On October 13, 2016 Enzo Biochem Inc. (NYSE:ENZ) reported strong results for the fourth quarter and fiscal year ended July 31, 2016, paced by revenue growth, margin expansion and litigation successes (Press release, Enzo Biochem, OCT 13, 2016, View Source [SID:SID1234515809]).

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Highlights
Fourth quarter fiscal 2016 revenue was $26.6 million and full year fiscal 2016 revenue was $102.8 million; increases of 4% and 5%, over the respective prior year periods. Enzo Clinical Labs revenue grew 5% in the fourth quarter of 2016 and generated double digit year over year revenue growth of 12%.

Clinical Labs and Life Sciences operating segments continue to be profitable and generate positive cash flow from operations.
Gross profit margins increased both quarterly and full year in both Life Sciences and Clinical Labs. In the fourth quarter of fiscal 2016, consolidated gross margin was 45% compared to 44% in the prior year period.

Net income for the fourth fiscal quarter was $36.1 million or $0.77 on a diluted share basis compared to $8.4 million or $0.18 on a diluted share basis in the prior year period. Full year net income was $45.3 million or $0.97 on a diluted basis compared to a loss of $2.3 million or $0.05 on a diluted share basis in the prior year.

New product approvals, along with a strong product development pipeline, underscore Enzo’s growth opportunities as a supplier of advanced lower cost molecular diagnostics for reimbursement constrained independent clinical labs.

Enzo Clinical Labs is growing market share in the women’s health market and expanding beyond the current regional New York area. During the year, three assays were approved by New York State.

At July 31, 2016, cash and cash equivalents were $67.8 million; working capital was $70.8 million. Cash flow provided by operations in the fourth quarter and year ended July 31, 2016 was $36.1 million and $53.1 million, respectively, driven by legal settlements and licenses and operating performance of business segments.

Comments by Barry Weiner, Enzo President:
"Fiscal 2016 was a highly successful year for Enzo Biochem. We solidified our growth opportunities on every front, setting a strong foundation for the future. Life Sciences’ product development emphasis on high profit margin products is paying off with several key approvals awarded in 2016. Enzo Labs came off a strong year with solid forward momentum from its expanding line of innovative molecular diagnostics, especially in the women’s health category, and a growing client roster. The unique combination of our Life Sciences development and marketing team with our Clinical Labs’ hands-on testing capabilities, and our deep patent estate, has resulted in a formidable development program, to prepare our broad pipeline of products for regulatory approval.

"This past year, New York State’s Health Department conditionally approved three new, highly efficient assays. We also have reported to the scientific community new analysis pointing to the effectiveness of our AmpiProbe platform technology. Included among the approved tests was our Candidiasis assay based on AmpiProbe and, last month, that of the stand-alone PLAQPRO Lp-PLA2 activity assay for identifying arterial inflammation, a possible potential indicator of coronary risk. Notably, both received approval for laboratory use just months after submission, and both are testaments to our growing expertise and recognition as a leading diagnostics supplier-producer in the women’s health field.

"On the operating side, we have also made significant progress. Costs are well under control, profit margins are enjoying an upward trend, and operating income at both Clinical Labs and Life Sciences remains positive. By bringing to resolution several court cases, legal expenses have trended lower, though this might change as possible trials could take place in calendar 2017. Meanwhile, with total patent infringement settlements and licenses in the past twenty-four months of over $100 million, our financial condition is robust and highly liquid. This is enabling us to pursue our growth strategies in the diagnostics market where, with Enzo’s highly efficient, economic and effective products, we are increasingly making our mark."

Fourth Quarter Results
Total revenues increased to $26.6 million, a $0.9 million or 4% improvement over a year ago. Gross profit was up 7%, to $12.1 million, equal to gross margin of 45%, compared to 44% a year ago. Research and development expenses held steady, as a percentage of revenues declined 100 basis points to 3%, while selling, general and administrative ("SG&A") costs likewise improved 100 basis points, to 42%, all of which underscores the Company’s effective management controls. The provision for uncollectible expenses remained flat at 3% of revenues, as a result of the Company’s effective credit procedures. Legal fees for the quarter declined by more than half, to $0.7 million, from $1.6 million a year ago.

Including $38.8 million legal settlements and licensing agreements, and a $0.4 million foreign currency loss, net income amounted to $36.1 million, or $0.77 per fully diluted share. In the year ago quarter, with net legal settlements at $11.3 million, net income totaled $8.4 million, or $0.18 per fully diluted share. Adjusted for the 2016 legal settlements and licensing agreements, the non-GAAP quarterly net loss amounted to $1.9 million or $0.04 on a fully diluted share basis, compared to a year ago non-GAAP net loss of $2.6 million, a 27% improvement. Non-GAAP adjusted EBITDA (earnings before interest, taxes, depreciation and amortization) was a negative $0.7 million, compared to a year ago negative $1.5 million, a 53% improvement.

Fiscal 2016 Results
With Clinical Labs revenues increasing by double digits, consolidated revenues rose to $102.8 million, up 5% from fiscal 2015’s $97.6 million. Gross profit for the year increased 6%, to $45.6 million, equaling gross margin of 44% in both years. R&D expenses were up modestly by 5% year over year, but flat at 3% as a percentage of revenues; SG&A increased 6%, but again held firm at 42% of revenues for both years; and legal expenses declined $2.4 million, or 27%, to $6.4 million.

Net income amounted to $45.3 million, or $0.97 per fully diluted share, including $57.3 million in net legal settlements and license agreement for the year. This compared to a year ago net loss of $2.3 million, or ($0.05) per share fully diluted, with net legal settlements and license agreements at $11.5 million in the prior year period. On a non-GAAP basis, adjusted for legal settlements and license agreements, extraordinary proxy and other expenses and related tax effects, the net loss was $9.2 million, or ($0.20) per share fully diluted, vs. a year earlier loss on a similar adjusted basis of $13.5 million, or ($0.30) per fully diluted share, a $4.3 million improvement. Non-GAAP adjusted EBITDA was a negative $5.0 million and $9.4 million, respectively, for the past two years, a $4.4 million improvement. Excluding direct legal litigation costs, adjusted EBITDA would be positive in the full year 2016 results.

As of July 31, 2016, cash and cash equivalents amounted to $67.8 million and total assets of were approximately $112.0 million.

Segment Results
Enzo Clinical Labs continued its strong growth, the result of the increased role of molecular diagnostics in its services mix, particularly those targeted to women’s health, as well as adding new clients and effective management of the Labs’ cost base. Fourth quarter revenues grew 5%, to $18.1 million. Gross profit improved 7%, to $12.1 million, and the gross margin percentage increased to 40%, from 39%. Operating income amounted to $0.8 million, compared to $0.5 million, up 60%.

Full year Lab revenues grew 12%, to $70.9 million. Gross profit consequently increased 18%, to $28.1 million, with the gross margin up 200 bps, to 40%, from 38%. The provision for uncollected receivables improved to 3.3%, from 3.8%, the result of improved collection procedures. Operating income more than doubled, to $1.2 million, from $0.5 million.

Enzo Life Sciences benefited from both higher margin product revenue and tight cost controls, although continuing to be challenged by a highly competitive environment and continued lower research funding, especially in academia. Product revenues were $8.1 million for the fourth quarters of both fiscal 2016 and 2015, with cost of revenues declining 6% in 2016, to $3.7 million. Gross profit on product revenues increased 5%, to $4.4 million, from $4.2 million, and gross margin advanced to 55%, from 52%. Excluding legal settlements, net, operating income improved to $1.0 million, compared to $0.6 million a year ago, up 66%.

Full year product revenues in 2016 amounted to $30.3 million, compared to $31.7 million in 2015. Products gross margin percentage increased by 200 basis points to 53% from 52%. Operating income amounted to $3.1 million, excluding $58.8 million from patent litigation settlements, compared to $4.4 million, excluding $11.5 million in settlements a year ago. Royalty and fee income declined to $1.5 million from $2.5 million a year earlier.

Product Development
In line with Enzo’s objective to develop, manufacture and sell high- throughput, high value reliable and affordable molecular diagnostic products and services that use our proprietary technologies to allow customers to meet their clinical needs, and to offer independent labs a counterweight to reduced reimbursement, Enzo has underway an aggressive product development program. This past year, the Company obtained conditional approval for several tests and assays from the New York State Department of Health, allowing the Company to provide these tests across the majority of the United States.

These approvals included our AmpiProbe technology platform that encompasses high sensitivity, real time nucleic acid amplification assays that is expected to provide low cost molecular diagnostics to benefit independent laboratories. At the same time, the AmpiProbe HCV Assay was approved for the quantitative detection of hepatitis C virus, which is expected to be the first in a line of expanded applications using the AmpiProbe platform. Last year, Enzo scientists presented data at the prestigious American Society for Clinical Pathology annual meeting showing new thresholds of sensitivity for the Company’s AmpiProbe – based HCV Assay. This demonstrated that the limit of detection was greater in sensitivity than leading commercially available HCV viral load assays.

Also approved was the Candidiasis Assay, the Company’s second test aimed at the rapidly expanding women’s health market, and Enzo Clinical Labs’ PLAQPRO Lp-PLA2 Assay, for evaluating lipoprotein-associated phospholipase A2 activity, a marker associated with the potential for coronary heart disease. Currently under development are tests for Hepatitis B virus, HIV viral diseases, and cancers, as well as a full spectrum of tests designed to identify a number of infectious diseases related to women’s health, one of the fastest growing segments of the molecular diagnostic market.

On October 13, 2016 OncoSec Medical Incorporated ("OncoSec") (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, reported that new clinical data from the Phase II Investigator Sponsored Trial led by the University of California, San Francisco (UCSF) to assess the combination of OncoSec’s investigational intratumoral therapy, ImmunoPulse IL-12, and Merck’s KEYTRUDA (pembrolizumab) in patients with unresectable metastatic melanoma and a low likelihood of response to an anti-PD1 alone will be presented at an oral poster presentation at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) ("SITC") Annual Meeting to be held on November 11-13, 2016, in National Harbor, MD (Press release, OncoSec Medical, OCT 13, 2016, View Source [SID:SID1234515795]).

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In August 2016, OncoSec announced the publication of a research assay in the Journal of Clinical Investigation that can be used as a predicative biomarker in melanoma patients. The assay shows that patients with a low frequency of CD8-positive inflamed tumors (that are PD-1 high and CTLA-4 positive) would pre-dispose them to low response rates to PD-1 inhibitor therapy alone. The Company is using this biomarker assay to pre-qualify patients in this ongoing combination study based on quantification of these type of CD8 cells. In the trial, patients deemed to be likely low responders were treated with a combination of systemic pembrolizumab and intratumoral ImmunoPulse IL-12 during the trial period. This presentation will provide an interim update of 15 treated patients.

The key endpoints of the study include: best overall response rate (ORR) by RECIST v1.1 and immune-related Response Criteria (irRC); safety and tolerability; duration of response; 24-week landmark progression-free survival; median progression-free survival; and overall survival.

Eligible patients were concurrently treated with pembrolizumab and ImmunoPulse IL-12 during the trial period.

Details of the presentation are as follows:

Abstract Title: Phase II Study of Intratumoral plasmid Interleukin 12 (pIL-12) with Electroporation in Combination with Pembrolizumab in Stage III/IV Melanoma Patients with Low Tumor Infiltrating Lymphocytes (Abstract #203921)
Lead Author: Alain Algazi, MD, Clinical Instructor, Department of Medicine (Hematology/Oncology), UCSF
Poster Number: 466
Date and Time: November 11, 2016 at 12:15 pm EDT (Oral poster presentation to be defined)
Location: Prince George’s Exhibition Hall AB, Gaylord National Resort & Convention Center

For more information about this trial, please visit:
View Source;rank=3

On October 13, 2016 DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, reported that the Company and its research collaborators have been invited to present data regarding the progress of VAL-083 at the following upcoming peer-reviewed scientific conferences (Press release, DelMar Pharmaceuticals, OCT 13, 2016, View Source [SID:SID1234515794]).

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European Association of NeuroOncology (EANO) Annual Meeting (Heidelberg, Germany Oct. 12 – 16, 2016);
AACR DNA Repair: Tumor Development and Therapeutic Response (Montreal, Canada Nov. 2 – 5, 2016);
AACR New Horizons in Cancer Research: Delivering Cures through Cancer Research (Shanghai, China Nov. 2 – 4, 2016);
Society for NeuroOncology Annual Meeting and CNS Anti-Cancer Drug Development Conference (Scottsdale, USA Nov. 16 – 20, 2016);
EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Symposium (Munich, Germany Nov 29 – Dec. 2, 2016); and
IASLC 17th World Congress on Lung Cancer (Vienna, Austria Dec. 4 – 7, 2016).

"We are pleased to accept these invitations to present new data at these prestigious peer-reviewed meetings," said Jeffrey Bacha, DelMar’s chairman & CEO. "Data presented at these global meetings will highlight the continued success of our strategy to leverage historical clinical validation from prior NCI-sponsored research with a modern understanding of VAL-083’s unique anti-cancer mechanism."

VAL-083 is a "first-in-class," small-molecule chemotherapeutic. In more than 40 Phase I and II clinical studies sponsored by the U.S. National Cancer Institute, VAL-083 demonstrated clinical activity against a range of cancers including lung, brain, cervical, ovarian tumors and leukemia both as a single-agent and in combination with other treatments.

"Taken together, these data support VAL-083’s potential to address unmet medical needs in major cancer indications for patients whose tumors have failed, or exhibit features that make them resistant or unlikely to respond to, current standard-of-care chemotherapy," added Mr. Bacha.

Details of DelMar’s upcoming scientific meeting presentations are as follows:

EANO 2016. On October 15, 2016, DelMar and its collaborators from the University of British Columbia will present an abstract entitled: "Dianhydrogalactitol (VAL-083) causes bifunctional alkylation leading to irreparable DNA double-strand breaks, S/G2 phase cell-cycle arrest and tumor cell death in an MGMT independent manner offering a unique treatment paradigm for GBM."
AACR DNA Repair: Tumor Development & Therapeutic Response Conference. On Friday November 4, 2016, DelMar and its collaborators from the University of British Columbia Prostate Cancer Research Center will present an abstract entitled: "Dissecting the Molecular Mechanism of Dianhydrogalactitol (VAL-083) in Cancer Treatment."
AACR New Horizons in Cancer Research: Delivering Cures through Cancer Research. On Friday November 4, 2016, DelMar and its collaborators from the University of Texas MD Anderson Cancer Center and the University of British Columbia will present an abstract entitled: "Assessment of dianhydrogalactitol in the treatment of relapsed or refractory non-small cell lung cancer."
Society for NeuroOncology Annual Meeting and CNS Anti-Cancer Drug Development Conference.
On Thursday November 17, 2016, DelMar will deliver an oral address on the unique mechanism of VAL-083 and its potential as a new treatment for central nervous system tumors including GBM and medulloblastoma during the "Drug Targets and the CNS Micro-Environment" session.
On Saturday November 19, 2016, DelMar and its collaborators from the University of British Columbia, UCSF and the Luxemburg Institute of Health will present an abstract entitled: "Molecular mechanisms of dianhydrogalactitol (VAL-083) in GBM treatment"
On Friday November 18, 2016, DelMar will present an abstract entitled: "Clinical trials of VAL-083 in patients with chemo-resistant glioblastoma"
EORTC-NCI-AACR. On Thursday December 1, 2016, DelMar and its collaborators from the University of British Columbia, UCSF, and the Luxemburg Institute of Health will present an abstract entitled: "Molecular mechanisms of dianhydrogalactitol (VAL-083) in overcoming GBM chemo-resistance"
IASCL World Congress on Lung Cancer. On Wednesday December 7, 2016, DelMar and its collaborators from MD Anderson, the Shanghai Cancer Center and the University of British Columbia will present an abstract entitled: "Assessment of Dianhydrogalactitol (VAL-083) in the Treatment of Relapsed or Refractory Non-Small Cell Lung Cancer"
About VAL-083
VAL-083 is a "first-in-class," small-molecule chemotherapeutic. In more than 40 Phase I and II clinical studies sponsored by the U.S. National Cancer Institute, VAL-083 demonstrated clinical activity against a range of cancers including lung, brain, cervical, ovarian tumors and leukemia both as a single-agent and in combination with other treatments.

VAL-083 has received an orphan drug designation in Europe for the treatment of malignant gliomas and the U.S. FDA Office of Orphan Products has granted an orphan designation to VAL-083 for the treatment of glioma, medulloblastoma and ovarian cancer.

The Company has completed a successful end of Phase II meeting with the US FDA and plans to advance VAL-083 into a pivotal clinical trial for GBM patients following bevacizumab failure. DelMar presented data from its Phase I/II clinical trial in refractory GBM at the 2016 American Association of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual meeting demonstrating that the median survival of 22 patients receiving an assumed therapeutic dose of VAL-083 (≥20mg/m2) was 8.35 months following bevacizumab (Avastin) failure compared to published literature where survival of approximately two to five months has been reported.

DelMar’s advanced development program will feature a single multi-center randomized Phase III study measuring survival outcomes compared to a "physicians’ choice" control, which, if successful, would serve as the basis for a New Drug Application (NDA) submission for VAL-083. The control arm will consist of a limited number of salvage chemotherapies currently utilized in the treatment of Avastin-failed GBM. The final pivotal trial design will be confirmed with the FDA following further discussions with the Company’s clinical advisors.

In addition to the pivotal trial, DelMar also plans to initiate two separate Phase II clinical trials in earlier-stage GBM patients.

In collaboration with the University of Texas MD Anderson Cancer Center: A non-comparative, biomarker-driven, Phase II study to determine if treatment of MGMT-unmethylated recurrent GBM with VAL-083 or CCNU improves overall survival at 9 months, compared to historical control in bevacizumab naïve patients. (clinicaltrials.gov identifier: NCT02717962)
In collaboration with Sun-Yat Sen University and Guangxi Wuzhou Pharmaceutical (Group) Co.: A single arm Phase II clinical trial to confirm the tolerability of DelMar’s dosing regimen in combination with radiotherapy (XRT) and to explore the activity of VAL-083 in newly diagnosed MGMT-unmethylated GBM patients whose tumors are known to express high levels of MGMT.
DelMar believes that data from these clinical trials, if successful, will form the basis of a new paradigm in the treatment for all GBM patients who fail, or whose tumors exhibit features that make them unlikely to respond to currently available chemotherapy.

In addition to its clinical research in GBM, DelMar believes that its research supports a unique mechanism of action for VAL-083 and that these data support the potential of VAL-083 as a new chemotherapy that may offer improved outcomes in the treatment of GBM and other solid tumors in patients whose tumors have failed or exhibit features that make them resistant to or unlikely to respond to current standard-of-care chemotherapy.

The company and its collaborators from the University of Texas MD Anderson Cancer Center recently presented data at the 11th Biennial Ovarian Cancer Research Symposium demonstrating that VAL-083 was able to overcome cisplatin-resistance in ovarian cancer cell lines with known p53 mutations and displays synergy with both cisplatin and AstraZeneca’s PARP inhibitor Olaparib against ovarian cancer in vitro.

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.