The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. The joint development team is working on improving the temperature stability of the mRNA vaccine candidate and targeting a -20°C storage temperature for late-stage clinical trials and at launch.

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The Pharma Data

NOVEMBER 12, 2020

12 November 2020 — The CALAVI Phase II trials for Calquence (acalabrutinib) in patients hospitalised with respiratory symptoms of COVID-19 did not meet the primary efficacy endpoint. Accessed October 2020. Accessed October 2020. Posted: November 2020. NCT identifier: NCT04380688. Available online.

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The Pharma Data

NOVEMBER 9, 2020

09, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the U.S. NanoFlu , its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults.

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The Pharma Data

JANUARY 21, 2021

In January 2020, it raised $69 million in Series D, bringing the then-total up to $150 million. 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). It filed for a U.S. IPO on January 15.

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The Pharma Data

DECEMBER 10, 2020

11, 2020 02:48 UTC. The vaccine targeted both the inner nucleocapsid (N) and the outer spike (S) proteins of the virus to maximize the immune response. The study showed this broad immune response led to the complete clearance of the virus in a matter of days after infection of previously-vaccinated primates.

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The Pharma Data

AUGUST 6, 2020

Under the pact, AZ will transfer the vaccine’s technology to BioKangtai, which will in return reserve enough capacity to make at least 100 million doses of the shot by the end of 2020 and expand to 200 million doses per year by the end of 2021. China has several home-grown COVID-19 vaccines in clinical development.

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The Pharma Data

NOVEMBER 9, 2020

10, 2020 (GLOBE NEWSWIRE) — Immunophotonics, Inc. announces the first patient treated in the phase 1b/2a clinical trial examining IP-001 in thermally ablated solid tumors. LOUIS and BERN, Switzerland, Nov. Markus Jörger, M.D.,

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The Pharma Data

OCTOBER 21, 2020

22, 2020 (GLOBE NEWSWIRE) — Adicet Bio, Inc. Nasdaq: ACET), a biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer and other diseases, today announced that the U.S. The clearance of the IND for ADI-001 by the FDA is a significant milestone in the development of CAR ??

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The Pharma Data

OCTOBER 25, 2020

26, 2020 11:00 UTC. 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. CAMBRIDGE, Mass.–( About Moderna.

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The Pharma Data

OCTOBER 19, 2020

20, 2020 10:45 UTC. Immune responses following vaccination with PNEUMOVAX 23 (month 13) were comparable in both vaccination groups for the 15 serotypes in V114. Results from both studies are based on opsonophagocytic activity (OPA) responses – a measure of vaccine-induced functional antibodies. KENILWORTH, N.J.–(

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The Pharma Data

JANUARY 19, 2021

In January 2020, it raised $69 million in Series D, bringing the then-total up to $150 million. 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). It hopes to raise $125 million in the IPO.

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The Pharma Data

MARCH 29, 2022

Discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020, the human monoclonal antibodies bind to distinct sites on the SARS-CoV-2 spike protein16 and were optimised by AstraZeneca with half-life extension and reduction of Fc effector function. 1-3 Evusheld was generally well-tolerated in the trial.

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The Pharma Data

JANUARY 20, 2021

INOVIO intends to use the net proceeds from this offering for the development of its clinical pipeline, including clinical development expenses relating to INO-4800 and research and development expenses, and for general corporate purposes, including working capital and general and administrative expenses.

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The Pharma Data

DECEMBER 20, 2020

21, 2020 (GLOBE NEWSWIRE) — SELLAS Life Sciences Group, Inc. We are encouraged by the data shown in these two studies of GPS in combination with checkpoint inhibitors and look forward to additional data from these studies,” stated Dragan Cicic, MD, Senior Vice President, Clinical Development of SELLAS. “We NEW YORK, Dec.

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The Pharma Data

NOVEMBER 1, 2020

Clinical Data Expected by End of Year. C linical study will start dosing patients on November 3 rd , 202 0 with clinical data expected to be available before the end of 2020. Furthermore, nasal anti-CD3 dampens cytotoxic CD8 T cell responses shown to cause lung damage in COVID-19.

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The Pharma Data

JANUARY 17, 2021

REX-001, Ixaka’s lead MCT product, is an autologous cell-based product in clinical development for the treatment of CLTI. REX-001 is currently being evaluated in the pivotal Phase III SALAMANDER clinical trial at multiple sites across Europe. A total of $15.4 References 1.

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The Pharma Data

AUGUST 20, 2020

These results informed the selection of the BNT162b2 candidate for the pivotal Phase 2/3 global study in up to 30,000 participants that started in July 2020, which has to date enrolled more than 11,000 participants, including in areas with significant SARS-CoV-2 transmission. The information contained in this release is as of August 20, 2020.

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The Pharma Data

SEPTEMBER 9, 2020

The proposed agreement is intended to provide a supply of 200 million doses and an option to purchase additional 100 million doses, with deliveries starting by the end of 2020, subject to regulatory approval. Deliveries would be starting by the end of 2020, subject to clinical success and regulatory authorization.

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The Pharma Data

NOVEMBER 10, 2020

Phase1b/2 clinical study to be conducted in the United States and several European countries. Oral administration of anti-CD3 monoclonal antibody is a novel approach to induce an anti-inflammatory immune response to suppress inflammation by inducing T regulatory (Tregs) cells in animal studies 3 ,4. Billion by 2025.

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The Pharma Data

DECEMBER 11, 2020

Friday, December 11, 2020. Government to supply doses in 2020 & 2021. In July 2020, Pfizer and BioNTech announced an agreement with the HHS and the DoD to meet the U.S. A breakdown of the diversity of clinical trial participants can be found here from more than 150 clinical trial sites in the U.S.,

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The Pharma Data

JANUARY 3, 2021

The clinical study was completed in collaboration with scientific teams at the Harvard Medical School (Boston, USA), Santa Casa de Misericórdia de Santos Hospital (Santos, Brazil) and INTRIALS, a world-class, full-service Latin American CRO based in São Paulo, Brazil. In a humanized mouse model (NOD/SCID IL2?c-/-),

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The Pharma Data

JANUARY 4, 2021

Barber’s work will give Kiromic a significant acceleration in the clinical development of its therapy platform and an even more significant advantage over its competitors. Chimeric PD-1 T-cells also release cytokines to further initiate immune responses to eradicate the tumor cells. “We believe Prof.

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The Pharma Data

DECEMBER 10, 2020

Thursday, December 10, 2020 – . Based on a data cut-off date of October 9, 2020, 37,706 participants had a median of at least two months of safety data available after dose 2 and contributed to the main safety dataset. The information contained in this release is as of December 10, 2020. Pfizer Disclosure Notice.

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The Pharma Data

DECEMBER 29, 2020

29, 2020 /PRNewswire/ — Phase 3 program in hospitalized patients to continue based on passing futility analysis on ability to reduce incidence of death or mechanical ventilation. As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes.

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The Pharma Data

DECEMBER 27, 2020

28, 2020 13:00 UTC. 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. CARLSBAD, Calif.–( –( BUSINESS WIRE )– Lineage Cell Therapeutics, Inc.

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The Pharma Data

NOVEMBER 29, 2020

. Observed CMV-neutralizing antibody responses and tolerability profile are consistent with previous interim results. 30, 2020 (GLOBE NEWSWIRE) — HOOKIPA Pharma Inc. HOOKIPA’s viral vectors target antigen presenting cells in vivo to activate the immune system. NEW YORK and VIENNA, Austria, Nov.

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The Pharma Data

OCTOBER 28, 2020

28, 2020 /PRNewswire/ — . Today’s data, involving an additional 524 patients from the ongoing Phase 2/3 trial, provides definitive final virology results and meets the clinical endpoint of reducing medical visits. Senior Vice President and Head of Global Clinical Development at Regeneron. TARRYTOWN, N.Y. ,

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The Pharma Data

MAY 7, 2021

under an Emergency Use Authorization (EUA) granted by the FDA on December 11, 2020. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine. The Pfizer-BioNTech COVID-19 Vaccine is currently available in the U.S.

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The Pharma Data

DECEMBER 17, 2020

17, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. TARRYTOWN, N.Y. ,

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The Pharma Data

SEPTEMBER 8, 2020

Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines. NanoFlu , its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults.

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The Pharma Data

JULY 21, 2021

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine. Procedures should be in place to avoid injury from fainting. The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.

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The Pharma Data

SEPTEMBER 8, 2020

Together, these nine companies have collectively developed more than 70 novel vaccines that have helped to eradicate some of the world’s most complex and deadly public health threats, underscoring their experience in clinical development and regulatory rigor, as well as their longstanding commitments to patient safety and public health.

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The Pharma Data

JUNE 25, 2021

CureVac began development of mRNA-based COVID-19 vaccine candidates in January 2020. The vaccine candidate chosen for first clinical development, CVnCoV, is an optimized, non-chemically modified mRNA, encoding the prefusion stabilized full-length spike protein of the SARS-CoV-2 virus, and formulated within Lipid Nanoparticles (LNPs).

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Creative Biolabs

JULY 12, 2020

They are currently working with Boehringer Ingelheim to further identify and develop these antibodies. They are expected to enter clinical development later this year. ” The researchers studied the SARS-CoV-2 antibody response of 12 people who recovered from COVID-19. .”

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Agency IQ

JUNE 9, 2023

The guidance looks very different from the draft that was published in February 2020, including changes in the scope of the guidance, its sponsorship, and the removal of all mentions of nonhuman primates for animal testing. BY RACHEL COE, MSC JUN 6, 2023 5:00 PM CDT What are nonclinical studies and when are they conducted in drug development?

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AUGUST 17, 2021

Esophageal cancer is the eighth most common cancer and the sixth leading cause of death from cancer worldwide, with approximately 600,000 new cases and over 540,000 deaths in 2020. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers. About Opdivo.

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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. Pfizer Disclosure Notice.

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