MacroGenics Agrees to Sell MARGENZA® to TerSera Therapeutics

ROCKVILLE, MD & DEERFIELD, IL, USA I October 22, 2024 I MacroGenics, Inc., a company specializing in the discovery, development, production, and commercialization of innovative antibody-based cancer therapies, and TerSera Therapeutics LLC, a private biopharmaceutical company focused on oncology and non-opioid pain management, have announced a significant agreement. TerSera Therapeutics will acquire the global rights to MARGENZA® (margetuximab-cmkb) from MacroGenics.

MARGENZA received approval from the U.S. Food and Drug Administration (FDA) in December 2020. It is approved in combination with chemotherapy for treating adult patients with metastatic HER2-positive breast cancer, particularly those who have undergone at least two prior anti-HER2 treatments, including one for metastatic disease. This approval was based on data from the pivotal Phase 3 SOPHIA clinical trial, which compared the safety and effectiveness of MARGENZA to Herceptin® (trastuzumab), both used alongside chemotherapy.

According to the agreement terms, TerSera will initially pay $40 million to MacroGenics at the time of closing. Additionally, MacroGenics stands to receive up to $35 million in sales milestone payments. The transaction is anticipated to conclude in the fourth quarter of 2024, contingent on standard closing conditions.

Scott Koenig, President and CEO of MacroGenics, stated that this deal will allow the company to concentrate on developing its pipeline of innovative oncology treatments. He expressed confidence in TerSera's established U.S. commercial infrastructure, which he believes can expand patient access to MARGENZA.

Edward Donovan, CEO of TerSera, emphasized the importance of MARGENZA as a treatment for metastatic HER2-positive breast cancer. He expressed excitement about adding MARGENZA to TerSera's oncology portfolio, reinforcing their dedication to breast cancer treatment.

MARGENZA carries a Boxed Warning for left ventricular dysfunction and embryo-fetal toxicity. Patients undergoing treatment with MARGENZA should be monitored for cardiac function and advised of potential risks to unborn children. Infusion-related reactions are also a concern and patients should be under observation during administration.

The most common side effects observed in patients treated with MARGENZA in combination with chemotherapy include fatigue, nausea, diarrhea, vomiting, and constipation, among others. These side effects occur in more than 10% of patients.

MARGENZA is indicated for adults with metastatic HER2-positive breast cancer who have previously undergone two or more anti-HER2 treatments, with at least one being for metastatic disease.

HER2-positive breast cancer is characterized by the overexpression of the HER2 protein, leading to aggressive tumor growth and poor prognosis. While monoclonal antibodies targeting HER2 have significantly improved patient outcomes, many patients still progress to later stages of the disease, highlighting the need for new effective treatments.

MARGENZA is an Fc-engineered monoclonal antibody targeting the HER2 protein. It inhibits tumor cell growth, reduces HER2 extracellular domain shedding, and mediates antibody-dependent cellular cytotoxicity (ADCC). MacroGenics' Fc Optimization technology has further enhanced MARGENZA's ability to engage the immune system, increasing in vitro ADCC and activating natural killer (NK) cells. The clinical significance of these in vitro findings is yet to be determined.

MacroGenics is a biopharmaceutical company dedicated to creating, developing, manufacturing, and commercializing cutting-edge monoclonal antibody-based cancer treatments. The company's product pipeline is primarily derived from its proprietary suite of next-generation antibody-based technology platforms, applicable across diverse therapeutic areas. MacroGenics' expertise in protein engineering has led to the development of promising product candidates and numerous strategic collaborations with global pharmaceutical and biotechnology firms.

TerSera Therapeutics, focused on oncology and non-opioid pain management, was founded in 2016. The company is committed to delivering meaningful outcomes for patients through its unique therapeutic portfolio. TerSera has been acknowledged as a 2024 Healthcare Top Workplace.