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

OCTOBER 14, 2020

15, 2020 /PRNewswire/ — Apexigen, Inc. , a clinical-stage biopharmaceutical company focused on discovering and developing a new generation of antibody therapeutics for oncology, announced today that the U.S. APX005M is a novel, humanized monoclonal antibody that stimulates the anti-tumor immune response.

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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. 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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Clinical Trials Vaccine Trials Immune Response 52

The Pharma Data

DECEMBER 13, 2020

14, 2020 /PRNewswire/ — Synlogic, Inc. Nasdaq: SYBX ), a clinical stage company bringing the transformative potential of synthetic biology to medicine, today announced SYNB1891 has advanced into the combination therapy stage of the ongoing Phase 1 trial. Nature Communications 11, 2739 (2020)). CAMBRIDGE, Mass. ,

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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

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

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

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

APRIL 26, 2022

Imfinzi and tremelimumab were granted Orphan Drug Designation in the US for the treatment of HCC in January 2020. Tremelimumab blocks the activity of CTLA-4, contributing to T-cell activation, priming the immune response to cancer and fostering cancer cell death.

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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

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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Treatment Immune Response Trials FDA Approval 52

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

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

APRIL 9, 2021

Esophageal cancer is the eighth most common cancer and the sixth leading cause of death from cancer worldwide, with approximately 604,000 new cases and over 544,000 deaths in 2020. The overall burden of ESCC is concentrated in Asia, where roughly 80% of the global cases occurred in 2020. 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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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

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

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

JANUARY 31, 2021

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. Gilead Forward-Looking Statements. Securities and Exchange Commission.

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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

SEPTEMBER 15, 2020

On a non-risk adjusted basis, these opportunities collectively represent more than $15 billion (excluding 20vPnC) in potential incremental revenue for Pfizer from 2020 to 2025, as well as aggregate peak annual sales potential of $35 billion to $40 billion (including 20vPnC). Penta was well tolerated. Safety was consistent with published data.

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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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Vaccine Clinical Trials Trials Licensing 52

The Pharma Data

DECEMBER 20, 2020

BT-001 is being co-developed through a 50/50 collaboration between BioInvent and Transgene. “This clinical trial approval sets the stage to further broaden BioInvent’s promising clinical pipeline. BT-001 is our fourth program in clinical development. LUND, Sweden and STRASBOURG, France , Dec.

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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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The Pharma Data

OCTOBER 14, 2020

15, 2020 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. Tonix’s lead CNS candidate, TNX-102 SL**, is in Phase 3 development for the management of fibromyalgia. The Company expects topline data in the Phase 3 RELIEF study in the fourth quarter of 2020. CHATHAM, N.J.,

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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 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

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

JUNE 30, 2021

Opdivo plus Yervoy was also approved in Japan by the Ministry of Health, Labour and Welfare (MHLW) in September 2020 for the treatment of MSI-H unresectable advanced or recurrent colorectal cancer progressing after cancer chemotherapy. achieving a complete response. CheckMate -142 Efficacy and Safety Results. About Opdivo.

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The Pharma Data

OCTOBER 26, 2020

27, 2020 06:30 UTC. Following the unauthorized download of all abstracts on the SITC website, Transgene is communicating the content of the late-breaking poster abstract that will be presented at the SITC 35th Anniversary Annual Meeting (SITC 2020), to be held virtually November 9-14, 2020. 38:2020 (suppl; abstr 4051).

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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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