The Pharma Data

SEPTEMBER 2, 2020

The randomised, double blind and placebo-controlled trial is designed to evaluate the safety, reactogenicity (tolerability) and immunogenicity (immune response) of the experimental COVID-19 vaccine candidate. If successful, the companies intend to request regulatory approval in the first half of 2021.

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Drug Target Review

JANUARY 15, 2024

To be therapeutically useful, antigenic peptides must be presented in a way that allows immune responses to destroy cancer cells without causing unacceptable damage to healthy tissue. The FEBS Journal 288:6159–6173 (2021). Many potential candidate antigens are under consideration. Froning K, Sereno A, Huang F, Demarest S.

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The Pharma Data

JANUARY 20, 2021

20, 2021 /PRNewswire/ — INOVIO Pharmaceuticals, Inc. The offering is expected to close on or about January 25, 2021 , subject to customary closing conditions. PLYMOUTH MEETING, Pa. , Gross proceeds to INOVIO from the offering are expected to be approximately $150.5 All of the shares are being sold by INOVIO.

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The Pharma Data

DECEMBER 3, 2020

Strong Th1 cell-mediated immune responses were also observed for the vaccine candidates with either adjuvant. Based on the positive Phase 1 results reported and the unprecedented need for COVID-19 vaccines, Clover and its partners are confident to enter late-stage clinical development for both adjuvanted vaccines.

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The Pharma Data

JANUARY 12, 2021

Ben-Moshe told BioSpace that BND-22 differs from traditional immunotherapy in that it can elicit a more total immune response. . “It It is a new immune checkpoint that is expressed on three different immune cells: Macrophages, [Natural Killer] NK cells, and T cells. [It]

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The Pharma Data

JUNE 2, 2022

A 30-plus valent pneumococcal candidate vaccine is also in pre-clinical development. We look forward to working with the many talented people at Affinivax to combine our industry-leading development, manufacturing, and commercialisation capabilities to make this exciting new technology available to those in need.”

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The Pharma Data

MAY 31, 2022

A 30-plus valent pneumococcal candidate vaccine is also in pre-clinical development. We look forward to working with the many talented people at Affinivax to combine our industry-leading development, manufacturing, and commercialisation capabilities to make this exciting new technology available to those in need.”.

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The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. Expected to enroll 415 participants; interim results expected in Q3 2021. The Companies expect interim results from this trial in the third quarter of 2021. About Translate Bio.

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The Pharma Data

JUNE 25, 2021

CureVac and GSK expect to progress the second-generation vaccine candidate into clinical testing in the third quarter of 2021, with the goal of introducing the vaccine in 2022, subject to regulatory approval. CureVac began development of mRNA-based COVID-19 vaccine candidates in January 2020. About CVnCoV.

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PerkinElmer

MAY 6, 2022

One approach currently being explored involves stimulating innate immune response pathways. For example, the STimulator of InterferoN Genes (STING) pathway, which is known to play a critical role in innate immunity in response to viral and bacterial DNA, has also been shown to promote anti-tumor immune responses.

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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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The Pharma Data

JANUARY 21, 2021

The 2021 trend of biotech initial public offerings (IPOs) continued this week. On January 5, 2021, the U.S. The compound was developed in the laboratory of Richard Childs, chief of the Laboratory of Transplantation Immunotherapy with the National Heart, Lung, and Blood Institute (NHLBI). Here’s a look. Precigen – Germantown, Md.-based

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The Pharma Data

JANUARY 31, 2021

Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial. These findings give confidence that Clover’s COVID-19 vaccine candidates are suitable for further clinical development.”

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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.

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The Pharma Data

JANUARY 12, 2021

“The T-cell and NK-cell target discovery approach complements our portfolio aimed at turning cold tumors hot and redirecting the innate immune system to elicit a sustained and durable immune response against tumors. Takeda will assume responsibility for funding all development and commercialization activities.

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The Pharma Data

OCTOBER 25, 2020

We are advancing the clinical development of mRNA-1273 with our Phase 3 COVE study, which is now fully enrolled with a representative demography of participants across ages, ethnicities and high-risk populations.

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The Pharma Data

NOVEMBER 9, 2020

(Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the U.S. Currently in late-phase clinical development, NVXCoV2373 is a stable, prefusion protein made using Novavax’ nanoparticle technology and includes its proprietary MatrixM adjuvant.

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The Pharma Data

JANUARY 3, 2021

. Both will help NexImmune advance current early-stage clinical trials and will guide Company’s translational efforts to develop new immunotherapy products. We are very honored to have someone of Dr. Zeldis’ caliber lead our scientific research and clinical development teams. GAITHERSBURG, Md.,

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The Pharma Data

AUGUST 17, 2021

Results from CheckMate -648 were presented in an oral session during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting and were selected for the official ASCO press program. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

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The Pharma Data

OCTOBER 21, 2020

The active IND enables the Company to initiate the first-in-human clinical trial to assess safety and efficacy of ADI-001 in NHL patients. The clearance of the IND for ADI-001 by the FDA is a significant milestone in the development of CAR ?? T cell products,” said Chen Schor, President and Chief Executive Officer of Adicet. “We

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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.

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The Pharma Data

MARCH 29, 2022

The pCR data from CheckMate -816 were presented at the American Association for Cancer Research (AACR) Annual Meeting 2021, and the EFS results will be presented in a clinical trials plenary session at the AACR Annual Meeting 2022 on April 11, 2022, beginning at 10:15 a.m. CT, in New Orleans, Louisiana. About Opdivo.

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The Pharma Data

APRIL 16, 2021

Food and Drug Administration in January 2021, and further applications are under review with health authorities globally. Results from the CheckMate -9ER trial were published in the New England Journal of Medicine in March 2021. To date, the Opdivo clinical development program has treated more than 35,000 patients.

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The Pharma Data

APRIL 11, 2021

Data selected for an oral presentation in a Clinical Trials Plenary Session at the American Association for Cancer Research Annual Meeting 2021. Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response.

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The Pharma Data

JANUARY 3, 2021

. The scientific approaches underlying this clinical study could potentially be effective against SARs, MERS, and all variants of coronaviruses. This trial is the first to evaluate nasally administered Foralumab to improve the immune system’s fight against coronaviruses. NEW YORK and LONDON, Jan.

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The Pharma Data

JANUARY 17, 2021

18, 2021 09:00 UTC. Previously Rexgenero Ltd, a UK-based company pioneering the development of cell therapies to treat serious diseases such as cancer and chronic limb-threatening ischaemia (CLTI), the launch of Ixaka follows integration of its nanoparticle gene therapy business in France and a shareholder restructuring.

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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.

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The Pharma Data

JANUARY 31, 2021

1, 2021 11:00 UTC. Delivery of viral antigens in potent vaccine vectors to elicit a strong immune response is a cornerstone of successful infectious disease vaccines,” said Karin Jooss, PhD, Executive Vice President of Research and Chief Scientific Officer of Gritstone. FOSTER CITY, Calif. & & EMERYVILLE, Calif.–(

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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.

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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.

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The Pharma Data

DECEMBER 29, 2020

(NASDAQ: REGN) today announced encouraging initial data from an ongoing Phase 1/2/3 clinical trial of the Regeneron antibody cocktail, casirivimab and imdevimab, in hospitalized COVID-19 patients requiring low-flow oxygen. Senior Vice President and Head of Global Clinical Development at Regeneron. futility analysis). .

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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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The Pharma Data

OCTOBER 14, 2020

. Results from the PRECISION Study Expected in First Half of 2021. Tonix is also currently enrolling participants in the Phase 3 RALLY study for the management of fibromyalgia using TNX-102 SL, and the results are expected in second half of 2021. CHATHAM, N.J.,

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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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The Pharma Data

DECEMBER 17, 2020

Senior Vice President and Head of Global Clinical Development at Regeneron and lead author of the publication. patients under an Emergency Use Authorization, and we also continue a robust clinical development program.” and Roche will develop, manufacture and distribute it outside of the U.S.

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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. Finally, in either scenario, sponsors should consider adverse effects directly related to the product’s interaction with a biological component of the immune system (e.g.,

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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. The FDA has set an action date of July 7, 2021.

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