TP Therapeutics and Almac Diagnostic Services Enter into Agreement to Develop Next-Generation Sequencing, Pan-Cancer Companion Diagnostic
October 24, 2018
New Diagnostic Assay Intended to Identify Patients with ROS1, NTRK or ALK Gene Fusions for Treatment with TP Therapeutics’ Investigational Drug, Repotrectinib
San Diego, CA, October 24, 2018 – TP Therapeutics, a clinical-stage precision oncology company developing novel drugs that address treatment resistance, and Almac Diagnostic Services, a global precision medicine company, today announced a global collaboration agreement to develop and commercialize a next-generation sequencing (NGS) companion diagnostic (CDx) for repotrectinib, TP Therapeutics’ investigational therapy rationally designed to target ROS1, NTRK1-3 and ALK gene fusions in advanced solid tumors.
Under the agreement, Almac will develop the NGS diagnostic based on the ArcherDx’s Anchored Multiplex PCR (AMP™) chemistry, with the intent of submitting it for regulatory approval in the United States. The companion diagnostic will initially allow Almac’s CLIA-accredited laboratory in Durham, N.C. to identify tumors with the targeted gene fusions, enabling physicians to select appropriate patients for treatment with repotrectinib.
“Almac provides us with deep experience in the development and regulatory approval of next-generation sequencing diagnostic assays, which will enable the selection of patients who may not otherwise have access to a targeted therapy like repotrectinib,” said Dr. J Jean Cui, founder, president and chief scientific officer of TP Therapeutics. “We look forward to working with Almac to co-develop repotrectinib with a next generation sequencing based companion diagnostic that detects the presence of ROS1, NTRK1-3 and ALK gene fusions.”
“Molecular testing is critical to identifying patients most likely to benefit from a targeted treatment,” said Paul Harkin, managing director, Almac Diagnostic Services. “We have great expertise in the development of biomarker assays across a wide range of technologies and targets, with an extensive track-record in developing and validating assays under design control and according to regulatory requirements. We are very pleased to work with TP Therapeutics on such a promising investigational therapy as repotrectinib.”
Repotrectinib is an investigational, next-generation tyrosine kinase inhibitor (TKI) developed for the treatment of patients with advanced solid tumors harboring ROS1, NTRK1-3 or ALK molecular rearrangements. Repotrectinib is a rationally designed, low molecular weight, macrocyclic TKI that is much smaller than current ROS1, TRK family and ALK inhibitors with the objective to systematically overcome the clinically acquired resistance mutations of ROS1, TRK family and ALK kinases, especially the gatekeeper and solvent front mutations.
Co-development of CDx and therapeutic products is critical to the advancement of targeted therapies and precision medicine. Companion diagnostics are tests designed to confirm the presence of a specific biomarker to assist physicians in selecting effective therapies for their patients, based on the individual molecular characteristics of each person. Incorporating a companion diagnostic strategy into a drug development program may help generate more effective treatments with improved safety profiles for patients.
The financial terms of the agreement were not disclosed.
About Almac Diagnostic Services
Almac Diagnostic Services is a global stratified medicine company specializing in biomarker driven clinical trials. The company is focused on the discovery, development and commercialization of diagnostic and companion diagnostic tests. We partner with biopharma companies to provide solutions ranging from biomarker discovery to CDx development including regulatory submissions and commercialization. We also facilitate biomarker clinical trial management and clinical test delivery from our CLIA-accredited labs. The tests developed at Almac Diagnostic Services have a wide range of applications including patient selection, and are utilized in phase I to phase III registrational clinical trials.
For more information visit: www.almacgroup.com/diagnostics.
About Repotrectinib (TPX-0005)
Repotrectinib (TPX-0005) is a potent and orally bioavailable investigational small-molecule inhibitor of ALK, ROS1 and TRK family kinases. The clinical benefits of targeting ALK, ROS1 or TRK fusion kinases have been demonstrated with multiple kinase inhibitors already approved for the treatment of ALK+ non-small cell lung cancer (NSCLC), in addition to crizotinib for ROS1+ NSCLC, and larotrectinib and entrectinib in clinical studies for TRK+ cancers. The successes of these therapies are overshadowed by the development of acquired resistance. The acquired solvent front mutations including ALK G1202R, ROS1 G2032R, TRKA G595R and TRKC G623R render a common clinical resistance to the current ALK, ROS1, and TRK inhibitors. Repotrectinib has demonstrated potency against wildtype and mutated ALK, ROS1 and TRK family kinases, especially the clinically significant solvent front mutations, gatekeeper mutations, and emerging compound mutations after multiple lines of treatment. Repotrectinib may provide a new opportunity to inhibit the abnormal signaling of ALK, ROS1, or TRK family kinases in solid malignancies, and overcome multiple resistance mechanisms seen in refractory patients. Repotrectinib is currently being evaluated in a Phase 1/2, open-label, multi-center, first-in-human study of the safety, tolerability, pharmacokinetics and anti-tumor activity in patients with advanced solid tumors harboring ALK, ROS1, or NTRK1-3 rearrangements (TRIDENT-1 study, www.clinicaltrials.gov number NCT03093116). Interested patients and physicians can contact the TP Therapeutics Oncology Clinical Trial Hotline at 1-858-276-0005 or email firstname.lastname@example.org.
1Note: TPX-0005 had an initial generic name of “ropotrectinib,” which was later changed to repotrectinib and is now the accepted name by USAN and WHO INN.
About TP Therapeutics Inc.
TP Therapeutics is a clinical-stage precision oncology company forging a new path for targeted cancer care. Founded in October 2013 by Dr. J. Jean Cui, the lead inventor of Pfizer’s oncology drugs crizotinib and lorlatinib, the company is developing a pipeline of novel drugs that aim to tackle treatment resistance and give new hope to patients who have stopped responding to available targeted therapies. Mounting clinical data for the company’s lead program, a next-generation kinase inhibitor targeting genetic drivers of non-small cell lung cancer and advanced solid tumors, has shown ongoing antitumor activity and durable responses among treatment-naïve and pre-treated patients. With additional programs underway to address similarly intractable oncogenic drivers, TP Therapeutics is marking a turning point in the way solid-tumor cancers are treated. For more information, visit www.tptherapeutics.com.
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About Almac Group
A unique culture delivering exceptional solutions
The Almac Group is an established contract development and manufacturing organization providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally.
Our innovative services range from R&D, biomarker discovery development and commercialization, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.
The international company is a privately owned organization that has grown organically over the past five decades now employing over 5,000 highly skilled personnel across 17 facilities including Europe, the US and Asia. Click here to view our facilities.
We have a global reputation for excellence built over 50 years of client service, delivering expertise right across the drug development lifecycle and offering a tailored solution to each of our clients.