Privately-owned Swiss, Basel-based, NBE-Therapeutics has appointed Steffen Heeger MD, Ph.D. as Chief Medical Officer to lead the clinical development of NBE-002, the company’s first iADC™ program targeting ROR1.
Heeger’s appointment was announced at the start of at the start of World ADC, the ‘must attend’ industry meeting for anyone involved in the development and manufacturing of ADCs, held October 8 – 11, 2019 in San Diego, CA.
NBE-Therapeutics’ immune-stimulatory antibody-drug conjugates or iADCs™ combine a uniquely effective anthracycline payload with site-specific enzymatic conjugation generating an entirely homogeneous ADCs with stable linkers.
Heeger will be responsible for the clinical development and all medical and regulatory aspects of NBE-002 with a focus on solid tumor indications of high unmet medical need, including triple-negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), and sarcomas, as well as for new programs from the NBE iADC™ platform.
Late stage development
Following successful completion of pivotal GLP-toxicology studies, NBE-Therapeutics’ lead iADC™ product NBE-002 is now in late-stage CMC and regulatory process to enable IND filing H1/2020 and First-in-Human (FiH) clinical trials in mid-2020.
NBE-Therapeutics’ was established with a vision is to developing next-generation antibody-drug conjugates with the goal of improving treatment options for cancer patients. The company leverages proprietary platforms covering all aspects of ADC development, including its Transpo-mAb Display™ technology for antibody discovery, its SMAC-Technology™ for site-specific payload conjugation of toxins to antibodies and a novel highly effective and immune-stimulatory anthracycline-based toxin platform.
Heeger, an oncologist, has over 15 years industry experience in clinical development of targeted cancer therapies. He held senior medical positions at Merck-Serono, MorphoSys in Germany. Throughout his career Heeger has led clinical development programs predominantly in areas of hematological malignancies and in solid tumors.
As vice president, head of clinical development and head of clinical operations at MorphoSys, Heeger primarily focused on the development and execution of clinical strategy for MorphoSys’ lead hematology and oncology products.
More recently, at Selvita in Poland, he was responsible for clinical, medical and regulatory affairs for the company’s oncology pipeline including SEL24, a first-in-class dual PIM/FLT3 kinase inhibitor for the treatment of acute myeloid leukemia, SEL120, a first-in-class selective CDK8 kinase inhibitor targeting hematological malignancies and solid tumors as well as new programs in targeted therapeutics, cancer metabolism and immunometabolism, and immune-oncology.
Internationally recognized with a strong track record in the clinical development of antibody-based, targeted oncology drugs, Heeger was instrumental for the development of the blockbuster drug cetuximab (Erbitux®; Eli Lilly & Company / Merck KGaA), a monoclonal therapeutic antibody targeting EGFR, but also for successful clinical development of other anti-cancer therapeutic antibodies, e.g. targeting CD19, CD38 and PSMA.
“We are excited that Steffen with his deep experience in clinical development of antibody-based oncology drugs has joined NBE-Therapeutics’ Management team as Chief Medical Officer,” noted Ulf Grawunder, CEO and Board member of NBE-Therapeutics.
“Heeger has taken a close look at our preclinical data in support of FiH clinical trials and has realized the outstanding potential of our lead iADC™, NBE-002 for cancer patients with difficult to treat tumors. His involvement in NBE will greatly expedite the initiation and execution of clinical trials for NBE and future iADC™ pipeline products,” Grawunder added.
“I have followed NBE-Therapeutics’ early discovery and preclinical ADC development activities over the years and I was always very intrigued by NBE-Therapeutics’ highly differentiated and effective ADC platform with high potential to significantly improve therapies for hematologic malignancies and solid tumors,” Heeger said, following his appointment as Chief Medical Officer.
“I was particularly intrigued by the high therapeutic index and immune-oncology function of NBE-Therapeutics’ iADCs, as well as the impressive safety profile of NBE-Therapeutics’ lead product NBE-002 in pivotal GLP-toxicology studies, especially when comparing to other ADCs in the field. I am convinced that NBE-Therapeutics iADCs have the potential to become best-in-class therapies in many difficult to treat cancer indications. I am very excited to advance and to develop a clinical pipeline of iADC drugs together with my management colleagues and NBE-Therapeutics stakeholders for the benefit of cancer patients in need of better therapies,” Heeger concluded.