BGNE Teams Up With NVS, Editas Slumps Over 15%, LLY’s Drug Shines In TRAILBLAZER-ALZ, MESO On Watch

Today’s Daily Dose brings you news about Lilly’s Alzheimer’s disease trial data, BeiGene’s collaboration agreement with Novartis, Mesoblast’s encouraging results from phase III trial of Rexlemestrocel-L in patients with chronic heart failure, and the resignation of Editas’ Chief Scientific Officer.

Read on…

1. Arcus to Present at ASCO-GI Symposium

Arcus Biosciences Inc. (RCUS) said that the dose-escalation portion of its phase I/Ib study evaluating the safety and tolerability of AB680 in combination with Zimberelimab and nab-paclitaxel plus gemcitabine (chemotherapy) in front-line metastatic pancreatic cancer has demonstrated encouraging signs of clinical activity.

The updated data from the phase I portion of this trial is slated to be presented at ASCO-GI Symposium on January 15 – with more mature safety and clinical response data to be reported that day.

RCUS closed Monday’s trading at $32.07, up 4.02%.

2. BeiGene Teams Up With Novartis To co-develop Tislelizumab

BeiGene Ltd. (BGNE) has entered into a collaboration and license agreement with Novartis Pharma AG (NVS) to co-develop its anti-PD-1 antibody Tislelizumab in the United States, Canada, Mexico, member countries of the European Union, United Kingdom, Norway, Switzerland, Iceland, Liechtenstein, Russia, and Japan.

The deal entitles BeiGene to receive an upfront cash payment of $650 million from Novartis, up to $1.3 billion upon the achievement of regulatory milestones, $250 million upon the achievement of sales milestones, and royalties on future sales of Tislelizumab in the licensed territory.

As per the agreement, BeiGene will be responsible for funding ongoing clinical trials of Tislelizumab, while Novartis has agreed to fund new registrational, bridging, or post-marketing studies in its territory.

Tislelizumab is conditionally approved in China for the treatment of patients with classical Hodgkin’s lymphoma. The drug is under review in China for first-line treatment of patients with advanced squamous NSCLC in combination with chemotherapy, for first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy, and for previously treated unresectable HCC.

In addition, 15 potentially registration-enabling clinical trials with Tislelizumab are being conducted in China and globally, including 13 phase III trials and two pivotal phase II trials.

BGNE closed Monday’s trading at $278.92, down 0.12%.

3. Editas’ Science Chief Resigns

Editas Medicine Inc.’s (EDIT) Chief Scientific Officer, Charles Albright, is relinquishing his post on January 15, 2020, to pursue another opportunity. A search is underway to find a successor to Albright.

In other news, the company announced that it has received FDA clearance to initiate the safety phase of its EDIT-301 clinical trial. EDIT-301 is an experimental, ex vivo gene editing cell medicine in development for the treatment of sickle cell disease.

Preparations are underway to initiate a phase I/II trial designed to assess the safety and efficacy of EDIT-301 for the treatment of sickle cell disease, dubbed RUBY.

The company has also provided a detailed timeline for its clinical programs.

The first patient in the adult mid-dose cohort of its Phase 1/2 BRILLIANCE clinical trial of EDIT-101 for the treatment of Leber congenital amaurosis 10 (LCA10) is expected to be dosed this quarter – with initial data to be reported by the end of 2021. A development candidate for the treatment of autosomal dominant retinitis pigmentosa 4 (RP4) is expected to be declared by the end of 2021. An Investigational New Drug (IND) application for EDIT-301 for the treatment of beta-thalassemia is anticipated to be filed by the end of this year.

EDIT closed Monday’s trading at $76.94, down 15.06%.

4. Lilly’s Alzheimer’s Drug proving to be a Trailblazer?

Shares of Eli Lilly and Co. (LLY) touched a new high on Monday, following positive results from a phase II trial of Donanemab in Alzheimer’s disease.

In the trial, dubbed TRAILBLAZER-ALZ, Donanemab met the primary endpoint of change from baseline to 76 weeks in the Integrated Alzheimer’s Disease Rating Scale (iADRS), slowing decline by 32 percent relative to placebo, which was statistically significant. The iADRS is a clinical composite tool combining the cognitive measure and functional measure – the two commonly used measures in Alzheimer’s disease.

Lilly plans to discuss the results with regulators to assess next steps for Donanemab.

A second pivotal Donanemab trial in Alzheimer’s, dubbed TRAILBLAZER-ALZ 2, is underway. Another trial for those who participated in TRAILBLAZER-ALZ, known as TRAILBLAZER-EXT, is ongoing.

LLY closed Monday’s trading at $185.94, up 11.74%.

5. Mesoblast’s DREAM-HF Data Catches Eye

Shares of Mesoblast Limited (MESO) jumped over 31% on Monday, on the back of encouraging additional data from the landmark phase III trial of Rexlemestrocel-L in patients with chronic heart failure.

In the trial, dubbed DREAM-HF, there was a 60% reduction in incidence of Major Adverse Cardiac Events (MACE) due to heart attacks or strokes and 68% reduction in the rate of recurrent hospitalizations from non-fatal heart attacks or strokes.

Armed with the encouraging phase III data of reduced mortality and morbidity, Mesoblast intends to meet with the FDA to discuss a potential approval pathway for Rexlemestrocel-L.

MESO closed Monday’s trading at $11.40, up 31.64%.

6. Stocks That Gained/Lost the Most

Zomedica Corp. (ZOM) closed Monday’s trading at $0.93, up 92.15%.

GeoVax Labs Inc. (GOVX) closed at $5.36, up 62.42%.

Avinger Inc. (AVGR) closed at $1.45, up 61.90%.

Medigus Ltd. (MDGS) closed at $2.20, down 15.38%.

Oncorus Inc. (ONCR) closed at $30.41, down 14.41%.

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