ImmunoPrecise Announces Debt Settlement of Previously Issued Debentures

On March 9, 2020 IMMUNOPRECISE ANTIBODIES LTD. (the "Company" or "IPA") (TSX VENTURE: IPA) (OTC QB: IPATF) reported that it wishes to settle up to $796,875 of previously issued debentures including interest by issuing up to 1,328,125 Shares at a price of $0.60 per Share (the "Debt Settlement") (Press release, ImmunoPrecise Antibodies, MAR 9, 2020, View Source [SID1234555310]). The purpose of the Debt Settlement is to reduce the ongoing debt obligations of the debentures and is subject to the approval of the TSX Venture Exchange.

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Curadigm announces the selection of its Nanoprimer technology by the National Cancer Institute for a characterization & development collaboration

On March 9, 2020 Curadigm, an early-stage nanotechnology company committed to improving treatment outcomes by redefining the therapeutic balance between bioavailability, toxicity, and efficacy, reported the selection of its Nanoprimer technology by the National Cancer Institute’s (NCI) Nanotechnology Characterization Laboratory (NCL) for characterization, based on its potential to significantly impact treatments in multiple disease indications, including cancer (Press release, Curadigm, MAR 9, 2020, View Source [SID1234555326]).

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The broad utility of the Nanoprimer technology is due to its unique nanomedicine approach to improve therapeutic action without modifying the therapeutic in any way. Rather, the Nanoprimer is administered intravenously just prior to a therapeutic, specifically and transiently occupying the liver pathways responsible for clearance. This temporarily increases the therapeutic’s bioavailability and subsequent accumulation in target tissue. This mechanism, targeting the universal upstream pathways involved in intravenous drug clearance, means the Nanoprimer can be used in combination with multiple classes of nanomedicines including nucleic acid and small molecule therapeutics or gene editing technologies.

Through this collaboration, the NCL, a leader in the characterization and development of Nanomedicines, will perform in-depth pre-clinical characterizations. These studies will support the Nanoprimer’s development, driving advancement toward filing an Investigational New Drug (IND) with the Food and Drug Administration (FDA) and future clinical development. This work will also support ongoing and future collaborations combining the Nanoprimer with therapeutics across diverse clinical indications.

Curadigm is a 2019 Nanobiotix spin-off, that aims to reshape and elevate the efficacy of intravenously administered therapeutics. The Nanoprimer technology is based on engineered, biocompatible nanoparticles that are administered just prior to the therapeutic and acts rapidly to temporarily occupy the Kupffer and liver sinusoidal endothelial (LSEC) cells. This precision-based approach leads to enhanced systemic bioavailability for increased therapeutic action.

The NCL was established to study the use of nanoparticles and nanomedicines to advance cancer research and to accelerate the development of promising and safe nanotechnology-based cancer therapeutics. The program provides pre-clinical testing and services on a competitive acceptance basis to companies, such as Curadigm, and is working in concert with other US agencies such as the FDA to accelerate the use of nanomedicines from early-stage development to clinical applications.

"The selection of our nanoprimer by the NCL is a major step for Curadigm," said Matthieu Germain, CEO of Curadigm. "The standardized cascade assay developed by the NCL is a great opportunity to accelerate the development of the Nanoprimer by providing additional data about its physico-chemical properties, safety and mechanism of action that will facilitate regulatory review. The results generated through this collaboration will also be instrumental in supporting our discussions with partners to develop their therapeutics with the Nanoprimer."

Lilly to Participate in Barclays Global Healthcare Conference

On March 9, 2020 Eli Lilly and Company (NYSE:LLY) reported that it will participate in the Barclays Global Healthcare Conference on Tuesday, March 10, 2020 (Press release, Eli Lilly, MAR 9, 2020, View Source [SID1234555311]. Ilya Yuffa, vice president, U.S. Diabetes, and Jeffrey Emmick, M.D., Ph.D., vice president, diabetes product development, will participate in a virtual fireside chat at 10:45 a.m., Eastern Time.

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A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s Investor website at View Source A replay of the presentation will be available on this same website for approximately 90 days.

GenFleet Closes $57 Million B Round for Oncology/Immunology Portfolio

On March 9, 2020 GenFleet Therapeutics (Shanghai) reported that it has closed a $57 million Series B financing, co-led by CDH Investments and Shenzhen Capital Group (Press release, GenFleet Therapeutics, MAR 9, 2020, View Source [SID1234555328]). Founded in 2017, GenFleet is developing novel large and small therapeutic molecules for oncology and immunology targets. The company says its projects are potential first-in-class therapeutics with technical advantages and large markets. It will use the capital for ex-China development and clinical trials of its existing pipelines, plus expanding its immunology platform, working on new projects and building an industrial base.

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Zentalis Leads a Trio of Biotechs Charting a Course for Wall Street

On March 9, 2020 Zentalis Pharmaceuticals reported set a preliminary $100 million target for its IPO, according to documents filed with the Securities and Exchange Commission (Press release, Zentalis Pharmaceuticals, MAR 9, 2020, View Source [SID1234555312]). The New York-based company has applied for a Nasdaq listing under the stock symbol "ZNTL." That company is joined by Ayala Pharmaceuticals and Lyra Therapeutics, both of which also filed IPO paperwork last Friday.

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Zentalis is developing small molecules to address biological pathways of cancers. The company says in its prospectus its small molecules are different than currently marketed therapies, and that they also have the potential to address large populations of cancer patients.

The Zentalis pipeline consists of four compounds, three of which are in early-stage clinical testing. Lead drug candidate, ZN-c5, is designed to target estrogen receptors (ER), proteins to which the hormone estrogen binds. Tumors that are ER positive and human epidermal growth factor receptor (HER2) negative rely on these proteins for their growth and survival. Zentalis’s ZN-c5 is an oral drug that’s a selective estrogen receptor degrader (SERD). The compound is in Phase 1/2 testing.

The Zentalis drug is intended to challenge fulvestrant (Faslodex), an AstraZeneca (NYSE: AZN) SERD. In 2018, the last year prior to the launch of generic competition, fulvestrant accounted for more than $1 billion in revenue for AstraZeneca. This drug is administered via two 5 mL intramuscular injections given once a month. In addition to being painful, injections of the drug into the muscle restricts how much ER degradation can be achieved, limiting its efficacy, Zentalis says.

As a once-daily pill, Zentalis believes its drug would offer patients more convenience. The drug might also be more effective. According to early data from a Phase 1/2 study, the drug was rapidly absorbed and achieved high exposure levels in the body. The Zentalis drug was well tolerated by patients and no dose-limiting toxicities were reported. Additional preliminary data from the dose escalation portion of the study are expected in the second half of this year.

The Zentalis drug is also being tested in combination with palbociclib (Ibrance), a Pfizer (NYSE: PFE) cancer drug that is FDA approved as a treatment for HR positive, HER2 negative breast cancer. Under an agreement with Pfizer, the pharmaceutical giant is supplying its drug for the study at no cost to Zentalis, according to the filing. Zentalis is responsible for conducting the study and paying for it. The agreement does not give Pfizer the right to participate in future Zentalis clinical trials, and each company keeps rights to their respective drugs.

The Zentalis pipeline also includes ZN-c3 and ZN-e4, drugs in early-stage development for solid tumors and non-small cell lung cancer respectively. Preliminary data for those tests are expected in 2021. Another Zentalis compound, ZN-d5, is an experimental treatment for B-cell lymphoma. In the first half of this year, the company plans to seek FDA clearance to begin clinical testing of that drug. Zentalis says in the prospectus that it will use the IPO proceeds to continue development of its three clinical-stage compounds and to advance its B-cell lymphoma drug to human testing.

Since its 2014 founding, Zentalis has raised $162.1 million, according to the filing. The most recent financing was an $85 million Series C round that closed in December. As of the end of last year, the company had $67.2 million in cash. Its largest shareholders include Recurium Equity, Matrix Capital Management Master Fund, and Viking Global Investors. The percentage of Zentalis held by those shareholders is more than 5 percent, but the exact amount was not disclosed.