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Monday, September 13, 2021

MyMD Pharma Starts Phase 2 Trial of MYMD-1 for Extending Healthy Lifespan

 Key objective of the trial is to reduce levels of the protein that causes inflammation and activates aging, TNF-α, in the blood

MYMD-1 is designed to become the first and only FDA-approved therapeutic solution for delaying aging and prolonging lifespan

MYMD-1’s primary purpose is to slow the aging process and extend human lifespan, but it is also showing promise as a potential treatment for COVID-19-related complications, and as an anti-fibrotic and anti-prolific therapeutic. Because it can cross the blood-brain barrier, MYMD-1 is also positioned to be a possible treatment for multiple sclerosis and other brain-related disorders.

In addition to the upcoming Phase 2 aging trial, MyMD previously announced that it intends to initiate a Phase 2 trial of MYMD-1 as a therapy for COVID-19-associated depression and cytokine elevation in the fourth quarter of 2021, with initial trial data expected in the first quarter of 2022.

https://finance.yahoo.com/news/mymd-pharmaceuticals-announces-fourth-quarter-140000209.html

Bristol Myers rolls out 3-year mesothelioma data for Opdivo/Yervoy at ESMO

 The Opdivo/Yervoy immunotherapy combo from Bristol Myers Squibb has earned some skepticism over the years from researchers questioning the efficacy of CTLA-4 in fighting tumors. But in advanced mesothelioma, the combination is showing multi-year clinical benefit in a particularly dire patient population.


After a minimum of three years follow-up, the Opdivo-Yervoy combo continued to beat out chemotherapy in terms of extending the lives of patients with unresectable malignant mesothelioma as a first-line therapy, according to updated data from the CHECKMATE-743 study set to be presented Friday at the ESMO virtual conference.


Twenty-three percent of patients treated with the combo were alive at the three-year mark compared with 15% on chemo, Bristol Myers said. Meanwhile, Opdivo/Yervoy continued to show a reduction in risk of death with a median OS of 18.1 months compared with 14.1 months for chemo.


Meanwhile, the combo continued to show durable responses underscoring those OS results. At three years, 28% of responders previously treated with Opdivo-Yervoy but off therapy for one year remained in response compared with 0% on chemo. Overall, the combo posted a median duration of response of 11.6 months compared with 6.7 months for chemo and an objective response rate that was “comparable” to chemo — 39.6% to 44%, respectively.


“For patients with malignant pleural mesothelioma, the prognosis is generally poor, with a five-year survival rate of approximately 10%,” said Solange Peters, an oncologist at the Lausanne University Hospital in Switzerland, in a statement. “In this aggressive cancer that historically has had limited treatment options, we’ve now not only seen the potential for patients to live longer with (Opdivo) plus (Yervoy), but that this benefit is sustained at three years compared to treatment with chemotherapy. These results give us further proof of the durability of the outcomes achieved with this combination.”


The Opdivo/Yervoy combo is now approved in 14 regulatory zones for this indication, where it received an initial FDA approval in October. The immunotherapy regimen was the first new systemic therapy approved to treat unresectable malignant mesothelioma since 2004.


The follow-on data is the first look at Bristol Myers’ planned slate at this year’s ESMO, which starts on Friday. In addition to the CHECKMATE-743 data, the drugmaker is rolling out more survival data for the Opdivo-Yervoy combo in other indications and an update on investigational LAG-3 inhibitor relatlimab’s pivotal study. There’s also a planned late-breaker from the Opdivo-Yervoy combo in CHECKMATE-649 in first-line gastric cancer.

https://endpts.com/bristol-myers-rolls-out-3-year-data-mesothelioma-data-for-opdivo-yervoy-in-first-look-at-esmo-slate/

NGM Biopharma upped to Strong Buy from Outperform by Raymond James

 Target to $39 from $27

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

European Frozen Food Giant Nomad Eyes Move Into Lab-Grown Fish

 Nomad Foods Ltd. is moving into cultured fish as the European frozen food giant looks to tap consumer appetite for alternative foods that’s fueling demand for fake meat and dairy.

The owner of the Birds Eye and Goodfella’s pizza brand agreed to work with San Diego-based startup BlueNalu Inc. to develop cell-based seafood in Europe, according to a statement. It’s the first accord in Europe between a consumer-packaged goods company and a cell-cultured seafood business, it said.

Faux fish accounts for just a tiny fraction of the alternative-protein market, a sector that wants to make production more humane and environmentally sustainable. BlueNalu earlier this year said it raised $60 million as it seeks to open a trial factory and start testing cultured fish products at food outlets across the U.S.

https://www.bnnbloomberg.ca/european-frozen-food-giant-nomad-eyes-move-into-lab-grown-fish-1.1651489

Silverback Therapeutics to Present Data from Phase 1/1b Clinical Trial at ESMO 2021

  Interim monotherapy and initial pembrolizumab combination data from the dose-escalation arm of the SBT6050-101 trial will be reported –

– Conference call to be held on Thursday, September 16, 2021, at 6:30 AM ET –

Conference Call and Webcast on Thursday, September 16, 2021, at 6:30 AM ET

Silverback’s management team will host a conference call on Thursday, September 16, 2021, at 6:30 AM ET following the release of the poster at the ESMO 2021 Virtual Congress. A live webcast, including slides, can be accessed through the Events section of the Company’s website at https://ir.silverbacktx.com/news-events/events. An archived replay will be available shortly after the conclusion of the event.

https://finance.yahoo.com/news/silverback-therapeutics-present-data-phase-120000703.html

MiMedX Tumbles as Two Late-Stage Trials Disappoint

 MiMedx stock (NASDAQ:MDXG) plunged by more than 52% in Monday’s premarket after the scandal-plagued company suffered setbacks in two late-stage musculoskeletal clinical trials.

The company said in a regulatory release that its key product - the dehydrated Human Amnion Chorion Membrane (mdHACM) - failed to meet critical endpoints in two separate clinical trials: a Phase 2B trial for the treatment of Knee Osteoarthritis (KOA) and a Phase 3 clinical trial for the treatment of Plantar Fasciitis (PF).

The findings do not support an application for a biologics license in the latter case, it added. The company said it will still pursue phase-III KOA confirmatory studies.

The results are a body blow for a company that has been overshadowed by the past wrongdoings of its previous management. Former chief executive Parker Petit and chief operating officer William Taylor was sentenced to a year in jail in Februaryy after being found guilty of inflating the company's financial statements in the middle of the last decade. The fraud had come to light in the course of a bitter public fight between Parker and short-sellers led by Mark Cohodes.

MiMedX's product pipeline had enough support on Wall Street and in financial media such as Bloomberg Opinion to fuel a 65% rally this year.

"If the $MDXG products do not work, as evidenced by the two failed clinical trials announced this morning, then the years of arguing are done, right?" tweeted Stat News's Adam Feuerstein.

https://finance.yahoo.com/news/mimedx-tumbles-two-stage-trials-075727122.html

Leap Therapeutics to Present New Data at ESMO 2021

 DKN-01 plus tislelizumab and chemotherapy demonstrated compelling activity in first-line patients with gastric or gastroesophageal junction cancer

- In patients who received a full cycle of DKN-01 therapy, the ORR was 68.2%, with 90% ORR in patients with DKK1-high tumors

- Further results will be presented at the ESMO 2021 Congress from September 16 to 21, 2021

- Company to host conference call on Friday, September 17, 2021 at 8:00 a.m. ET

Conference Call

Leap will host a conference call on Friday, September 17, 2021 at 8:00 a.m. Eastern Time to further discuss the data. In addition to Leap's executive management team, Dr Jaffer Ajani of M.D. Anderson Cancer Center and Dr. Samuel Klempner of Massachusetts General Hospital will be on the call. The call can be accessed by dialing (866) 589-0108 (U.S. and Canada) or (409) 231-2048 (international). The passcode for the conference call is 1729397. The presentation will be webcast live and may be accessed on the Investors page of the Company's website at https://investors.leaptx.com/, where a replay of the event will also be available for a limited time.

https://finance.yahoo.com/news/leap-therapeutics-present-data-distinguish-100000549.html