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

The Pharma Data

Through the multi-year collaboration, Kumquat will utilize its small molecule immuno-oncology (IO) platform to discover novel clinical candidates and Lilly has the option to select a certain number of drug candidates for further development and commercialization worldwide, excluding Greater China.

Novavax Announces COVID-19 Vaccine Clinical Development Progress

The Pharma Data

Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today provided an update on its COVID-19 vaccine program. Novavax completed enrollment of 15,000 participants in a pivotal Phase 3 clinical trial being conducted in the U.K.

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MERS DNA vaccine induces immunity, protects from virus challenge in preclinical model

Scienmag

Dose-sparing regimens and intradermal delivery have important implication for rapid clinical development of effective, well-tolerated and easy-to-distribute vaccines against MERS and other emerging coronaviruses.

Gene Therapy and Pharmacokinetics

Camargo

How and When to Incorporate PK Design into Your Gene Therapy Development Plan. While most gene therapy clinical studies are ongoing, a number of products are in advanced clinical development, and several are approved by FDA. Exposure-Response Considerations.

Sanofi/GSK restart COVID-19 vaccine trials after tweaking formulation

Pharma Phorum

Sanofi and GlaxoSmithKline are restarting clinical development of their COVID-19 vaccine, which was delayed after hitting a snag late last year. In December interim phase 1/2 trial results showed the vaccine produced a lower immune response in older adults.

Sanofi/GSK trial woes delay a billion COVID-19 shots by nine months

Pharma Phorum

Sanofi and GlaxoSmithKline have said their COVID-19 vaccine has hit a snag in clinical development, prompting analysts to note this could delay delivery of potentially more than a billion shots globally by up to nine months.

Prevention of Invasive Pneumococcal Disease in Adults 18 Years and Older Caused by 15 Serotypes

The Pharma Data

Clinical Data Supporting Approval Demonstrated Non-Inferior Immune Responses for the Serotypes Shared with PCV13 (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F). VAXNEUVANCE is indicated for active immunization for the prevention of invasive disease caused by the S.

Trials of Valneva COVID-19 vaccine begin in UK

Pharma Phorum

France’s Valneva begun the phase 1/2 clinical study of the inactivated vaccine candidate VLA2001 in sites across the UK, supported by the National Institute for Health Research (NIHR).

Exscientia starts trials of first AI-derived cancer immunotherapy

Pharma Phorum

The adenosine pathway has emerged as an attractive target for immuno-oncology R&D because it is thought to reduce the activity of misfunctioning regulatory T-cells that inhibit the immune response against cancers.

Valneva accelerates Lyme disease vaccine R&D project with Pfizer

Pharma Phorum

Under the agreement Valneva could receive up to $308 million in cash payments, after Pfizer paid $130 million up front for marketing rights to the vaccine if it succeeds in the clinic.

AZ expands phase 3 trials of COVID-19 vaccine frontrunner into US

Pharma Phorum

AstraZeneca has expanded development of COVID-19 vaccine AZD1222 into the US, beginning a phase 3 clinical trial across all adult age groups. The UK pharma said that the trial will recruit up to 30,000 adults aged 18 years or over to assess the safety, efficacy and immune response.

Novel nasal spray reduces COVID-19 viral replication in animal study

The Pharma Data

Treatment is being developed by Australian biotech Ena Respiratory. A novel nasal spray treatment, being developed by Australian biotech Ena Respiratory, produced promising results against COVID-19 in an animal study performed by Public Health England (PHE) scientists.

Synlogic Announces Advancement of SYNB1891 to Combination Arm Dosing with PD-L1 Checkpoint Inhibitor in the on-going Phase 1 Study for the Treatment of Solid Tumors and Lymphoma

The Pharma Data

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. SYNB1891 is an investigational drug for the intra-tumoral treatment of solid tumors and lymphoma, composed of an engineered Synthetic Biotic designed to activate the STING pathway in the tumor microenvironment in order to upregulate the patient’s immune response.

Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate

The Pharma Data

Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Immune Response Data.

Sanofi/Translate start clinical trial of mRNA COVID shot

Pharma Phorum

Sanofi and Translate BIO have begun a clinical trial of their potential mRNA COVID-19 shot, as the French pharma struggles to keep pace with rivals despite its background in vaccines. Clinical trial participants will receive one dose of MRT5500, or two doses 21 days apart.

Sanofi Keeps on Rolling With Biond Biologics Partnership

The Pharma Data

“The emphasis in the development of cancer immunotherapies has been placed so far mainly on drugs that stimulate the adaptive immune system to attack malignant cells, in particular T lymphocytes. It is being developed for the treatment of solid tumors. Keitma/Shutterstock.

UK gears up for ‘challenge trial’ of COVID-19 vaccine

Pharma Phorum

A spokesman for the government said: “We are working with partners to understand how we might collaborate on the potential development of a COVID-19 vaccine through human challenge studies.

Clover Biopharmaceuticals Announces Positive Phase 1 Data for its Adjuvanted S-Trimer COVID-19 Vaccine Candidates

The Pharma Data

Strong Th1 cell-mediated immune responses were also observed for the vaccine candidates with either adjuvant. We and our collaborators are steadfast in our commitment to the development of safe, effective and accessible COVID-19 vaccines for the global population.”.

Apexigen’s APX005M Granted Orphan Drug Designations for the Treatment of Esophageal and Gastroesophageal Junction Cancer and for the Treatment of Pancreatic Cancer

The Pharma Data

a clinical-stage biopharmaceutical company focused on discovering and developing a new generation of antibody therapeutics for oncology, announced today that the U.S. We are evaluating APX005M in a broad clinical program that includes more than 10 clinical trials in various indications and therapeutic combinations,” said Xiaodong Yang , MD, PhD, Chief Executive Officer of Apexigen. SAN CARLOS, Calif. , 15, 2020 /PRNewswire/ — Apexigen, Inc. ,

Lilly and Rigel Enter Strategic Collaboration to Develop RIPK1 Inhibitors

The Pharma Data

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. Pursuant to the collaboration, Lilly will also lead all clinical development of brain penetrating RIPK1 inhibitors in central nervous system (CNS) diseases.

Sanofi, GSK launch early trial for COVID-19 vaccine

The Pharma Data

Sanofi and GSK have begun a Phase I/II clinical trial testing their adjuvanted COVID-19 vaccine in healthy adults. Over 400 participants are being enrolled in the Phase I/II study after promising preclinical safety and immunogenicity data.

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

The Pharma Data

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.

CureVac provides update on Phase 2b/3 trial of first-generation COVID-19 vaccine candidate, CVnCoV

The Pharma Data

“In addition, the variant-rich environment underlines the importance of developing next-generation vaccines as new virus variants continue to emerge.” CureVac remains committed to COVID-19 vaccine development. CureVac N.V.

Sanofi and Translate Bio initiate Phase 1/2 clinical trial of mRNA COVID-19 vaccine candidate

The Pharma Data

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. MRT5500 is being developed under a collaboration and license agreement between Sanofi Pasteur and Translate Bio. Clinical Trails

The next generation of immunotherapy? Innate Pharma targets NK cells

Pharma Phorum

Clinical-stage oncology biotech Innate Pharma is on a mission to harness the power of natural killer cells to fight cancer. Founded in 1999, Marseille-based company Innate Pharma is on a mission to develop immunotherapies that take advantage of the body’s innate immune system.

NexImmune Strengthens Scientific Leadership by Appointing Jerome Zeldis as EVP R&D and Jeffrey Weber as Chief Scientific Advisor

The Pharma Data

Weber is a renowned melanoma specialist and leading immunotherapy translational and clinical scientist. 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.

EMA Validates Bristol Myers Squibb’s Applications for Opdivo (nivolumab) + Yervoy (ipilimumab) and Opdivo + Chemotherapy as First-Line Treatments for Unresectable Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

The Pharma Data

development lead, gastrointestinal cancers, Bristol Myers Squibb. 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.

Immunophotonics Announces First Patient Treated in Clinical Study Evaluating IP-001 in Patients with Advanced Solid Tumors

The Pharma Data

announces the first patient treated in the phase 1b/2a clinical trial examining IP-001 in thermally ablated solid tumors. The trial, conducted in collaboration with the Swiss Group for Clinical Cancer Research (SAKK), will assess the safety, tolerability and anti-tumor activity of IP-001 administered intratumorally following tumor ablation. The initiation of this clinical trial marks a significant milestone for Immunophotonics. LOUIS and BERN, Switzerland, Nov.

US Merck axes two COVID-19 vaccines, focuses on therapies instead

Pharma Phorum

Merck & Co is to axe development of two COVID-19 vaccine candidates, focusing on development of two therapies instead following disappointing results in early trials.

Race for COVID-19 vaccine hots up as EMA begins review of BioNTech/Pfizer jab

Pharma Phorum

The European Medicines Agency has begun a second “rolling review” of a potential coronavirus vaccine jointly developed by BioNTech and Pfizer, setting up a race with a rival from AstraZeneca and Oxford University.

RNA 56

A Look at This Week’s Biotech IPOs

The Pharma Data

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). The National Institutes of Health (NIH) is planning on taking over manufacturing and clinical development.

KSQ Therapeutics and Takeda Enter Broad Strategic Collaboration to Research, Develop and Commercialize Novel Immuno-Oncology Therapies

The Pharma Data

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.

Novavax COVID-19 Vaccine Granted Fast Track Designation by U.S. FDA

The Pharma Data

Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the U.S. President of Research and Development, Novavax. Clinical TrailsGAITHERSBURG, Md., 09, 2020 (GLOBE NEWSWIRE) — Novavax, Inc.

Minervax raises €47.4m in Series B funding round for GBS shot

Pharma Phorum

million (around $56 million) in a Series B funding round to take its novel group B streptococcus (GBS) vaccine into mid-stage clinical trials. GBS is responsible for nearly half of all life-threatening infections in newborns. Denmark’s MinervaX has raised €47.4

Mounting Prevalence of Neurological Disorders and the Key Companies Bidding to Solve the Riddle

Delveinsight

Age is one of the major contributors to the development of certain Neurological Disorders such as Parkinson’s disease and Alzheimer’s. Similarly, genetics, immune response, and environmental factors also influence the occurrence of Neurological Conditions.

Sanofi snaps up Kadmon and its transplant drug Rezurock

Pharma Phorum

The orally-active drug can be used in patients aged 12 and over after two other systemic therapies have been tried, and is thought to work by downregulating inflammatory immune cells and boosting the levels of T cells that help to regulate the immune system.

Merck takes on Lilly/Nektar in IL-2 with $1.85bn Pandion buy

Pharma Phorum

Pandion ’s lead candidate PT101 has completed a phase 1a clinical trial backing its safety and tolerability, and is due to start a phase 1a/2b study in ulcerative colitis and a phase 2 trial in systemic lupus erythematosus before the end of the year.

Bristol Myers Squibb Provides Update on Phase 2 Study of Deucravacitinib in Patients With Moderate to Severe Ulcerative Colitis

The Pharma Data

While we did not achieve proof of concept in this study, we are committed to advancing our deucravacitinib clinical program in inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, as well as in psoriatic arthritis, lupus and other immune-mediated diseases.

Adicet Announces FDA Clearance of IND Application for First-in-Class Allogeneic CAR Gamma-Delta T Cell TherapyPhase 1 Clinical Study will Evaluate ADI-001 Safety and Efficacy in Patients with B-cell non-Hodgkin’s lymphoma

The Pharma Data

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 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 therapy development activities. MENLO PARK, Calif.

Merck Announces Positive Topline Results from Two Additional Phase 3 Adult Studies Evaluating V114, Merck’s Investigational 15-valent Pneumococcal Conjugate Vaccine

The Pharma Data

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.

AstraZeneca takes COVID-19 vaccine to China with BioKangtai deal for 200M-dose capacity by 2021

The Pharma Data

Early clinical results showed AstraZeneca’s candidate, AZD1222, triggered both antibody and T-cell immune responses. China has several home-grown COVID-19 vaccines in clinical development.

Five Prime eyes financing after positive results with stomach cancer drug

Pharma Phorum

Fuelled by the positive results, Five Prime promptly announced plans for a public offering to fund further clinical development of bemarituzumab and other pipeline programmes.

Clover Biopharmaceuticals Announces Publication of Phase 1 Clinical Trial Data for its Adjuvanted COVID-19 Vaccine Candidates in The Lancet

The Pharma Data

Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial. Dynavax is a commercial stage biopharmaceutical company developing and commercializing novel vaccines.