AZN's Repurposed COVID-19 Drug Fails, NAVB On Watch, CVAC Rallies On Storage Advantage Of CVnCoV

biotech nov13

Today's Daily Dose brings you news about the failure of AstraZeneca's repurposed COVID-19 drug, reverse merger of MyMD with Akers, storage advantage of CureVac's COVID-19 shot, Navidea's promising results from its NAV3-31 phase IIb study, Inhibrx' phase I trial results of INBRX-109 in bone cancer.

Read on…

1. MyMD Pharma goes public via "reverse merger" with Akers

Shares of Akers Biosciences Inc. (AKER) jumped 29% Thursday after the company entered into a merger agreement with privately-held MyMD Pharmaceuticals.

The combined company is expected to be renamed MyMD Pharmaceuticals Inc. and remain listed on the NASDAQ under the new ticker symbol "MYMD."

The current Akers' shareholders will own approximately 20% of the combined company while current MyMD's shareholders will own approximately 80% of the combined company. The merger is expected to close in the first half of 2021.

Following the merger, the two companies will join as one to focus on developing and commercializing MyMD's novel immunotherapy pipeline assets, including MYMD-1, a first-in-class drug being developed to treat autoimmune and age-related diseases.

Two phase II clinical trials of MYMD-1 are expected to begin next quarter.

AKER closed Thursday's trading at $2.22, up 29.07%.

2. AstraZeneca's Calquence Joins List of Failed Repurposed COVID-19 Drugs

AstraZeneca PLC's (AZN) blood cancer med Calquence is the latest repurposed drug, which failed to reduce mortality in hospitalized patients with COVID-19 disease.

In a phase II program, dubbed CALAVI, Calquence in patients hospitalized with respiratory symptoms of COVID-19 did not meet the primary efficacy endpoint of increasing the proportion of patients who remained alive and free of respiratory failure.

The CALAVI program comprised of two phase II trials investigating Calquence plus Best Supportive Care (BSC) versus BSC alone in hospitalized patients with COVID-19 disease.

Roche's arthritis drug Actemra, Sanofi/Regeneron's rheumatoid arthritis drug Kevzara, and AbbVie's HIV med Kaletra are some of the repurposed drugs that have disappointed in COVID-19 trials.

AZN closed Thursday's trading at $56.84, down 2.03%.

3. CureVac Unveils Storage Advantage of COVID-19 Vaccine Candidate

Shares of CureVac NV (CVAC) jumped over 12% on Thursday, following encouraging news about the stability of its mRNA-based COVID-19 vaccine candidate CVnCoV.

According to the company, CVnCoV remains stable as a ready-to-use vaccine for up to 24 hours at room temperature. When stored at plus 5 degrees Celsius standard refrigerator temperature, CVnCoV remains stable for at least three months.

CVnCoV is currently under a phase IIa clinical trial in Peru and Panama. CureVac plans to initiate a pivotal phase IIb/III clinical study of the vaccine candidate by the end of 2020.

It should be noted that Pfizer/BioNTech's Covid-19 vaccine candidate BNT162b2, which has shown encouraging early results - demonstrating over 90% efficacy - in a global phase III trial, will be stable only when it is stored at minus 70 degrees Celsius or below. So, the ultra-low temperature storage may pose a significant challenge for the distribution of Pfizer/BioNTech's Covid shot while CureVac's COVID-19 vaccine candidate is compatible with standard fridge-temperature storage as well as a required room temperature application.

CVAC closed Thursday's trading at $69.69, up 12.51%.

4. Inhibrx' Phase I Bone Cancer Trial Data Encouraging

Inhibrx Inc.'s (INBX) phase I trial of INBRX-109 in patients with chondrosarcoma has yielded positive interim results.

Chondrosarcoma is rare type of bone cancer with approximately 2,800 new patients diagnosed annually in the United States and the European Union. There is currently no approved drug for the treatment of chondrosarcoma.

According to the interim results, of the 12 patients evaluable for efficacy in the ongoing trial, disease control was observed in 11 of them (92%) and 8 of 12 patients (67%) had a decrease in their tumor burden by RECIST. Two of the patients achieved partial responses with reductions in tumor size of 60% and 32% as of October 2020.

Commenting on the results, Mark Lappe, CEO for Inhibrx, said, "We believe the results in chondrosarcoma, a disease with a significant unmet need, are very promising. We are meeting with the Food and Drug Administration in the near future to discuss the design of a registration-enabling study that we anticipate initiating in the second quarter of next year."

INBX closed Thursday's trading at $19.53, up 1.72%.

5. Navidea Rallies on NAV3-31 phase IIb study Results

Shares of Navidea Biopharmaceuticals Inc. (NAVB) were up more than 43% in extended trading Thursday, following positive results from an analysis of 16 subjects who have completed Arm 3 of its ongoing NAV3-31 phase IIb study.

The NAV3-31 phase IIb study is designed to evaluate the reliability and sensitivity of Tilmanocept Uptake Value (TUV) on Tc 99m Planar Imaging in healthy controls and subjects with active rheumatoid arthritis.

The study includes 3 arms. The first arm is comprised of disease-free healthy controls and the second arm includes clinically diagnosed rheumatoid arthritis subjects on stable treatment. The third arm is a pilot arm of the upcoming phase III trial assessing the ability of Tc99m Tilmanocept to provide an early indicator of efficacy of anti-tumor necrosis factor alpha treatment in rheumatoid arthritis patients.

The analysis of Arm 3 of the trial suggests that Tc99m Tilmanocept imaging can provide early indicator of treatment response.

Commenting on the results, Jed Latkin, Navidea's Chief Executive Officer, said, "The data shared today once again demonstrate the power of Tilmanocept to aid in rheumatology treatment decisions and ultimately improve the course of care for the millions of people across the globe suffering from RA."

NAVB closed Thursday's trading at $2.24, down 0.44%. In after-hours, the stock was up 43.89% at $3.18.

6. So Long, Urovant

Urovant Sciences (UROV) is all set to be acquired by its largest investor Sumitovant Biopharma for $16.25 per share or approximately $584 million in total equity value in an all-cash merger.

Urovant Sciences is a clinical-stage biopharmaceutical company developing innovative therapies for urologic conditions. The company's lead drug candidate Vibegron, proposed for the treatment of overactive bladder, is under FDA review, with a decision expected by December 26, 2020.

The merger of Urovant Sciences with Sumitovant Biopharma is expected to be completed in the first quarter of next year.

Sumitovant is the parent company of five biopharma subsidiaries - Myovant, Urovant, Enzyvant, Altavant and Spirovant.

UROV closed Thursday's trading at $8.28, up 4.68%. In after-hours, the stock was up 90.58% at $15.78.

7. Stocks That Hit New Highs/Lows

MannKind Corp. (MNKD) closed Thursday's trading at a new high of $2.76, down 1.43%.

Oncorus Inc. (ONCR) closed at a new high of $22, up 3.38%.

Denali Therapeutics Inc. (DNLI) closed at a new high of $69.94, up 5.70%.

Neovasc Inc. (NVCN) closed at a new low of $0.74, down 2.81%.

Applied Therapeutics Inc. (APLT) closed at a new low of $15.44, down 0.39%.

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