Investments in R&D, key to growth

Investments in R&D, key to growth

Farmaindustria points out in its report that 20% of industrial investment in R&D in Spain comes from the pharmaceutical industry, and the latest ASEBIO report states that biotechnology companies account for 0.9% of GDP and support more than 120,000 jobs. Spain also has excellent conditions for the development of clinical trials, which is an opportunity to attract international investment and is an opportunity for patients.

At Oryzon we remain committed to developing highly innovative drugs in the field of epigenetics and investing in R&D as the company’s growth engine. In the first half of 2022 we have intensified our investments in R&D to €7.8 million (+28% compared to the same period of the previous year). Despite the international context, we maintain a solid financial position, recently reinforced with the signing of a convertible bond program for up to 20 million euros over 30 months, which provides financing to continue developing our exciting portfolio of projects until the first semester of 2024.

In oncology, we have obtained very positive data with iadademstat in the Phase II ALICE trial, in combination with azacitidine, in acute myeloid leukemia (AML). Recently presented 42-month data continue to confirm a high response rate, which is rapid and long-lasting, along with good tolerability. We plan to present the final data from this trial in December at ASH-2022.

We believe that the combinations with iadademstat will increase the therapeutic options for patients with AML both in first and second line. Thus, we will soon begin to recruit patients in a new US trial, FRIDA, in combination with gilteritinib in patients with relapsed/refractory FLT3 mutation. To complement the costs of executing this study, we have recently obtained a non-refundable public subsidy from the EU of 1.87 million euros.

We are also continuing preparations for new combination trials in solid neuroendocrine tumors. In small cell lung cancer (SCLC), STELLAR will be a multicenter, randomized Phase Ib/II trial of iadademstat with an immune checkpoint inhibitor in patients with first-line metastatic SCLC. In addition, we are about to start, also in the US, a collaborative Phase Ib/II trial in combination with synergistic agents in platinum R/R SCLC and in high-grade pulmonary and extrapulmonary neuroendocrine tumors (NETs). The recent signing of a collaboration with the US National Cancer Institute within the framework of the CRADA program is a success that supports our science and will allow us to considerably expand the clinical development of iadademstat using an extensive network of federal hospitals.

In neurology, we continue to advance the clinical development of vafidemstat. We continue to actively recruit patients in the Phase IIb PORTICO clinical trial in patients with Borderline Personality Disorder (BPD) in Europe and the US. As well as the Phase IIb EVOLUTION clinical trial in patients with schizophrenia which has also continued recruiting patients.

The company is also deploying a pioneering precision medicine approach to diseases of the nervous system, spearheading a first clinical trial in patients with Kabuki syndrome (KS). The company is finalizing the design of this new Phase I/II trial, called HOPE, which it plans to carry out in the US.

At Oryzon we are at a key moment, the new batch of clinical trials should lay the foundations for accelerated clinical development and faster market arrival. The latest additions of North American professionals with extensive experience in interactions with the FDA and the US financial environment, not only reinforce our permanent presence in this country, but will be critical for the execution of clinical programs and strategically advancing in the plan of alliances and approvals.

Samuel Edwards
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