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Wednesday, April 8, 2020

Vanda Pharma up 12% after hours on COVID-19 drug development plan

Vanda Pharmaceuticals (NASDAQ:VNDA) will collaborate with the University of Illinois at Chicago to investigate small molecules for the potential treatment of COVID-19.
The partnership will include the use of a high-throughput screening assay to identify candidates that may prevent cathepsin-L cleavage of SARS-CoV-2 glycoproteins that are required for viral processing in the host cell.
The company says it is also exploring drugs that may block the virus from entering the cell at an entry point called the angiotensin converting enzyme 2 receptor and drugs that inhibit the transmembrane protease serine 2 precursor.
The program includes the initiation of a study, ODYSSEY, evaluating tradipitant in hospitalized severely ill patients with COVID-19 pneumonia.
Shares up 12% after hours.
https://seekingalpha.com/news/3559497-vanda-pharma-up-12-after-hours-on-covidminus-19-drug-development-plan

Genfit reports FY results

Genfit (NASDAQ:GNFT): FY GAAP EPS of -€1.76.
Revenue of €40.96M (+446.9% Y/Y)
https://seekingalpha.com/news/3559500-genfit-reports-fy-results

Guidance for Licensed Pharmacists, COVID-19 Testing

On January 31, 2020, the Secretary of Health and Human Services declared that the 2019 novel coronavirus (COVID-19) is a public-health emergency for the United States. The United States Department of Health and Human Services (HHS) is the lead agency for the federal government’s response to the COVID-19 pandemic.
A key component of that response is rapidly expanding COVID-19 testing across America. Within HHS, the Office of the Assistant Secretary for Health leads federal efforts to support that expansion.
Pharmacists, in partnership with other healthcare providers, are well positioned to aid COVID-19 testing expansion. Pharmacists are trusted healthcare professionals with established relationships with their patients. The vast majority of Americans live close to a retail or independent community-based pharmacy. That proximity reduces travel to testing locations, which is an important mitigation measure. Pharmacists also have strong relationships with medical providers and hospitals to appropriately refer patients when necessary.
Therefore, as an Authority Having Jurisdiction under the Secretary’s March 10, 2020 declaration under the Public Readiness and Emergency Preparedness Act (PREP Act), OASH issues this guidance authorizing licensed pharmacists to order and administer COVID-19 tests, including serology tests, including serology tests, that the Food and Drug Administration (FDA) has authorized. See 85 Fed. Reg. 15,198, 15,202 (March 17, 2020); see also Pub. L. No. 109-148, Public Health Service Act § 319F-3, 42 U.S.C. § 247d-6d and 42 U.S.C. § 247d-6e.1 By doing so, such pharmacists will qualify as “covered persons” under the PREP Act. And they may receive immunity under the PREP Act with respect to all claims for loss caused by, arising out of, relating to, or resulting from, the administration or use of FDA-authorized COVID-19 tests. 42 U.S.C. § 247d-6d(a)(1).

Amarin to announce preliminary Q1 results April 13

Amarin (NASDAQ:AMRN) will host a conference call on Monday, April 13, at 4:30 pm ET to provide preliminary Q1 results and to update on its operations, including its planned appeal of the adverse patent related to Vascepa (icosapent ethyl).
Current consensus is a loss/share of ($0.09) on revenue of $129M.
Shares down 1% after hours.
https://seekingalpha.com/news/3559475-amarin-to-announce-preliminary-q1-results-april-13

Biopharma venture investors shrug off Covid-19

First-quarter venture investments barely register the pandemic – huge cash reserves should protect funding for biotech start-ups this year.
Clinical trials are being mothballed across the biopharma industry, and companies are delaying the launch of new products because of Covid-19. But if the $1.46bn that Arch Venture Partners has just raised for two new funds is anything to go by there is still substantial appetite for private financings, even at the very high-risk end of biotech.
The fact that Arch was able to amass such a huge war chest reflects a belief that biopharma will eventually return to some semblance of normality; patients will still require new and innovative drugs. Vantage‘s latest analysis of EvaluatePharma data also reflects venture’s seeming resilience to coronavirus, with the amount invested over the opening months of the year and the volume of deals showing very little retreat over previous quarters.
It should be noted that this analysis includes only companies developing human therapeutics, providing a look at the highest-risk end of biotech venture investing. Subsectors like Medtech and diagnostics are excluded, as is digital health, an industry that has seen a huge inflow of investment thanks to the Covid-19 pandemic.
If the current pace of investment is maintained for the rest of 2020 total funding could come in at around $13.2bn. While this is back down to 2017 levels, it is widely agreed that 2018 was an outlier, and the sums being raised are still very high, historically.
The volume of deals has stayed pretty constant for the past seven quarters, suggesting that a “new normal” is emerging. It also looks like mega-rounds remain very much a feature, as huge syndicates are formed to fund companies as far along development paths as possible.
This has concentrated venture cash into ever fewer hands, and one fallout of the pandemic could be to exacerbate this trend, with VCs perhaps leaning towards safer plays in the coming months.
Annual biopharma venture investments 
  Investment ($bn)  Financing count  Avg per financing ($m)  No. of rounds ≥$50m  No. of rounds ≥$100m 
Q1 2020 3.28 101 33.47 25 11
2019 14.67 417 36.41 116 36
2018 17.89 481 39.06 130 38
2017 13.21 528 27.40 76 19
2016 10.44 493 22.51 52 15
Of course at this point in the year everything is speculative, given that we have yet to see the full fallout from the pandemic. This will continue to affect supply chains for much of biopharma, interrupt the hiring plans of start-ups and almost certainly delay any non-Covid-19 related dealmaking.
Shielding the venture sector in the medium term is the fact that the good times of 2018 and 2019 allowed huge funds to be raised that will have to be deployed within defined timeframes. And, as the Arch fundraising demonstrates, limited partners, who supply the capital for funds, are still keen to allocate cash to this asset class.
But much depends on how long the disruption continues, something that is true for pretty much all sectors.
Biggest biotech venture rounds of Q1 2020
Company  Amount raised ($m) Location  Financing round
Immunocore 130.0 United Kingdom Series B
Nurix 120.0 USA Series D
Kallyope 112.0 USA Series C
SutroVax 110.0 USA Series D
Generation Bio 110.0 USA Series C
Source: EvaluatePharma. 
In an usual turn-up for the books the biggest financing of the quarter was led by a UK company, Immunocore. The troubled biotech has long been looking for money, and managed to secure $130m in a series B round, although the fact that this was a down round took some shine off.
While there were the usual suspects of oncology and gene therapy companies among the five largest rounds, Kallyope with its focus on small-molecule drugs targeting the gut showed that companies in lower-profile therapy areas can rake in substantial amounts of cash.
The timing of Sutrovax’s series D round at the end of March might have been coincidental, given the time it can take to put syndicates together. But alongside the group’s primary focus on pneumococcal infections, its cell-free protein synthesis vaccine platform, which promises to circumvent some of the efficacy and scaling issues of traditional vaccines, might have provided an additional attraction in coronavirus times.
The first quarter did not raise any obvious alarm bells for the financing of smaller companies. But it will be interesting to watch how venture chooses to allocate its money in the coming months.
https://www.evaluate.com/vantage/articles/data-insights/venture-financing/biopharma-venture-investors-shrug-covid-19

What to look for in upcoming Covid-19 trial readouts

Industry-sponsored clinical studies against the new coronavirus have proliferated, as have their designs and efficacy measures.
As attention in the battle to treat Covid-19 turns to the imminent readout of remdesivir studies in China investors will be trying to handicap the chances of Gilead’s own global trials, reading out a little later.
It is also worthwhile remembering other clinical studies that have recently got under way to treat and, in some cases, prevent the new coronavirus. An analysis of data on EvaluatePharma’s dedicated Covid-19 landing page reveals no fewer than 230 trials seeking to enrol nearly 200,000 subjects, but what should be especially interesting is the commercial studies and their endpoints.
This group comprises 20 trials of 17 projects, including of course Gilead’s two remdesivir studies, which could read out in May. A key consideration is whether studies have a blinded control, and in the case of remdesivir this is one of the main points differentiating Gilead from the Chinese trials.
The latter two tests, in 308 mild/moderate and 453 severe Covid-19 subjects, are quadruple-blinded and measure time to clinical recovery versus placebo. Gilead’s, meanwhile, are open-label: the moderate disease trial is versus standard of care while the severe is uncontrolled, and both measure disease improvement over 14 days.
Both sets of trials use a 200mg loading dose followed by 100mg for nine days, though Gilead’s also test five-day cohorts. On the one hand the China trials’ open-ended efficacy endpoint seems less strict than Gilead assuming an effect within 14 days, though of course the former’s blinded design is more stringent.
Another issue confounding comparisons is that the China groups recruited subjects within eight or 12 days of symptom onset, while Gilead specified up to four days from PCR confirmation of Covid-19. Evercore ISI says the former did not source remdesivir from Gilead, and Gilead has stated that it has no visibility on their data.
Commercial projects in clinical trials for Covid-19*
Project Company Study Enrolment Location Design Key efficacy measures
Remdesivir Gilead NCT04292730 600 Global Open-label 14-day hospital discharge vs SOC
Remdesivir Gilead NCT04292899 400 Global Uncontrolled 14-day fever normalisation
Plaquenil Sanofi Hydra 500 US & Mexico Quadruple-blinded All-cause mortality vs placebo
Plaquenil (prophylaxis) Sanofi Phydra 400 US & Mexico Quadruple-blinded 60-day Covid-19 infection vs placebo
Actemra Roche Covacta 330 ? Double-blinded 28-day clinical status vs placebo
Fludase Ansun Biopharma NCT03808922 250 Global Quadruple-blinded 28-return to room air vs placebo
CD24Fc Oncoimmune SAC-COVID 230 US Quadruple-blinded 14-day Covid-19 status vs placebo
ASC09 + Norvir Ascletis NCT04261907 160 China Open-label Time to recovery vs Kaletra
T89 Tasly NCT04285190 120 China Open-label Time to normal oxygen saturation vs placebo
Kevzara Sanofi/ Regeneron NCT04315298 400 US Quadruple-blinded % chg in CRP/time to improvement vs placebo
Kevzara Sanofi/ Regeneron NCT04327388 300 Europe Quadruple-blinded Fever resolution/15-day severity vs placebo
Kaletra Abbvie Solidarity 440 Canada Open-label 29-day Covid-19 infection vs SOC
PUL-042 (prophylaxis) Pulmotect NCT04313023 200 ? Quadruple-blinded 14-day Covid-19 prevention vs placebo
PUL-042 Pulmotect NCT04312997 100 US Quadruple-blinded 14-day Covid-19 severity vs placebo
IFX-1 Inflarx Panamo 130 Europe Open-label 5-day chg in PaO2/FiO2 vs SOC
Gamifant or Anakinra Swedish Orphan Biovitrum NCT04324021 54 Europe Open-label 15-day % off ventilation vs SOC
Piclidenoson Can-Fite NCT04333472 40 Israel Open-label Time to clinical recovery vs SOC
INOmax Mallinckrodt NONTM 20 Canada Uncontrolled FEV1 from baseline/QOL
mRNA-1273 (vaccine) Moderna NCT04283461 45 US Uncontrolled % seroconversion
Ad5-nCoV (vaccine) Cansino Biologics APICTH 108 China Uncontrolled Immunogenicity
*All projects therapeutic except where stated; excludes expanded-access programmes. Source: EvaluatePharma.
Among other projects, investors will also be keenly tracking the malaria/lupus drug Plaquenil, championed by President Donald Trump. Since the few scraps of data supporting this have largely been anecdotal, it is reassuring that Sanofi’s studies, ending late this year, are quadruple-blinded, and one measures the tough endpoint of all-cause mortality versus placebo.
Only two commercial vaccines are in trials at present, from Moderna and Cansino (The long path to an effective coronavirus vaccine, April 3, 2020). However, these will soon be joined by vaccines from Johnson & Johnson and the UK’s University of Oxford, the latter through a consortium that Oxford Biomedica joined today.
Ultimately, investors will want share prices to reflect progress; Gilead’s valuation has put on nearly $12bn year to date, while J&J’s gained $26bn when it revealed its lead Covid-19 vaccine candidate. This is despite J&J spelling out the not-for-profit basis of its work; Gilead too is unlikely to be able to charge much for remdesivir, while Plaquenil is off patent.
That said, the kudos for a company that brings an effective treatment to market, in terms of publicity and government recognition, will have its own value.
Covid-19 study totals
Stage Enrolment Trial count
Early phase 1 1,868 4
Phase 1 2,424 10
Phase 1/2 1,069 9
Phase 2 7,413 38
Phase 2/3 9,374 21
Phase 3 44,905 39
Phase 4 12,164 16
N/A 117,013 93
Total 196,230 230
Source: EvaluatePharma; excludes observational and epidemiology studies, and patient registries.
https://www.evaluate.com/vantage/articles/analysis/what-look-upcoming-covid-19-trial-readouts

Most NYC Covid-19 Cases Came From Europe, Genome Researchers Say

The explosion of Covid-19 cases in the New York City area resulted largely from infected patients who flew in from Europe, genome scientists say.
Researchers at NYU Langone Health said they’ve analyzed 75 samples from patients who were diagnosed with Covid-19, the disease caused by the novel coronavirus, at New York-area hospitals last month.
About two-thirds of the samples appear to have European origins, said Adriana Heguy, director of the Genome Technology Center at the medical center. The virus appears to have been imported to New York from the U.K. and several European countries, including France, Austria and the Netherlands, she said.
Genome sequencers are able to roughly correlate how a virus is spreading around the world by examining small mutations in a gene sequence of the pathogen as it’s transmitted from person to person. In the case of the coronavirus, whose RNA consists of about 30,000 genetic bases, or letters, it mutates about twice a month.
Those minor mutations tend not to change the potency of the virus. But they provide clues for genetic detectives to chart how they shift subtly over time, allowing them to create sprawling family trees, or phylogenies, that show how the coronavirus has spread from one part of the world or country to the next.

U.K. Origin

One of the first cases Heguy’s team sequenced, collected in early March, came from a Long Island resident with no travel history whose viral genome correlated with a strain circulating in England. That suggested the patient had contact with someone who had brought the virus over from the U.K.
The findings suggest that even after the Trump administration imposed travel restrictions from China, the virus continued to infiltrate the most populous U.S. city via daily flights from Europe.
Not all the New York virus samples have European origins. Some appear to have come from the U.S. West Coast, while others appear to link directly to Asia. That indicates that there are numerous chains of transmission in the metro area, as would be expected in such a large outbreak.
The NYU genome center had previously previously had been focused on sequencing for common diseases such as cancer and heart conditions. But in early March it switched to working almost exclusively on Covid-19.
“We basically turned our labs into Covid-19 labs overnight,” said Heguy. “That is all we are doing right now.”
https://www.bloomberg.com/news/articles/2020-04-08/most-nyc-covid-19-cases-came-from-europe-genome-researchers-say