CAMBRIDGE, MA, and PHILADELPHIA, PA – January 10, 2022 – Moderna Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, and Carisma Therapeutics Inc., a biopharmaceutical pioneer in engineered macrophage-based therapeutics, today announced that the two companies have entered into a strategic collaboration agreement to discover, develop and commercialize in vivo engineered chimeric antigen receptor monocyte (CAR-M) therapeutics for the treatment of cancer.

“We are excited to begin this collaboration with Carisma to further expand our oncology pipeline with a differentiated in vivo cell-therapy approach,” said Stephen Hoge, President of Moderna. “This exemplifies our strategy to partner with companies with deep biological expertise while leveraging Moderna’s core mRNA and LNP capabilities to further expand the reach of Moderna’s technology.”

“Moderna’s deep expertise in mRNA and LNP technologies opens up a potentially game-changing opportunity for engineered macrophages,” said Steven Kelly, President and Chief Executive Officer of Carisma. “In vivo delivery directly to monocytes and macrophages enables an off-the-shelf therapeutic approach that uses the patients’ own cells to provide a truly personalized treatment. By combining Carisma’s expertise in engineered macrophage biology and Moderna’s pioneering in vivo mRNA delivery technologies, we are excited about the potential of this novel therapeutic approach for treating cancer. We are thrilled to be working with Moderna.”

About the Collaboration

Under the terms of the agreement, Carisma will receive a $45 million up-front cash payment and an investment by Moderna in the form of a $35 million convertible note. Carisma will receive research funding and is eligible to receive development, regulatory, and commercial milestone payments, plus royalties on net sales of any products that are commercialized under the agreement. Carisma will be responsible for the discovery and optimization of development candidates while Moderna will lead the clinical development and commercialization of therapeutics resulting from the agreement. Moderna has the option to nominate up to twelve targets for development and commercialization.

About Moderna

In 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna’s capabilities have come together to allow the authorized use of one of the earliest and most-effective vaccines against the COVID-19 pandemic.

Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.

About Carisma Therapeutics
Carisma is a biopharmaceutical company dedicated to developing a differentiated and proprietary cell therapy platform focused on engineered macrophages, cells that play a crucial role in both the innate and adaptive immune response. The first applications of the platform, developed in collaboration with the University of Pennsylvania, are autologous chimeric antigen receptor (CAR)-macrophages for the treatment of solid tumors. Carisma is headquartered in Philadelphia, PA.

For more information, please visit www.carismatx.com

Moderna Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding: Moderna’s collaboration with Carisma to discover, develop and commercialize CAR-M therapeutics for the treatment of cancer; the terms of that collaboration; and the potential for the collaboration to lead to personalized cancer treatments. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include those risks and uncertainties described under the heading “Risk Factors” in Moderna’s most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna’s current expectations and speak only as of the date hereof.

Moderna Contacts:

Media:
Colleen Hussey
Director, Corporate Communications
617-335-1374

Investors:

Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
617-209-5834

Carisma Media Contact:

Christina Khoury-Folkens
(929) 299-5962

Creative Balloons appoints David Johnson as Chairman of the Board of Directors

ImCheck Therapeutics announced today the publication of the preclinical to clinical development of its lead immuno-oncology program, ICT01. The publication in the medical journal Science Translational Medicine details ImCheck’s butyrophilin (BTN)-based immuno-oncology approach and positions ImCheck as a pioneer in a nascent field of immunomodulation. ICT01 is a fully-humanized anti-BTN3A monoclonal antibody designed to selectively activate gamma 9 delta 2 (Vγ9Vδ2) T cells through all three isoforms of BTN3A (1/2/3), which are expressed on the surface of innate and adaptive immune cells and overexpressed on the tumor cells of a number of solid and hematologic cancers.

The article, titled “Development of ICT01, a first-in-class, anti-BTN3A antibody for activating Vγ9Vδ2 T cell-mediated anti-tumor immune response” describes the molecular mechanism of how ICT01 activates Vγ9Vδ2 T cells in a pAg-independent and BTN3A isoform-agnostic manner, overcoming the two key limitations of prior efforts to activate Vγ9Vδ2 T cells. In the first-in-human EVICTION Phase I/IIa clinical trial, ICT01 demonstrated selective activation of Vγ9Vδ2 T cells, causing them to rapidly migrate out of the circulation and into tumor tissue. Furthermore, ICT01-activated Vγ9Vδ2 T cells secrete IFNγ and TNFa that expands the anti-tumor immune response by recruiting CD3 and CD8 T cells into tumors.

“This very comprehensive publication describes the bench-to-bedside story of ICT01 and presents in detail ImCheck’s novel and differentiated immunotherapeutic approach,” said Paul Frohna, PharmD, Chief Medical Officer of ImCheck. “ICT01’s unique design circumvents prior limitations of activating Vγ9Vδ2 T cells in cancer patients, making it a promising candidate for the treatment of a broad range of cancers. We look forward to building upon these published results in an upcoming presentation at the SITC 2021 Annual Meeting.”

“Our mission is to apply our scientific expertise and clinical leadership with the BTN superfamily of immunomodulators to bring innovative therapeutics to patients. The publication of these findings in Science Translational Medicine exemplifies our leadership in BTN research as a promising avenue of investigation for cancer immunotherapy and supports the further development of our pipeline of other BTN-targeted programs,” stated Pierre d’Epenoux, Chief Executive Officer of ImCheck Therapeutics.

The publication was authored by ImCheck scientists in collaboration with the laboratory of Prof. Daniel Olive, Professor of Immunology and Director of the Oncology Research Programs at Aix Marseille University and the company’s scientific founder.

Ghent, Belgium – November 30, 2021 – Confo Therapeutics today announced that it has entered into a collaborative agreement with Regeneron Pharmaceuticals, Inc. whereby Confo’s technology platform, which uses conformationally selective VHH antibodies – ConfoBodies® – to stabilize GPCRs (G protein-coupled receptors) in disease-relevant conformations, will be applied with the goal of enabling the discovery of novel therapeutic antibody drug candidates. The agreement will leverage Confo’s expertise in addressing two GPCR targets for which functional antibodies are needed. Confo will be entitled to an upfront payment, research funding, and potential clinical, regulatory, and commercial payments. Further details regarding the agreement have not been disclosed.

Confo’s ConfoBody-based technology platform aims to overcome the limitations of drug discovery on GPCRs, the largest and most diverse group of membrane receptors targeted by approximately 30% of all commercialized drugs.

“With ten medicines approved by regulatory authorities, Regeneron is regarded in our industry as one of the most effective antibody discovery and development companies, with a successful track record of translating scientific insight into effective and innovative treatments. Working with them underscores the significant potential of our technology platform, in particular our new application to generate antibody drug candidates, and its promise to unveil GPCR drug targets and overcome a range of limitations of current approaches,” commented Cedric Ververken, Chief Executive Officer of Confo Therapeutics.

Christel Menet, Chief Scientific Officer of Confo Therapeutics added: “We value this opportunity to showcase the strength of this new addition to our technology suite and participate in what we hope will be the development of successful new antibody-based therapies. Parallel to this, we continue on our own drug development path, and drive innovative small molecule and biological therapeutics into our own pipeline.”

Heart valve diseases are among the most serious cardiac conditions affecting more than 12.7 million patients in Europe. In the last decade minimally invasive catheter-based solutions have been developed for other heart valve diseases, but none have been designed specifically for the tricuspid valve.

Tricuspid regurgitation is a frequent and serious disease for which open heart surgery and symptomatic pharmacologic treatment are the current standard treatment options. Owing to high mortality risk, access to open heart surgery is severely restricted and is not considered an option for more than 99% of patients with tricuspid regurgitation. The prognosis for patients without surgical repair is poor, with 2.2 years median survival. As such, there is an urgent need for minimally invasive, lower risk solutions to improve outcomes for patients with no other viable treatment options.

Topaz is an innovative device designed specifically to help patients suffering from severe tricuspid regurgitation without the need for open heart surgery. The Topaz device is the result of a French and German collaboration, and is implanted in a minimally invasive procedure through the patient’s femoral vein. It is designed specifically to fit the tricuspid valve anatomy and thus support ease of positioning and functionality.

Today’s announcement marks the successful first two implantations of Topaz in patients, which were done on a compassionate use basis.

The first patient to benefit from this technology is a 70-year-old woman with heart failure due to severe tricuspid regurgitation. She was no longer responding to medical treatment and considered inoperable given her condition and operative risk. The successful implantation of the Topaz tricuspid heart valve replacement system took place at University Hospital Henri Mondor in Créteil, France, on 7 June 2021, and was performed by Prof. Emmanuel Teiger and Dr. Romain Gallet de-Saint-Aurin with implantation time of 16 minutes. The Topaz device achieved complete correction of the tricuspid regurgitation, and the patient was discharged from hospital after four days and is returning to normal activity levels.