Mesothelioma Immunotherapy Receives Orphan Drug Designation
Research & Clinical TrialsAsbestos.com is the nation’s most trusted mesothelioma resource
The Mesothelioma Center at Asbestos.com has provided patients and their loved ones the most updated and reliable information on mesothelioma and asbestos exposure since 2006.
Our team of Patient Advocates includes a medical doctor, a registered nurse, health services administrators, veterans, VA-accredited Claims Agents, an oncology patient navigator and hospice care expert. Their combined expertise means we help any mesothelioma patient or loved one through every step of their cancer journey.
More than 30 contributors, including mesothelioma doctors, survivors, health care professionals and other experts, have peer-reviewed our website and written unique research-driven articles to ensure you get the highest-quality medical and health information.
About The Mesothelioma Center at Asbestos.com
- Assisting mesothelioma patients and their loved ones since 2006.
- Helps more than 50% of mesothelioma patients diagnosed annually in the U.S.
- A+ rating from the Better Business Bureau.
- 5-star reviewed mesothelioma and support organization.
Testimonials
My family has only the highest compliment for the assistance and support that we received from The Mesothelioma Center. This is a staff of compassionate and knowledgeable individuals who respect what your family is experiencing and who go the extra mile to make an unfortunate diagnosis less stressful. Information and assistance were provided by The Mesothelioma Center at no cost to our family.LashawnMesothelioma patient’s daughter
How to Cite Asbestos.com’s Article
APA
Whitmer, M. (2023, August 9). Mesothelioma Immunotherapy Receives Orphan Drug Designation. Asbestos.com. Retrieved September 21, 2023, from https://www.asbestos.com/news/2023/08/09/mesothelioma-immunotherapy-orphan-drug/
MLA
Whitmer, Michelle. "Mesothelioma Immunotherapy Receives Orphan Drug Designation." Asbestos.com, 9 Aug 2023, https://www.asbestos.com/news/2023/08/09/mesothelioma-immunotherapy-orphan-drug/.
Chicago
Whitmer, Michelle. "Mesothelioma Immunotherapy Receives Orphan Drug Designation." Asbestos.com. Last modified August 9, 2023. https://www.asbestos.com/news/2023/08/09/mesothelioma-immunotherapy-orphan-drug/.

A novel therapy for mesothelioma has been given orphan drug designation by the U.S. Food and Drug Administration.
Avenge Bio, a biotechnology company working on a new treatment platform for immunotherapy, announced it was granted the designation for its drug AVB-001 in June. It is currently enrolling patients in ongoing phase 1 and phase 2 clinical trials for the treatment of advanced ovarian cancer, primary peritoneal mesothelioma and fallopian tube cancer.
AVB-001 is a new treatment being developed by Avenge Bio using its LOCOcyte immunotherapy platform to treat solid tumors. It’s a first-in-human, single-arm, open-label, dose-escalation and expansion trial that is looking to assess the safety and tolerability for certain cancer patients.
Clinical Trials Now Enrolling
Avenge Bio is now enrolling an estimated 44 patients into its two-part clinical trial. The first phase is a dose escalation phase to determine the maximally tolerated dose and will be used for phase 2, a dose expansion phase.
The drug will be administered in up to 20 additional adult patients with “platinum-resistant, high-grade, serous adenocarcinoma of the ovary, primary peritoneum, or fallopian tube,” according to the company’s clinical trial information. There may be additional cohorts opened in phase 2 for “monotherapy or as an exploratory combination strategy.”
The study began in December 2022 and is estimated to be completed in August 2026. Among other qualifications, eligible candidates for the clinical trial must:
- Be over age 18
- Have a history of unresectable, platinum-resistant, high-grade, serous adenocarcinoma of the ovary, primary peritoneum or fallopian tube
- Have an Eastern Cooperative Oncology Group performance status of 0 to 1 at screening
- Have not had more than five lines of prior therapy
The clinical trial is being held at three locations: Massachusetts General Hospital in Boston, Women & Infants Hospital of Rhode Island in Providence and MD Anderson Cancer Center in Houston.

What Is Orphan Drug Status?
Orphan drug status is a special designation given to drugs or treatments intended to treat rare diseases or conditions – including mesothelioma – that affect a relatively small number of patients.
Supporting the development and evaluation of new treatments for a rare disease, typically affecting less than 200,000 Americans, has benefits for the maker, according to the FDA. Orphan drug designation qualifies sponsors for incentives that include tax credits for qualified clinical trials, exemptions from user fees and the potential for seven years of exclusive marketing after approval.
Ovarian cancer is linked to occupational and secondhand asbestos exposure, according to the International Agency for Research on Cancer. It is also linked to contaminated talcum powder products.
Recent studies have linked asbestos exposure to an increased risk of ovarian cancer, particularly among women who may have used asbestos-contaminated talcum powder. Advanced stages of ovarian cancer, in which the cancer has spread to distant organs in the patient’s body, has a 5-year survival rate of 17%.