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Thursday, March 2, 2023

Confo hands baton to Lilly for non-opioid pain med development in $40M upfront deal

 Eli Lilly will take the baton on developing a peripheral pain candidate from Confo Therapeutics, handing off $40 million upfront and a potential $590 million total down the track if all goes well.

Confo has been developing CFTX-1554 in phase 1 as a non-opioid option for neuropathic pain. The condition is caused by damage to the nerves outside of the brain and spinal cord. The therapy could also eventually be developed in other pain indications.

The biotech hopes that CFTX-1554 can address pain without causing side effects common with opioids and other pain meds such as addiction and sedation. The therapy is an inhibitor of the angiotensin II type 2 receptor. Confo believes CFTX-1554 can overcome challenges other companies have had in targeting this receptor.

Lilly will continue clinical development of the therapy beyond phase 1. Dosing in an early-stage study got underway in healthy participants in March 2022.

Lilly will pay out a $40 million upfront fee and the remaining $590 million based on milestones, plus royalties. The agreement also includes a program to develop Confo’s existing therapeutic antibody candidates that target the same receptor as CFTX-1554. Confo will continue to hold a co-investment option and could fund future development programs after clinical proof-of-concept for additional royalties.

Confo will turn to its small-molecule and biologics GPCR-targeted assets, said CEO Cedric Ververken.

Lilly, which markets migraine drugs Emgality and Reyvow, is no stranger to pain meds. CFTX-1554 will join the Big Pharma's portfolio of clinical-stage pain treatments that already spans three candidates, all of which are in phase 2 trials. There's a P2X7 receptor antagonist acquired from Asahi Kasei Pharma in 2021 for chronic pain conditions, a transient receptor potential ankyrin 1 antagonist being tested as a non-opioid treatment for chronic pain conditions and an SSTR4 agonist.

https://www.fiercebiotech.com/biotech/confo-hands-baton-lilly-non-opioids-pain-med-development

Genenta: FDA Grants Orphan Drug Designation for Treatment of Glioblastoma

 Genenta Science (NASDAQ: GNTA), a clinical-stage immuno-oncology company developing a cell-based platform harnessing the power of hematopoietic stem cells to provide durable and safe treatments for solid tumors, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Temferon™ for the treatment of glioblastoma multiforme (GBM).

https://finance.yahoo.com/news/fda-grants-orphan-drug-designation-114500847.html

Aldeyra: Priority Review for Retinal Cancer Trial

PDUFA Date is June 21, 2023

Planned U.S. Launch of ADX-2191 in Second Half of 2023, Pending Approval by the FDA

ADX-2191 with Potential to be the First FDA-Approved Drug Available for Patients Suffering from Primary Vitreoretinal Lymphoma

https://finance.yahoo.com/news/fda-accepts-priority-review-adx-120000024.html

Bristol Myers Squibb-Janssen Start Pivotal Phase 3 Stroke Therapy Trial

 Bristol Myers Squibb (NYSE: BMY) in collaboration with Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson and Johnson (Janssen) today announced the launch of the Phase 3 Librexia program studying milvexian, an investigational oral factor XIa (FXIa) inhibitor (antithrombotic).

The Librexia program is unrivaled as the most comprehensive FXIa development program to date and will provide important data from nearly 50,000 patients across three indication-seeking studies: Librexia STROKELibrexia ACS and Librexia AFEnrollment has begun for the Librexia STROKE trial, which is evaluating milvexian in addition to standard of care antiplatelet therapy for stroke prevention in patients after an acute ischemic stroke or high-risk transient ischemic attack. The Librexia ACS trial, which will evaluate event reduction in acute coronary syndromes in addition to standard of care antiplatelet therapy, and the Librexia AF trial, which will investigate milvexian compared to apixaban in the prevention of stroke in patients with atrial fibrillation, will also initiate during the first half of 2023.

https://finance.yahoo.com/news/bristol-myers-squibb-janssen-collaboration-115900398.html

Avadel Requests Final FDA Approval for Narcolepsy Treatment

 Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced today that it has submitted an amendment to the U.S. Food and Drug Administration (“FDA”) requesting final approval for LUMRYZ for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy. This submission follows a unanimous 3-0 panel decision by the United States Court of Appeals for the Federal Court (“Fed Circuit”) on February 24, affirming the previous ruling from the United States District Court for the District of Delaware (the “Delaware Court”), ordering Jazz Pharmaceuticals (“Jazz”) to delist its U.S. Patent No. 8,731,963 (“REMS Patent”) from FDA’s Orange Book. Jazz submitted its request to delist the REMS Patent to FDA on February 28.

https://finance.yahoo.com/news/avadel-pharmaceuticals-requests-final-fda-120000259.html

BioRestorative: Patent Application OKd for ThermoStem® Program

  BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX), a clinical stage company focused on stem cell-based therapies, today announced that the United States Patent and Trademark Office has issued a notice of allowance for a patent application related to the Company’s metabolic ThermoStem® program. The notice of allowance was issued on February 24, 2023.

https://finance.yahoo.com/news/biorestorative-therapies-receives-notice-allowance-123000515.html

UK PM Backs Official COVID-19 Inquiry After 100,000 WhatsApp Messages Released To Newspaper

 by Owen Evans and Alexander Zhang via The Epoch Times,

Prime Minister Rishi Sunak has defended an official COVID-19 inquiry as the “right way” to scrutinise the handling of the pandemic after former Health Secretary Matt Hancock’s WhatsApp messages were published in a British newspaper.

Based on a trove of more than 100,000 WhatsApp messages, The Daily Telegraph newspaper claimed on March 1 that England’s Chief Medical Officer Sir Chris Whitty advised Hancock in April 2020 that everyone going into care homes should be tested for COVID-19.

The relevant exchanges, from April 14, 2020, suggested that Hancock rejected the guidance, telling an aide the move just “muddies the waters” and introduced mandatory testing only for those coming from hospitals rather than the community.

Following the report, Hancock, who resigned in June 2021, disputed the claims made by the Telegraph, calling them “flat wrong,” and claiming the messages had been “spun to fit an anti-lockdown agenda.”

The Epoch Times hasn’t seen the texts and hasn’t been able to independently verify the claims.

British Prime Minister Rishi Sunak departs Downing Street ahead of the weekly Prime Ministers Questions in the House of Commons, in London, on March 1, 2023. (Dan Kitwood/Getty Images)

‘Colossal Whitewash’

Hancock had willingly given his WhatsApp messages to journalist Isabel Oakeshott to co-write a book called “Pandemic Diaries.”

In a piece in The Telegraph, titled “I had to release Matt Hancock’s COVID WhatsApp messages to avoid a whitewash,” Oakeshott wrote that following his resignation in June 2021, he downloaded the records from his phone and shared them with various people, including her.

“Suffice to say there was plenty of important material left over,” she said, calling the texts “a vital historical record at a time when we need urgent answers.”

Oakeshott, who has described COVID-19 lockdowns as an “unmitigated disaster,” said she was releasing the messages because it would take “many years” before the end of the official inquiry into the pandemic response, which she claimed could be a “colossal whitewash.”

“That’s why I’ve decided to release this sensational cache of private communications—because we absolutely cannot wait any longer for answers,” she said.

Official Inquiry

At Prime Minister’s Questions on March 1, Labour leader Sir Keir Starmer called on Sunak to ensure the official inquiry had all the support it needed “to report by the end of this year.”

Mentioning the Telegraph report, he said, “Now we don’t know the truth of what happened yet—there are too many messages and too many unknowns.”

“Families across the country will look at this, and the sight of politicians writing books portraying them as heroes or selectively leaking messages will be an insulting and ghoulish spectacle for them.”

Starmer said that the UK COVID-19 Inquiry—which has been set up to examine the UK’s response to and impact of the COVID-19 pandemic—has cost the taxpayer £85 million but “hasn’t heard from a single minster yet.”

Sunak insisted the official inquiry is the “right way” to investigate the government’s handling of the pandemic after Hancock’s messages made the headlines.

“There is a proper process to these things, it is an independent inquiry, it has the resources it needs, it has the powers it needs. And what we should do in this House is to let them get on and do their job,” he said.

‘Anti-Lockdown Agenda’

A spokesman for Hancock strongly disputed the claims made in the Telegraph report.

“These stolen messages have been doctored to create a false story that Matt rejected clinical advice on care home testing. This is flat wrong,” the spokesman said.

“On April 14, Matt received a response to his request for advice from the chief medical officer that testing was needed for people going into care homes, which he enthusiastically accepted.

“Later that day he convened an operational meeting on delivering testing for care homes, where he was advised it was not currently possible to test everyone entering care homes, which he also accepted.

“Matt concluded that the testing of people leaving hospital for care homes should be prioritised because of the higher risks of transmission, as it wasn’t possible to mandate everyone going into care homes got tested.”

The spokesman said that the Telegraph report left out a key part of a WhatsApp message, which demonstrated “there was a meeting at which advice on deliverability was given.”

“By omitting this, the messages imply Matt simply overruled clinical advice. That is categorically untrue. He went as far as was possible, as fast as possible, to expand testing and save lives.”

The spokesman added that it’s outrageous that “this distorted account of the pandemic is being pushed with partial leaks, spun to fit an anti-lockdown agenda.”

But the Telegraph’s Associate Editor Camilla Tominey denied the paper had doctored the WhatsApp messages, calling the allegation “simply not true.”

Talking to the BBC, she also defended Oakeshott after the journalist was accused of breaching a nondisclosure agreement signed when working on Hancock’s memoir.

“I support Isabel’s decision-making wholeheartedly. In the interest of openness, transparency, and accountability, she felt that she was sitting on a huge amount of information that the public had a right to know.”

https://www.zerohedge.com/political/uk-pm-backs-official-covid-19-inquiry-after-100000-whatsapp-messages-released-newspaper