Recent challenges around preparing, transporting, and administering COVID-19 vaccines have received national and international attention. As part of our ongoing COVID-19 response, the U.S Pharmacopeia (USP) rapidly engaged stakeholders and convened experts to identify and help address operational efficiency gaps to help increase COVID-19 vaccinations.

The new USP COVID-19 Vaccine Handling Toolkit provides critical information to pharmacists, doctors, nurses, nurse practitioners, physician assistants, health profession students, and others who are involved in handling COVID-19 vaccines. These resources facilitate operational efficiencies that can help accelerate delivery and support safe handling of COVID-19 vaccines while maintaining quality and ultimately the public’s trust.

When complete in early 2021, it will include operational strategies in three key areas:

Preparation and labeling

Storage, handling and transport

Waste and disposal

https://www.usp.org/covid-19/vaccine-handling-toolkit

2020 was an interesting year for the biotech industry and the BioHealth Capital Region as we adjusted to continue moving forward during the COVID-19 Pandemic. While the biggest stories in terms of dollars were related to the Coronavirus and funding to create a vaccine in record time, that didn’t stop other biotech companies from working hard to develop their research, science, and/or devices.

As we begin 2021, we ask the same question this time every year:
Who’s the next big success story that could emerge in the new year?

To answer that question, we looked back at our stories from 2020 to review the companies in our ecosystem poised for transformative funding transactions or collaborations in 2021.

Here are the six life science companies to keep an eye on in 2021 and beyond.

Click here to read more via BioBuzz

A nonprofit is considering Montgomery County as the site of a global pandemic center that would focus on prevention, research and response.

The Global Pandemic Prevention and Biodefense Center would serve as the “world’s epicenter” for pandemic prevention and biodefense ecosystem coordination.

Click here to read more via Bethesda Magazine

Immunomic Therapeutics Inc. has raised another $16 million following a mammoth raise in the spring of 2020.

The Rockville vaccine company secured the new capital to support its oncology programs, the company said in an email Friday to the Washington Business Journal. That’s after it surpassed its initial $50 million target with a total $61.3 million in new funding in April. The company disclosed the latest raise Thursday in a filing with the Securities and Exchange Commission.

Click here to read more via WBJ.

With a phase 3 data readout on its COVID-19 vaccine looming, Novavax has already started stockpiling doses ahead of an authorization. Now, thanks to a fresh manufacturing tie-up, the company’s ex-U.S. supplies just got a little more secure.

Novavax tapped Baxter BioPharma Solutions to handle commercial-scale vaccine manufacturing at its facility in Halle, Germany. Once production work kicks off, Baxter will be on deck to crank out supplies for the European and U.K. markets, the companies said.

The Deerfield, Illinois-based CMO will tackle fill-finish work on Novavax’s recombinant nanoparticle adjuvanted vaccine, a Novavax spokeswoman said via email. The company’s candidate, NVX-CoC2373, is still in phase 3, though it’s eyeing a phase 3 data readout sometime during the first quarter.

Click here to read more via FiercePharma

FREDERICK, Md – January [XX], 2021 – Veralox Therapeutics, a biotechnology company developing first-in-class small molecule therapeutics that treat the underlying pathologies of diseases with significant unmet medical needs, today announced it submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for initiation of a Phase 1 clinical trial of VLX-1005, a first-in-class small molecule inhibitor of 12-Lipoxygenase in development for the treatment of heparin-induced thrombocytopenia (HIT).

HIT is an immune complication of heparin therapy resulting in low platelet counts caused by antibodies to complexes of platelet factor 4 (PF4) and heparin. Currently, one third of hospitalized patients in the U.S., or about 12 million a year, receive heparin. HIT is the most important and most frequent drug‐induced type of thrombocytopenia.

“This IND submission is a key milestone for Veralox and a tribute to the hard work and dedication of our team to advance VLX-1005 to first in human studies,” said Jeffrey Strovel, Ph.D., Chief Executive Officer of Veralox Therapeutics, Inc.
“We are excited to continue our efforts to further develop this groundbreaking new therapy for patients suffering from HIT,” David Maloney, Ph.D., Chief Scientific Officer of Veralox Therapeutics.

About VLX-1005

VLX-1005 is a first-in-class and selective small molecule inhibitor 12-Lipoxygenase, a key target within the arachidonic acid pathway. Preclinical data has demonstrated that VLX-1005 halts immune driven platelet activation and thrombosis thus offering the potential of a lifesaving treatment for patients with HIT.

About Veralox Therapeutics

VERALOX Therapeutics Inc. (Veralox Website) is developing first-in-class therapeutics that target the underlying pathologies of diseases with unmet medical needs. The company’s lead candidate, VLX-1005, will be developed initially to treat patients with heparin-induced thrombocytopenia (HIT). Second generation therapeutic products are under development for T1D and other immune-mediated and inflammatory diseases.

Contact:
Jeffrey Strovel, CEO
Jeff@veralox.com

Myeloid to utilize MaxCyte’s Flow Electroporation® technology and ExPERT™ platform to advance its novel cell therapies to treat solid tumors, T cell lymphoma and glioblastoma

CAMBRIDGE, MA and GAITHERSBURG, MD, January 11, 2021 — Myeloid Therapeutics, Inc., a company harnessing and reprogramming myeloid cells to treat cancers, and MaxCyte, Inc., a global cell-based therapies and life sciences company, today announce the signing of a clinical and commercial licensing agreement.

Myeloid Therapeutics will obtain non-exclusive clinical and commercial rights to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform. This agreement enables Myeloid to advance its pipeline programs, including for engineered cell therapies targeting solid tumors, T cell lymphoma, and glioblastoma. In return, MaxCyte is entitled to receive undisclosed development and approval milestones, and sales-based payments, along with other licensing fees.

Myeloid’s ATAK™ platform leverages the unique power of myeloid cells to help patients fighting cancers that, until now, have been very difficult to treat. By targeting myeloid cells, the technology allows for diverse applications and Myeloid’s pipeline expansion is ongoing.

“We are very excited to be working with MaxCyte, an established leader in cell engineering. This agreement provides long-term access to MaxCyte’s unique electroporation technology platform, representing an important enabling step in the continued clinical advancement of targeted cell-based therapies, for patients with few if no options,” said Daniel Getts, PhD, CEO of Myeloid. “The ease of use and integration of MaxCyte instruments into our workflow allows us to envision rapid-same-day turnaround of cell treatments for patients presenting with aggressive tumors.”

Doug Doerfler, President & CEO of MaxCyte, said: “We are proud to support Myeloid’s work and are excited about the company’s novel approach to engineering and harnessing the innate capabilities of the myeloid cell. This agreement represents an important achievement for MaxCyte as it expands the use of our next-generation technology platform to support engineering in novel cell types. Myeloid’s ATAK™ technology is being developed for several critical applications in cancer.”

MaxCyte’s ExPERT instrument portfolio represents the next generation of leading, clinically validated, electroporation technology for complex and scalable cell engineering. By delivering high transfection efficiency, seamless scalability and enhanced functionality, the ExPERT platform delivers the high-end performance essential to enable the next wave of biological and cellular therapeutics.

About Myeloid Therapeutics

Myeloid Therapeutics is an immunology company focused on combining immunologic insights with cutting-edge technologies to harness myeloid cells to eradicate cancer and other diseases. The Company’s ATAKTM platform technology can be broadly applied, and it is initially advancing a cell therapy program for T cell lymphoma and a primed monocyte approach to treat glioblastoma. The ATAK platform is scalable to multiple treatment modalities and other disease areas in collaboration with partners. Myeloid expects to enter the clinic with its two lead programs in the first half of 2021. For more information, visit visit www.myeloidtx.com.

About MaxCyte

MaxCyte is a clinical-stage global cell-based therapies and life sciences company. As the inventors of the premier cell-engineering enabling technology, the Company helps bring the promise of next-generation cell and gene-editing therapies to life. The Company’s technology is currently being deployed by leading drug developers worldwide, including all of the top ten global biopharmaceutical companies. MaxCyte licenses have been granted for more than 120 cell therapy programs, with more than 90 licensed for clinical use, and the Company has now entered into twelve clinical/commercial license partnerships with leading cell therapy and gene editing developers. MaxCyte was founded in 1998 and is headquartered in Gaithersburg, Maryland, US. For more information, visit www.maxcyte.com

Myeloid Media Contact
Sarah Sutton
Glover Park Group
ssutton@gpg.com
+1 202-741-1990

MaxCyte Contacts: