Preliminary safety and clinical activity results for IPH4102 to be presented at the Third World Congress of Cutaneous Lymphomas

On October 13, 2016 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH), reported that preliminary safety and clinical activity results for the Phase I study testing IPH4102 in patients with relapsed/refractory cutaneous T-cell lymphomas ("CTCL") will be presented by Professor Martine Bagot, Head of the Dermatology Department at the Saint-Louis Hospital, Paris, at the Third World Congress of Cutaneous Lymphomas "3WCCL" (October 26-28, 2016, in New-York, USA) (Press release, Innate Pharma, OCT 13, 2016, View Source [SID:SID1234515792]).

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The presentation will be made available on the Company’s website, in the Product Pipeline – IPH4102 section after the session.

About the presentation:

Title: "First-in-Human, open label, multicenter phase I study of IPH4102, first-in-class humanized anti-KIR3DL2 mAb, in relapsed/refractory CTCL: preliminary safety and clinical activity results"
Scientific Session O. Therapeutics 3a: Endpoints & Clinical Trials
Date: October 28, 2016
Presentaton Time: 13:30 – 14:45 EST
Presenter: Pr. Martine Bagot, Head of the Dermatology Department, Saint-Louis Hospital, Paris
Location: Roone Arledge Auditorium – Alfred Lerner Hall at Columbia University – New York
About IPH4102 Phase I trial:

The Phase I trial is an open label, multicenter study of IPH4102 in patients with relapsed/refractory CTCL which is performed in Europe (France, Netherlands, and United Kingdom) and in the US (NCT02593045). Participating institutions include several hospitals with internationally recognized expertise: the Saint-Louis Hospital (Paris, France), the Stanford University Medical Center (Stanford, CA), the Ohio State University (Columbus, OH), the MD Anderson Cancer Center (Houston, Texas), the Leiden University Medical Center (Netherlands), and the Guy’s and St Thomas’ Hospital (United Kingdom). Approximately 60 patients with KIR3DL2-positive CTCL having received at least two prior lines of systemic therapy are expected to be enrolled in two sequential study parts:

A dose-escalation part including approximately 40 CTCL patients in 10 dose levels. Its objective is to identify the Maximum Tolerated Dose and/or the Recommended Phase 2 Dose (RP2D); the dose-escalation follows an accelerated 3+3 design;
A cohort expansion part with 2 cohorts of 10 patients each in 2 CTCL subtypes (transformed mycosis fungoides and Sézary syndrome) receiving IPH4102 at the RP2D until progression. Cohort design (CTCL subtype, number of patients…) may be revisited based on the findings in the dose escalation part of the study.
The primary objective of this trial is to evaluate the safety and tolerability of repeated administrations of single agent IPH4102 in this patient population. The secondary objectives include assessment of the drug’s antitumor activity. A large set of exploratory analyses aims at identifying biomarkers of clinical activity. Clinical endpoints include overall objective response rate, response duration and progression-free survival.

About IPH4102 Phase I trial:

The Phase I trial is an open label, multicenter study of IPH4102 in patients with relapsed/refractory CTCL which is performed in Europe (France, Netherlands, and United Kingdom) and in the US (NCT02593045). Participating institutions include several hospitals with internationally recognized expertise: the Saint-Louis Hospital (Paris, France), the Stanford University Medical Center (Stanford, CA), the Ohio State University (Columbus, OH), the MD Anderson Cancer Center (Houston, Texas), the Leiden University Medical Center (Netherlands), and the Guy’s and St Thomas’ Hospital (United Kingdom). Approximately 60 patients with KIR3DL2-positive CTCL having received at least two prior lines of systemic therapy are expected to be enrolled in two sequential study parts:

A dose-escalation part including approximately 40 CTCL patients in 10 dose levels. Its objective is to identify the Maximum Tolerated Dose and/or the Recommended Phase 2 Dose (RP2D); the dose-escalation follows an accelerated 3+3 design;
A cohort expansion part with 2 cohorts of 10 patients each in 2 CTCL subtypes (transformed mycosis fungoides and Sézary syndrome) receiving IPH4102 at the RP2D until progression. Cohort design (CTCL subtype, number of patients…) may be revisited based on the findings in the dose escalation part of the study.
The primary objective of this trial is to evaluate the safety and tolerability of repeated administrations of single agent IPH4102 in this patient population. The secondary objectives include assessment of the drug’s antitumor activity. A large set of exploratory analyses aims at identifying biomarkers of clinical activity. Clinical endpoints include overall objective response rate, response duration and progression-free survival.

Sunesis Announces Submission of Responses to the EMA Day 120 List of Questions for Marketing Authorization Application for Vosaroxin

On October 13, 2016 Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) reported that it has submitted its responses to European Medicines Agency (EMA) Day 120 List of Questions issued by the Committee for Medicinal Products for Human Use (CHMP) as part of the centralized review process of the Marketing Authorization Application (MAA) for vosaroxin as a treatment for relapsed/refractory acute myeloid leukemia (AML) in patients aged 60 years and older (Press release, Sunesis, OCT 13, 2016, View Source [SID:SID1234515808]). Sunesis expects to receive the EMA Day 180 List of Outstanding Issues before year-end.

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"We are pleased with the comprehensive set of answers and additional analyses that our team has provided in response to the EMA’s Day 120 list of questions," said Daniel Swisher, President and Chief Executive Officer of Sunesis. "As our regulatory efforts progress to bring vosaroxin to market in Europe as a treatment for relapsed/refractory AML, we are advancing active dialogues with potential pharma collaborators toward the goal of supporting a market launch in 2017. With the clock now restarting, we anticipate being one step closer to that goal."

About QINPREZO (vosaroxin)
QINPREZO (vosaroxin) is an anti-cancer quinolone derivative (AQD), a class of compounds that has not been used previously for the treatment of cancer. Preclinical data demonstrate that vosaroxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Both the U.S. Food and Drug Administration (FDA) and European Commission have granted orphan drug designation to vosaroxin for the treatment of AML. Vosaroxin is an investigational drug that has not been approved for use in any jurisdiction.

Vosaroxin’s Marketing Authorization Application for relapsed refractory AML is currently under review by the European Medicines Agency, and a regulatory decision regarding approval is expected in 2017.

The trademark name QINPREZO is conditionally accepted by the FDA and the EMA as the proprietary name for the vosaroxin drug product candidate.

VBL Therapeutics Announces Plans to Establish New Manufacturing Facility

On October 13, 2016 VBL Therapeutics (NASDAQ:VBLT), reported that it has engaged in a long-term lease contract of a new stand-alone facility in Modiin, Israel. The site will house VBL’s local biological drugs manufacturing facility, as the company plans ahead for potential commercialization of VB-111.

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The site design enables modular expansion of the manufacturing capacity, to supply growing demand following commercialization, while requiring only limited capital resources in the immediate stage. The near-term investment is not expected to materially impact VBL’s cash position. The Company projects that its current cash will suffice to support operations into 2019, beyond the readout of the pivotal GLOBE trial, while supporting a potential registration trial in ovarian cancer and the investment in the new facility. In addition, VBL expects that the establishment of the new facility will qualify for increased governmental financial incentives.

"Securing this new facility in Modiin fits strategically with our development plans and is an important step as we advance multiple clinical trials and move closer to potential commercialization of VB-111," stated Dror Harats, Chief Executive Officer of VBL Therapeutics.

The new facility will also include the company’s headquarters, discovery research and clinical development. VBL intends to operate and relocate to the new site in the second half of 2017.

VBL said that future commercial supply of VB-111 will likely involve a complementary source of supply, probably via a Contract Manufacturing partner in North America, although those plans have not yet been set.

Heat Biologics Remains on Track to Achieve Multiple Topline Data Readouts this Quarter

On October 13, 2016 Heat Biologics, Inc. (Nasdaq:HTBX), an immuno-oncology company developing novel therapies that activate a patient’s immune system against cancer, reported that it continues to remain on track to report topline data this quarter from its Phase 2 trials evaluating HS-410 and HS-110 for the treatment of non-muscle invasive bladder cancer (NMIBC) and non-small cell lung cancer (NSCLC), respectively, as well as its Phase 1b trial evaluating HS-110 in combination with Bristol-Myers Squibb’s anti-PD-1 checkpoint inhibitor, Opdivo, for the treatment of NSCLC (Press release, Heat Biologics, OCT 13, 2016, View Source [SID:SID1234515797]).

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"We are pleased with the progress we are making and look forward to reporting top-line data in both our NMIBC and NSCLC trials later this quarter," commented Jeff Wolf, Heat’s Founder and CEO. "We are encouraged by our early data in bladder cancer that suggests we are activating a robust antigen-specific immune response and our data in lung cancer that suggest HS-110 may improve response rates for patients with ‘cold tumors’ who typically have lower response rates to checkpoint inhibitor monotherapy."

TG Therapeutics, Inc. Amends the GENUINE Phase 3 Clinical Trial to Accelerate Study Completion by Revising Primary Endpoint to Overall Response Rate

On October 13, 2016 TG Therapeutics, Inc. (NASDAQ:TGTX) reported that it has filed with the FDA an amended protocol for the GENUINE Phase 3 trial (Press release, TG Therapeutics, OCT 13, 2016, View Source [SID:SID1234515796]). Prior to the amendments, the GENUINE study consisted of two parts:

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Part I to evaluate the effect of the addition of TG-1101 to ibrutinib on overall response rate (ORR) in approximately the first 200 patients enrolled, to support a filing for accelerated approval of TG-1101; and
Part II to evaluate the effect of the addition of TG-1101 to ibrutinib on progression-free survival (PFS) in all study patients (approximately 330), to support a filing for full approval of TG-1101.
The amended protocol contains the following substantive changes:

Part II of the study has been eliminated, and accordingly, the study’s sole primary endpoint will be ORR as originally contemplated in Part I; and
Target enrollment has been reduced to approximately 120 randomized patients.

At the new study size, the study is 90% powered to show a statistically significant improvement in ORR, with the minimal detectable difference of approximately 20% (absolute difference between the arms). Additionally, patients will be followed until progression, but the study will no longer be powered for PFS.

The Company expects that it will complete enrollment in the revised trial by year end 2016, and will have topline data available in the first half of 2017. If the results of the study are positive, the Company plans to request a pre-BLA meeting to discuss the data and a filing strategy with the FDA. The Company has communicated with the FDA regarding its intention to file a BLA for accelerated approval if the results are positive and the FDA has agreed that a pre-BLA meeting can be requested based on ORR data from the GENUINE study. Assuming a positive outcome of a pre-BLA meeting, targeted to occur in the fourth quarter of 2017, the Company believes it could file a BLA in the first half of 2018.

Michael S. Weiss, the Company’s Executive Chairman and Interim Chief Executive Officer, stated, "Today’s announcement marks an important milestone for the Company. Given the GENUINE enrollment challenges we’ve faced to date, we are very excited to accelerate the trial to a rapid conclusion, while also maintaining the ability to potentially file the data for accelerated approval. The GENUINE study, as amended, remains a robust, randomized clinical trial, which we believe, if positive, could support accelerated approval for patients with relapsed/refractory high-risk CLL. Moreover, we believe the amended study and revised regulatory strategy is consistent with the recent accelerated approvals for novel agents in CLL, which notably were not pursuant to an SPA but occurred after the finding of positive ORR results. Importantly, with completion of enrollment now expected by year end, we and our clinical trial sites can focus our resources on completing our UNITY-CLL Phase 3 trial as quickly as possible. Early enrollment in UNITY-CLL is very encouraging and we anticipate that study will be fully enrolled before filing a BLA for the GENUINE study. UNITY-CLL remains unchanged and unaffected by the amendments to the GENUINE study, and if positive, could support full approval for both TG-1101 and TGR-1202 based on its primary endpoint of PFS." Mr. Weiss continued, "We have greatly appreciated all of the guidance and counsel from the FDA in designing our clinical programs and we look forward to continuing our collaborative working relationship as we accelerate toward the conclusion of enrollment into the GENUINE study this year and ORR data in the first half of 2017."