Biotech week ahead, Dec. 28

Biotech stocks advanced for a fifth straight week in thin holiday trading. The gains, however, were more modest amid worries concerning the emergence of a new strain of coronavirus in the U.K.

The news flow of the week comprised mixed clinical trial readouts, COVID-19 drug and vaccine announcements, a few M&A announcements and a small-ticket IPO.

Gene therapy stocks uniQure N.V. QURE 0.81% and Voyager Therapeutics, Inc. VYGR 5.45% came under pressure after the Food and Drug Administration placed their respective clinical programs on hold.

Ocugen Inc (NASDAQ: OCGN) was some of the big news of the week, with the strength stemming from an agreement to co-develop a vaccine against SARS-CoV-2.

Here are the key catalysts for the week ahead:

PDUFA Dates

Viatris Inc VTRS 0.62%, which was formed following the merger of the erstwhile generic pharma company Mylan and Pfizer Inc.'s PFE 0.45% Upjohn generic unit, awaits FDA approval for its BLA for MYL-1402O, a proposed biosimilar to Avastin from Roche Holdings AG Basel ADR Common Stock RHHBY 0.14%. This is being developed in partnership with India's Biocon. The PDUFA goal date is Dec. 27 (Sunday).

The FDA is scheduled to rule on Osmotica Pharmaceuticals PLC's OSMT 3.21% NDA for Ontinua (arbaclofen) ER for treating spasticity in patients with multiple sclerosis. The investigational asset had faced an earlier rejection in 2016 due to manufacturing issues at clinical trial sites. Following a resubmission, the FDA has set a PDUFA action date of Dec. 29 (Tuesday).

Proposed Regulatory Filings

Atara Biotherapeutics Inc ATRA 1.25%: Rolling biologic license approval, or BLA, submission of tab-cel for Epstein-Barr virus-positive post-transplant disorder planned to be initiated by end of 2020, with finalization of the submission planned for the third quarter of 2021.

Vertex Pharmaceuticals Incorporated VRTX 0.59%: Submission of a supplemental new drug application for Trikafta is planned for the fourth quarter. Trikafta is a triple combination of elexacaftor, tezacaftor/ivacaftor and ivacaftor, in children, ages 6-11 years, with cystic fibrosis with certain mutations. It was approved for people, aged 12 years and older in late October.

Incyte Corporation INCY 0.64%: A new drug application, or NDA, for ruxolitinib cream in atopic dermatitis is planned for the end of 2020.

Oyster Point Pharma Inc OYST 3.78%: The company is on track to submit an NDA for OC-01 for dry eye disease in the fourth quarter.

Eyenovia Inc EYEN 1.39%: An NDA submission for MicroStat (brand name: Mydcombi) for pharmacologic mydriasis is planned for the end of 2020.

Coherus Biosciences Inc CHRS 1.58%: A BLA for the internally developed Humira biosimilar, CHS-1420, is expected by the end of 2020.

Stealth BioTherapeutics Corp MITO 12.5%: An NDA submission for elamipretidein Barth syndrome is anticipated by year-end.

Cara Therapeutics Inc CARA: An NDA submission for Korsuva injection for the treatment of pruritus in hemodialysis patients, is planned for the fourth quarter.

Clinical Readouts — Pending Q4 Releases

RedHill Biopharma Ltd RDHL 5.19%: Top-line data from the U.S. Phase 2 study of opaganib in 40 severe COVID-19 patients

Dynavax Technologies Corporation DVAX 5.71%: Final immunogenicity data from the Phase 1 study of Heplisav-B in patients on hemodialysis

Immunic Inc IMUX 3.19%: Phase 2 data for IMU-838 in primary sclerosing cholangitis

Altimmune Inc ALT 9.27%: Results from this Phase 1b study NasoShield intranasal anthrax vaccine

Pending 2020 Year-End Releases

Catalyst Pharmaceuticals Inc CPRX: Top-line proof-of-concept data from the Phase 2 study of Firdapse in spinal muscular atrophy type-3

Aprea Therapeutics Inc APRE 0.44%: Top-line data from the Phase 3 study of eprenetapopt with Bristol-Myers Squibb Co's BMY 0.3% azacitidine as frontline therapy in HMA-naïve TP53 mutant myelodysplastic syndromes patients

Bellerophon Therapeutics Inc BLPH 6.51%: Top-line data from the Phase 2 dose escalation study of INOpulse in pulmonary hypertension-sarcoidosis

Merus NV MRUS 1.03%: Clinical update on the Phase 1 trial of MCLA-158 in patients with solid tumors

Ultragenyx Pharmaceutical Inc RARE 2.55%: Data from Cohort 4 of the Phase 1/2 study of investigational gene therapy DTX401 for glycogen storage disease Type Ia (a prophylactic steroid regimen is added to the same dose as used for Cohort 2 and 3)

IPO Quiet Period Expiries

Kinnate Biopharma Inc KNTE 2.15%
Seer, Inc. SEER 4.14%
Sigilon Therapeutics, Inc. SGTX 2.39%
Silverback Therapeutics Inc 

SBTX 4.59%

https://www.benzinga.com/general/biotech/20/12/18929244/the-week-ahead-in-biotech-dec-27-jan-2-data-releases-regulatory-filings-to-move-stocks 

5 Biotech Stocks That Generated 1,000%+ Returns In 2020

 The biopharma sector weathered the COVID-19 pandemic fairly well, with the Shares Nasdaq Biotechnology Etf 

IBB 0.76% outperforming the S&P 500 Index. This defensive sector also benefited from opportunity in the form of SARS-CoV-2, the virus that causes COVID-19.

It, therefore, comes as a no surprise that two of the top five gainers among biotech stocks are vaccine developers.

Here are the biotechs that advanced in excess of 1,000% thus far this year:

Novavax, Inc. NVAX 1.32% (Gain: +2799%)

Much of Novavax's rally is attributable to its coronavirus vaccine program. The company identified its investigational vaccine, codenamed NVX-CoV2373, in early April. It is a stable, prefusion protein made using the company's proprietary nanoparticle technology, with Matrix-M adjuvant added to it.

Ahead of the initiation of the coronavirus vaccine program, the shares received a lift from positive developments concerning its influenza vaccine candidate NanoFlu.

After proceeding seamlessly with its vaccine program, Novavax Is currently facing a setback as it is experiencing a delay in the start of the U.S. leg of the late-stage study of NVX-CoV2373.

With two companies having already received conditional approvals for their vaccine candidates, Novavax is under pressure to expeditiously bring its coronavirus vaccine program to fruition.

Vaxart Inc VXRT 3.42% (+1940%)

This South San Francisco, California-based company was among the earliest to embark on a vaccine program against SARS-CoV-2.

The company announced in late January the initiation of the program based on its proprietary oral vaccine platform, VAAST. The company selected a lead candidate, an oral recombinant vaccine, in late May.

In a bid to expedite its vaccine program, Vaxart appointed Andrei Floroiu, a biopharma industry veteran with experience in vaccine manufacturing, as its CEO in mid-June. The company filed an investigational new drug application for commencing the Phase 1 study in early August, and the application was cleared by the FDA in mid-September. About a month later, the company commenced the Phase 1 study of the investigational vaccine, codenamed VXA-CoV2-1.

"We look for interim follow-up safety updates at one month and two months post-dosing to be positive catalysts in 1Q21," HC Wainwright analyst Vernon Bernardino said in a note.

Cardiff Oncology Inc CRDF 0.21% (+1,563%)

Cardiff's shares had been flatlining since late-2018 up until the middle of 2020.

The company's lead clinical-stage candidate, onvansertib is a third-generation, oral and highly-selective adenosine triphosphate competitive inhibitor of the serine/threonine polo-like-kinase 1, which is over-expressed in multiple cancers including leukemias, lymphomas and solid tumors. It is being evaluated in multiple Phase 2 studies for indications, including metastatic castration-resistant prostate cancer, colorectal cancer and acute myeloid leukemia.

The shares began turning the corner after the company reported a $13.5 million equity investment in mid-June. It got another leg-up in mid-September following a presentation at the ESMO virtual conference, providing data on onvansertib in KRAS-mutant metastatic colorectal cancer. The rally has accelerated since then.

Genprex Inc GNPX 14.88% (+1,297%)

This gene therapy company received a shot in the arm from a mid-February licensing agreement with the University of Pittsburgh for a diabetes gene therapy that may have the potential to cure Type 1 and Type 2 diabetes. The stock, however, gave back much of the gain in about a month.

The company's immunogene therapy Reqorsa is being evaluated for non-small cell lung cancer.

Trillium Therapeutics Inc TRIL 4.16% (+1,068%)

The clinical stage immuno-oncology company has been broadly higher this year, although its shares have pulled back since early December.

The company is developing two pipeline assets: TTI-621 and TTI-622. TTI-621 is currently being evaluated in a phase 1 trial in patients with relapsed/refractory hematologic malignancies, while TTI-622 is being studied in a two-part, phase 1a/1b study in patients with advanced relapsed or refractory lymphoma or multiple myeloma.

https://www.benzinga.com/general/biotech/20/12/18914817/5-biotech-stocks-that-generated-1-000-returns-in-2020

COVID-19 tailwinds will continue for PC industry after vaccines - 2021 forecast

 

• The global PC market is heading toward the end of 2020 in a strong position, coming off a 10-year shipment high in Q3 due to the pandemic's work and learn from home shifts. But the backing trends could continue next year even as vaccines become more widely available.
• 2021 forecast: Earlier this month, research firm IDC forecast that PC demand (notebooks and desktops) will grow 18.2% Y/Y in Q4 and 1.4% in 2021.
• Notebook PC sales are expected to increase 26.4% in Q4 and 3.2% next year, while desktops will decline in both periods.
• "Earlier this year it seemed like this would be a six-month bump to the industry, but as we look at the supply chain pipeline into 2021, it's clear that the surge has more legs. The education backlog remains extensive and many school districts around the world are doing everything they can to secure inventory. At the same time consumers seem to be buying all ranges of notebook PCs from low-end entry level systems to high-end gaming machines. It is important to note that all of this is happening at a time when other device categories like smartphones, PC monitors, TVs, and gaming consoles are also growing. A clear shift in consumer spend has happened," says IDC's Ryan Reith, program VP of Worldwide Mobile Device Trackers.
• IDC notes that longer-term forecasts for PC shipments and average selling prices have increased as the number of PCs per household increases and as consumers keep buying "PCs further up the stack."
• Recent news that backs the forecast: Lenovo (OTCPK:LNVGY), the world's largest PC maker, reported Q2 results last month that featured a 53% Y/Y jump in net profits. The company predicted a 5-10% industry-wide increase for PC total addressable market for next year.
• HP (NYSE:HPQ) then reported an upside Q4 report with a 25% boost in Consumer notebook sales and a strong profit forecast. Dell's (NYSE:DELL) Q3 print included record Client Solutions revenue and an upside operating margin as sales of higher-end devices offset the strong mix of low-margin Chromebooks.
• https://seekingalpha.com/news/3647426-covidminus-19-tailwinds-will-continue-for-pc-industry-after-vaccines-2021-forecast

Possible Prophylactic for SARS-CoV-2 with Melatonin, Vitamin C and Zinc in Animals

 Sabiha Fatima 1, Syed Shams Zaidi 2, Ashwag Saleh Alsharidah 3, Feda S Aljaser 4, Naheed Banu 5

 
• DOI: 10.3389/fvets.2020.585789

• Abstract

  SARS-CoV-2, an epidemic, causes severe stress in both human and animals and may induce oxidative stress (OS) and increases susceptibility to infection. Domestic animals are found infected by their COVID-2 suffering owners. Chronic immobilization stress (CIS), a model of psychological and physical stress of confinement, can trigger depression and anxiety in animals. We evaluated the ameliorative effect of the proposed SARS-CoV-2 prophylactic drugs melatonin, vitamin C, and zinc on CIS-induced OS, inflammation, and DNA damage in rats. Forty male Swiss albino rats (200-250 g, 7-9 weeks old) were divided into five groups as controls, CIS, treated with melatonin (20 mg/kg), and vitamin C plus zinc [VitC+Zn (250 + 2.5 mg/kg)] alone or in combination (melatonin+VitC+zinc) subjected to CIS for 3 weeks. CIS was induced by immobilizing the whole body of the rats in wire mesh cages of their size with free movement of head. Exposure to CIS significantly compromised the circulatory activities of superoxide dismutase, catalase, and glutathione with enhanced malondialdehyde, inflammatory markers (IL-6, IL10, and TNFα), and lymphocyte DNA damage in comparison to controls. Treatment with melatonin and VitC+Zn alone or in combination significantly restored the altered biochemical parameters and DNA damage of stressed rats to their respective control values. However, the cumulative action of melatonin with VitC+Zn was more effective in alleviating the CIS-induced OS, inflammation, and DNA damage. The present study indicates that the antioxidant combination can be an effective preventive measure to combat severe psychological and confinement stress-induced biochemical changes in animals due to abnormal conditions such as SARS-CoV-2.

• https://pubmed.ncbi.nlm.nih.gov/33344529/

UK prepares for decision on AZ/Oxford vaccine as COVID cases soar

 The UK’s COVID-19 vaccination programme could get a speed boost, with the country’s drugs regulator expected to make a decision on a shot from Oxford University/AstraZeneca in the next few days.

If the vaccine becomes available the UK will be able to step up its vaccination programme as large swathes of the country face draconian “Tier 4” restrictions due to the emergence of as more infectious variant.

Latest figures show that there were nearly 40,000 cases recorded yesterday, the highest since mass testing began, although it’s thought infection rates were higher during the first wave of the virus in spring when tests were not readily available.

The Medicines and Healthcare products Regulatory Agency (MHRA) began a fast-track rolling review of the vaccine in November and reports point towards a decision between Christmas and New Year.

The UK has ordered 100 million doses of the vaccine, which is based on an adenovirus vector and is easy to handle than rivals from Pfizer/BioNTech and Moderna.

AZ’s vaccine, dubbed AZD1222, is stored at normal refrigerator temperatures while the Pfizer/BioNTech and Moderna shots need to be kept at around -70C and -20C respectively to maintain the integrity of their RNA structure.

According to health secretary Matt Hancock, the full dossier of trial evidence is now with the regulator, which is poised to make a decision in the coming days.

AZ’s vaccine is safe and effective, according to the data publicly available so far, although it seems that giving a half-dose shot first following a second full dose is more effective.

Just how this will be viewed by regulators is unclear, as are the plans to distribute the vaccine.

With two full doses, efficacy is around 62%, according to findings released towards the end of last month based on data from nearly 9,000 patients in the UK and Brazil.

Efficacy rose to around 90% in just over 2,700 patients given the low dose-high dose formulation, which was stumbled on by mistake because of a manufacturing error.

Quite what the MHRA will make of this is not clear, nor is it known whether the regulator has more up-to-date figures than those announced at the end of November.

Professor Sir John Bell, the government’s life sciences tsar and Regius Chair of Medicine at the University of Oxford, told BBC Radio 4’s Today programme yesterday:  “We are getting to be about prime time now.

“I would expect some news pretty shortly, I doubt we will make Christmas now but just after Christmas I would expect.

“And I have no concerns whatsoever, the data looks better than ever.”

https://pharmaphorum.com/news/uk-prepares-for-decision-on-az-oxford-shot-as-covid-cases-soar/

Singapore Airlines Launches COVID-19 'Digital Health Passport' For Passengers

 As the world stumbles into 2021 in a matter of days, life, as we know it, will never be normal again, referring to good ole' days of the pre-pandemic. 

For months, readers may have heard us discuss "COVID passports," "immunity passports," or at least speak on the subject of those who don't get tested for COVID-19 or vaccinated will face travel restrictions. 

Well, from conspiracy theory to conspiracy fact, Singapore Airlines this week is the first major carrier to introduce a digital health certificate to verify passengers' testing history and vaccination status. 

On Dec. 23, the new digital health verification process was rolled out for passengers traveling on flights operated by the carrier from Jakarta or Kuala Lumpur to Singapore, according to a Singapore Airlines press release. 

The airline explains passengers will take COVID-19 tests at local clinics in Jakarta and Kuala Lumpur and be issued "digital or paper health certificates with a QR code." These forms of immunity passes will be checked by airport security and Singapore's immigration authority. 

"This is a faster and more secure way to validate a passenger's health credentials than the existing protocols, speeding up both the airport check-in process and the immigration entry process into Singapore. It would make it easier for SIA customers to control their information, reduce friction during their travel journey, and result in a more seamless experience with the aid of digital technologies in the new normal," the airline said. 

JoAnn Tan, Acting Senior Vice President Marketing Planning, Singapore Airlines, said the rollout of immunity passports "will be an integral part of air travel for the foreseeable future." 

In October, passengers flying from London's Heathrow Airport to Newark on a United Airlines flight were part of a pilot program to test passengers for the virus. 

Just weeks ago, Lance Gokongwei, President and CEO of Cebu Pacific, the Philippines' largest budget airline, announced health passports would be "essential" for travel. 

In the April and May timeframe,  the mayor of the French city of Nice and Bill Gates were among the most prominent voices discussing health passports. 

Even after the virus pandemic ends, these health passports will be sticking around could offer evidence that a traveler has been vaccinated - not just for COVID-19, but any other disease. 

This is just another example of elites tightening their control and surveillance on the masses. 

https://www.zerohedge.com/geopolitical/singapore-airlines-launches-covid-19-digital-health-passport-passengers