Coherus BioSciences Sees Positive Results From Toripalimab Study

 Coherus BioSciences Inc. and Shanghai Junshi Biosciences Co. said they saw positive results from a study evaluating toripalimab plus chemotherapy for the first-line treatment of recurrent or metastatic nasopharyngeal carcinoma.

The companies said the interim analysis met the primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression free survival compared with chemotherapy alone.

The study also met secondary endpoints of progression free survival assessed by the investigator and objective response rate assessed by a blinded independent review committee. There also was a longer duration of response, a higher disease control rate and higher one- and two-year survival rates for the toripalimab arm.

The safety profile of toripalimab was consistent with that observed in previously reported toripalimab clinical trials.

https://www.marketscreener.com/quote/stock/COHERUS-BIOSCIENCES-INC-18460920/news/Coherus-BioSciences-Sees-Positive-Results-From-Toripalimab-Study-35518177/

Surface Oncology in Clinical Trial Collaboration With Roche

 Surface Oncology Inc. on Friday said it is in a clinical trial collaboration with Roche Holding AG to evaluate SRF388 in combination with Roche's atezolizumab and bevacizumab in patients with treatment-naive hepatocellular carcinoma.

The clinical-stage immuno-oncology company said atezolizumab plus bevacizumab has been shown to significantly improve overall survival and is the new standard of care for unresectable or metastatic HCC. Surface said the addition of SRF388 to the proven efficacy of the atezolizumab/bevacizumab regimen has the "potential to further improve outcomes in this challenging disease."

Surface Oncology shares were up 4% to $9.42 in premarket trading.

Surface Oncology also said Friday that SRF388 demonstrated monotherapy activity in data being presented at the American Society of Clinical Oncology Annual Meeting. Surface said SRF388 produced a partial response in a heavily pretreated patient with lung cancer.

Preliminary SRF388 results indicate promising single-agent activity in a heavily pretreated population, including a confirmed partial response demonstrating 66% tumor shrinkage and symptomatic improvement in a patient with squamous cell non-small-cell lung carcinoma.

https://www.marketscreener.com/quote/stock/SURFACE-ONCOLOGY-INC-42796669/news/Surface-Oncology-in-Clinical-Trial-Collaboration-With-Roche-35520640/

Investors, patients await FDA decision on Biogen Alzheimer's drug due Monday

 

U.S. regulators are slated to decided by Monday whether to approve Biogen Inc's controversial Alzheimer's disease drug, and Wall Street analysts and industry observers are deeply divided on its chances of making it over the finish line.

Given the desperate need for anything that can help patients with the mind-wasting disease, some analysts are betting on approval, while others put the chances well below 50%.

If approved, Biogen's aducanumab would be the first treatment to address an underlying cause of the memory-robbing, condition, which is the sixth leading cause of death in the United States.

The Food and Drug Administration decision will impact not only Biogen and its partner Eisai Co Ltd, but other drugmakers developing Alzheimer's drugs such as Eli Lilly and Co. And, as a signal of the agency's permissiveness, the decision could have ramifications for other neurological treatments and the broader pharmaceutical industry.

Aducanumab is an antibody designed to remove amyloid plaque from the brain, but only one of two large-scale trials showed that it significantly slowed progression of the disease. All previous experimental medicines employing the same approach to Alzheimer's so far have failed. Patient advocates are lobbying for the drug to be approved, citing the high unmet medical need, but many doctors remain skeptical.

A panel of outside advisers to the FDA voted in November that aducanumab had not been proven to slow Alzheimer's progression, despite a report from agency staff that said results from the successful trial were persuasive.

"We support a decision for approval of aducanumab ... It ushers in a new era of potential treatments," Dr. Joanne Pike, chief strategy officer at the Alzheimer's Association, told Reuters.

Oppenheimer last month raised to 50% from 33% its odds for an aducanumab approval, citing comments from Biogen that it is preparing for a commercial launch. "If the FDA approves aducanumab, (Biogen) could go to circa $400, and if not, to circa $200," Mizuho Securities analyst Salim Syed said in a recent research note.

Biogen shares were trading near $271 on Thursday, down from their 52-week high of $355.63 reached in November before the advisory committee vote. Bank of America Securities analyst Geoff Meacham said in an interview that he puts the odds at 75% that the FDA will not approve Biogen's drug.

Others said approval remains possible. "I am going out on a limb, saying a two in three chance or so," ISI Group analyst Umer Raffat said in a recent webcast.

Analysts have also speculated that the FDA could proffer a narrow approval - limiting aducanumab's use to certain patients, for instance, or requiring more data to prove that the drug is effective.

Biogen declined to comment on whether the FDA may make such a move.

The FDA's decision may be viewed as a barometer for how strict the agency will be under the Biden administration, which has yet to name an FDA commissioner. Currently, the agency is being run by Acting Commissioner Janet Woodcock.

"If the FDA does approve, I think it could signal probably more regulatory flexibility," BofA's Meacham said.

Aducanumab was studied in patients with early disease who test positive for a component of amyloid brain plaques. Some trial patients needed to be monitored for brain swelling. Biogen estimates that around 1.5 million Americans would be eligible for the drug, which is given by monthly infusion, raising concerns about costs for both diagnostics and treatment. Analysts project annual aducanumab sales of $1.26 billion by 2023, according to Refinitiv data.

https://www.marketscreener.com/quote/stock/EISAI-CO-LTD-6492461/news/Eisai-nbsp-Investors-patients-await-FDA-decision-on-Biogen-Alzheimer-s-drug-due-Monday-35518334/

Putin Plans to Offer Vaccinations to Visiting Foreigners for a Fee

 Russia may provide coronavirus vaccinations for a fee to foreigners who travel to the country, President Vladimir Putin told an economic forum on Friday, as Moscow seeks to enhance its global reputation with its Sputnik V vaccine.

Addressing the St Petersburg International Economic Forum (SPIEF), Putin said many people are coming to Russia to get a shot. "I am asking the government to study this issue in full by the end of the month, to establish conditions for foreign citizens to get vaccinated in our country for a fee," he said without providing more detail.

The Russian vaccine has been approved by 66 nations and is under review both by the World Health Organization and the European Medicines Agency(EMA). Approval by the latter agency is required for use in the European Union.

The pace of vaccination in Russia has been slower than in many developed countries. The health minister said last week around 17 million of Russia's 144 million people had received at least one dose.

Those attending the conference were required to have coronavirus tests and wear masks and gloves. Moscow pitches the gathering as the Russian version of the annual World Economic Forum in Davos, Switzerland. Many other big global events were either cancelled or moved online amid the pandemic.

Attended by a couple thousand people, the SPIEF is intended to attract foreign investment to Russia, but activity was more subdued this year.

Rosneft, Russia's top oil company, skipped its usual booth, and its CEO, Igor Sechin, decided against running a public panel about the global oil market as he has traditionally done.

Sechin, in a mask and gloves, told a Reuters correspondent to "mind a distance" when approached. The former and current CEOs of BP Plc, Bob Dudley and Bernard Looney, were there in masks. BP holds a 19.75% stake in Rosneft.

https://www.usnews.com/news/world/articles/2021-06-04/putin-plans-to-offer-vaccinations-to-visiting-foreigners-for-a-fee

Mexico to apply U.S.-supplied J&J shots to 18-40 year olds along border

 Mexico will administer the Johnson & Johnson vaccine shots it is getting from the United States to 18 to 40 year olds along the Mexico-U.S. border region with the aim of reopening the shared border by late June, Foreign Minister Marcelo Ebrard said on Friday.

Mexican President Andres Manuel Lopez Obrador said on Thursday that following a conversation with U.S. Vice President Kamala Harris, the United States had agreed to send Mexico one million doses of Johnson & Johnson's vaccine against COVID-19.

https://finance.yahoo.com/news/mexico-apply-u-supplied-j-121356060.html

Pakistan produces Chinese CanSinoBio COVID vaccine, brands it PakVac

  Pakistan has started producing the single dose Chinese CanSinoBio COVID-19 vaccine to be able to deliver 3 million doses a month, health officials said.

Branded PakVac, an initial batch of 118,000 doses of the vaccine is ready to be delivered to the government on Friday, the National Institute of Health (NIH) said two days after the inauguration of the production plant in Islamabad.

Pakistan signed a deal with CansinoBio late March to import a concentrate of the vaccine in bulk to process and package the vaccine locally.

"This is a co-production along with CanSino in Pakistan," professor Aamer Ikram, the NIH's executive director, told Reuters.

Ikram said the Chinese firm was supplying a vaccine concentrate which the plant then formulated, processed and packaged. CanSinBio had transferred some of its production technology to Pakistan and is supervising operations, he said.

Quality control was being carried out by Pakistan. "We've acquired technology and expertise to ensure quality control," he said.

The plant will start producing 3 million doses a month starting July, he said.

SELF RELIANCE

At the plant's inauguration on Tuesday, Health Minister Faisal Sultan described the local production a "milestone in the journey to achieve to self-reliance".

Both him and Ikram said the transfer of technology could help Pakistan to eventually manufacture the vaccine.

To be more cost effective, 10 doses of PakVac will be filled into one vial.

According to the officials PakVac will save around 25% on vaccine cost, which according to government figures amounts to $250 million so far.

Pakistan, which has a population of 220 million people, faced initial vaccination hesitancy and a shortage of vaccine supplies, but last week started mass vaccination for all adults.

It has so far relied heavily on its ally China in vaccine procurement and of the six vaccines approved for use in Pakistan, three - Sinopharm, SinoVac and CanSinoBio - are from China.

The government says it has procured over 18 million vaccine doses via purchases or donations from China and allocations from the World Health Organisation and the GAVI Vaccine Alliance.

The inoculation programme has administered 8.5 million doses of coronavirus vaccines so far, according to official figures. Pakistan reported more than 928,000 coronavirus infections and 21,105 deaths, with 1,893 cases and 83 fatalities on Friday.

Pakistan's biotech and pharmaceutical industry is underdeveloped and the country produces few vaccines.

"Our cooperation not only effectively contributes to Pakistan's efforts in fighting against the COVID-19 ... it reduces its dependence of the vaccine import," said Chinese ambassador to Pakistan Nong Rong said at the plant's inauguration.

https://news.trust.org/item/20210604135759-p1mmb/

Britain says G7 countries in health agreement for clinical trials boost

 Britain said that the G7 group of advanced economies agreed on Friday to speed up and share results from clinical trials on, for instance, vaccines to better tackle the COVID-19 pandemic and future threats to global health.

The G7 Therapeutics and Vaccines Clinical Trials charter sets out shared principles to accelerate the speed with which clinical trials generate evidence to enable timely and decisive action on findings, said Britain’s health ministry.

“It contains a series of measures to make us all safer by improving clinical trials, quicker and wider access to safe vaccines, better use of data, more accurate health surveillance tools and greater collaboration between countries,” British health minister Matt Hancock said in a statement on Friday.

https://www.metro.us/britain-says-g7-countries/