ITK

Aclaris Therapeutics Reports Third Quarter 2023 Financial Results and Provides a Corporate Update

Retrieved on: 
Montag, November 6, 2023

WAYNE, Pa., Nov. 06, 2023 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced its financial results for the third quarter of 2023 and provided a corporate update.

Key Points: 
  • Net loss was $29.3 million for the third quarter of 2023 compared to $20.0 million for the third quarter of 2022.
  • Total revenue was $9.3 million for the third quarter of 2023 compared to $19.0 million for the third quarter of 2022.
  • Research and development (R&D) expenses were $23.9 million for the quarter ended September 30, 2023 compared to $23.7 million for the prior year period.
  • General and administrative (G&A) expenses were $7.1 million for the quarter ended September 30, 2023 compared to $5.8 million for the corresponding prior year period.

Corvus Pharmaceuticals Announces Publication of Preclinical Data Demonstrating Potential of ITK Inhibition with Soquelitinib as a Novel Approach to T Cell-Mediated Inflammatory and Immune Diseases

Retrieved on: 
Mittwoch, November 1, 2023

BURLINGAME, Calif., Nov. 01, 2023 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, today announced the publication of preclinical data that demonstrated the potential of ITK inhibition as a novel approach to treat T cell-mediated inflammatory and immune diseases. Corvus’ ITK inhibitors include soquelitinib (formerly known as CPI-818), which was used in the preclinical studies and is currently in clinical trials for oncology indications, and several next-generation molecules that are being optimized for use in a variety of inflammatory and immune disease indications.

Key Points: 
  • “Our research on soquelitinib and selective ITK inhibition is uncovering valuable new information about immune function and the role of ITK in different diseases,” said James Rosenbaum, M.D., senior vice president of research at Corvus.
  • “The activity of soquelitinib in various inflammatory and immune disease models highlights the essential role of ITK in multiple T cell functions.
  • The publication is now available online as a preprint at bioRxiv.org and on the Publications and Presentations page of the Corvus website.
  • With this new publication, we further demonstrate the wide range of opportunities for ITK inhibition across specific indications with ongoing patient needs for new therapies.

Aclaris Therapeutics Announces Positive Results from Phase 1 Multiple Ascending Dose Trial of ATI-2138, an Investigational Oral Covalent ITK/JAK3 Inhibitor

Retrieved on: 
Montag, September 18, 2023

WAYNE, Pa., Sept. 18, 2023 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced positive results from ATI-2138-PKPD-102, a Phase 1 Multiple Ascending Dose (MAD) trial of the investigational compound ATI-2138.

Key Points: 
  • WAYNE, Pa., Sept. 18, 2023 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced positive results from ATI-2138-PKPD-102, a Phase 1 Multiple Ascending Dose (MAD) trial of the investigational compound ATI-2138.
  • Based on these results, Aclaris will progress this program into a Phase 2a proof of concept study in patients with ulcerative colitis, its previously announced intended first clinical development target, and anticipates initiation of the trial in early 2024.
  • Aclaris is also exploring the potential of conducting a second proof of concept trial in an additional T cell-mediated autoimmune disease.
  • ATI-2138-PKPD-102 was a two-week Phase 1 MAD trial to investigate the safety, tolerability, PK and PD of ATI-2138 in healthy volunteers.

Corvus Pharmaceuticals Confirms Planned Initiation of Soquelitinib (CPI-818) Phase 3 Registrational Clinical Trial in Peripheral T Cell Lymphoma Following Meeting with FDA

Retrieved on: 
Mittwoch, September 6, 2023

BURLINGAME, Calif., Sept. 06, 2023 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, confirmed today that it completed an End-of-Phase/Pre-Phase 3 meeting with FDA on its plans to initiate a Phase 3 registrational clinical trial of soquelitinib (formerly CPI-818), the Company's ITK inhibitor product candidate, in relapsed peripheral T cell lymphoma (PTCL).

Key Points: 
  • “We are pleased with the outcome of our End-of-Phase/Pre-Phase 3 meeting with FDA, allowing us to advance ITK inhibition with soquelitinib into a potentially registrational clinical trial for patients with relapsed peripheral T cell lymphoma,” said Richard A. Miller, co-founder, president and chief executive officer of Corvus.
  • “We appreciate the FDA’s input and their confirmation on the key aspects of the trial design, including sample size, dosing, eligibility, comparator arm and endpoints.
  • We are now focused on finalizing the study protocol, qualifying trial sites and completing other standard steps required to initiate the trial.
  • ET (5:30 a.m. PT), to discuss the soquelitinib Phase 3 clinical trial plan and other business updates.

Corvus Pharmaceuticals Provides Business Update and Reports Second Quarter 2023 Financial Results

Retrieved on: 
Dienstag, August 8, 2023

BURLINGAME, Calif., Aug. 08, 2023 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, today provided a business update and reported financial results for the second quarter ended June 30, 2023.

Key Points: 
  • ET / 1:30 p.m. PT
    BURLINGAME, Calif., Aug. 08, 2023 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, today provided a business update and reported financial results for the second quarter ended June 30, 2023.
  • The latest data from the trial was reported at the International Conference on Malignant Lymphoma, which took place June 13-17, 2023 in Lugano, Switzerland.
  • Based on its current plans, Corvus expects its cash to fund operations into the second half of 2024.
  • ET (1:30 p.m. PT), during which time management will provide a business update and discuss the second quarter 2023 financial results.

Corvus Pharmaceuticals Announces Publication of Preclinical Data Demonstrating Potential Novel Approach to Immunotherapy Based on Inhibition of ITK with Soquelitinib (CPI-818)

Retrieved on: 
Donnerstag, Juli 6, 2023

BURLINGAME, Calif., July 06, 2023 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, today announced the publication of preclinical data on soquelitinib (formerly known as CPI-818), the Company’s ITK inhibitor product candidate, which highlighted the selective inhibition of ITK to potentially enhance anti-tumor immune response to hematologic and solid tumors and provide a novel approach to cancer immunotherapy.

Key Points: 
  • The publication is now available online as a preprint at bioRxiv.org and on the Publications and Presentations page of the Corvus website.
  • “This significant scientific report demonstrates the potential of highly selective ITK inhibition, now enabled by soquelitinib.
  • The findings reported indicate that ITK is a novel drug target and its blockade may enhance the body’s immune response to cancer.
  • Led to in vivo anti-tumor activity in several mouse tumor models, including colon, renal, melanoma, B cell and T cell tumors.

Corvus Pharmaceuticals Presents New CPI-818 Interim Data at the International Conference on Malignant Lymphoma

Retrieved on: 
Donnerstag, Juni 15, 2023

BURLINGAME, Calif., June 15, 2023 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, today announced new data for CPI-818, the Company’s ITK inhibitor, demonstrating the potential to treat a variety of solid and hematological cancers based on a novel immunotherapy mechanism of action. The data includes updated interim results from the CPI-818 Phase 1/1b clinical trial that continues to demonstrate the potential of ITK inhibition and the absolute lymphocyte count (ALC) biomarker in T cell lymphoma (TCL). The data is being presented in a poster at the International Conference on Malignant Lymphoma (ICML) meeting, which is taking place June 13-17, 2023 in Lugano, Switzerland.

Key Points: 
  • The data includes updated interim results from the CPI-818 Phase 1/1b clinical trial that continues to demonstrate the potential of ITK inhibition and the absolute lymphocyte count (ALC) biomarker in T cell lymphoma (TCL).
  • The data is being presented in a poster at the International Conference on Malignant Lymphoma (ICML) meeting, which is taking place June 13-17, 2023 in Lugano, Switzerland.
  • “The preclinical and clinical data indicate a consistent and comprehensive rationale based on the biology and mechanism of immune enhancement resulting from selective ITK inhibition.
  • We see this in the interim tumor response data, which showed that a majority of the patients treated with the optimal dose of 200mg twice per day of CPI-818 experience tumor regression.

Corvus Pharmaceuticals to Present New CPI-818 Data at the International Conference on Malignant Lymphoma

Retrieved on: 
Mittwoch, Mai 17, 2023

BURLINGAME, Calif., May 17, 2023 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, today announced that it will present new data for CPI-818, the Company’s ITK inhibitor, at the International Conference on Malignant Lymphoma (ICML) meeting, which is taking place June 13-17, 2023 in Lugano, Switzerland.

Key Points: 
  • BURLINGAME, Calif., May 17, 2023 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, today announced that it will present new data for CPI-818, the Company’s ITK inhibitor, at the International Conference on Malignant Lymphoma (ICML) meeting, which is taking place June 13-17, 2023 in Lugano, Switzerland.
  • “We look forward to presenting data at ICML supporting the biology and mechanism of immune enhancement resulting from selective ITK inhibition, along with the latest clinical data from our Phase 1/1b clinical trial of CPI-818 for T cell lymphoma.
  • CPI-818 is currently being studied in a Phase 1/1b clinical trial as a single agent therapy in patients with relapsed TCL.
  • Corvus recently incorporated a minimum absolute lymphocyte count (ACL) as an eligibility criterion for enrollment in the clinical trial.

Corvus Pharmaceuticals Provides Business Update and Reports First Quarter 2023 Financial Results

Retrieved on: 
Montag, Mai 8, 2023

BURLINGAME, Calif., May 08, 2023 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, today provided a business update and reported financial results for the quarter ended March 31, 2023.

Key Points: 
  • ET / 1:30 p.m. PT
    BURLINGAME, Calif., May 08, 2023 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, today provided a business update and reported financial results for the quarter ended March 31, 2023.
  • The clinical trial is expected to enroll up to 60 patients and initial data is anticipated before the end of 2023.
  • As of March 31, 2023, Corvus had cash, cash equivalents and marketable securities totaling $34.5 million.
  • The decrease of $0.5 million was primarily due to lower clinical trial and manufacturing costs associated with the development of mupadolimab.

Daewoong Pharmaceutical announces a Global License Agreement for DWP213388, a new drug candidate for autoimmune disease with Vitalli Bio

Retrieved on: 
Freitag, April 28, 2023

SEOUL, South Korea and OAKLAND, Calif., April 27, 2023 /PRNewswire/ -- Daewoong Pharmaceutical (CEO Jeon Sengho and Lee Chang-jae) announced today that it had signed a Global License Agreement for its autoimmune disease drug candidate DWP213388 with Vitalli Bio, a US biotechnology company, on April 28.

Key Points: 
  • With this agreement, Daewoong Pharmaceutical will grant exclusive rights for the development and commercialization of DWP213388 in the global market to Vitalli Bio, a portfolio company of Aditum Bio.
  • In return, Daewoong will receive over $10 million in upfront commitments, and the deal is worth up to $477 million.
  • In addition, Vitalli Bio will be granted an option to license earlier stage dual-target inhibitors in development by Daewoong.
  • Daewoong Pharmaceutical will continue to introduce innovative new drugs that are recognized in the global pharmaceutical market."