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10-Q – Quarterly report [Sections 13 or 15(d)]

Exicure has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Exicure, 2017, SEP 12, 2017, View Source [SID1234521881]).

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Oncology Research: New Opportunities for Menarini and OBT

On September 12, 2017. Menarini Ricerche (Menarini Group) and Oxford BioTherapeutics (OBT), an international biotechnology company, reported that they have initiated a multicenter first-in-human clinical study to evaluate MEN1309, an antibody drug conjugate for the treatment of metastatic solid cancers, as well as for the treatment of non-Hodgkin’s lymphoma (Press release, Menarini, SEP 12, 2017, View Source [SID1234526945]).

The phase I study of MEN1309 will be conducted in major European oncology centers in Italy, Spain, Belgium and the UK. MEN1309 is a fully-human monoclonal IgG1 antibody coupled to DM4, a maytansinoid toxin targeting the tumour antigen CD205. In patient derived models and xenografts, MEN1309 showed strong anti-tumor activity in triple-negative breast (TNBC), pancreatic, and bladder cancers, as well as diffuse large B-cell lymphoma (DLBCL), a type of non-Hodgkin lymphoma (NHL), consistent with the expression of CD205 seen in these cancer types.

"MEN1309 could become an innovative treatment option for many cancer patients" said Andrea Pellacani (General Manager, Menarini Ricerche). "We are very pleased with the progress of our strategic oncology alliance with Oxford BioTherapeutics. Menarini has a long-standing commitment to advancing the treatment of cancer, and we look forward to accelerating our shared pipeline with OBT in clinical development."

This open label trial will start by enrolling patients with solid tumors in the first dose escalation phase, followed by a second dose escalation in NHL. The subsequent expansion cohorts phase will aim at identifying the recommended phase II dose in specific indications among solid tumors and NHL. In addition, the trial will investigate the correlation of the clinical response with target antigen expression.

"We are delighted to initiate clinical development of the second oncology programme in our partnership with the Menarini Group" said Christian Rohlff, Oxford BioTherapeutics’ CEO. "By bringing together OBT’s world-class discovery capabilities with Menarini’s clinical development and manufacturing expertise, the partnership is successfully advancing exciting programs aimed at large unmet clinical need in oncology."

Under the collaboration, Menarini is responsible for the clinical development, up to the clinical proof of concept study, and then for the full development and regulatory approval in its territories: Europe, Asia, and Latin America. OBT is responsible for full development, approval and commercialization in North America and Japan.

MEN1112, the first program from the collaboration for the treatment of Acute Myeloid Leukemia (AML), is currently progressing through the phase I dose escalation trial in relapsed/refractory AML patients.

Polaris Announces Results of a Phase 2 Trial of ADI‑PEG 20 in Relapsed/Refractory or Poor-risk Acute Myeloid Leukemia

On September 12, 2017 Polaris Group reported that its lead therapeutic ADI‑PEG 20 (pegylated arginine deiminase) demonstrated a good safety profile and an efficacy signal as monotherapy in a phase 2 trial in relapsed/refractory or poor-risk acute myeloid leukemia (AML) patients, as reported in the journal Scientific Reports (Press release, Polaris Pharmaceuticals, SEP 12, 2017, View Source [SID1234526282]). The study was conducted at multiple sites in Taiwan and at MD Anderson Cancer Center in the US.

Among the 21 evaluable patients enrolled in this study, two patients had complete response to the treatment, with response duration of 7.5 and 8.8 months. Seven patients had stable disease in response to the treatment. The treatment appeared to be safe and well tolerated.

"Based on the encouraging efficacy signal from this ADI‑PEG 20 monotherapy study, we have initiated a phase 1 trial combining ADI‑PEG 20 with low-dose cytarabine in poor-risk AML patients," said John Bomalaski, M.D., Executive Vice President, Medical Affairs at Polaris Pharmaceuticals, Inc.

About ADI‑PEG 20

ADI‑PEG 20 is a biologic being developed by Polaris Group to treat cancers carrying a major metabolic defect that renders them unable to internally synthesize arginine. Because arginine is essential for protein synthesis and survival of cells, these cancer cells become dependent upon the external supply of arginine to survive and grow. ADI‑PEG 20 is designed to deplete the external supply of arginine, causing arginine-dependent cancer cells to die while leaving the patient’s normal cells unharmed. Multiple cancers have been reported to have a high degree of arginine-dependency and can potentially be treated with ADI‑PEG 20.

The Japanese patent office intends to grant BioInvent’s important patent relating to the immune-oncology antibody BI-1206

On September 12, 2017 BioInvent International AB (OMXS: BINV) reported that the Japanese patent office has decided that the company’s first patent application relating to the immune-oncology antibody BI-1206 now can proceed to grant (Press release, BioInvent, SEP 12, 2017, View Source [SID1234520495]). The patent will be granted once all remaining administrative actions, such as payment of fees, have been completed by BioInvent. This patent is important since it covers the use of the company’s drug candidate BI-1206, and similarCD32b antibodies, in combination with a CD19 or CD20 antibody, such as rituximab, in the treatment of cancer or inflammatory diseases in certain groups of patients.

This will be the third patent granted in this patent family, after the patents granted in Australia and by the European Patent Office. There are also corresponding patent applications pending in other countries.

Sandoz proposed biosimilar rituximab accepted for review by the FDA

On September 12, 2017 Sandoz, a Novartis Division, and the pioneer and global leader in biosimilars, reported that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) under the 351 (k) pathway for a proposed biosimilar to the reference medicine, Rituxan** (rituximab) (Press release, Novartis, SEP 12, 2017, View Source [SID1234520494]).

Rituxan** is used to treat blood cancers including non-Hodgkin’s lymphoma (follicular lymphoma and diffuse large B-cell lymphoma) and chronic lymphocytic leukemia, as well as immunological diseases such as rheumatoid arthritis.

"The cost of treating cancer in the US is a major concern for many patients and their families as well as for the healthcare system[3]" said Mark Levick, MD PhD, Global Head of Development, Biopharmaceuticals. "With the FDA acceptance of our regulatory submission for proposed biosimilar rituximab, we plan to deliver patients a high-quality Sandoz biosimilar that, following approval, could help drive healthcare savings and increase competition, while freeing up resources for and supporting patient access in other areas of cancer care including innovative therapies."

The BLA consists of a comprehensive data package that includes analytical, preclinical and clinical data. Clinical studies included a pharmacokinetic/pharmacodynamic (PK/PD) trial in rheumatoid arthritis (ASSIST-RA)[4], and a Phase III confirmatory safety and efficacy study in follicular lymphoma (ASSIST-FL)[5]. Sandoz believes these data provide confirmation that the proposed biosimilar matches the reference medicine in terms of safety, efficacy and quality.

Sandoz is committed to increasing patient access to high-quality biosimilars. As the pioneer and global leader in biosimilars, Sandoz has five biosimilars marketed worldwide, as well as a leading global pipeline. We plan to launch a total of five major oncology and immunology biosimilars between 2017 and 2020. This includes biosimilar rituximab, which was approved by the European Commission for use in Europe in June 2017 (marketed as Rixathon).

Sandoz is well positioned to continue leading the biosimilars industry based on its experience and capabilities in development, manufacturing and commercialization. As a division of Novartis, the first global healthcare company to establish a leading position in both innovative and off-patent medicines, Sandoz benefits strongly from this unique blend of experience and expertise in many different market environments.

Sandoz also continues to champion policy and legislation that enables patients and the healthcare system to benefit from biosimilars. This was demonstrated by the recent US Supreme Court unanimous positive decision related to the Notice of Commercial Marketing (NCM). The Supreme Court ruled that NCM can be provided before FDA approval, accelerating patient access to future US biosimilars by 180 days. The Court also provided additional clarity on how the "patent dance," the process by which biosimilar manufacturers may provide confidential and proprietary information to the manufacturer of the reference medicine in the patent exchange process, will function.