Cotinga Pharmaceuticals Announces Initiation of Next Cohort of Phase 1b/2a Combination Trial of COTI-2 in Solid Tumors

Cotinga Pharmaceuticals Inc. (TSX Venture: COT) (“Cotinga” or the “Company”)

, a clinical-stage pharmaceutical company advancing a pipeline of targeted therapies for the treatment of cancer, announced today that the Company has initiated the third cohort of its ongoing Phase 1b/2a clinical trial of COTI-2 plus cisplatin in solid tumors. The objective of the third cohort is to continue to evaluate the safety and tolerability of COTI-2 in combination with standard-of-care cisplatin.

“We are pleased to report that the DEC voted unanimously to continue dose escalation in our combination trial, with the new dosage level of 1.7 mg/kg, an increase from the 1.0 mg/kg level of cohort 2”, said Alison Silva, Cotinga’s President & CEO. “We are pleased with the Committee’s recommendation and trial advancement. The patients in our ongoing Phase 1b/2a trial are suffering from a wide spectrum of cancers with little to no therapeutic options, and we are hopeful that combining existing chemotherapy regimens with COTI-2 could be a potential treatment as we have demonstrated and published in a number of preclinical studies. We remain committed to advancing the clinical development of COTI-2, and we will continue to provide key updates as the trial progresses.”

Phase 1b/2a Trial of COTI-2

The ongoing trial of COTI-2 will focus on evaluating COTI-2 as a combination therapy for the potential treatment of a wider range of cancers. In 2017, the Company announced top-line data from the gynecological malignancies arm of the trial demonstrating monotherapy with COTI-2 was generally safe and well-tolerated. Monotherapy with COTI-2 also exhibited an encouraging pharmacokinetic/pharmacodynamic profile and signals of efficacy.

The current protocol amendment being implemented by the Company in May 2018 expands the ongoing trial to evaluate COTI-2 in combination with various standard-of-care chemotherapy regimens in a wide spectrum of cancers.

This protocol amendment evaluates COTI-2 combined with standard-of-care cisplatin in up to 30 patients with any of the following malignancies: ovarian, fallopian tube, primary peritoneal, endometrial, cervical, lung, pancreatic or colorectal cancer, or head and neck squamous cell carcinoma. Patients in this dose finding study will be given a 60 mg/m2 IV dose of cisplatin every three weeks in combination with an oral dose of COTI-2 five days per week. Up to five COTI-2 dose levels will be evaluated ranging from 0.5 mg/kg to 3.5 mg/kg and patient assessments will occur every six weeks. Primary outcome measures will evaluate safety and tolerability and determine the maximum tolerated dose and recommended Phase 2 dose for COTI-2 as a combination therapy. Secondary and exploratory outcome measures will evaluate pharmacokinetics and various signals of efficacy. Additional details on the protocol amendment are available on clinicaltrials.gov. 

About Cotinga Pharmaceuticals Inc.

Cotinga Pharmaceuticals is a clinical-stage pharmaceutical company that uses proprietary artificial intelligence technologies to pursue a targeted and transformational approach to treating cancer and other unmet medical needs. Cotinga’s CHEMSAS® technology is intended to accelerate the discovery and development of novel drug therapies, allowing the Company to build a pipeline of potential drug candidates faster and with a higher probability of success than traditional methods.

The Company’s lead compound, COTI-2, has a novel p53-dependent mechanism of action with selective and potent anti-cancer activity. P53 mutations occur in over 50% of all cancers.  COTI-2 is initially being evaluated in combination with various standard-of-care chemotherapy regimens for the treatment of a wide spectrum of cancers in a Phase 1b/2a clinical trial at the MD Anderson Cancer Center at the University of Texas. The Company has secured orphan drug status in the United States for COTI‐2 for the treatment of ovarian cancer. Preclinical data suggests that COTI-2 could dramatically improve the treatment of cancers with mutations in the p53 gene.

The Company’s second lead compound, COTI-219, is a novel oral small molecule compound targeting the mutant forms of KRAS without inhibiting normal KRAS function. KRAS mutations occur in up to 30% of all cancers and represent a tremendous unmet clinical need and a desirable drug target. COTI-219 is undergoing IND-enabling studies to support a regulatory submission.

Follow @CotingaPharma on Twitter at http://twitter.com/CotingaPharma.

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

For more information, visit http://www.cotingapharma.com/ or contact: Alison SilvaPresident and CEOTel: 1-800-798-6860Email: [e-mail]

Notice to Readers:

Information contained in this press release may contain certain statements which constitute “forward-looking statements” as such term is defined under applicable securities laws. Forward‐looking statements by their nature are not guarantees of future performance and are based upon management’s current expectations, estimates, projections and assumptions. For example, “…we are hopeful that combining existing chemotherapy regimens with COTI-2 could be a potential treatment...” Is a forward-looking statement. Cotinga operates in a highly competitive environment that involves significant risks and uncertainties, which could cause actual results to differ materially from those anticipated in these forward‐looking statements. Management of Cotinga considers the assumptions on which these forward‐looking statements are based to be reasonable, but as a result of the many risk factors, cautions the reader that actual results could differ materially from those expressed or implied in these forward-looking statements. Information in this press release should be considered accurate only as of the date of the release and may be superseded by more recent information disclosed in later press releases, filings with the securities regulatory authorities or otherwise. Except as required by law, Cotinga assumes no obligation to update forward-looking statements should circumstances or management's expectations, estimates, projections and assumptions change.