Stockholm, Sweden (Press Release) – Oncopeptides AB (Nasdaq Stock­holm: ONCO) an­nounces to­day that the com­pany will provide an up­date on patient recruitment in the on­go­ing phase 3 study OCEAN, as well as a general up­date from all the com­pany's clin­i­cal stud­ies in a webcast at 10.00am (CET) to­day.

Conference call for in­­vestors, analysts and the media, Wednesday, 24 April 2019, at 10 am (CET).

CEO Jakob Lindberg will provide an overview of on­go­ing clin­i­cal stud­ies and ac­­tiv­i­ties in con­nec­tion with these.

Phone num­bers for par­tic­i­pants from:

Sweden: +46850558357
Europe: +443333009030
USA: +18335268382

The conference call will also be streamed on the website www.oncopeptides.com and via the link below.

https://tv.streamfabriken.com/2019-04-24-oncopeptides-press-conference

OCEAN

In the sec­ond half of 2018, Oncopeptides com­mu­ni­cated that the patient recruitment rate in the com­pany's phase 3 study OCEAN was lower than initially esti­mated when the study was ini­ti­ated in 2017. The com­pany implemented a num­ber of measures to in­­crease patient recruitment in 2018. For example, the num­ber of hos­pi­tals participating in the study was in­­creased by almost 50% and hos­pi­tals are still being added. These ac­­tiv­i­ties have been ef­fec­tive, and the recruitment rate has in­­creased sig­nif­i­cantly. However, they have not entirely made up for the deviation from the initial forecast and the com­pany now esti­mates that the last patient in (LPI) will take place during Q1 2020, which corresponds to a delay of 6 to 9 months com­pared to pre­vi­ously com­mu­ni­cated timelines.

"After the initiation of OCEAN, poma­lido­mide has been used more and more as a sec­ond line treat­ment op­tion for patients with mul­ti­ple myeloma. This is a strong pos­i­tive for mel­flu­fen and its future sales poten­tial based on the OCEAN trial design as a head-to-head comparison with poma­lido­mide. At the same time as being pos­i­tive for the value of OCEAN it also rep­re­sents a patient recruitment chal­lenge since those patients cannot be part of the OCEAN study. It takes time to estab­lish­ a new recruitment forecast since patient recruitment variability is high be­tween dif­fer­en­t months and is fur­ther amplified by the ex­pan­sion of the num­ber of hos­pi­tals in the study. Despite all the actions taken, we have now de­ter­mined that we will not meet the original en­roll­ment goal," commented Jakob Lindberg, CEO of Oncopeptides.

HORIZON

In late summer 2018, Oncopeptides decided to ex­pand the study from 80 to 150 RRMM patients in order to provide a more extensive and robust dataset. This de­ci­sion was based on the promising clin­i­cal data pre­sented during 2018. The study has attracted sig­nif­i­cant interest among treating physicians and new clin­i­cal centers have been added. The com­pany esti­mates that the last patient entering the study will take place during Q3, which is in line with pre­vi­ous forecasts.

By in­creas­ing the num­ber of patients in the study to collect a larger amount of clin­i­cal data, the study be­comes more relevant from a regu­la­tory point of view. As pre­vi­ously com­mu­ni­cated in the year-end re­port, the plan is to discuss these promising data with regu­la­tory author­i­ties in­­clud­ing the FDA. A meeting with the FDA has now been scheduled and will be held be­fore the summer.

ANCHOR

The com­bi­na­tion study where mel­flu­fen is used to­geth­er with dexa­meth­a­sone and either dara­tu­mu­mab or bor­tez­o­mib in RRMM patients has started well, and initial re­­sults from the phase 1 part were pre­sented at ASH in De­cem­ber 2018. There is a large interest for this study, in par­tic­u­lar in com­bi­na­tion with dara­tu­mu­mab, and the phase 2 part is now on­go­ing. Tolerability and clin­i­cal ac­­tiv­ity look promising in both groups. Based on the promising pre­lim­i­nary re­­sults and the large interest in treating RRMM patients with mel­flu­fen to­geth­er with dara­tu­mu­mab, Oncopeptides is planning to start a phase 3 study with this com­bi­na­tion later this year.

BRIDGE

The study in RRMM patients with im­paired renal function started as planned in the autumn of 2018. An up­date of the protocol has been con­ducted, prompted by the FDA, which will soon allow patients with both mod­er­ate and severe renal im­pair­ment to be treated with mel­flu­fen. The study is planned to be fully recruited in the autumn of 2019, in line with our original forecast.

The in­for­ma­tion in the press re­lease is in­for­ma­tion that Oncopeptides is obliged to make pub­lic pur­su­ant to the EU Market Abuse Regulation. The in­for­ma­tion was sub­mitted for pub­li­ca­tion, through the agency of the contact person above, on April 24, 2019 at 07.30 (CET).

About Oncopeptides

Oncopeptides is a pharma­ceu­tical com­pany devel­op­ing drugs for the treat­ment of can­cer. The com­pany is focusing on the devel­op­ment of the lead prod­uct can­di­date mel­flu­fen, a novel peptide con­ju­gated al­kyl­ator, belonging to a new class of drugs called Peptidase Enhanced Compounds (PEnC). Melflufen is in devel­op­ment as a new treat­ment for the hema­to­logical can­cer mul­ti­ple myeloma and is cur­rently being tested in a global pivotal Phase 3 trial and in three addi­tional sup­porting clin­i­cal trials. Oncopeptides' head­quar­ters is located in Stock­holm, Sweden and the com­pany is listed in the Mid Cap segment on Nasdaq Stock­holm with the ticker ONCO.

Source: Oncopeptides.