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Toray Initiating Phase II Clinical Trials with TRK-950 for Gastric Cancer Patients

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Aug. 30, 2023

Toray Industries, Inc.

Tokyo, Japan, August 30, 2023 – Toray Industries, Inc., today announced that it will launch Phase II clinical trials (see Glossary note 1) for gastric cancer patients in the United States, Japan, and South Korea for a global comparative study of TRK-950. The company is developing this agent to treat solid tumors.

TRK-950 is a monoclonal antibody (note 2) that binds to and attacks cancer cells by targeting Caprin-1 (note 3), a novel cancer therapeutic target that Toray discovered. Caprin-1 is strongly expressed on the cell membrane surfaces of gastric cancer and most other solid tumors and far less so on the cell membrane surfaces of normal tissues. It is also highly expressed on the cell membrane surfaces of metastatic cancer cells and cancer stem cells, which cause cancers to metastasize and recur (see Reference 1). Toray has accordingly worked on TRK-950 development to inhibit cancer cell growths and metastases and cancer recurrences while minimizing side effects for many solid tumors.

The company has conducted Phase I and Phase Ib clinical trials in the United States and France since 2017 and a Phase I trial in Japan since 2022. Thus far, it has administered TRK-950 to 155 cancer patients. In trials with gastric cancer patients (in combination with ramucirumab and paclitaxel, the standard second-line therapy for gastric cancer), Toray administered TRK-950 in two dose levels. The inhibitions of cancer growth (no cancer growth) were observed in all nine patients receiving 10 mg/kg of this agent during treatment. The partial responses (at least 30% cancer shrinks) were observed in five individuals. Caprin-1 expressed strongly in four of the nine patients (note 4). All of those four were among the individuals showing partial responses (Reference 2).

It is in light of these results that Toray decided to conduct Phase II clinical trials in gastric cancer patients with strong Caprin-1 expressions. The company has obtained approval for these trials from the United States Food and Drug Administration. It has have submitted its clinical trial plans to the Pharmaceuticals and Medical Devices Agency in Japan. An application to Korea’s Ministry of Food and Drug Safety is under review. 

This Phase II clinical trial is a randomized (note 5) comparative study of TRK-950 in combination with ramucirumab and paclitaxel as a second-line (note 6) therapy in patients with gastric cancer in which Caprin-1 is strongly expressing, with a progression-free survival (note 7) as a primary endpoint (note 8) to evaluate efficacy.

In Phase Ib clinical trials, several cases with cancers other than gastric cancer failed to respond to previous treatments but did respond to administering TRK-950 in combination (see Reference 3). Toray will push forward with development to broaden the administration of TRK-950 to other cancers as well.

Toray has committed to clinically developing TRK-950 worldwide in line with its corporate philosophy of contributing to society by creating new value through innovative ideas, technologies, and products. It looks to obtain early approval of this agent as a first-in-class, or breakthrough, cancer treatment.

Anticipated treatment concept for TRK-950

(1)  A clinical trial evaluates the safety and efficacy of a drug candidate substance in humans during development. Phase I studies confirm the safety and pharmacokinetics of new drug candidates in humans. Phase II and III studies compare the safety, dose responses, and safety and efficacy of candidates with control drugs (including placebos). In the clinical development of cancer drugs, these studies are conducted with cancer patients, beginning with Phase I trials.
(2)  Monoclonal antibody: When viruses, cancer cells, and other foreign substances invade the human body, B cells, which are a type of immune cell, produce antibodies binding to them to attack and eliminate the invaders. A monoclonal antibody is a clone of an antibody produced by one type of B cell that uniformly binds to specific sites of foreign substances. Monoclonal antibodies are used in many of antibody drugs.
(3)  Caprin-1 is a novel cancer therapeutic target that Toray first discovered to be highly expressed on the cell membrane surfaces of solid tumors.
(4) Caprin-1 is highly expressed on the surface of cancer cell membranes in cancer tissues.
(5)  Randomization is the process of determining which patients receive particular therapeutic agents in comparative trials.
(6)  Second-line treatments for inoperable cancer start after discontinuing first-line regimes because of low or declining efficacy.
(7)  Progression Free Survival (PFS)
Progression Free Survival refers to the time during and after treatment when a cancer does not progress and a disease is stable.
(8) A primary endpoint is the most important item in a clinical trial that relates directly to the trial’s main objective.

1.  Okano F, Saito T, Minamida Y, Kobayashi S, Ido T, Miyauchi Y, Wasai U, Akazawa D, Kume M, Ishibashi M, Jiang K, Aicher A, Heeschen C, Yonehara T. Identification of Membrane-expressed CAPRIN-1 as a Novel and Universal Cancer Target, and Generation of a Therapeutic Anti-CAPRIN-1 Antibody TRK-950. Cancer Res Commun. 2023;3(4):640-58.
2. Cassier PA, Matrana MR, Hanna DL, George B, Sharma S, Kelly RJ, Okano F, Von Hoff DD, Blay J-Y. A phase-Ib study of TRK-950 combined with anticancer treatment regimens in patients with gastric and gastroesophageal junction (GEJ) cancer.
J Clin Oncol. 2023;41(4 suppl.):pp.361.
3. Hanna D, Cassier P, Alistar A, Sharma S, Matrana M, George B, EI-Khoueiry AB, Okano F, Von Hoff DD, Blay J-Y. A Ph-Ib study of TRK-950 combined with anti-cancer treatment regimens in patients with advanced solid tumors. Eur J Cancer 2022;174(suppl 1): S32-3.

Related release

February 28, 2017—Toray Starts Clinical Trials for Cancer Treatment Agent TRK-950 (in Japanese only)