Clinical Trials

MAIA Biotechnology to Participate in H.C. Wainwright 24th Annual Global Investment Conference

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Thursday, September 8, 2022
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MAIA Biotechnology, Inc. , (NYSE American: MAIA) (MAIA, the Company), a targeted therapy, immuno-oncology company focused on developing potential first-in-class oncology drugs, announced today that the management team will participate in the H.C. Wainwright 24th Annual Global Investment Conference that will be held September 12th 14th.

Key Points: 
  • MAIA Biotechnology, Inc. , (NYSE American: MAIA) (MAIA, the Company), a targeted therapy, immuno-oncology company focused on developing potential first-in-class oncology drugs, announced today that the management team will participate in the H.C. Wainwright 24th Annual Global Investment Conference that will be held September 12th 14th.
  • The MAIA team is scheduled to present on September 12th at 7:00 am ET and will host investor meetings at the Conference through September 14th.
  • MAIA cautions that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements.
  • In this release, unless the context requires otherwise, MAIA, Company, we, our, and us refers to MAIA Biotechnology, Inc. and its subsidiaries.

Bicara Therapeutics to Host Webinar to Review Latest Clinical Trial Data for BCA101

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Thursday, September 8, 2022
Oncology, Health, Genetics, Clinical Trials, Research, Science, Biotechnology, Online, Neoplasm, EGFR, European Society for Medical Oncology, Tumor microenvironment, Therapy, Recurrence, ESMO, Neck, Principal, Pembrolizumab, Cetuximab, PD-1, Dana–Farber Cancer Institute, Center, Oncology, Congress, Clinical trial, Q&A, Review, Patient, Pharmaceutical industry, Vaccine

Bicara Therapeutics, a clinical-stage biotechnology company developing dual-action biologics designed to elicit a potent and durable immune response in the tumor microenvironment, today announced that it will host a virtual webinar to review the latest clinical trial data for BCA101, a first-in-class EGFR/TGF-trap bifunctional antibody designed to deliver superior anti-tumor efficacy with an improved therapeutic window to solid tumors.

Key Points: 
  • Bicara Therapeutics, a clinical-stage biotechnology company developing dual-action biologics designed to elicit a potent and durable immune response in the tumor microenvironment, today announced that it will host a virtual webinar to review the latest clinical trial data for BCA101, a first-in-class EGFR/TGF-trap bifunctional antibody designed to deliver superior anti-tumor efficacy with an improved therapeutic window to solid tumors.
  • During the webinar, Dr. Glenn Hanna, principal investigator from Dana-Farber Cancer Institute, will review the Phase 1 data presented at the European Society of Medical Oncology (ESMO) Congress 2022.
  • Promising preclinical data suggest that BCA101 is superior to the anti-EGFR antibody cetuximab in preventing tumor recurrence, as well as in restoring immune activation.
  • Bicaras lead asset, BCA101, a first-in-class EGFR / TGF--trap bifunctional antibody, is currently enrolling patients in a Phase 1/1b study.

Exscientia Welcomes Caroline Rowland as Chief People Officer

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Thursday, September 8, 2022
Biotechnology, Health, Pharmaceutical, Clinical Trials, Health Technology, People, University, Management consulting, Technology, CEO, Cambridge Network, Precision medicine, Heart, Science, Medicine, Nasdaq, Therapy, Human capital, Doctor of Philosophy, Drug discovery, Business studies, Private Securities Litigation Reform Act, Drug development, Place, Patient, Deloitte, Management, Pharmaceutical industry, Diageo

Exscientia plc (Nasdaq: EXAI) today announced that Caroline Rowland has joined Exscientia as Chief People Officer.

Key Points: 
  • Exscientia plc (Nasdaq: EXAI) today announced that Caroline Rowland has joined Exscientia as Chief People Officer.
  • Caroline brings over 20 years of global experience in optimising organisational effectiveness and unlocking higher levels of company performance through operational growth and a sense of belonging.
  • Carolines expertise and guidance will be invaluable in helping Exscientia excel as a globally diverse and innovative organisation.
  • To support this mission, I believe that differentiating the employee experience by cultivating an empowering, creative and supportive environment is essential to success, said Caroline Rowland, Exscientias Chief People Officer.

Silence Therapeutics Announces FDA Fast Track Designation for SLN124, a Novel Investigational siRNA Therapy for the Treatment of Polycythemia Vera

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Thursday, September 8, 2022
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SLN124 demonstrated proof of mechanism and was well tolerated in a healthy volunteer study completed last year.

Key Points: 
  • SLN124 demonstrated proof of mechanism and was well tolerated in a healthy volunteer study completed last year.
  • "The granting of Fast Track Designation represents an important recognition by the FDA of SLN124s potential to address a significant unmet need in the treatment of PV," said Craig Tooman, President and Chief Executive Officer of Silence.
  • Fast Track designation aims to facilitate the development and accelerate the review of new therapeutics that are intended to treat serious or life-threatening conditions and that potentially address an unmet medical need.
  • Drugs that are granted this designation are given the opportunity for more frequent interactions with the FDA, as well as potential pathways for expedited approval.

Seres Therapeutics to Present at World Anti-Microbial Resistance Congress

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Thursday, September 8, 2022
Health, FDA, Infectious Diseases, Stem Cells, Clinical Trials, Pharmaceutical, Biotechnology, Patient, COVID-19, Security (finance), BLA, Cancer, Cirrhosis, Hematopoietic stem cell transplantation, Research, Therapy, Food and Drug Administration, Infection, Tissue, Antimicrobial, National Harbor, Maryland, SEC, AMR, David Berry (inventor), Bloodstream infections, U.S. Securities and Exchange Commission, Carbapenem-resistant enterobacteriaceae, Nasdaq, Company, FDA, CRE, Clostridioides difficile infection, Immunodeficiency, Risk, Private Securities Litigation Reform Act, Ulcerative colitis, Growth, VRE, Graft-versus-host disease, Pharmaceutical industry, Serica

Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, today announced that Matthew Henn, Ph.D., Chief Scientific Officer at Seres, will be presenting at the World Anti-Microbial Resistance Congress being held on September 7-8, 2022 in National Harbor, Maryland.

Key Points: 
  • Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, today announced that Matthew Henn, Ph.D., Chief Scientific Officer at Seres, will be presenting at the World Anti-Microbial Resistance Congress being held on September 7-8, 2022 in National Harbor, Maryland.
  • ET today a presentation entitled: Microbiome Therapeutics to Potentially Transform the Management of Antimicrobial Resistant Infections.
  • Seres clinical and preclinical data suggest that microbiome therapeutics may provide a novel approach to reduce the risk of antibiotic-resistant bacterial infection.
  • Seres approach developing microbiome therapeutics for Infection Protection has been clinically validated by the Companys SER-109 program, an investigational product for the prevention of recurrent C. difficile infection.

Osmol Therapeutics Announces Appointment of Teresa Bitetti, President, Global Oncology Business Unit at Takeda Pharmaceuticals, to the Board of Directors

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Thursday, September 8, 2022
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Osmol Therapeutics, a privately held biopharmaceutical company focused on developing a treatment to prevent chemotherapy-induced peripheral neuropathy (CIPN), today announced that Teresa Bitetti, President of the Global Oncology Business Unit at Takeda Pharmaceutical Company Ltd., has joined the Board of Directors of Osmol Therapeutics.

Key Points: 
  • Osmol Therapeutics, a privately held biopharmaceutical company focused on developing a treatment to prevent chemotherapy-induced peripheral neuropathy (CIPN), today announced that Teresa Bitetti, President of the Global Oncology Business Unit at Takeda Pharmaceutical Company Ltd., has joined the Board of Directors of Osmol Therapeutics.
  • Teresa Bitetti, has over 20 years of experience in developing and commercializing oncology products, including global responsibility for oncology business activities, said Bob Linke, President and Chief Executive Officer, Osmol Therapeutics.
  • On behalf of all of us at Osmol, I welcome Teresa to the Board of Directors.
  • Teresa Bitetti, is currently President of the Global Oncology Business Unit at Takeda Pharmaceutical Company Ltd. and is responsible for oncology business activities around the world, overseeing a global portfolio consisting of therapies in hematological malignancies and lung cancer.

KalVista Pharmaceuticals Reports First Fiscal Quarter Results

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Thursday, September 8, 2022
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(NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors, today provided an operational update and released financial results for the first fiscal quarter ended July 31, 2022.

Key Points: 
  • (NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors, today provided an operational update and released financial results for the first fiscal quarter ended July 31, 2022.
  • First Fiscal Quarter and Recent Business Highlights:
    Announced the initiation of the KONFIDENT-S open label extension study for sebetralstat in the on-demand treatment of HAE.
  • First Fiscal Quarter Financial Results:
    Revenue: No revenue was recognized for the three months ended July 31, 2022 or July 31, 2021.
  • KalVista Pharmaceuticals, Inc. is a pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors for diseases with significant unmet need.

Selexis and NexImmune Sign Service Agreement to Advance Multiple Immunotherapies Targeting Rare Cancers and Autoimmune Disorders

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Thursday, September 8, 2022
Oncology, Health, Infectious Diseases, Stem Cells, Clinical Trials, Pharmaceutical, Biotechnology, Nanoparticle, Nanotechnology, HLA, Technology, Cancer, AIM, Degenerative disease, Time, Vaccine, Solution, Multiple myeloma, Disease, AML, Toxic shock syndrome, Immunosuppression, Infection, Multimedia, Nasdaq, Immunotherapy, NEXI, Industry, Immortalised cell line, Patient

Per the agreement, NexImmune will leverage Selexis SUREtechnology Platform, a suite of cell line development technologies that significantly reduce the time, effort, and costs associated with developing high-performance mammalian cell lines.

Key Points: 
  • Per the agreement, NexImmune will leverage Selexis SUREtechnology Platform, a suite of cell line development technologies that significantly reduce the time, effort, and costs associated with developing high-performance mammalian cell lines.
  • We are excited to continue our longstanding relationship with NexImmune and are proud to be its cell line development provider of choice.
  • We are thrilled to have a partner in Selexis, as an industry-leading cell line development provider, said NexImmune Chief Scientific Officer, Mathias Oelke.
  • NexImmune is also developing AIM nanoparticle constructs and modalities for potential clinical evaluation in oncology and in disease areas outside of oncology, including autoimmune disorders and infectious disease.

Global Clinical Trials Outsourcing Market Outlook & Forecast 2022-2027: Virtual Clinical Trials are Rapidly Increasing in the Biopharma Industries - ResearchAndMarkets.com

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Thursday, September 8, 2022
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The "Clinical Trials Outsourcing Market - Global Outlook & Forecast 2022-2027" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Clinical Trials Outsourcing Market - Global Outlook & Forecast 2022-2027" report has been added to ResearchAndMarkets.com's offering.
  • The Covid-19 pandemic gave an absolute massive shift and forced the clinical trial industries to look for outsourcing.
  • Globally, more than 2,093,000 pharma start-ups are running in the market; this rise in smaller companies will demand outsourcing clinical trials.
  • Due to lower capital availability, lack of infrastructure, and expertise, small biopharma companies look towards outsourcing clinical trials.

Cardior Announces CE Marking of CardiorHealth miR-132 PCR Kit Used in Ongoing HF-REVERT Phase 2 Clinical Study

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Thursday, September 8, 2022
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By using the CardiorHealth miR-132 PCR kit, Cardior ensures consistent measurement of miR-132 levels following CDR132L treatment across all clinical trial centers as an indicator of the target engagement and the compounds mechanism of action.

Key Points: 
  • By using the CardiorHealth miR-132 PCR kit, Cardior ensures consistent measurement of miR-132 levels following CDR132L treatment across all clinical trial centers as an indicator of the target engagement and the compounds mechanism of action.
  • Cardior is developing CDR132L as a therapeutic candidate to improve cardiac systolic and diastolic function in patients with heart failure.
  • The CardiorHealth miR-132 PCR kit is the first PCR kit designed to monitor the treatment with a non-coding RNA-based therapeutic.
  • CE mark approval of the kit was based on the clinical evaluation of the test in patients receiving various doses of CDR132L or placebo, where the kit demonstrated comparable results to a similar testing protocol used in Cardiors Phase 1b clinical study.