Peloton CEO urges customers to read safety warnings after child dies in treadmill accident

 Peloton Interactive Inc Chief Executive Officer John Foley on Thursday asked owners of its treadmills to check safety warnings after a child died in an accident involving the company’s exercise equipment.

“While we are aware of only a small handful of incidents involving the Tread+ where children have been hurt, each one is devastating to all of us at Peloton,” Foley said in a letter to owners of the Peloton Tread+.

“To prevent accidents, please take care to review and follow all the safety warnings and instructions that we provide,” he said.

Foley also expressed his and Peloton’s condolences to the victim’s family.

Shares of the company fell 2.9% to $104.73 in afternoon trade.

https://www.reuters.com/article/us-peloton-accident/peloton-ceo-urges-customers-to-read-safety-warnings-after-child-dies-in-treadmill-accident-idUSKBN2BA2BX

Senior-focused healthcare platform agilon health files for a $100 million IPO

 agilon health, which provides a senior-focused value-based care platform for primary care physicians, filed on Thursday with the SEC to raise up to $100 million in an initial public offering.

Capitalizing on emerging value-based care opportunities, agilon's model provides the necessary capabilities, capital, and business model for existing physician groups to create a Medicare-centric, globally capitated line of business. Since establishing its inaugural partnership with an anchor physician group in 2017, the company now has 16 anchor physician groups across 17 geographies. The primary care physicians on agilon's platform serve approximately 210,000 patients enrolled in Medicare Advantage, and the company grew total membership by 45% in 2020.

The Long Beach, CA-based company was founded in 2016 and booked $1.2 billion in sales for the 12 months ended December 31, 2020. It plans to list on the NYSE under the symbol AGL. agilon health filed confidentially on December 21, 2020. J.P. Morgan, Goldman Sachs, BofA Securities, Deutsche Bank and Wells Fargo Securities are the joint bookrunners on the deal. No pricing terms were disclosed.

Relevant Profile: AGL

https://www.renaissancecapital.com/IPO-Center/News/79615/Senior-focused-healthcare-platform-agilon-health-files-for-a-$100-million-I

U.S extends travel restrictions at Canada, Mexico land borders

 U.S. land borders with Canada and Mexico will remain closed to non-essential travel until at least April 21, the U.S. government said on Thursday.

The 30-day extension is the second announced under President Joe Biden and comes as U.S lawmakers in northern border states have urged lifting the nearly year-old restrictions to address the COVID-19 pandemic.

In a notice Thursday, the Department of Homeland Security said the three countries have all “determined that non-essential travel ... poses additional risk of transmission and spread of the virus.” Canadian Public Safety Minister Bill Blair confirmed the extension of restrictions on Twitter.

Canada has shown little interest in lifting the restrictions and last month imposed new COVID-19 testing requirements for some Canadians returning at land crossings.

On Jan. 26, the U.S. government began requiring nearly all international air travelers to get negative COVID-19 test results within three days of travel but has no similar requirements for land border crossings.

The Biden administration has spent weeks reviewing whether to impose COVID-19 testing requirements for land border crossings but has not issued new requirements.

In an executive order in January, Biden directed U.S. officials to “immediately commence diplomatic outreach to the governments of Canada and Mexico regarding public health protocols for land ports of entry.”

U.S. lawmakers say Americans who own property in Canada cannot maintain their homes. Border towns and businesses have been hard hit by the lack of cross-border traffic.

Hundreds of thousands of people cross the U.S.-Mexico border daily, and Mexico has extremely limited COVID-19 testing capacity, U.S. officials say.

Representative Tom Massie of Kentucky said at a March 2 hearing a vacationing Kentucky family recently tested positive in Mexico for COVID-19 and could not return to the United States on a flight.

“They flew to Tijuana, walked across the border to the United States, got on an airplane in San Diego and then returned to Kentucky,” Massie said.

https://www.reuters.com/article/us-health-coronavirus-usa-canada/u-s-extends-travel-restrictions-at-canada-mexico-land-borders-idUSKBN2BA1OG

U.S. to send 4M doses of AstraZeneca vaccine to Mexico, Canada in loan deal

 The United States plans to send roughly 4 million doses of AstraZeneca’s COVID-19 vaccine that it is not using to Mexico and Canada in loan deals with the two countries, an administration official told Reuters on Thursday.

Mexico will receive 2.5 million doses of the vaccine and Canada is to receive 1.5 million doses, the official said.

“We’re lending a portion of our releasable doses of AstraZeneca vaccine,” the official said on condition of anonymity. “We only put the virus behind us if we’re helping our global partners.”

White House spokeswoman Jen Psaki confirmed the plan, first reported by Reuters, to send doses to Mexico and Canada. “It is not fully finalized yet but it is our aim,” she told a daily briefing.

The Biden administration has come under pressure from allies worldwide to share vaccines, particularly from AstraZeneca, which is authorized for use in other countries but not yet in the United States.

AstraZeneca has millions of doses made in a U.S. facility, and has said that it would have 30 million shots ready at the beginning of April. The company’s shares rose slightly on the news.

The deal to share the vaccine, which is still being finalized, does not affect President Joe Biden’s plans to have vaccine available for all adults in the United States by the end of May, the official said. It does not reduce the supply of available vaccine in the United States.

The deal is likely to be announced publicly in the coming days.

Two officials said the vaccine would be delivered in “short order” once the deal was completed, but they declined to give a more specific timetable.

The “releasable” vaccines are ready to be used once they arrive. Under the deal, the United States will share doses with Mexico and Canada now with the understanding that they will pay the United States back with doses in return. The official said that would take place later this year.

The United States had no plans to share the vaccine with other countries at this time, he said.

“They are our neighbors, they are our partners,” the official said about Mexico and Canada. Mexican President Andres Manuel Lopez Obrador had requested the vaccine previously. The official said the countries were in touch about the vaccine loan. “We’ve been working through the diplomatic channels,” he said.

Reports of blood disorders have prompted more than a dozen nations to suspend use of AstraZeneca’s vaccine but on Thursday the EU’s drug watchdog said that after an investigation it is still convinced the benefits of that vaccine outweigh the risks.

Biden has said if the United States has a surplus of vaccine, it will share it with the rest of the world. The White House has focused on vaccinating people in the United States, which has seen more than 530,000 people die from virus.

The country was getting prepared to roll out the AstraZeneca vaccine domestically if it gets authorization from the U.S. Food and Drug Administration, the official said.

The official noted that the United States has pledged $4 billion to the COVAX vaccine facility that aims to deliver coronavirus vaccines to poor countries.

The United States does not need the AstraZeneca shots to meet its target of having enough doses for all U.S. adults by the end of May.

The three authorized vaccine makers – Pfizer Inc/BioNTech SE, Moderna Inc, and Johnson & Johnson – have promised to deliver nearly 500 million doses to the United States by then.

https://www.reuters.com/article/us-health-coronavirus-usa-mexico-exclusi/exclusive-u-s-to-send-four-million-doses-of-astrazeneca-vaccine-to-mexico-canada-in-loan-deal-official-idUSKBN2BA22S

EU's drug regulator backs 'safe and effective' AstraZeneca vaccine

 The EU’s drug watchdog said on Thursday it is still convinced the benefits of AstraZeneca’s COVID-19 vaccine outweigh the risks following an investigation into reports of blood clots that prompted more than a dozen nations to suspend its use.

The European Medicines Agency (EMA) director Emer Cooke said the watchdog could not definitively rule out a link between blood clot incidents and the vaccine in its investigation into 30 cases of a rare blood clotting condition.

But she said in a briefing the “clear” conclusion of the review was that the vaccine benefits in protecting people from the risk of death or hospitalisation outweighs the possible risks.

“This is a safe and effective vaccine,” she said.

The agency will, however, update its guidance to include an explanation for the patient about the potential risks and in information for healthcare professionals, she said.

“If it were me, I would be vaccinated tomorrow,” Cooke said.

But EMA wants “to raise awareness among people who have been vaccinated or are going to be vaccinated about things they should look out for,” she said.

The agency has been under growing pressure to clear up safety concerns after a small number of reports in recent weeks of bleeding, blood clots and low platelet counts in people who have received the shot.

The agency’s review covering 5 million people, included 30 cases of unusual blood disorders in people in the European Economic Area (EEA), which links 30 European countries.

Cooke said the EMA is in touch with regulators around the world to keep tabs on possible side-effects of all COVID vaccines.

The EMA’s focus and primary concern has been on cases of blood clots in the head, a rare condition that’s difficult to treat called cerebral venous thrombosis (CVT) or a subform known as cerebral venous sinus thrombosis (CVST), it said earlier this week.More than 45 million of the shots have been administered across the EEA.

At least 13 European countries, including France, Germany and Italy, have stopped administering the shot pending the review, the latest blow to the bloc’s faltering inoculation campaign.

Britain’s medicines regulator said on Thursday it was investigating five cases of CVST among people given AstraZeneca’s vaccine but it also reaffirmed that the benefits of the shot far outweighed any possible risks.

The World Health Organization has also this week reaffirmed its support for the shot.

AstraZeneca has said a review covering more than 17 million people who had received its shots in the EU and Britain had found no evidence of an increased risk of blood clots.

Many governments have said the decision to pause inoculations was out of an abundance of caution.

But experts have warned the political interference could undermine public confidence and hobble the bloc’s slow vaccination campaign as governments struggle to tame more infectious variants.

The bloc’s vaccine roll-out has lagged the United States and former EU member Britain.

https://www.reuters.com/article/us-health-coronavirus-eu-astrazeneca/eus-drug-regulator-backs-safe-and-effective-astrazeneca-vaccine-idUSKBN2BA25E

Exelixis In Collaboration and Supply Agreement with Merck KGaA, Pfizer

 Exelixis Inc. said it is in a clinical trial collaboration and supply agreement with Merck KGaA and Pfizer Inc. for the ongoing phase 1b study of Stellar-001, previously called XL092-001.

The company said this would add three new cohorts that will evaluate the safety and tolerability of XL092 in combination with avelumab in patients with locally advanced or metastatic urothelial carcinoma.

Avelumab is being co-developed and co-commercialized by Merck KGaA and Pfizer. Exelixis is sponsoring the clinical trial and Merck KGaA and Pfizer will provide avelumab for use in the trial.

"Although several therapies are now available to treat bladder cancers, the prognosis for patients with advanced disease remains poor and more options are needed. Evaluating how XL092 may positively impact care when paired with immunotherapy is central to our goal of improving therapeutic outcomes for patients with this and other difficult-to-treat cancers," said Gisela Schwab, president of product development and medical affairs and chief medical officer of Exelixis.

https://www.marketscreener.com/quote/stock/MERCK-KGAA-436395/news/Exelixis-In-Collaboration-and-Supply-Agreement-with-Merck-KGaA-and-Pfizer-32728895/

Pfizer ships out two cancer ADCs alongside its tech platform to Pyxis Oncology

 The hype around antibody-drug conjugates (ADCs) has been growing in recent years after big bucks deals and approvals from the likes of AstraZeneca/Daiichi and Immunomedics putting a spotlight on the approach.

Now, Cambridge, Massachusetts-based biotech Pyxis Oncology is hoping to get in on the action, and it’s tapping one of the world’s biggest pharma companies for that.

In the new deal, financials of which were not made public, Pfizer will out-license two ADC candidates, to be known as PYX-201 and PYX-203, while also giving Pyxis a license for its ADC technology platform, including various payload classes, linker technology and site-specific conjugation techniques “for the future development of additional ADCs.”

While there were no details on actual figures, as part of the deal Pfizer gets an upfront payment and equity in Pyxis, and can also nab development and sales-based milestone payments, as well as tiered royalties on potential sales.

The Big Pharma will also funnel in an equity investment made by its CV arm, Pfizer Ventures. Again, however, they were no figures released.  

“This collaboration represents successful execution of our overarching corporate strategy to marry in-house organic growth with strategic in-licensing and partnerships to develop our multi-asset multi-platform portfolio,” said Lara Sullivan, M.D., CEO of Pyxis.

“We look forward to advancing these candidates to the clinic and ultimately achieving the company’s vision to bring new treatment options to patients with difficult-to-treat cancer.”

Sullivan is no stranger to Pfizer, having spent years as a research at the Big Pharma, before becoming president of Pfizer’s 2017 spinout company SpringWorks. She left back in 2019 to run Pyxis.

The first of the two meds, PYX-201, is a first-in-class non-internalizing ADC that targets a tumor-restricted antigen that is overexpressed in several solid tumor types to selectively kill tumor cells while boosting an anti-cancer immune response.

PYX-203, meanwhile, is an ADC that targets an antigen expressed in certain blood cancers. PYX-203 utilizes a DNA-damaging agent designed to lower the risk of drug resistance and disease relapse.

Pfizer already markets its own ADC, Besponsa (inotuzumab ozogamicin) a CD22-directed ADC for patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL), which came out of a partnership with Celltech/UCB.

Pfizer has a number of ADCs in its pipeline against various targets, though a year back it tossed out PF-06688992, an ADC composed of a monoclonal antibody against the ganglioside GD3. Three years ago it also backed out of a $635 million next-gen antibody-drug conjugates deal with CytomX, originally penning this pact in 2013. It will hope to have better luck with Pyxis.

“The early generations of ADCs demonstrated significant potency, but considerable room remains for innovation to generate highly effective ADCs with an improved safety profile,” added Ronald Herbst, Ph.D., chief scientific officer of Pyxis.

“PYX-201 and PYX-203 represent the next generation of ADCs that use innovative conjugation technologies. By combining highly specific antibodies targeting clinically validated tumor markers with established linkers and both novel and proven payloads, we are excited to translate the extensive validating preclinical studies conducted by Pfizer to an improved clinical profile for patients.”

https://www.fiercebiotech.com/biotech/pfizer-ships-out-two-cancer-adcs-alongside-its-tech-platform-to-pyxis-oncology-and-its