23andMe doses first patient in ph2a anti-tumour monotherapy

 Human genetics and biopharma company, 23andMe Holding Co has announced it has dosed the first patient in the phase 2a portion of its open-label phase 1/2a study (NCT05199272) evaluating 23ME-00610, an investigational antibody targeting CD200R1, in patients with advanced solid malignancies.

The phase 2a portion of the phase 1/2a study will evaluate the anti-tumour activity of the 23ME-00610 monotherapy in multiple, previously disclosed expansion cohorts and seek to further characterise the safety, tolerability, pharmacokinetic and pharmacodynamic profile of 23ME-00610.

The tumour indications for the expansion phase were selected based on pre-clinical and published data of the activity and expression of CD200R1 and its ligand, CD200, together with immune cell and tumour characteristics that have the potential to increase the likelihood of a response to CD200R1 inhibition.

The expansion cohorts will enrol patients with the following: clear cell renal cell carcinoma; epithelial ovarian, fallopian tube, or primary peritoneal carcinoma; neuroendocrine cancers; small cell lung cancer; and microsatellite instability-high (MSI-H) or tumour mutational burden-high (TMB-H) cancers that have progressed on standard therapies. Additionally, adolescents with locally advanced unresectable or metastatic solid malignancies will also be enrolled.

The phase 2a component is to include assessment of objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) in the expansion cohorts, and 23andMe anticipates that it will present an update from the phase 1 dose escalation portion of the study “at a scientific conference this year”. It will also be making investor presentations today and 8th March.

Dr Jennifer Low, head of therapeutics development at 23andMe, said: “We’re pleased that 23ME-00610 has reached this next phase of clinical development and look forward to evaluating this drug candidate in a number of cancers that are inadequately treated with existing therapies.”

Dr Low further commented: “The initiation of the next phase in our evaluation of 23ME-00610 marks an important milestone on this journey, and we appreciate the dedication and contributions of the patients and investigators to our ongoing clinical trial.”

23andMe Holdings Co seeks to help people access, understand, and benefit from the human genome. The company has more than 13.4 million genotyped customers, over 80% of whom consent to participate in research.

Scientists at 23andMe study the aggregate, de-identified genetics of these participants, alongside more than 4 billion self-reported health data points, the bioinformatic analyses aiding discovery of an immuno-oncology genetic signature to pinpoint genes that may be promising targets for cancer immunotherapies. One such target is CD200R1: a receptor found predominantly on immune cells, by targeting CD200R1, 23ME-00610 blocks the receptor on T-cells and myeloid cells, which might restore their ability to kill cancer cells.

In October 2022, 23andMe signed a deal to acquire privately-held Lemonaid Health in a $400 million deal marking a move into the online health sector, having gone public earlier last year through a blank cheque company backed by Virgin Group founder Sir Richard Branson.

https://pharmaphorum.com/news/23andme-doses-first-patient-ph2a-anti-tumour-monotherapy

Leqembi still too pricey, says ICER in updated review

 Drug cost-effectiveness organisation ICER has revised its view of Eisai’s new Alzheimer’s disease therapy Leqembi, but has concluded that the price set by the pharma group is still too high.

The influential organisation said a fair price for the amyloid-busting drug would be between $8,900 and $21,500 per year, a little bit higher than its earlier range of $8,500 and $20,600, but still well below the $26,500 set by Eisai after it was approved in January.

ICER has also reiterated its position that the evidence that Leqembi (lecanemab) has a clinical benefit for patients over supportive care is “promising, but inconclusive,” with chief medical officer David Rind saying that current evidence is that the drug “mildly slows the loss of cognition in patients with early Alzheimer’s.”

He added that the first drug that shows definitively that it can halt or reverse dementia in Alzheimer’s will “warrant a very high price in the US health system.”

At the moment the cost-effectiveness deliberations are somewhat academic, as use of Leqembi remains restricted to subjects in clinical trials, under the limitations imposed by the US Centers for Medicare and Medicaid Services (CMS) for all amyloid-targeting Alzheimer’s therapies, which were slammed by patient organisations as “pernicious” last week.

That could change if the FDA decides to upgrade the current conditional approval of Leqembi to a full approval, which could follow the final results of the phase 3 CLARITY-AD study, which revealed a 27% reduction in cognitive decline compared to placebo at an interim readout.

Those results could be available within a few weeks, and then ICER’s number-crunching could have a bearing on discussions on Medicare reimbursement.

The broad price range reflects the difficulties in appraising new medicines for a complex disease like Alzheimer’s, where there is an incomplete understanding of the underlying molecular mechanisms that could be targeted with disease-modifying therapies.

One big reason for the range is the association between Leqembi and amyloid-related imaging abnormalities (ARIA), a group of side effects that can lead to brain swelling and bleeding, and in some cases has fatal consequences.

Rind said the risk of ARIA with Leqembi introduces “uncertainties as to whether the average benefits of lecanemab exceed its risks.”

ICER’s latest Evidence Report will be up for discussion at a virtual public meeting of the California Technology Assessment Forum (CTAF) on 17th March. It incorporated feedback from the earlier version that was published last year.

ICER also confirmed that it had removed Eli Lilly’s amyloid drug donanemab from its appraisal, after early approval was rejected by the FDA in January.

https://pharmaphorum.com/news/leqembi-still-too-pricey-says-icer-updated-review

Amneal: FDA Filing Acceptance of Abbreviated New Drug Application for Naloxone Generic

 Amneal Pharmaceuticals, Inc. (NYSE: AMRX) today announced the U.S. Food and Drug Administration (FDA) has accepted for review the Abbreviated New Drug Application (ANDA) for naloxone hydrochloride nasal spray, USP, 4mg, which is the generic version of Narcan® and is used in the treatment of a known or suspected opioid overdose emergency.

"Naloxone hydrochloride nasal spray is a critical tool in addressing the opioid public health emergency across the United States," said Andy Boyer, Chief Commercial Officer, Amneal Generics. "We are well prepared to launch this product at a significant scale and substantially increase access to this life-saving medicine as we work to help combat this endemic crisis."

https://finance.yahoo.com/news/amneal-announces-u-fda-filing-110100469.html

Neuralink, other brain-chip makers face long road to FDA approval

 Neuralink, founded in 2016, has yet to receive FDA approval to test its brain chip in humans. Other implant makers have spent years or decades on research to secure U.S. regulatory approvals

SYNCHRON

Synchron, like Neuralink, aims to help patients with severe paralysis control digital devices. It received U.S. approval for human testing in July 2021, five years after applying to the U.S. Food and Drug Administration (FDA). The company first tested its device on four patients in Australia who successfully sent text messages with their minds – no typing required. Synchron recently raised $75 million, including from funds backed by tech billionaires Bill Gates and Jeff Bezos. As of late February, Synchron had implanted two patients with the device out of a total of six planned for its first U.S. trial.

MEDTRONIC

Medtronic is a leader among several companies producing deep-brain stimulation (DBS) devices. The FDA first approved Medtronic’s implant, to treat Parkinson’s disease, in 1997. Since then, more than 175,000 patients have been implanted with the device. The device reduces Parkinson’s tremors and lessens other motor-control symptoms such as stiffness and slowness.

NEUROPACE

NeuroPace, founded in 1997, didn’t secure FDA approval for its brain implant to treat epilepsy until 2013. The device is used by adult patients who have tried at least two medications but still suffer from frequent and disabling seizures, according to the company. The device lessens the frequency of such episodes.

BLACKROCK NEUROTECH

Blackrock Neurotech, established in 2008, has tested its brain implant in humans for almost two decades. It says the device has been shown to enable people with paralysis to control digital devices, prosthetics, and their own limbs. The company had hoped to secure approval to commercialize the implant from the FDA by last year but is still working on it, according to the company.

PRECISION NEUROSCIENCE

Precision Neuroscience, founded in 2021, includes as its co-founder former Neuralink founding member Benjamin Rapoport. The company bills its brain implant as “minimally invasive.” The implant, shaped like a piece of tape, is designed to conform to the surface of the brain. Unlike some other implants, its wires and electrodes do not need to pierce brain tissue, the company says. Like Neuralink, the company has not yet secured approval for clinical trials.

https://finance.yahoo.com/news/factbox-neuralink-other-brain-chip-110706320.html

U.S. unveils new cybersecurity strategy with tighter regulations

 The White House on Thursday announced a new cybersecurity strategy in the latest effort by the U.S. government to bolster its cyber defenses amid a steady increase in hacking and digital crimes targeting the country.

The strategy, which is intended to guide future policy, urges tighter regulation of existing cybersecurity practices across industries and improved collaboration between the government and private sector.

It comes after a series of high-profile hacking incidents by domestic and foreign actors against the United States and amid the military conflict between Russia and Ukraine, in which cyber warfare has featured prominently.

The strategy names China and Russia as the most prominent cybersecurity threats to the United States. On a call with reporters, a U.S. official who declined to be named, said part of the new strategy was aimed at reining in Russian hackers.

"Russia is serving as a de facto safe haven for cybercrime, and ransomware is a predominant issue that we're dealing with today," the official said.

Ransomware attacks, in which cyber criminal gangs seize control of a target's systems and demand ransom payments, are among the most common type of cyber attacks and have impacted a wide range of industries in recent years.

"The criminal justice system isn't going to be able to on its own address this problem – we do need to look at other elements of national power," the official added. "So we're hopeful that Russia understands the consequences of malicious activity in cyberspace, and will continue to be restrained."

The strategy calls for building coalitions with foreign partners "to create pressure on Russia and other malicious actors to change their behavior," said a second U.S. official on the call, who also declined to be named.

"I think we've seen some success in sustaining those coalitions over the last year," the official added.

Among a range of things, the strategy calls for improving standards of patching vulnerabilities in computer systems, and implementing an executive order that would require cloud companies to verify the identity of foreign customers.

https://finance.yahoo.com/news/u-unveils-cybersecurity-strategy-tighter-100604566.html

Biden aims billions in taxpayer money at companies' labor, supply practices

 U.S. President Joe Biden is using $1.5 trillion in new federal spending to continue his push to reshape the U.S. economy, redirect corporate profits and reverse a decades-old decline in the benefits that go to workers.

With a new team of progressive-leaning economic advisers and a fiscal war chest of three massive spending bills, the Biden administration is using new guidelines to pressure companies to expand childcare, produce more in the United States and hire more equitably.

Every president puts his stamp on how federal money is spent, but Biden was using a broader range of tools, including tax changes, implementation of new legislation and stepped-up anti-trust enforcement to affect change, said Ganesh Sitaraman, who heads a new political economy initiative at Vanderbilt University.

"What Biden and his advisers are doing is solving problems that exist in the economy. They are pushing forward an agenda aimed at building things in America again ... and taking on corporate power," he said.

Biden ran on a major reset of the U.S. economy, and against the idea popularized during the Ronald Reagan era that tax cuts for businesses and the wealthy unleash investment that would "trickle down" to the broader economy.

The Commerce Department on Tuesday rolled out the terms for companies to apply for $52 billion in semiconductor manufacturing subsidies that require them to plan for access to child care for their workers, use low-emission energy sources, limit stock buybacks, and allow their workers to unionize.

The $430-billion Inflation Reduction Act gives the U.S. Treasury oversight of $270 billion in tax incentives, which the agency says it is focusing at clean energy projects that pay workers good wages and hire apprentices. A Department of Energy provision in the act requires companies to focus on workforce training, ensure diversity and engage "environmental justice" communities in planning. And the $1 trillion bipartisan Infrastructure bill is stacked with "Made in America" quotas.

https://www.yahoo.com/lifestyle/biden-aims-billions-taxpayer-money-192309168.html

Biden seeks $1.6 bln to tackle COVID relief fraud ahead of Republican probes

President Joe Biden plans to ask Congress to provide $1.6 billion in new funding to tackle fraud tied to U.S. pandemic relief programs and help victims of identity theft, the White House said.

The push, led by White House adviser Gene Sperling, will seek to demonstrate renewed toughness on pandemic fraud ahead of promised investigations by House of Representatives Republicans on the trillions of dollars in COVID-19 pandemic aid approved under both former President Donald Trump, a Republican, and Biden, his Democratic successor.

The aid, among other things, helped pay for expanded unemployment benefits to workers and forgivable loans under the Paycheck Protection Program to companies if they kept workers employed.

The funding request includes $600 million to help investigate large-scale fraud by criminal syndicates, $600 million for fraud and identity theft protection, and $400 million to help victims who have had their identities stolen, according to the White House.

In addition, Biden wants Congress to increase the statute of limitations on serious pandemic unemployment insurance fraud to 10 years, the White House said.

The money would help triple the size of the COVID Strike Force teams created by the Justice Department. In one case, an investigation by the task force recovered $286 million in stolen pandemic relief funds, and investigators have identified several equally important cases, according to the White House.

The money would also help improve the website IdentityTheft.gov to help it provide individuals with a one-stop shop to report identity crimes and to receive personalized identity theft recovery assistance.

The U.S. is already probing many fraud cases pegged to federal assistance programs, such as the Paycheck Protection Program, unemployment insurance and Medicare.

The federal government likely awarded about $5.4 billion in COVID aid to people with questionable Social Security numbers, a federal watchdog said in a report last month.

https://www.yahoo.com/entertainment/biden-seeks-1-6-bln-100000331.html