Intellia up 5% on new data from CRSPR/Cas9 programs

Intellia Therapeutics (NTLA +4.7%) perks up, albeit on below-average volume, on the heels of its program updates:

NTLA-5001 in AML: Data show that the company’s approach using CRISPR engineering to develop a homogeneous T cell product produced superior function toward targets in vitro. IND to be submitted to FDA in H1.

NTLA-2001 for transthyretin amyloidosis (ATTR): IND to be filed mid-year.

CRISPR/Cas9-based therapy for hereditary angioedema (HAE): In non-human primates, the knockout of the KLKB1 gene resulted in a 90% reduction in kallikrein activity, a level that should produce a clinically meaningful impact on HAE attack rates. Kallikrein plays a key role in the release of bradykinin, a blood vessel-dilating peptide that causes vascular leakage and angioedema in HAE sufferers. The company expects to nominate a candidate in H1.

Fellow CRISPR players Editas Medicine (EDIT +2.3%) and CRISPR Therapeutics (CRSP +3.7%) are up as well.

https://seekingalpha.com/news/3540102-intellia-up-5-on-new-data-from-crspr-cas9-programs

Arbutus bails on AB-452

Based on findings from preclinical studies, Arbutus Biopharma (NASDAQ:ABUS) has decided not to advance AB-452, its first-generation oral hepatitis B-specific RNA destabilizer, opting instead to continue development of its next-generation candidate.

In October 2018, it announced a delay in the start of a Phase 1 study to allow more time to characterize the compound.

https://seekingalpha.com/news/3540032-arbutus-bails-on-abminus-452-shares-down-15-premarket

Zai Lab application for omadacycline accepted in China

The China National Medical Products Administration has accepted for review Zai Lab’s (ZLAB +1%) marketing application seeking approval to use omadacycline to treat community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections.

The tetracycline antibiotic is sold in the U.S. under the brand name Nuzyra by licensor Paratek Pharmaceuticals (PRTK).

https://seekingalpha.com/news/3540042-zai-lab-application-for-omadacycline-accepted-in-china

FDA accepts Kite application for CAR T for aggressive type of leukemia

The FDA accepts under Priority Review Gilead Sciences (NASDAQ:GILD) unit Kite Pharma’s marketing application for CAR T therapy KTE-X19 for the treatment of adults with relapsed/refractory mantle cell lymphoma, a rare and aggressive type of non-Hodgkin lymphoma (NHL).

The agency’s action date is August 10.

https://seekingalpha.com/news/3540022-fda-accepts-kite-application-for-car-t-for-aggressive-type-of-nhl

Clover Produces 2019-nCoV Subunit Vaccine Candidate

Clover Biopharmaceuticals, a global clinical-stage biotechnology company focused on developing novel and transformative biologic therapies, announced today that it has successfully produced its trimeric Spike-protein (“S-Trimer”) subunit vaccine candidate for 2019-nCoV via a mammalian cell expression system. In addition, Clover scientists have used the newly obtained S-Trimer and successfully detected antigen-specific antibody in sera from multiple fully recovered patients who were previously infected by the virus. Importantly, Clover is the first company in the world to disclose a 2019-nCoV vaccine candidate that can successfully be recognized by antibodies produced by previously-infected patients, supporting that S-Trimer has preserved the native structure of the viral spike (S) protein and thus may elicit a protective-immune response as a vaccine. This work was carried out with the support of leadership teams from Chengdu Hi-Tech Park and Chengdu Clinical Center for Public Health in China.
Similar to other enveloped RNA viruses such as HIV, RSV and Influenza, 2019-nCoV is also an RNA virus that has a trimeric spike (S) protein on its viral envelope. The trimeric S protein of 2019-nCoV is responsible for binding to host cell surface receptor ACE2 and subsequent viral entry. Symptoms in infected patients include fever, coughing and breathing difficulties, and it can be fatal.
Upon knowing the genomic DNA sequence of this newly identified 2019-nCoV last month, Clover scientists immediately started designing the viral S-protein construct and completed its gene synthesis. Utilizing our patented Trimer-Tag^© technology, Clover has produced a S-Trimer subunit vaccine that resembles the native trimeric viral spike via a rapid mammalian cell-culture based expression system. Having one of the largest in-house, commercial-scale cGMP biomanufacturing capabilities in China, Clover could potentially be able to rapidly scale-up and produce large-quantities of a new coronavirus vaccine.
Clover has previously developed recombinant subunit-Trimer vaccines for RSV and Influenza viruses utilizing its Trimer-Tag^© technology and has demonstrated that they are able to evoke protective neutralizing antibody responses in multiple animal models.
https://www.biospace.com/article/releases/clover-successfully-produced-2019-ncov-subunit-vaccine-candidate-and-detected-cross-reacting-antibodies-from-sera-of-multiple-infected-patients/

Inovio OKd on Phase 1/2 Trial for DNA Medicine for Rare Disease

• Respiratory Papillomatosis (RRP) is a rare, potentially fatal orphan disease caused by Human Papillomavirus (HPV) 6 and 11
• Inovio’s DNA medicine pipeline includes 15 clinical programs focused on HPV-associated diseases, cancer, and infectious diseases, including the novel coronavirus (2019-nCoV)

Inovio Pharmaceuticals, Inc. (NASDAQ: INO) today announced the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application to evaluate its DNA medicine INO-3107 in a Phase 1/2 trial for treatment of Recurrent Respiratory Papillomatosis or RRP. RRP is a rare disease caused by the human papillomavirus (HPV) types 6 and 11 infections, a condition that causes noncancerous tumor growths leading to life-threatening airway obstructions, and occasionally can progress to cancer. Currently, the disease is incurable and is mostly treated by surgery, which temporarily restores the airway. The tumor almost always recurs and the surgery must be repeated, often multiple times a year. RRP can severely impact the quality of life for those living with the disease.
The open-label, multicenter Phase 1/2 trial will enroll approximately 63 subjects in the U.S. and will evaluate the efficacy, safety, tolerability, and immunogenicity of INO-3107 in subjects with HPV 6 and/or 11-associated RRP who have required at least two surgical interventions per year for the past three years for the removal of associated papilloma(s). For this study, adult subjects will first undergo surgical removal of their papilloma(s) and then receive four doses of INO-3107, one every three weeks. The primary efficacy endpoint will be a doubling or more in the time between surgical interventions following the first dose of INO-3107 relative to the frequency prior to study therapy. Upon obtaining sufficient safety and potential efficacy data in adults, Inovio plans to expand the trial to include pediatric patients as well as a potential booster regimen.
“Inovio’s investigational DNA medicine INO-3107 is designed to destroy and clear tumors caused by HPV 6 and 11 infections from the body exactly where they are hiding,” said Jeffrey Skolnik, M.D., Inovio’s Vice President of Clinical Development. “We believe this DNA medicine has the potential to provide people living with RRP a long-term, if not life-long, improvement in their disease, especially as an alternative to often successive and debilitating surgeries that may temporarily remove HPV growths from the airways but do not address the underlying recurring virus.”
https://www.biospace.com/article/releases/inovio-receives-authorization-from-the-u-s-fda-to-begin-phase-1-2-clinical-trial-for-ino-3107-a-dna-medicine-to-treat-a-rare-disease-recurrent-respiratory-papillomatosis-rrp-/

Nissan to halt production at Japan factory due to coronavirus

Nissan Motor Co (7201.T) will temporarily halt production at its plant in Kyushu, southwestern Japan, due to the coronavirus, the Japanese automaker said on Monday, as the outbreak starts to strain the global supply chain.
In a statement, Nissan, the first automaker to halt production at a plant in Japan because of the outbreak, said that output would be affected on Friday and Feb. 17, due to supply shortages of parts from China.
The stoppage could impact production of around 3,000 vehicles, the Nikkei newspaper reported said, underlining the extent to which manufacturers in the world’s third-largest economy are reliant on China for supplies.

Nissan’s Kyushu plant produces models including the Serena minivan for the Japanese market and the Rogue SUV crossover, Nissan’s top-selling car in the United States. It has an annual capacity of 530,000 vehicles.
Two production lines at the Kyushu plant would be halted on Feb. 14, the Nikkei said, adding that another line which mainly cars for export, would be stopped on Feb.17.
Nissan said it was preparing to restart production in China at the earliest from Feb. 17 at its plants in Huadu, Guangdong Province and Dalian, Liaoning Province, while restart dates for other plants had yet to be confirmed.

The coronavirus outbreak – declared a global health emergency by the World Health Organization – has disrupted Chinese manufacturing and that is having an effect on plants abroad.
In South Korea, Hyundai Motor (005380.KS), Kia Motors (000270.KS) and Renault subsidiary RSM have all announced closures citing disruption to supply of parts from China.
https://www.reuters.com/article/us-china-health-nissan/nissan-to-halt-production-at-japan-factory-due-to-coronavirus-idUSKBN20419A