23 October 2023

BerGenBio ASA: New Data on BerGenBio’s Selective AXL Inhibitor Bemcentinib Released Today at 2023 ESMO Meeting

BERGEN, Norway, October 23, 2023 – BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, today announced that the full results of its Phase 2 BGBC008 study of bemcentinib and pembrolizumab in second line Non-Small Cell Lung Cancer (NSCLC) were presented during the European Society of Clinical Oncologists (ESMO) Annual Meeting 2023.

The poster presentation is now available on BerGenBio’s website under →Pipeline→Scientific Publications.

In addition, on October 21st, Dr.  Oddbjorn Straume, M.D., Ph.D., Assistant Professor, Clinical Science at the Haukeland University Hospital in Bergen, Norway presented results of the Investigator Led Study LBA52 of bemcentinib in addition to pembrolizumab or the targeted therapies dabrafenib/trametinib in 1L and 2L metastatic melanoma patients.

Cristina Oliva, Chief Medical Officer of BerGenBio, commented: “The full data analysis of the BGBC008 second line NSCLC study of bemcentinib in combination with the immune checkpoint inhibitor pembrolizumab showed promising long-term clinical benefits in patients regardless of their prior therapies, or PD-L1 status.  In addition, the combination of bemcentinib with pembrolizumab was well tolerated with no new safety signals identified.  These data provide a strong foundation for further clinical investigations of bemcentinib in NSCLC patients with high unmet needs, including those with STK11 mutations.”

Dr. Oliva continued, “During the meeting, our collaborator, Dr. Oddbjorn Straume, also presented data on the combination of bemcentinib with standard of care therapies in first line and second line melanoma patients. While this small study failed to show the benefit of adding a selective AXL inhibitor to the treatment for melanoma patients, the results are consistent with the current limited understanding of the function of AXL in melanoma.In totality, these new data substantiate BerGenBio’s focused strategy on the treatment of first line NSCLC patients with STK11m patients in our on-going BGBC016 study.”

-End-

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 COVID-19.

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

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.

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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.