Biotechnology

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 Presents Updated Data from Phase 2 MARIO-275 Trial in Urothelial Cancer (UC) and Phase 2 MARIO-3 Trial in Triple Negative Breast Cancer (TNBC)

Tuesday, July 27, 2021 - 12:31pm

These data provide preliminary, but compelling evidence of eganelisibs potential to improve outcomes for patients with these two types of cancer.

Key Points: 
  • These data provide preliminary, but compelling evidence of eganelisibs potential to improve outcomes for patients with these two types of cancer.
  • These results are consistent with the results from MARIO-275, which show the similar translation of disease control into a meaningful survival benefit for patients.
  • For patients with TNBC, the potential to extend progression free survival, regardless of PD-L1 status, would be a transformational breakthrough.
  • MARIO-275 is a global, randomized, controlled combination study of eganelisib combined with Opdivo in I/O nave urothelial cancer.

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.

Deciphera Pharmaceuticals to Announce Second Quarter 2021 Financial Results and Host Conference Call and Webcast on August 3, 2021

Tuesday, July 27, 2021 - 12:00pm

Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH) today announced that it will report its second quarter 2021 financial results on Tuesday, August 3, 2021.

Key Points: 
  • Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH) today announced that it will report its second quarter 2021 financial results on Tuesday, August 3, 2021.
  • In connection with the earnings release, Decipheras management team will host a live conference call and webcast at 4:30 PM ET on Tuesday, August 3, 2021, to discuss the Companys financial results and provide a corporate update.
  • The conference call may be accessed by dialing (866) 930-5479 (domestic) or (409) 216-0603 (international) and referring to conference ID 9943767.
  • A webcast of the conference call will be available in the Events and Presentations page in the Investors section of the Companys website at https://investors.deciphera.com/events-presentations .

Antibe Therapeutics Provides July 2021 Corporate Update

Tuesday, July 27, 2021 - 12:00pm

Antibe is taking a comprehensive approach to maximizing the likelihood of a successful Phase III program outcome.

Key Points: 
  • Antibe is taking a comprehensive approach to maximizing the likelihood of a successful Phase III program outcome.
  • The program also combines several state-of-the-art aspects, including the hiring of leading providers of bioanalytic, quality control and data management services.
  • The latter will enable us to track and manage screening and enrollment in real-time, ensuring that the subject population matches trial criteria.
  • Antibe Therapeutics assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those reflected in the forward-looking statements except as required by applicable law.

Verastem Oncology Announces Updated Phase 1/2 FRAME Study Data in Low Grade Serous Ovarian Cancer Selected for a Mini Oral Presentation at the European Society of Medical Oncology Congress 2021

Tuesday, July 27, 2021 - 12:00pm

Patients with low-grade serous ovarian cancer urgently need better solutions due to low response rates and tolerability issues associated with other therapeutic approaches.

Key Points: 
  • Patients with low-grade serous ovarian cancer urgently need better solutions due to low response rates and tolerability issues associated with other therapeutic approaches.
  • The company-sponsored, registration-directed Phase 2 RAMP 201 study is well underway, with top-line results from the selection phase expected during the first half of 2022.
  • The FRAME study was expanded to include new cohorts in pancreatic cancer, KRAS mutant endometrioid cancer and KRAS-G12V NSCLC.
  • Verastem Oncology is also supporting an investigator-initiated Phase 2 trial evaluating VS-6766 with defactinib in patients with metastatic uveal melanoma.

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.