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BOSTON, Sept. 23, 2024 (GLOBE NEWSWIRE) -- Carrick Therapeutics Inc., an oncology-focused biopharmaceutical company discovering and developing highly differentiated therapies, today announced that the first patient has been dosed in the Phase 1 clinical trial evaluating CT7439, a novel cyclin dependent kinase 12/13 (CDK12/13) inhibitor / Cyclin-K glue-degrader. CDK12/13 is implicated in multiple cancer types, as they regulate transcription elongation, RNA splicing, as well as cleavage and polyadenylation. DNA damage response genes are particularly suppressed by loss of CDK12/13 activity. The clinical trial is enrolling patients with advanced solid tumors, including ovarian, breast and Ewing's Sarcoma. "Initiation of our CT7439 Phase 1 clinical trial marks the advancement of our second therapeutic into the clinic for aggressive and resistant forms of cancer,” said Tim Pearson, Chief Executive Officer of Carrick Therapeutics. “CT7439 is the first CDK12/13 inhibitor to enter clinical development, and we are encouraged by its potential as monotherapy or combination therapy across multiple tumor types.” The Phase 1 clinical trial is a modular design, beginning with a dose escalation for the initial administration of CT7439 to patients. The initial clinical evaluation will be focused on safety and pharmacokinetics, with an opportunity for early Proof of Principle using a blood based pharmacodynamic assay of the homologous recombination repair (HRR) pathway. Clinical trial details can also be found on www.clinicaltrials.gov under study ID: NCT06600789. For additional information on the clinical trial, please contact hello@carricktherapeutics.com. About CT7439CT7439 is an inhibitor of CDK12/13 as well as a 'glue degrader' of Cyclin-K, which is the obligate co-factor for CDK12/13, giving both first-in-class and best-in-class potential. This dual modality significantly increases the potency of the compound and leads to the inhibition of DNA repair at the transcriptional level. CDK12/13 regulates gene transcription through the activation of RNA Polymerase II. It has the potential to synergise with other agents targeting DDR such as the PARP inhibitors in multiple cancer types, including breast, ovarian and Ewing’s Sarcoma. About Carrick TherapeuticsCarrick Therapeutics is an oncology-focused biopharmaceutical company developing highly differentiated novel therapies that address significant unmet needs. The Company’s lead program, samuraciclib, is a novel oral first-in-class inhibitor of CDK7 currently in multiple Phase 2 clinical trials for metastatic HR+ breast cancer. The Company is collaborating with Roche, Menarini Group and Arvinas/Pfizer to evaluate novel combinations of samuraciclib with oral SERD endocrine therapies. Additionally, Carrick is developing CT7439, a novel CDK12/13 inhibitor / Cyclin-K glue-degrader, which is currently in a Phase 1 clinical trial. For more information about Carrick Therapeutics, please visit www.carricktherapeutics.com Carrick Contact Carrick TherapeuticsJenny Horsfield, Chief Business Officerjenny.horsfield@carricktherapeutics.com Investors and MediaLuke Heagle, Real Chemistrylheagle@realchemistry.com

BOSTON, Feb. 14, 2024 (GLOBE NEWSWIRE) -- Carrick Therapeutics, Ltd., an oncology-focused biopharmaceutical company discovering and developing highly differentiated therapies, today announced that the first patient has been dosed in its Phase 1b/2 clinical trial evaluating the combination of samuraciclib (CT7001), an investigational oral and first-in-class inhibitor of CDK7, and vepdegestrant (ARV-471), an investigational oral PROTAC® (PROteolysis TArgeting Chimera) estrogen receptor (ER) degrader, being jointly developed by Arvinas (Nasdaq: ARVN) and Pfizer (NYSE: PFE) in women with ER+, HER2- metastatic breast cancer who have previously received a CDK4/6 inhibitor. “We’re excited to expand clinical development of samuraciclib with our Phase 1b/2 clinical trial evaluating the combination of samuraciclib and vepdegestrant, another step forward in addressing an important need for patients with advanced breast cancer,” said Tim Pearson, Chief Executive Officer of Carrick Therapeutics. “We believe there is great potential for this combination treatment, based on the encouraging initial clinical trial data for vepdegestrant and Pfizer’s deep expertise in developing treatments for breast cancer.” The Phase 1b/2 clinical trial has two parts. In Phase 1b, escalating doses of samuraciclib and vepdegestrant will be tested to determine appropriate doses of each therapy to be used in combination. In Phase 2, additional patients will be enrolled to further explore the safety and efficacy of the selected doses. This clinical trial evaluating the novel combination of samuraciclib and vepdegestrant is being conducted as part of the TACTIVE-U study in collaboration with Arvinas and Pfizer under a clinical trial collaboration and supply agreement. Clinical trial details can also be found on under study ID: NCT06125522. For additional information on the clinical trial, please contact hello@carricktherapeutics.com. About Vepdegestrant (ARV-471) Vepdegestrant is an investigational, orally bioavailable PROTAC protein degrader designed to specifically target and degrade the estrogen receptor (ER) for the treatment of patients with ER positive (ER+)/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer. In preclinical studies, vepdegestrant demonstrated up to 97% ER degradation in tumor cells, induced robust tumor shrinkage when dosed as a single agent in multiple ER-driven xenograft models, and showed increased anti-tumor activity when compared to a standard of care agent, fulvestrant, both as a single agent and in combination with a CDK4/6 inhibitor. In July 2021, Arvinas announced a global collaboration with Pfizer for the co-development and co-commercialization of vepdegestrant; Arvinas and Pfizer will equally share worldwide development costs, commercialization expenses, and profits. Ongoing and planned clinical trials will continue to monitor and evaluate the safety and anti-tumor activity of vepdegestrant. About Samuraciclib (CT7001) Samuraciclib is the most advanced CDK7 inhibitor in clinical development. Inhibiting CDK7 is a promising therapeutic strategy in cancer as CDK7 regulates the transcription of cancer-causing genes, promotes uncontrolled cell cycle progression and promotes resistance to anti-hormone therapy. Samuraciclib has demonstrated a favorable safety pro encouraging efficacy in early clinical studies. In addition to the above studies, samuraciclib has further potential in prostate, pancreatic, ovarian and colorectal cancers. Samuraciclib has been granted Fast Track designation from the U.S. Food and Drug Administration (FDA) for use in combination with fulvestrant for the treatment of CDK4/6i resistant HR+, HER2- advanced breast cancer. Carrick is collaborating with Roche, Menarini Group and Arvinas/Pfizer to evaluate novel combinations of samuraciclib with Roche’s oral SERD giredestrant, Menarini Group’s oral SERD elacestrant, and Arvinas/Pfizer’s proteolysis targeting chimera (PROTAC) Estrogen Receptor degrader vepdegestrant (ARV-471) in late-stage CDK4/6i resistant HR+, HER2- metastatic breast cancer. About Carrick Therapeutics Carrick Therapeutics is an oncology-focused biopharmaceutical company developing highly differentiated novel therapies that address significant unmet needs. The Company’s lead program, samuraciclib, is a novel CDK7 inhibitor currently in Phase 2 clinical trials for HR+ breast cancer. Additionally, Carrick is developing CT7439, a novel CDK12/13 inhibitor / Cyclin-K glue-degrader, which is expected to enter a Phase 1 clinical trial in mid-2024. For more information about Carrick Therapeutics, please visit Carrick Contacts Carrick Therapeutics Jenny Horsfield, Chief Business Officer jenny.horsfield@carricktherapeutics.com Investors and Media Luke Heagle, Real Chemistry lheagle@realchemistry.com

BOSTON, Dec. 15, 2023 (GLOBE NEWSWIRE) -- Carrick Therapeutics, an oncology-focused biopharmaceutical company discovering and developing highly differentiated therapies, today announced that the first patient has been dosed in its Phase 2b clinical trial evaluating the combination of samuraciclib (CT7001), an oral and first-in-class inhibitor of CDK7, and fulvestrant, an intramuscular injected selective estrogen receptor degrader (SERD), in women with HR+, HER2- advanced breast cancer previously treated with a CDK4/6 inhibitor. “We continue to make great progress in evaluating the combination of samuraciclib and fulvestrant with the dosing of the first patient in the Phase 2b study,” said Tim Pearson, Chief Executive Officer of Carrick Therapeutics. “There is a large unmet need in treatment for women with HR+, HER2- breast cancer, which represents more than two thirds of all new female breast cancer cases. We previously announced data from a single-arm Ph2a study with this combination therapy that demonstrated both clinical activity and tolerability. As such, we are encouraged by the potential of samuraciclib to be a first and best-in-class treatment for women with advanced breast cancer.” The randomized Phase 2b clinical trial will evaluate the Progression Free Survival benefit of the novel combination of samuraciclib with fulvestrant in comparison to fulvestrant alone for patients with breast cancer that have progressed following treatment with a CDK4/6 inhibitor. The clinical trial is being conducted with support from Pfizer Ignite, a new end-to-end service for biotech companies with high potential science that leverages the company’s significant R&D capabilities, scale and expertise to accelerate the development of breakthrough therapies. Carrick maintains full economic ownership and control of samuraciclib and its pipeline. Clinical trial details can also be found on www.clinicaltrials.gov under study ID: NCT05963984. For additional information on the clinical trial, please contact hello@carricktherapeutics.com. About Samuraciclib (CT7001)Samuraciclib is the most advanced CDK7 inhibitor in clinical development. Inhibiting CDK7 is a promising therapeutic strategy in cancer as CDK7 regulates the transcription of cancer-causing genes, promotes uncontrolled cell cycle progression and promotes resistance to anti-hormone therapy. Samuraciclib has demonstrated a favorable safety profile and encouraging efficacy in early clinical studies. In addition to the above studies, samuraciclib has further potential in prostate, pancreatic, ovarian and colorectal cancers. Samuraciclib has been granted Fast Track designation from the U.S. Food and Drug Administration (FDA) for use in combination with fulvestrant for the treatment of CDK4/6i resistant HR+, HER2- advanced breast cancer. Carrick is collaborating with Roche, Menarini Group and Arvinas/Pfizer to evaluate novel combinations of samuraciclib with Roche’s oral SERD giredestrant, Menarini Group’s oral SERD elacestrant, and Arvinas/Pfizer’s proteolysis targeting chimera (PROTAC) Estrogen Receptor degrader vepdegestrant (ARV-471) in late-stage CDK4/6i resistant HR+, HER2- metastatic breast cancer. About Carrick TherapeuticsCarrick Therapeutics is an oncology-focused biopharmaceutical company developing highly differentiated novel therapies that address significant unmet needs. The Company’s lead program, samuraciclib, is a novel CDK7 inhibitor currently in Phase 2 clinical trials for HR+ breast cancer. Additionally, Carrick is developing CT7439, a novel CDK12/13 inhibitor / Cyclin-K glue-degrader, which is expected to enter a Phase 1 clinical trial in the first half of 2024. For more information about Carrick Therapeutics, please visit www.carricktherapeutics.com Carrick Contacts Carrick TherapeuticsJenny Horsfield, Chief Business Officerjenny.horsfield@carricktherapeutics.com Investors and MediaLuke Heagle, Real Chemistrylheagle@realchemistry.com