CDC classification system for HIV infection

Elucida Oncology to Present New Clinical and Preclinical Data at the 2023 AACR Annual Meeting

Retrieved on: 
Tuesday, April 11, 2023

“Our ultra-small CDCs are differentiated from antibody drug conjugates by their rapid renal elimination and their ability to penetrate deep into solid tumors.

Key Points: 
  • “Our ultra-small CDCs are differentiated from antibody drug conjugates by their rapid renal elimination and their ability to penetrate deep into solid tumors.
  • Additionally, CDCs deliver more drug payload and bind to cancer cells with high avidity.
  • Taken together, we believe that these unique properties have the potential to improve efficacy and tolerability of targeted payloads for cancer patients,” stated Geno Germano, President and CEO of Elucida Oncology.
  • Title: ELU-FRα-1: A Study to Evaluate ELU001, a C’Dot Drug Conjugate, in Patients with Solid Tumors that Overexpress Folate Receptor Alpha (FRα)

Huichao Liang, An Expert on AIDS Combined with Gynecological Oncology, Receives Excellent Popular Science Worker Award

Retrieved on: 
Friday, February 24, 2023

Among gynecological tumors, cervical cancer, endometrial cancer and ovarian cancer are still the most important female reproductive system malignancies threatening women's health.

Key Points: 
  • Among gynecological tumors, cervical cancer, endometrial cancer and ovarian cancer are still the most important female reproductive system malignancies threatening women's health.
  • How to improve the survival rate and cure rate of gynecological tumor patients is the focus of research of gynecological oncology experts at home and abroad.
  • Huichao Liang spent a lot of time and energy on the integration and improvement of the medical team.
  • As an infectious disease combined with gynecological oncology expert, Huichao Liang must face the terrible viruses and bacteria and defeat them with wisdom.

Capricor Therapeutics Announces First Patient Dosed in Pivotal Phase 3 Study of CAP-1002 for the Treatment of Duchenne Muscular Dystrophy

Retrieved on: 
Tuesday, July 19, 2022

SAN DIEGO, July 19, 2022 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company focused on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of muscular and other select diseases, today announced commencement of dosing in HOPE-3, a Phase 3 clinical trial investigating CAP-1002, a cell therapy for treating late-stage Duchenne muscular dystrophy (DMD). HOPE-3 is a randomized, double-blind, placebo-controlled study designed to enroll approximately 70 patients in the United States. Capricor recently announced a partnership with Nippon Shinyaku Co., Ltd. which has commercialization and distribution rights in the U.S. This partnership provides funding for the support of HOPE-3 as well as other potential milestone-based payments to support the clinical development of CAP-1002 in DMD.

Key Points: 
  • Capricor recently announced a partnership with Nippon Shinyaku Co., Ltd. which has commercialization and distribution rights in the U.S.
  • Beginning this clinical trial is a significant milestone, not only for Capricor, but most importantly for those boys and young men with DMD.
  • Duchenne muscular dystrophy is a genetic disorder characterized by progressive weakness and chronic inflammation of the skeletal, heart and respiratory muscles.
  • Capricor's lead candidate, CAP-1002, is an allogeneic cardiac-derived cell therapy that is currently in clinical development for treating Duchenne muscular dystrophy.

Capricor Therapeutics Announces Statistically Significant Clinical Benefits in Skeletal Muscle Function in Non-Ambulant Duchenne Muscular Dystrophy Patients Treated with CAP-1002 in HOPE-2 Open Label Extension Study

Retrieved on: 
Monday, June 27, 2022

SAN DIEGO, June 27, 2022 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company focused on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of muscular and other select diseases, today announced positive one-year results from its HOPE-2 open label extension study in non-ambulant patients with later-stage Duchenne muscular dystrophy (DMD). Data from the rollover open label extension (OLE) study show statistically significant improvements on the Performance of the Upper Limb (PUL version 2.0) scale for patients on CAP-1002 testing three different hypotheses of treatment benefit during the open label extension. Capricor presented these results at a late-breaking session at this year’s Parent Project Muscular Dystrophy (PPMD) Annual Conference.

Key Points: 
  • In the study, CAP-1002 was made available to all of the original 20 patients enrolled in the HOPE-2 study.
  • The HOPE-2 open label extension study remains ongoing, and all participants continue to be monitored for safety and functional performance.
  • Duchenne muscular dystrophy is a devastating genetic disorder characterized by progressive weakness and chronic inflammation of the skeletal, heart and respiratory muscles.
  • Capricor's lead candidate, CAP-1002, is an allogeneic cardiac-derived cell therapy that is currently in clinical development for treating Duchenne muscular dystrophy.

Elucida Oncology’s Lead Clinical Candidate ELU001 to Be Featured in Two Abstracts at the American Association for Cancer Research Annual Meeting

Retrieved on: 
Monday, April 4, 2022

MONMOUTH JUNCTION, N.J., April 04, 2022 (GLOBE NEWSWIRE) -- Elucida Oncology, a clinical-stage biotechnology company developing the next frontier in targeted cancer therapy, announced today two abstracts featuring ELU001, its lead CDot Drug Conjugate (CDC) clinical candidate, will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2022, to be held April 8-13, in New Orleans.

Key Points: 
  • MONMOUTH JUNCTION, N.J., April 04, 2022 (GLOBE NEWSWIRE) -- Elucida Oncology, a clinical-stage biotechnology company developing the next frontier in targeted cancer therapy, announced today two abstracts featuring ELU001, its lead CDot Drug Conjugate (CDC) clinical candidate, will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2022, to be held April 8-13, in New Orleans.
  • Multi-valent targeting, greater payload delivery, and deep tumor penetration are important properties distinguishing CDCs from ADCs.
  • Pre-clinical studies continue to demonstrate the significant ability of CDCs to target both high and lower FR expressing tumor cells, resulting in enhanced cell killing as compared to an ADC designed to target the FR antigen.
  • Additionally, preclinical data demonstrates ELU001 is highly effective at eliminating FR positive AML cells in vitro and in vivo, supporting its further assessment in clinical trials for pediatric patients with CBFA2T3-GLIS2 fusions overexpressing FR.

The Lancet Publishes Positive Results from Capricor Therapeutics’ Phase 2 Study Evaluating CAP-1002 in Late-Stage Duchenne Muscular Dystrophy

Retrieved on: 
Friday, March 11, 2022

SAN DIEGO, March 11, 2022 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company focused on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of a broad spectrum of diseases, announced today that The Lancet, a renowned peer-reviewed global medical source for clinical and global health, has published positive results from Capricor’s HOPE-2 Phase 2 clinical trial using lead asset, CAP-1002, to treat patients in advanced stages of Duchenne muscular dystrophy (DMD). Specifically, the study demonstrated that young men in the advanced stages of DMD experienced improvements in both skeletal and cardiac muscle function after receiving four doses of CAP-1002 over the course of one year. The paper titled, “Repeated intravenous cardiosphere-derived cell therapy in late-stage Duchenne muscular dystrophy (HOPE-2): a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial,” can be accessed here.

Key Points: 
  • The paper titled, Repeated intravenous cardiosphere-derived cell therapy in late-stage Duchenne muscular dystrophy (HOPE-2): a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial, can be accessed here .
  • Capricor is initiating our Phase 3, HOPE-3 clinical study imminently as we move towards potential commercialization.
  • Study patients were treated via intravenous delivery with either CAP-1002 (150 million cells per infusion) or a placebo every three months.
  • Duchenne muscular dystrophy is a devastating genetic disorder characterized by progressive weakness and chronic inflammation of the skeletal, heart and respiratory muscles.

Elucida Oncology to Present at Two Upcoming Scientific Conferences

Retrieved on: 
Thursday, March 3, 2022

Elucida Oncology, Inc., is a clinical-stage biotechnology company pioneering the next frontier in targeted cancer therapy with its first-in-class, ultra-small nanoparticle CDot drug conjugate (CDC) platform.

Key Points: 
  • Elucida Oncology, Inc., is a clinical-stage biotechnology company pioneering the next frontier in targeted cancer therapy with its first-in-class, ultra-small nanoparticle CDot drug conjugate (CDC) platform.
  • CDCs are designed to penetrate deeper into tumors and deliver a significantly higher payload compared to antibody drug conjugates (ADCs).
  • This combined with greater avidity for the target antigen, longer retention in tumors with minimal systemic exposure due to rapid renal clearance confers unique Target or Clear properties.
  • In preclinical studies, this has resulted in enhanced efficacy irrespective of antigen expression levels with reduced off-target toxicity, thereby potentially addressing the limitations of ADCs and other novel drug carriers.

Capricor Therapeutics and Nippon Shinyaku Enter Partnership for Exclusive Commercialization and Distribution of CAP-1002 for the Treatment of Duchenne Muscular Dystrophy in the U.S.

Retrieved on: 
Tuesday, January 25, 2022

SAN DIEGO, Jan. 25, 2022 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR) (“Capricor” or “the Company”), a biotechnology company focused on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of a broad spectrum of diseases, announced today that it has entered into a partnership with Nippon Shinyaku Co., Ltd., a Japanese pharmaceutical company listed on the TYO (US subsidiary: NS Pharma), for the exclusive commercialization and distribution in the United States of Capricor’s lead asset, CAP-1002, for the treatment of Duchenne muscular dystrophy (DMD), a rare neuromuscular disease with limited treatment options.

Key Points: 
  • The regulatory pathway for CAP-1002 is supported byRMAT ( Regenerative Medicine Advanced Therapy Designation ) as well as Orphan Drug Designation .
  • Under the terms of the agreement, Capricor will be responsible for the conduct of HOPE-3 as well as the manufacturing of CAP-1002.
  • "The partnership with Nippon Shinyaku aligns us with a larger, seasoned pharmaceutical company experienced in rare disease with specific expertise in DMD.
  • Nippon Shinyaku recently launched Viltepso , an exon skipping agent for the treatment of DMD and has a fully assembled U.S. team to support a broad commercialization effort.

Ascletis Announces U.S. IND Approval of ASC22 (Envafolimab), a Subcutaneously Administered PD-L1 Antibody for Functional Cure of Chronic Hepatitis B

Retrieved on: 
Monday, January 17, 2022

HANGZHOU and SHAOXING, China, Jan. 17, 2022 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672) announces today the Investigational New Drug (IND) application approval by U.S. Food and Drug Administration (FDA) and initiation of global development of ASC22 (Envafolimab), a first-in-class, subcutaneously administered PD-L1 antibody for functional cure of chronic hepatitis B (CHB).

Key Points: 
  • Such inclusion is a singular honor and indicates the high level with which the AASLD review committee regards Ascletis' research in CHB functional cure.
  • "ASC22 (Envafolimab) U.S. IND approval enables us to initiate U.S. and global clinical trials for CHB functional cure.
  • Viral Diseases: (1) Hepatitis B Virus (functional cure): focus on breakthrough therapies for CHB functional cure with a subcutaneously-injected PD-L1 antibody ASC22 and Pegasys as cornerstone drugs.
  • (3) HIV/AIDS: ASC22, an immune therapy to restore HIV-specific immune responses and eventually lead to a functional cure of HIV-infected patients.

Elucida Oncology Provides Corporate Update and Outlines Key Upcoming Milestones

Retrieved on: 
Wednesday, January 5, 2022

Importantly, recent release of pivotal data for an antibody drug conjugate (ADC) also directed at FR further validated the target and increased our confidence in ELU001, said Geno Germano, President and CEO of Elucida Oncology.

Key Points: 
  • Importantly, recent release of pivotal data for an antibody drug conjugate (ADC) also directed at FR further validated the target and increased our confidence in ELU001, said Geno Germano, President and CEO of Elucida Oncology.
  • Elucida Oncology, Inc., is a clinical-stage biotechnology company pioneering the next frontier in targeted cancer therapy with its first-in-class, ultra-small nanoparticle CDot drug conjugate (CDC) platform.
  • CDCs are designed to penetrate deeper into tumors and deliver a significantly higher payload compared to antibody drug conjugates (ADCs).
  • For more information on Elucida Oncology, Inc., please visit www.elucidaoncology.com .