On November 7, 2017 OncoResponse reported that it has closed the acquisition of Paganini Biopharma, acquiring all of its assets including an anti-epithelial membrane protein 2 (EMP2) fully human monoclonal antibody, ONCR-201 (Press release, OncoResponse, NOV 7, 2017, View Source [SID1234521815]). EMP2 is implicated as an oncoprotein in cancer biology and in addition to its overexpression associated with tumor-promoting activities in various tumor types, it has been shown to play a role in signaling migration and invasion of cancer stem cells.

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"EMP2 is highly over expressed in breast cancer including triple negative, ovarian cancer and endometrial cancer as well as glioblastoma, and the anti-tumor effect of ONCR-201 in pre-clinical models is striking," said Clifford J. Stocks, CEO of OncoResponse. "Preclinical data support the potential of ONCR-201 to work as both a highly-targeted monotherapy as well as synergistically in combination with immunotherapy and current standard of care. ONCR-201 is now on an IND-track toward first-in-human studies to begin in 2019."

Financial terms of the acquisition were not disclosed.

Paganini Biopharma was founded on technology originated in the Department of Pathology and Laboratory Medicine of the School of Medicine at UCLA under a license agreement from the UCLA Technology Development Group. Paganini co-founder Madhuri Wadehra, Ph.D., Associate Professor at UCLA, will be a consultant to OncoResponse. "We are thrilled to put our technology and antibodies in the hands of strong drug developers and look forward to seeing this medicine reach cancer patients," said Gary Lazar, MD, CEO of Paganini.

About ONCR-201

ONCR-201 is a fully human recombinant monoclonal antibody developed to target and inhibit the function of epithelial membrane protein 2 (EMP2).

EMP2 is a cancer promoting protein, highly expressed in epithelial malignancies and associated with tumorigenesis, with triple negative breast cancer highly prominent on that list. EMP2 positive tumors have been shown to be more aggressive and invasive. Expression of EMP2 within the tumor correlates with faster disease progression and worse prognosis and is associated with the regulation of expression of several cancer stem cell-associated markers. Cancer stem cells, typically resistant to chemotherapy and radiation, are believed to be a main cause for cancer persistence and responsible for relapse, metastasis and rise of new tumors.

In preclinical studies, the administration of anti-EMP2 monoclonal antibody significantly reduces primary and secondary tumor load, and expression of cancer stem cell markers, and demonstrates benefit of survival that extends beyond cessation of treatment.

On November 7, 2017 Alligator Bioscience (Nasdaq Stockholm: ATORX), a biotechnology company developing antibody-based pharmaceuticals for tumor-directed immunotherapy, reported results from a clinical phase I first-in-human study of the drug candidate ADC-1013 (JNJ-64457107), a human, monospecific, agonistic, IgG1 antibody targeting the co-stimulatory receptor CD40 (Press release, Alligator Bioscience, NOV 7, 2017, View Source [SID1234538683]). The study results show that ADC-1013 is generally well tolerated and support further clinical development of ADC-1013 as a mono- or combination therapy. The data will be presented in an oral and poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 32nd Annual Meeting in National Harbor, Maryland, US, on 10 and 11 November 2017.

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"We are very excited about the continued progress and promising early data of ADC-1013", said Per Norlén, CEO at Alligator Bioscience. "The data indicate that it is well tolerated at clinically relevant doses. There is clear evidence supporting activation of CD40 receptors, which together with the clinical observations give us increased confidence for the continued clinical development of ADC-1013."

A total of 23 patients were treated with ADC-1013, either intratumorally or intravenously. Focus on this study was on intratumoral administration, with only five patients receiving ADC-1013 intravenously. Alligator’s partner Janssen Biotech, Inc., is currently performing a phase I dose-escalation study investigating intravenous administration of ADC-1013.

Adverse events throughout the study were primarily fatigue, pyrexia, nausea and vomiting, and were mostly CTCAE Grade 1 or 2 and transient. Intratumoral administration of ADC-1013 into superficial metastases was well tolerated at doses up to at least 400 μg/kg. Two patients experienced dose limiting effects (grade 3 abdominal pain) at 400 μg/kg after injections into deeper (i.e. hepatic) lesions.

Secondary outcome measures on tumor efficacy included a best overall response of stable disease for at least 12 months in one patient who received 400 µg/kg intratumorally into a superficial lesion with intraindividual dose escalation up to 900 µg/kg.

Alligator Bioscience will give both an oral and poster presentation at the SITC (Free SITC Whitepaper) meeting, with the title: "First-in-human study with intratumoral administration of a CD40 agonistic antibody: preliminary results with ADC-1013/JNJ-64457107 in advanced solid malignancies". The oral presentation will be held at session Clinical Trials: New Agents, starting at 1:45 p.m. ET (7:45 p.m. CET) on 10 November 2017. The accompanied study poster will be presented on Saturday 11 November.

For further information about the program, please visit the conference web site: View Source

For further information:
Cecilia Hofvander, Director Investor Relations & Communications
Phone +46 46 286 44 95
E-mail: [email protected].

This release contains information that Alligator Bioscience AB (publ) 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 set out above, at 2:00 p.m. CET on 7 November 2017.

Notes to editors

About ADC-1013
ADC-1013 is a drug candidate intended for immunotherapy of different types of cancer. Pre-clinical data have shown that the ADC-1013 antibody effectively activates T-cells, mediated through binding to the co-stimulatory receptor CD40 on dendritic cells. The increased T-cell activation enables the immune system to attack the cancer. In addition, since some cancer cells express CD40 on the surface, ADC-1013 may act also through a secondary mechanism of action killing cancer cells directly.

In August 2015, Alligator licensed global development rights for ADC-1013 (JNJ-64457107) to Janssen Biotech, Inc. Currently, Janssen Biotech, Inc. performs a phase I dose-escalation clinical study (ClinicalTrials: NCT02829099) with intravenous administration of ADC-1013. This study is ongoing with approximately 50 patients recruited to date.

About the ADC-1013 intratumoral clinical phase I study
The study to be presented is a multicenter, open-label phase I study in patients with late stage solid tumors no longer responding to standard treatment evaluating safety and tolerability, pharmacokinetics, immunogenicity, biomarker response and clinical response. The study is a dose-escalation study, involving intratumoral (22.5-400 µg/kg) and intravenous (75 µg/kg) administration of ADC-1013 at five hospitals in Sweden, Denmark and the UK. The study was performed by Alligator and includes 24 enrolled patients and ten different tumor types. For further information, please visit View Source; NCT02379741.

Nabi Biopharmaceuticals has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Nabi Biopharmaceuticals, 2017, NOV 7, 2017, View Source [SID1234521662]).

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Alder Biopharmaceuticals has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Alder Biopharmaceuticals, 2017, NOV 7, 2017, View Source [SID1234521704]).

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Paratek Pharmaceuticals has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Paratek Pharmaceuticals, 2017, NOV 7, 2017, View Source [SID1234521730]).

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