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.

US FDA grants approval for Merck’s pneumococcal vaccine for children

Pharmaceutical Technology

It was based on findings from seven double-blind, randomised, clinical trials that evaluated the safety, tolerability and immunogenicity of the vaccine in infants, children and adolescents.

Astellas and Sutro partner to develop immunostimulatory ADCs

Pharmaceutical Technology

Astellas Pharma and Sutro Biopharma have entered a global, strategic partnership and licencing agreement to discover and develop new immunostimulatory antibody-drug conjugates (iADCs). Astellas and Sutro will expedite the development of iADCs for three different biological targets.

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.

Gilead snaps up MiroBio and its checkpoint agonists for $405m

pharmaphorum

MiroBio was formed in 2019 to develop checkpoint agonist antibodies for autoimmune and inflammatory disorders that can be used to apply the “natural brakes” of the immune system. 7 integrin, with three candidates in early-stage clinical development.

Astellas pumps $90m into Sutro immuno-oncology alliance

pharmaphorum

million in possible milestone payments apiece for up to three development programmes based on Sutro’s immunostimulatory antibody-drug conjugate (iADC) technology. Astellas has agreed a $1.36

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.

AZ halts development of Beta variant COVID-19 vaccine

Pharma Phorum

AstraZeneca confirmed today that it has discontinued clinical development of a follow-up to its COVID-19 vaccine Vaxzevria targeted at the Beta variant of the virus, which started development before the emergence of the Delta and Omicron strains.

GSK to acquire clinical-stage biopharmaceutical company Affinivax, Inc.

The Pharma Data

Affinivax), a clinical-stage biopharmaceutical company based in Cambridge, Boston, Massachusetts, for a $2.1 billion in potential development milestones. A 30-plus valent pneumococcal candidate vaccine is also in pre-clinical development.

GSK to acquire clinical-stage biopharmaceutical company Affinivax, Inc.

The Pharma Data

billion in potential development milestones Proposed acquisition provides access to next-generation 24-valent pneumococcal vaccine candidate in phase II development and highly innovative, MAPS TM technology Supports development of a strong portfolio of innovative vaccines and specialty medicines.

Symvivo’s Oral COVID-19 Vaccine Enters Clinical Trials

XTalks

Canadian clinical-stage biotech company Symvivo Corporation has developed an oral COVID-19 vaccine that entered clinical trials this week. The first healthy volunteer was dosed with the vaccine in Australia as part of the bacTRL-Spike COVID-19 Phase I clinical trial. He explained that by taking the vaccine orally “allows for a mucosal response in the intestine that can trigger signals to eliminate viruses in the body.”. COVID-19 Clinical Trials.

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).

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.

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.

Bristol Myers Squibb Provides Update on CheckMate -914 Trial Evaluating Opdivo (nivolumab) Plus Yervoy (ipilimumab) as Adjuvant Treatment of Localized Renal Cell Carcinoma

The Pharma Data

Bristol Myers Squibb thanks the patients and investigators involved in the CheckMate -914 clinical trial. 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. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

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.

Tremelimumab accepted under Priority Review in the US for patients with unresectable liver cancer in combination with Imfinzi

The Pharma Data

STRIDE regimen of a single priming dose of tremelimumab added to Imfinzi is the first dual immune checkpoint blockade regimen to improve overall survival in a Phase III trial in this setting.

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.

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.

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.

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, 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.

CDC’s ACIP Unanimously Votes to Provisionally Recommend Use of Merck’s VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) as an Option for Pneumococcal Vaccination in Infants and Children

The Pharma Data

VAXNEUVANCE is indicated for active immunization for the prevention of invasive disease caused by the Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in individuals 6 weeks of age and older.

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

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.

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.

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.

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

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.

Astellas says Pompe gene therapy clears safety hurdle

Pharma Phorum

With the safety of gene therapies thrown into the spotlight by a series of FDA clinical holds, Astellas has said that an interim readout in a phase 1/2 trial of its Pompe disease candidate AT845 hasn’t found any cause for concern.

Opdivo (nivolumab) with Chemotherapy as Neoadjuvant Treatment for Resectable Non-Small Cell Lung Cancer

The Pharma Data

Application based on CheckMate -816, the only Phase 3 trial to demonstrate improved event-free survival and pathologic complete response with an immunotherapy-based combination in the neoadjuvant setting of NSCLC. vice president, thoracic cancers development lead, Bristol Myers Squibb.