Polio detected in NYC sewage suggesting local circulation of virus

 Polio has been detected in New York City wastewater, suggesting local circulation of the virus, health officials said on Friday.

New York State Health Commissioner Dr. Mary Bassett called the findings alarming. Bassett said local and federal health officials are aggressively assessing how far polio has spread in the city and in New York state.

“For every one case of paralytic polio identified, hundreds more may be undetected,” Bassett said. ”The best way to keep adults and children polio-free is through safe and effective immunization.”

Polio can result in permanent paralysis of the arms and legs and death in some cases. Health officials are calling on people who are not vaccinated to get their shots immediately.

Routine vaccinations among children have declined in New York City since 2019, which has increased the risk of outbreaks, according to health officials. About 14% of New York City children ages 6 months to 5 years old have not completed their vaccination series against polio, which means they are not fully protected against the virus.

Overall, 86% of children ages 5 and under in New York City have received three doses of the polio vaccine, according to health officials. But there are some neighborhoods in the city where less than 70% of children are up to date on their polio vaccines, which puts kids in these communities at risk of catching polio.

New York state health officials confirmed last month that an unvaccinated adult in Rockland County, a suburb of New York City, caught polio and suffered paralysis. Polio was subsequently detected in sewage in Rockland County and neighboring Orange County.

The strain that the unvaccinated adult caught is genetically linked to the sewage samples in Rockland and Orange counties. It’s unclear where the chain of transmission began, but health officials have said the sewage samples indicate there’s local spread of the virus in the New York City metropolitan area.

One in 25 people who catch polio develop viral meningitis and one in 200 will become paralyzed, according to health officials. Most people who catch polio do not develop symptoms, though some have symptoms similar to the flu such as sore throat, fever, fatigue, nausea and stomach pain. There is no cure for the disease, but it can be prevented through vaccination.

“The risk to New Yorkers is real but the defense is so simple – get vaccinated against polio,” said New York City Health Commissioner Dr. Ashwin Vasan.

Children should receive four doses of the vaccine: One dose at 6 weeks through 2 months, a second dose at 4 months, a third at 6 months through 18 months, and a fourth at ages 4 to 6 years old.

People who are unvaccinated and older than age 4 should receive three doses of the vaccine. Adults who have received only one or two should get another one or two, no matter how long it has been since the earlier doses.

The U.S. was declared polio free in 1979, though travelers have occasionally brought the virus into the country, according to the Centers for Disease Control and Prevention. New York state last confirmed a case in 1990 and the U.S. previously confirmed a case in 2013.

Polio struck fear into parents’ hearts in the 1940s before vaccines were available. More than 35,000 people became paralyzed from polio every year during that period, according to the CDC.

But a successful vaccination campaign in the 1950s and 1960s dramatically reduced the number of infections.

https://www.cnbc.com/2022/08/12/polio-detected-in-new-york-city-sewage-suggesting-local-circulation-of-virus-health-officials-say.html

'Rewiring the Brain' to Treat Tinnitus

 Researchers from the University of Auckland have found that the use of a cell phone technology-based polytherapeutic that delivers white noise can improve symptoms for people suffering from tinnitus.

The ringing, buzzing or whistling noise associated with tinnitus, noises that no one else can hear, can be disruptive to one's life. There have been multiple attempts to develop therapies for tinnitus, but so far, none have been approved in the United States. Now, researchers from New Zealand believe they may have found a solution where others have failed.

The approach includes using an app on a mobile device, as well as "Bluetooth bone conduction headphones, neck pillow speaker and a cloud-based clinician dashboard" that enables messaging and app personalization, according to the study methodology. In a study of 61 patients, the participants were randomized 1:1 to use the prototype of the digital polytherapeutic or a self-help app available on mobile devices that produced white noise. 

Prior to the use of the technology, a patient is screened by an audiologist who develops a personalized treatment plan for each patient. The plan combines a range of digital tools that are based on the patient's experience with tinnitus.

The research team reported that patients who used the digital polytherapeutic saw "clinically significant improvements" in 12 weeks compared to those who used the white noise app. The research team said their digital polytherapeutic "rewires the brain" to de-emphasize the sounds associated with tinnitus. The rewiring turns the ringing or buzzing into a kind of background noise that "has no meaning or relevance to the listener," Grant Searchfield, an associate professor in audiology at the university, told Neuroscience News.

"Earlier trials have found white noise, goal-based counseling, goal-oriented games and other technology-based therapies are effective for some people some of the time," Searchfield told the publication. "This is quicker and more effective, taking 12 weeks rather than 12 months for more individuals to gain some control."

Study results have been published in Frontiers in Neurology.

Phil Sanders, another research team member, expressed his excitement for the patients who saw improvements. For many participants, Sanders said tinnitus had been "taking over their lives or attention."

For the New Zealand team, the next steps include refining their prototype and running larger clinical studies that could lead to potential regulatory approval in the U.S. and elsewhere. 

Tinnitus is a common issue that affects more than 50 million people in the U.S.. Unlike cancer or Parkinson's disease, tinnitus isn't a disease. Instead, it's the symptom of other medical issues, although the exact cause is unknown. Healthcare providers believe the problem is caused by abnormal activity in the parts of the brain responsible for processing sound, the Cleveland Clinic reports.  

There is no drug for tinnitus, although some have tried to develop one. In 2018, Auris Medical saw its Phase III tinnitus treatment Keyzilen fail to meet endpoints. It was the second time the therapy failed in the clinic. 

Elon Musk is also looking at tinnitus. The entrepreneur who helped launch Neuralink has been developing a brain-computer interface that has applications in multiple areas, including tinnitus. In addition to tinnitus, Musk hopes the neural lace technology may provide people with severe spinal cord injuries the ability to use computers with only their brains. However, before either of these applications can be tested in humans, Neuralink will have to enter the clinic. 

https://www.biospace.com/article/new-zealand-team-takes-brain-rewiring-approach-to-treating-tinnitus/

AstraZeneca, Daiichi Sankyo’s Enhertu 1st HER2-Directed Therapy for NSCLC

 AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu has been approved by the U.S. Food and Drug Administration as the first HER2-directed medicine for patients with HER2-mutant metastatic NSCLC, a particularly lethal form of the disease.

Friday morning, the two companies announced that Enhertu (trastuzumab deruxtecan) was approved for the treatment of patients diagnosed with unresectable or metastatic NSCLC whose tumors have activating HER2 mutations. The FDA’s nod was granted under the accelerated approval pathway based on the objective response rate of 57.7% and a duration of response seen in clinical studies. AstraZeneca and Daiichi Sankyo noted that additional clinical data may be required by the FDA from a confirmatory trial due to the parameters of accelerated approval.

Ahead of approval, Enhertu was granted both Breakthrough Therapy designation and Priority Review for this indication. HER2, a tyrosine kinase receptor growth-promoting protein, is expressed on multiple tumor types, including lung, breast, gastric and colorectal cancers. The mutated forms of HER2 have been recognized as a legitimate target. 

In NSCLC, the most common form of lung cancer, HER2 mutations occur in 2% to 4% of patients. Bob T. Li, an oncologist at Memorial Sloan Kettering Cancer Center, called the approval an important milestone for lung cancer.

“After two decades of research into the role of targeting HER2 in lung cancer, the approval of the first HER2-directed treatment option validates HER2 as an actionable target in lung cancer and marks an important step forward for treating this patient population with unmet medical needs,” Li said in a statement.

The approval also marks the third tumor type the FDA has approved Enhertu for in three years. The other two indications are breast and gastric cancers.

Ken Keller, president and chief executive officer of Daiichi Sankyo, expressed excitement about the approval and the expanded use of Enhertu against HER2 tumors. Keller said the latest approval “underscores its significant potential” across HER2-targetable tumors.

Interim data from the Phase II DESTINY-Lung02 study showed that Enhertu, an engineered HER2-directed antibody-drug conjugate, led to a 57.7% objective response rate. This was observed following a blinded independent review.

The companies noted a small number of patients, less than 2%, saw complete responses at the interim review, while partial responses were observed in 55.8% of patients. The median duration of response was 8.7 months, the companies said. Full results from the trial will be presented at an upcoming medical conference.

Dave Fredrickson, oncology business unit head at AstraZeneca, noted that HER2-mutant non-small cell lung cancer is an aggressive form of the disease. It typically affects younger patients and there are few treatment options, which leads to a poor prognosis for those patients, he said.

“Today’s news provides these patients with the opportunity to benefit from a targeted therapy and highlights the importance of testing for predictive markers, including HER2 in lung cancer, at the time of diagnosis to ensure patients receive the most appropriate treatment for their specific disease,” Fredrickson said in a statement.

Alongside the approval of Enhertu for this indication, the FDA also approved companion diagnostic tests to detect HER2 mutations in lung tumor tissue and plasma.

Last week, the FDA approved Enhertu for the treatment of patients with unresectable or metastatic HER2-low breast cancer. The approval was based on the DESTINY-Breast04 study in which Enhertu demonstrated a 49% improvement in median overall survival by more than six months compared to chemotherapy alone. With that study, Enhertu became the first HER-2-directed therapy to demonstrate a survival benefit in this population.

Enhertu has previously been approved as a treatment for adults with unresectable or metastatic HER2-positive breast cancer who have had two or more previous anti-HER2-based treatments in the metastatic setting. Last year, Enhertu also became the first HER2-directed medication in the past 10 years approved by the FDA to treat gastric cancer.

https://www.biospace.com/article/astrazeneca-and-daiichi-sankyo-s-enhertu-becomes-first-her2-directed-therapy-for-nsclc/

GSK, Sanofi and Haleon shares stabilise after Zantac litigation slump

 

Shares in GSK, Sanofi <SASY.PA and Haleon began to stabilise on Friday after the companies said that nothing material had changed regarding U.S. litigation focused on heartburn drug Zantac.

The companies' share prices had fallen sharply this week on investor concern about the litigation over potential cancer-causing impurities that prompted the drug's withdrawal from markets in 2019 and 2020. The first U.S. trial is expected to start this month.

https://www.marketscreener.com/quote/stock/GSK-PLC-9590199/news/GSK-Sanofi-and-Haleon-shares-stabilise-after-Zantac-litigation-slump-41291169/

Biotech stocks pin bounce back hopes on M&A boost

 

Plunging valuations have made biotech companies tempting acquisition targets for cash-rich Big Pharma and a flurry of deals is just what the battered sector needs to turn a corner.

Pfizer's $5.4 billion acquisition of Global Blood Therapeutics, which was announced on Monday, is the fourth deal in the sector since the pharma giant bought Biohaven for $11.6 billion in May, adding to optimism that large drugmakers are back in the market to pick up cheaper firms.

Industry experts predict biotech firms that are closer to getting their product to market or already have a drug approved are likely to become M&A targets for large drugmakers, some of whom are staring at patent expirations of their cash cow drugs.

GRAPHIC: Biotech M&A since Pfizer's Biohaven deal (

)

"(There have been) acquisitions of companies that have late-stage assets and also the theme of large-cap companies keeping an eye on mid-caps approaching blockbusters," RBC Capital Markets analyst Gregory Renza said. "So needing to replenish portfolios and finding companies like those are key."

Biotech company stocks have been battered in the past few months as investors booked profits after a sharp rise in valuations in 2021, with the rout exacerbated by a dearth of large deals and lack of positive data from clinical trials.

The Nasdaq Biotechnology index fell nearly 28% in the year till the Pfizer-Biohaven deal was announced in May. Since then, the index is up over 18%.

The SPDR S&P Biotech ETF is also up 34% in that period, while iShares Biotechnology ETF is up about 19%.

"Pfizer's move put boards across big pharma on notice that if you're not in the market buying these companies while they're cheap, your competitors will," Thomas Hayes, chairman and managing member of Great Hill Capital in New York, said.

Still, not all analysts are convinced the bottom has been reached for these stocks and believe there is still a long way to go for biotechs, especially considering the risky nature of the business.

"I don't think we'll get back to 2021 (funding) levels ... but we're seeing a nice virtuous cycle of good data, more capital entering the space and more M&A," Sean Sun, portfolio manager at Thornburg Investment Management, said.

Sentiment around the beaten-down sector has improved in the past month.

About $86 million was poured into iShares Biotechnology ETF in July, compared with $7 million in June, following outflows in the two preceding months, according to Refinitiv Lipper data.

The number of stocks in the biotech index that trade below their cash level has also reduced. One of four biotech stocks that are part of the index now trade below their cash level, from one of three in the last week of June, Refinitiv data showed.

"The fundamentals are strong as ever, the valuations have corrected and the acquirers have a boatload of money," said Lee Brown, global healthcare leader for investment research firm Third Bridge. "So it's sort of like - let's party."

https://www.marketscreener.com/quote/stock/AMGEN-INC-4847/news/Biotech-stocks-pin-bounce-back-hopes-on-M-A-boost-41297434/

Lexicon started at Overweight by Piper

 Target $10

https://finviz.com/quote.ashx?t=LXRX

Aptinyx misses endpoint in Phase 2b Study of NYX-2925 in Fibromyalgia

 Aptinyx Inc. (Nasdaq: APTX), a clinical-stage biopharmaceutical company developing transformative therapies for the treatment of brain and nervous system disorders, today announced results from a Phase 2b clinical study evaluating the effects of NYX-2925 in patients with fibromyalgia. NYX-2925 did not achieve statistically significant separation from placebo on the study’s primary endpoint, which assessed the change from baseline in average daily pain on the numeric rating scale (NRS) during week 12.

https://finance.yahoo.com/news/aptinyx-reports-results-phase-2b-111500641.html