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Tuesday, April 2, 2024

Biomea Fusion cut to Neutral from Overwreight by JPMorgan

 Target to $14 from $51

https://finviz.com/quote.ashx?t=BMEA&p=d

Facebook Shared Private DMs With Netflix 'For Nearly A Decade' According To Lawsuit

 Facebook parent Meta is alleged to have allowed Netflix to see private user DMs "for nearly a decade" in order to help the streaming giant tailor content to users, according to claims made in an explosive new lawsuit.

According to court documents originally filed last April and finally unsealed on March 23, Netflix and Facebook "enjoyed a special relationship" for "bespoke access" to user data, which Netflix paid over $100 million for.

According to the filing:

By 2013, Netflix had begun entering into a series of “Facebook Extended API” agreements, including a so-called ‘Inbox API’ agreement that allowed Netflix programmatic access to Facebook’s user’s private message inboxes, in exchange for which Netflix would “provide to FB a written report every two weeks that shows daily counts of recommendation sends and recipient clicks by interface, initiation surface, and/or implementation variant (e.g., Facebook vs. non-Facebook recommendation recipients).

...

In August 2013, Facebook provided Netflix with access to its so-called “Titan API,” a private API that allowed a whitelisted partner to access, among other things, Facebook user’s “messaging app and non-app friends.”

The anti-trust class-action lawsuit was filed by two UC citizens, Maximilian Klein and Sarah Grabert, who claim that the two Silicon Valley behemoths agreed to "custom partnerships and integrations that helped supercharge Facebook’s ad targeting and ranking models" from at least 2011 stemming from the personal relationship between Mark Zuckerberg and Netflix co-founder Reed Hastings.

"Within a month" of Hastings joining Facebook's board, the two companies signed an "Inbox API" (Application Programming Interface) which allowed Netflix "programmatic access to Facebook’s user’s private message inboxes," the Daily Mail reports.

In exchange for this data, Netflix would provide Facebook a report every fortnight which showed how users interact with the streaming media platform.

As the Mail notes, Meta and other Silicon Valley companies have been forced to pay millions of dollars in fines for its mishandling of private user information.

In 2022, Ireland fined Meta €265 million ($284 million) after data about more than half a billion users leaked online.

Full names, phone numbers, locations and birthdays of users who used the platform between 2018 and 2019 were leaked online by a 'bad actor' who Meta said exploited a security vulnerability.

That same year, Meta agreed to pay $725million to settle a security breach case related to Cambridge Analytica, the British social media engineering company that was brought into the limelight after its role in the Brexit vote and the 2016 presidential election was exposed. -Daily Mail

In 2018, Facebook's former chief technology officer, Mike Schroepfer, said that as many as 87 million Facebook users had their information improperly shared with Cambridge Analytica. Andrew Bosworth, his successor, said in a leaked email that the Cambridge Analytica scandal was a "non-event," claiming that the data mining company "were snake oil salespeople. The tools they used didn't work, and the scale they used them at wasn't meaningful."

https://www.zerohedge.com/technology/facebook-shared-private-dms-netflix-nearly-decade-according-lawsuit

Ship owner looking to limit liability in Baltimore bridge collapse

 The owner and management company of the cargo ship that crashed into the Francis Scott Key Bridge in Baltimore last week asked a federal judge Monday to limit its legal liability for the deadly bridge collapse. 

In a joint “limitation of liability” filing Monday, Singapore-based Grace Ocean Pte. Ltd., the cargo ship’s owner, and Synergy Marine Pte. Ltd., the ship’s manager, asked a federal court in Maryland to limit their liability to about $43.6 million. 

The vessel is valued at up to $90 million and was owed more than $1.1 million in income from the freight, per the filings. Attorneys noted repair costs will total about $28 million, along with at least $19.5 million for salvage expenses. 

The 984-foot cargo ship, named the Dali, was attempting to leave Baltimore Harbor on its way to Sri Lanka last Tuesday when it lost power and crashed into the Francis Scott Key Bridge. The crash caused the bridge’s span to collapse into the Patapsco River. 

The ship was able to issue a last-minute mayday call to allow police to halt traffic moments before the crash, but eight individuals working on the bridge were unable to get off and were sent into the water when the ship struck.

Two workers were rescued and survived, and divers found two bodies in a submerged truck. The four other workers, who have not been found, are presumed dead. 

Monday’s filing is routine for cases under U.S. maritime law. The companies also used a pre-Civil War provision of maritime law that would let them to seek to limit their liability to the value of the Dali’s remains after the crash, The Associated Press reported.

Morningstar DBRS, a credit rating agency, predicted the incident could amount to the costliest marine insured loss in history, surpassing the record losses from the 2012 Costa Concordia cruise ship accident. The insured losses could total between $2 billion and $4 billion, the agency said. 

The federal court in Maryland will determine who is responsible and how much is owed, though cases of this kind often take years to completely resolve, Martin Davies, director of Tulane University Law School’s Maritime Law Center, told the AP. 

“Although it’s a humongous case with a very unusual set of circumstances, I don’t think it’s going to be that complicated in legal terms,” he said, per the newswire. “All aspects of the law are very clear here, so I think the thing that will take the time here is the facts. What exactly went wrong? What could have been done?”

Experts told the newswire the cost to rebuild the bridge could total at least $400 million, or up to twice of that, depending on the design. 

The collapse has closed the Port of Baltimore, a major shipping hub along the East Coast that provides more than 15,000 direct jobs and more than 139,000 indirect jobs. The U.S. Coast Guard opened an auxiliary channel Monday near the wreckage for commercially essential vessels, the first step in an extensive process to reopen the main channel. 

Officials said while they are trying to get commerce flowing as much as possible, the salvage process will be extensive, and there has been no definitive timeline for when the port could reopen. A tugboat was the first vessel to use the channel Monday. 

https://thehill.com/regulation/court-battles/4569647-ship-owner-looking-to-limit-liability-baltimore-bridge-collapse/

IceCure Submits FDA Regulatory Filing for New XSense™ Cryoablation System

  IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure" or the "Company"), developer of the ProSense® System, a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today announced it has filed a 510(k) submission with the United States Food and Drug Administration ("FDA") for clearance of its next-generation single probe cryoablation system, the XSense™ System and cryoprobes. The filing contains a request for clearance for all of the indications for which ProSense® has already received the requisite FDA clearance, including general minimally invasive cryoablation applications for the kidney, liver, fibroadenomas and neurology.

This new application for IceCure's next-generation single probe XSense™ with cryoprobes is based on the current clearance of the ProSense® System, and is being processed separately from the Company's De Novo application for the breast cancer indication.

https://www.biospace.com/article/releases/icecure-submits-fda-regulatory-filing-for-new-xsense-cryoablation-system-with-cryoprobes/

Gritstone Fails Cancer Vaccine Trial, Plans Phase III and Public Offering

 Despite mixed mid-stage data, Gritstone bio is determined to head to Phase III with its personalized cancer vaccine. The biotech’s stock took a 32% pre-trading plummet Tuesday morning after the preliminary data drop was immediately followed by a public offering announcement.  

GRANITE is Gritstone’s first oncology program. It’s being tested in patients with newly diagnosed, metastatic microsatellite-stable colorectal cancer (MSS-CRC) following a chemotherapy regimen with bevacizumab. 

Patients in the open-label Phase II/III trial showed an early trend toward benefit for GRANITE. However, a short-term circulating tumor DNA (ctDNA) response analysis did not demonstrate a difference in the 39 patients treated versus the 28 in the control arm. Patients on the GRANITE vaccine regimen showed a molecular response of 30%, while the control arm came in at 41.7%. Gritstone pointed to the unanticipated continuation of the drop in ctDNA from induction chemotherapy in both arms, which generated similar short-term response rates. 

“We simply got it wrong,” Gritstone CEO Andrew Allen said in a statement, acknowledging the inherent risk of “pioneering new spaces.” 

Gritstone contends that a long-term analysis of more mature progression-free survival data in the third quarter will still lead to a Phase III regulatory discussion. Median PFS in high-risk patients was 12 months on GRANITE versus seven months in the control arm. 

The population targeted by Gritstone’s most advanced program is a tough one. Metastatic colorectal cancer is the second most common cause of cancer death with up to 97% of patients categorized as metastatic microsatellite stable. These types of patients do not often benefit from checkpoint inhibitors, the company said, adding that their personalized neoantigen-directed vaccine could potentially drive efficacy in a metastatic “cold” tumor.  

A cold tumor is surrounded by cells that suppress immune response to prevent T cells from attacking. J. Randolph Hecht, an investigator in the Phase II/III study, said GRANITE has the potential for benefit in not only MSS-CRC but other cold tumors as well. 

The trial announcement celebrated the early trend in benefit for PFS and extended PFS benefit in high-risk patients. The biotech also pointed out it was able to manufacture a vaccine for each of the 39 patients in the treatment arm with a 100% success rate. 

At the close of 2023, Gritstone projected its cash runway wouldn't take the company through 2024. After posting the Phase II/III data on Monday, Gritstone announced a public offering of $32.5 million.  

In February 2023, the biotech cut 40% of its workforce following a delay of its Phase IIb study for a self-amplifying mRNA COVID-19 vaccine, which cost the company funding from the U.S. Biomedical Advanced Research and Development Authority. 

https://www.biospace.com/article/gritstone-fails-cancer-vaccine-trial-plans-phase-iii-and-public-offering-/

Ipsen Inks Potential $900M Deal with Sutro to Secure Global Rights to Preclinical ADC

 Ipsen is the latest biopharma to close a licensing deal in the hot antibody-drug conjugate market. The French company announced Tuesday that it has signed an agreement securing exclusive global rights to Sutro Biopharma’s STRO-003 preclinical asset in a potential $900 million deal.

Sutro’s STRO-003 antibody-drug conjugate (ADC) candidate is in the final stages of preclinical development and targets the ROR1 tumor antigen, which is known to be overexpressed in many different cancer types including solid tumors and hematological malignancies, according to the company.

Under the agreement, Ipsen will be responsible for Phase I preparation activities including submission of the Investigational New Drug (IND) application, as well as all subsequent clinical development and global commercialization activities. According to the announcement, STRO-003 will be the first ADC candidate to join Ipsen’s portfolio.  

Sutro will get $900 million in potential upfront, development, regulatory, and commercial milestones. This includes around $90 million in near-term payments, such as an equity investment and tiered royalties on sales.

“The potential for ADCs in oncology is well-documented and we are excited by the addition of STRO-003, Ipsen’s first ADC candidate with best-in-class potential,” Mary Jane Hinrichs, head of early development at Ipsen, said in a statement. “STRO-003 is a next-generation ROR1 ADC, leveraging Sutro’s site-specific technology to generate a highly stable conjugate, coupled with exatecan payloads, that have shown significant potential in solid tumors. This is our focus as we prepare to enter Phase I, harnessing Ipsen’s global expertise in oncology development, while also reinforcing our commitment to bringing new medicines to patients with few treatment options.”

This is not the first time that Sutro has partnered with a major biopharma company. In June 2022, Astellas and Sutro forged a global collaboration to discover and develop new immunostimulatory ADCs, paying the San Francisco biotech $90 million upfront. 

In addition to Tuesday’s Ipsen deal, Sutro also announced that it is offering up over 14 million shares of its common stock for $5.18 apiece, which is expected to raise around $75 million before expenses. Sutro is planning to use the cash from this offering for many projects, including boosting the biotech’s working capital, developing its commercialization infrastructure, expanding its manufacturing capabilities, acquisitions and other general purposes. The offering will close on April 4, 2024.

The ADC space continues to attract strong investment, with smaller companies like Tubulis receive  cash injections. Last month, China-based Hansoh Pharmaceutical group expanded its collaboration with Biotheus to obtain a license to its ADC for $694.8 million.

https://www.biospace.com/article/ipsen-inks-potential-900m-deal-with-sutro-to-secure-global-rights-to-preclinical-adc/

PAUL, PETERS BIPARTISAN BIODEFENSE AND LIFE SCIENCE RESEARCH INVESTIGATION

  U.S. Senators Rand Paul (R-KY) and Gary Peters (D-MI), Ranking Member and Chairman of the Senate Homeland Security and Governmental Affairs Committee, announced a joint investigation of national security threats posed by high-risk biological research and technology in the U.S. and abroad. Paul and Peters plan to hold hearings and conduct government-wide oversight on areas including high-risk life science research, biodefense, synthetic biology, biosafety and biosecurity lapses, early warning capabilities for emerging outbreaks or possible attacks, and potential origins of the COVID-19 pandemic. This bipartisan oversight effort will assess and identify measures to mitigate longstanding and emerging risks and threats that may result in serious biological incidents – whether deliberate, accidental, or natural. The investigation will also seek to increase transparency and strengthen oversight of taxpayer-funded life sciences research, laboratories in the U.S. and abroad, and detection of biological threats.   

“It is well past time for the Senate to conduct a bipartisan inquiry into the origins of COVID-19, and, as part of this investigation, we finally will be holding Committee hearings to do just that,” said Ranking Member Paul. “In order to prevent a more catastrophic pandemic from occurring, we must understand the nature of US-funded biotechnology and hold accountable those who engage in risky gain-of-function research. This investigation is groundbreaking, marking the first government-wide examination of taxpayer-funded, high-risk life science research. I’ve been banging on the doors of federal agencies for the past three years, relentlessly seeking information on COVID-19, but it’s been nothing short of a wild goose chase. To prevent repeating past mistakes, it’s crucial we fully comprehend the dangers of engaging in potentially hazardous bioresearch. This involves shining a spotlight on the gaping holes in oversight throughout the federal research processes and procedures.”

“Biotechnologies, such as CRISPR, are rapidly advancing, and our understanding of biological risks and threats is constantly evolving. While many of these advancements have the potential to greatly benefit Americans, we must also ensure we are addressing and minimizing the serious risks they can also pose to our health and national security,” said Senator Peters. “This bipartisan oversight effort will allow us to take a comprehensive look at whether the federal government is taking the necessary steps to keep Americans safe from current and future biological threats.”  

https://www.hsgac.senate.gov/media/reps/paul-and-peters-announce-bipartisan-biodefense-and-life-science-research-investigation/