Molecular Partners to Conduct Phase II Trial of MP0250, a Multi-DARPin Targeting VEGF and HGF, in Multiple Myeloma

January 8, 2016
  • MP0250 to be studied in combination with bortezomib and dexamethasone
  • Patient enrollment expected to start in second half of 2016
PDF

Zurich-Schlieren, January 8, 2016. Molecular Partners AG (ticker: MOLN) today announced its Phase II strategy for MP0250, a multi-DARPin drug candidate that blocks vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF), in multiple myeloma (MM). The company plans to conduct a Phase II clinical trial of MP0250 in combination with bortezomib (Velcade®) and dexamethasone in patients with MM who have developed resistance to bortezomib and have received at least two prior regimens, including bortezomib and an immunomodulatory drug (IMiD). Molecular Partners expects to enroll the first patient in the second half of 2016.

“While several new therapies have become available in recent years, multiple myeloma remains an incurable disease in which patients commonly relapse and develop resistance to therapy,” commented Dr. Andreas Harstrick, Chief Medical Officer at Molecular Partners. “We are therefore very excited to advance the Phase II program for MP0250 in multiple myeloma, as preclinical results suggest it works on different steps in tumor progression, providing a strong biologic rationale for its use in this disease.”

In a preclinical model of MM, the combination of MP0250 and bortezomib showed substantial antitumor activity in settings where bortezomib had very little effect as a single agent. In addition to inhibiting tumor growth, the combination of MP0250 and bortezomib resulted in a significant reduction in bone destruction, one of the most important clinical hallmarks of this disease.

The announcement of Molecular Partners’ Phase II strategy for MP0250 in MM comes as the company continues to advance the drug candidate’s Phase I program in patients with solid tumors. A team of independent researchers recently presented preliminary Phase I data demonstrating good tolerability, favorable pharmacokinetics (PK), and sustained exposure over multiple applications of MP0250 in patients with solid tumors. The Phase I results, presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston, Mass., USA, constitute the first demonstration in patients of the potential role of DARPin-based therapy in oncology.

“Due to their small size, high potency, high stability and flexible architecture, DARPin therapies have the potential to overcome many of the limitations of conventional anticancer therapies, and may provide a powerful platform for advancing the field of oncology,” commented Dr. Michael Stumpp, Chief Scientific Officer of Molecular Partners. “Based on research conducted to date and planned clinical trials, DARPins may emerge as a new class of molecules that package multiple benefits within a single drug, allowing physicians to inhibit multiple critical pathways at once.”

About Multiple Myeloma
Multiple myeloma (MM) is a hematological (blood) cancer that develops in the antibody-producing plasma cells found in the bone marrow. The malignant plasma cells produce large quantities of non-functional antibodies called M proteins, which are the hallmark characteristic of MM. Malignant myeloma cells accumulate in the bone marrow and crowd out the normal plasma cells that help fight infection as well as the cells responsible for producing red and white blood cells.(1) The accumulation results in a marked reduction of normally functioning antibodies and lowered blood cell counts. Additionally, myeloma cell growth in the bone marrow often leads to bone loss, increasing the risk of fractures. Other complications of MM include susceptibility to infection (due to a weakened immune system), anemia, and kidney problems.(2) MM is one of the most common hematologic malignancies in the world,(3) with a global annual incidence of more than 124’000 new cases.(4) Worldwide, the disease causes more than 87’000 deaths each year.(5)

About Molecular Partners in Oncology
Molecular Partners is advancing a growing proprietary pipeline of DARPin therapies in oncology. The most advanced systemic DARPin, MP0250, is in a Phase I clinical study in patients with solid tumors. MP0250 inhibits both VEGF and HGF from binding to their receptors, thereby blocking tumor growth and tumor spreading. The second most advanced oncology DARPin is MP0274, which has broad anti-HER activity, inhibiting both HER1, HER2, and HER3-mediated downstream signaling and leading to induction of apoptosis. MP0274 is currently in preclinical development. The current focus of Molecular Partners in research is immuno-oncology.

About Molecular Partners AG
Molecular Partners is a clinical-stage biopharmaceutical company that is developing a new, powerful class of therapies known as DARPins. DARPins are potent, specific, and versatile small-protein therapies, which have the potential to offer benefits over conventional monoclonal antibodies or other currently available protein therapeutics. The DARPin technology has the potential to offer a multi-specific approach to treatment, which enables DARPins to target multiple pathways, or multiple epitopes on a single target to achieve substantial patient benefit. DARPins have the potential to advance modern medicine and significantly improve the treatment of serious diseases, including cancer and sight-threatening disorders.
Molecular Partners has four compounds in various stages of clinical and preclinical development and several more in the research stage, with a current focus on ophthalmology and oncology. The company has ongoing research and development partnerships with leading pharmaceutical companies, including Allergan and Janssen, and is backed by established biotech investors. For more information regarding Molecular Partners, go to: www.molecularpartners.com.

For further details, please contact:
Dr. Christian Zahnd, CEO
christian.zahnd@molecularpartners.com
Tel.: +41 (0) 44 755 77 00
Tel.: +41 (0) 44 755 77 00

Dr. Patrick Amstutz, COO
patrick.amstutz@molecularpartners.com
Tel.: +41 (0) 44 755 77 00

Rolf Schläpfer
Hirzel.Neef.Schmid.Counselors
rolf.schlaepfer@konsulenten.ch
Tel.: +41 (0) 43 344 42 42

Legal Notice
This communication does not constitute an offer or invitation to subscribe for or purchase any securities of Molecular Partners AG. This publication may contain certain forward-looking statements and assessments or intentions concerning the company and its business. Such statements involve certain risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of the company to be materially different from those expressed or implied by such statements. Readers should therefore not place reliance on these statements, particularly not in connection with any contract or investment decision. The Company disclaims any obligation to update these forward-looking statements, assessments or intentions.

——
References:
1) What is multiple myeloma? Norwalk, CT: Multiple Myeloma Research Foundation; 2015. http://www.themmrf.org/multiple-myeloma/what-is-multiple-myeloma/. Accessed 29 December 2015.

2) Multiple myeloma complications. Norwalk, CT: Multiple Myeloma Research Foundation; 2015. http://www.themmrf.org/multiple-myeloma/multiple-myeloma-complications/. Accessed 6 January 2016.

3) de Mel S, Lim SH, Tung M L, Chng WJ. Implications of heterogeneity in multiple myeloma. BioMed Res Int. 2014;2014:232546. doi:10.1155/2014/232546.

4) GLOBOCAN 2012: World, multiple myeloma, number of new cancers in 2015 (all ages). Lyon, France: World Health Organization (WHO), International Agency for Research on Cancer (IARC); 2015. http://globocan.iarc.fr/old/burden.asp?selection_pop=224900&Text-p=World&selection_cancer=17270&Text-c=Multiple+myeloma&pYear=3&type=0&window=1&submit=%C2%A0Execute. Accessed 29 December 2015.

5) GLOBOCAN 2012: World, multiple myeloma, number of cancer deaths in 2015 (all ages). Lyon, France: World Health Organization (WHO), International Agency for Research on Cancer (IARC); 2015. http://globocan.iarc.fr/old/burden.asp?selection_pop=224900&Text-p=World&selection_cancer=17270&Text-c=Multiple+myeloma&pYear=3&type=1&window=1&submit=%C2%A0Execute. Accessed 29 December 2015.