Branches of biology

DGAP-News: CEVEC Pharmaceuticals GmbH: CEVEC closes growth financing round to serve strong demand in viral vector technologies for cell and gene therapies

Tuesday, July 27, 2021 - 1:07pm

CEVEC also announced that the ELEVECTA(R) Technology is currently being implemented in HEK293 as a second host cell type.

Key Points: 
  • CEVEC also announced that the ELEVECTA(R) Technology is currently being implemented in HEK293 as a second host cell type.
  • As HEK293 is the most widely used host cell line in gene therapy manufacturing, CEVEC expects to see a significant increase in demand from clients and partners.
  • "We are delighted to be part of this financing round with the aim of accelerating the company's growth and becoming market leader for stable vector manufacturing technologies in cell and gene therapies."
  • The company's product portfolio comprises platform technologies for gene therapy viral vectors, vaccines and complex recombinant proteins.

DGAP-News: AC Immune acquires AFFiRiS' Specific Active Immunotherapy (SAIT) anti-alpha-synuclein programs targeting neurodegenerative diseases

Tuesday, July 27, 2021 - 1:07pm

"The acquisition of these programs by this pioneer in precision medicine and active vaccination for neurodegenerative diseases validates our AFFITOME(R) technology platform and the development projects based on it."

Key Points: 
  • "The acquisition of these programs by this pioneer in precision medicine and active vaccination for neurodegenerative diseases validates our AFFITOME(R) technology platform and the development projects based on it."
  • The Company's ultimate goal is to improve the lives of patients suffering from these diseases by providing specific immunotherapies.
  • Following the sale of its SAIT anti-alpha-synuclein programs to AC Immune in an all-stock transaction, AFFiRiS will concentrate on partnering activities to facilitate the further development of its programs in cardiovascular and neurodegenerative disease indications.
  • AFFiRiS published positive Phase 1 clinical results with active immunotherapies targeting PCSK9 to treat the cardiovascular condition hypercholesterolemia.

AC Immune acquires AFFiRiS’ Specific Active Immunotherapy (SAIT) anti-alpha-synuclein programs targeting neurodegenerative diseases

Tuesday, July 27, 2021 - 1:00pm

Under the terms of the agreement, AC Immune is acquiring all of AFFiRiS assets and underlying intellectual property related to active vaccine candidates targeting alpha-synuclein and USD 5 million in cash for 7.1 million shares of AC Immune common stock based on a price of USD 8.26 per common share.

Key Points: 
  • Under the terms of the agreement, AC Immune is acquiring all of AFFiRiS assets and underlying intellectual property related to active vaccine candidates targeting alpha-synuclein and USD 5 million in cash for 7.1 million shares of AC Immune common stock based on a price of USD 8.26 per common share.
  • The acquisition of these programs by this pioneer in precision medicine and active vaccination for neurodegenerative diseases validates our AFFITOME technology platform and the development projects based on it.
  • Following the sale of its SAIT anti-alpha-synuclein programs to AC Immune in an all-stock transaction, AFFiRiS will concentrate on partnering activities to facilitate the further development of its programs in cardiovascular and neurodegenerative disease indications.
  • AFFiRiS published positive Phase 1 clinical results with active immunotherapies targeting PCSK9 to treat the cardiovascular condition hypercholesterolemia.

Kronos Bio Announces FDA Clearance of Investigational New Drug Application for Lanraplenib (LANRA) for Treatment of Patients with Acute Myeloid Leukemia (AML)

Tuesday, July 27, 2021 - 1:00pm

SAN MATEO, Calif. and CAMBRIDGE, Mass., July 27, 2021 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, today announced the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug Application (IND) for lanraplenib (LANRA), allowing the company to proceed with a Phase 1/2 clinical trial of LANRA in patients with relapsed or refractory FLT3-mutated acute myeloid leukemia (AML) in combination with gilteritinib. Kronos Bio expects to initiate the trial in the fourth quarter of this year. The company is developing LANRA as a next-generation spleen tyrosine kinase (SYK) inhibitor, with improved pharmacokinetic (PK) and pharmacologic properties compared with entospletinib (ENTO), the company’s lead program. ENTO will be evaluated in combination with standard chemotherapy in a planned Phase 3 clinical trial in patients newly diagnosed with NPM1-mutated AML.

Key Points: 
  • Previously, LANRA demonstrated an acceptable safety profile in clinical trials of more than 250 healthy volunteers and patients with autoimmune diseases.
  • Kronos Bio is developing ENTO for the treatment of patients who are newly diagnosed with NPM1-mutated acute myeloid leukemia (AML) and eligible for intensive induction chemotherapy.
  • Results of a Phase 1b/2 study of entospletinib (GS-9973) monotherapy and in combination with induction chemotherapy in newly diagnosed patients with acute myeloid leukemia.
  • Entospletinib in combination with induction chemotherapy in previously untreated acute myeloid leukemia: response and predictive significance of HOXA9 and MEIS1 expression.

BioVie Presents Data Supporting use of NE3107 in the Treatment of Alzheimer’s Disease at 2021 Alzheimer’s Association International Conference

Tuesday, July 27, 2021 - 1:00pm

BioVie has obtained authorization from the U.S. Food & Drug Administration to initiate a pivotal Phase 3 trial of NE3107 in Alzheimers Disease called the NM101 study ( NCT04669028 ).

Key Points: 
  • BioVie has obtained authorization from the U.S. Food & Drug Administration to initiate a pivotal Phase 3 trial of NE3107 in Alzheimers Disease called the NM101 study ( NCT04669028 ).
  • NM101 is a randomized double blind, placebo-controlled, US multicenter study of NE3107 in 316 subjects with mild to moderate Alzheimers Disease.
  • At the AAIC this year there are literally hundreds of presentations on inflammation and Alzheimers disease and dozens on insulin resistance and AD.
  • NE3107 is the first potentially disease modifying, anti-inflammatory insulin sensitizer therapy in a phase 3 trial, said Cuong Do, Chief Executive Officer of BioVie.

Ultragenyx Receives Orphan Drug Designation from FDA and European Commission for UX053, an Investigational mRNA-therapy for the Treatment of Glycogen Storage Disease Type III

Tuesday, July 27, 2021 - 1:00pm

The FDA Orphan Drug Designation program provides orphan status to drugs and biologics that are intended for the safe and effective treatment, diagnosis, or prevention of rare diseases that affect fewer than 200,000 people in the U.S.

Key Points: 
  • The FDA Orphan Drug Designation program provides orphan status to drugs and biologics that are intended for the safe and effective treatment, diagnosis, or prevention of rare diseases that affect fewer than 200,000 people in the U.S.
  • Among the benefits of orphan designation in the U.S. are seven years of market exclusivity following FDA approval, waiver or partial payment of application fees, and tax credits for clinical testing expenses conducted after orphan designation is received.
  • Glycogen Storage Disease Type III, or GSDIII, a disease caused by a glycogen debranching enzyme (AGL) deficiency that results in glycogen accumulation in the liver and muscle.
  • The company is led by a management team experienced in the development and commercialization of rare disease therapeutics.

electroCore Announces Issuance of New Patent for Migraine Treatment using Smartphones

Tuesday, July 27, 2021 - 1:00pm

11,065,444 to electroCore, relating to the use of a mobile phone for stimulating the trigeminal nerve to treat disorders.

Key Points: 
  • 11,065,444 to electroCore, relating to the use of a mobile phone for stimulating the trigeminal nerve to treat disorders.
  • One or more electrodes apply electrical impulses through the patient's skin modulating a targeted nerve to treat the medical condition.
  • This newly allowed patent is owned by electroCore and is the latest U.S. patent to issue in connection with the companys non-invasive development program for pain.
  • The company's current indications are the preventive treatment of cluster headache and migraine and the acute treatment of migraine and episodic cluster headache.

Cidara Therapeutics to Present New Data for Rezafungin at the International Society for Human and Animal Mycology (ISHAM) Asia Congress

Tuesday, July 27, 2021 - 1:00pm

isolates collected in Asia-Pacific countries, in two presentations at the International Society for Human and Animal Mycology (ISHAM) Asia Congress taking place virtually from August 6-8, 2021.

Key Points: 
  • isolates collected in Asia-Pacific countries, in two presentations at the International Society for Human and Animal Mycology (ISHAM) Asia Congress taking place virtually from August 6-8, 2021.
  • Rezafungin is a novel once-weekly echinocandin currently being studied in Phase 3 trials for the treatment and prevention of serious fungal infections incriticallyill patients.
  • ISHAM Asia is a new conference aiming to increase opportunities for regional healthcare professionals and researchers and encourages their participation to interact with global leaders in the field of medical mycology.
  • Cidara is developing long-acting therapeutics designed to transform the standard of care for patients facing serious fungal or viral infections.

FDA Gives Green Light for Multiple Sclerosis Stem Cell Trial

Tuesday, July 27, 2021 - 12:00pm

Non-profit research organization Hope Biosciences Stem Cell Research Foundation (HBSCRF) has received FDA authorization for a randomized, double-blind, single center, Phase II clinical trial to assess the efficacy of multiple intravenous infusions of autologous adipose-derived mesenchymal stem cells in improving symptoms and quality of life in patients with mild-to-moderate multiple sclerosis (MS).

Key Points: 
  • Non-profit research organization Hope Biosciences Stem Cell Research Foundation (HBSCRF) has received FDA authorization for a randomized, double-blind, single center, Phase II clinical trial to assess the efficacy of multiple intravenous infusions of autologous adipose-derived mesenchymal stem cells in improving symptoms and quality of life in patients with mild-to-moderate multiple sclerosis (MS).
  • A single infusion in the treatment group consists of 200 million stem cells, or approximately 1.2 billion stem cells per patient over the course of study.
  • HBSCRF remains the only organization globally to administer pure, fresh mesenchymal stem cells, an adult stem cell harvested from fat, in such high quantities over repeat treatments.
  • Clinical trial authorizations encompass COVID-19 prevention and treatment , traumatic brain injury , Parkinsons disease , and multiple sclerosis.

David P. White, M.D. Appointed Senior Vice President of Medical Affairs at Apnimed

Tuesday, July 27, 2021 - 12:30pm

Apnimed, a clinical-stage company focused on advancing pharmacologic treatments for obstructive sleep apnea and related disorders, today announced that David P. White, M.D., a world-renowned leader in sleep disorders has been appointed Senior Vice President of Medical Affairs.

Key Points: 
  • Apnimed, a clinical-stage company focused on advancing pharmacologic treatments for obstructive sleep apnea and related disorders, today announced that David P. White, M.D., a world-renowned leader in sleep disorders has been appointed Senior Vice President of Medical Affairs.
  • Clinicians understand that obstructive sleep apnea is a prevalent and debilitating medical condition affecting the health and well-being of patients.
  • There is a tremendous unmet need for a safe, effective, and easy-to-use treatment option that addresses the underlying cause of the disease.
  • In addition to his new position at Apnimed, Dr. White is a Professor of Medicine, part-time, at Harvard Medical School in Boston, Mass.