Compass aims at $50M IPO to push lead antibody through the clinic

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."

Insmed to Host Third Quarter 2020 Financial Results Conference Call on Thursday, October 29, 2020

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.

CNS Pharmaceuticals Completes U.S. Manufacturing of Berubicin for Phase 2 Clinical Trial

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.

AbSci Announces $65 Million Financing Led by Casdin Capital

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."

Kyowa Kirin North America Announces Recipients of Patient Education Grants to Address Disparities for African-American Patients with Cutaneous T-Cell Lymphomas (CTCL)

On October 20 2020 Kyowa Kirin, Inc., an affiliate of Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151) a global specialty pharmaceutical company, reported the Cutaneous Lymphoma Foundation and the Lymphoma Research Foundation as the first recipients of grants to support the education of African-American patients about cutaneous T-cell lymphomas (CTCL) and address racial disparities in diagnosis, treatment and outcomes (Press release, Kyowa Kirin, OCT 20, 2020, View Source [SID1234568705]). Studies show African American patients are more likely to present with higher stage CTCL and at an earlier age.1 Kyowa Kirin has designed a general grant program to help identify programs that can raise awareness and encourage earlier diagnosis and treatment. The grant program continues with new funding being made available to support additional projects that can help improve outreach, diminish disparities and improve outcomes.

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Kyowa Kirin Issues a Renewed Call for Submissions, with the Grant Program Extended to 2021

With its grant, the Cutaneous Lymphoma Foundation is establishing an inclusion and diversity task force to develop a needs-assessment survey. Findings will be used to develop effective tactics and programs to engage and support the Black, Indigenous, People of Color (BIPOC) community. "This funding gives us a chance to focus on African-American patients, in particular, who often go undiagnosed or diagnosed at a more advanced stage of the disease. By engaging and learning from this community, we can find innovative ways to improve communication and new approaches that connect with these patients," says Susan Thornton, Chief Executive Officer, Cutaneous Lymphoma Foundation. "This would be a significant step toward empowering individuals and improving outcomes. It means a lot that Kyowa Kirin is supporting that work."

Additionally, the Lymphoma Research Foundation (LRF) will utilize grant funds to host a CTCL Facebook Live event in February 2021 in conjunction with World Rare Disease Day and African American History month. The event will aim to empower African American patients, family members, caregivers, and loved ones coping with a CTCL diagnosis with information on CTCL, treatment options, and clinical trials. "The Lymphoma Research Foundation sees the need for targeted educational programs to address knowledge gaps in underserved patient populations. Especially as the pandemic continues, we need to find new ways of engaging patient communities with helpful resources and information. Kyowa Kirin’s support helps us to better reach and serve African American CTCL patients," says Meghan Gutierrez, Chief Executive Officer, LRF.

"Health disparities have grown even more pronounced during the pandemic. We feel the need to take action by finding and supporting partners who can conduct effective outreach to African American communities, with credible information," says Deborah Braccia, Vice President, Medical Affairs, Kyowa Kirin North America. "By continuing to fund this grant program, we hope to engage more organizations in our efforts to overcome barriers to CTCL diagnosis and treatment."

In a continuation of the grant program, Kyowa Kirin is seeking project proposals that can help to close gaps in awareness and understanding of CTCL among African-American communities, informing patients about prevalence and epidemiology, risk factors, diagnosis and care pathways. Applications for funds are due by December 10, 2020.

Kyowa Kirin encourages proposals from the following individuals or organizations who are focused on a mission related to patient education and/or healthcare improvement: Patient advocacy organizations or non-profit foundations; organizations dedicated to African-American empowerment and/or healthcare; public health/social work/nursing/pharmacy schools or students within these schools; healthcare institutions (both large and small); and other entities with a mission related to patient education and/or healthcare improvement.

Kyowa Kirin will make $100,000 available in funds to support these initiatives starting in 2021. Individual projects requesting up to $35,000 will be considered.

Proposals and questions should be submitted to the North America Grant Review Committee mailbox at [email protected] by December 10, 2020.