Lund, Sweden (Press Release) – BioInvent Inter­na­tional (STO:BINV) is today providing an update on its clin­i­cal and pre­clin­i­cal drug pro­grams. Several positive inter­actions with regu­la­tory author­i­ties have taken place and clin­i­cal trials with three of the Company’s anti­bodies are ex­pec­ted to start in 2016. A scientific advice meeting with the UK Medicines and Healthcare Products Regulatory Agency (MHRA) was held in preparation for the first clin­i­cal study of BI-1206. The study plan presented to the regulator, as well as BioInvent’s data, were well received. Cancer Research UK plans to submit the Clinical Trial Application in April 2016.

With an in­­creased commitment to the BI-505 pro­gram, BioInvent will submit a clin­i­cal trial appli­ca­tion to the US Food and Drug Admin­istra­tion (FDA) in December 2015.

BioInvent and its partner Oncurios is planning to start a clin­i­cal trial with TB-403 in medulloblastoma during early 2016.

BioInvent has estab­lish­ed itself as a com­pany with strong clin­i­cal pro­grams and a strong position in the immuno-oncology area.

BI-1206

BI-1206 is an anti­body that blocks the CD32b protein which is overexpressed in lym­phoma (cancer in the lymphatic system). By combining today’s standard of care ther­apy ritux­i­mab­ (Rituxan®/MabThera®) with BI-1206, it is possible to achieve a better anti-tumour effect. The planned Phase l/ll clin­i­cal study will be sponsored, man­aged and funded by one of the world’s largest scientific non-profit organisations, Cancer Research UK. This is done under an agree­ment with BioInvent as part of the Clinical Development Partnerships Scheme, a joint ini­tia­tive between the Centre For Drug Development and Cancer Research Technology.

• In a recent scientific advice meeting with the MHRA, the design of the first clinical study with BI-1206 was discussed. The study will enrol patients with non-Hodgkin lymphoma and chronic lymphatic leukaemia.
• Cancer Research UK plans to submit a Clinical Trial Application for the Phase I/II study to the MHRA in April 2016. The lead clinical site at the University of Southampton and at least three other clinical trial sites in the UK will be involved in the trial and aim to be ready to open to recruitment as soon as all necessary regulatory and ethical approvals are in place.
• In collaboration with leading academic institutions, BioInvent has started preclinical evaluation of BI-1206 against different sub-types of non-Hodgkin lymphoma using human material from biobanks. The results will provide an important basis for designing the continuing clinical programme.

“The meeting with the UK regu­la­tory agency, MHRA, is an important step forward for BI-1206. We have reached an important mile­stone in this highly inno­va­tive pro­gram. We are now in a good position to ad­vance this pro­gram further to­wards market registration for carefully selected patient cohorts with the greatest medical need,” says Michael Oredsson, CEO of BioInvent.

BI-505

BI-505 is a human anti­body against ICAM-1 developed by BioInvent, which will be clin­i­cally tested in cooperation with researchers at Penn Medicine as an immuno-oncological ther­apy to prevent or delay relapse in patients with multiple myeloma (a form of bone marrow cancer) undergoing stem-cell trans­plan­ta­tion. Preclinical data indicates im­proved activity against myeloma when BI-505 is admin­istered in com­bi­na­tion with Velcade® or Revlimid®. BI-505’s favourable safety profile has been dem­onstrated in a pre­vi­ous phase I trial. This and the unique mech­a­nism of action, “flagging” remaining myeloma cells for elimination by actively recruited macrophages, as well as the poten­tial to inhibit ICAM-1 dependent survival signals between myeloma cells and tumour stroma, indicate a unique possibility of improving the thera­peutic effect of stem-cell trans­plan­ta­tion.

• Bioinvent plans to submit an application to the FDA in the USA, requesting to start the randomised, controlled phase II study on multiple myeloma patients undergoing autologous stem-cell transplantation, by December 2015 with Penn Medicine as the coordinating site.
• The study is expected to start in the first quarter of 2016, which is in line with previous communication.
• BioInvent has decided to assume overall responsibility for the study as sponsor of the trial. This will improve control of data and enable expansion of the trial to additional sites, if required.

“By taking on over­all responsibility and in­creas­ing the number of trial centres for the study with BI-505 we can generate data of the quality required by author­i­ties to enter into discussions regarding a registration procedure based on successful phase II data,” says Anna Teige Wickenberg, Vice Pres­i­dent Clinical Development, BioInvent.

TB-403

BioInvent and its partner Oncurious are planning to start a new clin­i­cal study with the anti­body TB-403 against certain rare forms of cancer in the brain, nervous system and connective tissue in children and adolescents. TB-403 has already been eval­u­ated in clin­i­cal studies in adults for other cancers and has dem­onstrated a good safety profile. The project’s new direction is based on new knowledge about the anti­body’s mech­a­nism of action. BioInvent has the right to 40 per­cent of all future revenue from the project.

• The study, which is expected to start in early 2016, will be implemented in cooperation with a network of specialist clinics in the USA with good access to the relevant patient cohorts.
• The preparations for study start are well underway.
• The first safety evaluation part of the study includes patients with medulloblastoma (tumour in the cerebellum), neuroblastoma (tumour in the sympathetic nervous system), Ewings sarcoma (tumour in the connective tissue) and alveolar rhabdomyosarcoma (tumour in the connective tissue), whereas children with medulloblastoma will be included in the efficacy evaluation part of the study.

“Children who suffer from these serious cancers are in great need of more effective treat­ment and we have therefore prioritised designing a study that should give us the answer as to whether TB-403 is effective in children with medulloblastoma,” says Michael Oredsson, CEO of BioInvent.

REGULATORY T-CELLS (TREG)

Regulatory T-cells (Tregs) have a strong ability to inhibit various immune responses. A series of clin­i­cal studies show that anti­bodies targeting CTLA-4 and PD-1 can induce a very long-lasting response in some cancer patients. BioInvent’s F.I.R.S.T™ tech­nology plat­form is an excellent tool for identi­fi­ca­tion of both target structures and anti­bodies in the Treg area.

• BioInvent has succeeded in identifying high-affinity antibodies with depleting activity against regulatory T-cells
• A first pool of mouse-reactive anti-Treg antibodies, which can be screened in well- established preclinical models to identify novel targets particularly suitable for antibody-mediated Treg depletion, or modulation of Treg immune suppressive activity, have been identified. Target: antibody pairs will be used to evaluate new drug targets and antibody mechanism-of-action in preclinical proof-of-concept tests, paving way for human cross-reactive, or functionally equivalent human lead clinical candidate antibodies. BioInvent recently announced that the Company has received a non-exclusive licence for a special type of antibody format, IgG2B. Preclinical trials with IgG2B antibodies have shown that this antibody type has the potential to more independently activate immune cells e.g. macrophages and T cells to promote anticancer immune responses. When targeted to appropriate receptors, the IgG2b isotype is expected to increase chances of developing new effective drugs in the immune-oncology area.

OX-40

BioInvent is work­ing in cooperation with Cancer Research Technology (CRT) and the University of Southampton in the UK to develop new immuno­therapeutic cancer drugs based on anti­bodies that target OX-40 and 4-1BB, two known co-receptors that help activate T-cells and long-lasting antitumor immune responses.

· Antibodies with high affinity, agonistic activity on effector T-cells and the ability to elim­i­nate regu­la­tory T-cells in vitro have been generated. · Preclinical in vivo studies to document proof-of-concept for BioInvent’s anti­bodies in the OX-40 project will be ini­ti­ated during the first quarter of 2016.

TUMOUR ASSOCIATED MYELOID CELLS

(TAM) Myeloid cells are essential to our innate immune system, but they can also be “hijacked” by tumours to sup­port growth and cancer spread. In the fourth quarter of 2015, BioInvent worked on preparations to develop function-modulating anti­bodies against tumour asso­ci­ated myeloid cells (TAM), a type of white blood cell that is recruited by cancer cells to sustain growth and spread, and prevent immune attack. Antibody-mediated “reprogramming” of immune-suppressive tumour-associated myeloid cells into anti-tumor effector cells is therefore a very attractive thera­peutic concept and rep­re­sents an area of research in which BioInvent and its partners are at the cutting edge.

“F.I.R.S.T is a unique plat­form to identify new anti­body-based drugs that more specifically destroy, or transform, cancer-driving immune cells such as Treg and TAM. Preclinical data indicates that anti­bodies against Treg and TAM can sig­nif­i­cantly im­prove the effects of the immuno­therapies avail­able today and make it possible to treat cancers where current immuno­therapies aren’t work­ing due to a strongly suppressed immune response to the cancer,” says Björn Frendéus, Chief Scientific Officer, BioInvent.

About BioInvent

BioInvent Inter­na­tional AB develops immune on­col­ogy drugs. With one of the world’s largest anti­body libraries, and a unique, pro­pri­e­tary discovery method, BioInvent can identify the optimal cellular targets and anti­bodies for the treat­ment of various tumor types. BioInvent has also con­siderable ex­peri­ence in and a facility for process devel­op­ment and pro­duc­tion of anti­bodies for clin­i­cal studies. This makes it possible to develop pro­pri­e­tary drug projects, but also to supply leading inter­na­tional pharma­ceu­tical com­pa­nies with effective tools for their drug devel­op­ment. BioInvent cur­rently has three pro­pri­e­tary projects in or close to clin­i­cal devel­op­ment and part­ner­ship agree­ments with seven global pharma­ceu­tical and bio­tech com­pa­nies. More in­for­ma­tion is avail­able at www.bioinvent.com.

The press release con­tains state­ments about the future, consisting of subjective assump­tions and forecasts for future scenarios. Predictions for the future only apply as the date they are made and are, by their very nature, in the same way as research and devel­op­ment work in the bio­tech segment, asso­ci­ated with risk and uncertainty. With this in mind, the actual out­come may deviate sig­nif­i­cantly from the scenarios described in this press release.

Source: BioInvent Inter­na­tional.