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Tuesday, May 18, 2021

Exact Sciences Applauds Recommendation To Lowers Starting Age for Colorectal Cancer Screening to 45

National Task Force supports Cologuard® as a screening option and screening expands to an additional ˜19 million Americans

The United States Preventive Services Task Force (USPSTF) today released its final colorectal cancer screening recommendation that screening begin at age 45. Exact Sciences' (NASDAQ: EXAS) Cologuard®, referred to as sDNA-FIT, is included as a recommended screening option for all average-risk patients between the ages of 45 and 75.

https://finance.yahoo.com/news/exact-sciences-applauds-final-task-000500888.html

Iovance updates on FDA assay comments

 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, today announced receipt of regulatory feedback from the U.S. Food and Drug Administration (FDA) regarding its potency assays for lifileucel. Previously, the company reported the submission of assay data to the FDA and recently the FDA provided comments regarding the data package.

Following FDA feedback, Iovance will continue its ongoing work developing and validating its potency assays and plans to submit additional assay data and to meet with the FDA in the second half of 2021. The company's biologics license application (BLA) submission for lifileucel is now expected to occur during the first half of 2022.

“TIL is a first-in-class, one-time administration cell therapy and the first potential BLA for a cell therapy in solid tumors,” stated Maria Fardis, Ph.D., MBA, Iovance President and Chief Executive Officer. “As such, TIL product is complex by nature and alignment with FDA on a potency assay is an important step toward BLA submission. With a regenerative medicines advanced therapy (RMAT) designation for lifileucel, FDA recognizes the unmet need for patients with metastatic melanoma who progress after anti-PD1 therapy.”

https://finance.yahoo.com/news/iovance-biotherapeutics-provides-regulatory-lifileucel-203000277.html

Sarepta posts positive data from Duchenne study

 

  • Results from the first 11 participants enrolled in Study 9001-103 ENDEAVOR showed robust transduction, delivering mean vector genome copies of 3.87 per nucleus

  • Treated patients achieved mean micro-dystrophin expression levels of 55.4% of normal as measured by western blot

  • Micro-dystrophin was properly localized to the muscle sarcolemma, with patients achieving mean percentage of dystrophin positive fibers of 70.5% and intensity of micro-dystrophin expression of 116.9% of normal control, as measured by immunofluorescence (IF)

  • Safety profile consistent with prior studies and no new safety signals identified

Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced positive 12-week expression and safety results from the first 11 participants enrolled in Study SRP-9001-103, an open-label study known as ENDEAVOR being conducted in partnership with Roche. In results from the first clinical study using commercially representative material, SRP-9001 (rAAVrh74.MHCK7.micro-dystrophin) demonstrated robust expression of micro-dystrophin and no new safety signals from prior studies, supporting its potentially differentiated profile for the treatment of Duchenne muscular dystrophy. SRP-9001 is an investigational gene transfer therapy intended to deliver its micro-dystrophin-encoding gene to muscle tissue for the targeted production of the micro-dystrophin protein.

“We are delighted by these seminal results from the ENDEAVOR Study, our first trial results with SRP-9001 made by our commercial-scale manufacturing process. These data show strong transduction of the micro-dystrophin gene, resulting in robust expression of the properly localized micro-dystrophin protein, and did so with no new or unexpected safety signals,” said Doug Ingram, president and chief executive officer, Sarepta. “In addition to characterizing and differentiating SRP-9001, these results confirm the extraordinary work done over the last two and a half years to build an at-scale gene therapy manufacturing process and corresponding analytics sufficient to meet the needs of the Duchenne population with what we believe will be a potentially life-changing therapy. Armed with these data, we will seek a meeting with the FDA with the goal of rapidly starting our registrational study.”


https://finance.yahoo.com/news/sarepta-therapeutics-investigational-gene-therapy-125000922.html


Nektar publishes on positive anti-tumor study data

 Results demonstrate NKTR-255's differentiated pharmacologic profile versus precomplexed IL-15 agonists, supporting its potential as a potent immunotherapy agent --

Nektar Therapeutics (Nasdaq: NKTR) today announced the publication of preclinical data from its second major immuno-oncology cytokine program, NKTR-255, in the Journal for ImmunoTherapy of Cancer (JITC). NKTR-255 is a novel recombinant human Interleukin-15 (rhIL-15) receptor agonist designed to activate the IL-15 pathway to expand both natural killer (NK) cells and memory CD8+ T cell populations. The published data demonstrate that NKTR-255 retains the full spectrum of IL-15 biology but with improved pharmacologic properties and anti-tumor activity versus other rhIL-15 agonists. These preclinical findings support Nektar's robust clinical development program for NKTR-255 in patients with hematologic malignancies and solid tumors.

https://finance.yahoo.com/news/nektar-therapeutics-announces-first-publication-120000993.html

Onconova started at Buy by Guggenheim

 Target $4

https://finviz.com/quote.ashx?t=ONTX

India Unlikely to Resume Sizable COVID-19 Vaccine Exports Until October

 India is unlikely to resume major exports of COVID-19 vaccines until at least October as it diverts shots for domestic use, three government sources said, a longer-than-expected delay set to worsen supply shortages from the global COVAX initiative.

Battling the world's biggest jump in coronavirus infections, India halted vaccine exports a month ago after donating or selling more than 66 million doses. The move has left countries including Bangladesh, Nepal, Sri Lanka and many in Africa scrambling for alternate supplies.

The World Health Organization, which co-leads COVAX, on Monday called on vaccine makers outside India to advance supplies to the programme given the shortfall from the South Asian country.

The sources, who spoke to Reuters on the condition of anonymity as they were not authorised to talk to media on the subject, said India's vaccination drive will now take priority as its tally of coronavirus infections crosses 25 million and daily death toll hits a record high.

"We don't have to officially convey to all countries as we are not obligated to do," one of the sources said about the decision to hold back exports. "It was internally discussed and some countries were asked not to expect export commitments given the current Indian situation."

The source did not name the countries told about the delay.

The other two sources said the exact timing for resuming exports could change depending on how soon India is able to control the second wave of cases that has overwhelmed the health system.

India's Ministry of External Affairs, which is coordinating and overseeing all vaccine exports, did not respond to a request for comment on the matter.

'TRULY DREADFUL WAVE'

A spokesman for Serum Institute of India, the world's biggest vaccine maker, said the focus for now is on supplying vaccines to India. It had previously expected shipments to restart from June.

Asked about the October timeline, COVAX co-lead GAVI told Reuters at least 140 million doses it had expected from the Serum Institute by the end of May will now remain in India.

"As India confronts a truly dreadful wave of the pandemic, Indian vaccine production, including the 140 million vaccine doses initially destined for COVAX, have been committed to protecting its own citizens," a GAVI spokeswoman said in an email.

"We offer the government of India our full support in their effort to bring the virus under control and stand ready to help in any way we can."

COVAX has a deal with the Serum Institute to deliver 1.1 billion doses of either the AstraZeneca or Novavax shots.

The head of UNICEF on Monday asked G7 countries to donate supplies to COVAX as an emergency measure to address a severe shortfall caused by disruptions to Indian vaccine exports.

UNICEF, which is helping supply COVID-19 vaccines through COVAX, estimates the supply shortfall at about 190 million by the end of June.

U.S. President Joe Biden said on Monday his country would export at least 20 million doses of the Pfizer/BioNTech, Moderna and Johnson & Johnson shots, on top of 60 million AstraZeneca doses he had already planned to give to other countries.

Biden's move came as WHO Director-General Tedros Adhanom Ghebreyesus warned the world has reached a situation of "vaccine apartheid", calling on wealthier nations and vaccine producers to increase vaccine sharing.

https://www.usnews.com/news/world/articles/2021-05-18/exclusive-india-unlikely-to-resume-sizable-covid-19-vaccine-exports-until-october-sources

Novartis's Sandoz to Invest in Antibiotic Manufacturing in Europe

 Novartis AG said Tuesday that its generics division Sandoz is investing in new antibiotics-manufacturing technology in Europe over the next three to five years, expanding two sites and foreseeing the closure of a third.

The investment, which amounts to a total of 150 million euros ($182.3 million), is for the company's facilities in Kundl, Austria, and Palafolls, Spain, Novartis said.

As part of the plan, Sandoz is set to phase out its current production of active pharmaceutical ingredients at its Les Franqueses site in Spain, which it plans to close by 2024, Novartis said. Production of sterile active pharmaceutical ingredients is set to be transferred from Kundl to Palafolls in 2025, according to Novartis.

The company added that it would offer full support to employees who might be affected by the changes.

https://www.marketscreener.com/quote/stock/NOVARTIS-AG-9364983/news/Novartis-s-Sandoz-to-Invest-in-Antibiotic-Manufacturing-in-Europe-33286757/