NIA Small Business Showcase: Calder Biosciences Inc.

Vaccines have issues with shelf life and potency. Furthermore, there are no vaccines for a lot of common diseases, such as the highly contagious respiratory syncytial virus (RSV), which infects the respiratory tract of most children before they are 2 years old.

Calder Biosciences is a vaccine immunogen design company developing novel RSV and universal influenza subunit vaccines, which both represent multibillion-dollar market opportunities with mitigated clinical risk. Calder applies its patented, nanoscale, targeted crosslinking technology to lock key viral proteins in the conformation that best elicits protective antibody responses and, in so doing, improves the thermostability and shelf life of the resulting vaccine immunogens.

Current estimates are that an RSV vaccine would command a market opportunity of $2 billion to $3 billion per year and that a universal flu vaccine would command an additional market opportunity of at least $1 billion per year.

Calder has a favorable risk/reward profile, because it does not perform de novo discovery but instead engineers solutions to well-characterized problems that are uniquely addressable with its dityrosine (DT) conformational locking technology.

Company Milestones

Scientific

• 2019: Achieved animal proof of principle for Calder’s conformational locking technology (DT bonding). Calder’s RSV DT prefusion (DT-preF) vaccine immunogen is both substantially more stable in vitro and more potent in vivo than our comparator, DS-Cav1, which was originally designed by NIH and is now being developed by GSK. In vitro, Calder’s F protein holds the prefusion conformation at 4°C for more than five weeks, at which time more than 90% of DS-Cav1 has lost its prefusion conformation. In vivo, Calder’s F protein is three times more potent than that of DS-Cav1, and it holds 95% of its potency for more than a month at 4°C.
• 2019: Began preclinical development of the lead vaccine candidate, RSV DT-preF (e.g., cell line development, process design and development, toxicity study design, regulator discussions).

Business

In addition to its management team, Calder has established a strong group of advisors, including Claudio Bertuccioli, Ph.D., finance and business development advisor (formerly a partner at Ascent Biomedical Ventures and a principal at Rho Ventures) and a world-renowned scientific advisory board: Jason McLellan, Ph.D., Barry Buckland, Ph.D., and Florian Schödel, M.D., Ph.D. In addition, the company has established collaborations with NIH (Barney Graham, M.D., Ph.D.), the University of Pittsburgh, the University of Miami, and the University of Texas at Austin.

Financial Overview

Calder has raised $13 million in grant awards from NIH, $1 million from the Innovation Fund (via the Bill & Melinda Gates Foundation and the International AIDS Vaccine Initiative [IAVI]), and about $1 million in taxes and other incentives.

In addition to substantial grant financing, Calder is seeking equity investment and/or opportunities or a co-development partnership for its RSV DT-preF program. Specifically, Calder is looking for $9 million to achieve a manufacturing proof of concept (for Chemistry, Manufacturing, and Controls [CMC] and a toxicity study) and an additional $11 million to achieve a clinical proof of concept (for a Current Good Manufacturing Practice [cGMP] run and a 200-subject Phase 1 study).

Working with Torreya Partners LLC, Calder has entered partnership conversations with several midsize pharmaceutical and biotechnology companies. Calder is seeking equity financing to expedite preclinical development.

Intellectual Property

Calder’s patent portfolio consists of four issued U.S. patents and their international counterparts. Another five U.S. and Patent Cooperation Treaty (PCT) patent applications are in prosecution.

Calder is collaborating with NIH to improve NIH’s DS-Cav1 design. As part of this collaboration, Calder has licensed rights to use and commercialize NIH’s RSV technology. With the license, NIH has agreed to provide information on CMC and preclinical and clinical development of the in-house program carried out by NIH.

Product Development and Regulatory Strategy

Calder is in the final stages of preparing a U.S. Food and Drug Administration (FDA) briefing for an INitial Targeted Engagement for Regulatory Advice on CBER producTs (INTERACT) meeting that will set the stage for a development program. The company plans to pursue an adjuvant strategy that implements the immunological findings obtained through collaborations with the University of Pittsburgh and the University of Miami. Initial formulation studies will be carried out by PATH.

Commercialization Strategy

Calder will seek a buyout of its company or partnership with one of the larger companies. Manufacturing would be either outsourced to contract manufacturers or taken on by a pharmaceutical partner. Assuming that clinical development is successful and FDA approval is the result, the pharmaceutical partner would take on sales and marketing, and Calder would retain milestone payments and a royalty revenue stream on vaccine sales. It is also possible that during development, a pharmaceutical partner might choose to acquire Calder’s DT technology to prevent competitors from accessing it.

In 2018, Calder became a client of Torreya, a global investment banking boutique for life sciences companies. With Torreya, Calder has held a series of meetings with multiple pharmaceutical companies interested in the RSV vaccine space to explore new partnership opportunities. Calder is currently engaged in early licensing conversations with two interested parties.

Company Details

Calder Biosciences Inc. website

140 58th Street, Bldg. A, Unit 8J
Brooklyn, NY 11220

Industry: Therapeutics

Management Team:

• Founder, President, and Chief Executive Officer: Chris Marshall, Ph.D.
• Vice President of Research & Development: Mark Yondola, Ph.D.
• Vice President of Clinical Development & Regulatory: Dirk Pleimes, M.D.

Point of Contact:

Chris Marshall, Ph.D.
Email Chris Marshall
(917) 806-4057