Anavex Initiates Placebo-Controlled U.S. Phase 2 Clinical Trial of ANAVEX®3-71 in Schizophrenia

 First patient screened ahead of schedule

Trial to investigate positive, negative, and cognitive domains of schizophrenia

ANAVEX^®3-71’s differentiated dual novel mechanism of action offers the potential to synergistically activate both SIGMAR1 and M1 muscarinic receptors and treat all symptom domains of schizophrenia without the side effects of standard of care antipsychotics

Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative, neurodevelopmental, and psychiatric disorders, including Alzheimer's disease, Parkinson's disease, Rett syndrome, schizophrenia, and other central nervous system (CNS) diseases, today announced that the first patient in its U.S. FDA cleared placebo-controlled Phase 2 clinical study of ANAVEX^®3-71 for the treatment of schizophrenia has been screened ahead of schedule.

https://www.biospace.com/article/releases/anavex-life-sciences-initiates-placebo-controlled-u-s-phase-2-clinical-trial-of-anavex-3-71-in-schizophrenia/

AstraZeneca Caps US Inhaler Out-of-Pocket Costs on Heels of Boehringer

 AstraZeneca announced Monday that it plans to expand its U.S. savings programs to its inhaled respiratory portfolio and cap the out-of-pocket expenses to $35 per month. The announcement comes just 10 days after Boehringer Ingelheim moved to improve the affordability of its inhalers for COPD and asthma.

Starting on June 1, 2024, eligible patients will pay at the most $35 for all U.S. inhaled respiratory medicines, including Airsupra, Symbicort, Bevespi Aerosphere and Breztri Aersophere.The company also announced it “substantially” reduced the list price of Symbicort in January and is planning to provide more discounts and rebates for its respiratory drugs.However, AstraZeneca noted that government restrictions exclude people enrolled in federal government insurance programs from co-pay support.

“AstraZeneca’s expanded savings programs build on our longstanding commitment to addressing barriers to access and affordability for patients living with respiratory diseases to ultimately help patients lead healthier lives,” CEO Pascal Soriot said in a statement. “We remain dedicated to addressing the need for affordability of our medicines, but the system is complex, and we cannot do it alone. It is critical that Congress bring together key stakeholders to help reform the healthcare system so patients can afford the medicines they need, not just today, but for the future.”

Monday’s move by AstraZeneca comes as Boehringer Ingelheim announced a similar initiative earlier this month.The German pharma is capping out-of-pocket costs at $35 per month for eligible patients for its inhaler drugs. Boehringer said this program plans to “dramatically decrease” patient costs, especially those underinsured or uninsured. Boehringer’s initiative also plans to start on June 1 as well. 

The capped medicines include Boehringer’s Atrovent, Spiriva, Stiolto, Combivent and Striverdi.

“The U.S. healthcare system is complex and often doesn’t work for patients, especially the most vulnerable. While we can’t fix the entire system alone, we are bringing forward a solution to make it fairer. We want to do our part to help patients living with COPD or asthma who struggle to pay for their medications,” Boehringer Ingelheim USA CEO Jean-Michel Boers said in a statement in early March. 

AstraZeneca’s $35 initiative comes as it has faced pressure recently from the U.S. government to provide more doses of its RSV vaccine Beyfortus. At the same time, the pharma reluctantly agreed last year to participate in the Medicare Drug Price Negotiation Program under the Inflation Reduction Act. 

https://www.biospace.com/article/astrazeneca-caps-us-inhaler-out-of-pocket-costs-on-heels-of-boehringer/

J&J-Backed Contineum Unveils IPO Plans to Advance MS Pipeline

 Contineum Therapeutics on Friday filed for an initial public offering, hoping to drum up additional support to advance its pipeline of small molecule drugs for multiple sclerosis and other neuroscience, inflammation and immunology indications.

The California-based biotech did not specify a fundraising target in its SEC document, but several media reports indicate that Contineum is aiming to raise $150 million. At this stage in the initial public offering (IPO) process, it’s customary for companies to put $100 million as a maximum value placeholder in their S-1 forms.

Contineum also did not reveal when it expects to close its IPO, only noting that it hopes to wrap the offering up within the year. Once completed, Contineum will trade on the Nasdaq Global Select Market Under the ticker symbol CNTM.

The biotech will use the IPO proceeds to complete the Phase II trial for its most mature candidate PIPE-307, which is currently being developed in partnership with Johnson & Johnson for the treatment of relapse remitting multiple sclerosis (RRMS), according to its SEC filing. The companies signed their global license and development deal in April 2023, with J&J dropping $50 million upfront and pledging up to $1 billion in potential milestone payments.

PIPE-307 is a brain-penetrant small molecule inhibitor of the muscarinic type 1 M1 receptor (M1R), which plays a key role in various brain functions such as attention, memory and sleep regulation. According to a 2021 study published in ACS Medicinal Chemistry Letters, and conducted by company scientists, blocking M1R in the brain could promote the remyelination of neurons while repairing nerve function in RRMS.

Contineum is currently running a Phase II study for PIPE-307 as an adjunctive treatment for RRMS. The company is also assessing the potential of the candidate in depression, for which J&J is planning to launch a Phase II study this year.

In addition to PIPE-307, Contineum will also use the IPO proceeds to advance its lead asset PIPE-791, which is being developed for idiopathic pulmonary fibrosis (IPF) and progressive MS. In IPF, PIPE-781 works by targeting the lysophosphatidic acid 1 receptor (LPA1R), which drives cellular cascades for vascular leakage and fibroblast recruitment while reducing fibrosis.

In progressive MS, PIPE-781’s mechanism of action targets neuroinflammation and promotes remyelination, both of which are prominent disease pathways. According to Contineum’s SEC document, PIPE-781 is currently the “only brain-penetrant LPA1R antagonist in clinical development for progressive MS.”

Contineum maintains the 2024 IPO spree as the industry tries to bounce back from a record low last year. This year’s class includes CG Oncology, ArriVent BioPharma, Kyverna Therapeutics and Metagenomi.

https://www.biospace.com/article/j-and-j-backed-contineum-unveils-ipo-plans-to-advance-ms-pipeline-/

GSK Builds Case for Broader Jemperli Label in Endometrial Cancer with Phase III Data

 GSK on Saturday unveiled new data from its Phase III RUBY program demonstrating better survival outcomes in a wide range of endometrial cancer patients treated with Jemperli (dostarlimab), potentially setting the PD-1 blocker up for a label expansion.

Hesham Abdullah, senior vice president and global head of oncology R&D at GSK, said in a statement that RUBY’s findings show that Jemperli-based regimens “could benefit a broader set of patients with endometrial cancer,” adding that the pharma has been amassing a “growing body of evidence supporting the role of dostarlimab-gxly as the backbone” of its immuno-oncology development program.

RUBY is a randomized and double-blinded Phase III study comprised of two parts. The first part assessed the efficacy and safety of Jemperli with carboplatin-paclitaxel, followed by maintenance with Jemperli monotherapy, versus carboplatin-paclitaxel with placebo and placebo maintenance therapy.

Part two used the same regimen of Jemperli with carboplatin-paclitaxel as an initial treatment, but combined the PD-1 inhibitor with GSK’s PARP inhibitor Zejula (niraparib) for maintenance treatment. The comparator arm received placebo with carboplatin-paclitaxel, followed by placebo.

Results from the first part showed that the Jemperli regimen significantly reduced the risk of death by 31% versus the chemotherapy counterpart. Patients in the Jemperli arm likewise had a “clinically meaningful improvement” in overall survival (OS) of 16.4 months.

The Jemperli combo was also similarly beneficial in an exploratory analysis of patients with mismatch repair proficient (MMRp)/microsatellite stable (MSS) tumors, cutting their risk of death by 21%. OS in this subpopulation improved by seven months.

GSK will file a regulatory submission in the first half of this year, using data from the first part of RUBY to expand Jemperli’s label to cover the overall endometrial cancer population, according to the pharma’s announcement.

Part two evaluated progression-free survival (PFS) and found that patients in the Jemperli-Zejula arm saw a 40% drop in the risk of disease progression or death. These patients also saw a clinically meaningful 6.2-month improvement in median PFS. In MMRp/MMS patients, the combo regimen reduced the risk of death or disease progression by 37% and increased median PFS by six months.

GSK previously announced positive PFS findings from part two of Ruby in December 2023, though it did not reveal specific data at the time.

Jemperli is a monoclonal antibody that works by targeting and binding the PD-1 receptor and blocking its interaction with corresponding ligands. This mechanism of action disables the cancer cells’ ability to evade the immune system and enhances the body’s anti-cancer immune activity.

The monoclonal antibody was first approved in 2021 for the treatment of recurrent or advanced endometrial cancer patients who are mismatch repair deficient. It has since picked up several more approvals, including one for frontline endometrial cancer in August 2023, beating out Merck’s dominant blockbuster treatment Keytruda (pembrolizumab).

https://www.biospace.com/article/gsk-builds-case-for-broader-jemperli-label-in-endometrial-cancer-with-phase-iii-data/

AstraZeneca Shows Lynparza Combo Could Address Unmet Endometrial Cancer Need

 AstraZeneca on Monday reported that the combination of Lynparza (olaparib) and Imfinzi (durvalumab) more than doubled the median duration of response in patients with mismatch repair proficient endometrial cancer.

The data come from a Phase III trial that evaluated the effect of giving the checkpoint inhibitor Imfinzi and PARP inhibitor Lynparza after chemotherapy in patients with advanced or recurrent endometrial cancer. AstraZeneca shared headline data from the trial in October 2023, when it reported that the drug combination reduced the risk of disease progression or death by 45% compared to chemotherapy alone.

Researchers presented more data from the DUO-E trial at the Society of Gynecologic Oncology Annual Meeting on Women’s Cancer in San Diego. The presentation focused on a post-hoc analysis that split the trial population up based on whether they had mismatch repair proficient or deficient cancer.

Checkpoint inhibitors have previously proven more effective in patients with mismatch repair deficient (dMMR) endometrial cancer, leading to FDA approvals for Merck’s Keytruda (pembrolizumab) and GSK’s Jemperli (dostarlimab) in that subpopulation.

AstraZeneca enrolled dMMR and in patients with mismatch repair proficient (pMMR) patients in DUO-E. Dividing the dataset into two subpopulations showed that the Lynparza-Imfinzi combination was most effective in dMMR. Median overall survival (OS) in the dMMR chemotherapy control arm was 23.7 months. The trial is yet to reach the median OS in the cohorts that received Imfinzi as a single agent or the checkpoint inhibitor in combination with Lynparza.

The median duration of response in dMMR patients was 10.5 months in the chemotherapy arm and 29.9 months in the Lynparza-Imfinzi combination cohort. The Imfinzi arm is yet to reach the median duration of response.

While the effect of adding Lynparza to Imfinzi in dMMR is unclear, with patients responding to the PD-1 checkpoint inhibitor alone, the PARP inhibitor appears to have a bigger effect in pMMR. The median durations of response in the chemotherapy, Imfinzi and Lynparza combination cohorts were 7.6 months, 10.6 months and 18.7 months, respectively. 

AstraZeneca tracked a similar pattern in the progression-free survival (PFS) data. Median PFS rose from 9.7 months and 9.9 months, respectively, in the chemotherapy and Imfinzi cohorts to 15.0 months in the Lynparza combination group. The Imfinzi and Lynparza combination pMMR arms are yet to reach median OS. In the chemotherapy pMMR group, the median OS was 25.9 months.

The results suggest there may be a role for the Lynparza-Imfinzi combination in pMMR, a setting where there is unmet need because checkpoint inhibitors are less effective. AstraZeneca has submitted filings for DUO-E to regulators in the U.S., Europe and Japan.

https://www.biospace.com/article/astrazeneca-shows-lynparza-combo-could-address-unmet-endometrial-cancer-need/

Biden’s new ‘boat anchor’ shoes meant for maximum ‘stability’ as falls spark concern

 President Biden’s newest shoes have opened up renewed debate about his health and physical condition, with some speculating they were designed to prevent the president from falling.

“Biden’s handlers are forcing him to wear a new pair of ‘lifestyle sneakers’ because he trips so much,” reads a tweet from RNC Research on Saturday, referring to Biden’s new shoes.

Observers have likened the shoes to “boat anchors” and “piers,” but the “Inside Edition” report attached to the tweet revealed that the president’s new shoes are actually “lifestyle sneakers” that are made by the shoe brand Hoka.

The “Inside Edition” report notes that the shoes are “designed for maximum comfort and support while walking or hiking.”

Biden’s specific shoe is called the “Hoka Transport,” the report said, a shoe that has a “wide sole” that is “no doubt great for stability.”

The report notes that the president “does have a history of stumbling” but that the shoe is “quite comfortable” and feels like “walking on air.”

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President Biden has been sporting a new pair of Hoka shoes.REUTERS

“The shoe bears the seal of approval from the American Podiatric Association for being beneficial to foot health,” the report said, noting Biden’s physical last month revealed that the president suffers from sensory peripheral neuropathy in his feet.

“Peripheral neuropathy refers to damage to nerves,” said Dr. Gabrelle Laurenti, a podiatrist interviewed for the report. “Whether it’s from trauma or a disease, there’s some kind of damage to nerves.”

Biden has had multiple public stumbles, falls and near misses as president, the most recent example coming while he climbed the stairs to board Air Force One last month. In that incident, the president was able to catch himself on the handrail before continuing his climb.

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The shoes are “designed for maximum comfort and support while walking or hiking.”AFP via Getty Images

That stumble came after a number of near misses on Air Force One stairs in 2021 prompted the White House team to employ shorter stairs that would allow the president to climb them more easily, and a New York Times report from February noted that the Secret Service now positions an agent at the bottom of the stairs when Biden disembarks the plane.

Biden has also taken falls when not climbing stairs, including an infamous trip while onstage during the 2023 Air Force Academy commencement.

Reached for comment by Fox News Digital, White House Deputy Press Secretary Andrew Bates explained that the president uses the shoes for exercise.

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Biden has a history of stumbling.AFP via Getty Images
“I know y’all don’t care for presidents who exercise. But don’t worry – you’ll get used to it,” Bates told Fox News Digital

https://nypost.com/2024/03/18/us-news/joe-bidens-new-boat-anchor-shoes-meant-for-maximum-stability/

'Silver lining: Tutoring the elderly is growing fast in China'

 China's rapidly aging population is fuelling a promising and fast-growing market for companies providing recreational classes and activities for the elderly middle class, from yoga to African drumming and smartphone photography.

The growth potential of the industry contrasts sharply with the decline of the after-school private tutoring sector following a government crackdown in 2021 aimed at boosting record low birth rates by lowering education costs.

"Education industries are transitioning to the silver economy," said Qiu Peilin, the Beijing head of Mama Sunset, an elderly learning business which has opened five centres in the Chinese capital since launching in April 2023.

Consulting firm Frost & Sullivan expects China's senior learning market to grow at a compound annual growth rate of 34% by 2027 to 120.9 billion yuan ($16.8 billion), up from 28 billion yuan in 2022.

It's a numbers game.

Over the next decade, roughly 300 million Chinese will enter retirement - the equivalent of almost the entire U.S. population. One in every two people aged over 65 in the Asia-Pacific region will live in China by 2040, Euromonitor estimates.

While China's demographic crisis is threatening its industrial base, government finances and poverty alleviation efforts, some investors see the growing pool of elderly as a sure bet.

Mama Sunset, which offers 20 different classes to thousands of Chinese aged 50-plus, is in talks with domestic investors to expand to 200 franchised centres across the country in the next three years, when it wants to list on the Hong Kong exchange.

Nasdaq-listed Quantasing, the largest online elderly learning provider in China according to Frost & Sullivan, plans to hire more tai chi and traditional medicine tutors to add to existing classes ranging from memory training to video editing.

It also plans to leverage its customer base to sell products such as moxa sticks, used in traditional medicine, or Baijiu, a Chinese liquor.

Quantasing's revenues grew 24.7% year-on-year for the final quarter of last year to $980.5 million yuan ($136.2 million), while its total registered users shot up 44.6% year-on-year to 112.4 million at the end of 2023.

"It's a real sunrise industry," the firm's CEO Matt Peng said.

China's government is also getting involved, announcing in January tax incentives and financial support for products and services for the elderly. Premier Li Qiang pledged in March further efforts to develop "the silver economy," without elaborating.

The provincial government of Hebei provided the land and space for Mama Sunset's Cangzhou branch as part of a poverty alleviation program.

BIG BASE, LOW INCOMES

Some analysts warn, however, that a flood of investment into industries targeting the elderly may get ahead of itself if China cannot make the leap that other aging societies have made - escaping the middle income trap first.

Low retirement incomes and insecurities related to basic needs including healthcare in a society where many of the elderly are reliant on their child for financial support will limit the industry's potential, analysts say.

Rachel He, research manager at Euromonitor, said China's elderly population was a promising consumer base but it was questionable whether it would match the significance of the market in Japan and South Korea in the near term.

She cited "deep income inequality" and more conservative attitudes among Chinese elderly who were less inclined to spend money on themselves.

Average monthly urban pensions range from around 3,000 yuan in less developed provinces to about 6,000 yuan in Beijing. Nomura estimates 160 million Chinese receive rural pensions of only around 100 yuan per month.

One class at Mama Sunset costs 50-60 yuan, while a 36-class package costs 1,980 yuan. At Quantasing, one- to three-month packages range between 1,980 and 3,699 yuan.

Cui Chunyun, a 60-year-old retired accountant in Beijing, takes Mama Sunset's dance classes to stay fit to keep pace with her five grandchildren and delay going into a nursing home.

"I want to be able to move, even people older than 70 can still dance, we have to move to live."

https://www.yahoo.com/news/silver-lining-tutoring-elderly-growing-230526077.html