Vaccine

ANAVEX®2–73 (Blarcamesine) Phase 2B/3 Study Met Primary and Key Secondary Endpoints, Showing Statistically Significant Reduction of Clinical Decline in Global Clinical Study of Patients With Early Alzheimer’s Disease

Retrieved on: 
Friday, December 2, 2022

ANAVEX2-73 met the primary endpoints ADAS-Cog1 and ADCS-ADL2 and key secondary endpoint CDR-SB3 with statistically significant results.

Key Points: 
  • ANAVEX2-73 met the primary endpoints ADAS-Cog1 and ADCS-ADL2 and key secondary endpoint CDR-SB3 with statistically significant results.
  • ANAVEX2-73 treatment met the primary endpoints and reduced clinical decline on the global cognitive and functional scales over 48 weeks in the analysis of the Intent-to-treat (ITT) population.
  • ANAVEX2-73 demonstrated visible improvement in patients with Alzheimers disease.
  • On average, patients, who improved cognitively with ANAVEX2-73 treatment, improved by ADAS-Cog cognition score of -4.03 points.

Paratek Announces Inducement Grants under NASDAQ Listing Rule 5635(c)(4)

Retrieved on: 
Thursday, December 1, 2022

The restricted stock units are subject to the terms and conditions of the Paratek Pharmaceuticals, Inc. 2017 Inducement Plan, as amended, and the terms and conditions of the restricted stock unit award agreement covering each grant.

Key Points: 
  • The restricted stock units are subject to the terms and conditions of the Paratek Pharmaceuticals, Inc. 2017 Inducement Plan, as amended, and the terms and conditions of the restricted stock unit award agreement covering each grant.
  • Paratek is also conducting a Phase 2b Study in a rare disease, nontuberculous mycobacterial (NTM) pulmonary disease, caused by Mycobacterium abscessus complex with NUZYRA.
  • Paratek estimates this opportunity represents a potential $1 billion addressable market in the United States.
  • Paratek retains the development and commercialization rights for sarecycline in the rest of the world.

Cellectis to Host a Live Webcast and Provide a Company Update on December 13, 2022

Retrieved on: 
Thursday, December 1, 2022

The event will feature presentations by the management team and will be followed by a Q&A.

Key Points: 
  • The event will feature presentations by the management team and will be followed by a Q&A.
  • Cellectis headquarters are in Paris, France, with locations in New York, New York and Raleigh, North Carolina.
  • Cellectis is listed on the Nasdaq Global Market (ticker: CLLS) and on Euronext Growth (ticker: ALCLS).
  • These forward-looking statements, which are based on our managements current expectations and assumptions and on information currently available to management.

ImmunoGen Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Retrieved on: 
Thursday, December 1, 2022

Each option is subject to the terms and conditions of the Inducement Plan and the terms and conditions of a stock option agreement covering the applicable grant.

Key Points: 
  • Each option is subject to the terms and conditions of the Inducement Plan and the terms and conditions of a stock option agreement covering the applicable grant.
  • The Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously employees of ImmunoGen (or following a bona fide period of non-employment), as an inducement material to such individuals entering into employment with ImmunoGen, pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules.
  • The Employee Options and the Char Options were granted as such inducement material to the new employees and Mr. Char becoming employees of ImmunoGen.
  • ImmunoGen is developing the next generation of antibody-drug conjugates to improve outcomes for cancer patients.

Innoforce Opens GMP Manufacturing Facility & Corporate Headquarters in Hangzhou, China to Provide CDMO Services for Global Supply of RNA, Cell & Gene Therapies

Retrieved on: 
Thursday, December 1, 2022

HANGZHOU, China, Dec. 1, 2022 /PRNewswire/ -- Innoforce, a global provider of end-to-end contract development and manufacturing services (CDMO), today announced that it commenced GMP manufacturing at its new site in Hangzhou, China. The new facility is built to offer process development & manufacturing services for the global supply of RNA, plasmid DNA, viral vectors, and cell therapeutics through research, clinical and commercial stages. It will also serve as the corporate headquarters for the company.

Key Points: 
  • HANGZHOU, China, Dec. 1, 2022 /PRNewswire/ --Innoforce, a global provider of end-to-end contract development and manufacturing services (CDMO), today announced that it commenced GMP manufacturing at its new site in Hangzhou, China.
  • The new facility is built to offer process development & manufacturing services for the global supply of RNA, plasmid DNA, viral vectors, and cell therapeutics through research, clinical and commercial stages.
  • The company is investing a total of more than $200 million in its 550,000 square-foot advanced therapies manufacturing base with a full suite of technology platforms.
  • Innoforce offers end-to-end contract development and manufacturing service (CDMO), including GMP manufacturing of RNA, plasmid DNA, viral vectors, and cell therapies.

Affimed to Host Investor Event Highlighting AFM13 Clinical Development at 2022 ASH Annual Meeting

Retrieved on: 
Thursday, December 1, 2022

Date and Time: Saturday, December 10 at 4:00 p.m. CST / 5:00 p.m. EST / 23:00 CET

Key Points: 
  • Date and Time: Saturday, December 10 at 4:00 p.m. CST / 5:00 p.m. EST / 23:00 CET
    Affimed will host an investor event to review AFM13 clinical data and development plans in CD30 expressing malignancies.
  • The investor event will take place in-person and virtually and a webcast of the event will be available in the Webcasts section on the Investors page of Affimeds website at https://www.affimed.com/investors/webcasts-and-corporate-presentation/ .
  • To reserve your place in the live event, please contact Alex Fudukidis via e-mail at [email protected] .
  • AFM13 is a CD30/CD16A bispecific Innate Cell Engager (ICE) that is investigated in Hodgkin Lymphoma (HL) and T cell lymphoma (TCL).

Cocrystal Pharma Highlights Progress with CC-42344 as a Potential Oral Treatment for Pandemic and Seasonal Influenza A at the World Antiviral Congress 2022

Retrieved on: 
Thursday, December 1, 2022

BOTHELL, Wash., Dec. 01, 2022 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) announces that progress with CC-42344 for the treatment of pandemic and seasonal influenza A from its Phase 1 study was presented today at the World Antiviral Congress 2022 underway in San Diego. The presentation, “Novel Broad-Spectrum Influenza A PB2 Inhibitor: Clinical Update,” was delivered by Cocrystal President and co-interim CEO Sam Lee, PhD and the slides are available here.

Key Points: 
  • BOTHELL, Wash., Dec. 01, 2022 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) announces that progress with CC-42344 for the treatment of pandemic and seasonal influenza A from its Phase 1 study was presented today at the World Antiviral Congress 2022 underway in San Diego.
  • We appreciate the opportunity to present our antiviral drug discovery platform technology and favorable interim Phase 1 data, said Dr. Lee.
  • Seasonal and pandemic influenza A continue to be major global health threats, especially given the potential for resistance against approved antivirals.
  • Our presentation highlights potential clinical benefits for the treatment of pandemic influenza and the advantages of the oral influenza antiviral CC-42344 drug, which targets the PB2 protein of the influenza polymerase complex.

Editas Medicine to Host Virtual Event to Highlight Initial Clinical Data from the RUBY Trial of EDIT-301 for Severe Sickle Cell Disease

Retrieved on: 
Thursday, December 1, 2022

The clinical data will include safety data from the first two patients and efficacy data from the first patient treated with EDIT-301.

Key Points: 
  • The clinical data will include safety data from the first two patients and efficacy data from the first patient treated with EDIT-301.
  • In sickle cell disease, the red blood cells are misshapen in a sickle shape instead of a typical disc shape.
  • EDIT-301 is an experimental cell therapy medicine under investigation for the treatment of severe sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT).
  • The RUBY trial is a single-arm, open-label, multi-center Phase 1/2 study designed to assess the safety and efficacy of EDIT-301 in patients with severe sickle cell disease.

Maravai LifeSciences Announces Updated CEO Leadership Transition Plans

Retrieved on: 
Thursday, December 1, 2022

SAN DIEGO, Dec. 01, 2022 (GLOBE NEWSWIRE) -- Maravai LifeSciences, Inc. (NASDAQ: MRVI), a global provider of life science reagents and services to researchers and biotech innovators, announced plans for William “Trey” Martin, III to serve as President of Maravai’s Biologics Safety Testing Segment beginning December 5, 2022, and expects that Martin will assume the role of Chief Executive Officer of Maravai LifeSciences on July 27, 2023. Christine Dolan, the current Chief Operating Officer of Maravai’s Biologics Safety Testing Segment, will continue to serve in that role and will report to Martin. Carl Hull, Maravai’s co-founder, will continue to serve as Maravai’s Executive Chairman and Interim Chief Executive Officer.

Key Points: 
  • Christine Dolan, the current Chief Operating Officer of Maravais Biologics Safety Testing Segment, will continue to serve in that role and will report to Martin.
  • Carl Hull, Maravais co-founder, will continue to serve as Maravais Executive Chairman and Interim Chief Executive Officer.
  • Martin, Maravai, and the Danaher entities have reached a confidential settlement pursuant to which Maravai and Martin have agreed to limit Martins responsibilities for Maravai and preclude his involvement in Maravais Nucleic Acid Production Segment through July 26, 2023.
  • We are thrilled to have Trey rejoin Maravais executive team as President of our Biologics Safety Testing Business, said Carl Hull, Executive Chairman and Interim Chief Executive Officer of Maravai.

IMUNON Presentation at World Vaccine & Immunotherapy Congress Highlights PLACCINE Preclinical Proof of Concept and Key Competitive Advantages

Retrieved on: 
Thursday, December 1, 2022

PLACCINE is IMUNONs non-viral, non-device plasmid DNA-based vaccine modality targeting multiple antigens from a single vector.

Key Points: 
  • PLACCINE is IMUNONs non-viral, non-device plasmid DNA-based vaccine modality targeting multiple antigens from a single vector.
  • In addition, the data presented showed that IMUNONs plasmid DNA vaccine yielded comparable yet more durable antigen expression than either the protein or a commercial mRNA vaccine.
  • We are delighted to share preclinical proof of concept along with highlighting key competitive advantages to a global audience of vaccine and immunotherapy leaders, said Dr. Corrine Le Goff, IMUNONs President and Chief Executive Officer.
  • IMUNON assumes no obligation to update or supplement forward-looking statements that become untrue because of subsequent events, new information or otherwise.