On December 5, 2016 Oxford BioMedica plc ("Oxford BioMedica" or "the Group") (LSE: OXB), a leading gene and cell therapy group, reported the findings from Novartis on their clinical trial (ELIANA) evaluating the efficacy and safety of CTL019, an investigational chimeric antigen receptor T cell (CAR T) therapy, in relapsed/refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL). Oxford BioMedica produces the lentiviral vector expressing CTL019 and has a CAR-T partnership with Novartis.

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The findings were presented during an oral session on Saturday 3rd December 2016 at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting (Abstract #221, December 3, 4:00-5:30 p.m.). Novartis reported that the global Phase II study found that 82% (41 of 50) of infused patients achieved complete remission or complete remission with incomplete blood count recovery at three months post CTL019 infusion. For all patients with complete remission, no minimal residual disease was detected. In addition, the estimated relapse-free rate among responders was 60% (95% CI: 36, 78) six months after infusion with CTL019. Novartis confirmed their intention to file CTL019 with the US Food and Drug Administration (FDA) in early 2017 for pediatric and young adult patients with r/r B-cell ALL.

John Dawson, Chief Executive Officer of Oxford BioMedica, commented: "We are pleased that Novartis has reported exciting progress with its investigational therapy CTL-019, and that Novartis confirm their commitment to advancing CTL019 and working closely with the FDA and EMA in the coming months."

On December 5, 2016 CytomX Therapeutics, Inc. (Nasdaq:CTMX), a biopharmaceutical company developing investigational Probody therapeutics for the treatment of cancer, reported the selection of the fourth target by Bristol-Myers Squibb under the companies’ current strategic oncology collaboration established in 2014 (Press release, CytomX Therapeutics, DEC 5, 2016, View Source;p=RssLanding&cat=news&id=2227453 [SID1234517019]). As a result, Bristol-Myers Squibb will pay CytomX $15 million. This constitutes the final target selection under this agreement.

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"We are thrilled with the continued progress in our alliance with Bristol-Myers Squibb that has included two new target selections this year and the recent presentations of strong preclinical proof-of-concept data for our anti-CTLA-4 Probody therapeutic program at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Symposium on Immuno-Oncology and the Society for Immunotherapy in Cancer (SITC) (Free SITC Whitepaper) Annual Meeting," said Sean McCarthy, D.Phil., president and chief executive officer of CytomX Therapeutics. "We look forward to continued progress in each of these collaboration programs as we pursue our vision of transforming lives with safer, more effective therapies."

Investigational therapeutics developed with CytomX’s Probody platform are designed to be active in the tumor while sparing healthy tissue. By restricting activity to the tumor microenvironment, investigational Probody therapeutics directed against both validated and novel targets have been shown preclinically to enable anti-tumor efficacy with an enhanced safety window, relative to traditional antibody-based therapies.

About the Collaboration Agreement
Under the terms of the agreement, which was entered into in May of 2014, CytomX granted Bristol-Myers Squibb exclusive worldwide rights to develop and commercialize Probody therapeutics for up to four oncology targets. Bristol-Myers Squibb made an upfront payment of $50 million to CytomX in 2014, and provides research funding over the course of the research term. Upon the selection of the third and fourth targets, Bristol-Myers Squibb pays CytomX selection payments. CytomX is also eligible to receive additional preclinical payments and up to $298 million in future development, regulatory and sales milestone payments for each collaboration target, as well as tiered royalties rising from mid-single digit to low double digits on net sales of each product commercialized by Bristol-Myers Squibb.

On December 5, 2016 MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) reported the presentation of updated safety and efficacy data from two ongoing phase 2 clinical studies evaluating MOR208, an Fc-modified investigational antibody targeting CD19, in patients with advanced B-cell malignancies, at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in San Diego, California/USA (Press release, MorphoSys, DEC 5, 2016, View Source [SID1234516968]).

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Continued long-lasting responses of more than 26 months reported in patients with relapsed/refractory NHL in a phase 2a trial with MOR208 monotherapy

An oral presentation reported data from a phase 2a study evaluating single-agent MOR208 in 92 patients with various subtypes of relapsed or refractory non-Hodgkin’s lymphoma (NHL) including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL) and other indolent NHL (iNHL). Results were consistent with prior updates from the study, reflecting in particular a continuation of long-lasting responses of more than 26 months.

"Patients with NHL, who are refractory or show relapse after previous anti-CD20-based therapies, have limited treatment alternatives and usually a very poor prognosis. These updated results illustrate our ongoing efforts to develop MOR208 as a potential new CD19-based antibody therapy for patients suffering from B-cell malignancies, including DLBCL, in phase 2 studies in combination with other cancer drugs," said Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG.

At the last cutoff date, June 3, 2016, three patients with DLBCL and six with iNHL were in remission and on study treatment, with the longest responses in both subgroups ongoing for more than 26 months. Of these nine patients, seven showed complete responses and 2 experienced partial responses. The median duration of response was 20.1 months for DLBCL and not yet reached for iNHL. The overall response rate (ORR), based on complete responses (CR) and partial responses (PR), was 36% in the DLBCL subgroup and 33% in iNHL patients (both based on evaluable patients). Based on all patients with DLBCL and iNHL in the study, the ORR was 26% and 29%, respectively. The progression free survival (PFS) rate at 12 months was 39% in both subgroups. In addition to the patients with an objective response (PR or CR), the majority of patients with stable disease (SD) (5/6 DLBCL and 14/17 iNHL) had a reduction in target lesion size (central assessment).

PFS was similar in patients with rituximab non-refractory versus rituximab refractory tumors. Fifty-two patients (57%) in the study were classified as having rituximab refractory disease. Of those, five of 24 patients (21%) with DLBCL and five of 22 patients (23%) with iNHL responded to MOR208. Of the 10 responders with rituximab refractory disease, six had a response duration longer than 10 months, two of which lasted for more than 26 months.

The most common adverse events were infusion-related reactions (IRRs) occurring in 12% of the patients (11% of grade 1 or 2, 1% of grade 4) and neutropenia occurring in 12% of patients (3% of grade 1 or 2, 9% of grade 3 or higher). No treatment-related deaths were reported.

Number and title of the presentation
Abstract #623
Jurczak et al: Single-Agent MOR208 in Relapsed or Refractory (R-R) Non-Hodgkin’s Lymphoma (NHL): Results from Diffuse Large B-Cell Lymphoma (DLBCL) and Indolent NHL Subgroups of a Phase IIa Study

Combination of MOR208 with lenalidomide and ibrutinib in CLL from phase 2 investigator-initiated trial

A second presentation is a poster from investigators at The Ohio State University, who reported on an investigator-initiated trial (IIT) evaluating MOR208 in combination with lenalidomide in three cohorts of patients with chronic lymphatic leukemia (CLL): previously untreated CLL patients, relapsed/refractory CLL patients; and patients with Richter’s Transformation.

The trial also included a 4th cohort of ibrutinib-treated CLL patients with identified resistance mutations to ibrutinib in the tumors (molecular relapse) but no confirmed clinical relapse where MOR208 was added to ibrutinib therapy. Recent data have generally shown poor clinical outcomes in patients who relapse after a therapy with the BTK inhibitor ibrutinib and whose leukemia cells carry a mutation in the BTK gene prior to relapse.

According to the data presented, 34 patients have been enrolled in the study so far, 27 receiving MOR208 in combination with lenalidomide (11 of which in the previously untreated cohort, 11 in the relapsed/refractory cohort, 5 in the Richter’s Transformation cohort) and 7 receiving MOR208 plus ibrutinib, with patient accrual still ongoing.

Most frequent hematological adverse event over all cohorts were thrombocytopenia in 47% of patients (9% grade 3 or higher) and neutropenia in 35% (21% grade 3 or higher). There were no unexpected serious adverse events reported.

According to the abstract, in the group of CLL patients with ibrutinib-resistant cells receiving MOR208 in addition to ibrutinib, four out of seven patients have been on study for at least 3 cycles of 28 days each already, and no patient had developed progressive disease at the time of abstract data cut-off. Preliminary activity has been seen in all cohorts, including ibrutinib-resistant CLL patients.

"There is a high unmet medical need for CLL patients, especially those showing resistance to ibrutinib therapy," said Dr. Jennifer Woyach, Assistant Professor of Internal Medicine at Ohio State University. "Therefore we added an additional cohort to our ongoing CLL study to evaluate MOR208 in combination with ibrutinib in order to investigate whether MOR208 could be a promising combination partner in this setting. We are looking forward to the continuation of the trial and to present further results going forward."

Number and title of the presentation
Abstract #4386
Woyach et al: Updated Results from a Phase II Study of the Fc Engineered CD19 Antibody MOR208 in Combination with Lenalidomide for Patients with Chronic Lymphocytic Leukemia (CLL) and Richter’s Transformation or Ibrutinib for Patients with Ibrutinib-Resistant Clones

MorphoSys held an Investor & Analyst Event at the 2016 ASH (Free ASH Whitepaper) Annual Meeting on December 5, 2016, at 8:00pm PST (December 6, 2016: 4:00am GMT, 5:00am CET). Two clinical investigators presented clinical data for MorphoSys’s investigational agents MOR208 and MOR202.
A replay and the presentation will be made available at View Source
Webcast: View Source

On December 5, 2016 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, reported key presentations of clinical and scientific data related to its products at the San Antonio Breast Cancer Symposium (SABCS), being held in San Antonio, Texas, from December 6-10, 2016 (Press release, Spectrum Pharmaceuticals, DEC 5, 2016, View Source [SID1234516921]).

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For more information about the SABCS meeting and for a complete list of abstracts, please refer to the conference website at View Source

The following are key ROLONTISTM (eflapegrastim) related abstracts being presented at the SABCS meeting:

Abstract # Type Title First Author Date/Time
Location: Hall 1
OT1-01-11 Poster
Randomized phase 3 study of a novel, long-acting G-CSF (eflapegrastim) versus pegfilgrastim in the management of chemotherapy-induced neutropenia in early-stage breast cancer patients receiving docetaxel and cyclophosphamide (TC) (ADVANCE study)

Schwartzberg Wednesday, Dec 7
5:00 PM
P5-11-09 Poster
Sustained efficacy of eflapegrastim in breast cancer patients in a phase 2, open-label, dose-ranging study

Vacirca Friday, Dec 9
5:00 PM
P5-11-07 Poster
Pharmacokinetics of eflapegrastim in a phase 2 open-label dose-ranging study in breast cancer patients receiving TC regimen

Vacirca Friday, Dec 9
5:00 PM
P5-11-08 Poster
Immunogenicity of eflapegrastim in a Phase 2 Open-Label Dose-Ranging Study of eflapegrastim in Breast Cancer Patients Receiving TC Regimen

Vacirca Friday, Dec 9
5:00 PM
The following key poziotinib related abstract will be presented at the SABCS meeting:

Abstract # Type Title First Author Date/Time
Location: Hall 1
OT1-02-10 Poster
A phase 2 study of poziotinib in patients with HER2-positive metastatic breast cancer (MBC) who have received prior HER2 regimens for MBC

Lathrop Wednesday, Dec 7
5:00 PM

On December 5, 2016 NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, reported advances in precision oncology using the Prosigna Breast Cancer Gene Signature Assay and the PAM50 gene signature, the basis for Prosigna, will be presented at the 2016 CTRC-AACR San Antonio Breast Cancer Symposium (SABCS) (Press release, NanoString Technologies, DEC 5, 2016, View Source [SID1234516969]). In addition, numerous customers will be presenting data generated using NanoString’s nCounter Analysis System, including several involving immuno-oncology.

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"The volume and impact of the clinical research being presented at the SABCS underscores our commitment to improving the lives of breast cancer patients," said Brad Gray, president and chief executive officer of NanoString Technologies. "These studies demonstrate that our Prosigna Assay can improve decision-making in early-stage breast cancer today, and that a modified companion diagnostic version of this assay has future potential in triple negative breast cancer. The studies also show that our nCounter Analysis System is continuing to grow in prominence as an important tool among breast cancer researchers."

NanoString and its collaborators will present three oral presentations and fourteen posters covering Prosigna/PAM50 and other nCounter-based research at SABCS, which is being held December 6-10, 2016.

Following are details for each presentation of data involving Prosigna and the PAM50 gene signature (all times are in Central Standard Time):

Wednesday, December 7, 2016

Abstract: P1-07-10
Poster: Prediction of 10 year distant recurrence (DR) using the Prosigna (PAM50) assay in histological subgroups of a Danish Breast Cancer Cooperative Group (DBCG) cohort of postmenopausal Danish women with hormone receptor-positive (HR+) early breast cancer (EBC) allocated to 5yr of endocrine therapy (ET) alone
Authors: Laenkholm A-V, Jensen M-B, Buckingham W, Schaper C, Knoop A, Eriksen JO, Rasmussen BB, Ferree S, Haffner T, Kiboel T, Ejlertsen B.
Location: Hall 1
Time: 5:00 – 7:00 p.m.

Abstract: P1-09-09
Poster: Efficacy and gene expression results from SOLTI1007 NEOERIBULIN phase II clinical trial in HER2-negative early breast cancer
Authors: Prat A, Ortega V, Villagrasa P, Paré L, Galván P, Oliveira M, Nucíforo P, Lluch A, Morales S, Amillano K, Lopez R, Gonzalez R, Manso L, Martinez J, Llombart A, De la Peňa L, Di Cosimo S, Rubio IT, Harbeck N, Baselga J, Cortés J
Location: Hall 1
Time: 5:00 – 7:00 p.m.
Thursday, December 8, 2016

Abstract: P2-05-04
Poster: Evaluation of intra-tumor heterogeneity, test reproducibility and their impact in breast cancer samples assessed by Prosigna: results from a Decision Impact prospective study and a matched case-control study
Authors: Rouzier R, Bonneau C, Cayre A, Hequet D, Gentien D, Bonhomme A, Mouret-Reynier M-A, Dubot C, Cottu P, Roulot A, Morel P, Salomon A, Callens C, Guinebretiere J-M, Penault-Llorca F
Location: Hall 1
Time: 7:30 – 9:00 a.m.

Abstract: P2-03-03
Poster: Molecular differences between screen-detected and interval breast cancers are largely explained by PAM50 subtypes
Authors: Czene K, Ivansson E, Klevebring D, Tobin NP, Lindström LS, Holm J, Prochazka G, Hilliges C, Palmgren J, Törnberg S, Humphreys K, Hartman J, Frisell J, Rantalainen M, Lindberg J, Hall P, Bergh J, Grönberg H, Li J
Location: Hall 1
Time: 7:30 – 9:00 a.m.

Abstract: P2-05-16
Poster: Establishment of molecular profiling for individual treatment decisions in early breast cancer – clinical impact of PAM50 and PAM50 risk of recurrence score after more than 16 years follow up.
Authors: Naume B, Borgen E, Falk RS, Ohnstad HO, Lien TG, Aaserud M, Sveli MAT, Kyte JA, Kristensen V, Geitvik G, Schlichting E, Wist E, Sørlie T, Russnes H
Location: Hall 1
Time: 7:30 – 9:00 a.m.

Abstract: S3-03
Oral Session: General Session 3
Poster: PAM50 intrinsic subtype as a predictor of pathological complete response following neoadjuvant dual HER2 blockade without chemotherapy in HER2-positive breast cancer: First results of the PAMELA clinical trial
Authors: Prat Aparicio A, Cortes Castan J, Pare L, Galvan P, Bermejo B, Martínez N, Vidal M, Pernas S, Lόpez R, Muñoz M, Nuciforo P, Fasani R, Morales S, Oliveira M, de La Peña L, Peláez A, Llombart A
Location: Hall 3
Time: 10:00 a.m.
Friday, December 9, 2016

Abstract: S6-05
Oral Session: General Session 6: Comprehensive comparison of prognostic signatures for breast cancer in TransATAC
Authors: Sestak I, Buus R, Cuzick J, Dubsky P, Kronenwett R, Ferree S, Sgroi D, Schnabel C, Baehner R, Mallon E, Dowsett M.
Location: Hall 3
Time: 4:15 p.m.
Saturday, December 10, 2016

Abstract: P6-07-01
Poster: Development of a Prosigna (PAM50)-based classifier for the selection of advanced triple negative breast cancer (TNBC) patients for treatment with enzalutamide
Authors: Danaher P, Skewis L, Mashadi-Hossein A, Carey C, Ram N, Gowen-MacDonald J, Harris E, Cesano A, Ferree S, Uppal H, Buckingham W.
Location: Hall 1
Time: 7:30 – 9:00 a.m.
Additional abstracts and posters demonstrate the diverse applications and robust performance of the nCounter Analysis System in immuno-oncology and biomarker validation, including:

Wednesday, December 7, 2016

Abstract: P1-05-22
Poster: The value of RNA-Seq for the detection of clinically actionable targets in breast cancer – A small cohort analysis
Authors: Meissner T, Amallraja A, Mark A, Andrews A, Connolly C, Young B, De P, Williams C, Leyland-Jones B
Location: Hall 1
Time: 5:00 p.m.
Thursday, December 8, 2016

Abstract: P2-04-07
Poster: Immune profiling of post neoadjuvant high metastatic risk (RCB-II/III) residual disease in patients with early triple negative breast cancers
Authors: Irshad S, Cheang M, Gazinka P, Naidoo K, Buus R, Pinder S, Dowsett M, Tutt A
Location: Hall 1
Time: 7:30 – 9:00 a.m.

Abstract: P2-04-19
Poster: Elucidating the tumor immune microenvironment phenotype in early stage untreated BRCA mutated breast cancer patients
Authors: Force J, Abbott S, Broadwater G, Kimmick G, Westbrook K, Hwang S, Kauff N, Stashko I, Weinhold K, Nair S, Hyslop T, Blackwell K, Castellar E, Marcom PK
Location: Hall 1
Time: 7:30 – 9:00 a.m.

Abstract: S4-01
Oral Session: General Session: A novel BRD4 inhibitor enhances endocrine therapy efficacy and circumvents endocrine-resistance in estrogen receptor-positive breast cancer models
Authors: De Angelis C, Nardone A, Cataldo ML, Fu X, Trivedi M, Yi S, Breckenridge D, Chamnsess GC, Vitorino P, Osborne CK, Schiff R
Location: Hall 3
Time: 3:15 – 5:00 p.m.

Abstract: PD5-06
Poster: Prognostic value of molecular tumor infiltrating lymphocyte (mTIL) signatures in HER2-positive breast cancer patients in N9831 and FinHer/FinXX trials
Authors: Chumsri S, Serie DJ, Mashadi-Hossein A, Tenner KS, Lauttia SL, Moreno-Aspitia A, McLaughlin SA, Nassar A, Warren S, Danaher P, Colon-Otero G, Lindman H, Joensuu H, Perez EA, Thompson EA
Location: Stars at Night Ballroom 1&2 – 3rd Level
Time: 5:00 – 7:00 p.m.
Friday, December 9, 2016

Abstract: P4-07-06
Poster: MicroRNAs associated with acquired taxane resistance in a breast cancer cell line model
Authors: Taylor KJ, Chong T, D’Costa A, Yao C, Gourley C, Cameron DA, Bartlett JMS, Spears M
Location: Hall 1
Time: 7:30 – 9:00 a.m.

Abstract: P4-12-09
Poster: The immune response in triple negative breast cancer
Authors: Gillgrass AE, Pond GR, Levine MN, Whelan TJ, Hassell JA, Bane AL
Location: Hall 1
Time: 7:30 – 9:00 a.m.
Saturday, December 10, 2016

Abstract: P6-07-07
Poster: ESR1 amplification and 5′-3′ exon imbalance in metastatic breast cancer
Authors: Oesterreich S, Basudan A, Preideigkeit N, Hartmaier RJ, Bahreini A, Gyanchandani R, Leone JP, Lucas PC, Hamilton RL, Brufsky AM, Lee AV
Location: Hall 1
Time: 7:30 – 9:00 a.m.

Abstract: P6-09-47
Poster: The development of personalized diagnostic tests and therapeutic strategies in breast cancer
Authors: Kutasovic JR, Rozali E, Miranda M, Lakhani SR, Al-Ejeh F
Location: Hall 1
Time: 7:30 – 9:00 a.m.
You can learn more about the Prosigna Breast Cancer Gene Signature at booth #525.