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MRNA, PFE/BNTX COVID-19 Vaccines Move Into Phase 3, CytoDyn On Watch, GNCA To Report Data On Jul.30

biotech july28 lt

Today's Daily Dose brings you news about Moderna moving its COVID-19 vaccine candidate into phase III testing, Pfizer/BioNTech selecting BNT162b2 vaccine candidate for SARS COV-2 to advance into phase II/III trial, positive results from TCR2 Therapeutics' phase I/II trial of TC-210 for mesothelin-expressing solid tumors, Spectrum Pharma's non-small cell lung cancer trial results, and MediciNova joining the COVID-19 vaccine fray, among others.

Read on…

1. CytoDyn to Provide COVID-19 Trial Updates On Jul.30

CytoDyn Inc. (CYDY.OB) is scheduled to host a conference call on July 30, 2020, to provide a comprehensive update on its two trials for COVID-19 patients with mild-to-moderate and severe-to-critical indications.

The company is testing Leronlimab in a phase II trial in mild-to-moderate COVID-19 population and in a phase IIb/III trial in severe and critically ill COVID-19 population.

On July 21, the company announced patient safety data from its over-enrolled COVID-19 phase II trial for mild-to-moderate indications.

CYDY.OB closed Monday's trading at $5.55, up 2.78%.

2. Diffusion Pharma Sees Delay in Patient Enrollment in Phase Ib COVID-19 Study

Diffusion Pharmaceuticals Inc. (DFFN) has been asked by the FDA to make some changes in the design of the proposed phase Ib/IIb study to test trans sodium crocetinate in COVID-19 patients.

As a result of the FDA's suggested protocol modifications and other things, the company now expects enrollment of the first patient in the phase Ib part of the study in August and not in July as was previously estimated.

If all goes well as planned, the first clinical data from the COVID-19 trial is expected to be available early in the fourth quarter of 2020.

DFFN closed Monday's trading at $1.14, down 13.64%.

3. Genocea Gathers Momentum

Shares of Genocea Biosciences Inc. (GNCA) are gathering steam in the run-up to the presentation of data from Part B of its phase I/IIa clinical trial of its personalized cancer vaccine candidate GEN-009.

Part B of the study is evaluating the safety, immunogenicity, and preliminary antitumor activity of GEN-009 in adult patients with cutaneous melanoma, non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), urothelial carcinoma, or renal cell carcinoma. The Company plans to present initial clinical data on the first 5 patients from Part B on July 30.

Data from Part A of the study that evaluated the safety and immunogenicity of GEN-009 as monotherapy in certain solid tumor cancer patients were presented at ASCO20 Virtual Scientific Program.

GNCA touched a new high of $5.74 in intraday trading on Monday, before closing at $5.53, up 23.44%.

4. Lumos Pharma to Get Non-dilutive Capital

Lumos Pharma Inc. (LUMO) has entered into a definitive agreement to sell its Priority Review Voucher, valued at $100 million, to Merck.

The Priority Review Voucher (PRV) was granted in conjunction with the approval by the FDA of ERVEBO, a vaccine developed by Lumos Pharma's licensee, Merck, for the prevention of the Zaire Ebola virus disease.

As per the deal, Lumos Pharma will receive approximately $60 million which represents its 60% interest in the total value of the PRV. The $60 million will be received in two non-contingent payments, $34 million in 2020, and $26 million in the first quarter of 2021.

The sale of the PRV provides an important source of non-dilutive capital to fund additional investment in the pipeline and the evaluation of other assets for potential acquisitions or partnerships, according to Lumos.

As of March 31, 2020, Lumos had cash and cash equivalents totaling $85.8 million.

The company is planning to initiate a phase IIb trial of its lead candidate LUM-201 in pediatric growth hormone deficiency prior to the end of this year.

LUMO closed Monday's trading at $14.81, down 2.89%. In after-hours, the stock was up 20.39% at $17.83.

5. MediciNova Teams Up With BioComo, Mie University to Develop SARS-CoV-2 Vaccine

Shares of MediciNova Inc. (MNOV) touched a new 52-week high of $13.25 in intraday trading after the company announced an agreement with BioComo and Mie University, Japan, for joint development of a SARS-CoV-2 vaccine.

The potential SARS-CoV-2 vaccine uses BC-PIV, a human parainfluenza virus type 2 vector developed by BioComo and Tetsuya Nosaka, professor of the Department of Microbiology and Molecular Genetics, Mie University Graduate School of Medicine.

The development of the novel BC-PIV SARS-CoV-2 vaccine was initiated by BioComo and Mie University in March of this year. BioComo and Mie University have granted MediciNova exclusive worldwide development rights to use BC-PIV for SARS-CoV-2 vaccine development.

BC-PIV SARS-COV-2 vaccine can be developed as an intra-nasal vaccine in addition to an intra-muscular injection because of its high affinity to nasal and upper respiratory tract mucosa, which is the same route of the natural infection of SARS-CoV-2, according to BioComo.

MNOV closed Monday's trading at $11.00, up 95.04%. In after-hours, the stock fell 10.91% to $9.80.

6. Moderna Advances COVID-19 Vaccine Candidate into Phase III Study

Moderna Inc. (MRNA), one of the top contenders in the race to develop a COVID-19 vaccine, has begun its phase III study of mRNA-1273 against the novel coronavirus.

The phase III study, dubbed COVE, is expected to include approximately 30,000 participants in the United States, testing the mRNA-1273 vaccine at a dosage of 100 µg. The primary endpoint will be the prevention of symptomatic COVID-19 disease.

COVE is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases and the Biomedical Advanced Research and Development Authority (BARDA).

Early this month, the company announced that it has completed enrollment of its phase II study of the mRNA-1273 vaccine, which is testing two dose levels - 50 µg and 100 µg.

Only the interim results of phase I study, which tested 25 µg and 100 µg dose levels of the vaccine candidate, have been announced, and they were promising.

Meanwhile, Moderna is involved in a patent dispute with Arbutus Biopharma over a drug-delivery technology. Last week, the U.S. Patent Trial and Appeal Board ruled in favor of Arbutus, sending Moderna's share price down as much as 20%, as investors feared that the mRNA-1273 vaccine could see some patent challenge.

However, Moderna has issued a statement saying that the improved proprietary LNP formula, used to manufacture mRNA-1273, is not covered by the Arbutus patents and that it is not aware of any significant intellectual property impediments for any products it intends to commercialize, including mRNA-1273.

MRNA closed Monday's trading at $79.91, up 9.15%.

7. NGM Biopharma Initiates CATALINA Study

NGM Biopharmaceuticals Inc. (NGM) has initiated a phase II trial of intravitreal injections (IVT) of NGM621 in patients with geographic atrophy secondary to age-related macular degeneration.

The phase II study, dubbed CATALINA, is a multicenter, randomized, double-masked, sham-controlled study evaluating safety and efficacy of intravitreal injections of NGM621 every four or eight weeks for 48 week.

Geographic atrophy, an advanced form of age-related macular degeneration, is a progressive retinal degenerative disease associated with irreversible loss of vision, diminished quality of life, and eventual blindness.

NGM closed Monday's trading at $18.32, up 2.29%.

8. Pfizer/BioNTech Select BNT162b2 to Test in Phase III Trial

Pfizer Inc. (PFE) and BioNTech SE (BNTX) have begun a global phase II/III safety and efficacy clinical study of its modified messenger RNA vaccine candidate BNT162b2.

BNT162b2 is one of the four vaccine candidates in Pfizer/BioNTech's BNT162 mRNA-based vaccine program. During preclinical and clinical studies of the four BNT162 RNA vaccine candidates, BNT162b1 and BNT162b2 emerged as strong candidates based on assessments of safety and immune response.

Of the two, BNT162b2 has been selected to progress to the phase II/III study based on the totality of available data from preclinical and clinical studies, including select immune response and tolerability parameters.

The phase II/III study of BNT162b2 is designed to enroll up to 30,000 participants aged 18 to 85 years and is expected to include approximately 120 sites globally, including 39 states across the United States and countries including Argentina, Brazil, and Germany.

BNTX closed Monday's trading at $86.53, up 2.80%.

9. scPharma To Face FDA In December

scPharmaceuticals Inc.'s (SCPH) resubmitted New Drug Application for FUROSCIX has been accepted for review by the FDA, with a decision date set for December 30, 2020.
FUROSCIX, a proprietary, subcutaneously delivered furosemide solution, is proposed as an outpatient alternative for the treatment of worsening heart failure due to congestion.

This is FUROSCIX's second go-around with the FDA. In June 2018, it was turned down by the regulatory agency.

SCPH closed Monday's trading at $7.37, up 0.82%.

10. Spectrum Pharma's Cohort 2 Trial of ZENITH20 Study Achieves Key Goal

Spectrum Pharmaceuticals Inc.'s (SPPI) ZENITH20, a phase II clinical trial of Poziotinib has met the pre-specified primary endpoint in Cohort 2 in which previously treated non-small cell lung cancer (NSCLC) patients with HER2 exon 20 insertion mutations were enrolled.

The Cohort 2 of the ZENITH20 clinical trial was designed to be a registrational study and it enrolled a total of 90 patients who received an oral, once-daily dose of 16 mg of Poziotinib.

According to the trial results, the median duration of response was 5.1 months, with a median follow up of 8.3 months. The disease control rate (DCR) was 70% and the median progression-free survival was 5.5 months.

The ZENITH20 trial is comprised of 7 independent cohorts. In December 2019, the company reported that the primary endpoint for Cohort 1 was not met but clinical activity was seen. The Cohort 1 involved previously treated non-small-cell lung cancer with EGFR exon 20 insertion mutations.

SPPI closed Monday's trading at $3.24, up 3.51%. In after-hours, the stock was up 70.68% at $5.53.

11. TCR2 Therapeutics' Solid Tumor Candidate TC-210 Shows Promising Results

Shares of TCR2 Therapeutics Inc. (TCRR) jumped more than 25 percent on Monday, following positive interim data from the first five patients treated in the phase I portion of its phase I/II trial of TC-210 for mesothelin-expressing solid tumors.

All five patients showed tumor regression and clinical benefit was observed in the heavily pre-treated cancer patients. TC-210 demonstrated a manageable toxicity profile, with only one patient exhibiting TC-210-related non-hematologic grade >2 toxicity and no evidence of neurotoxicity or on-target, off-tumor toxicity, according to the company.

In other news, the company announced that it has commenced an underwritten public offering of 6 million shares of its common stock.

TCRR closed Monday's trading at $16.39, up 25.11%. In after-hours, the stock gained another 3.72% and was at $17.

12. Stocks That Moved On No News

Fulgent Genetics Inc. (FLGT) closed Monday's trading at $26.46, up 35.62%.

Capricor Therapeutics Inc. (CAPR) closed Monday's trading at $9.81, up 27.07%.

Arcturus Therapeutics Holdings Inc. (ARCT) closed Monday's trading at $63.19, up 17.67%.

iBio Inc. (IBIO) closed Monday's trading at $4.66, down 15.27%.

Altimmune Inc. (ALT) closed Monday's trading at $22.43, down 12.49%.

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