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EQ Soars, INMB Up On Promising Alzheimer's Trial Data, ALT To Move AdCOVID Into Clinical Trial In Q4

biotech july14 lt

Today's Daily Dose brings you news about Altimmune's progress in ints intranasal COVID-19 vaccine candidate, Independent Data Monitoring Committee recommending stopping of Celsion's phase III OPTIMA study, FDA refusing to accept for review CytoDyn's Biologics License Application for Leronlimab, multi-fold jump in the share price of Equillium, and promising Alzheimer's trial data of INmune Bio, among others.

Read on…

1. Altimmune To Advance COVID-19 Vaccine Candidate Into Phase I Trial In Q4

Altimmune Inc. (ALT) gained more than 11 percent on Monday, following encouraging preclinical studies of its intranasal COVID-19 vaccine candidate, AdCOVID.

The preclinical studies of the AdCOVID vaccine, which were conducted in collaboration with the University of Alabama at Birmingham, showed strong serum neutralizing activity and potent mucosal immunity in the respiratory tract. The induction of IgA antibody in the respiratory tract may be necessary to block both infection and transmission of the virus to prevent further spread of COVID-19, noted the Company.

Based on the promising results, the Company plans to begin the manufacturing of AdCOVID and advance the vaccine candidate to a phase I safety and immunogenicity study in the fourth quarter of this year.

In other news, the Company has offered to sell 3.37 million shares of its common stock and, to certain investors in lieu thereof, pre-funded warrants to purchase 1.63 million shares of its common stock at an exercise price of $0.0001 per share. The public offering price of each share of common stock is $23.00 and the public offering price of each pre-funded warrant is $22.999 per underlying share.

ALT touched a new high of $28.67 in intraday trading before closing the day at $25, up 11.86%.

2. Celsion Tumbles As Committee Recommends Stopping OPTIMA Study

Shares of Celsion Corporation (CLSN) fell more than 63% on receipt of the recommendation from an Independent Data Monitoring Committee to consider stopping its phase III OPTIMA Study.

The phase III OPTIMA trial is evaluating ThermoDox in combination with radiofrequency ablation (RFA) for the treatment of hepatocellular carcinoma (HCC), or primary liver cancer.

The OPTIMA Study enrolled 554 patients at 65 clinical sites in North America, Europe, China, and the Asia Pacific. The primary endpoint is overall survival while key secondary endpoints include progression-free survival, time to disease progression, and safety.

The Independent Data Monitoring Committee's recommendation was based on the second pre-planned interim analysis which found that the OPTIMA Study is unlikely to meet its primary efficacy endpoint of overall survival.

Celsion plans to conduct a thorough analysis of the unblinded study data before making a final decision.

CLSN closed Monday's trading at $1.29, down 63.97%.

3. CytoDyn Hit With Refusal to File letter

Shares of CytoDyn Inc. (CYDY.OB) plunged more than 21% on Monday, as the FDA refused to accept for review the Company's Biologics License Application for Leronlimab as a combination therapy with highly active antiretroviral therapy, or HAART, for highly treatment-experienced HIV patients.

In its Refusal to File letter, the FDA has informed the Company that its Biologics License Application does not contain certain information needed to complete a substantive review and therefore is not taking it up for review. The regulatory agency has not required any additional clinical trials to be conducted.

CytoDyn intends to request a Type A meeting with the FDA to discuss its request for additional information.

CYDY.OB closed Monday's trading at $3.70, down 21.78%.

4. Equillium Gallops As Partner Biocon Reports Promising COVID-19 Trial Results

Shares of Equillium Inc. (EQ) skyrocketed more than 700 percent on Monday, following promising clinical trial results of Itolizumab in patients hospitalized with COVID-19.

In the trial conducted in India by Biocon, Equillium's partner, there were no deaths, and all patients recovered in the Itolizumab arm while three patients died and the remainder recovered in the control arm. The mortality benefit observed in the Itolizumab arm was statistically significant and patients who received Itolizumab also experienced significant reductions in inflammatory cytokines such as IL-6 and TNFa, as reported by India-based Biocon.

Equillium acquired the exclusive rights to develop and commercialize Itolizumab for the US and Canada markets from Biocon in May 2017. This licensing agreement was expanded to include Australia and New Zealand in December 2019.

A global randomized controlled clinical trial of Itolizumab in COVID-19 patients is being planned by Equillium.

Itolizumab has been approved for restricted emergency use for the treatment of cytokine release syndrome (CRS) in COVID-19 patients with moderate to severe acute respiratory distress syndrome (ARDS) in India.

We had alerted readers to EQ on Jan.3, 2020 when it was trading around $4. (Report titled: Equillium (EQ) Well Equipped For 2020…)

EQ closed Monday's trading at $26.50, up 730.72%. In after-hours, the stock was down 24.08% to $20.12.

5. Gritstone Fails To Impress

Gritstone Oncology (GRTS) plunged more than 50% on Monday, despite favorable phase I studies of GRANITE, a personalized neoantigen-based immunotherapy, and SLATE, an off-the-shelf immunotherapy.

In the GRANITE trial, at dose/intensity level 3, no disease progression was observed and there was a clear clinical benefit ongoing in metastatic colorectal cancer patients, according to the Company.

In the SLATE trial, there was evidence of clinical benefit and minor but sustained tumor shrinkage in multiple NSCLC patients with KRAS G12C mutations who had progressed on prior CPI (checkpoint inhibitor) therapy.

GRANITE and SLATE are expected to advance into phase II trials in the second half of this year.

GRTS closed Monday's trading at $4.02, down 50.31%.

6. INmune Bio Soars On Promising Alzheimer's Trial Data

INmune Bio Inc.'s (INMB) interim data from a phase Ib clinical trial of XPro1595 in Alzheimer's disease has demonstrated that the compound decreases neuroinflammation by 40.6% in a brain fiber pathway important for learning and memory in patients with Alzheimer's disease.

As part of the study, the biomarker data obtained from six patients treated with XPro1595 for 12 weeks were compared with data from 25 Alzheimer's patients from the Alzheimer's Disease Neuroimaging Initiative (ADNI) that are part of a natural history database in patients with Alzheimer's.

Over a 12-week period, whole brain inflammation increased by 5.1% in the ADNI patients compared to an increase of 1.7% and a decrease of 2.3% in patients treated weekly with 0.3mg/kg or 1.0mg/kg of XPro1595, respectively.

Moreover, there was a 40.6% reduction in neuroinflammation in the Arcuate Fasciculus in patients treated with XPro1595. The Arcuate Fasciculus is a major white matter anterior/posterior tract (white matter bundle) containing long and short fibers that connect the frontal, parietal and temporal lobes and is important for language and short-term memory. By contrast, the ADNI cohort had a 4.6% increase in Arcuate Fasciculus neuroinflammation, noted the Company.

INMB closed Monday's trading at $8.85, up 26.43%. In after-hours, the stock gained 92.20% and was at $17.01.

7. NextCure Discontinues NC318 Monotherapy Trial In Two Cohorts

NextCure Inc. (NXTC) has decided not to advance the non-small cell lung cancer and ovarian cancer cohorts into phase II portion of its phase I/II trial evaluating lead candidate NC318 as a monotherapy.

The decision to discontinue the two cohorts was taken based on the current enrollment criteria and clinical response data.

However, the Company continues to enroll in head and neck squamous cell carcinoma (HNSCC) and triple-negative breast cancer cohorts of the trial.

In other news, the Company announced the resignation of Kevin N. Heller, M.D., the company's chief medical officer, effective August 4, 2020. A search is on for a new chief medical officer.

NXTC closed Monday's trading at $8.15, down 54.42%.

8. Pfizer/BioNTech COVID-19 Vaccine Program On Fast Track

Two of the four investigational vaccine candidates from Pfizer Inc. (PFE) and BioNTech SE's (BNTX) BNT162 mRNA-based vaccine program being developed to help protect against SARS-CoV-2 have received Fast Track designation from the FDA.

The two vaccine candidates BNT162b1 and BNT162b2 are currently being evaluated in ongoing Phase 1/2 clinical studies in the United States and Germany.

Early data from the ongoing U.S. Phase 1/2 study for BNT162b1 were reported on July 1, 2020, and it revealed that at day 28, all subjects who received 10 µg or 30 µg of BNT162b1 had significantly elevated receptor-binding domain (RBD)-binding IgG antibodies and neutralizing antibodies much higher than the sera of convalescent patients who had contracted SARS-CoV-2. The level of antibodies relates to a vaccine's efficacy.

Early data from the German trial of BNT162b1 are expected to be released in July.

9. Vanda Soars On Tradipitant News

The FDA has granted authorization to Vanda Pharmaceuticals Inc.'s (VNDA) investigational drug Tradipitant for use in a single patient for treating gastroparesis in an Individual Patient Expanded Access protocol.

Gastroparesis is a condition in which food stays in the stomach for longer than normal.

In December 2018, the FDA imposed a partial clinical hold on two proposed clinical studies of Tradipitant, stating that Vanda is required first to conduct additional chronic toxicity studies in canines, monkeys, or minipigs before allowing patients access in any clinical protocol beyond 12 weeks.

The patient who has now been given expanded access had previously participated in a randomized study of Tradipitant in gastroparesis for 12 weeks. The patient and treating physician requested expanded access to continue treatment beyond 12 weeks, as the treating physician had judged that tradipitant was the only treatment that effectively managed the patient's gastroparesis symptoms.

Tradipitant is an NK-1R antagonist licensed by Vanda from Eli Lilly and Co. (LLY).

VNDA closed Monday's trading at $11.36, down 1.13%. In after-hours, the stock was up over 10% at $12.59.

10. Stocks That Moved On No News

BiondVax Pharmaceuticals Ltd. (BVXV) closed Monday's trading at $51.10, up 22.87%.

Vaccinex Inc. (VCNX) closed Monday's trading at $4.65, up 17.72%.

Aridis Pharmaceuticals Inc. (ARDS) closed Monday's trading at $7.45, up 14.62%.

Nkarta Inc. (NKTX) closed Monday's trading at $38.52, down 19.58%.

Poseida Therapeutics, Inc. (PSTX) closed Monday's trading at $13.48, down 12.18%.

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