Engitix builds liver disease pipeline with series A and drug collaboration

On January 19, 2022 Engitix reported that With the close of its Series A round at €48M ($54M), the tissue models company has shifted its business from providing drug discovery services to developing its own treatment pipeline for liver diseases (Press release, Engitix, JAN 19, 2022, View Source [SID1234610299]).

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When Engitix was spun out of University College London in 2016, the startup primarily aimed to provide tissue models to pharmaceutical companies for speeding up drug discovery in liver disease. As the company closes a €48M Series A round and drug discovery partnership with the Milan-based Dompé Farmaceutici this week, Engitix is reinforcing its plans to become a drug developer in its own right.

Drug candidates are typically tested in the lab using cell cultures, which are easy to grow and screened in large numbers. However, they don’t well resemble the structures of human organs, which are made up of cells and the extracellular matrix between them.

Engitix is developing drug testing models that are a closer imitation of real organs than cell cultures. The company sources extracellular matrix scaffolds from diseased and healthy organs from biobanks and grows cells on the scaffold to simulate a real organ.

Many companies are working on ways to screen drug candidates using more informative methods than cell cultures. Earlier this week, the Swiss startup EraCal deployed a high-throughput drug screening model based on zebrafish in a drug discovery collaboration with Novo Nordisk. There are also many firms that bioprint organs using polymer gels and cells.

By using human tissue scaffolds, Engitix’s models can shed light on local conditions influencing the behavior of tumor cells, such as blood vessels and immune cells, known as the microenvironment.

Engitix raises $54 million to advance ECM target discovery platform

On January 19, 2022 Engitix Therapeutics Ltd. reported that it has raised $54 million in a series A round to advance early programs arising from its human extracellular matrix (ECM) target discovery platform towards the clinic with the support of new partner and equity investor Dompé Farmaceutici SpA (Press release, Engitix, JAN 19, 2022, View Source [SID1234610085]).

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Cancer Advances, Inc. Announces Abstract and Poster Presentation at ASCO GI – Role of an anti-gastrin vaccine (PAS) in combination with a PD-1 antibody on growth and metastasis of gastric cancer

On January 19, 2022 Cancer Advances, Inc., a clinical stage biopharmaceutical company developing therapeutics for gastrointestinal cancers, reported that it will host a virtual presentation of its poster at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium being held from January 20-22, 2022, at the Moscone West Building in San Francisco, CA (Press release, Cancer Advances, JAN 19, 2022, View Source [SID1234606797]).

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The researchers evaluated the effect of Cancer Advances’ Polyclonal Antibody Stimulator (PAS) vaccine and PD-1 antibody therapy alone or in combination in a murine model of gastric cancer. PAS monotherapy was found to significantly decrease tumor growth rate and fibrosis in the tumor microenvironment, and to eliminate metastases. The impact of combination therapy on these factors was greater still, although PD-1 therapy alone was not significantly different from placebo. Details of the abstract and poster presentation are below:

Abstract 334: Role of an anti-gastrin vaccine (PAS) in combination with a PD-1 antibody on growth and metastasis of gastric cancer

Link to Related Publication: https://www.frontiersin.org/articles/10.3389/fonc.2021.788875/full

The research was conducted in collaboration with presenter, Jill P. Smith, MD, professor of medicine and oncology at Georgetown University Medical Center, through a sponsored agreement with Cancer Advances, Inc. Cancer Advances plans to seek approval for PAS in the treatment of gastric and pancreatic cancers.

CURALEAF COMPLETES ACQUISTION OF BLOOM DISPENSARIES

On January 19, 2022 Curaleaf Holdings, Inc. (CSE: CURA / OTCQX: CURLF) ("Curaleaf" or the "Company"), a leading international provider of consumer products in cannabis, reported the completion of its previously announced acquisition of Bloom Dispensaries ("Bloom"), a vertically integrated, single state cannabis operator in Arizona (the "Transaction") (Press release, Curaleaf Holdings, JAN 19, 2022, View Source [SID1234606759]). With the close of the Transaction, Curaleaf’s retail footprint has reached 13 dispensaries in Arizona and 121 nationwide.

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Boris Jordan, Executive Chairman of Curaleaf, stated, "Bloom is an excellent strategic fit for Curaleaf as it further expands our capacity and retail footprint in Arizona with an attractive set of assets, enabling us to better serve the state’s US$1.4 billion-plus annual market opportunity. Adding to these benefits, Bloom will be immediately accretive to our adjusted EBITDA margins. On behalf of the Board of Directors and management team, I am pleased to officially welcome Bloom to the Curaleaf family."

Joseph Bayern, CEO of Curaleaf, stated, "We are very excited to complete our acquisition of Bloom. Bloom is an ideal asset to expand Curaleaf’s presence in Arizona having built a strong and profitable business by consistently delivering the highest quality products to the market. Arizona represents a significant market opportunity with strong long-term growth potential, and we believe the combination of our two companies will enable Curaleaf to accelerate our growth strategy in the state."

Bloom Dispensaries Highlights:

·2021 revenue of approximately US$66 million and EBITDA margins of more than 40%.
·Four retail dispensaries located in the cities of Phoenix, Tucson, Peoria, and the only dispensary currently in Sedona.
·Two adjacent cultivation and processing facilities located in north Phoenix totaling approximately 63,500 sq. ft. of space.

Transaction Details:

Under the terms of the agreement, Curaleaf paid an aggregate purchase price of approximately US$211 million on a cash and debt free basis with target working capital. The purchase price is subject to standard adjustments based on the actual working capital in the company at close. The purchase price will be paid US$51 million in cash at close, with the remaining approximately US$160 million to be paid through the issuance three promissory notes of US$50 million, US$50 million, and US$60 million due, respectively, on the first, second and third anniversary of closing of the Transaction. At the option of the sellers of Bloom, the third promissory note may be paid by the Company by issuing up to 4,881,392 subordinate voting shares of Curaleaf Holdings at a fixed price of US$13.85 per share on the third anniversary of closing. The notes will be recourse only to shares and assets of Bloom and will not be guaranteed by any Curaleaf entity.

Momelotinib Review Article Published in Journal of Hematology & Oncology Highlights Importance of Anemia Benefit for Myelofibrosis Patients

On January 19, 2022 Sierra Oncology, Inc. (NASDAQ: SRRA), a late-stage biopharmaceutical company dedicated to delivering targeted therapies for rare cancers, reported the publication of a review article in the Journal of Hematology & Oncology that outlines the potential ability of momelotinib—a novel JAK1, JAK2 and ACVR1 / ALK2 inhibitor—to address the critical unmet need of anemia for myelofibrosis patients (Press release, Sierra Oncology, 19 19, 2022, View Source [SID1234605666]). Srdan Verstovsek, MD, PhD, Chief, Section for Myeloproliferative Neoplasms, Department of Leukemia, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center and co-Primary Investigator of the pivotal Phase 3 MOMENTUM study, co-authored the article.

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"We are delighted to see this publication that reinforces momelotinib as the potential JAK inhibitor of choice for myelofibrosis patients with anemia—a need that is currently not met with approved JAK inhibitors. We look forward to sharing MOMENTUM topline data the end of January 2022," said Stephen Dilly, MBBS, PhD, President and Chief Executive Officer at Sierra Oncology.

Myelofibrosis is characterized by constitutional symptoms, including fatigue, body and bone pain and excessive sweating or fever; splenomegaly (enlarged spleen); and anemia. Moderate-to-severe anemia afflicts 40-60% of myelofibrosis patients at the time of diagnosis and increases to up-to 90% of patients over time.1 Anemia is a predictor of reduced overall survival and is associated with a nearly four-fold increase in the risk of death compared to no anemia, with a median survival of just 2.1 years.2,3

While JAK inhibitors are the mainstay of treatment options for myelofibrosis patients, currently approved JAK inhibitors cause myelosuppression, worsening anemia and creating poorer outcomes for patients. This profile creates a critical gap in the myelofibrosis treatment landscape and the need for a therapy that can address all three hallmarks of disease.

The authors noted in the publication, "Momelotinib’s mechanism of action uniquely positions it amongst approved and late-stage JAK inhibitors to be able to significantly alleviate the inflammation-driven, iron-restricted anemia of MF [ myelofibrosis] and eliminate/prevent RBC [red blood cell] transfusion dependence in a significant portion of MF patients besides treating the other two cardinal features of MF (splenomegaly and constitutional symptoms)."

To read the full article, titled "Momelotinib: an emerging treatment for myelofibrosis patients with anemia," please visit the Journal of Hematology & Oncology website.

About Momelotinib

Momelotinib is a selective and orally bioavailable JAK1, JAK2 and ACVR1 / ALK2 inhibitor for the potential treatment of myelofibrosis. Myelofibrosis results from dysregulated JAK-STAT signaling and is characterized by constitutional symptoms, splenomegaly (enlarged spleen) and progressive anemia.

Momelotinib is currently under investigation in the MOMENTUM clinical trial, a global, randomized, double-blind Phase 3 study for symptomatic and anemic myelofibrosis patients. The study enrolled 195 patients based on a planned 180 patients across 21 countries. Topline data are anticipated by the end of January 2022, and assuming positive results, the company intends to file an NDA with the FDA in the second quarter of 2022.