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ADMP Snubbed Again, FDA Delay's Decision On BMY's Liso-cel, MRNA's COVID-19 Vaccine 94.5% Effective

biotech nov17 lt

Today's Daily Dose brings you news about the efficacy data of Moderna's COVID-19 vaccine candidate, FDA's refusal to approve Adamis Pharma's ZIMHI for the reversal of opioid overdose again, initial data from RAPT Therapeutics' ongoing Phase 1/2 trial for FLX475 in multiple cancer indications, INOVIO moving ahead with the initiation of the phase II segment of its planned phase II/III clinical trial for COVID-19 shot INO-4800, and delay in the FDA decision of Bristol Myers' B-cell lymphoma CAR-T therapy Liso-cel.

Read on…

1. FDA Snubs Adamis Yet Again

Shares of Adamis Pharmaceuticals Corp. (ADMP) plunged over 41% on Monday, following FDA's refusal to approve the company's lead drug candidate ZIMHI for the reversal of opioid overdose, yet again.

ZIMHI is a 5 mg dose of Naloxone. The standard treatment for opioid overdose is Naloxone at 2 mg dosage.

In its Complete Response Letter, the FDA has raised new Chemistry, Manufacturing and Controls (CMC) issues. It should be noted that the FDA had refused to approve ZIMHI last November too citing issues related to Chemistry, Manufacturing and Controls.

ADMP closed Monday's trading at $0.40, down 41.22%.

2. FDA Delays Decision on Bristol Myers' B-cell lymphoma CAR-T therapy

The FDA has informed Bristol Myers Squibb (BMY) that the decision on the company's Biologics License Application for lisocabtagene maraleucel (liso-cel), due on November 16, will be delayed as the review couldn't be completed in time.

Liso-cel is proposed for the treatment of adults with relapsed or refractory (R/R) large B-cell lymphoma after at least two prior therapies.

Due to travel curbs amid the Covid-19 pandemic, the inspection of a third-party manufacturing facility related to Liso-cel in Texas could not be completed by the FDA and therefore the decision has been postponed until the inspection can be completed.

No new anticipated action date has been provided.

BMY closed Monday's trading at $64.50, up 1.38%.

3. INOVIO Initiates Phase II Portion Of INNOVATE Trial

INOVIO (INO) has received FDA clearance to proceed with the phase II segment of its planned phase II/III clinical trial for INO-4800, its COVID-19 vaccine candidate, dubbed INNOVATE.

In September of this year, the FDA had imposed a partial clinical hold on the company's planned INNOVATE study raising additional questions about the trial, including its CELLECTRA 2000 delivery device to be used in the trial.

Now that the FDA has given the go ahead for the phase II segment, this part of the INNOVATE trial, which is expected to enroll approximately 400 participants at up to 17 U.S. sites, will evaluate safety, tolerability and immunogenicity of INO-4800 in a 2-dose regimen (1.0 mg or 2.0 mg) against a placebo.

The phase III segment of the INNOVATE trial remains on partial clinical hold until INOVIO satisfactorily resolves the FDA's remaining questions related to the CELLECTRA 2000 device that will be used to deliver INO-4800 directly into the skin.

INO closed Monday's trading at $12.85, up 14.53%.

4. JNJ Begins testing 2-dose COVID-19 Vaccine Regimen in Phase 3 Study

Johnson & Johnson (JNJ) has initiated a phase III trial of a two-dose regimen of its COVID-19 vaccine candidate Ad26.COV2.S. This trial, dubbed ENSEMBLE 2, will enroll up to 30,000 participants worldwide to test a two-dose vaccine regimen given 56 days apart.

A phase III trial, evaluating Ad26.COV2.S as a single dose vaccine, dubbed ENSEMBLE, is already underway. The ENSEMBLE and ENSEMBLE 2 trials will run in parallel.

JNJ closed Monday's trading at $150.85, up 0.63%.

5. Moderna Reveals Efficacy of COVID-19 Shot, Updates Storage Requirements

Moderna Inc.'s (MRNA) COVID-19 vaccine candidate mRNA-1273 has demonstrated an efficacy of 94.5% in its phase III study, reveals the first interim analysis data.

The phase III study, dubbed COVE, enrolled more than 30,000 participants in the U.S. and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases. The participants were randomized 1:1 to receive either two injections of mRNA-1273 at the 100 µg dose level, given 28 days apart, or two shots of saline placebo.

The primary endpoint is the prevention of symptomatic COVID-19 disease while key secondary endpoints include prevention of severe COVID-19 disease and prevention of infection by SARS-CoV-2.

In the first interim analysis, 90 cases of COVID-19 were observed in the placebo group compared to 5 cases in the mRNA-1273 group, which results in a vaccine efficacy of 94.5%. In the placebo group, 11 severe cases of COVID-19 were observed compared to none in the mRNA-1273 vaccinated group.

As for the safety profile, no significant safety concerns were observed in the mRNA-1273 arm and the vaccine was generally well tolerated.

Moderna intends to seek Emergency Use Authorization from the FDA for mRNA-1273 in the coming weeks and also plans to submit applications for authorizations to global regulatory agencies.

The company expects to have approximately 20 million doses of mRNA-1273 ready to ship in the U.S. by the end of this year, and is on track to manufacture 500 million to 1 billion doses globally in 2021.

Moderna has also shared some encouraging updates related to shelf life of its COVID-19 vaccine candidate.

For shipping and longer-term storage, Moderna expects that mRNA-1273 will be maintained at minus 20 degrees Celsius, equal to most home or medical freezer temperatures, for up to 6 months. At standard refrigerator temperatures of 2 to 8 degrees Celsius, the vaccine candidate can remain stable for 30 days, up from previous estimate of 7 days. Once the vaccine is removed from the refrigerator for administration, it can be kept at room temperature conditions for up to 12 hours.

Last week, Pfizer and BioNTech reported that in the first interim efficacy analysis of the phase III trial, their COVID-19 vaccine BNT162b2 was found to be more than 90% effective in preventing COVID-19.

BNT162b2 is said to 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 transport and distribution of Pfizer/BioNTech's COVID-19 shot.

MRNA closed Monday's trading at $97.95, up 9.58%.

6. RAPT Reports Positive Interim Data from Phase 1/2 trial with FLX475, But Shares Plunge

Shares of RAPT Therapeutics Inc. (RAPT) cratered more than 46%, despite positive initial clinical data from its ongoing Phase 1/2 trial for FLX475 in multiple cancer indications.

The phase I portion of the trial evaluated 4 doses of FLX475 as monotherapy and 3 doses of FLX475 in combination with Merck's Keytruda in patients with cancers of different types.

In the monotherapy cohort of the Phase I portion, disease control was observed in 14 of the 17 evaluable patients, including an unconfirmed partial response in a patient with relapsed metastatic cervical cancer. In the combination cohorts, disease control was observed in 13 of the 14 evaluable patients, including two confirmed partial responses - in a patient with NSCLC and in a patient with urothelial cancer.

The phase II portion of the trial is evaluating FLX475 as a monotherapy and in combination with Keytruda in patients with charged tumors like Epstein Barr virus (EBV) positive lymphoma, nasopharyngeal cancer, and head and neck cancer.

There was a significant target tumor reduction in the first two patients with EBV+ lymphoma treated with FLX475 monotherapy - with 1 patient achieving a durable complete metabolic response and continues on study after more than nine months. The company plans to expand the EBV+ lymphoma monotherapy cohort and initiate a separate expansion cohort in EBV+ lymphoma in combination with Keytruda.

In the nasopharyngeal cancer cohort, of the 10 evaluable patients treated with FLX475 monotherapy, seven of them exhibited stable disease as best response. Seven of the 10 patients crossed over to combination therapy where significant clinical activity has been observed. Of the six evaluable patients who crossed over, five patients demonstrated significant tumor shrinkage, with three of the patients showing a partial response (two confirmed and one unconfirmed).

As for the head and neck cancer cohort, 5 of the 10 patients treated with FLX475 monotherapy exhibited stable disease as best response. Six patients initially treated with monotherapy crossed over to combination therapy, with one achieving a partial response and a second patient with an unconfirmed partial response.

In a separate combination treatment cohort that had enrolled 17 patients with head and neck cancer, 10 are evaluable so far. Substantial tumor reduction has been observed in four of the 10, including one confirmed complete response and three patients with greater than 20 percent tumor reduction, according to the company.

In other news, RAPT Therapeutics reported a net loss of $14.6 million or $0.60 per share for the third quarter of 2020 compared to a net loss of $10.0 million or $12.41 per share in the year-ago period.

RAPT closed Monday's trading at $16.41, down 46.14%.

7. Stocks Hitting New Highs/Lows

SQZ Biotechnologies Co. (SQZ) closed Monday's trading at a new high of $30.33, up 26.37%.

Spruce Biosciences Inc. (SPRB) closed at a new high of $24.99, up 9.03%.

Champions Oncology Inc. (CSBR) closed at a new 52-week high of $12.23, up 14.94%.

180 Life Sciences Corp. (ATNF) closed at a new low of $2.25, down 8.16%.

Jaguar Health, Inc. (JAGX) closed at a new low of $0.19, down 3.47%.

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