursuant to existing license agreements, as well as for working capital and general corporate purposes. The offering is expected to close on or about July 17, 2025, subject to the satisfaction of customary closing conditions.

The securities described above are being offered pursuant to a registration statement on Form S-1 (File No. 333-288656), as amended, which was filed with the U.S. Securities and Exchange Commission ("SEC") on July 14, 2025, and was declared effective by the SEC on July 16, 2025. A final prospectus relating to the offering will be filed with the SEC, and once available, may be obtained on the SEC’s website at View Source The offering is being made only by means of a prospectus forming part of the effective registration statement. Electronic copies of the prospectus relating to this offering, when available, may also be obtained from Maxim Group LLC, 300 Park Avenue, 16th Floor, New York, New York 10022, Attention: Syndicate Department, by telephone at (212) 895-3745 or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On July 16, 2025 Genetic Leap, a clinical stage, AI-native biotech pioneering RNA genetic therapeutics, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for GL-IL2-138, the company’s small-molecule modulator of natural interleukin-2 (IL-2) (Press release, Genetic Leap, JUL 16, 2025, View Source [SID1234654414]).

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IL-2 is a pleiotropic cytokine that regulates the careful homeostatic balance between immune tolerance and activation. The tremendous potential of IL-2 to address multiple major diseases is universally recognized. Recombinant IL-2 protein (rIL-2) was the first FDA-approved immunotherapy proven effective against cancer at high dose, though toxicity has historically limited its use. And low dose rIL-2 is clinically effective in autoimmune and neurodegeneration diseases. But numerous attempts by pharma companies to remove toxicity from rIL-2 muteins have flopped, earning IL-2 its reputation as an impossible target.

Genetic Leap addressed this herculean challenge by developing a small molecule drug that binds endogenous IL-2 mRNA to drive controlled, systemic production of natural IL-2 protein by immune cells, which has many advantages over rIL-2 including:

Superior potency and durability

Oral dosing with high tolerability

Broad "pipeline-in-a-pill" potential across oncology, immunology (I&I), and neurodegeneration
"We created the Genetic Leap AI platform to deliver breakthroughs like GL-IL2-138," said Dr. Bertrand Adanve, Founder and CEO of Genetic Leap. "Innovative medicine that defies known scientific limitations, like a sci-fi drug made real. GL-IL2-138 is like combining Humira (leading autoimmune biologic) and Keytruda (leading cancer biologic) into one oral pill without the downsides and applicable to even more diseases. GL-IL2-138 is poised to be a giant leap for human health, and Genetic Leap is the company making it happen."

The drug will now be tested in a randomized, double-blind, placebo-controlled phase 1 clinical trial to evaluate its tolerability, pharmacokinetics and pharmacodynamics in humans.

On July 16, 2025 SandboxAQ and iOncologi reported a strategic collaboration to jointly develop, validate, and commercialize a novel high-fidelity mRNA vaccine for glioblastoma, the most common and aggressive malignant brain tumor in adults (Press release, iOncologi, JUL 16, 2025, View Source [SID1234654415]). The joint effort combines SandboxAQ’s proven software and biologics technology for drug candidate identification and lead optimization with iOncologi’s deep tech immunotherapy design and clinical expertise to overcome longstanding barriers in brain cancer treatment.

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Because treatment options are limited, people diagnosed with glioblastoma usually survive less than two years. This aggressive cancer accounts for about 15% of all primary brain tumors, about 300,000 new cases and more than 200,000 deaths worldwide each year, according to the World Health Organization.

"Glioblastoma’s rapid progression and high mortality rate make it one of the most devastating cancers in the world," said Jack Hidary, CEO of SandboxAQ. "Our collaboration with iOncologi aims to create a new and effective treatment for this challenging condition, pairing the most comprehensive oncology datasets with advanced quantitative AI tools and simulation techniques, greatly accelerating the drug discovery process."

The joint program aims to deliver a lead therapeutic candidate into the clinic within 18 months by combining SandboxAQ’s AQBioSim platform for drug discovery and optimization, with iOncologi’s leadership in immunotherapy design and clinical execution. iOncologi specializes in precision immunotherapies that reprogram and redirect the immune system to target tumors previously considered untreatable, particularly those shielded by the blood-brain barrier or cloaked in immune tolerance.

"iOncologi is reimagining cancer immunotherapy by integrating immune intelligence, mRNA engineering, and drug delivery platforms into universal and adaptable, patient-specific treatment models," said Dr. Edgardo Rodriguez-Lebron, CEO of iOncologi. "By combining this with SandboxAQ’s ability to model and rapidly optimize molecules across vast chemical and biological spaces, we are well-positioned to advance a truly transformative therapeutic for glioblastoma, and eventually for other treatment-resistant solid tumors."

SandboxAQ’s AQBioSim platform uses Large Quantitative Models (LQMs) grounded in physics and chemistry to rapidly identify potential drug candidates, simulate molecular behavior and design new potential drug molecules, in the same way as other generative models might output text or images. SandboxAQ’s generative chemistry AI model has been shown to design new molecules with better binding characteristics than the next best technologies, such as large-scale virtual screening, and it does this 100 times faster and at lower cost.

"SandboxAQ’s Large Quantitative Models and AI simulation techniques have proven their ability to rapidly identify and design molecules that address some of the most challenging diseases including Alzheimer’s and Parkinson’s," said Nadia Harhen, General Manager of AI Simulation and head of the AQBioSim division at SandboxAQ. "By adapting the technology stack to oncology, we believe we can make a significant impact where traditional approaches and other advanced technologies have failed."

In June, SandboxAQ also announced a collaboration with Stand Up To Cancer (SU2C) to support SU2C-funded cancer research projects. Leveraging LQMs, the initiative aims to accelerate the development of new treatments, including supporting efforts to detect hard-to-diagnose and treat cancers, and leverage predictive modeling to optimize treatment response and monitor potential recurrence.

On July 16, 2025 Imugene Limited (ASX:IMU) (Company), a clinical stage immuno-oncology company, reported it has received firm commitments from institutional and sophisticated investors (Placement Subscribers) for a $22.5 million placement of 68.2 million new fully paid ordinary shares (New Shares) in the Company at a price of $0.33 per share (Placement) (Press release, Imugene, JUL 16, 2025, https://mcusercontent.com/e38c43331936a9627acb6427c/files/8f06edf2-4d00-ada9-d455-5d6b87cbf237/Imugene_Completes_225M_Placement_and_c_15M_SPP.pdf [SID1234654399]).

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The Placement is being followed by an SPP, to raise up to $15 million, for existing eligible shareholders (Eligible Shareholders), with applications up to a maximum of $100,000. The SPP will be made to Eligible Shareholders at the same terms as the Placement and will be subject to shareholder approval.

Under the Placement and SPP (together, the Offer), Placement Subscribers and Eligible Shareholders are anticipated to receive three (3) free attaching listed options for every four (4) New Shares subscribed for under the Offer (Attaching Options). The Attaching Options will have an exercise price of $0.43 per option with an expiration of 30 March 2026 and will be subject to shareholder approval. It is intended that the Attaching Options will be quoted on the ASX.

Placement Subscribers and Eligible Shareholders are also anticipated to receive one (1) additional free option for every one (1) Attaching Option exercised prior to 30 March 2026 (Piggyback Option). The Piggyback Options will have an exercise price of $0.86 per option, with an expiration of 30 June 2028, and will be subject to shareholder approval. It is intended that the Piggyback Options will be quoted on the ASX.

The full details of the rights and liabilities attaching to the Attaching Options and Piggyback Options are annexed to this announcement.

The funds raised from the Offer will be used:

 to fund research and development of the azer-cel program through a pivotal clinical trial in CY26;
 extending the funding runway into mid CY27; and
 general administrative and working capital.

Imugene Managing Director and CEO Leslie Chong said: "Following the strong support received in the recent oversubscribed placement, Imugene is pleased to extend this opportunity to existing retail shareholders through a Share Purchase Plan (SPP), enabling participation on the same terms. The placement, together with the SPP and existing cash reserves, places the company in a strong financial position to progress the azer-cel program towards a potential pivotal Phase 2 clinical trial, based on the promising efficacy data reported earlier this week".

About the Placement

Under the terms of the Placement, the Company has secured firm commitments for $22.5 million and proposes to issue up to 68.2 million New Shares to Placement Subscribers at a price of $0.33 per share, representing a discount of:

 22.4% to the last close of $0.4250 on 11 July 2025; and
 19.6% to the five-day VWAP of $0.4107 up to and including 11 July 2025.

The Placement is being conducted under Imugene’s existing placement capacity pursuant to ASX Listing Rule 7.1.

For every four (4) New Shares subscribed for by Placement Subscribers under the Placement, Imugene intends to issue three (3) Attaching Options. The Attaching Options will have an exercise price of $0.43 per option and expiry date of 30 March 2026. For every one (1) Attaching Option exercised prior to the expiry date, Imugene intends to issue one (1) Piggyback Option, with an exercise price of $0.86 and an expiration of 30 June 2028.

The Attaching Options and Piggyback Options (New Options) will be set out in a prospectus (Prospectus). The issuance of the New Options will be subject to shareholder approval at an extraordinary general meeting (EGM) to be convened shortly.

Bell Potter Securities Limited and E&P Capital Pty Ltd acted as Joint Lead Managers and Bookrunners to the Placement and are entitled to the fees as set out In the Appendix 3B lodged today.

About the SPP

The Company will also offer an SPP to Eligible Shareholders at an offer price of $0.33 per share (Offer Price). This is the same price as for the Placement and, as with the Placement, the SPP is currently not underwritten.

Under the SPP, Eligible Shareholders listed on the Imugene register at 7:00pm (Sydney time) on the record date of Tuesday, 15 July 2025 with an address in Australia or New Zealand, will be offered the opportunity to apply for up to $100,000 of New Shares in Imugene, without incurring brokerage fees or other transactions costs, irrespective of their holding size. The SPP will be subject to certain eligibility criteria and other terms and conditions of the SPP which will be out in in the Prospectus and dispatched to eligible shareholders.

The New Shares Issued under the SPP will be subject to shareholder approval at an EGM expected to be held in August 2025.

Notwithstanding the target raise amount of $15 million for the SPP, the Company reserves its right to increase or decrease the amount to be raised under the SPP.

As with the Placement, for every four (4) New Shares subscribed for by Eligible Shareholders under the SPP, Imugene intends to issue three (3) Attaching Options on the same terms as the Placement. For every one (1) Attaching Option exercised by an Eligible Shareholders prior to the expiry date, Imugene intends to issue one (1) Piggyback Option on the same terms as the Placement. The Attaching Options and Piggyback Options are subject to shareholder approval.

Additionally, the Company reserves the right to issue up to 4.4 million options to investors who commit to take-up shortfall of the SPP (subject to the Corporations Act 2001 (Cth) and ASX Listing Rules, including shareholder approval if required).