ATHE Gets Funds For Parkinson's Research, No Safety Issues For QURE's Trial, TNXP On Watch

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Today's Daily Dose brings you news about Alterity securing funds for Parkinson's research, the Independent Data Monitoring Committee recommending ERYTECH's pancreatic cancer trial to continue, Ocugen's $23 million registered direct offering, uniQure's Huntington's disease trial, and Tonix Pharma's proposed diagnostic skin test to measure T cell immunity to SARS-CoV-2.

Read on…

1. Alterity Secures Funding From Michael J. Fox Foundation

Alterity Therapeutics (ATHE), formerly known as Prana Biotechnology, has been awarded $495 thousand in funding by The Michael J. Fox Foundation for Parkinson's Research to determine optimal dosing of its lead drug candidate ATH434 for Parkinson's disease (PD) based on imaging of brain iron.

The fund will be used to evaluate the pharmacologic profile of ATH434 in a primate model to determine the optimal dose of the compound in future Parkinson's disease clinical trials. This is the second grant that Alterity has received from The Michael J. Fox Foundation to support the development of ATH434 in PD - the first grant of $200 thousand having been awarded in August 2011.

ATH434 is also being explored in other indications and the compound is expected to advance into phase II clinical trial for Multiple System Atrophy later this year.

ATHE closed Monday's trading at $1.98, up 3.66%.

2. ERYTECH Slumps as IDMC recommends pancreatic cancer trial to Continue

ERYTECH Pharma S.A. (ERYP) slumped nearly 15% on Monday, following interim superiority analysis results from a phase III clinical trial evaluating Eryaspase in second-line pancreatic cancer, dubbed TRYbeCA-1.

The interim superiority analysis could have resulted in the study either concluding early for superiority if compelling improvement of overall survival was demonstrated or continue as planned with final analysis expected to be reported in Q4 2021.

Investors were disappointed that the study was not stopped early, which let to the stock price taking a hit. The Independent Data Monitoring Committee (IDMC) has recommended that the trial continue to final analysis, which is expected the fourth quarter of this year.

The TRYbeCA-1 trial has enrolled 512 patients, slightly above the target enrollment of 482 patients, at approximately 90 clinical sites in Europe and the United States.

ERYP closed Monday's trading at $9.55, down 14.73%.

3. Ocugen Soars on $23Mln Registered Direct Offering

Shares of Ocugen Inc. (OCGN) soared as much as more than 250% on Monday, following a $23 million registered direct offering of its common stock.

The company has agreed to sell an aggregate of 3 million shares of its common stock to healthcare-focused institutional investors at a purchase price of $7.65 each in the registered direct offering. The offering is expected to close on or about February 10, 2021.

The company has a deal in place with India's Bharat Biotech to co-develop, supply, and commercialize Bharat Biotech's COVID-19 vaccine, Covaxin, for the United States market. The vaccine is currently in phase III trial in India. Bharat Biotech secured emergency use approval for Covaxin in India as recently as January 3, 2021. In a clinical trial, this vaccine has been found to be effective against the UK variant as well.

OCGN closed Monday's trading $15.81, up 201.14%. In after-hours, the stock was down 11.64% at $13.97.

4. No SAFETY Concerns for uniQure's Huntington's disease Trial

The independent Data Safety Monitoring Board has recommended uniQure N.V.'s (QURE) phase I/II clinical trial evaluating gene therapy candidate AMT-130 for the treatment of Huntington's disease to proceed with enrollment as no significant safety concerns were noted.

The decision was based after reviewing six-month safety data from the first two enrolled patients and the 90-day safety data from the next two enrolled patients in the study. The study is designed to enroll a total of 26 patients with early manifest Huntington's disease - split into a 10 patient, low-dose cohort followed by a 16 patient, higher-dose cohort randomized to treatment with AMT-130 or an imitation (sham) surgery.

uniQure expects to achieve full patient enrollment in Cohort 1 by mid-year 2021.

A rival gene therapy in the works for Huntington's disease is Voyager Therapeutics Inc.'s (VYGR) VY-HTT01. An application seeking clearance to begin a Phase 1b clinical trial of VY-HTT01 in Huntington's disease patients has been put on hold by the FDA since October 2020, pending the resolution of certain chemistry, manufacturing and controls matters.

QURE closed Monday's trading at $38.75, up 7.64%.

5. All Eyes on Tonix - and, Here's why?

Tonix Pharmaceuticals Holding Corp. (TNXP) plans to develop a diagnostic skin test, TNX-2100 to measure T cell immunity to SARS-CoV-2, the virus that causes COVID-19.
T cell immunity to CoV-2 persists longer than antibody immunity, is sometimes present in the absence of a measurable antibody response and is believed to provide an important element of protection against serious COVID-19 illness after infection with CoV-2.

The only currently available methods to detect T cell immunity to CoV-2 require expensive, multi-step sample preparation and in vitro T cell stimulation in highly specialized laboratories using methods that have not been amenable to standardization.

The TNX-2100 test is designed to be administered in the same way as skin tests for tuberculosis, sold as Tubersol or Aplisol or generically as the Mantoux tuberculin purified protein derivative (PPD) test, added the company.

Tonix is also developing TNX-1800, a potential COVID-19 vaccine, and expects to report efficacy data from animal challenge studies of the vaccine candidate in the first quarter of 2021.

The company's lead drug candidate is TNX-102 SL1 for Fibromyalgia. Last December, the company announced positive results from a phase III trial of TNX-102 SL 5.6 mg in Fibromyalgia, dubbed RELIEF. A second phase III trial of TNX-102 SL 5.6 mg for Fibromyalgia, dubbed RALLY, is ongoing. Interim results from this study are expected in the second quarter of this year.

In other news, the company has offered to sell 58.33 million shares of common stock to institutional investors, par value $0.001 per share at an offering price of $1.20 each. The gross proceeds of the offering will be approximately $70 million.

TNXP closed Monday's trading at $1.55, up 22.05%. In after-hours, the stock gained another 14% and was at $1.78.

6. Stocks That Gained/Lost The Most In A Day

Aeterna Zentaris Inc. (AEZS) closed Monday's (Feb.8, 2021) trading at $3.34, up 200.90%.

CRH Medical Corporation (CRHM) closed at $3.92, up 79.82%.

Zosano Pharma Corporation (ZSAN) closed at $1.93, up 75.45%.

Freeline Therapeutics Holdings plc (FRLN) closed at $15.70, down 9.87%.

Hancock Jaffe Laboratories Inc. (HJLI) closed at $8.91, down 8.71%.

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