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Tuesday, June 30, 2020

Hoth Agrees with Va. Commonwealth U on Potential Covid Treatment Research

Hoth Therapeutics, Inc. (NASDAQ: HOTH), a biopharmaceutical company, today announced entering into a sponsored research agreement with Virginia Commonwealth University (VCU) for a potential COVID-19 treatment.

Research will operate under the direction of Dr. Michael Peters to develop and optimize peptide biomimetics in order to achieve high binding rates of peptide to the RBD of SARS-Cov-2 spike protein at the nanomolar level with demonstrated negligible toxicity through combined computational and experimental efforts. Specifically, point mutations will be conducted in-silico in order to seek to improve the stability and binding properties of these decoy peptides. These optimized, in-silico peptides will be synthesized and experimentally characterized through structure determination, binding to the spike protein, and finally cell challenge assays with SARS-Cov-2.  Hoth Therapeutics has exclusive license to this novel peptide COVID-19 therapeutic.

Sun BioPharma’s SBP-101 Fast Track’d for type of pancreatic cancer

The FDA designates Sun BioPharma’s (OTCQB:SNBP) lead candidate SBP-101 for Fast Track review for the treatment of patients with pancreatic ductal adenocarcinoma, the most common type of pancreatic cancer.
Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application.
SBP-101 is currently being evaluated in a Phase 1a/1b clinical trial in these patients.

Cellular Biomedicine to update on pipeline July 13

Cellular Biomedicine (NASDAQ:CBMG) will host an online investor event  on Monday, July 13, at 8:00 AM ET to update investors on its clinical and preclinical programs.

T2 Bio.systems launches COVID-19 molecular diagnostic test in U.S

T2 Biosystems has completed the validation of its T2SARS-CoV-2 Panel, its molecular test for COVID-19. Commercial launch is underway under emergency use authorization
The T2SARS-CoV-2 Panel runs on the Company’s T2Dx Instrument, an automated, random access system capable of performing seven tests simultaneously. Provides sample-to-answer results in less than two hours, utilizing a nasopharyngeal swab sample.
Additionally, the company announced interim Q2 earnings and estimates revenue in the range of $2.4M – $2.6M, compared to $1.8M in the prior year period.
At the end of the period, expects cash and cash equivalents of ~$36.5M.
(NASDAQ:TTOO) shares is up 33.9% to $1.70 in AH

Nasdaq’s $1.2 trillion biotech index draws Europe’s COVID drug hunters

Spain’s Pharma Mar is looking at listing on New York’s Nasdaq market, joining a flurry of biotech companies aiming to tap investors’ voracious appetite for the sector as it tests one of its therapies to treat COVID-19.
The move comes several weeks after the company started mid-stage human trials of cancer drug Aplidin in COVID-19 patients.
The preliminary tests were “super encouraging”, although the sample is still too small to be statistically significant, Chairman Jose Maria Fernandez Sousa-Faro told Reuters.
Pharma Mar’s Madrid shares have almost tripled to 7.51 euros ($8.41) since mid March, taking its market valuation to 1.67 billion euros ($1.87 billion).
The pharma industry’s search for a treatment for COVID-19 has sparked a parallel hunt among investors for the companies most likely to succeed.
That has seen the Nasdaq’s biotech index soar about 25% in the second quarter, its best quarterly performance in nearly 20 years, to reach a total value of $1.2 trillion.
It has also opened the door to initial public offerings (IPOs), in marked contrast to the broader financial market where the pandemic has sapped interest in new issues.
Global IPO volumes – at $53.7 billion in the first six months of the year – are at their lowest level since 2016, while European IPO volumes are at eight year lows, according to Refinitiv data.
“There’s a number of midsized biotech firms in the UK and elsewhere in Europe that are in preliminary talks with investors in New York about a potential listing there,” said one banker involved in the discussions.
“There is a sophisticated pharma investor base on Nasdaq that goes beyond anything we have here in Europe at the moment, and the sector is red hot.”
Shares in Nasdaq-listed U.S. firms Moderna, Novavax and Inovio Pharmaceuticals, which are testing potential vaccines against COVID-19, have soared this year.
Other European drugmakers including Sanofi also have Nasdaq listings, and German drugmaker CureVac is planning a U.S. IPO next month as it starts trials of its experimental COVID-19 vaccine.
Earlier this month, Royalty Pharma launched the second-largest pharmaceutical listing ever.
BETTER UNDERSTANDING
A U.S. presence would give Pharma Mar better access to investors who understand biotech cycles and value research and development more than in Spain, where investors put greater focus on profits, Fernandez said.
Rather than listing directly, Pharma Mar is considering buying a rival in the United States, which could then provide a way to join the Nasdaq, he said.
The company could use revenues of as much as $1 billion it stands to make by 2026 from a deal with Jazz Pharmaceuticals for lung cancer treatment Lurbinectedin in the United States, he said.
“We could buy an anti-tumour drugmaker in the U.S. or in Japan or a biotech in the U.S.,” Fernandez said, though he added he hadn’t spoken to any outside advisers yet.
“It’s a very recent idea,” he said.
The potential target could also be an anti-viral drugmaker.
Given its cash position, Pharma Mar doesn’t plan a public offering in New York, though Fernandez doesn’t rule it out if the acquisition target required more money than the company has.


FDA OKs Ultragenyx’s Dojolvi for rare metabolic disorders

The FDA approves Ultragenyx’s (NASDAQ:RARE) Dojolvi (triheptanoin) for the treatment of pediatric and adult patients with molecularly confirmed long-chain fatty acid oxidation disorders (LC-FAOD), a group of rare inherited disorders in which the body is unable to synthesize long-chain fatty acids into energy.
Triheptanoin is a highly purified, synthetic, 7-carbon fatty acid triglyceride specifically designed to provide medium-chain, odd-carbon fatty acids as an energy source and metabolite replacement for people with LC-FAOD.
The company says Dojolvi should be available in 30 days.
Management is currently hosting a conference call to discuss the nod.

Y-mAbs starts rolling U.S. application for omburtamab for type of pediatric cancer

Y-mAbs Therapeutics (NASDAQ:YMAB) launches the rolling submission of its U.S. marketing application seeking approval of omburtamab for the treatment of pediatric patients with CNS/leptomeningeal metastases (cancer has spread to the membranes lining the brain and spinal cord) from neuroblastoma.
Omburtamab is a monoclonal antibody that binds to an immune checkpoint molecule called B7-H3 that is over-expressed in several types of cancer.