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EU Begins 1st Rolling Review Of COVID-19 Vaccine, SLDB To Restart DMD Trial, ENLV Soars, TARA Abuzz

biotech oct02 lt

Today's Daily Dose brings you news about the first rolling review of a COVID-19 vaccine in the EU, reverse merger of privately held Chinook Therapeutics with Aduro, Enlivex Therapeutics' positive top-line results of an investigator-initiated clinical trial of Allocetra in COVID-19 patients in severe/critical condition, FDA lifting the clinical hold on Solid Biosciences' IGNITE DMD trial, and Vaccibody's deal with Roche to develop neoantigen cancer vaccines.

Read on…

1. EU begins First Rolling Review of COVID-19 vaccine

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has started the 'rolling review' of AZD1222, the COVID-19 vaccine candidate, being developed by AstraZeneca plc (AZN) in collaboration with the University of Oxford.

This marks the first 'rolling review' of a COVID-19 vaccine, and the data being reviewed by the committee comes from laboratory studies (non-clinical data). The CHMP decided to start the rolling review of the AZD1222 vaccine based on preliminary results from non-clinical and early clinical studies which suggest that the vaccine triggers the production of antibodies and T cells (cells of the immune system, the body's natural defense) that target the virus.

AZD1222 advanced into phase III testing in the U.S. in late August. The vaccine candidate is being tested in phase II/III trials in the U.K. and Brazil and in phase I/II trial in South Africa.

Early this month, AstraZeneca paused all the AZD1222 vaccine trials following a single event of an unexplained illness, which is believed to be transverse myelitis that occurred in the UK phase III trial. While the trials of the vaccine candidate in the UK and other countries have resumed, the trial continues to remain on hold in the U.S. as regulators have asked the company to furnish further data over its safety.

Gilead Sciences' antiviral Veklury (remdesivir), which secured conditional marketing authorization from the European Medicines Agency in July for the treatment of COVID-19 in adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen, was also assessed under the rolling review process.

AZN closed Thursday's trading at $54.30, down 0.91%.

2. Chinook Going Public via 'Reverse Merger' with Aduro

Privately held Chinook Therapeutics is going public via a reverse merger with publicly traded immunotherapy company Aduro Biotech Inc. (ADRO).

Aduro Biotech has announced a one-for-five reverse stock split which will come into effect with the open of the market on Friday, October 2, 2020. The closing of the merger is anticipated to take place on or around October 5, 2020. Following the closing of the merger, the combined company will be renamed Chinook Therapeutics and will trade under the ticker symbol "KDNY."

The combined company will advance a pipeline of clinical-stage programs in kidney diseases, led by Atrasentan and BION-1301 in IgA Nephropathy.

ADRO closed Thursday's trading at $2.860, up 17.70%.

3. Enlivex's Allocetra Proves efficacy in COVID-19 Trial

Shares of Enlivex Therapeutics Ltd. (ENLV) jumped over 40% on Thursday, following positive top-line results of an investigator-initiated clinical trial of Allocetra in COVID-19 patients in severe/critical condition.

Allocetra is an immunotherapy that is being developed to rebalance life-threatening hyperactivity of the immune system, using the immune system's own natural regulation mechanisms.

The clinical trial involved five COVID-19 patients, of which three were in severe condition and two in critical condition.

All five patients had a complete recovery from their respective severe/critical condition and were released from the hospital after an average of 5.5 days (severe) and 8.5 days (critical), following administration of Allocetra at which time they were all COVID-19 PCR negative, the company noted.

Allocetra was found to be well tolerated, with no reported severe adverse events.

ENLV closed Thursday's trading at $8.79, up 47.98%.

4. Solid Biosciences to Restart Duchenne Muscular Dystrophy Trial in Q1

The FDA has lifted the clinical hold placed on Solid Biosciences Inc.'s (SLDB) phase I/II study of SGT-001 for the treatment of Duchenne muscular dystrophy, dubbed IGNITE DMD.

SGT-001 is an investigational novel adeno-associated viral (AAV) vector-mediated gene transfer therapy designed to address the underlying genetic cause of Duchenne.

Duchenne Muscular Dystrophy, or DMD in short, is a rare genetic disorder characterized by muscle wasting and is caused by the absence of dystrophin, a protein necessary for muscle function. DMD usually affects boys, and its prevalence is roughly 1 in 3,500 boys worldwide.

The IGNITE DMD trial was placed on hold last November, following a serious adverse event experienced by one of the study subjects.

With the company satisfactorily addressing all clinical hold questions - by providing manufacturing information, updated safety and efficacy data for all patients dosed, and providing direction on total viral load to be administered per patient - the FDA has given the go-ahead to restart the trial.

Solid Biosciences is planning to resume dosing in the IGNITE DMD trial in the first quarter of 2021.

SLDB closed Thursday's trading at $3.4, up 70.44%.

5. Vaccibody in Deal with Roche to develop neoantigen Cancer Vaccines

Oslo, Norway-based Vaccibody AS has entered into an exclusive worldwide license and collaboration agreement with Roche's (RHHBY.OB) Genentech for the development and commercialization of DNA-based individualized neoantigen vaccines for the treatment of cancers.

Through this partnership, Genentech and Vaccibody will progress Vaccibody's investigational product, VB10.NEO, into clinical trials in the U.S. and in Europe. Vaccibody will be responsible for the development of VB10.NEO through the end of phase Ib while Genentech will be responsible for development and commercialization thereafter.

The partnership entitles Vaccibody to receive initial upfront and near-term payments of $200 million and potential milestone payments of up to $515 million, in addition to tiered royalties.

A phase I/IIa trial of VB10.NEO in patients with locally advanced or metastatic solid tumors is currently underway.

RHHBY.OB closed Thursday's trading at $42.79, down 0.05%.

6. Perceptive Takes 5.8% Stake in Protara

Shares of Protara Therapeutics Inc. (TARA) were up over 4% in extended trading Thursday, following news of Perceptive Advisors Llc taking a 5.8 percent ownership in the company.

Protara Therapeutics' lead product candidate is TARA-002 for the treatment of Lymphatic Malformations. The company plans to request a meeting with the FDA Division of Vaccines and Related Products Applications by year-end to discuss the regulatory path for TARA-002 in Lymphatic Malformations.

TARA-002 is based on the broad immunopotentiator OK-432, which is approved in Japan and Taiwan for the treatment of Lymphatic Malformations and multiple oncologic indications.

TARA closed Thursday's trading at $16.97, up 0.83%.

7. Stocks That Moved On No News

Anixa Biosciences Inc. (ANIX) closed Thursday's trading at $2.97, up 22.22%.

CTI BioPharma Corp. (CTIC) closed Thursday's trading at $2.47, up 15.12%.

Iterum Therapeutics plc (ITRM) closed Thursday's trading at $1.20, up 14.29%.

Pliant Therapeutics Inc. (PLRX) closed Thursday's trading at $19.89, down 12.19%.

Nurix Therapeutics, Inc. (NRIX) closed Thursday's trading at $30.94, down 11.37%.

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