- The news that Pfizer and BioNTech's COVID-19 vaccine is 90% effective, on a preliminary basis is apparently prompting investors in personal protective equipment (PPE) makers/sellers to head for the exits.
- Selected tickers: Lakeland Industries (LAKE -14.6%), Alpha Pro Tech (APT -18.4%), Edison Nation (EDNT -0.6%)
- https://seekingalpha.com/news/3633713-positive-data-on-pfizer-biontech-covidminus-19-vaccine-pressures-personal-protective-gear
Monday, November 9, 2020
Positive data on Pfizer/BioNTech COVID-19 vax pressures personal protective gear makers
OncoSec drops despite positive data from TAVO + Merck's Keytruda in metastatic melanoma
- OncoSec Medical (NASDAQ:ONCS) announces new positive interim data from its KEYNOTE-695 Phase 2b trial evaluating TAVO (tavokinogene telseplasmid), a DNA plasmid-based interleukin-12 (IL-12), in combination with Merck's (NYSE:MRK) KEYTRUDA (pembrolizumab) in rigorously defined anti-PD1 checkpoint resistant metastatic melanoma patients.
- TAVO + KEYTRUDA led to a 30% ORR in the first 54 out of 100 planned patients (95%CI [18.0%, 43.6%]) (16/54), much higher than the primary efficacy endpoint of 20% ORR determined by blinded independent review.
- Complete response rate was 6% (3/54).
- 9% (5/54) patients had 100% reduction of target lesions.
- ORR was 35% (n=6/17) and 40% (n=6/15) in patients with Stage IV M1c/M1d disease and with prior exposure to ipilimumab, respectively.
- Median duration of response is currently 12.2 months (95% CI, 5.6-NE).
- Median study follow-up was 13.5 months.
- Only 5.4% Grade 3 treatment-related adverse events were observed.
- The data were will be presented at the Society for Immunotherapy of Cancer's (SITC) 35th Anniversary Annual Meeting .
- OncoSec also announced pre-clinical data showing that CORVax12 triggers an immune response against the SARS-CoV-2 virus. CORVax12 combines OncoSec's TAVO with the National Institute of Health (NIH)'s COVID-19 "spike" protein.
- https://seekingalpha.com/news/3633684-oncosec-drops-11-despite-positive-data-from-tavo-mercks-keytruda-in-metastatic-melanoma
Pfizer Makes $60M Equity Investment in Homology Medicines
Pfizer has agreed to purchase 5 million of Homology's common shares at a price of $12 each as part of the Pfizer Breakthrough Growth Initiative, which was announced earlier this year. The purchase by Pfizer is expected to close on or around Tuesday.
In connection with the investment, Dr. Seng Cheng, senior vice president and chief scientific officer of Pfizer's Rare Disease Research Unit, will join Homology's Scientific Advisory Board to participate in matters related to the development of the company's phenylketonuria product candidates: HMI-102 gene therapy candidate for adults with PKU and HMI-103 gene editing candidate for pediatric patients with PKU. Homology has granted Pfizer a right of first refusal on future transactions involving these programs.
Phenylketonuria, or PKU, is an inherited metabolic disorder that can cause intellectual disability and other serious health issues. Currently, there are no treatment options for PKU that target the underlying genetic cause of the disease, Homology said. The company, citing the National PKU Alliance, said the disease affects nearly 16,500 people in the U.S. and 50,000 people worldwide.
Homology said it intends to use the net proceeds of the offering to help fund its PKU clinical trials, as well as its central nervous system programs.
Based on current projections, together with the anticipated proceeds of $60 million from the Pfizer equity investment, Homology expects cash resources to fund operations into the third quarter of 2022.
Novavax experimental coronavirus vaccine gets FDA 'fast-track' status
Novavax Inc said on Monday its experimental coronavirus vaccine had gained the U.S. Food and Drug Administration's "fast-track" status.
The U.S. drug developer, which is testing the drug in a late-stage trial in the UK, said a U.S. and Mexico-based late-stage trial was on track to begin by the end of November, and data from that trial could support U.S. authorization.
The company last month delayed the start of the trial of the vaccine, NVX-CoV2373, by roughly a month due to delays in scaling up the manufacturing process.
The fast-track status makes companies eligible to submit sections of a marketing application on a "rolling" basis as soon as some data becomes available, rather than wait for all the data before submitting the application.
Behind Pfizer's vaccine, an understated husband-and-wife 'dream team'
Positive data on BioNTech and U.S. partner Pfizer Inc's COVID-19 vaccine is an unlikely success for the married couple behind the German biotech firm, who have devoted their lives to harnessing the immune system against cancer.Pfizer said on Monday said its experimental vaccine was more than 90% effective in preventing COVID-19 based on initial data from a large study.
Pfizer and BioNTech are the first drugmakers to show successful data from a large-scale clinical trial of a coronavirus vaccine. The companies said they have so far found no serious safety concerns and expect to seek U.S. emergency use authorization later this month.
From humble roots as the son of a Turkish immigrant working at a Ford factory in Cologne, BioNTech Chief Executive Ugur Sahin, 55, now figures among the 100 richest Germans, together with his wife and fellow board member Oezlem Tuereci, 53, according to weekly Welt am Sonntag.
The market value of Nasdaq-listed BioNTech, which the pair co-founded, had ballooned to $21 billion as of Friday's close from $4.6 billion a year ago, with the firm set to play a major role in mass immunisation against the coronavirus.
"Despite his achievements, he never changed from being incredibly humble and personable," said Matthias Kromayer, board member of venture capital firm MIG AG, whose funds have backed BioNTech since its inception in 2008.
He added Sahin would typically walk into business meetings wearing jeans and carrying his signature bicycle helmet and backpack with him.
Doggedly pursuing his childhood dream of studying medicine and becoming a physician, Sahin worked at teaching hospitals in Cologne and the southwestern city of Homburg, where he met Tuereci during his early academic career.
Medical research and oncology became a shared passion.
Tuereci, the daughter of a Turkish physician who had migrated to Germany, said in a media interview that even on the day of their wedding, both made time for lab work.
Together they honed in on the immune system as a potential ally in the fight against cancer and tried to address the unique genetic makeup of each tumour.
Life as entrepreneurs started in 2001 when they set up Ganymed Pharmaceuticals to develop cancer-fighting antibodies, but Sahin - by then a professor at Mainz university - never gave up academic research and teaching.
They won funding from MIG AG as well as from Thomas and Andreas Struengmann, who sold their generic drugs business Hexal to Novartis in 2005.
That venture was sold to Japan's Astellas in 2016 for up to $1.4 billion. By then, the team behind Ganymed was already busy building BioNTech, founded in 2008, to pursue a much broader range of cancer immunotherapy tools.
That included mRNA, a versatile messenger substance to send genetic instructions into cells.
DREAM TEAM
For MIG's Kromayer, Tuereci and Sahin are a "dream team" in that they reconciled their visions with the constraints of reality.
The BioNTech story took a twist when Sahin in January came across a scientific paper on a new coronavirus outbreak in the Chinese city of Wuhan and it struck him how small the step was from anti-cancer mRNA drugs to mRNA-based viral vaccines.
BioNTech quickly assigned about 500 staff to project "light speed" to work on several possible compounds, winning pharma giant Pfizer and Chinese drugmaker Fosun as partners in March.
Matthias Theobald, a fellow oncology professor at Mainz university who has worked with Sahin for 20 years, said his tendency towards understatement belies a relentless ambition to transform medicine, exemplified by the leap of faith to a COVID-19 vaccine.
"He is a very modest and humble person. Appearances mean little to him. But he wants to create the structures that allow him to realise his visions and that's where is aspirations are far from modest," Theobald said.
Sahin told Reuters on Monday the read-out amounted to an "extraordinary success rate" but that he did not know earlier in the year how difficult the task overall would be.
"It's certainly not something that you would easily voice as a serious scientist, but it was within the realms of possibility from the beginning."
Aptevo Therapeutics rallies as Tang Capital discloses 54% stake
- Aptevo Therapeutics (NASDAQ:APVO) rose 113% premarket, currently trading at $50.52 after Tang Capital Partners reported a 54.4% stake in a new 13D regulatory filing.
- The reporting persons have expended an aggregate of ~$28.1M to purchase 1.76M Aptevo shares through the open market.
- APVO share price has grown exponentially to ~267% over the past five days.
- https://seekingalpha.com/news/3633435-aptevo-therapeutics-rallies-113-tang-capital-discloses-54-stake
AC Immune and Wuxi Biologics boost development of TDP-43 antibodies
- AC Immune (NASDAQ:ACIU) and WuXi Biologics (OTCPK:WXXWY) plan to accelerate advancement of AC Immune’s TDP-43 antibody into clinical development for NeuroOrphan indications.
- This next phase of the strategic partnership between the companies builds on the know-how of ACIU's drug discovery and development platforms and WuXi's expertise in manufacturing innovative biologics.
- A particular focus is developing AC Immune’s clinical antibody candidate to ensure it has high affinity for TDP-43 and is capable of preventing the intercellular spread of toxic species.
- Through the new agreement, the company gains access to WuXi Biologics’ proprietary platforms, including cell line development platform. AC Immune will retain all intellectual property rights to molecules.
- https://seekingalpha.com/news/3633437-ac-immune-and-wuxi-biologics-boost-development-of-tdpminus-43-antibodies
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