2021, Clinical Development, Immune Response and Small Molecule

2021

Clinical Development

Immune Response

Small Molecule

Lilly and Kumquat Biosciences Announce Collaboration to Discover and Develop Novel Small Molecules that Stimulate Tumor-Specific Immune Responses

The Pharma Data

JULY 29, 2021

Loxo Oncology at Lilly, a research and development group of Eli Lilly and Company (NYSE: LLY), and Kumquat Biosciences today announced an exclusive collaboration focused on the discovery, development and commercialization of potential novel small molecules that stimulate tumor-specific immune responses.

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Small Molecule Immune Response Research Laboratories Laboratories

2021 Biotech IPOs Get Off to a Roaring Start

The Pharma Data

JANUARY 19, 2021

With this kind of a start, 2021 may be scorching. The company hopes to raise $140 million of common stock, which will be used to advance its clinical and earlier stage programs and for R&D, working capital and general corporate purposes. Last year was a record number of IPOs in the biotech industry, with 81 raising $13.5

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Trending Sources

Gilead Strengthens Early Pipeline in Oncology and Inflammation Through the Acquisition of XinThera

The Pharma Data

MAY 15, 2023

The acquisition complements Gilead’s existing clinical development priorities by adding additional pipeline assets for well-validated targets in oncology and inflammation. Both programs have the potential to address multiple indications, offering broad development opportunities alone and in combination with Gilead’s portfolio.

Small Molecule

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Lineage Cell Therapeutics Provides End of Year Shareholder Letter

The Pharma Data

DECEMBER 27, 2020

(NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today provided a year-end review and an outline of its plans for 2021.

Therapies

Therapies Production Clinical Trials Treatment

Pfizer and BioNTech Share Positive Early Data on Lead mRNA Vaccine Candidate BNT162b2 Against COVID-19

The Pharma Data

AUGUST 20, 2020

Assuming clinical success, Pfizer and BioNTech are on track to seek regulatory review of BNT162b2 as early as October 2020 and, if regulatory authorization or approval is obtained, currently plan to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses by the end of 2021. and Germany.

Vaccine

Vaccine Clinical Trials Trials Immune Response

Pfizer and BioNTech Celebrate Historic First Authorization in the U.S. of Vaccine to Prevent COVID-19

The Pharma Data

DECEMBER 11, 2020

Government to supply doses in 2020 & 2021. In collaboration with Operation Warp Speed, Pfizer and BioNTech, as well as other vaccine companies are expected to deliver hundreds of millions of vaccine doses to Americans by the end of 2021. immediately, with delivery fulfillment expected to be completed in 2021.

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Vaccine Clinical Trials Licensing Licensing

Pfizer and BioNTech to Potentially Supply the EU with 200 Million Doses of mRNA-based Vaccine Candidate Against SARS-CoV-2

The Pharma Data

SEPTEMBER 9, 2020

billion doses by the end of 2021. During preclinical and clinical studies, BNT162b1 and BNT162b2 emerged as strong candidates based on assessments of safety and immune response. billion doses by the end of 2021. and Germany as well as animal immunogenicity studies.

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PFIZER AND BIONTECH ANNOUNCE COLLABORATION WITH BIOVAC TO MANUFACTURE AND DISTRIBUTE COVID-19 VACCINE DOSES WITHIN AFRICA

The Pharma Data

JULY 21, 2021

To facilitate Biovac’s involvement in the process, technical transfer, on-site development and equipment installation activities will begin immediately. Pfizer and BioNTech expect that Biovac’s Cape Town facility will be incorporated into the vaccine supply chain by the end of 2021. Pfizer Disclosure Notice.

Vaccine

Vaccine Clinical Trials Licensing Licensing

Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of Their COVID 19 Vaccine

The Pharma Data

MAY 7, 2021

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine. The information contained in this release is as of May 7, 2021. The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.

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Pfizer and BioNTech to Provide COVID-19 Vaccine Doses for Olympic Athletes at the 2020 Tokyo Games

The Pharma Data

MAY 6, 2021

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine. The information contained in this release is as of May 6, 2021. This press release features multimedia. View the full release here: [link]. Pfizer Disclosure Notice.

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Pfizer and BioNTech Announce Publication of Results from Landmark Phase 3 Trial of BNT162b2 COVID-19 Vaccine Candidate in The New England Journal of Medicine

The Pharma Data

DECEMBER 10, 2020

A breakdown of the diversity of clinical trial participants can be found here from approximately 150 clinical trials sites in the U.S., The Phase 3 trial is designed as a 1:1 vaccine candidate to placebo, randomized, observer-blinded study to obtain safety, immune response, and efficacy data needed for regulatory review.

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Analysis Life Sciences Thank You FDA finalizes new guidance on nonclinical assessment of potential immunotoxicity

Agency IQ

JUNE 9, 2023

For this reason, animal models are still used both during drug discovery and the more intensive nonclinical studies conducted during clinical development. However, this guideline is primarily intended to provide recommendations on evaluating the immune system’s response to small molecule drugs.

FDA

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Lilly and Rigel Enter Strategic Collaboration to Develop RIPK1 Inhibitors

The Pharma Data

FEBRUARY 22, 2021

(Nasdaq: RIGL) today announced a global exclusive license agreement and strategic collaboration to co-develop and commercialize Rigel’s R552, a receptor-interacting serine/threonine-protein kinase 1 (RIPK1) inhibitor, for all indications including autoimmune and inflammatory diseases. vice president of immunology at Lilly. About Rigel.

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Tonix Pharmaceuticals Enrolls First Participant in the PRECISION Study, an Observational Study to Facilitate Development of Precision Medicine Techniques for COVID-19 Vaccines and Therapeutics

The Pharma Data

OCTOBER 14, 2020

. Results from the PRECISION Study Expected in First Half of 2021. Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. CHATHAM, N.J.,

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BioNTech announces first patient dosed in Phase 2 clinical trial of mRNA-based BNT111 in patients with advanced melanoma

The Pharma Data

JUNE 26, 2021

BNT111 is the lead product candidate from BioNTech’s FixVac platform that targets a fixed combination of mRNA-encoded, tumor-associated antigens with the objective of triggering a strong and precise immune response against cancer and is fully owned by BioNTech. About FixVac. About BioNTech.

Clinical Trials

Clinical Trials Trials Immune Response Vaccine

Pfizer and BioNTech Announce Data from Preclinical Studies of mRNA-based Vaccine Candidate Against COVID-19

The Pharma Data

SEPTEMBER 9, 2020

producing CD8+ T cell responses, which is thought to promote an anti-viral effect. In a preclinical murine model, a single IM immunization of BNT162b2 (0.2, CD4+ and CD8+ T-cells from splenocytes isolated from BNT162b2-immunized mice were strongly positive for IFN? billion doses by the end of 2021.

Vaccine

Vaccine RNA Clinical Trials Immune Response

Advances in the Battle Against Autoimmune Disease

The Pharma Data

DECEMBER 15, 2020

Anokion is responsible for preclinical activities and Phase I clinical development of partnered programs, and Bristol Myers Squibb will fund subsequent trials and commercial activities at clinical proof-of-concept. Small Molecule Inhibitors. The FDA has set an action date of July 7, 2021.

Disease

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Pfizer Investor Day Features Significant Number of Pipeline Advances for COVID-19 Programs and Across Numerous Therapeutic Areas

The Pharma Data

SEPTEMBER 15, 2020

In addition to the COVID-19 vaccine program, Pfizer aims to deliver five innovative vaccines by 2025, subject to clinical success and regulatory approval. Based on the acceptable safety profile and the favorable immune response data, including the 4th dose response data, Pfizer received Breakthrough Therapy Designation.

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Drug Discovery Digest

Lilly and Kumquat Biosciences Announce Collaboration to Discover and Develop Novel Small Molecules that Stimulate Tumor-Specific Immune Responses

2021 Biotech IPOs Get Off to a Roaring Start

Trending Sources

Gilead Strengthens Early Pipeline in Oncology and Inflammation Through the Acquisition of XinThera

Lineage Cell Therapeutics Provides End of Year Shareholder Letter

Pfizer and BioNTech Share Positive Early Data on Lead mRNA Vaccine Candidate BNT162b2 Against COVID-19

Pfizer and BioNTech Celebrate Historic First Authorization in the U.S. of Vaccine to Prevent COVID-19

Pfizer and BioNTech to Potentially Supply the EU with 200 Million Doses of mRNA-based Vaccine Candidate Against SARS-CoV-2

PFIZER AND BIONTECH ANNOUNCE COLLABORATION WITH BIOVAC TO MANUFACTURE AND DISTRIBUTE COVID-19 VACCINE DOSES WITHIN AFRICA

Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of Their COVID 19 Vaccine

Pfizer and BioNTech to Provide COVID-19 Vaccine Doses for Olympic Athletes at the 2020 Tokyo Games

Pfizer and BioNTech Announce Publication of Results from Landmark Phase 3 Trial of BNT162b2 COVID-19 Vaccine Candidate in The New England Journal of Medicine

Analysis Life Sciences Thank You FDA finalizes new guidance on nonclinical assessment of potential immunotoxicity

Lilly and Rigel Enter Strategic Collaboration to Develop RIPK1 Inhibitors

Tonix Pharmaceuticals Enrolls First Participant in the PRECISION Study, an Observational Study to Facilitate Development of Precision Medicine Techniques for COVID-19 Vaccines and Therapeutics

BioNTech announces first patient dosed in Phase 2 clinical trial of mRNA-based BNT111 in patients with advanced melanoma

Pfizer and BioNTech Announce Data from Preclinical Studies of mRNA-based Vaccine Candidate Against COVID-19

Advances in the Battle Against Autoimmune Disease

Pfizer Investor Day Features Significant Number of Pipeline Advances for COVID-19 Programs and Across Numerous Therapeutic Areas

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