Matinas Topline Results of LYPDISO™ Against Vascepa Positive

 – LYPDISO™ demonstrated a statistically significant 46% relative percent increase in EPA change from baseline over Vascepa® –

– LYPDISO™ demonstrated a 39% relative difference in response over Vascepa in TG reduction –

– Primary endpoint of percent change from baseline to end of treatment in triglycerides in the pharmacodynamic population did not meet statistical significance over Vascepa® –

– Per protocol analysis demonstrated statistical significance and superiority vs. Vascepa® on several key lipid and inflammatory markers –

– Management to host conference call today, Monday, February 1, 2021 at 8:00 a.m. ET –

The conference call can be accessed by dialing 877-407-5976 for participants in the U.S. or Canada and 412-902-0031 for international callers (reference passcode 13715418).

The conference call will also be webcast live on Matinas' website, www.matinasbiopharma.com, under the ‘Investors’ section and will be archived there for 90 days.

https://www.globenewswire.com/news-release/2021/02/01/2167088/0/en/Matinas-BioPharma-Announces-Topline-Results-from-ENHANCE-IT-Study-of-LYPDISO-Against-Vascepa.html

Gilead partners with cancer biotech Gritstone on HIV immunotherapy

 

• Gilead will partner with a small Californian biotech to develop an immunotherapy for HIV, announcing Monday a collaboration-and-option deal with the company, Gritstone Oncology, that could be worth hundreds of millions of dollars.
• Per deal terms, Gilead will pay Gritstone $30 million upfront and invest another $30 million in the smaller company's stock. Gritstone could receive as much as $725 million more, should Gilead exercise an option to take the treatment forward following early clinical tests, and if other, unspecified milestones are met. All or some of that money may never materialize, however, if development doesn't go as planned.
• Gilead and Gritstone envision the immunotherapy working much like a vaccine to teach the immune system which targets to attack and destroy, except they plan for it to be used as treatment rather than for prevention.

Gritstone, as its full name suggests, was started as a cancer drug developer. Since launching a little more than five years ago, the biotech's chief focus has been advancing research into personalized and donor-based cancer immunotherapy.

Lately, though, Gritstone is making headlines for its efforts in infectious disease. Two weeks ago, the company announced plans to develop a coronavirus vaccine together with the U.S. National Institutes of Health and the Bill and Melinda Gates Foundation. Borrowing from its cancer work, Gritstone believes it can design a vaccine capable of eliciting a stronger response from virus-killing T cells than current candidates and will soon start a Phase 1 clinical trial.

Shares in Gritstone more than tripled following the coronavirus vaccine announcement.

Monday's deal with Gilead calls more attention to the infectious disease applications of Gritstone's cancer research.

Some of the preclinical testing underpinning Gritstone's immunotherapies used model proteins derived from simian immunodeficiency virus, the monkey version of HIV. These proteins functioned as stand-ins for the cancer proteins Gritstone aims to teach the body to target with immunotherapy.  

The T cell response in monkeys treated by Gritstone "captured the attention of Gilead's virology team," said Karin Jooss, head of research and development at Gritstone, in a Feb. 1 statement.

Gilead sells more than half a dozen HIV therapies, which combined earn the company billions of dollars each year. But while all are potent drugs, capable of keeping the deadly virus in check, none are curative and must be taken chronically.

Like other companies in HIV research, Gilead has worked to develop longer- and longer-lasting treatments, including an experimental drug called lenacapavir now in late-stage testing. The biotech also has four drugs in earlier stages that are designed to be steps toward the broader goal of an HIV cure.

Gilead and Gritstone have similarly high hopes for the vaccine-based approach they plan to take under Monday's collaboration deal. Gilead will use Gritstone's vaccine-like technology, which combines an adenovirus vector with self-amplifying messenger RNA, to target HIV-specific "antigens," or target proteins, that it's developing. The idea, according to Gilead and Gritstone, is to train the immune system to destroy HIV-infected cells.

The idea of a "T cell vaccine" for HIV is not new, however, and past efforts using different approaches have come up short, too.

Gilead will be responsible for a Phase 1 study of the therapeutic vaccine, after which it has the choice to obtain an exclusive license for further development.

https://www.biopharmadive.com/news/gilead-gritstone-hiv-vaccine-immunotherapy/594258/

Dynavax Gets $99M Funding for Covid Response Adjuvant Manufacturing

  Dynavax Technologies Corporation (Nasdaq: DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, and the Coalition for Epidemic Preparedness Innovations (CEPI) today announced they have entered into an agreement to support the supply of Dynavax's CpG 1018 advanced adjuvant to be used in approved COVID-19 vaccines developed by CEPI grantees.

Under the terms of the agreement, CEPI will provide Dynavax funding of up to $99 million through a forgivable loan for the manufacturing of CpG 1018 with the potential to support hundreds of million doses of COVID-19 vaccine for delivery in 2021 through COVAX. COVAX is the global initiative to ensure rapid and equitable access to COVID-19 vaccines for all countries, regardless of income level. This stockpile of CpG 1018 will be first available for purchase by CEPI grantees for use in approved COVID-19 vaccines. Dynavax will sell the reserved CpG 1018 under separate commercial supply agreements made directly with CEPI grantees within price parameters agreed with CEPI. Upon sale of CpG 1018 manufactured under this agreement, Dynavax will reimburse CEPI for the funded manufacturing cost. If the relevant vaccine programs are unsuccessful and no alternative use is found for the adjuvant, the loan will be forgiven.

https://finance.yahoo.com/news/dynavax-cepi-announce-99-million-120100542.html

Gilead Ups Ownership In Arcus to 19.5%

 Arcus Biosciences, Inc. (NYSE:RCUS), an oncology-focused biopharmaceutical company working to create best-in-class cancer therapies, today announced that Gilead Sciences is increasing its ownership in Arcus to 19.5%, from approximately 13%, by purchasing 5,650,000 additional shares of Arcus’s common stock at a per share purchase price of $39.00.

"Gilead’s additional investment in Arcus demonstrates the strength of our relationship, a recognition of the depth of our pipeline and our shared commitment to bringing innovative, transformative therapies to cancer patients as quickly as possible," said Terry Rosen, Ph.D., Chief Executive Officer of Arcus. "The proceeds from this financing will support and enable the acceleration of our development plans for our four clinical-stage molecules, including AB680, our small molecule CD73 inhibitor, for which we recently presented encouraging data in first-line metastatic pancreatic cancer. We appreciate Gilead’s continued confidence in Arcus and our ability to execute. We look forward to providing a multitude of data readouts across our entire portfolio of clinical molecules, including the ARC-7 study interim analysis for domvanalimab expected in the second quarter, throughout what we expect will be a transformational year for the company."

The Arcus-Gilead partnership, which closed in July 2020, includes an Option, License and Collaboration Agreement, a Common Stock Purchase Agreement, and an Investor Rights Agreement. Collectively, this transaction established a 10-year partnership to co-develop and co-commercialize next-generation cancer immunotherapies, provided for an initial equity investment and upfront payment to Arcus totaling $375 million, and gave Gilead the right, but not the obligation, to make additional equity investments in Arcus by purchasing additional shares of Arcus’s common stock. Arcus and Gilead entered into an amended and restated Common Stock Purchase Agreement to provide for this purchase of 5,650,000 additional shares of Arcus’s common stock. No other agreements or terms were amended. Following this investment, Arcus expects its cash and investments to fund its operations through at least 2023.

https://finance.yahoo.com/news/gilead-sciences-increase-ownership-arcus-130000181.html

Pfizer, BioNTech Preclinical Data from Investigational COVID Vax Program in Nature

  Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that preclinical data in non-human primate and mouse models from Pfizer and BioNTech’s mRNA-based vaccine candidates, BNT162b1 and BNT162b2, for the prevention of COVID-19 were published in the journal Nature. Some of these data were initially made available to the public on September 9, 2020 via the online preprint server, bioRxiv. For additional details, please read the previously issued press release.

The preclinical data found immunization of rhesus macaques with either the BNT162b1 or BNT162b2 vaccine candidate elicited SARS-CoV-2 neutralizing geometric mean titers 8.2 to 18.2 times that of a SARS-CoV-2 convalescent human serum panel. Additionally, the vaccine candidates protected macaques from SARS-CoV-2 challenge, with BNT162b2 protecting the lower respiratory tract from the presence of viral RNA and with no evidence of disease enhancement. In mice, one intramuscular dose of either vaccine candidate elicited a dose-dependent antibody response with high virus-entry inhibition titers and strong TH1 CD4+ and IFNg + CD8+ T-cell responses.

These preclinical results contributed to the decision by Pfizer and BioNTech to commence the pivotal Phase 3 safety and efficacy portion of the clinical study to evaluate potential prevention of COVID-19 disease by BNT162b2.

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564 (b) (1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including Full EUA Prescribing Information available at www.cvdvaccine.com.

AUTHORIZED USE IN THE U.S.:
The Pfizer-BioNTech COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.

IMPORTANT SAFETY INFORMATION FROM U.S. FDA EMERGENCY USE AUTHORIZATION PRESCRIBING INFORMATION:

• Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine.
• Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer-BioNTech COVID-19 Vaccine.
• Monitor Pfizer-BioNTech COVID-19 Vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines (https://www.cdc.gov/vaccines/covid-19/).
• Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine.
• The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.
• In clinical studies, adverse reactions in participants 16 years of age and older included pain at the injection site (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%), injection site swelling (10.5%), injection site redness (9.5%), nausea (1.1%), malaise (0.5%), and lymphadenopathy (0.3%).
• Severe allergic reactions, including anaphylaxis, have been reported following the Pfizer-BioNTech COVID-19 Vaccine during mass vaccination outside of clinical trials. Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine.
• Available data on Pfizer-BioNTech COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.
• Data are not available to assess the effects of Pfizer-BioNTech COVID-19 Vaccine on the breastfed infant or on milk production/excretion.
• There are no data available on the interchangeability of the Pfizer-BioNTech COVID-19 Vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of Pfizer-BioNTech COVID-19 Vaccine should receive a second dose of Pfizer-BioNTech COVID-19 Vaccine to complete the vaccination series.
• Vaccination providers must report Adverse Events in accordance with the Fact Sheet to VAERS at https://vaers.hhs.gov/reportevent.html or by calling 1-800-822-7967. The reports should include the words “Pfizer-BioNTech COVID-19 Vaccine EUA” in the description section of the report.
• Vaccination providers should review the Fact Sheet for Information to Provide to Vaccine Recipients/Caregivers and Mandatory Requirements for Pfizer-BioNTech COVID-19 Vaccine Administration Under Emergency Use Authorization.
• Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including Full EUA Prescribing Information available at www.cvdvaccine-us.com.

https://www.streetinsider.com/Globe+Newswire/Pfizer+and+BioNTech+Publish+Preclinical+Data+from+Investigational+COVID-19+Vaccine+Program+in+Nature/17892787.html

Novartis (NOVN:SW) (NVS) PT Raised to CHF89 at HSBC

https://www.streetinsider.com/Analyst+Comments/Novartis+%28NOVN%3ASW%29+%28NVS%29+PT+Raised+to+CHF89+at+HSBC/17892398.html

Novavax (NVAX) Now A Premier COVID Vaccine Company: Jefferies

 

Jefferies analyst Kelechi Chikere reiterated a Buy rating and $200.00 price target on Novavax (NASDAQ: NVAX).  Thinks FDA EUA possible.

https://www.streetinsider.com/Analyst+Comments/Novavax+%28NVAX%29+Is+Now+A+Premier+COVID+Vaccine+Company%2C+Jefferies+Thinks+FDA+EUA+Possible/17884735.html