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ALEC Falls Despite Promising Results, DNLI Makes Progress In COVID-19 Trial, EARS, ONTX On Watch

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Today's Daily Dose brings you news about Alector's frontotemporal dementia trial results, Auris Medical's upcoming clinical trial catalyst, Denali's progress in COVID-19 trial, and disappointing results from Roche's phase III COVACTA study.

Read on…

1. Alector Reports Promising Data, Yet Stock Plunges

Shares of Alector Inc. (ALEC) plunged more than 23 percent on Wednesday, despite announcing promising preliminary data from its phase Ib and phase II studies of AL001 for the treatment of people with frontotemporal dementia with a progranulin gene mutation.

AL001 was generally safe and well-tolerated in the phase Ib study and after continuous dosing in 15 asymptomatic and symptomatic frontotemporal dementia with a progranulin gene mutation (FTD-GRN) participants in the phase II study. Moreover, in the phase II study, AL001 resulted in sustained restoration of plasma progranulin levels in all FTD-GRN participants back to normal range and the majority of symptomatic FTD-GRN participants showed a decrease in plasma neurofilament light chain (NfL) levels from baseline, noted the company.

So what spooked investors?

The company in its Press Release has stated that due to the COVID-19 pandemic, several clinical sites for the phase II study were temporarily closed or conducted with reduced or remote patient assessments during the evaluation period. As a result, some participants missed a dose of AL001 or missed clinical assessments during the treatment period.

Only as recently as last week, did the company announce the dosing of the first patient in its pivotal phase III clinical trial, named INFRONT-3, evaluating AL001 in people at risk for or with frontotemporal dementia due to a progranulin gene mutation.

ALEC closed Wednesday's trading at $16.31, down 23.57%.

2. AnPac Bio-Medical on Course to meet Target

Shares of AnPac Bio-Medical Science Co. Ltd. (ANPC) jumped over 28 percent on news that it had completed over 180,000 Cancer Differentiation Analysis ("CDA") based tests as of July 15, 2020.

The CDA test uses liquid-based technology to detect the risk of cancer and non-cancerous diseases and is minimally invasive, side-effect-free, and highly automated, according to the company.

ANPC closed Wednesday's trading at $7.19, up 28.39%.

3. Auris Medical To Report Data This Quarter

Auris Medical Holding Ltd. (EARS) has completed patient enrollment in Part A of its phase II trial of intranasal betahistine for the treatment of acute vertigo.

The phase II trial, dubbed TRAVERS, is comprised of two parts - Part A and Part B.
In Part A of the TRAVERS trial, three ascending doses of intranasal betahistine (AM-125) or placebo, administered three times daily over a total of four weeks is tested in a total of 30 patients. The interim results from Part A of the study are expected this quarter.

The results from the interim analysis will inform the selection of two doses for further testing against a placebo in an estimated 72 patients in Part B of the trial, noted the company.

EARS closed Wednesday's trading at $0.92, down 4.13%.

4. Bluebird/Bristol Myers Resubmit Ide-cel To FDA

Bristol Myers Squibb (BMY) and bluebird bio (BLUE) have resubmitted their Biologics License Application to the FDA, seeking approval of Idecabtagene Vicleucel for the treatment of patients with heavily pretreated relapsed and refractory multiple myeloma.

In May, the FDA had refused to accept for review the Idecabtagene Vicleucel BLA and had sought additional details related to the Chemistry, Manufacturing, and Control (CMC) module of the BLA.

The resubmitted BLA includes further details on the Chemistry, Manufacturing and Controls (CMC) module to address the outstanding regulatory requests.

Idecabtagene Vicleucel, also known as Ide-cel, is a B-cell maturation antigen (BCMA)-directed genetically modified autologous chimeric antigen receptor (CAR) T cell immunotherapy. It is also under review by the European Medicines Agency.

BLUE closed Wednesday's trading at $62.34, down 5.20%.

5. Denali Makes Progress in COVID-19 Drug Trial

Denali Therapeutics Inc.'s (DNLI) investigational drug DNL758 has entered into a phase Ib study in hospitalized adult patients with severe COVID-19 lung disease.

DNL758, discovered by Denali and partnered with Sanofi (SNY), is a small molecule inhibitor of RIPK1 that does not cross the blood-brain barrier, and is being developed for patients with peripheral inflammatory diseases.

The phase Ib study of DNL758 in COVID-19 is being conducted by Sanofi.

DNLI closed Wednesday's trading at $23.70, down 0.21%.

6. F-star Therapeutics To Go Public Via Reverse Merger

F-star Therapeutics Limited, a privately-held clinical-stage biopharmaceutical company, is all set to go public through a reverse merger with Spring Bank Pharmaceuticals Inc. (SBPH).

The transaction, which has been approved by both companies, is expected to close in late 2020. Following closing, the combined company will operate under the name F-star Therapeutics Inc., and will trade on the Nasdaq Capital Market under the ticker symbol "FSTX".

SBPH closed Wednesday's trading at $2.08, down 19.07%. In after-hours, the stock was up 17.78% at $2.44.

7. Onconova to Report INSPIRE Data in Q3

Onconova Therapeutics Inc.'s (ONTX) phase III trial of intravenous Rigosertib in patients with myelodysplastic syndromes, dubbed INSPIRE, has reached the required number of survival events to conduct data evaluation.

The company anticipates announcing topline data from the INSPIRE trial by the end of the third quarter of 2020.

ONTX closed Wednesday's trading at $1.28, up 13.27%.

8. Repare Therapeutics Marches Ahead

Repare Therapeutics Inc. (RPTX) has dosed the first patient in its phase I/II clinical trial of RP-3500 for the treatment of solid tumors with selected genomic alterations.

This multi-center dose-escalation and expansion trial is expected to enroll approximately 230 patients with advanced solid tumors of any histology that harbor gene alterations determined pre-clinically to suggest sensitivity to RP-3500 alone or in combination with Pfizer's PARP inhibitor, Talzenna.

The company made its debut on the Nasdaq on June 19, 2020, offering its shares at a price of $20 each. The stock opened the first day of trading at $32.49 and closed that session at $30.80.

RPRX closed Wednesday's trading at $24.57, up 8.05%.

9. Roche's COVACTA Trial Flops

Roche's (RHHBY) phase III study of Actemra/RoActemra in hospitalised adult patients with severe COVID-19 associated pneumonia has not met the primary or secondary goals.

The study, dubbed COVACTA, did not meet its primary endpoint of improved clinical status or the key secondary endpoints, which included the difference in patient mortality at week four.

The COVACTA trial was conducted in collaboration with the Biomedical Advanced Research and Development Authority (BARDA).

Actemra/RoActemra is an approved drug for rheumatoid arthritis, paediatric juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, giant cell arteritis and CAR-T cell-induced cytokine release syndrome.

RHHBY.OB closed Wednesday's trading at $44.75, up 0.61%.

10. Viking Faces Busy Year Ahead

Viking Therapeutics Inc. (VKTX) has a couple of events lined up for this year.

The company's lead product candidate is VK2809, under a phase IIb in patients with biopsy-confirmed NASH and fibrosis, dubbed VOYAGE. The U.S. enrollment is continuing in the study and it is on track to begin opening ex-U.S. sites during the third quarter of 2020.

New data from a completed 12-week phase II trial of VK2809 in patients with non-alcoholic fatty liver disease (NAFLD) and hypercholesterolemia is slated to be presented at the European Association for the Study of the Liver (EASL) conference on August 28. The topline data from this study was reported in September 2018.

The company's VK0214, being evaluated as a potential treatment for X-linked adrenoleukodystrophy (X-ALD), is expected to move into clinical development this quarter.

VKTX closed Wednesday's trading at $6.61, up 0.30%.

11. Stocks that Moved On No News

Adamis Pharmaceuticals Corp.(ADMP) closed Wednesday's trading at $1.45, up 31.22%.

Qualigen Therapeutics Inc. (QLGN) closed Wednesday's trading at $6.42, up 27.13%.

Mallinckrodt plc (MNK) closed Wednesday's trading at $2.38, up 20.81%.

Celldex Therapeutics Inc. (CLDX) closed Wednesday's trading at $9.65, down 13.30%.

Calliditas Therapeutics AB (CALT) closed Wednesday's trading at $21.61, down 10.33%.

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