Moderna, AstraZeneca and J&J coronavirus shots rev up for NIH tests beginning in July: WSJ

Fiercepharma | June 10, 2020

As leading coronavirus vaccines make their way through early stages of human testing, the NIH is plotting much larger efficacy studies this summer. U.S. researchers plan to run phase 3 trials of vaccines from Moderna, AstraZeneca and Johnson & Johnson in the coming months, the Wall Street Journal reports.  The NIH intends to start a phase 3 trial of Moderna’s vaccine in July, followed by an August trial of AstraZeneca’s vaccine and a September study of Johnson & Johnson’s shot, a U.S. government researcher told the newspaper. All three of the shots are based on brand-new technologies, and they're all reportedly among finalists in the Operation Warp Speed program. Former FDA chief Scott Gottlieb has publicly questioned the picks, pointing out the team's reliance on new technologies. Johnson & Johnson has not previously disclosed any human testing for its vaccine and the company has previously said it’s aiming to enter human studies in September. But on Wednesday, the company said it's accelerating its timeline, with plans to start a phase 1/2a study in July.

Spotlight

One of the amazing blessings of getting to work at an agency is we get to see over 50 different companies and the challenges that they face. In today’s video, we’re going to talk about the biggest B2B marketing challenges that we see every day as an agency.

Spotlight

One of the amazing blessings of getting to work at an agency is we get to see over 50 different companies and the challenges that they face. In today’s video, we’re going to talk about the biggest B2B marketing challenges that we see every day as an agency.

Related News

Moberg Pharma decides on fully guaranteed rights issue of approximately SEK 150 million

Moberg Pharma | November 06, 2020

The Board of Directors of Moberg Pharma AB (publ) (OMX: MOB) ("Moberg Pharma" or "the Company") has today resolved to carry out a fully guaranteed issue of new ordinary shares and warrants ("Units") with preferential rights for existing shareholders (the "Rights Issue") of approximately SEK 150 million before transaction costs. The Rights Issue requires the approval of an extraordinary general meeting (the "Extraordinary General Meeting"). The proceeds will be used for registration activities and clinical work for MOB-015. When the Rights Issue is completed, the Company intends to terminate the current convertible note agreement. By a separate press release, the Company has today announced its intention to distribute the BUPI project to the shareholders of Moberg Pharma through a Lex Asea distribution with a subsequent listing on Nasdaq First North Growth Market during the Q1 of 2021.

Read More

PHARMACY MARKET

Kairos Pharma Received FDA Approval of the IND Application for an Investigational New Drug

Kairos Pharma, Ltd. | March 15, 2022

Kairos Pharma, Ltd. a privately-held clinical-stage biotechnology company focused on cancer drug resistance and immunotherapy, announced today that its activated T cell therapy, KROS 201, has received FDA approval to move forward with a Phase 1 clinical trial in patients with recurrent glioblastoma. Kairos Pharma is funding the phase I trial, which will occur at Cedars Sinai Medical Center in Los Angeles. John Yu, M.D., Kairos CEO, commented, "This IND acceptance is the second substantial clinical milestone within the past month as Kairos accelerates toward its clinical goals for 2022. This first-in-man Phase 1 clinical trial will activate T cells against the cancer stem cells at the root of glioblastoma." "This achievement pushes the envelope of immune therapies designed to target T cells against devastating cancers." Neil Bhowmick, Ph.D., Kairos Chief Scientific Officer KROS 201 activated T cells (ATCs) are killer T cells created in cell culture by activating a patient's white blood cells with cytokines or T cell activating signals and priming dendritic cells with antigens specific to glioblastoma cancer stem cells. Patients with recurrent glioblastoma are given the strongly activated T cells intravenously. As a result, cancer stem cells, which are the source of cancer, are killed by these cells. In February, the FDA granted an IND for a Phase 2 trial of ENV105 with apalutamide, in addition to the planned Phase 1 trial of activated T cell treatment for KROS 201. In 2022, an ENV105 Phase 1 trial with Tagrisso (AstraZeneca) for lung cancer is expected. Kairos Pharma also published a notice of allowance of their patent Compositions and Methods for Treating Fibrosis by the United States Patent and Trademark Office, which coincides with the advancement of its clinical milestones. The method of treating fibrosis and certain types of cancer, the composition of matter, and the administration of therapy utilizing KROS-401, a cyclic peptide inhibitor of the IL-4 and IL-13 cytokine receptor complex, are all covered by this patent. This drug has been proven to treat fibrosis and cancer by reversing the M1 to M2 immunosuppressive macrophage shift in cancer and fibrosis. CEO of Kairos Pharma, Dr. John Yu, stated, "This milestone further supports the already substantial and diversified intellectual property portfolio of Kairos and enables the unfettered clinical development of this novel and transformative therapeutic." Dr. Ramachandran Murali, Kairos VP of Research and Development and inventor of the KROS 401 molecule, commented, "KROS-401, in addition to fibrosis and cancer, opens a new avenue in therapeutic development for neurological disorders such as Alzheimer's disease."

Read More

BUSINESS INSIGHTS

Iktos and Zealand Pharma to Develop Artificial Intelligence Technology for Peptide Drug Design

Iktos | June 22, 2022

Iktos, a company specialized in Artificial Intelligence for new drug design, announced a research collaboration with Zealand Pharma A/S a biotechnology company changing lives with innovative peptide-based medicines to co-develop generative and predictive AI technologies for peptide drug design. Iktos’ AI technology, based on a comprehensive data-driven chemical structure generation technology, brings new insights into the drug discovery process. This technology automatically designs virtual novel molecules with all the characteristics of a successful drug molecule. Iktos has recently diversified its R&D efforts into the development of an AI technology for peptide-based therapeutics and has developed state-of-the-art generative and predictive models to facilitate design of novel peptide therapeutics with desired properties. Zealand Pharma A/S has a track record of successfully inventing and developing novel peptide-based drugs. This success is based on the extensive experience in improving the therapeutic characteristics of peptides. Zealand Pharma has a keen interest in expanding its computational chemistry toolbox to include AI and machine learning based approaches for the design of novel therapeutic peptides. Under the agreement, Zealand will contribute its expertise in peptide drug discovery to Iktos’ generative modelling technologies and expertise in machine learning and AI. “We are very pleased to join forces with Zealand Pharma and leverage their deep know-how in peptide therapeutics with our state-of-the-art existing technology assets to peptide drug discovery. We look forward to working with Zealand’s experienced R&D team to build leading/state of the art peptide generative and predictive modelling technology in the field of peptides - a new area for Iktos.” Yann Gaston-Mathé, President and CEO of Iktos About IKTOS Incorporated in October 2016, Iktos is a French start-up company specialized in the development of artificial intelligence solutions applied to chemical research, more specifically medicinal chemistry and new drug design. Iktos is developing a proprietary and innovative solution based on deep learning generative models, which enables, using existing data, to design molecules that are optimized in silico to meet all the success criteria of a small molecule discovery project. The use of Iktos technology enables major productivity gains in upstream pharmaceutical R&D. Iktos offers its technology both as professional services and as a SaaS software platform, Makya™. Iktos is also developing Spaya™, a synthesis planning software based upon Iktos’s proprietary AI technology for retrosynthesis. Iktos has recently diversified its R&D efforts into the development of an AI technology for peptide-based therapeutics and has developed state-of-the-art generative and predictive models to facilitate design of novel peptide therapeutics with desired properties.

Read More