GlobeNewswire

Checkpoint Therapeutics Initiates Registrational Development Programs for Anti-PD-L1 Antibody CK-301

Del

Ongoing endometrial and colorectal cancer cohorts intended to support BLA submissions

NEW YORK, Jan. 07, 2019 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (NASDAQ: CKPT), a clinical-stage immuno-oncology biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers, today announced that the ongoing multi-center clinical trial of CK-301 has been expanded to enroll patients in three cohorts intended to support requests for accelerated approval and Biologics License Application (BLA) submissions to the U.S. Food and Drug Administration (FDA). These cohorts include:

  • Microsatellite instability-high (MSI-H) endometrial cancer that has progressed following one or two prior anti-cancer therapies;
  • Microsatellite stable (MSS) endometrial cancer that has progressed following one or two prior anti-cancer therapies; and
  • MSI-H or mismatch repair deficient (dMMR) colorectal cancer that has progressed on or after, or been intolerant of, previous treatments, including a fluoropyrimidine- and oxaliplatin- and irinotecan-based chemotherapy.

Each cohort is evaluating a fixed dose of 800 mg CK-301 every two weeks (Q2W). The primary endpoint for each cohort is objective response rate (ORR), and secondary endpoints include duration of response (DOR), progression-free survival (PFS), and overall survival (OS). The ongoing trial is also enrolling cohorts of patients with non-small cell lung cancer (NSCLC) and cutaneous squamous cell carcinoma. 

“We are excited to advance our first immuno-oncology drug candidate, CK-301, into these potentially registration-enabling cohorts, representing a significant milestone in the execution of our strategy to obtain multiple accelerated approvals for our anti-PD-L1 antibody,” said James F. Oliviero, President and Chief Executive Officer of Checkpoint. “We look forward to presenting interim safety and efficacy data from the ongoing clinical trial in the coming months.”

The Phase 1, open-label, multi-center trial is evaluating the safety and tolerability of ascending doses of CK-301 in checkpoint therapy-naïve patients with selected recurrent or metastatic cancers. Following completion of dose escalation in 2018, multiple dose expansion cohorts were initiated. Preliminary data from the ongoing trial suggest that CK-301 is safe and well-tolerated across dose levels ranging from 200 mg to 800 mg administered every two weeks and 1200 mg administered every three weeks, with treatment-related adverse events consistent with marketed anti-PD-1/PD-L1 antibodies.      

About CK-301
CK-301 is a fully-human monoclonal antibody of IgG1 subtype that directly binds to Programmed Death Ligand-1 (PD-L1) and blocks the PD-L1 interaction with the Programmed Death Receptor-1 (PD-1) and B7.1 receptors. PD-L1 is an immune-inhibitory checkpoint molecule expressed on epithelial and vascular endothelial cells, as well as by a number of immune cells, and is utilized by tumor cells as an immune escape mechanism. CK-301’s primary mechanism of action is based on the inhibition of the interaction between PD-L1 and its receptors PD-1 and B7.1, which removes the suppressive effects of PD-L1 on anti-tumor CD8+ T-cells to restore the cytotoxic T cell response.

About Checkpoint Therapeutics
Checkpoint Therapeutics, Inc. (“Checkpoint”) is a clinical-stage, immuno-oncology biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers. Checkpoint is evaluating its lead small-molecule, targeted anti-cancer agent, CK-101, a third-generation EGFR inhibitor, in a Phase 1/2 clinical trial for the treatment of patients with EGFR mutation-positive non-small cell lung cancer (NSCLC). In addition, Checkpoint is currently evaluating its lead antibody product candidate, CK-301, an anti-PD-L1 antibody licensed from the Dana-Farber Cancer Institute, in an ongoing Phase 1 clinical trial in checkpoint therapy-naïve patients with selected recurrent or metastatic cancers, including ongoing cohorts intended to support one or more Biologics License Application submissions. Checkpoint is headquartered in New York City. For more information, visit www.checkpointtx.com.

Forward‐Looking Statements
This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Such statements include, but are not limited to, statements relating to our plans to submit one or more BLAs and seek accelerated approvals for CK-301, any statements relating to our growth strategy and product development programs, and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to our growth strategy; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; risks relating to the results of research and development activities; risks relating to the timing of starting and completing clinical trials; risks relating to our ability to seek accelerated approvals for our drug candidates; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

Company Contact:
Jaclyn Jaffe
Checkpoint Therapeutics, Inc.
(781) 652-4500
ir@checkpointtx.com

Investor Relations Contact:
Jeremy Feffer
Managing Director, LifeSci Advisors, LLC
(212) 915-2568
jeremy@lifesciadvisors.com

Media Relations Contact:
Tony Plohoros
6 Degrees
(908) 940-0135
tplohoros@6degreespr.com

Om GlobeNewswire

GlobeNewswire
GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://globenewswire.com

GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

Følg saker fra GlobeNewswire

Registrer deg med din epostadresse under for å få de nyeste sakene fra GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra GlobeNewswire

ISSI HyperFlash™ memory has successfully been designed into the NXP i.MX RT106A MCU-based solution for AVS (Alexa Voice Service)19.3.2019 21:30:00 CETPressemelding

MILPITAS, Calif., March 19, 2019 (GLOBE NEWSWIRE) -- Integrated Silicon Solution, Inc. a leader in advanced memory solutions, today announced the adoption of HyperFlash™ memory IS26KL256S-DABLI00 (256Mb 3.3V BGA package) with NXP’s i.MX RT106A MCU based solution for AVS (Alexa Voice Service). The Alexa Voice Service (AVS) is a virtual assistant developed by Amazon that provides cloud-based automatic speech recognition (ASR) and natural language understanding (NLU) to provide information, media playback, communication and smart device control capabilities to consumers. HyperFlash™ memory based on the HyperBus™ technology dramatically improves memory performance while reducing pin count and board space, essential for NXP’s implementation to save BOM cost without compromising performance to do XIP (execute-in-place) operations. “NXP is an important partner for us. We are very glad that NXP adopted our HyperFlash™ solution. HyperFlash™ fits nicely in the application to meet the increasingl

NLS Pharmaceutics Announces the Completion of the Merger between NLS Pharma Ltd., NLS-1 Pharma Ltd. and NLS-0 Pharma, Unifying the Global Operations and Development of Nolazol®19.3.2019 21:05:00 CETPressemelding

The combined company was named NLS Pharmaceutics Ltd (NLS) STANS, Switzerland, March 19, 2019 (GLOBE NEWSWIRE) -- NLS Pharmaceutics Ltd (NLS), a Swiss biotech firm focusing on the development of novel treatments for Attention-Deficit/Hyperactivity Disorder (ADHD) and other cognitive disorders and impairments, today announced the closing of the merger of NLS Pharma Ltd., NLS-1 Pharma Ltd. and NLS-0 Pharma, effective immediately. The combined company was named “NLS Pharmaceutics Ltd.” The sideways merger brings together the global operations and assets of the three companies in order to streamline the development of Nolazol®, a controlled release formulation of mazindol that is currently being developed as a non-amphetamine DEA schedule C-4 treatment option for ADHD and narcolepsy, as well as a promising pipeline of early to late-stage compounds focusing on ADHD, sleep disorder and other rare diseases. Leading the combined company as Chief Executive Officer is Alex Zwyer, who served as c

INVNT Recognised for Xero and TEDxSydney Work at The Event Marketing Awards 201919.3.2019 14:30:00 CETPressemelding

HONG KONG, March 19, 2019 (GLOBE NEWSWIRE) -- INVNT, the global live brand storytelling agency™, in partnership with Xero has received the Best Corporate Event Gold Award at the prestigious Event Marketing Awards 2019 organised by Campaign Asia-Pacific and CEI, for its production, management and design of Xerocon Brisbane 2018 – Australasia’s largest technology conference for the accounting industry. During the ceremony, which was held at the Eaton Club in Hong Kong on Tuesday evening local time, INVNT was also recognised with the Best Sustainability Bronze Award alongside client TEDxSydney, for the production of the not-for-profit organisation’s flagship event in 2018, which was themed around the concept of HumanKind and saw the agency devise and implement a series of environmentally friendly initiatives. Now in their fourth year, the Event Marketing Awards organised by Campaign Asia-Pacific and CEI recognise best practice in the creation, planning, production and management of innova

Crocus Technology Unveils its 2nd Generation TMR Linear Sensor with Unparalleled Temperature Stability19.3.2019 13:00:00 CETPressemelding

The CT100 is a unique TMR magnetic sensor with industry-leading performance SANTA CLARA, Calif., March 19, 2019 (GLOBE NEWSWIRE) -- Crocus Technology Inc., a leading supplier of disruptive Tunnel Magneto-Resistance (TMR) sensors, today announces the CT100 device, an advanced, high-performance linear (1D) magnetic sensor based on Crocus’ patented and unique TMR-based technology. The CT100 has best-in-class performance across a wide temperature range coupled with an extremely low linearity error, low hysteresis, and low noise which enables it to address many consumer, industrial and automotive applications and markets. The CT100 outperforms competitors’ xMR or Hall-based linear magnetic sensor technology available today in terms of performance, deviation over temperature, current consumption, and overall robustness. The CT100 does not require any expensive flux guides or concentrators, chopping circuits or set/reset pulses and operates over a wide magnetic field range. Crocus’s revolutio

Despite Brexit Uncertainty, Business Schools in UK Continue to See Strong International Demand19.3.2019 09:00:00 CETPressemelding

Majority of Candidates Say Brexit has No Impact on Decision to Study in the United Kingdom RESTON, Va., March 19, 2019 (GLOBE NEWSWIRE) -- In response to the initial Brexit vote in June 2016, the Graduate Management Admission Council™ (GMAC™) has been tracking Graduate Management Admission Test™ (GMAT™) examinee interest in studying in the UK. This has included periodic surveys of non-U.K. citizens who sent a GMAT score report to a UK business school program, as an indication of where they are interested in studying. In the immediate aftermath of the vote, it was unclear what the impact would be on the international flow of students to UK programs, which are heavily reliant on enrollees from other countries. Brexit, it’s been feared, could restrict or complicate the student visa process and dampen international candidates’ postgraduation job prospects in the UK, both because of possible changes to work visa policies and jobs leaving the UK. However, the most recent survey findings, fro

General Electric Company: Doc re. GE files DEFA14A19.3.2019 08:00:00 CETPressemelding

FAIRFIELD, Conn., March 19, 2019 (GLOBE NEWSWIRE) -- Company ISIN Symbol Headline General Electric Company US3696041033 London: GEC | Paris: GNE Doc re: GE files DEFA14A March 18, 2019 On March 18, 2019, General Electric Company (the "Company") filed a DEFA14A (Definitive Additional Materials) with the U.S. Securities and Exchange Commission ("SEC"), which has been submitted to the U.K. National Storage Mechanism and will be available shortly for inspection at http://www.morningstar.co.uk/uk/NSM. It is also available on the SEC's website at http://www.sec.gov and on the Company's website at https://www.ge.com/investor-relations/events-reports. CONTACT: GE Jennifer Erickson +001 646 682 5620 jennifer.erickson@ge.com This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this informatio