On October 20, 2020 ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, reported that FDA has completed its administrative review and accepted ANGLE’s FDA submission for substantive review (Press release, ANGLE, OCT 20, 2020, View Source [SID1234568786]).

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As announced on 28 September 2020, ANGLE has submitted a full Class II De Novo FDA Submission for its Parsortix PC1 system seeking FDA clearance for use with metastatic breast cancer (MBC) patients ("the Submission"). ANGLE has now received an Acceptance Review Notification from FDA that the Submission has been accepted. The administrative acceptance review is a formal process undertaken by FDA to determine that the Submission contains all of the necessary elements and information needed by FDA to proceed with substantive review.

The Submission is the output of five years’ work including extensive dialogue with FDA, and the development of over 400 technical reports and documents, which have been submitted to FDA.

FDA’s goal is to make a decision about a De Novo request in 150 review days. Review days are calculated as the number of calendar days between the date the De Novo request was received by FDA and the date of FDA’s decision. The review clock stops, however, when FDA requests further information or clarification from the Company. ANGLE believes that the earliest prospect of FDA clearance is Q2 CY21.*

ANGLE Founder and Chief Executive, Andrew Newland, commented:

"We are pleased that our FDA submission has successfully completed FDA administrative review and is now in substantive review. We believe there is a tremendous opportunity for ANGLE to secure the first ever FDA clearance for a platform that captures and harvests intact circulating tumour cells from patient blood for subsequent analysis, in the first instance for metastatic breast cancer."

On October 20, 2020 Compass Therapeutics reported that $60 million private offering (Press release, Compass Therapeutics, OCT 20, 2020, View Source [SID1234568785]). It filed to raise up to $50 million in its Nasdaq debut.

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The funds will bankroll clinical trials for its lead program, CTX-471, an antibody that activates CD137, a receptor found on T cells and natural killer (NK) cells, Compass said in a securities filing. These include a study of CTX-471 on its own that Compass plans to wrap in the second half of 2021, as well as a second phase 1 study in combination with Roche’s Herceptin and/or Eli Lilly’s Erbitux slated to begin in the first half of next year. The company hopes to kick off a phase 2/3 study by early 2022, it said in the filing.

The IPO will also pay for the manufacturing of CTX-471 for clinical trials as well as the development and validation of manufacturing ahead of commercialization.

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Beyond its lead asset, Compass will use some of the capital to support a pair of earlier-stage bispecific antibodies—CTX-8371, which targets PD-1 and PD-L1, and CTX-8573, which targets NKp30 and BCMA—as well as new R&D in bispecifics, according to the filing.

The IPO comes three months after Olivia Ventures acquired Compass in June—the combined company took on the Compass Therapeutics name along with its mission to develop immuno-oncology drugs. It picked up $60 million in a private placement at the time from several of its backers, including OrbiMed, F-Prime Capital and Cowen Healthcare Investments, as well as from new investors.

Compass’ work is based on an old technology, monoclonal antibodies, but it’s moved that approach into the fast lane.

RELATED: Compass Therapeutics’ immuno-oncology prospect clears solid tumors in mice

"We have built a technology internally that allows us to drug two new targets per month and from the start of antigen-in-hand to fully human therapeutic candidate is only about two months’ time," Compass CEO Tom Schuetz, M.D., Ph.D., said in a previous interview.

"One of our founding principles was to create a company that thinks differently about monoclonal antibody-based drug discovery," Schuetz said. "In order to do that, we created a discovery platform that is quite powerful. [We’re trying to] generate all the components we need to be able to drug the human immune system more effectively. This might be with multispecific medicines, or it might be with combination regimens. We’re going to let the data lead us to the best therapeutics and therapeutic regimens."

On October 20, 2020 Insmed Incorporated (Nasdaq: INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, reported that it will release its third quarter 2020 financial results on Thursday, October 29, 2020 (Press release, Insmed, OCT 20, 2020, View Source [SID1234568708]).

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Insmed management will host a conference call for investors beginning at 8:30 a.m. ET on Thursday, October 29, 2020 to discuss the financial results and provide a business update.

Shareholders and other interested parties may participate in the conference call by dialing (833) 340-0284 (domestic) or (236) 712-2425 (international) and referencing conference ID number 8292364. The call will also be webcast live on the company’s website at www.insmed.com.

A replay of the conference call will be accessible approximately two hours after its completion through November 12, 2020 by dialing (800) 585-8367 (domestic) or (416) 621-4642 (international) and referencing conference ID number 8292364. A webcast of the call will also be archived for 90 days under the Investor Relations section of the company’s website at www.insmed.com.

On October 20, 2020 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, reported that the Company’s U.S. manufacturer, Pharmaceutics International, Inc. ("Pii"), has completed the manufacturing process for Berubicin Drug Product, its lead drug candidate for the treatment of glioblastoma multiforme (GBM), an aggressive form of brain cancer currently considered incurable (Press release, CNS Pharmaceuticals, OCT 20, 2020, View Source [SID1234568707]).

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"Completing the manufacturing process for Berubicin in the United States is an essential step in our preparations to file an IND during the fourth quarter of this year," stated John Climaco, CEO of CNS Pharmaceuticals. "We are extremely pleased to achieve yet another milestone in our preparation efforts and demonstrate our continued ability to execute upon both our operational and clinical strategies in a timely and proficient manner. We remain committed to further progressing our trial preparations, as we look forward to initiating a U.S. Phase 2 trial for Berubicin during the first quarter of 2021."

The Company implemented a dual-track drug product manufacturing strategy to mitigate COVID-19-related delay risks, diversify its supply chain and provide for localized availability of Berubicin. Under this strategy, it engaged two separate manufacturers for Berubicin on different continents. In the United States, the Company engaged Pii, who has now completed manufacturing, and in Italy it engaged BSP Pharmaceuticals S.p.A. ("BSP"). BSP has begun the manufacturing process, which is expected to be completed early in the fourth quarter this year.

In addition to its manufacturing efforts, the Company has also made progress in its clinical trial preparations. CNS recently engaged Worldwide Clinical Trials as the contract research organization, Image Analysis Group ("IAG") as the imaging partner, and Berry Consultants as a biostatistical advisor for its Phase 2 trial design. The Company has also added Dr. Patrick Wen, a renowned neuro-oncologist, to its Scientific Advisory Board. The FDA granted the Company Orphan Drug Designation (ODD) for Berubicin for the treatment of malignant gliomas, which include GBM. The designation provides Berubicin with certain benefits during the product’s development to treat malignant gliomas and provides CNS with the potential for market exclusivity upon the drug’s approval for that use.

On October 20, 2020 AbSci, a growth-stage synthetic biology company whose Protein Printing technology enables rapid and low-cost biomanufacturing and discovery of biotherapeutics, reported a $65 million Series E equity financing (Press release, AbSci, OCT 20, 2020, View Source [SID1234568706]). The round was led by Casdin Capital with participation from other new investors, Redmile Group and ArrowMark Partners, and other existing investors, including Phoenix Venture Partners. Representatives of Casdin Capital and Redmile Group will join AbSci’s Board of Directors as a part of the financing.

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"We believe AbSci’s Protein Printing technology has a unique opportunity to support the commercialization of next-generation biologics which have long been considered unmanufacturable," said Eli Casdin, Chief Investment Officer and Founder at Casdin Capital. "In addition, AbSci’s differentiated commercial model presents a unique opportunity to share in their partners’ successes with opportunities for a revenue stream from drug development all the way through to approval and commercialization. We look forward to supporting AbSci as they execute on their vision to transform biomanufacturing and drug discovery."

Proceeds from the financing will be used to increase production capacity, accelerate facility expansion and support research and development activities. AbSci is making protein production as simple as DNA synthesis through its revolutionary Protein Printing technology, which combines the power of E. coli SoluPro with a cutting-edge synthetic biology platform for generation of high-diversity strain libraries and high-throughput screening assays. This technology delivers unprecedented titers with superior product quality for any biotherapeutic protein allowing biopharmaceutical companies to get the absolute best drug candidate to market.

"At AbSci, our mission is to revolutionize biopharmaceutical discovery and manufacturing using our Protein Printing technology to enable unprecedented precision and speed," said Sean McClain, Founder and CEO of AbSci. "Our team is committed to continually innovate and push the boundaries of what is possible. We are grateful to our new and existing investors for their support of our vision and we look forward to deploying this capital to transform the future of biomanufacturing."