RCEL On The Move, FTSV Acquired, NCNA On Watch, FDA Nod For SNY, COVID-19 Update
Today’s Daily Dose brings you news about an update on AVITA’s RECELL System, Gilead’s acquisition of Forty Seven, Karyopharm’s multiple myeloma’s trial results, and FDA approval of Sanofi’s Sarclisa.
AVITA Medical Limited (RCEL) has initiated a pivotal study of RECELL System for the reconstruction of skin defects not associated with a burn injury.
The study, designed to enroll at least 65 patients, will compare the clinical performance of conventional skin grafting to the use of the RECELL System in combination with more widely meshed autografts on acute full-thickness non-burn skin defects.
The RECELL System was approved by the FDA in September 2018 for use in the treatment of acute thermal burns in patients 18 years and older. The product is also marketed in Australia and Europe.
Revenue of RECELL System for the six-month period ended December 31, 2019, was A$9.68 million compared to A$1.81 million in the year-ago period.
RCEL closed Monday’s trading at $8.32, up 8.19%.
Forty Seven Inc. (FTSV) is all set to be acquired by Gilead Sciences Inc. (GILD) for $95.50 per share in cash, which equates to a total value of about $4.9 billion.
Forty Seven is a clinical-stage immuno-oncology company and its lead investigational drug is Magrolimab, a humanised monoclonal antibody targeting CD 47, a transmembrane protein overexpressed in many types of cancer.
The transaction is anticipated to close during the second quarter of 2020.
FTSV closed Monday’s trading at $93.91, up 61.91%.
Shares of Karyopharm Therapeutics Inc. (KPTI) touched a new 52-week high on Monday, following positive results from a phase III trial of XPOVIO in multiple myeloma, dubbed BOSTON.
The BOSTON trial evaluated once-weekly XPOVIO in combination with once-weekly Velcade and low-dose dexamethasone compared to standard twice-weekly Velcade plus low-dose dexamethasone in patients with multiple myeloma who have received one to three prior lines of therapy.
The study met its primary endpoint of a statistically significant increase in progression-free survival (PFS). The median PFS in the once-weekly XPOVIO in combination with once-weekly Velcade and low-dose dexamethasone arm was 13.93 months compared to 9.46 months in the twice-weekly Velcade plus low-dose dexamethasone arm, representing a 47% increase in median PFS.
XPOVIO received accelerated approval from the FDA on July 3, 2019, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Karyopharm expects to submit data from the phase III BOSTON study to serve as the confirmatory trial.
The Company is also planning to seek expanded approval of XPOVIO as a second line treatment for patients with relapsed or refractory multiple myeloma.
In other news, the Company announced that it has commenced a registered underwritten public offering of $150 million in shares of its common stock and that it intends to provide the underwriters a 30-day option to purchase up to $22.5 million in shares of its common stock.
KPTI closed Monday’s trading at $27.72, up 69.65%. In after-hours, the stock was down 6.17% at $26.01.
NuCana plc (NCNA), a clinical-stage biopharmaceutical company focused on improving treatment outcomes for cancer patients, is scheduled to make a presentation at the Cowen and Company 40th Annual Health Care Conference on March 3, 2020.
The Company’s drug candidates are based on its proprietary ProTide technology. The lead drug candidate is Acelarin.
— A phase III study of Acelarin plus cisplatin for the first-line treatment of patients with biliary tract cancer, dubbed NuTide:121, is ongoing.
— A phase II study of single-agent Acelarin for patients with platinum-resistant ovarian cancer, dubbed PRO-105, is underway, with data expected this year.
— Last August, enrollment in an investigator-sponsored phase III study of Acelarin as first-line treatment compared to gemcitabine for patients with metastatic pancreatic cancer, dubbed Acelarate, was suspended as the trial was unlikely to meet the goals. Interim data from this trial are expected to be reported this year.
Next up in the pipeline are NUC-3373 and NUC-7738.
— NUC-3373 is under a phase Ib study in patients with advanced colorectal cancer and in phase I testing in patients with advanced solid tumors, with data from both the trials anticipated in 2020.
— NUC-7738 is in phase I development in patients with advanced solid tumors, with data expected this year.
NCNA closed Monday’s trading at $5.99, up 45.74%. In after-hours, the stock was up 11.85% at $6.70.
The FDA has approved Sanofi’s (SNY) Sarclisa in combination with pomalidomide and dexamethasone for the treatment of adults with relapsed refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.
Multiple myeloma is said to be the second most common blood cancer, affecting more than 130,000 patients in the U.S. About 32,000 Americans are diagnosed with multiple myeloma each year.
In a pivotal clinical trial, Sarclisa in combination with pomalidomide and dexamethasone significantly reduced the risk of disease progression or death by 40% compared to pomalidomide and dexamethasone alone.
Sarclisa is expected to be available to patients in the U.S. shortly at a list price of $650 per 100 mg vial and $3,250 per 500 mg vial. For a typical patient in the U.S., between 70-80 kg (154-176 lbs), this correlates to a cost of $5,200 per infusion, noted the Company.
The drug is under review by the European Medicines Agency.
SNY closed Monday’s trading at $48.74, up 5.38%. In after-hours, the stock gained another 1.56% to $49.50.
In the U.S., six people have died due to the novel coronavirus in Washington state and the number of confirmed cases in the nation has risen to 105.
Globally, over 88,000 people have been infected with the virus and more than 3,000 have died – with the vast majority of them being in China.
Outside China, Iran, Italy and South Korea have been worst hit – with Iran reporting 66 deaths, Italy 52 deaths, and South Korea 29 deaths (Source: CNN).
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