Gilead Sciences and Gritstone Announce Collaboration Utilizing Gritstone’s Vaccine Platform Technology for HIV Cure
Gilead Sciences, Inc. (Nasdaq: GILD) and Gritstone Oncology, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company developing next generation cancer and infectious disease immunotherapies, today announced that the companies have entered into a collaboration, option and license agreement to research and develop a vaccine-based immunotherapy as part of Gilead’s efforts to find a curative treatment for human immunodeficiency virus (HIV) infection.
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Gilead and Gritstone will develop an HIV-specific therapeutic vaccine using Gritstone’s proprietary prime-boost vaccine platform, comprised of self-amplifying mRNA (SAM) and adenoviral vectors, with antigens developed by Gilead.
“While HIV treatment has advanced dramatically over the past three decades, people living with HIV still face a lifetime of therapy,” said Diana Brainard, MD, Senior Vice President, Virology Therapeutic Area, Gilead Sciences. “Curing HIV remains the ultimate aspiration for Gilead’s HIV research and development efforts. Gritstone’s vaccine technology has the potential to educate the immune system to specifically recognize and destroy HIV-infected cells by leveraging SAM and adenoviral vectors. This, along with our other partnerships and internal programs, reflects Gilead’s commitment to continuing innovation to discover a cure for HIV and bring about an end to the HIV epidemic.”
“We are excited to be partnering with Gilead, a company that has decades long experience improving care for people living with HIV, to advance a novel immunotherapy using our proprietary platform for the treatment of HIV infection,” said Andrew Allen, MD, PhD, Co-Founder, President and Chief Executive Officer of Gritstone. “It is well-established that CD8+ T cells are critical for the elimination of virally infected cells, and we have built a highly differentiated vaccine platform that has been shown to generate large numbers of antigen-specific T cells, including CD8+ T cells, even in advanced and immunocompromised cancer patients. On the heels of our recent COVID-19 program initiation in partnership with the NIH, this program adds to our growing infectious disease pipeline supported by collaborations with leading biopharma and renowned institutions.”
“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. “Our preclinical work at Gritstone developing our powerful prime-boost vaccine technology utilized simian immunodeficiency virus (SIV) derived antigens as model antigens, which are very similar to HIV-1. The resulting strong, durable and broad anti-SIV CD8+ T cell responses and T cell memory data captured the attention of Gilead’s virology team. We jointly performed further experiments that generated additional compelling data, which was also complemented by our exciting clinical data with neoantigens in cancer patients. We are delighted to now advance our partnership and product candidates for the treatment of patients with HIV infection.”
Terms of the Agreement
Under the terms of the agreement, Gilead will make a $60 million payment at closing, consisting of a $30 million upfront cash payment and a $30 million equity investment at a premium. Gilead will be responsible for conducting a Phase 1 study for the HIV-specific therapeutic vaccine and holds an exclusive option under the collaboration to obtain an exclusive license to develop and commercialize the HIV-specific therapeutic vaccine beyond Phase 1. Gritstone is also eligible to receive up to an additional $725 million if the option is exercised and if certain clinical, regulatory and commercial milestones are achieved, as well as mid single-digit to low double-digit tiered royalties on net sales upon commercialization.
Locust Walk served as transaction advisor to Gritstone
Johnson & Johnson Announces Single-Shot Janssen COVID-19 Vaccine Candidate Met Primary Endpoints in Interim Analysis of its Phase 3 ENSEMBLE TrialINOVIO’s VGX-3100 Demonstrates Positive Phase 2 Efficacy In Treatment of Precancerous Vulvar Dysplasia Caused by HPV-16/18
Johnson & Johnson (NYSE: JNJ) (the Company) today announced topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the investigational single-dose COVID-19 vaccine in development at its Janssen Pharmaceutical Companies met all primary and key secondary endpoints. The topline safety and efficacy data are based on 43,783 participants accruing 468 symptomatic cases of COVID-19.
The Phase 3 ENSEMBLE study is designed to evaluate the efficacy and safety of the Janssen COVID-19 vaccine candidate in protecting moderate to severe COVID-19, with co-primary endpoints of 14 days and 28 days following vaccination. Among all participants from different geographies and including those infected with an emerging viral variant, Janssen’s COVID-19 vaccine candidate was 66% effective overall in preventing moderate to severe COVID-19, 28 days after vaccination. The onset of protection was observed as early as day 14. The level of protection against moderate to severe COVID-19 infection was 72% in the United States, 66% in Latin America and 57% in South Africa, 28 days post-vaccination.
“Johnson & Johnson embarked on the global effort to combat the COVID-19 pandemic a year ago, and has brought the full force of our capabilities, as well as tremendous public-private partnerships, to enable the development of a single-shot vaccine. Our goal all along has been to create a simple, effective solution for the largest number of people possible, and to have maximum impact to help end the pandemic,” said Alex Gorsky, Chairman, Board of Directors and Chief Executive Officer, Johnson & Johnson. “We’re proud to have reached this critical milestone and our commitment to address this global health crisis continues with urgency for everyone, everywhere.”
Prevention of severe disease; protection against COVID-related hospitalization and death
The vaccine candidate was 85 percent effective in preventing severe disease across all regions studied,[i] 28 days after vaccination in all adults 18 years and older. Efficacy against severe disease increased over time with no cases in vaccinated participants reported after day 49.
The Janssen COVID-19 vaccine candidate demonstrated complete protection against COVID-related hospitalization and death, 28 days post-vaccination. There was a clear effect of the vaccine on COVID-19 cases requiring medical intervention (hospitalization, ICU admission, mechanical ventilation, extracorporeal membrane oxygenation (ECMO), with no reported cases among participants who had received the Janssen COVID-19 vaccine, 28 days post-vaccination.
“These topline results with a single-shot COVID-19 vaccine candidate represent a promising moment. The potential to significantly reduce the burden of severe disease, by providing an effective and well-tolerated vaccine with just one immunization, is a critical component of the global public health response,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson. “A one-shot vaccine is considered by the World Health Organization to be the best option in pandemic settings, enhancing access, distribution and compliance. Eighty-five percent efficacy in preventing severe COVID-19 disease and prevention of COVID-19-related medical interventions will potentially protect hundreds of millions of people from serious and fatal outcomes of COVID-19. It also offers the hope of helping ease the huge burden placed on healthcare systems and communities.”
In the study, the definition of severe COVID-19 disease included laboratory-confirmed SARS-CoV-2 and one or more of the following: signs consistent with severe systemic illness, admission to an intensive care unit, respiratory failure, shock, organ failure or death, among other factors. Moderate COVID-19 disease was defined as laboratory-confirmed SARS-CoV-2 and one or more of the following: evidence of pneumonia, deep vein thrombosis, shortness of breath or abnormal blood oxygen saturation above 93%, abnormal respiratory rate (≥20); or two or more systemic symptoms suggestive of COVID-19.
Protection was generally consistent across race, age groups, including adults over 60 years of age (N= 13,610), and across all variants and regions studied, including South Africa where nearly all cases of COVID-19 (95%) were due to infection with a SARS-CoV-2 variant from the B.1.351 lineage[ii].
Multi-continent Study Provides Clinical Data on Multiple Emerging Viral Mutations
The ENSEMBLE study results include efficacy against newly emerging strains of coronavirus, including some highly infectious variants present in the US, Latin America and South Africa. The Phase 3 ENSEMBLE trial is being conducted at the height of the COVID-19 pandemic in eight countries and three regions, at a time when disease spread has accelerated throughout the world resulting in people having increased exposure to the virus.
“These results are a testament to the extraordinary efforts of everyone involved in our COVID-19 vaccine candidate clinical program, and we are extremely grateful to the clinical trial staff and trial participants for their invaluable contributions,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development. “Changing the trajectory of the pandemic will require mass vaccination to create herd immunity, and a single-dose regimen with fast onset of protection and ease of delivery and storage provides a potential solution to reaching as many people as possible. The ability to avoid hospitalizations and deaths would change the game in combating the pandemic.”
Trial participants of the phase 3 ENSEMBLE study continue to be followed for up to two years for assessments of safety and efficacy. Therefore, these data may be updated based on ongoing analysis. The comprehensive available data set will be submitted to a peer-reviewed journal in the coming weeks.
Phase 3 ENSEMBLE Study Safety Data
The analysis included a concurrent review of the available Phase 3 ENSEMBLE study safety data by the Data and Safety Monitoring Board (DSMB), an independent group of experts, that did not report any significant safety concerns relating to the vaccine. A review of adverse events indicated that a single-dose of Janssen’s COVID-19 vaccine candidate was generally well-tolerated.
The safety profile was consistent with other vaccine candidates using Janssen’s AdVac® technology among more than 200,000 people to date. Overall fever rates were 9% and Grade 3 fever 0.2%. Overall serious adverse events (SAEs) reported were higher in participants who received placebo as compared to the active vaccine candidate. No anaphylaxis was observed.
Janssen Vaccine Candidate Access and Distribution
The Company is committed to bringing an affordable COVID-19 vaccine on a not-for-profit basis for emergency pandemic use, pending regulatory authorizations.
In addition, the Janssen vaccine candidate is compatible with standard vaccine distribution channels. If authorized, Janssen’s single-dose vaccine candidate is estimated to remain stable for two years at -20°C (-4°F), at least three months of which can be at temperatures of 2-8°C (36°F–46°F). The Company will ship the vaccine using the same cold chain technologies it uses today to transport other innovative medicines.
The Company intends to file for U.S. Emergency Use Authorization (EUA) in early February and expects to have product available to ship immediately following authorization. It expects to share more information on specifics of deployment as authorizations are secured and contracts are finalized. The Company’s anticipated manufacturing timeline will enable it to meet its 2021 supply commitments, including those signed with governments and global organizations.
Phase 3 ENSEMBLE Study Design
The Phase 3 ENSEMBLE study is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety and efficacy of a single-dose vaccine versus placebo in adults 18 years old and older.
The ENSEMBLE study was designed to evaluate the safety and efficacy of the Janssen vaccine candidate in protecting against both moderate and severe COVID-19 disease, with assessment of efficacy as of day 14 and as of day 28 as co-primary endpoints.
Phase 3 ENSEMBLE Study Demographics
The trial, conducted in eight countries across three continents, includes a diverse and broad population including 34% (N= 14,672) of participants over age 60.
The study enrolled 44% (N=19,302) of participants in the United States, 41% (N=17,905) in Central and South America (Argentina, Brazil, Chile, Colombia, Mexico, Peru) and 15% (N=6,576) in South Africa.
Forty-five percent of participants are female, 55% male.
Among participants globally, 59% are White/Caucasian; 45% are Hispanic and/or Latinx; 19% are Black/African American; 9% are Native American and 3% are Asian. In the United States, 74% are White/Caucasian; 15% are Hispanic and/or Latinx; 13% are Black/African American; 6% are Asian and 1% are Native American.
Forty-one percent of participants in the study had comorbidities associated with an increased risk for progression to severe COVID-19 (overall 41%), obesity (28.5%), type 2 diabetes (7.3%), hypertension (10.3%), HIV (2.8%); also other immunocompromised participants were in the study.
Janssen’s Vaccine Technology
The investigational Janssen COVID-19 vaccine candidate leverages the Company’s AdVac® vaccine platform, which was also used to develop and manufacture Janssen’s European Commission-approved Ebola vaccine regimen and construct its Zika, RSV, and HIV investigational vaccine candidates.
The Janssen AdVac® viral vector technology can induce potent and long-lasting humoral and cellular immune responses, enabling the pursuit of vaccines for disease targets that are currently unpreventable or untreatable.
Johnson & Johnson continues to develop and test its COVID-19 vaccine candidate in accordance with ethical standards and sound scientific principles. The Company is committed to transparency and sharing information related to its ongoing clinical studies – including the ENSEMBLE study protocol.
ENSEMBLE has been funded in whole or in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), under Contract No. HHSO100201700018C, and in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) at the U.S. Department of Health and Human Services (HHS).
Janssen has worked with BARDA since 2015 on innovative solutions for influenza, chemical, biological, radiation and nuclear threats and emerging infectious diseases such as Ebola. In February 2020, Janssen and BARDA began work on the development of a COVID-19 vaccine based on Janssen’s AdVac® technology.
The Janssen Pharmaceutical Companies entered into a collaboration with the Beth Israel Deaconess Medical Center (BIDMC) to support the development of the preventive vaccine candidate for COVID-19.
Janssen’s COVID-19 vaccine program has been designed to be thorough and driven by science. As such, the Company is also investigating immune responses for different doses and dosing regimens as well as studying a two-dose regimen of its COVID-19 vaccine candidate for efficacy in the Phase 3 ENSEMBLE 2 study.
Sanofi to provide support to BioNTech in manufacturing their COVID-19 vaccine to help address public health needs
Sanofi and BioNTech have today entered into an agreement under which Sanofi will support manufacturing and supply of BioNTech’s COVID-19 vaccine which is being co-developed with Pfizer.
Sanofi will provide BioNTech access to its established infrastructure and expertise to produce over 125 million doses of COVID-19 vaccine in Europe. Initial supplies will originate from Sanofi’s production facilities in Frankfurt from summer of 2021.
“We are very conscious that the earlier vaccine doses are available, the more lives can potentially be saved. Today’s announcement is a pivotal step towards our industry’s collective goal of putting all the effort in to curb this pandemic,” said Paul Hudson, Chief Executive Officer, Sanofi. “Although vaccination campaigns have started around the world, the ability to get shots into arms is being limited by lower than expected supplies and delayed approval timelines owing to production shortages. We have made the decision to support BioNTech and Pfizer in manufacturing their COVID-19 vaccine in order to help address global needs, given that we have the technology and facilities to do so. As always, our top priority is to focus our efforts and capabilities on fighting this global pandemic. First and foremost, we will do this by continuing to develop our own COVID-19 vaccines candidates, in parallel with this industrial cooperation.”
Sanofi’s priority is to continue to develop its two COVID-19 vaccine candidates
Phase 1/2 study results of the vaccine candidate showed an immune response comparable to patients who recovered from COVID-19 in adults aged 18 to 49 years, but a low immune response in older adults likely due to an insufficient concentration of the antigen.
The Companies plan to initiate a new Phase 2 study in February 2021 with support from the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), that will evaluate the vaccine candidate with an improved antigen formulation in order to achieve high-level immune response across all age groups. If data are positive, a global Phase 3 study could start in Q2 2021. Positive results from this study would lead to regulatory submissions in the second half of 2021, with potential availability of doses in the fourth quarter of 2021.
Preclinical data showed that two immunizations of the mRNA vaccine induced high neutralizing antibody levels that are comparable to the upper range of those observed in infected humans. Sanofi expects the Phase 1/2 study to start in Q1 2021.
SPUTNIK V VACCINE AUTHORIZED IN ARMENIA
The Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund) announces that the Sputnik V vaccine has been approved by the Ministry of Health of the Republic of Armenia.
The vaccine was approved by a Decree of the Ministry of Health based on data of Phase III clinical trials in Russia without conducting additional trials in Armenia.
To date Sputnik V has been registered in Russia, Belarus, Argentina, Bolivia, Serbia, Algeria, Palestine, Venezuela, Paraguay, Turkmenistan, Hungary, UAE, Iran, Republic of Guinea and Tunisia.
Kirill Dmitriev, CEO of the Russian Direct Investment Fund, said:
“The number of Russia’s partners among the CIS which have authorized the use of Sputnik V, is constantly increasing. Today we announce the approval of Sputnik V by the Ministry of Health of Armenia enabling the country to start vaccination of the population with one of the best vaccines against coronavirus in the world. This vaccine cooperation will protect people’s health and will help to bring the country closer to lifting the restrictions imposed due to coronavirus.”
Sputnik V has a number of key advantages:
· Efficacy of Sputnik V is over 90%, with full protection against severe cases of COVID-19.
· The Sputnik V vaccine is based on a proven and well-studied platform of human adenoviral vectors, which cause the common cold and have been around for thousands of years.
· Sputnik V uses two different vectors for the two shots in a course of vaccination, providing immunity with a longer duration than vaccines using the same delivery mechanism for both shots.
· The safety, efficacy and lack of negative long-term effects of adenoviral vaccines have been proven by more than 250 clinical studies over two decades.
· Over 1.5mn people have already been vaccinated with Sputnik V.
· The developers of the Sputnik V vaccine are working collaboratively with AstraZeneca on a joint clinical trial to improve the efficacy of AstraZeneca vaccine.
· The Sputnik V vaccine has been approved in Russia, Belarus, Serbia, Argentina, Bolivia, Algeria, Palestine, Venezuela, Paraguay, Turkmenistan, Hungary, UAE, Iran, Republic of Guinea and Tunisia; the process to approve the vaccine in the EU has been initiated.
· There are no strong allergies caused by Sputnik V.
· The storage temperature of Sputnik V at +2+8 C means it can be stored in a conventional refrigerator without any need to invest in additional cold-chain infrastructure.
· The price of Sputnik V is less than $10 per shot, making it affordable around the world.