Poseida Therapeutics Inc. PSTX, -0.76% shares dropped in the extended session Monday as the biotech drug maker announced a safety trial for a prostate cancer drug had been halted because of a patient death. Poseida shares, which closed the regular session down 0.8% at $13.00 and been halted on the news, dropped as much as 38% after hours, and were last down 32%. In a Securities and Exchange Commission filing, Poseida said the Food and Drug Administration paused the company’s Phase 1 trial for its prostate cancer treatment dubbed P-PSMA-101 to investigate the death of a patient enrolled in the study. The clinical investigator on the study said the death was “possibly” related to the treatment. Poseida launched its initial public offering in July with shares priced at $16 a piece.
Monday, August 17, 2020
Krystal Biotech’s gene therapy an Orphan Drug in U.S. for cystic fibrosis
The FDA has designated Orphan drug tag to Krystal Biotech (NASDAQ:KRYS), to KB407 for cystic fibrosis. KB407 is an inhaled, repeat-dose gene therapy product
Currently the drug candidate is in preclinical studies and the company plans to file an IND in 2021.
Gilead ‘pleased’ with Tango partnership, expands cancer targets in revised deal
Saying it is “very pleased” with the productivity of the collaboration thus far, Gilead Sciences (NASDAQ:GILD) has agreed to expand its 2018 oncology-focused partnership with privately held Tango Therapeutics.
Under the new multiyear agreement, Tango will leverage its proprietary CRISPR-enabled functional genomics target discovery platform to identify novel immune evasion targets, increasing the expected number to 15 from five.
GILD will have options to secure global rights to all programs directed at these targets over the next seven years. It will also have the right to pay option extension fees for Tango to lead through early-stage clinical development. Tango will have the option to co-develop and co-promote the lead products for up to five programs in the U.S.
The partnership excludes Tango’s lead programs. In addition, it has the rights to identify targets outside the immune evasion space.
Under the terms of the revised deal, GILD will pay Tango $125M upfront, invest $20M in Tango equity, have the option to in-license up to 15 programs over the next seven years for up to $410M per program and pay tiered low double-digit royalties on net sales.
Profits and losses will be equally shared on co-developed and co-promoted products in the U.S. while Tango will be eligible for milestone payments and royalties on ex-U.S. sales.
Testing of CanSino’s COVID-19 candidate vaccine begins in Russia
Russia’s Petrovax has started a late-stage trial of a COVID-19 candidate vaccine from CanSino Biologics Inc in the country, records show, as the Chinese drug firm steps up testing abroad to close in on regulatory approval.
The Ad5-nCoV vaccine already has approval for use by China’s military after early and mid-stage trials, and further late-stage trials are being lined up for Mexico and Saudi Arabia.
CanSino last month said it was in talks for opportunities to launch late-stage – or Phase 3 – trials in Saudi Arabia, Russia, Brazil and Chile.
The company has won a patent approval from Beijing for the vaccine, Chinese state media reported on Sunday, citing documents from the country’s intellectual property regulator.
This is the first trial of a potential vaccine developed by a foreign company to take place in Russia, while the country prepares to start mass production of its domestic shot developed by Moscow’s Gamaleya Institute.
Russian pharmaceutical company Petrovax confirmed it was running the trial for CanSino in a statement on Saturday.
If the vaccine is approved in the country, it said it would also produce the shot at its facilities in the Moscow region, with plans to supply the Russian market, as well as CIS countries. It didn’t give further details.
CanSino and compatriots including Sinovac Biotech Ltd and China National Pharmaceutical Group Co Ltd (Sinopharm) are testing candidates overseas as China becomes less conducive for Phase 3 trials due to its small number of new COVID-19 cases.
The completion of Phase 3 trials is generally required for regulatory approval to distribute a vaccine for public use.
Russia’s state register bit.ly/2DSHY0O for clinical trials showed a Phase 3 study of CanSino’s potential shot, expected to recruit 625 participants across eight medical institutes to test the safety and effectiveness of Ad5-nCoV, began on Friday.
CanSino declined to offer more details on the Russian trial when contacted by Reuters, saying the information was confidential.
Last month, Russian biotech group Biocad said it was discussing producing in China a potential COVID-19 vaccine being developed by Russia’s Vector state virology institute.
With 927,745 cases, Russia has the world’s fourth-highest number of infections.
Lannett to exclusively distribute generic Flovent Diskus in US August 17, 2020
Lannett Company (NYSE:LCI) inks an agreement with Respirent Pharmaceuticals Co., Ltd. for exclusive U.S. distribution rights to the latter’s generic version of GlaxoSmithKline’s (NYSE:GSK) asthma med Flovent Diskus (Fluticasone Propionate Powder Inhaler).
Per IQVIA, the U.S. market is $94M.
LCI also has exclusive U.S. distribution rights to Repirent’s generic version of GSK’s Advair Diskus (Fluticasone Propionate – Salmeterol Xinafoate Powder Inhaler), the term of which has been extended to 12 years from 10.
CytoSorbents to commercialize CytoSorb in Northeast, Mid-Atlantic, Fla.
CytoSorbents (NASDAQ:CTSO) has entered into separate agreements with InvoSurg Inc. and Surgical Partners to commercialize CytoSorb under its FDA Emergency Use Authorization (EUA) in adult, critically-ill, COVID-19 patients with imminent or confirmed respiratory failure.
Covering 15 states, Surgical Partners and InvoSurg will work with CytoSorbents to sell and distribute CytoSorb in Florida, and the Northeast and Mid-Atlantic U.S., from Maine to Virginia, respectively.
“CytoSorb is the only FDA EUA blood purification technology to target cytokine storm reduction using CytoSorbents’ proprietary, highly biocompatible polymer beads,” stated Mr. Chris Cramer, Vice President of Business Development of CytoSorbents.
Financial terms are not disclosed.
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