Press release
Dec 16, 2016  ·  Regulatory information

Cantargia and SMS-oncology conclude agreement on implementation of clinical phase I/IIa trial

Lund (Sweden) and Amsterdam (Netherlands), 16 December 2016: Cantargia AB (“Cantargia”, CANTA) intends to initiate its first clinical study in the first half of 2017. In the autumn the company engaged in preparations for the start of the clinical phase I/IIa study aimed at non-small cell lung cancer and pancreatic cancer. Cantargia and Specialized Medical Services-oncology BV (“SMS-oncology”) in Amsterdam, the Netherlands, have today announced that SMS-oncology has been selected as the company’s contract research organisation (“CRO”).

In autumn 2016, Cantargia continued its preclinical studies and the preparations required for the start of the company’s first clinical trial with its lead product CAN04, which is scheduled to begin in the first half of 2017. The preparations include signing an agreement with a CRO, which is the organisation that will implement the clinical phase I/IIa study. An agreement has now been concluded with SMS-oncology in Amsterdam, the Netherlands.

Cantargia has held a follow-up meeting with key opinion leaders (“KOLs”) that took part in the company’s Scientific Advisory Board meeting in late May 2016, which has resulted in a general design for the study. The study is aimed at non-small cell lung cancer (“NSCLC”) and pancreatic cancer, and will look at safety and dosage in the initial stage and treatment effects in the second stage. The second stage of the study will also cover combination therapies in which Cantargia’s CAN04 product candidate is combined with currently used treatments for NSCLC or pancreatic cancer. By this, CAN04 has the potential to achieve synergies as well as providing additional data, which could accelerate the overall development of CAN04. The clinical phase I/IIa study will be conducted in the BeNeLux countries and Scandinavia, and it is expected that an initial presentation of the phase I data will be made approximately one year after the start of the study. Several highly regarded hospitals have indicated an interest in taking part in the study. The protocol will be based on an adaptive design, providing increased flexibility during the course of the trial. A committee including international experts will then evaluate the results of the phase I stage along with Cantargia’s preclinical data to determine the final design of the phase IIa stage based on a number of predefined criteria.

“We are very pleased with having selected SMS-oncology as our partner in this important trial. We have had a very productive working relationship in developing the study protocol and during the Scientific Advisory Board. We feel ready to take the next step with SMS-oncology as our partner”, Göran Forsberg, CEO of Cantargia, says.

“Cantargia’s CAN04 product candidate is an innovative product with the potential to become a part of tomorrow’s cancer treatments. SMS-oncology has broad expertise in precisely these type of studies and we are happy that Cantargia has chosen to implement their first clinical study together with us”, Philine van den Tol, CEO of SMS-oncology, says.

About SMS-oncology

SMS-oncology is a full-service oncology CRO specialized in early phase and immuno-oncology trials throughout Europe. SMS-oncology offers the complete range of clinical services from study design to completion, covering phase I to phase IV. In addition to clinical operations, the company provides expert advice on oncology drug development and study protocol design to navigate the best way forward as it understands the challenges of developing anti-cancer drugs in the highly competitive oncology market. As such, SMS-oncology takes pride in providing Direction to its sponsors for successful oncology drug development. SMS-oncology has its registered office in Amsterdam. For more information, please refer to www.sms-oncology.com.

About Cantargia

Cantargia AB (publ), reg.no. 556791-6019, is a biotech company that is developing an antibody-based cancer treatment, which aims to attack cancer cells and arrest the inflammation of the tumour. The original discovery by the research team behind Cantargia was the overexpression of a specific target molecule, interleukin 1 receptor associated protein “IL1RAP”, in cancer stem cells in patients with leukemia that is not found in normal stem cells in the bone marrow. In preclinical studies (in vitro and in vivo) the antibody, targeted at IL1RAP, has been shown to have two potential mechanisms of action, which are complementary. The Company has selected a product candidate, CAN04, for future studies in humans and development activities have been focused on non-small cell lung cancer and pancreatic cancer. 
Cantargia is listed on Nasdaq Stockholm First North (ticker: CANTA). Sedermera Fondkommission is the company’s Certified Adviser. More information about Cantargia is available at www.cantargia.com.

For further information, please contact

Göran Forsberg, CEO                                                                             Raymond Hoffmans, CBDO
Telephone: +46 (0)46 275 62 60                                                             Telephone: +31 (0)20 4350 580
E-mail: goran.forsberg@cantargia.com                                                   E-mail:  r.hoffmans@sms-oncology.com
Certified Adviser: Sedermera Fondkommission                                      www.sms-oncology.com

This constitutes information that Cantargia is required to publish under the EU’s Market Abuse Regulation. The information was submitted for publication through the above contact person on 16 December 2016, at 08.30.


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