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Wednesday, December 9, 2020

Evelo Biosciences identifies new lead oncology candidate

 

  • In addition to positive topline data from early-stage atopic dermatitis study with EDP1815 announced earlier today, Evelo Biosciences (EVLO +12.2%) has announced that it is prioritizing EDP1908 as its lead clinical candidate in oncology given its superior preclinical activity over EDP1503.
  • The Company said it will halt recruitment in Phase 1/2 trial of EDP1503 and will wind down the study. Additionally, interim data from Phase 1/2 trial evaluating EDP1503+pembrolizumab combination, in triple-negative breast cancer, showed that the combination was well-tolerated, with an overall response rate of 17% and a disease control rate of 25% in the 12 patients who received the higher dose. Data were presented at the San Antonio Breast Cancer Symposium.
  • Plans to advance EDP1908 into the clinic in 1H of 2022.
  • https://seekingalpha.com/news/3642989-evelo-biosciences-identifies-new-lead-oncology-candidate

Pfizer, BioNTech COVID vaccine snatches another win in Canada

 

  • Canada has become the latest country to approve the COVID-19 vaccine co-developed by Pfizer (PFE) and BioNTech (BNTX). Already approved in the U.K. and Bahrain, the vaccine, code-named BNT162b2, is undergoing the FDA review this week ahead of a potential emergency use authorization in the U.S.
  • “Health Canada and the Public Health Agency of Canada will closely monitor the safety of the vaccine once it is on the market and will not hesitate to take action if any safety concerns are identified,” Health Canada said in a statement.
  • The recommendation for use in people 16 years of age or older, could change as “Pfizer-BioNTech are running further clinical trials on children of all age groups”, it further added.
  • Pfizer and BioNTech are on track to supply 20 million doses to Canada through 2021, including 249,000 doses scheduled to deliver this month.
  • Yesterday, Britain kicked off its COVID-19 vaccination campaign giving the Pfizer/BioNTech jab to a 90-year old retired shop clerk.
  • https://seekingalpha.com/news/3643002-pfizer-biontech-covid-vaccine-snatches-another-win-in-canada

Biotech SPAC Frazier Lifesciences Acquisition prices upsized $120M IPO

 

  • Frazier Healthcare Partners’ CPAC, Frazier Lifesciences Acquisition Corporation (FLACU) has priced its initial public offering of 12M units (from 10M units) at $10/unit, for gross proceeds of $120M.
  • Each unit consists of one Class A ordinary share and one-third of one redeemable warrant to purchase one Class A ordinary share at $11.50.
  • Trading commenced today on the Nasdaq.
  • Offering is expected to close on December 11.
  • Underwriters' over-allotment is an additional 1.8M units.
  • Frazier Lifesciences Acquisition Corporation intends to focus on the biotechnology sector in developed countries including, but not limited to, the United States and countries in Europe.
  • https://seekingalpha.com/news/3643003-biotech-spac-frazier-lifesciences-acquisition-prices-upsized-120m-ipo

Moderna downgraded to 'Hold' at Needham, looks ‘fully-valued’

 

  • Moderna (NASDAQ:MRNA), a potential winner in the COVID-19 vaccine race, receives a downgrade from Needham from ‘Buy’ to ‘Hold’ rating.
  • The company’s COVID-19 jab, MRNA-1273, undergoing review across the world for regulatory approval, is scheduled to face the FDA Advisory Committee meeting next week, potentially leading to an Emergency Use Authorization.
  • The analyst Alan Carr notes, with the development of the vaccine, "Moderna has made significant progress in 2020 towards validation of its mRNA platform” arguing, the stock, after a +770% YTD gain compared to the +18% rise in the S&P 500 Index, appears ‘fully valued’.
  • Despite a potential upside from the EUA, Carr believes, the approval will not ‘justify a meaningfully higher price target’, until data emerge on ‘competitor vaccine updates and additional data from other Moderna programs’.
  • Despite trading -4.27% lower today, the stock has gained more than a fifth in value over the past five days.
  • https://seekingalpha.com/news/3642978-moderna-stock-downgraded-to-hold-needham-looks-fully-valued

Editas Medicine Rising for Third Consecutive Day

 Shares of Editas Medicine (NASDAQ:EDIT) were up 13.9% as of 10:47 a.m. EST on Wednesday. This marked the third consecutive day of double-digit gains for the stock after Editas announced new data over the weekend for its experimental gene-editing therapy EDIT-301 at the American Society of Hematology (ASH) annual meeting.


There are probably two factors at play with Editas' big jump over the last three days. Obviously, investors remain bullish about the prospects for EDIT-301. Editas reported high levels of gene editing in red blood cells of patients with sickle cell disease. This editing resulted in what the company called "remarkable correction" of sickle cell disease in cells.

The second factor is that Editas has underperformed the other leading CRISPR gene-editing stock so far this year. CRISPR Therapeutics(NASDAQ:CRSP) shares have skyrocketed close to 150% year to date while Editas' shares are now up more than 60%. Like Editas, CRISPR Therapeutics has a gene-editing candidate targeting sickle cell disease and related rare genetic blood disorder beta-thalassemia. 

CRISPR Therapeutics' program is farther along than EDIT-301 is and has had positive results so far from an early stage clinical study. That's the main reason its shares have risen more than Editas. However, my hunch is that the latter's latest announcement has caused many investors to recognize the potential that Editas has. And that's helped the biotech stock start to catch up with its rival's stock performance.

It's important to remember, though, that EDIT-301 is still only at the preclinical stage. Editas does have another program, EDIT-101, that's being evaluated in an early stage clinical study targeting rare genetic eye disease Leber congenital amaurosis type 10 (LCA10). 

The next potential catalyst for Editas could be right around the corner. The company expects to file for approval with the Federal Drug Administration (FDA) by the end of 2020 to begin a phase 1/2 study of EDIT-301 in treating sickle cell disease.

https://www.fool.com/investing/2020/12/09/why-editas-medicine-stock-is-rising-for-a-third-co/

Rocket Pharma at 5-Year High On Promising Gene Therapy

 Rocket Pharmaceuticals (RCKT) announced positive Phase 1 test results for a gene therapy in heart disease — prompting RCKT stock to surge early Wednesday.

The gene therapy aims to treat Danon Disease, a genetic disorder that leads to severe and frequently fatal cardiomyopathy. Cardiomyopathy is when the heart muscle must work incredibly hard to pump blood to the rest of the body.

Early testing shows the gene therapy was well tolerated and reduced several key biomarkers of the disease, Rocket said in a news release.

"Based on these early results, we believe that a low dose of (the drug called) RP-A501 has the potential to confer meaningful therapeutic benefit with an overall manageable safety profile," Chief Executive Gaurav Shah said in a written statement.

In early trading on the stock market today, RCKT stock flew 81.7% higher, near 58.20. That put RCKT stock at its highest point since mid-2015. Shares are also well above their 50-day and 200-day moving averages, according to MarketSmith.com.

Danon Disease is caused by deficient levels of a protein called LAMP2B. Rocket tested a low dose of its drug in three patients, and then a high dose in two patients. Two patients who received a low dose of the gene therapy a year ago showed LAMP2B levels more than 50% above normal levels.

All three low-dose patients showed improvements in a marker of heart failure and improvement in a hallmark of Danon Disease. Two showed improvements on a marker used to diagnose heart attacks. Further, those two had improved cardiac output.

"These early results suggest a path to a potentially transformative option for Danon Disease, and possibly the first viable gene therapy approach for cardiac diseases," CEO Shah said.

Gene Therapy Safe In Low-Dose Group

The gene therapy also proved to be safe in three patients who received low dose. There were no unexpected side effects related to the gene therapy. All three low-dose patients experienced elevated enzymes. The elevated enzymes responded to corticosteroids and other immunosuppressive drugs. Patients' enzyme levels normalized one to two months after treatment.

One patient who received the highest dose experienced abnormally low levels of platelets and acute kidney injury. The patient returned to normal within three weeks. But Rocket said the event was related to the gene therapy.

Also, on Wednesday, Rocket announced an offering of RCKT stock. The biotech company is selling $175 million shares of its common stock. Underwriters will have a 30-day option to buy up to an additional 15% of the shares of RCKT stock sold in the offering.

Rocket said it will use the proceeds to fund development of its gene therapies.

https://www.investors.com/news/technology/rckt-stock-surges-promising-gene-therapy

Xenetic Biosciences soars after partner's upbeat trial news

 Shares of Xenetic Biosciences Inc. XBIO, +356.49% skyrocketed on massive volume toward a 17-month high in morning trading Wednesday, after the Massachusetts-based biopharmaceutical company said its partner PJSC Pharmsynthez provided "positive" data from a Phase 3 trial of its treatment for anemia patients with kidney disease. The stock blasted 349.4% higher on volume of 140.3 million shares, which was enough to make it the most actively traded on major U.S. exchanges, and compared with the full-day average of about 327,366 shares. PJSC's Phase 3 study leverage's Xenetic's PolyXen platform technology designed for protein or peptide therapeutics, and enables biological drugs by prolonging their circulating half-life and potentially improving other pharmacological properties. "The PolyXen platform continues to demonstrate broad utility and ability to modulate the pharmacokinetic and pharmacodynamic profiles of protein drugs," said Xenetic Chief Executive Jeffrey Eisenberg. "We are pleased with the positive results Pharmsynthez has reported and we look forward to the outcome of their registration filing in Russia for Epolong, which they expect to submit in 2021." Xenetic's stock, which was on track to close at the highest level since July 2019, has now more than tripled (up 237.0%) year to date, while the iShares Nasdaq Biotechnology ETF IBB, -0.40% has rallied 24.5% and the S&P 500 SPX, -0.19% has gained 14.4%.

https://www.marketwatch.com/story/xenetic-biosciences-stock-more-than-quadruples-on-massive-volume-after-partners-upbeat-trial-news-2020-12-09