Life sciences

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.

SpringWorks Therapeutics Appoints Dr. James Cassidy as Chief Medical Officer

Tuesday, July 27, 2021 - 1:00pm

STAMFORD, Conn., July 27, 2021 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer,announced today that James (Jim) Cassidy, M.D., Ph.D., has been appointed Chief Medical Officer.

Key Points: 
  • STAMFORD, Conn., July 27, 2021 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer,announced today that James (Jim) Cassidy, M.D., Ph.D., has been appointed Chief Medical Officer.
  • Jim brings significant oncology experience as a physician-scientist and industry leader to our efforts at SpringWorks, where we remain intensely focused on continuing to build a leading targeted oncology company with a diversified portfolio of differentiated programs, said Saqib Islam, Chief Executive Officer of SpringWorks.
  • I would also like to thank Jens for his contributions to SpringWorks and wish him well in his future endeavors.
  • Dr. Cassidy joins SpringWorks from Regeneron Pharmaceuticals, where he was Vice President of Oncology Strategic Program Direction.

Infinity Pharmaceuticals Reports Second Quarter 2021 Financial Results and Provides Company Update

Tuesday, July 27, 2021 - 12:30pm

Infinity Pharmaceuticals, Inc. (Nasdaq: INFI) (Infinity or the Company), a clinical-stage biotechnology company developing eganelisib (IPI-549), a potentially first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic, today announced its second quarter 2021 financial results and provided a corporate update.

Key Points: 
  • Infinity Pharmaceuticals, Inc. (Nasdaq: INFI) (Infinity or the Company), a clinical-stage biotechnology company developing eganelisib (IPI-549), a potentially first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic, today announced its second quarter 2021 financial results and provided a corporate update.
  • Ms. Perkins continued, Were thrilled to have Dr. Peluso return to Infinity in the role of Chief Scientific Officer during this exciting time for Infinity.
  • Second Quarter 2021 Financial Results:
    At June 30, 2021, Infinity had total cash, cash equivalents and available-for-sale securities of $97.3 million, compared to $106.8 million at March 31, 2021.
  • Research and development expense for the second quarter of 2021 was $8.0 million, compared to $6.1 million in the same period in 2020.

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.

IACTA Pharmaceuticals Appoints Yogesh Bahl as Chief Financial Officer and Eric Carter, M.D., Ph.D., as Chief Medical Officer

Tuesday, July 27, 2021 - 12:30pm

IACTA Pharmaceuticals, Inc. (IACTA), an innovation leader in ophthalmic therapeutics, today announced the appointment of Yogesh Bahl as Chief Financial Officer (CFO) and Eric Carter, M.D., Ph.D., as Chief Medical Officer (CMO).

Key Points: 
  • IACTA Pharmaceuticals, Inc. (IACTA), an innovation leader in ophthalmic therapeutics, today announced the appointment of Yogesh Bahl as Chief Financial Officer (CFO) and Eric Carter, M.D., Ph.D., as Chief Medical Officer (CMO).
  • All told, I believe IACTA has the right team in place to bring these much-needed ophthalmic innovations to the underserved patients who need them.
  • Yogesh Bahl brings over 25 years of pharmaceutical experience in strategy, finance, accounting, audit, and risk management.
  • Prior to Allergan, Dr. Carter served as Chief Science Officer, Head of R&D and Chief Medical Officer of King Pharmaceuticals from 2007 until the company was acquired by Pfizer in 2011.

Rigel Announces Conference Call and Webcast to Report Second Quarter 2021 Financial Results and Business Update

Tuesday, July 27, 2021 - 12:30pm

(Nasdaq:RIGL) today announced that it will report its second quarter 2021 financial results after market close on Tuesday, August 3, 2021.

Key Points: 
  • (Nasdaq:RIGL) today announced that it will report its second quarter 2021 financial results after market close on Tuesday, August 3, 2021.
  • Rigel senior management will follow the announcement with a live conference call and webcast at 4:30pm Eastern Time (1:30pm Pacific Time) to discuss the financial results and give an update on the business.
  • In addition, Rigel has product candidates in development with partners AstraZeneca, BerGenBio ASA, and Daiichi Sankyo.
  • 1The product for this use or indication is investigational and has not been proven safe or effective by any regulatory authority.

Regeneron and AstraZeneca to Research, Develop and Commercialize New Small Molecule Medicines for Obesity

Tuesday, July 27, 2021 - 12:00pm

As published in Science , the new target was found by sequencing nearly 650,000 people and identifying individuals with rare protective mutations.

Key Points: 
  • As published in Science , the new target was found by sequencing nearly 650,000 people and identifying individuals with rare protective mutations.
  • "As experts on genetics and human biology, Regeneron is excited to join forces with the chemistry and small molecule leaders at AstraZeneca, as we seek to develop new medicines tackling the harmful and costly obesity epidemic."
  • "We are pleased to announce this important collaboration with Regeneron to identify small molecule modulators against GPR75, a newly identified target with genetic validation in metabolic disorders.
  • Worldwide the prevalence of obesity has more than tripled since 1975, and approximately 650 million adults are estimated to live with obesity today.

Day One Receives FDA Rare Pediatric Disease Designation for DAY101 for the Treatment of Pediatric Low-Grade Glioma

Tuesday, July 27, 2021 - 12:00pm

In addition to FDA Rare Pediatric Disease Designation, DAY101 has been granted Breakthrough Therapy designation by the FDA for the treatment of patients with pLGG harboring an activating RAF alteration who require systemic therapy and who have either progressed following prior treatment or who have no satisfactory alternative treatment options.

Key Points: 
  • In addition to FDA Rare Pediatric Disease Designation, DAY101 has been granted Breakthrough Therapy designation by the FDA for the treatment of patients with pLGG harboring an activating RAF alteration who require systemic therapy and who have either progressed following prior treatment or who have no satisfactory alternative treatment options.
  • In addition, DAY101 has received Orphan Drug designation from the FDA for the treatment of malignant glioma and orphan designation from the European Commission for the treatment of glioma.
  • The FDA has also granted Rare Pediatric Disease Designation to DAY101 for the treatment of low-grade gliomas harboring an activating RAF alteration that disproportionately affects children.
  • In addition, DAY101 has received Orphan Drug designation from the FDA for the treatment of malignant glioma and orphan designation from the European Commission for the treatment of glioma.

Olink: CORAL to use the Olink Proteomics platform to identify novel protein biomarkers and biological mechanisms for neurological diseases

Tuesday, July 27, 2021 - 12:00pm

UPPSALA, Sweden, July 27, 2021 (GLOBE NEWSWIRE) -- Olink Holding AB (publ) (Olink) (Nasdaq: OLK) today announced that CORAL, a new collaborative community of scientists, will use the Olink Proteomics platform to identify novel protein biomarkers and biological mechanisms for neurological diseases.

Key Points: 
  • UPPSALA, Sweden, July 27, 2021 (GLOBE NEWSWIRE) -- Olink Holding AB (publ) (Olink) (Nasdaq: OLK) today announced that CORAL, a new collaborative community of scientists, will use the Olink Proteomics platform to identify novel protein biomarkers and biological mechanisms for neurological diseases.
  • CORAL is a new collaborative community of scientists that work on diverse neurological conditions studying blood and cerebrospinal fluid (CSF) on the Olink Proteomics platform to identify novel biomarkers and biological mechanisms for neurological diseases.
  • CORAL is a collaborative community of scientists that work on diverse neurological conditions studying blood and CSF to identify novel biomarkers and biological mechanisms for neurological diseases.
  • The purpose of CORAL is to accelerate the development of biomarkers and mechanisms for neurological diseases, starting from array-based proteomics up to validation and implementation in the clinic.

MicroPort® Cardiac Rhythm Management Business Announces US$150 Million Series C Investment

Tuesday, July 27, 2021 - 8:49am

SHANGHAI, July 27, 2021 /PRNewswire/ -- MicroPort Scientific Corporation ("MicroPort") announced that MicroPort Cardiac Rhythm Management Limited ("MicroPort CRM"), which is MicroPort's subsidiary focused on developing and commercializing implantable pacemaker and defibrillator devices and related technologies to manage cardiac rhythm disorders, has entered into definitive agreements in connection with its Series C financing with total investment proceeds of US$150 million.

Key Points: 
  • SHANGHAI, July 27, 2021 /PRNewswire/ -- MicroPort Scientific Corporation ("MicroPort") announced that MicroPort Cardiac Rhythm Management Limited ("MicroPort CRM"), which is MicroPort's subsidiary focused on developing and commercializing implantable pacemaker and defibrillator devices and related technologies to manage cardiac rhythm disorders, has entered into definitive agreements in connection with its Series C financing with total investment proceeds of US$150 million.
  • Hillhouse Capital Group and MicroPort will co-lead the Series C investment and will invest US$20 million and US$47 million, respectively.
  • After the completion of this transaction, MicroPort will continue to be the majority shareholder of MicroPort CRM.
  • Through its long-standing expertise in CRM, MicroPort CRM develops, manufactures and markets around the world cardiac pacemakers, implantable cardiac defibrillators, cardiac resynchronization systems and ECG diagnostic solutions for the management of cardiac rhythm disorders and heart failure.