Sanofi says European Commission approves Aubagio for children and adolescents » 09:5006/1806/18/21
The European Commission…
The European Commission has approved Aubagio for the treatment of pediatric patients 10 to 17 years of age with relapsing-remitting multiple sclerosis, or RRMS, Sanofi announced. "The approval confirms Aubagio as the first oral multiple sclerosis therapy for first-line treatment of children and adolescents with MS in the European Union," the company said.
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Sanofi says Phase 3 data from CADENZA study met primary composite endpoint » 07:0706/1106/11/21
Results from Part A of…
Results from Part A of CADENZA, a pivotal Phase 3 double-blind, placebo-controlled study evaluating the safety and efficacy of sutimlimab in people with cold agglutinin disease, or CAD, without a recent history of blood transfusion within the prior six months, will be presented in an oral session at the European Hematology Association 2021 Congress, Sanofi announced. The data demonstrated treatment with sutimlimab resulted in rapid and sustained inhibition of C1-activated hemolysis in people with CAD, noted within one week of treatment, and clinically significant improvements in hemoglobin and fatigue when compared to placebo during the course of the study. The primary efficacy outcome was the proportion of patients who met all three of the following components: improvement in hemoglobin greater than or equal to 1.5 g/dL from baseline at treatment assessment timepoint, average of Weeks 23, 25, and 26; avoidance of transfusions from Week 5 through Week 26; and avoidance of other CAD-related therapies beyond what was permitted from Week 5 through Week 26. The secondary efficacy measures assessed improvement from baseline in key indicators of the disease process including hemoglobin, bilirubin, lactate dehydrogenase levels, and quality of life as measured by Functional Assessment of Chronic Illness Therapy-Fatigue Score.
Innate Pharma to present latest ANKET preclinical data » 05:3006/1006/10/21
Innate Pharma (IPHA)…
Innate Pharma (IPHA) announced it will present the latest preclinical data from its next- generation, proprietary, multi-specific NK cell engager platform known as ANKET at the Federation of Clinical Immunology Societies, or FOCIS, meeting. Specifically, Innate will share new data from its tetra-specific ANKET molecule, which is the first NK cell engager technology to engage activating receptors, or NKp46 and CD16, a tumor antigen and a cytokine in a single molecule. This latest innovation leverages the advantages of harnessing NK cell effector functions against cancer cells and also provides proliferation and activation signals targeted to NK cells. This data set is built on Innate's existing tri-specific NK cell engager technology, which has demonstrated NK cell activation, cytotoxicity and efficient control of tumor growth in preclinical models. In preclinical studies, tetra-specific ANKET demonstrated in vitro the ability to induce human NK cell proliferation, cytokine production and cytolytic activity against cancer cells expressing the targeted antigen. Tetra-specific ANKET also demonstrated in vivo anti-tumor efficacy in several tumor models, allowing regression of established tumors as well as control of metastasis, associated with increased NK cell infiltration, cytokine and chemokine production at the tumor site. ANKET showed also pharmacodynamic effect, low systemic cytokine release and a manageable safety profile in non-human primates. Innate's lead ANKET asset, IPH6101, has shown anti-tumor activity in pre-clinical models, including encouraging pharmacokinetic, pharmacodynamic and safety data in preliminary non-human primate studies. In January, Sanofi (SNY) made the decision to progress this program into investigational new drug, or IND-enabling studies. As part of the previously announced research collaboration, the companies are also currently working on the second research program.
Translate Bio achieves milestone related to influenza mRNA vaccine program » 07:5206/0706/07/21
Translate Bio (TBIO)…
Translate Bio (TBIO) announced it has achieved a manufacturing milestone under the collaboration with Sanofi Pasteur related to its influenza mRNA vaccine program. Translate Bio will receive a $50 million payment from Sanofi Pasteur (SNY) for the successful manufacture, release, and delivery of clinical drug product to supply Sanofi Pasteur's Phase 1 influenza clinical trial which is anticipated to begin in the coming weeks. The Phase 1 clinical trial will evaluate a monovalent influenza vaccine candidate and will inform the next steps of the mRNA-based influenza vaccine program.
Sanofi partners with BIG, EORTC and AFT to initiate SERD trial » 05:4006/0406/04/21
Sanofi is partnering with…
Sanofi is partnering with the Breast International Group, or BIG, the European Organization for Research and Treatment of Cancer, or EORTC, and the Alliance Foundation Trials, or AFT, to initiate a pivotal trial of an oral selective estrogen receptor degrader, or SERD, in the adjuvant setting. The Phase 3 AMEERA-6 study will evaluate the efficacy and safety of Sanofi's amcenestrant vs tamoxifen for women with estrogen receptor-positive, or ER+, breast cancer who were unable to continue their adjuvant aromatase inhibitor, or AI, therapy. As per the terms of the pre-study agreement, Sanofi will be the sponsor and will provide funding and investigational drug product for the global study. BIG will conduct the study within the BIG network, EORTC will oversee study management and data analysis, as well as the medical management, and AFT will conduct the United States portion of the study. Sanofi will conduct this global study in selected countries outside the geographical scope of the academic networks, as further described in a follow-on agreement under negotiation among the four parties. The protocol is being developed in collaboration with all four parties, including AFT, BIG, EORTC and Sanofi.
Sanofi launches EUR3M Planet Mobilization fund » 08:1006/0306/03/21
As part of a…
As part of a long-standing commitment to reduce the environmental footprint of the company's products and activities, Sanofi launched a EUR 3 million Planet Mobilization fund to support employee ideas and projects that will further contribute to a healthier environment. This year, three Sanofi teams will have their projects funded. For several years, Sanofi has been implementing a global environmental roadmap, Planet Mobilization, which is embedded in Sanofi's long-term strategy. The program covers all Sanofi activities and sites and the entire lifecycle of products, from raw materials used in production all the way to their disposal.
Sanofi, Merck announce U.S. availabity of pediatric combination vaccine » 06:4806/0106/01/21
Vaxelis developed as part…
Vaxelis developed as part of a partnership between Sanofi Pasteur (SNY) and Merck (MRK) is now available in the U.S. Vaxelis is a hexavalent (combination vaccine available in the U.S. Vaxelis is a vaccine given to protect your child from getting diphtheria, tetanus, pertussis, polio, Hib, and hepatitis B. Vaxelis is given to children from 6 weeks through 4 years of age and is given as 3 shots, one at 2 months, one at 4 months and one at 6 months of age. On February 11, 2021, the U.S. Centers for Disease Control and Prevention's Advisory Committee included Vaxelis as a combination vaccine option in the CDC's recommended Child and Adolescent Immunization Schedule. Vaxelis will be widely available in the U.S. through traditional public and private channels, including directly from Sanofi Pasteur via vaccineshoppe.com.
Merck and Sanofi's Vaxelis pediatric vaccine is now available in the U.S. » 06:4806/0106/01/21
Vaxelis, a Diphtheria and…
Vaxelis, a Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine, developed as part of a partnership between Sanofi Pasteur, the global vaccines business unit of Sanofi (SNY), and Merck (MRK), known as MSD outside the U.S. and Canada, is now available in the U.S. Vaxelis is the first and only hexavalent combination vaccine available in the U.S. Vaxelis is a vaccine given to protect children from getting diphtheria, tetanus, pertussis, polio, Hib, and hepatitis B.
Sanofi, GSK initiate Phase 3 clinical efficacy study of COVID vaccine candidate » 06:4505/2705/27/21
Sanofi (SNY) and…
Sanofi (SNY) and GlaxoSmithKline (GSK) started enrolment in their Phase 3 clinical study to assess the safety, efficacy and immunogenicity of their adjuvanted recombinant-protein COVID-19 vaccine candidate. The global randomized, double-blind, placebo-controlled Phase 3 study will include more than 35,000 volunteers aged 18 and older from several countries, including sites in the US, Asia, Africa and Latin America. The primary endpoint of the study is the prevention of symptomatic COVID-19 in SARS-CoV-2 naive adults, with secondary endpoints being the prevention of severe COVID-19 disease and prevention of asymptomatic infection. In a two-stage approach, the study will initially investigate the efficacy of a vaccine formulation targeting the original D.614 virus, while a second stage will evaluate a second formulation targeting the B.1.351, or South African, variant. The design of the Phase 3 study, conducted across a broad diversity of geographies, also allows evaluation of the efficacy of the candidate against a variety of circulating variants. "We are encouraged to see first vaccinations starting to take place in such an important, pivotal Phase 3 study, as we believe that our unique technology platform will provide a clinically-relevant vaccine option. We have adapted our vaccine development strategy based on forward-looking considerations as the virus continues to evolve, as well as anticipating what may be needed in a post-pandemic setting," said Thomas Triomphe, Executive Vice President, Global Head of Sanofi Pasteur.
Olema selloff brings 'compelling' entry point, says JPMorgan » 07:0805/2505/25/21
Olema Oncology (OLMA)…
Olema Oncology (OLMA) shares are down 48% year-to-date due to the broader biotech market volatility as well as competitive concerns in the complete estrogen receptor antagonist/selective ER degrader class following Sanofi's (SNY) AMEERA-3 study readout, JPMorgan analyst Anupam Rama tells investors in a research note. The analyst believes AMEERA-3 concerns are overblown and that the properties of OP-1250 are differentiated. Current share levels provide a "compelling entry point" for Olema shares heading into initial Phase 1 OP-1250 results in the second half of 2021, contends Rama.