On November 27, 2025 Imugene Ltd (ASX:IMU), a clinical-stage immuno-oncology company, and JW Therapeutics (Shanghai) Co., LTD (HKEX:2126), a leading biotechnology company focused on cell-based immunotherapies, reported a co-development collaboration to evaluate the combination of Imugene’s oncolytic virus CF33-CD19 (onCARlytics) and JW’s Carteyva—a CD19- directed autologous CAR-T cell therapy—for patients with advanced solid tumors.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This collaboration includes preclinical in vitro and in vivo studies, followed by a Phase 1 investigator-initiated trial to be conducted exclusively in China at premier CAR-T clinical centers. The approach utilizes Imugene’s CF33-CD19 virus to induce CD19 expression on tumor cells, rendering them susceptible to targeting by CD19 CAR-T therapies—a transformative "mark and kill" strategy.

"This collaboration allows us to validate our onCARlytics platform in combination with an approved autologous CAR-T product," said Leslie Chong, Managing Director and CEO of Imugene. "We believe Carteyva which is already approved in blood cancer is an ideal choice, and this initiative enables us to generate impactful data efficiently while exploring a breakthrough treatment paradigm for solid tumours."

With clear go/no-go decision points, and milestones, the collaboration ensures disciplined capital allocation while enabling strategic flexibility.

(Press release, Imugene, NOV 27, 2025, https://mcusercontent.com/e38c43331936a9627acb6427c/files/2f4974d7-399e-d9a4-0ddd-55588cedec81/Strategic_Collaboration_with_JW_Therapeutics.pdf [SID1234660990])

On November 27, 2025 GC Genome, a leading clinical genomics and liquid biopsy company, reported that its collaborative study with Professor Byeon, Jeong-Sik’s team at Asan Medical Center has been published in The American Journal of Gastroenterology(AJG).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

GC Genome applied its proprietary AI-based fragmentomics technology, used in its MCED test, ai-CANCERCH. This study demonstrates the potential for a convenient, alternative to colonoscopy and fecal based screening methods, while enabling early detection of colorectal cancer and advanced adenomas.

Study Overview

A total of 1,677 individuals were enrolled, including: 302 with CRC, 108 with AA
1,267 with normal colonoscopy as healthy or non-cancer controls
The test analyzes cfDNA fragmentomic signatures using low-coverage whole-genome sequencing (Lc-WGS) combined with a proprietary AI algorithm, enabling highly sensitive detection of early-stage disease.

Key Findings

CRC sensitivity: 90.4%
Specificity in individuals with normal colonoscopy: 94.7%
Sensitivities by CRC stage : 84.2% (stage I), 85.0% (stage II), 94.4% (stage III), and 100.0% (stage IV)
Sensitivity for T1N0 lesions (eligible for endoscopic resection): 90.0%
Sensitivity for AA: 58.3%
The results remained consistent regardless of: CRC locations (left vs. right colon), age of CRC patients(<60 vs. ≥60), and AA locations

These findings highlight the test’s potential as a reliable cfDNA-based blood test for CRC screening and early prevention.

A GC Genome spokes person stated "Detecting colorectal cancer together with precancerous lesions represents a meaningful advance in prevention. With our fragmentomics technology now validated through publication in a leading gastroenterology journal, GC Genome will continue expanding global clinical collaborations and screening applications."

(Press release, GC Genome, NOV 27, 2025, View Source [SID1234660991])

On November 27, 2025 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech", HKEX: 6990) reported TROP2 ADC sacituzumab tirumotecan (sac-TMT) monotherapy for advanced or metastatic urothelial carcinoma (UC) patients has been published in the journal of Annals of Oncology (Impact Factor: 65.4). This study provides the first evidence of sac-TMT’s potential significant clinical benefit for patients with advanced UC.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This publication is based on the efficacy and safety results of cohort 9 of a phase II MK-2870-001/KL264-01 study evaluating sac-TMT monotherapy in patients with advanced or metastatic UC and disease progression after chemotherapy and immune checkpoint inhibitors. Sac-TMT employs the only currently available irreversible conjugation technology, combined with the novel toxin – a topoisomerase I inhibitor KL610023 (T030). This enhances stability, ensuring greater release of the toxin T030 at tumor sites. It guarantees precise and potent tumor cell killing, achieving an effective balance between efficacy and safety. With its unique structural design, sac-TMT has demonstrated outstanding therapeutic potential in clinical studies.

The results showed that sac-TMT 5 mg/kg monotherapy every 2 weeks demonstrated promising antitumor activity in participants with heavily pretreated advanced or metastatic UC, with a manageable safety profile, warranting further evaluation of sac-TMT in this population.

As of data cutoff (February 17, 2025), 49 participants were treated with sac-TMT; 37 (76%) had received ≥2 prior lines of therapy. Median follow-up was 18.8 months. The confirmed ORR was 31% (sac-TMT as second-line therapy demonstrated a confirmed ORR of 50%) and the disease control rate was 71%. Median DOR was not reached, and the 12-month probability of sustained response was 53%. Median PFS was 5.5 months, with 12-month PFS rate was 29%. Safety with sac-TMT was manageable, the most frequent grade 3 or 4 treatment-related adverse events (AEs) (≥5%) were hematologic toxicities and stomatitis, with no febrile neutropenia events or grade 5 treatment-related AEs.

Professor Ye Dingwei, Vice President of Fudan University Shanghai Cancer Center, stated, "Traditional chemotherapy has limited efficacy for advanced or drug-resistant UC. The emergence of precision medicines like ADCs is breaking through treatment bottlenecks for patients with poor response to chemotherapy. We are delighted to observe the encouraging clinical outcomes achieved by the sac-TMT monotherapy regimen, particularly its outstanding efficacy even among heavily pretreated patients. This development injects new momentum into the treatment landscape for advanced UC and offers patients a more precise therapeutic option."

About sac-TMT

Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as non-small cell lung cancer (NSCLC), breast cancer (BC), gastric cancer (GC), gynecological tumors, among others. Sac-TMT is developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases the payload KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells.

In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc, Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (which includes Mainland China, Hong Kong, Macao and Taiwan).

To date, three indications for sac-TMT have been approved and marketed in China for the treatment of adult patients with unresectable locally advanced or metastatic triple negative breast cancer (TNBC) who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting), EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy and EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC who progressed after treatment with EGFR-TKI therapy. Sac-TMT is the world’s first TROP2 ADC drug approved for marketing in lung cancer. In addition, the sNDA for sac-TMT for the treatment of adult patients with unresectable locally advanced, metastatic HR+/HER2- BC who have received prior endocrine therapy and other systemic treatments in the advanced or metastatic setting was accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), and was included in the priority review and approval process.

As of today, the Company has initiated 9 registrational clinical studies in China. MSD has initiated 15 ongoing Phase 3 global clinical studies of sac-TMT as a monotherapy or with pembrolizumab or other anti-cancer agents for several types of cancer. These studies are sponsored and led by MSD.

(Press release, Kelun, NOV 27, 2025, View Source [SID1234660992])

On November 26, 2025 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, reported that Dean Schorno, the company’s chief financial officer, will present a company overview at the Piper Sandler 37th Annual Healthcare Conference on Wednesday, December 3, 2025, at 8:30 am ET.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

To access the live webcast or archived recording, visit the Investor Relations section of the company’s website at www.rigel.com. Please connect to Rigel’s website prior to the start of the live webcast to allow for any software downloads.

(Press release, Rigel, NOV 26, 2025, View Source [SID1234660976])

On November 26, 2025 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company with a pipeline of first-in-class1 targeted and immune-mediated therapeutics to fight cancer, reported the closing of its previously announced registered direct offering priced at the market under Nasdaq rules for the purchase and sale of 1,172,414 shares of its common stock (or common stock equivalents), at an offering price of $3.625 per share of common stock (or common stock equivalent). Additionally, in a concurrent private placement, the Company issued and sold short-term unregistered warrants to purchase up to an aggregate of 1,172,414 shares of common stock at an exercise price of $3.50 per share. The short-term unregistered warrants are immediately exercisable and will expire eighteen months following the effective date of the registration statement registering the resale of the shares of common stock issuable upon exercise of the warrants.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

The aggregate gross proceeds to the Company from the offering were approximately $4.25 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The potential additional gross proceeds to the Company from the short-term unregistered warrants, if fully exercised on a cash basis, will be approximately $4.1 million. No assurance can be given that any of such short-term unregistered warrants will be exercised. The Company intends to use the net proceeds from this offering primarily for working capital and general corporate purposes.

The shares of common stock (or common stock equivalents) described above (but not the short-term unregistered warrants issued in the concurrent private placement and the shares issuable thereunder) were offered and sold by the Company in a registered direct offering pursuant to a "shelf" registration statement on Form S-3 (File No. 333- 280918) that was filed with the Securities and Exchange Commission (the SEC), on July 19, 2024, as amended on January 24, 2025, which was declared effective by the SEC on January 27, 2025. The offering of the securities in the registered direct offering was made only by means of a base prospectus and prospectus supplement that forms a part of the effective registration statement. Electronic copies of the final prospectus supplement and the accompanying base prospectus may also be obtained from H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

The short-term 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 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.

(Press release, Tempest Therapeutics, NOV 26, 2025, View Source [SID1234660977])