On November 7, 2017 Five Prime Therapeutics, Inc. (NASDAQ:FPRX), a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics, previously reported that the abstract featuring data from the Phase 1a/1b clinical trial evaluating the immunotherapy combination of its CSF-1R antibody, cabiralizumab (FPA008), with Opdivo (nivolumab), Bristol-Myers Squibb’s PD-1 immune checkpoint inhibitor, has been selected for a late-breaking oral presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 32nd Annual Meeting, being held Nov. 8-12, 2017 in National Harbor, Maryland (Press release, Five Prime Therapeutics, NOV 7, 2017, View Source [SID1234521647]).

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Five Prime will host a conference call and live audio webcast on Saturday, November 11, 2017, at 5:45 p.m. (ET). Lewis T. "Rusty" Williams, President and Chief Executive Officer, Aron Knickerbocker, Chief Operating Officer, Helen Collins, Chief Medical Officer and Dr. Zev Wainberg, Assistant Professor of Medicine at UCLA, will review the data presented at SITC (Free SITC Whitepaper) earlier that day.

The live audio webcast may be accessed through the "Events & Presentations" page in the "Investors" section of the company’s website at www.fiveprime.com. Alternatively, participants may dial (877) 878-2269 (domestic) or (253) 237-1188 (international) and refer to conference ID 4092848.

The archived conference call will be available on Five Prime’s website beginning approximately two hours after the event and will be archived and available for replay for at least 30 days after the event.

On November 7, 2017 ChemoCentryx, Inc., (Nasdaq:CCXI), a biopharmaceutical company developing new medications targeted at inflammatory and autoimmune diseases and cancer, reported financial results for the third quarter ended September 30, 2017 (Press release, ChemoCentryx, NOV 7, 2017, View Source [SID1234521673]).

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"Our pursuit of new and better medicines for people with orphan diseases has been relentless," said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. "Dedicated to creating value for patients and shareholders alike, we at CCXI started with basic science in the discovery of novel molecules that selectively inhibit chemoattractant receptors, which are the molecular guidance systems of destructive inflammatory cells involved in a wide range of diseases and conditions. Now we have advanced two of those novel molecules, avacopan and CCX140, well into late-stage clinical trials. In doing so, we move closer to the next phase of value creation – the potential commercialization of our targeted medicines to help those suffering from serious renal diseases."

Recent Highlights

ChemoCentryx’s Phase III ADVOCATE trial of avacopan for the treatment of ANCA-associated vasculitis has surpassed 30 percent of its target patient enrollment with more than 185 sites activated. The trial will test the safety and efficacy of avacopan following 12 months of treatment and will include approximately 300 patients. In addition to testing the effect of avacopan on improving active vasculitis, the ADVOCATE trial will also test the effect of avacopan on preventing a recurrence of vasculitis.

ChemoCentryx recently received orphan designation in Switzerland from SwissMedic for avacopan for the treatment of two forms of ANCA-vasculitis: microscopic polyangiitis and granulomatosis with polyangiitis (formerly known as Wegener’s granulomatosis). This designation is in addition to the previously received orphan designations from the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for avacopan to treat ANCA-vasculitis.

ChemoCentryx recently launched a registration-supporting clinical trial to study avacopan in a second indication, C3 Glomerulopathy (C3G), a rare disorder that often affects the young, requiring dialysis and often kidney transplant. Sites have been activated for the trial and patient enrollment has begun. Earlier this year ChemoCentryx announced that it had received both EMA orphan medicinal product designation and FDA orphan drug designation for avacopan in the treatment of C3G.

ChemoCentryx is launching a third registration-supporting trial, involving its CCR2 inhibitor, CCX140, to treat the debilitating kidney disorder known as Focal Segmental Glomerulosclerosis (FSGS), for which there is no approved treatment option. The Company plans to launch a trial in the fourth quarter of 2017.
Third Quarter 2017 Financial Results

Pro forma cash, cash equivalents, investments and remaining upfront commitments totaled $154.8 million at September 30, 2017.

Revenue was $9.0 million for the third quarter, compared to $4.1 million for the same period in 2016. The increase in revenue from 2016 to 2017 were due to: (i) amortization of the upfront license fee commitments from Vifor pursuant to the avacopan and CCX140 agreements; as well as (ii) collaboration revenue for development services under the CCX140 Agreement in 2017. These increases were partially offset by lower grant revenue from the FDA to support the clinical development of avacopan for the treatment of patients with ANCA vasculitis.

Research and development expenses were $12.3 million for the third quarter, compared to $8.4 million for the same period in 2016. The increase in research and development expenses from 2016 to 2017 was primarily attributable to the initiation and patient enrollment of the avacopan Phase III ADVOCATE trial in patients with ANCA vasculitis and start-up expenses for the Phase II clinical trial of avacopan for the treatment of C3G. These increases were partially offset by lower costs associated with the completion of the avacopan CLEAR and CLASSIC Phase II clinical trials for the treatment of ANCA vasculitis and enrollment completion of the CCX872 Phase I trial in patients with advanced pancreatic cancer in 2016.

General and administrative expenses were $3.6 million for the third quarter, compared to $3.2 million for the same period in 2016. The increase from 2016 to 2017 was primarily due to accounting related fees associated with preparing to meet the requirements pursuant to the Sarbanes-Oxley Act of 2002.

Net losses for the third quarter were $6.6 million, compared to $7.1 million for the same period in 2016.

Total shares outstanding at September 30, 2017 were approximately 48.8 million shares.

The Company expects to utilize cash and cash equivalents in the range of $50 million and $55 million in 2017, of which $39.0 million has been used for the nine months ended September 30, 2017.

Conference Call and Webcast

The Company will host a conference call and webcast today, November 7, 2017 at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time. To participate by telephone, please dial 877-303-8028 (Domestic) or 760-536-5167 (International). The conference ID number is 7796287. A live and archived audio webcast can be accessed through the Investors section of the Company’s website at www.ChemoCentryx.com. The archived webcast will remain available on the Company’s website for fourteen (14) days following the conference call.

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 Provectus Biopharmaceuticals, Inc. (OTCQB: PVCT, www.provectusbio.com), ("Provectus" or the "Company"), a clinical-stage biotechnology company leading the development of the first small molecule oncolytic immunotherapy, PV-10, as an investigational single agent for locally advanced disease as well as in combination with another agent for widely metastatic disease, both for multiple cancer indications, reported the United States Patent and Trademark Office (the "USPTO") has granted U.S. patent ("USP") 9,808,524 for the combination of intralesional ("IL") PV-10 with systemic immunomodulatory therapy, including anti-PD-1 and anti-PD-L1 agents, for the treatment of melanoma and cancers of the liver (Press release, Provectus Pharmaceuticals, NOV 7, 2017, View Source [SID1234521816]). This new patent is a continuation of USP 9,107,887, Provectus’ first cancer combination therapy patent granted by the USPTO in 2015. Pfizer, Inc. is a co-assignee on both patents.

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PV-10 is an injectable formulation of rose bengal disodium, and represents nearly a decade of work by Provectus to optimize the synthetic process for manufacturing rose bengal and its related halogenated xanthene analogs to meet modern global requirements for pharmaceutical use. IL injection of PV-10 can induce immunogenic cell death that results in tumor-specific reactivity in circulating CD8+ T cells.

Provectus recently presented preliminary results from the Company’s ongoing Phase 1b/2 study of IL PV-10 in combination with KEYTRUDA (pembrolizumab), Merck’s systemic anti-PD-1 (programmed death receptor-1) antibody agent, at the Society for Melanoma Research 2017 Congress, held in Brisbane, Australia on October 18-21. Adverse events were consistent with the established patterns for each drug, and there were no unexpected toxicities or evidence of compounded toxicity. Preliminary overall efficacy included 10% complete response, 50% objective response, and 60% clinical benefit, with the highest responses observed in Stage IV M1c melanoma patients (all per RECIST 1.1).

The Phase 1b portion of the study continues to enroll patients at clinical sites in the U.S. and Australia (NCT02557321); Stage IV patients with at least one injectable lesion who are candidates for KEYTRUDA are eligible. A total of up to 24 patients would receive the combination of IL PV-10 and KEYTRUDA every three weeks for five cycles (i.e., for up to 12 weeks, with no further PV-10 administered after week 12), followed by only KEYTRUDA every three weeks for up to 24 months. The primary endpoint for the Phase 1b trial is safety and tolerability; objective response rate and progression-free survival are key secondary endpoints (both assessed via RECIST 1.1 after five treatment cycles, and then every 12 weeks thereafter).

Dominic Rodrigues, Chairman of the Company’s Board of Directors, said, "This patent continues our work to expand intellectual property protection of PV-10, and to augment the potential commercial value of Provectus’ clinical development program in cancer combination therapy."

Mr. Rodrigues also said, "Provectus’ ongoing Phase 1b study of PV-10 and KEYTRUDA is based on a rational study design for Stage IV melanoma patients with visceral disease, and provides for the investigation of the potential for small molecule oncolytic immunotherapy to demonstrate orthogonality to and synergy with checkpoint inhibition, combination therapy measures of safety and efficacy, respectively."

Mr. Rodrigues concluded, "Numerous players around the world, with approved or investigational drugs within each class of systemic immuno-oncology agent, are pursuing smaller and smaller pieces of market share because drugs within each of these classes may be similar or, indeed, equivalent. Assuming a rational clinical basis for combination, another form of differentiation is needed to gain and protect market share for cancer combination therapy. We believe this aspect of our company’s patent estate provides for proprietary combinations with protected agents."

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.