AZN, IQV Team Up To Accelerate COVID-19 Vaccine Work, RIGL's ITP Drug Repurposed, IMV On Watch

(RTTNews) - Today's Daily Dose brings you news about Aldeyra's stock sales to two healthcare-focused investment funds, AstraZeneca teaming up with a contract research organization to accelerate the development of its COVID-19 vaccine candidate, Blueprint Medicines' collaboration with Roche, the progress in IMV's COVID-19 vaccine candidate, the next milestone in Moderna's potential COVID-19 vaccine mRNA-1273, and FDA declining to approve Verrica Pharma's VP-102 for molluscum contagiosum, among others.

Read on…

1. Aldeyra Well-funded

Aldeyra Therapeutics Inc. (ALDX) has sold an aggregate of 4.58 million shares of common stock to two healthcare-focused investment funds - Perceptive Advisors LLC and Avidity Partners Management LP - for a price of $4.25 per share. The aggregate gross proceeds were approximately $19.5 million.

The Company's Dry Eye disease drug candidate is Reproxalap. Last week, Aldeyra said that it intends to initiate two clinical trials to assess the activity of Reproxalap in reducing tear levels of RASP (reactive aldehyde species). The FDA has confirmed the use of RASP as an objective sign for the treatment of dry eye disease.

Top-line results from the first of the RASP trials are expected by the end of 2020, pending potential disruptions due to the COVID-19 pandemic. In addition, a safety trial in dry eye disease patients is expected to be initiated in the fourth quarter of 2020.

ALDX closed Tuesday's trading at $5.70, up 21.28%.

2. AstraZeneca Ropes In IQVIA To Accelerate COVID-19 Vaccine Development

AstraZeneca PLC (AZN) has roped in contract research organization IQVIA (IQV) to accelerate the development of its potential COVID-19 vaccine, AZD1222, under the Operation Warp Speed project.

As part of the collaboration, an expansive subject study, which will leverage IQVIA's Virtual Trial solutions including Study Hub, is expected to begin enrolling participants this summer.

The terms of the collaboration have not been disclosed.

IQV closed Tuesday's trading at $147.78, up 4.60%.

3. Blueprint Medicines Teams Up With Roche For Pralsetinib

Blueprint Medicines Corporation (BPMC) has entered into a global collaboration with Roche to develop and commercialize Pralsetinib, an investigational once-daily oral precision therapy for the treatment of people with RET-altered cancers, including non-small cell lung cancer, medullary thyroid cancer, other thyroid cancers, and other solid tumors.

Pralsetinib, proposed for the treatment of RET fusion-positive NSCLC, RET mutation-positive MTC, and RET fusion-positive thyroid cancer, is under FDA priority review, with a decision expected on November 23, 2020.

As per the deal, Blueprint Medicines and Genentech, a member of the Roche Group, will co-commercialize Pralsetinib and equally share profits in the U.S. For regions, outside the U.S., excluding Greater China, Roche will have exclusive commercialization rights for Pralsetinib.

The deal entitles Blueprint Medicines to receive $775 million in upfront payments, comprising $675 million in cash and $100 million equity investment priced at $96.57 per share, besides being eligible to receive up to $927 million in potential milestones, plus royalties on net product sales outside the U.S.

CStone Pharmaceuticals will retain all rights to the development and commercialization of Pralsetinib in Greater China under its existing collaboration with Blueprint Medicines.

BPMC closed Tuesday's trading at $79.97, up 4.33%.

4. GlaxoSmithKline Gets Favorable Recommendation from FDA Panel

An FDA panel has voted 12-0 recommending approval of GlaxoSmithKline's (GSK) Belantamab mafodotin for patients with relapsed/refractory multiple myeloma.

Belantamab mafodotin is proposed for the treatment of patients with relapsed or refractory multiple myeloma who have received at least four prior therapies including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody.

The final FDA decision on Belantamab mafodotin is expected next month.

GSK closed Tuesday's trading at $40.70, up 1.57%.

5. IMV's COVID-19 Vaccine Candidate Chugs Along

Shares of IMV Inc. (IMV) (IMV.TO) jumped more than 50% on Tuesday, following an update on DPX-COVID-19, its candidate vaccine to prevent COVID-19 infection.

In preclinical studies, DPX-COVID-19 has demonstrated its capacity to induce strong immunogenicity including the binding on target to the spike protein and viral neutralization.

The Company has completed the current good manufacturing practice ("cGMP") formulation and manufacturing process development for DPX-COVID-19, with multiple batches having been successfully produced.

The Company intends to commence phase I clinical trials of DPX-COVID-19 vaccine this summer with results expected in the Fall of 2020. If all goes well as planned, phase II trials of the vaccine candidate are expected to be initiated in the second half of this year.

IMV closed Tuesday's trading at $4.63, up 54.33%.

6. Moderna To Initiate Phase 3 Trial of COVID-19 Vaccine This Month

Moderna Inc. (MRNA), which reported encouraging interim results from a phase I study of mRNA-1273, its COVID-19 vaccine candidate, in May, expects the phase III trial to be initiated on July 21.

A phase II study evaluating two doses of mRNA-1273 vaccine, namely 50 µg or a 100 µg, and placebo is fully enrolled. This study is evaluating the safety, reactogenicity, and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart.

The planned phase III study of the mRNA-1273 vaccine is expected to include approximately 30,000 participants at the 100 µg dose level in the U.S. The primary endpoint will be the prevention of symptomatic COVID-19 disease. Key secondary endpoints include the prevention of severe COVID-19 disease (as defined by the need for hospitalization) and prevention of infection by SARS-CoV-2.

Moderna has completed the manufacture of vaccine required to start the phase III study.

MRNA closed Tuesday's trading at $75.04, up 4.54%.

7. Repurposing Rigel's Immune Thrombocytopenia Drug For COVID-19

Rigel Pharmaceuticals Inc.'s (RIGL) approved drug for chronic immune thrombocytopenia TAVALISSE is being evaluated as a treatment of COVID-19 pneumonia in an investigator-sponsored trial being conducted by the Imperial College London.

The trial will be a two-stage open-label, controlled clinical trial with patients randomized (1:1:1) to TAVALISSE (fostamatinib), Novartis' Jakafi (Ruxolitinib), or standard of care. Treatment will be administered twice daily for 14 days and patients will receive a follow-up assessment at day 14 and day 28 after the first dose, according to the Company.

The primary objective will be to determine the efficacy of TAVALISSE and the efficacy of Jakafi compared to standard of care to reduce the proportion of hospitalized patients progressing from mild or moderate to severe COVID-19 pneumonia.

The trial will be supported by Rigel and Novartis.

RIGL closed Tuesday's trading at $4.12, up 90.97%. In after-hours, the stock lost 7.88% and was at $3.80.

8. FDA Says 'No' To Verrica Pharma's VP-102

Verrica Pharmaceuticals Inc.'s (VRCA) VP-102, its proprietary, drug-device combination, proposed for the treatment of molluscum contagiosum, has been turned down by the FDA.

Molluscum contagiosum is a common, highly contagious viral skin infection affecting an estimated 6 million people in the United States, primarily children. Currently, there are no FDA-approved treatments for this viral skin disease.

In its Complete Response Letter, the FDA has sought additional information regarding certain aspects of the CMC (Chemistry, Manufacturing, and Controls) process for the drug/device combination, as well as Human Factors validation. No clinical safety or efficacy issues have been identified.

The Company plans to request a Type A meeting to discuss the issues that were described in the Complete Response Letter and other matters relating to the steps required for the resubmission of the VP-102 New Drug Application.

VRCA closed Tuesday's trading at $8.47, down 3.75%.

9. Stocks That Moved On No News

Caladrius Biosciences Inc. (CLBS) closed Tuesday's trading at $3.00, up 38.89%.

T2 Biosystems Inc. (TTOO) closed Tuesday's trading at $1.62, up 21.80%.

VBI Vaccines Inc. (VBIV) closed Tuesday's trading at $4.51, up 18.68%.

Equillium Inc. (EQ) closed Tuesday's trading at $13.98, down 47.25%.

Unum Therapeutics Inc. (UMRX) closed Tuesday's trading at $2.84, down 13.41%.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


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