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GI Innovation-LaNova Medicines Signs MOU for GI-102 + ADC Pancreatic Cancer Combination Therapy

On January 22, 2025 GI Innovation (KQ:358570) reported that it signed a Memorandum of Understanding (MOU) with LaNova Medicines (LaNova) for the development of GI-102 and ADC pancreatic cancer combination therapy (Press release, GI Innovation, JAN 22, 2025, View Source;adc-pancreatic-cancer-combination-therapy-302356896.html [SID1234649837]).

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This MOU was held on January 15th, local time, during JP Morgan Healthcare Conference (San Francisco, USA).

From the left, Rhee Byung-geon, Chairman and CEO of GI Innovation, Dr. Crystal Quin, CEO of LaNova Medicines, and Jang Myoung-ho, CSO of GI Innovation. (Source: GI Innovation)
From the left, Rhee Byung-geon, Chairman and CEO of GI Innovation, Dr. Crystal Quin, CEO of LaNova Medicines, and Jang Myoung-ho, CSO of GI Innovation. (Source: GI Innovation)
The two companies have been conducting combination therapy study of the immuno-oncology drug GI-102 and ADC LM-302 targeting Claudin18.2 and recently observed excellent anticancer activity in a preclinical pancreatic cancer model.

Both substances are in the clinical stage. GI-102 has completed phase 1 clinical trial in the US and Korea and can quickly enter phase 2. LM-302 is currently in phase 3 clinical trial for 3L and above gastric cancer in China. Pancreatic cancer has no approved immunotherapy, and the only approved treatment is a chemotherapy cocktail, but its treatment efficacy is low and its toxicity is high. Through this agreement, both companies will conduct clinical trial targeting patients with metastatic pancreatic cancer.

Dr. Myoung Ho Jang, CSO said, "We are delighted to be conducting a combination study with LaNova, which is recognized by global pharma companies. LaNova’s ADC, which directly destroys tumor cells to increase the response rate, and GI-102, which can enhance immune memory to increase overall survival, are expected to be a combination therapy that can change the pancreatic cancer treatment paradigm."

"GI-102 exemplifies GI Innovation’s robust R&D capabilities in immunotherapy. We are excited to explore its combination with LaNova’s Claudin18.2 ADC, LM-302, which holds the potential to provide a novel therapeutic option for pancreatic cancer patients" Dr. Crystal Qin, LaNova CEO emphasized.

Akeso Received Payment for the Development Collaboration on Tagitanlimab

On January 22, 2025, Akeso Inc. (9926.HK) reported that it had received payment from Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. ("Sichuan Kelun") for their collaboration on the development of tagitanlimab, an innovative humanized monoclonal antibody targeting PD-L1, following its recent marketing approval by China’s National Medical Products Administration (Press release, Akeso Biopharma, JAN 22, 2025, https://www.prnewswire.com/news-releases/akeso-received-payment-for-the-development-collaboration-on-tagitanlimab-302357079.html [SID1234649835]).

In 2014, Akeso signed a cooperation agreement with Sichuan Kelun for the development of tagitanlimab. Under the terms of the agreement, Akeso will receive royalties from the commercial sales of tagitanlimab in addition to the development payment.

Tagitanlimab marks Akeso’s second oncology product to yield commercial royalties, following pucotenlimab, a PD-1 monoclonal antibody developed in collaboration with Lepu Biopharma in 2016.

Dr. Yu Xia, founder, chairwoman, president, and CEO of Akeso, said: "Congratulations to our partners. We are thrilled about continuously successful approval of our innovative products, and truly anticipate their outstanding commercialization performance. This achievement highlights Akeso’s strong R&D capabilities and our commitment to innovation. Since its inception, Akeso has established multiple external collaborations, including ivonescimab with Summit Therapeutics, quavonlimab with Merck and pucotenlimab with Lepu Biopharma. These partnerships not only benefit patients but also deliver significant returns for both Akeso and our collaborators. Looking ahead, Akeso will continue to pursue a diversified strategy for new drug development, leveraging global resources to drive the high-quality commercialization of our independently developed innovative therapeutics."

Tyra Biosciences Announces Poster Presentations at 2025 ASCO Gastrointestinal Cancers Symposium

On January 22, 2025 Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, reported that two abstracts were accepted for presentation at the 2025 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI), taking place January 23-25, 2025, in San Francisco, CA (Press release, Tyra Biosciences, JAN 22, 2025, View Source [SID1234649834]).

Details of the poster presentations are below:

Title: "A multicenter, open-label, first-in-human study of TYRA-200 in advanced intrahepatic cholangiocarcinoma and other solid tumors with activating FGFR2 gene alterations (SURF201)"
Abstract: TPS646
Presenting Author: Robin Kate Kelley, MD, University of California San Francisco
Session: Trials in Progress Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract
Date/Time: January 24, 2025, 11:30 AM – 1:00 PM PST, Level 1, West Hall

Title: "TYRA-430: First reversible FGFR4/3 inhibitor designed to overcome current challenges in FGF19-driven hepatocellular carcinoma treatment"
Abstract: 583
Presenting Author: Ronald Swanson, Ph.D., Tyra Biosciences
Session: Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract
Date/Time: January 24, 2025, 11:30 AM – 1:00 PM PST, Level 1, West Hall

The abstracts related to these posters and additional information can be found on the ASCO (Free ASCO Whitepaper) GI website.

About TYRA-200

TYRA-200 is an oral, investigational, FGFR1/2/3 inhibitor with potency against activating FGFR2 gene alterations and resistance mutations. The Phase 1 clinical study of TYRA-200, SURF201 (Study in PrevioUsly treated and Resistant FGFR2+ Cholangiocarcinoma and Other Advanced Solid Tumors) (NCT06160752), is a multi-center, open label study designed to evaluate the maximum tolerated dose (MTD) and the recommended Phase 2 dose of TYRA-200, as well as to evaluate the preliminary antitumor activity of TYRA-200. SURF201 is currently enrolling and dosing adults with advanced/metastatic intrahepatic cholangiocarcinoma and other advanced solid tumors with activating alterations in FGFR2.

About TYRA-430

TYRA-430 is an oral, investigational FGFR4/3-biased inhibitor for FGF19+/FGFR4-driven cancers. The US Food and Drug Administration has cleared Tyra’s Investigational New Drug application to proceed with a Phase 1 clinical study of TYRA-430. The Phase 1 study will be a multicenter, open-label, first-in-human study of TYRA-430 in advanced hepatocellular carcinoma (HCC) and other solid tumors with activating FGF/FGFR pathway aberrations (SURF431).

ImaginAb, Inc. Innovative Biologics Technology platform acquired by Telix to enable Next-Generation Therapeutic Assets discovery

On January 22, 2025 ImaginAb, Inc., reported that it has entered into an agreement to sell a pipeline of next-generation therapeutic candidates, proprietary novel biologics technology platform, and a protein engineering and discovery research facility to Telix Pharmaceuticals Limited (ASX: TLX; Nasdaq: TXL) (Press release, ImaginAb, JAN 22, 2025, View Source [SID1234649833]).

Following the closing of this transaction, ImaginAb Inc., will focus on developing its lead imaging candidate, CD8 ImmunoPET, which is currently in Phase 2 clinical trials and has been licensed by numerous pharmaceutical and biotech companies for use in imaging within immunotherapy clinical trials, primarily in oncology. In addition, ImaginAb will continue to partner in advancing the pivotal prostate cancer imaging agent, which is currently being evaluated in Phase 2 clinical trials and as a surgical resection tool.

Dr. Anna Wu, Founder of ImaginAb, commented, "We are very pleased that Telix recognizes the potential of our novel biological technology platform including enabling Telix to explore new disease areas with state-of-the-art radiotherapeutic technology. These radiopharmaceutical agents represent the culmination of significant effort and resources by our scientific team. I extend my congratulations to everyone at ImaginAb for reaching this significant milestone. This transaction further validates our novel minibody platform."

Dr. Wu continued, "With the sale of our radiopharmaceutical platform, ImaginAb will continue the development of its CD8 platform. We are encouraged that numerous pharmaceutical and biotech companies have incorporated our technology in their immuno-oncology clinical trials."

Jefferies LLC and Stifel, Nicolaus & Company, Incorporated served as financial advisors to ImaginAb on the transaction.

Cadonilimab (PD-1/CTLA-4) Phase III Data for First Line Treatment of Advanced Gastric Cancer Published in Nature Medicine

On January 22, 2025 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that the prestigious medical journal Nature Medicine published the results of the company’s independently developed PD-1/CTLA-4 bispecific antibody cadonilimab in combination with oxaliplatin and capecitabine for the first-line treatment of unresectable locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma in a Phase III clinical study (COMPASSION-15/AK104-302) (Press release, Akeso Biopharma, JAN 22, 2025, View Source [SID1234649832]). The results of the COMPASSION-15 study were previously orally presented at the 2024 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.

This recognition represents an additional validation of cadonilimab’s clinical value in addressing critical unmet need. Previously, clinical research findings on cadonilimab in the treatment of various malignancies have been published in internationally renowned journals such as The Lancet, The Lancet Oncology, Nature Medicine, Drugs, and Clinical Cancer Research.

The Phase III clinical data in the Nature Medicine publication indicates that, regardless of PD-L1 expression, cadonilimab combined with chemotherapy regimen significantly improves overall survival benefits for the entire population of advanced gastric cancer patients and reduces the risk of disease-related death (OS HR 0.62). Even for the PD-L1 low-expressing and negative group, the cadonilimab regimen demonstrated a meaningful survival benefit for patients (OS HR 0.70), effectively addressing the current limitations of PD-1 monoclonal antibody first-line treatment for PD-L1 low-expression and negative gastric cancer.

In September 2024, the cadonilimab regimen for the first-line treatment of advanced gastric cancer was approved and is now widely used in clinical practice, offering a comprehensive and efficacious immunotherapy option for patients. A Phase III clinical trial of cadonilimab combined with a VEGFR-2 monoclonal antibody for PD-1/L1 inhibitor-pretreated advanced gastric adenocarcinoma and gastroesophageal junction adenocarcinoma patients is currently advancing on scheduling. Akeso’s comprehensive clinical strategy for both first-line and subsequent-line treatments in various cancer types will further expand cadonilimab’s indications, providing a novel and effective solution for these patients. Cadonilimab’s ability to target both PD-1 and CTLA-4, two key immune checkpoints, demonstrates its synergistic anti-tumor mechanisms, further demonstrating Akeso’s leadership in the global bispecific antibody field for cancer immunotherapy.

Currently, cadonilimab is being investigated in over 23 clinical studies across 16 indications, targeting tumor types such as gastric cancer, lung cancer, liver cancer, cervical cancer, and pancreatic cancer. In addition to the already approved indications for recurrent/metastatic cervical cancer and first-line gastric cancer, as well as the first-line cervical cancer indication currently under review, cadonilimab is also undergoing five Phase III clinical trials for liver cancer, non-small cell lung cancer, and gastric cancer. Research across multiple indications, including cervical cancer, gastric cancer, and non-small cell lung cancer, has demonstrated that cadonilimab exhibits breakthrough efficacy across "broad population", demonstrating clinically meaningful positive outcomes for PD-L1 high-expressing, low-expressing, and even PD-L1-negative patient populations. Clinical benefit across multiple cancer types and tumor PD-L1 expression status shows that cadonilimab not only advances current cancer immunotherapies, but also significantly broadens their patient coverage. Cadonilimab holds the potential to become a cornerstone drug in the next generation of cancer immunotherapy and is expected to be widely used in combination with antibody-drug conjugates (ADCs) and other high-potential targets.