On March 10, 2017 Endocyte, Inc. (NASDAQ:ECYT), a leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy, reported financial results for the fourth quarter ending December 31, 2016, and provided a clinical and business update (Press release, Endocyte, MAR 10, 2017, View Source [SID1234518063]).

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"We are pleased to report progress on several aspects of the business during the last several weeks," commented Mike Sherman, president and CEO at Endocyte. "The separately announced collaboration with Seattle Children’s Research Institute and Dr. Michael Jensen, an innovator and thought leader in the field of chimeric antigen receptor T-cell (CAR T-cell) immunotherapies, is an indication of the promise of our technology and a reflection of our commitment to establishing partnerships intended to bring early stage programs to the clinic more rapidly and drive more value from our pipeline. Mike Andriole joining us as chief financial officer also adds significant experience and capacity to pursue value driving partnerships going forward."

"We also anticipate receiving additional clinical data on our lead assets, EC1169 and EC1456, during 2017 as we advance two additional agents toward the clinic," continued Mr. Sherman.

EC1169 (PSMA-tubulysin) Program Outline

Currently enrolling patients in the expansion phase of the EC1169 trial in up to 50 second-line chemotherapy and up to 50 taxane-naïve metastatic castrate-resistant prostate cancer (mCRPC) patients at a maximum clinical once per week dose of 6.5 mg/m2
Patients are scanned with Endocyte’s proprietary imaging agent, EC0652, to identify the presence of disease that expresses prostate-specific membrane antigen (PSMA)
Primary endpoint of this expansion phase is radiographic progression-free survival (rPFS), measured at 5 months for taxane-naïve mCRPC patients and at 3 months for second-line chemotherapy patients
Secondary endpoints which will provide earlier insight into drug activity include overall response rates as measured by response evaluation criteria in solid tumors (RECIST) 1.1 and prostate-specific antigen (PSA)
Enrollment is not limited based on the results of the scan with EC0652 but primary endpoints of the trial are to be assessed in PSMA-positive patients
EC1456 (Folate-tubulysin) Program Outline

Currently enrolling expansion cohort of up to 40 folate-receptor (FR) positive non-small cell lung cancer (NSCLC) patients, as determined by an etarfolatide scan, to receive the maximum clinical twice per week dose of 6.0 mg/m2
Patients included in this expansion phase of the trial will have received first-line chemotherapy and may have also been treated with anti-PD-1 therapy
Exploring a more frequent dosing schedule, four times per week, in indications that are typically FR-positive, such as ovarian and endometrial cancers
Also conducting an ovarian cancer surgical study to assess various attributes of the drug release within targeted tumors
Upcoming Expected Milestones

Safety and efficacy updates for both EC1169 and EC1456 ongoing clinical trials expected at the Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in June, 2017
Updated pre-clinical data for CAR T-cell program expected to be presented at a medical conference in the first half of 2017
Expect to file Investigational New Drug (IND) application for EC2629 in mid 2017. EC2629 leverages a proprietary warhead with a dual mechanism of action: targeting both FR+ cancer cells and tumor associated macrophages (TAMs)
Completion of pre-clinical evaluations for CAR T-cell program expected in second half of 2017
Initiation of enrollment for EC2629 phase 1 trial expected in second half of 2017
Pre-clinical preparatory work on EC2319 in anticipation of potential IND in 2018. EC2319 targets and disables activated macrophages which otherwise produce pro-inflammatory cytokines associated with chronic inflammatory disease
Fourth Quarter 2016 Financial Results

Endocyte reported a net loss of $11.1 million, or $0.26 per basic and diluted share, for the fourth quarter of 2016, compared to a net loss of $9.8 million, or $0.23 per basic and diluted share for the same period in 2015.

Research and development expenses were $8.2 million for the fourth quarter of 2016, compared to $6.4 million for the same period in 2015. The increase was primarily attributable to increases in expenses related to the EC1169 phase 1 trial, including drug manufacturing expenses.

General and administrative expenses were $3.1 million for the fourth quarter of 2016, compared to $3.5 million for the same period in 2015. The decrease was primarily attributable to a decrease in compensation expense, which was partially offset by an increase in expenses related to patent and recruiting fees.

Cash, cash equivalents and investments were $138.2 million at December 31, 2016, compared to $146.7 million at September 30, 2016, and $173.6 million at December 31, 2015.

Financial Expectations

The company anticipates its cash balance at the end of 2017 to be approximately $100 million.

About EC1456 and etarfolatide

EC1456 is an investigational therapeutic SMDC constructed of a high affinity FR-targeting ligand conjugated through a spacer and bioreleasable linker system to a potent cytotoxic microtubule inhibitor, TubBH. Patient FR-status is determined using the investigational companion imaging agent, etarfolatide.

About EC1169 and EC0652

EC1169 is an investigational therapeutic SMDC constructed of a high affinity prostate specific membrane antigen (PSMA)-targeting ligand conjugated through a bioreleasable linker system to a potent microtubule inhibitor, tubulysin B hydrazide (TubBH). Patient PSMA-status is determined using the investigational companion imaging agent, EC0652.

On March 10, 2017 Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) reported an agreement with F. Hoffmann-La Roche Ltd (Roche) whereby Roche has agreed to supply their PD-L1 blocking antibody Tecentriq (atezolizumab) for a clinical study combining Bavarian Nordic’s cancer vaccine, CV301, and Tecentriq in patients with urothelial carcinoma, or bladder cancer (Press release, Bavarian Nordic, MAR 10, 2017, View Source [SID1234518061]).

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Bavarian Nordic plans to conduct a phase 2 study in patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy, a patient population where Tecentriq has accelerated approval in the U.S. CV301 is designed to generate a T cell response to both CEA and MUC1, two tumor antigens that are highly over expressed in bladder cancers. This study will evaluate the hypothesis that combining a checkpoint inhibitor with a cancer vaccine such as CV301 could be synergistic by enhancing the immune response seen in this patient population to date. The study is anticipated to initiate around the end of 2017.

"In keeping with our strategy to expand the potential of CV301, we are extremely pleased to enter into this collaboration with Roche. This represents our second collaboration in the advancement of CV301 as combination therapy in multiple cancers. We look forward to the initiation of this study and to explore the potential synergy of our programs for the benefit of patients with bladder cancer," said Paul Chaplin, President and CEO of Bavarian Nordic.

Under the terms of the agreement, Roche has committed to supplying Tecentriq to Bavarian Nordic during the phase 2 trial. Bavarian Nordic will be responsible for conducting the clinical trial, and both companies will share data from the trial. Bavarian Nordic continues to retain all commercial rights to CV301.

About CV301
CV301 is an immunotherapy candidate which is being developed under a CRADA with the National Cancer Institute (NCI). CV301 targets two tumor-associated antigens, CEA and MUC1, which are over-expressed in multiple solid tumors, including lung, bladder and colorectal cancer. Similar to PROSTVAC, CV301 uses a prime/boost dosing schedule. CV301 incorporates a modified version of vaccinia (MVA-BN, a proprietary technology of Bavarian Nordic) as a priming dose, followed by multiple fowlpox boosts, and encodes the TRICOM costimulatory molecules. In December 2016, the MAGNI-lung-01 study was initiated. This Phase 1b/2 study evaluates the combination of CV301 and OPDIVO (nivolumab) from Bristol-Myers Squibb in patients with non-small cell lung cancer.