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CELC Inks Breast Cancer Trial Collaboration, CANF Soars On Deal With Ewopharma, MRUS On Watch

biotech march17 lt

Today's Daily Dose brings you news about Celcuity's collaboration with MD Anderson Cancer Center, Can-Fite's licensing deal with Ewopharma, Lilly's LUCENT-1 ulcerative colitis study results, and anticipated milestones of Merus.

Read on…

1. Celcuity Teams Up With MD Anderson Cancer Center, Novartis and Puma

Celcuity Inc. (CELC) has teamed up with MD Anderson Cancer Center, Novartis AG (NVS), and Puma Biotechnology Inc., (PBYI) to study a new drug regimen in breast cancer.

The study will be a phase II trial evaluating the efficacy and safety of two targeted therapies, Novartis' TABRECTA and Puma Biotechnology's NERLYNX, in patients with previously treated metastatic HER2-negative breast cancer selected with Celcuity's CELsignia Multi-Pathway Activity Test.

Under the agreement, MD Anderson will serve as the sponsor and Bora Lim MD, a medical oncologist at Baylor College of Medicine, and Rachel Layman MD, a medical oncologist at MD Anderson, will serve as the co-principal investigators of this study.

TABRECTA and NERLYNX are targeted therapies approved by the FDA to treat non-small cell lung cancer and HER2-positive breast cancer, respectively.

CELC closed Tuesday's trading at $13.75, up 1.85%.

2. Can-Fite Soars on Licensing Deal with Ewopharma

Can-Fite BioPharma Ltd. (CANF) has signed an exclusive distribution agreement with Switzerland-based Ewopharma for Piclidenoson in the treatment of psoriasis and Namodenoson in the treatment of liver diseases namely, hepatocellular carcinoma and nonalcoholic steatohepatitis.

The agreement entitles Can-Fite to receive $2.25 million upfront from Ewopharma, with up to an additional $40.45 million payable upon the achievement of regulatory and sales milestones plus 17.5% royalties on net sales.

In exchange, Ewopharma will have the exclusive right to market and sell Piclidenoson in Central Eastern European (CEE) countries and Namodenoson in CEE countries and Switzerland. Ewopharma has the right to extend the distribution agreement to new indications that Can-Fite may identify for its drug candidates.

A phase III trial of Piclidenoson in psoriasis, dubbed Comfort, is underway. An independent Data Monitoring Committee, which conducted a pre-planned interim analysis of the Comfort trial of Piclidenoson, last October, recommended that the study be continued.

Namodenoson has been successfully trialed in a phase I/II study in hepatocellular carcinoma and a phase III study is under preparation in this indication. This compound has also been successfully studied in a Phase II study in patients with NAFLD/NASH and a phase IIb study in this indication is under preparation.

CANF closed Tuesday's trading at $2.92, up 43.14%.

3. Germany Temporarily Suspends AstraZeneca's COVID-19 vaccine

Germany is the latest country to temporarily suspend the use of AstraZeneca's COVID-19 vaccine AZD1222 as a precaution following reports of blood clots in people receiving that jab.

The decision to temporarily suspend the use of the AstraZeneca vaccine was based on the recommendation of the Paul Ehrlich Institute (PEI). With newly reported cases of cerebral vein thrombosis in those receiving the AstraZeneca COVID-19 vaccine, the Paul Ehrlich Institute is of the opinion that more investigations are needed.

4. Lilly's LUCENT-1 Ulcerative Colitis Trial Meets All Goals

Eli Lilly and Co.'s (LLY) phase III study of Mirikizumab for the treatment of patients with moderate to severe ulcerative colitis has met the primary and all key secondary endpoints.

In the 12-week study, dubbed LUCENT-1, the primary endpoint of clinical remission was met compared to placebo. Clinical remission is met when inflammation of the colon is controlled or resolved, leading to normalization or near-normalization of symptoms such as stool frequency and bleeding.

The trial also met all key secondary endpoints with statistical significance, including reduced bowel urgency, clinical response, endoscopic remission, symptomatic remission and improvement in endoscopic histologic inflammation.

The full LUCENT study results, including data from LUCENT-2 and LUCENT-3, will be disclosed at a future congress or publication, added the company.

LLY closed Tuesday's trading at $190.90, up 0.92%.

5. Merus to Present Zenocutuzumab Data at ASCO

Merus N.V. (MRUS) is scheduled to present efficacy and safety data from its phase I/II trial of Zenocutuzumab monotherapy in NRG1 gene fusion-positive solid tumors, dubbed eNRGy, at the 2021 American Society of Clinical Oncology Annual Meeting, to be held in June.

Zenocutuzumab was granted Orphan Drug Designation by the FDA for pancreatic cancer last August and Fast Track Designation for the treatment of patients with metastatic solid tumors harboring NRG1 gene fusions that have progressed on standard-of-care therapy in January 2021.

Also in the pipeline are MCLA-158, which is under a phase I dose expansion trial in patients with gastro-esophageal and head-and-neck cancers; MCLA-145, which is under a phase 1 dose escalation study, including a safety dose expansion phase, in patients with solid tumors; and MCLA-129, which is all set to enter into a phase 1 dose escalation study, including a safety dose expansion phase, for the treatment of various solid tumors, in the U.S. this year.

Merus, which ended 2020 with cash of $207.8 million, received $60.0 million in January 2021 from a collaboration with and equity investment by Lilly and raised $129.7 million in aggregate net proceeds from a follow-on offering.

MRUS closed Tuesday's trading at $23.34, up 5.90%. In after-hours, the stock gained another 6.04% and was at $24.75.

6. Stocks That Hit New High

Enzo Biochem Inc. (ENZ) closed Tuesday's (Mar.16, 2021) trading at $4.08, up 37.84%.

Capital Senior Living Corporation (CSU) closed at $45.18, up 24.81%.

Affimed N.V. (AFMD) closed at $8.34, up 13.62%.

Vincerx Pharma, Inc. (VINC) closed at $25.90, up 9.05%.

Soliton Inc. (SOLY) closed at $17.52, up 4.85%.

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