28 May 2024

BerGenBio ASA: BerGenBio Announces NCI Clinical Collaboration with UT Health San Antonio and Sobi®

 

Bergen, Norway, May 28, 2024, – BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, announced today that it has entered into a clinical trial agreement with the Mays Cancer Center at The University of Texas Health Science Center at San Antonio (UT Health San Antonio) and Swedish Orphan Biovitrum AB (Sobi®) (STO:SOBI), a specialized international biopharmaceutical company.

The parties will collaborate to study BerGenBio’s selective AXL inhibitor, bemcentinib, in combination with Sobi’s pacritinib in patients with advanced lung adenocarcinoma. The clinical study is externally funded and is complementary to BerGenBio’s ongoing Ph1b/2a clinical study in first-line Non-Small Cell Lung Cancer patients with mutations in the STK11 gene.

Bemcentinib is a first-in-class, selective, oral once-a-day inhibitor of AXL receptor tyrosine kinase, a promising therapeutic target for serious diseases. Pacritinib (marketed as VONJO®) is a JAK2 inhibitor indicated for treatment of myelofibrosis, a bone marrow disorder, and works by blocking certain growth factors and cytokines.

The clinical study will advance the ground-breaking work of Josephine A. Taverna, MD, a thoracic oncologist at the Mays Cancer Center and Assistant Professor in the Division of Hematology and Oncology at UT Health San Antonio. Dr. Taverna’s prior research has demonstrated that AXL and JAK-STAT3 work together to transmit signals that promote tumor growth and metastasis in advanced lung cancer. The study will be performed in collaboration with Sobi® and will be led by Dr. Taverna as the principal investigator and is funded by a grant received from the National Cancer Institute (NCI) of the National Institutes of Health (NIH).

Martin Olin, Chief Executive Officer of BerGenBio stated, “We are excited to work with two stellar partners to bring this intriguing area of research to patients. This study will further extend our knowledge of the role of selective AXL inhibition with bemcentinib in lung cancer, our area of highest strategic focus.”

Dr. Taverna commented, “Our data suggests that targeting the AXL-STAT3 pathway with bemcentinib and pacritinib can prevent tumor cells from recruiting tumor-associated macrophages and other aggressive host cells into the tumor microenvironment, disrupting tumor growth and metastatic spread. Understanding this discovery could shed light on novel therapeutic strategies for lung cancer.”

Contacts

Martin Olin CEO, BerGenBio ASA

ir@bergenbio.com

Rune Skeie, CFO, BerGenBio ASA

rune.skeie@bergenbio.com

 

Investor Relations / Media Relations

Jan Lilleby

jl@lillebyfrisch.no

About BerGenBio ASA

BerGenBio is a clinical-stage biopharmaceutical company focused on developing transformative drugs targeting AXL as a potential cornerstone of therapy for aggressive diseases, including cancer and severe respiratory infections. The Company is focused on its proprietary lead candidate, bemcentinib, a potentially first-in-class selective AXL inhibitor in development for STK11 mutated NSCLC and severe respiratory infections. BerGenBio is based in Bergen, Norway with a subsidiary in Oxford, UK. The company is listed on the Oslo Stock Exchange (ticker: BGBIO). For more information, visitwww.bergenbio.com

About Mays Cancer Center at UT Health San Antonio

The Mays Cancer Center at UT Health San Antonio (https://cancer.uthscsa.edu/) is one of only four National Cancer Institute-designated Cancer Centers in Texas. The Mays Cancer Center provides leading-edge cancer care, propels innovative cancer research and educates the next generation of leaders to end cancer in South Texas. To learn more, visit https://cancer.uthscsa.edu.

Stay connected with the Mays Cancer Center onFacebook (https://www.facebook.com/UTHealthsaMDAnderson),Twitter (https://twitter.com/UTHealthSAMDA),LinkedIn (https://www.linkedin.com/company/uthealthsa),Instagram (https://www.instagram.com/uthealthsamdanderson/)andYouTube (https://www.youtube.com/@uthealthsamdanderson).

  

About The University of Texas Health Science Center at San Antonio

The University of Texas Health Science Center at San Antonio (https://www.uthscsa.edu/) (UT Health San Antonio) is one of the country’s leading health science universities and is designated as a Hispanic-Serving Institution by the U.S. Department of Education. With missions of teaching, research, patient care and community engagement, its schools of medicine, nursing, dentistry, health professions, graduate biomedical sciences and public health have graduated more than 42,550 alumni who are leading change, advancing their fields and renewing hope for patients and their families throughout South Texas and the world. To learn about the many ways “We make lives better®,” visit UTHealthSA.org (https://uthscsa.edu/?utm_source=uthealthsaorg&utm_medium=pageredirect&utm_campaign=uthealthsa).

Stay connected with The University of Texas Health Science Center at San Antonio onFacebook (https://www.facebook.com/UTHealthSA),Twitter (https://twitter.com/uthealthsa),LinkedIn (https://www.linkedin.com/company/uthealthsa),Instagram (https://www.instagram.com/uthealthsa/)andYouTube (https://www.youtube.com/uthscsa/).

Forward looking statements

This announcement may contain forward-looking statements, which as such are not historical facts, but are based upon various assumptions, many of which are based, in turn, upon further assumptions. These assumptions are inherently subject to significant known and unknown risks, uncertainties, and other important factors. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this announcement by such forward-looking statements.

  

This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.

About Oncoinvent

Oncoinvent is developing Radspherin®, a receptor-independent alpha radiation therapy that leverages the unique anatomy of the abdominal cavity to destroy residual micrometastases using a single, highly localized dose of alpha radiation. The initial clinical focus is treatment of ovarian and colorectal cancer patients after surgical removal of the primary tumor and visible metastases in the peritoneum, the thin membrane lining the abdominal cavity and covering the abdominal organs.

This radiopharmaceutical is designed to prevent or delay recurrence in the peritoneal cavity, keeping patients disease-free for longer than the current standard of care and thereby also impacting overall survival. It is broadly applicable to any cancer that spreads to the peritoneum, e.g. ovarian, colorectal, and gastric cancers. Radspherin® stands out for its simplicity, excellent safety profile, and seamless integration into existing surgical workflows. Oncoinvent’s product is easy to use, avoids systemic delivery and significant toxicity. It is also differentiated in being simple to manufacture, scalable, and supply de-risked.

Data from two trials in ovarian (phase 1) and colorectal (phase 1/2a) cancers, are highly promising, showing an excellent safety profile and meaningful signals of efficacy. Interim data from an ongoing, randomized, controlled phase 2 ovarian cancer trial is expected in 2026. With cost-effective manufacturing, blockbuster potential, active pharma partnership momentum, plus strong endorsements from leading experts, Oncoinvent is built for scale and commercial success, and is set to become the new standard for post-surgical cancer care. The Company was founded by the originators of Algeta and Xofigo (acquired by Bayer).

Øystein Soug

Chief Executive Officer

soug@oncoinvent.com

Oystein Soug has over 15 years of experience in biotechnology, holding several management positions. Most recently, Mr. Soug was CEO of Arxx Therapeutics, where he led the company to initiate the clinical programme and was responsible for the merger with Dutch pharma company Oxitope Pharma to create Calluna Pharma. Prior to Arxx, he served as CFO and then CEO of Targovax, an Oslo listed biotechnology company, which went public during Mr. Soug’s tenure. Mr. Soug started his career in biotech as CFO of Oslo-listed radiopharmaceutical company Algeta. During this period, the company conducted a successful phase 3 trial, launched its radium-223 based prostate cancer drug Xofigo® and out-licensed the drug. Mr. Soug co-led the sale of the company to Bayer in 2014.

Mr. Soug holds an MSc in Economics and
Financial Markets from Universität St. Gallen in Switzerland in 1997

Anders Månsson

Chief Executive Officer

mansson@oncoinvent.com

Anders Månsson is a business executive with over 25 years of experience from management roles in the pharmaceutical industry, focusing on commercialisation and M&A + licensing. Mr. Månsson has held leading roles in the industry both in his native Sweden and in other European countries, and he has worked extensively with the USA and Asia as focus markets in global roles.

Mr. Månsson holds a B.Sc. degree in Business & Economics from Lund’s University in Sweden as well as an MBA from Business School Lausanne in Switzerland. He has a broad-based industrial experience, featuring both large multinational companies such as Meda, Ferring & LEO Pharma, and including leading roles in start-ups and smaller biotech companies. On top of his executive role in Oncoinvent, Mr. Månsson holds two non-executive director positions serving on the board of EQL Pharma AB as well Immetric AB, the latter being an investment company focusing on life science.