On December 2, 2015 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH) reported that a first patient has been dosed in the Phase I clinical trial of IPH4102 in patients with relapsed/refractory cutaneous T-cell lymphomas (Press release, Innate Pharma, DEC 2, 2015, View Source [SID:1234508386]). IPH4102 is a first-in-class cytotoxic antibody against KIR3DL2, a tumor marker specifically expressed in most subtypes of CTCL. It has an orphan drug designation in the European Union for the treatment of CTCL.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Pierre Dodion, Chief Medical Officer of Innate Pharma, said: "We are proud of and enthused by this major milestone for IPH4102, a program that was fully developed in house. The program has benefited from constant collaboration with Saint-Louis Hospital (Paris, France), and especially with Pr. Martine Bagot, Head of the Dermatology Department and co-discoverer with Pr. Armand Bensussan of the target KIR3DL2. Now, with the involvement of additional international expert centers in Europe and the USA, we believe that we are in optimal conditions to bring this exciting drug to patients with a high unmet medical need".

Hervé Brailly, CEO and co-founder of Innate Pharma, added: "From a strategic point of view, IPH4102 is an important addition to and diversification of our pipeline: it is our first cytotoxic antibody, aiming at depleting KIR3DL2 expressing cells. Developing it in a targeted patient population with an associated biomarker points to a very straightforward path to potentially reach regulatory approval. This prompts our interest in keeping the full rights to develop this drug and eventually market it on our own".

This Phase I trial comprises a dose escalation and a cohort expansion, which are expected to deliver data at the end of 2017 and 2018 respectively. The program was presented in New York during a Key Opinion Leader event chaired by Pr. Youn H. Kim, MD, Professor of Dermatology, Director of the Multidisciplinary Cutaneous Lymphoma Program and Medical Director of the Photopheresis Service at the Stanford Medical Center, as well as in Paris during a Key Opinion Leader event chaired by Pr. Martine Bagot. The presentations are available on Innate Pharma’s website.

About IPH4102 Phase I trial:

The Phase I trial is an open label, multicenter study of IPH4102 in patients with relapsed/refractory cutaneous T-cell lymphomas which is performed in Europe (France, Netherlands, United Kingdom) and in the US. Participating institutions include several hospitals with internationally recognized expertise: the Saint-Louis Hospital (Paris, France), the MD Anderson Cancer Center (Houston, Texas), the Stanford University Medical Center (Stanford, CA), the Ohio State University (Columbus, OH), 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 cohorts. Its objective is to identify the Maximum Tolerated Dose and/or the Recommended Phase 2 Dose (RP2D);

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. The CTCL subtypes may be adjusted 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 IPH4102 in this patient population. The secondary objectives include assessment of the drug’s antitumor activity and identification of biomarkers of this activity. Clinical endpoints include overall objective response rate, response duration and progression-free survival.

On December 2, 2015 LifeMap Sciences, Inc. ("LifeMap"), a life sciences technology company and a subsidiary of BioTime, Inc., and MedGenome, Inc. ("MedGenome"), a genomics-based diagnostics and research company, reported a global collaboration agreement (Press release, BioTime, DEC 2, 2015, View Source;p=RssLanding&cat=news&id=2119546 [SID:1234508385]). The agreement will strengthen LifeMap’s next generation sequencing (NGS) analysis solutions in the oncology field by incorporating data from MedGenome’s OncoMD database for use by LifeMap clients. The Oncology NGS market is a significant growth driver within the multi-billion dollar global NGS market.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

LifeMap‘s NGS products facilitate and enhance biomedical research and healthcare outcomes. Powered by its comprehensive, proprietary GeneCards knowledgebase, LifeMap’s NGS analytics software can rapidly and cost-effectively identify genetic variants that impact disease management and health outcomes. The GeneCards knowledgebase is used by more than 3000 institutions in over 200 countries worldwide.

OncoMD is a comprehensive knowledge base of cancer specific somatic and germ line variations collected from peer-reviewed scientific publications. It enables users to easily identify mutation prevalence in multiple cancer types as well as sensitivity to approved therapies via linkage of mutations to approved drugs and open clinical trials.

"Integrating OncoMD into our NGS analysis products is another important milestone in our ongoing NGS solutions development initiatives," said David Warshawsky, Ph.D., President and Chief Executive Officer of LifeMap Sciences. "MedGenome’s OncoMD provides the latest scientific evidence and drug information to enable identification of driver mutations and the impact of targeted, personalized drugs in the oncology area; elements of significant interest to our current and future clients in the oncology arena."

"We are happy to partner with LifeMap Sciences and to offer its users our unique annotations on cancer variants," said Dr Kartik Kumaramangalam, Chief of Global Products & Services at MedGenome. "This is in line with our commitment to develop products and solutions that enable oncologists and researchers to gather insights into the genetics of cancers."

On December 02, 2015 Oncothyreon Inc. (Nasdaq:ONTY), a clinical-stage biopharmaceutical company dedicated to the development of therapeutic products that can improve the lives and outcomes of patients with cancer, reported that it will conduct a conference call on Tuesday, December 8, 2015 at 4:30 p.m. Eastern Time (1:30 p.m. Pacific) to discuss new clinical data from ongoing clinical trials of ONT-380, an orally active, reversible and selective small-molecule HER2 inhibitor being developed for the treatment of metastatic breast cancer (Press release, Oncothyreon, DEC 2, 2015, View Source [SID:1234508382]). The data, which include additional and updated clinical trial data on ONT-380 for the treatment of patients with HER2-positive metastatic breast cancer, as well as an analysis of patients who suffer from central nervous system (CNS) metastases, are slated for presentation during the San Antonio Breast Cancer Symposium (SABCS) being held December 8-12, 2015 in San Antonio, TX.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

To participate in the call by telephone, please dial (877) 280-7291 (United States) or (707) 287-9361 (International). In addition, the call will be webcast live and can be accessed on the "Events" page of the "News & Events" section of Oncothyreon’s website at www.oncothyreon.com. An archive of the webcast will be available after completion of the discussion and will be posted on the Oncothyreon website.

On December 2, 2015 Delcath Systems, Inc. (NASDAQ: DCTH), a specialty pharmaceutical and medical device company focused on oncology with an emphasis on the treatment of primary and metastatic liver cancers, reported that physicians in Europe have completed over 250 treatments with Delcath Hepatic CHEMOSAT Delivery System (CHEMOSAT) since the second generation of CHEMOSAT was launched (Press release, Delcath Systems, DEC 2, 2015, View Source;p=RssLanding&cat=news&id=2119515 [SID:1234508381]). Physicians in Europe have used CHEMOSAT in both commercial and clinical settings to treat patients for a wide variety of cancers in the liver, including ocular melanoma liver metastases, hepatocellular carcinoma and intrahepatic cholangiocarcinoma, and liver metastases from colorectal cancer, breast cancer and others.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Concurrently, Delcath announces the activation of the prestigious Harley Street Clinic (HSC) in London, United Kingdom as a CHEMOSAT treatment site. HSC is a specialist private hospital that provides complex cardiac, cancer and neurosciences care. HSC is supported by HCA International and owned by HCA Inc., the largest provider of private healthcare in the world. Julian Hague, M.D., an interventional radiologist with HSC, performed the clinic’s first CHEMOSAT treatment on a patient with breast cancer liver metastases in November.

"I believe the future of interventional oncology lies in tailoring the treatment to the individual patient," said Dr. Hague. "I believe having CHEMOSAT in our treatment armamentarium represents major progress in our ability to provide liver directed therapies to patients."

"The completion of our 250th CHEMOSAT treatment and the activation of the Harley Street Clinic highlight the steady progress our team has made in expanding the clinical adoption of this therapy," said Jennifer K. Simpson, Ph.D., MSN, CRNP, President and Chief Executive Officer of Delcath Systems. "Over the past two years our team has built a strong commercial and clinical footprint for CHEMOSAT in Europe. We look forward to continuing to build on this momentum in the New Year in order to increase revenue and, importantly, to enhance the lives of patients suffering with these life-limiting conditions."

On December 2, 2015 Novartis reported that it will present data that highlight advancements in targeted combination therapy research, and underscore the company’s continued commitment to bringing innovative treatments to patients living with advanced breast cancer at the 2015 CTRC-AACR San Antonio Breast Cancer Symposium (SABCS), December 8-12 (Press release, Novartis, DEC 2, 2015, View Source [SID:1234508378]). Novartis will present 55 abstracts showcasing key real-world data from Afinitor (everolimus), Tykerb (lapatinib) and several investigational compounds in advanced breast cancer [1].

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"These data presented at SABCS reinforce the current focus toward combination therapies as the standard treatment for hormone receptor-positive, HER2 negative advanced breast cancer," said Alessandro Riva, MD, Global Head, Novartis Oncology Development and Medical Affairs. "Given the breadth of our portfolio, we are well positioned to explore innovative treatment combinations with the goal of providing the greatest benefit for patients living with advanced breast cancer."

Key Afinitor presentations show real-world data that add to the growing body of evidence demonstrating the benefit of staying on treatment:

BOLERO-2: cfDNA analysis from BOLERO-2 plasma samples identifies a high rate of ESR1 mutations: Exploratory analysis for prognostic and predictive correlation of mutations reveals different efficacy outcomes of endocrine therapy-based regimens (SABCS Oral Poster: #S2-07; December 9, 4:45 PM CST)

EVEREXES: Clinical effectiveness of everolimus and exemestane in advanced breast cancer patients from Asia and Africa: First efficacy and updated safety results from the phase IIIb study (SABCS Abstract #P4-13-09; December 11, 7:30 AM CST)

Evaluation of miracle mouthwash (MMW) plus hydrocortisone versus prednisolone mouth rinses as prophylaxis for everolimus-associated stomatitis: Preliminary results of a randomized phase II study (SABCS Abstract #P1-15-06; December 9, 5:00 PM CST)

BALLET: Stomatitis following everolimus (EVE) plus exemestane (EXE) in patients with hormone receptor-positive (HR+), HER2-advanced breast cancer (ABC) in the BALLET trial (SABCS Abstract #P4-13-10; December 11, 7:30 AM CST)

BRAWO: Stomatitis in patients treated with everolimus and exemestane – Results of the 3rd interim analysis of the non-interventional trial (SABCS Abstract #P4-13-08; December 11, 7:30 AM CST)

BRAWO: Impact of physical activity/exercise on adverse events and quality of life during treatment with everolimus and exemestane for ER+ women – Results of the 3rd interim analysis (SABCS Abstract #P4-13-07; December 11, 7:30 AM CST)

BRAWO: Results of the third interim analysis – Sub-analysis of patients < 70 years and >= 70 years (SABCS Abstract #P4-13-06; December 11, 7:30 AM CST)

Investigational data in PI3K/mTOR and CDK 4/6 pathways demonstrate value of inhibiting multiple targets via dual or triplet therapy:

BELLE-2: PIK3CA status in circulating tumor DNA predicts efficacy of buparlisib plus fulvestrant in postmenopausal women with endocrine-resistant HR+/HER2- advanced breast cancer: First results from the randomized, Phase III BELLE-2 trial (SABCS Oral Presentation #S6-01; December 11, 3:15 PM CST)

NeoPHOEBE: Phase II, randomized, parallel-cohort study of neoadjuvant buparlisib (BKM120) in combination with trastuzumab and paclitaxel in women with HER2-positive, PIK3CA mutant and PIK3CA wild-type primary breast cancer (SABCS Abstract #P1-14-01; December 9, 5:00pm CST)

Triplet therapy with ribociclib, everolimus, and exemestane in women with HR+/HER2- advanced breast cancer (SABCS Abstract #P6-13-01; December 12, 7:30 AM CST)

Phase Ib/II study of ribociclib and alpelisib and letrozole in ER+, HER2- breast cancer: Safety, preliminary efficacy and molecular analysis (SABCS Abstract #P3-14-01; December 10, 5:00 PM CST)

Data from the Make Your Dialogue Count (MYDC) survey, which sought to better understand how to improve communications among advanced breast cancer patients, caregivers and health care professionals, explore emotional effects of advanced breast cancer on caregivers:

The experience of caregivers of women with metastatic breast cancer: Insights from the MYDC survey (SABCS Abstract #P1-11-06; December 9, 5:00 PM CST)
Other noteworthy data to be presented at SABCS on Tykerb (lapatinib) and Sandoz proposed biosimilar pegfilgrastim:

NeoALTTO: Whole exome sequencing of pre-treatment biopsies to identify DNA aberrations associated with response to HER2-targeted therapies in breast cancer (SABCS Oral Poster #S5-01; December 11, 9:30 AM CST)

NeoALTTO (BIG 1-06): Breast ultrasound (US) and mammography (Mx) and response to neoadjuvant LAP, TRAS and their combination in HER2+ breast cancer (SABCS Abstract #P6-01-04; December 12, 7:30 AM CST)

ALTTO: The impact of early LAP-induced rash on DFS and OS (SABCS Abstract # PD5-07; December 10, 5:00 PM CST)
Results from PROTECT 1; A randomized, double-blind trial comparing the efficacy and safety of a proposed biosimilar pegfilgrastim (LA-EP2006) with reference pegfilgrastim in patients with breast cancer (SABCS Abstract #P1-10-01; December 9, 5:00 PM CST)
To read more about the Novartis research approach and perspectives on current trends in the breast cancer treatment landscape, visit www.novartisoncology.com/stories.