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Monday, September 14, 2020

Late-stage study of Humanigen lead drug in Covid to continue unchanged

The Independent Data Safety Monitoring Board (DSMB) has completed pre-specified interim analysis for Humanigen’s (OTCQB:HGEN) lead drug candidate lenzilumab Phase 3 trial for COVID-19 and recommended that the study continue unmodified.

The DSMB conducted the analysis after 50% of the expected recoveries were captured, and assessed the Phase 3 trial data for safety, futility, sample size and power assumptions.

The company expects to complete the targeted enrollment of 300 patients this month, with topline data expected in the next quarter.

Lenzilumab is a Humaneered anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody.

Recently, the company announced lenzilumab demonstrated positive effect in COVID-19 in case-control study

https://seekingalpha.com/news/3613618-late-stage-study-of-humanigens-lead-drug-in-covidminus-19-to-continue-unchanged

Lilly baricitinib shows positive action in hospitalized Covid patients

Eli Lilly (NYSE:LLY) announces positive preliminary results from an NIAID-sponsored clinical trial, ACTT-2, evaluating the combination of baricitinib and Gilead Sciences’ (NASDAQ:GILD) remdesivir in more than 1,000 hospitalized COVID-19 patients.

The study met the primary endpoint of reducing the time to recovery compared to remdesivir. Specifically, there was about a one-day reduction in median recovery time in the baricitinib + remdesivir arm versus the remdesivir alone arm. The effect was statistically significant.

Recovery was defined as the participant being well enough for hospital discharge, meaning the participant either no longer required supplemental oxygen or ongoing medical care in the hospital, or was no longer hospitalized at Day 29.

A key secondary endpoint, patient clinical status at day 15, was also met, although there were 31 total secondary endpoints.

The company plans to discuss potential emergency use authorization with the FDA. If authorized, the JAK1/JAK2 inhibitor, in-licensed from Incyte (NASDAQ:INCY), will be available through commercial channels.

It also plans to review the data with NIAID to assess any impact on another Phase 3, BARRIER, evaluating baricitinib versus background therapy in hospitalized adult COVID-19 patients in the U.S., Europe, Asia and Latin America.

The FDA approved baricitinib, branded as Olumiant, in June 2018 for rheumatoid arthritis.

https://seekingalpha.com/news/3613560-lillys-baricitinib-shows-positive-action-in-hospitalized-covidminus-19-patients

InflaRx launches late-stage study of IFX-1 in COVID-19 induced pneumonia

InflaRx (NASDAQ:IFRX) has commenced global Phase 3 part of its Phase 2/3 trial with IFX-1 in severe COVID-19 induced pneumonia with the initiation of the first site in the Netherlands. Also the German regulatory authority, has approved the Phase 3 trial.

The 360-subject study’s primary endpoint will be 28-day all-cause mortality; key secondary endpoints will include assessment of organ support and disease improvement.

An interim analysis is planned after enrollment of 180 patients, with a potential for an early stop for efficacy or futility.

In June, the company reported no difference in the change from baseline to day 5 in oxygenation index between the IFX-1 cohort and those receiving best supportive care alone, the primary endpoint (with additional parameters until day 28).

IFX-1 is a monoclonal anti-human complement factor C5a antibody designed to induce an anti-inflammatory response by blocking the biological activity of C5a.

https://seekingalpha.com/news/3613578-inflarx-launches-late-stage-study-of-ifxminus-1-in-covidminus-19-induced-pneumonia

Seattle Genetics teams up with Merck in cancer

Seattle Genetics (NASDAQ:SGEN), +9% premarket and Merck (NYSE:MRK) announce two new strategic oncology collaborations.

The companies will globally develop and commercialize Seattle Genetics’ ladiratuzumab vedotin, an investigational antibody-drug conjugate (ADC) targeting LIV-1 for breast cancer and other solid tumors.

The collaboration will pursue a broad joint development program evaluating ladiratuzumab vedotin as monotherapy and in combination with Merck’s anti-PD-1 therapy Keytruda (pembrolizumab) in triple-negative breast cancer, hormone receptor-positive breast cancer and other LIV-1-expressing solid tumors.

Under the terms of the agreement, Seattle Genetics will receive a $600M upfront payment and Merck will make a $1B equity investment in 5M shares of Seattle’s common stock at a price of $200/share.

In addition, Seattle Genetics is eligible for progress-dependent milestone payments of up to $2.6B. Including the upfront payment, equity investment and milestone payments, SGEN is eligible to receive up to $4.2B.

The companies will jointly develop and commercialize ladiratuzumab vedotin and equally share profits worldwide.

Separately, Seattle Genetics has granted Merck an exclusive license to commercialize TUKYSA (tucatinib), a small molecule tyrosine kinase inhibitor, for the treatment of HER2-positive cancers, in Asia, the Middle East and Latin America and other regions outside of the U.S., Canada and Europe. SGEN retains commercial rights and will record sales in the U.S., Canada and Europe.

The Company will receive $125M million from Merck as an upfront payment, up to $65 of milestone payments, $85M in prepaid R&D payments and tiered royalties on sales of TUKYSA in Merck’s territory.

Merck will also co-fund a portion of the TUKYSA global development plan, which encompasses several trials across HER2-positive cancers, including breast, colorectal, gastric and other cancers.

Seattle Genetics will host a conference call to discuss these collaborations today at 9:00 a.m. ET.

https://seekingalpha.com/news/3613576-seattle-genetics-teams-up-merck-in-cancer

Cassava Sciences rallies on positive data on lead drug in Alzheimer’s

Cassava Sciences (NASDAQ:SAVA) announces final results from a 64-subject Phase 2b clinical trial evaluating lead candidate sumifilam (PTI-125) in Alzheimer’s disease (AD) patients.

Treatment with sumifilam produced statistically significant improvements in a range of AD-related biomarkers compared to placebo, the primary endpoint. The response rate, defined as patients who showed biomarker improvements, was 98%.

Sumifilam was safe and well-tolerated.

The positive outcome is a reversal of fortune for the study. In May, the company reported that the trial failed to achieve the primary endpoint due to high variability in biomarker data in the control group. It says the analysis, conducted by outside labs, is no longer valid.

Small molecule PTI-125 targets an altered form of filamin A, a scaffolding protein found throughout the body. A highly toxic form of the protein is present in the brains of AD sufferers which disrupts the normal function of neurons, leading to neurodegeneration and brain inflammation. PTI-125 is designed to restore the normal shape of filamin A in the brain, improving the function of multiple brain receptors and dampening neuroinflammation.

Development is ongoing.

Management will host a conference call this morning at 8:30 am ET to discuss the results.

https://seekingalpha.com/news/3613579-cassava-sciences-rallies-100-on-positive-data-on-lead-drug-in-alzheimers

Sunday, September 13, 2020

Sanofi’s hemophilia drug comes into focus as delays hit rival BioMarin

Results from a small study of hemophilia patients published in The New England Journal of Medicine suggest a drug being developed by the French pharmaceutical giant Sanofi could challenge market-leading treatments for the rare bleeding disorder.

Hemophilia patients lack certain proteins needed to clot blood. In the more common, hemophilia A form, the missing protein is called Factor VIII. People without this disorder typically have around 100% Factor VIII levels, though anywhere between 50% and 150% is considered “normal.” Having less than 1% the normal amount of protein is a sign of severe hemophilia.

People with severe hemophilia A typically use injectable drugs multiple times a week to replace the clotting proteins they lack. Sanofi has been developing a longer-lasting version, meant to be used once weekly or less, that it acquired when it bought Bioverativ in 2018.

Last year it produced the first significant results from that program, a study that looked at 16 men with severe hemophilia A. Patients who received a high dose of the company’s drug, BIVV001, had Factor VIII levels at 38% five days after treatment. At day seven, average levels were still at 17%.

New details unveiled Thursday in NEJM show those patients’ protein levels were in normal range through day four. Study authors wrote these results imply Sanofi’s drug could be given on a weekly interval, which would be longer than most of the currently available hemophilia therapies. In fact, the time it took for patients’ bodies to go through half of BIVV001 was about 43 hours, or three to four times longer than so-called recombinant Factor VIII drugs.

“This effect would transform severe hemophilia A into a mild disease,” Pier Mannucci, a researcher who currently sits as chairman of the Department of Internal Medicine and Medical Specialties at the University of Milan, wrote in an editorial accompanying the published data.

Sanofi’s drug also appeared to be safe. No patient developed inhibitors — a type of antibody that attacks replacement clotting protein and is a major concern for hemophilia patients. Researchers also didn’t see overactive immune responses or anaphylactic events in the month after patients were treated.

The BIVV001 data come during a renaissance period for hemophilia drug research. Companies are working on more durable medicines that could revolutionize care both for patients and for the healthcare system.

“Overall, as a long-standing insider of hemophilia care amid lights and shadows, I am impressed by the amazing progress that is still occurring in the management of this ancient scourge,” Mannucci wrote.

Gene therapy, in particular, has attracted attention for its potential to effectively cure the disease. BioMarin looked as though it would secure the first ever Food and Drug Administration approval of a hemophilia gene therapy last month. But in a shocking twist, the agency said it needed more data before it could clear the treatment, known as Roctavian, for use.

BioMarin won’t have the data required to meet the agency’s request until the tail end of 2021.

The company disclosed this week that it’s run into a delay in Europe as well. Regulators there want one year’s worth of data for all patients in a large, ongoing clinical trial who are receiving a high dose of Roctavian. BioMarin said completing that request won’t be possible until this November.

As BioMarin sorts out those data challenges, other gene therapies and longer-lasting therapies are inching closer to market. Sanofi, for example, has already kicked off a larger study of BIVV001.

If Sanofi can replicate the findings from the smaller trial, it could set up BIVV001 not just for approval, but to become “the first choice among factor VIII replacement products administered intravenously because of the reduction of the dosing frequency,” Mannucci wrote.

BIVV001 may also, according to Mannucci, provide a competitive threat to Hemlibra, a market-leading hemophilia A drug from Roche that is given once weekly and, sometimes, once monthly.

Overcoming Hemlibra might be difficult, however. In the first half of 2020, Roche recorded Hemlibra sales of just over 1 billion Swiss francs. After less than three years on market, Hemlibra has taken 23% of total U.S. patient share, according to Roche.

https://www.biopharmadive.com/news/sanofi-hemophilia-drug-bivv001-nejm/585000/

My Face Covering Is Causing Acne. What Can I Do?

Wearing a face covering has become a necessary way of life as we continue to combat COVID-19. Unfortunately, this risk reducing measure can result in ‘maskne’—acne, breakouts, and skin irritation caused by prolonged wearing of a face covering.

Andrew F. Alexis, MD, MPH, Professor and Chair, Department of Dermatology; Mount Sinai West and Mount Sinai Morningside; and Director of the Skin of Color Center at Mount Sinai, explains what you can do to prevent breakouts while staying safe.

I think my face mask is irritating my skin. What can I do to prevent this?

Wearing a mask can inflame or irritate the skin in a number of ways. First, the pressure and friction on the bridge of the nose and behind the ears can lead to redness, soreness, bruising, and even erosions—erosions are particularly prevalent when N95 masks are worn for long hours.

Strategies for prevention include hydrating the skin and protecting the skin barrier with a gentle cleanser. After cleansing, use a non-comedogenic moisturizing lotion—a moisturizer formulated to not block pores—that contains hydrating and skin-protective ingredients such as ceramides, hyaluronic acid, glycerin, and dimethicone.

Ceramides are natural lipids that help support the skin’s barrier while hyaluronic acid attracts water and therefore, helps to hydrate the skin . Another moisturizing agent—glycerin—attracts moisture into the skin and dimethicone helps to seal the moisture by preventing it from evaporating from the skin surface.

Is there a material that is better for skin and more ‘moisture wicking’ that should be worn in warmer weather?

Fabric-based face coverings made of 100 percent cotton are breathable and recommended for the summer. They should be washed daily to prevent the build-up of oil and bacteria that can contribute to acne and related skin conditions. It is also important to wash the face twice daily—morning and evening—with a gentle cleanser. Unlike traditional soaps, gentle cleansers have mild surfactants (they are synthetic detergents or “syndets”) and have hydrating ingredients like glycerin.

I have to wear a face covering for hours each day. What else can I do to relieve irritation?

For health care, essential workers, and others who may wear N95s for long hours, placing a thin prophylactic silicone foam dressing to the bridge of the nose and behind the ears is a helpful tip—but one must ensure the seal of the mask is not compromised. If irritation does occur, applying a thin layer of healing ointment—like petroleum jelly—to the affected areas can help.

Also, when possible and in a safe/socially distanced environment, periodically removing the mask can provide extra relief and reduce the risk of heat rash or irritation from prolonged mask wearing.

Do you have any other advice about keeping skin healthy while wearing a face mask?

To avoid breakouts, I recommend doing without makeup – at least under the mask.

Additionally, ‘maskne’ sufferers may want to try using a benzoyl peroxide gel (5.5 percent or less). This is a useful non-prescription treatment for mild acne.