On October 27, 2015 ArQule, Inc. (Nasdaq:ARQL) reported that six posters, with pre-clinical and clinical data for tivantinib, ARQ 087, ARQ 092, and ARQ 751, will be presented at the AACR (Free AACR Whitepaper)-NCI-EORTC Conference in Boston, Mass (Press release, ArQule, OCT 27, 2015, View Source [SID:1234507802]). All posters will be presented on November 7th from 12:30 p.m. to 3:30 p.m. as part of Poster Session B in Exhibit Hall C-D.

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Poster Presentations

Poster Number: B111
Poster Title: Efficacy of AKT Inhibitor ARQ 092 Compared with Sorafenib in a Cirrhotic Rat Model with Hepatocellular Carcinoma

Poster Number: B151
Poster Title: In FGFR2 Driven Tumors, Preclinical Pharmacokinetics (PK), Pharmacodynamics (PD), and Efficacy Translate into Clinical Activity of ARQ 087

Poster Number: B181
Poster Title: Association of AKT1E17K and PIK3CAH1047R Mutations with Efficacy of ARQ 092 In Vitro, In Vivo and in Patients

Poster Number: B183
Poster Title: Targeting PI3K Pathway Dependent Endometrial Tumors with Allosteric Inhibitors, ARQ 092 and ARQ 751

Poster Number: B185
Poster Title: ARQ 092 Enhances the Efficacy of Paclitaxel, Lapatinib, Trastuzumab, Trametinib, and ARQ 087 both in Cancer Cell Lines and Mouse Xenograft Cancer Models

Poster Number: B194
Poster Title: Tivantinib in Combination with Erlotinib vs Erlotinib Alone for EGFR Mutant NSCLC: Subgroup Results from the Phase 3 MARQUEE Study

Precision Medicine

Tivantinib is enrolling in two biomarker-driven phase 3 trials, METIV-HCC and JET-HCC. ARQ 087 is enrolling in a biomarker-driven phase 2 trial in intrahepatic cholangiocarcinoma (iCCA) with FGFR translocations. ARQ 092 is enrolling in a phase 1b biomarker-driven trial in patients with AKT and PI3K activating mutations including patients with breast, endometrial and ovarian cancers.

About MET and tivantinib (ARQ 197)

Tivantinib is an orally administered, selective inhibitor of MET, a receptor tyrosine kinase, which is currently in Phase 3 clinical trials. In healthy adult cells, MET can be present in normal levels to support natural cellular function, but in cancer cells, MET can be inappropriately and continuously activated. When abnormally activated, MET plays multiple roles in aspects of human cancer, including cancer cell growth, survival, angiogenesis, invasion and metastasis. The activation of certain cell signaling pathways, including MET, has also been associated with the development of resistance to anti-EGFR (epidermal growth factor receptor) antibodies such as cetuximab and panitumumab.

Pre-clinical data have demonstrated that tivantinib inhibits MET activation in a range of human tumor cell lines and shows anti-tumor activity against several human tumor xenografts. In clinical trials to date, treatment with tivantinib has been generally well tolerated and has shown clinical activity in a number of tumors. Tivantinib has not yet been approved for any indication in any country.

In December 2008, ArQule and Daiichi Sankyo signed a license, co-development and co-commercialization agreement for tivantinib in the U.S., Europe, South America and the rest of the world, excluding Japan, China (including Hong Kong), South Korea and Taiwan.

About the AKT Pathway, ARQ 092 and ARQ 751

ARQ 092 and ARQ 751 are orally available, selective small molecule inhibitors of the AKT kinase. The AKT pathway when abnormally activated is implicated in multiple oncogenic processes such as cell proliferation and apoptosis. This pathway has emerged as a target of potential therapeutic relevance for compounds that inhibit its activity, which has been linked to a variety of cancers as well as to select non-oncology indications.

ARQ 092, the lead compound in ArQule’s AKT program, has completed Phase 1a clinical testing and has advanced into Phase 1b expansion testing in cohorts of patients with endometrial cancer, lymphoma and tumors harboring either AKT or PI3K mutations. A number of next-generation compounds in the Company’s AKT program are in early to late stages of pre-clinical development. The company plans to file an Investigational New Drug (IND) application by the end of 2015 for ARQ 751, a next generation AKT inhibitor.

About FGFR and ARQ 087

ARQ 087 is a multi-kinase inhibitor designed to preferentially inhibit the fibroblast growth factor receptor ("FGFR") family with demonstrated efficacy in FGFR2 amplified tumors. The FGFR pathway is disrupted in several ways in human cancer, thus providing numerous therapeutic targets for an inhibitor of this pathway. ARQ 087 has demonstrated inhibition of tumor growth and downstream signaling in vivo in tumors whose growth is driven by these targets.

Signals of single agent activity with this compound were observed in Phase 1a testing. Phase 1b expansion cohorts with ARQ 087 include patients with cholangiocarcinoma and adrenocortical tumors, as well as those with FGFR translocations, amplification and mutations. Clinical development of ARQ 087 has advanced into Phase 2 for intrahepatic cholangiocarcinoma ("iCCA") following the observation of two confirmed partial responses in this patient population in the Phase 1 portion of the program.

(Filing, 10-Q, Bristol-Myers Squibb, OCT 27, 2015, View Source [SID:1234507811])

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On October 27, 2015 ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that develops targeted anticancer therapeutics using its ADC technology, reported financial results for the three-month period ended September 30, 2015 – the first quarter of the Company’s 2016 fiscal year (Press release, ImmunoGen, OCT 27, 2015, View Source [SID:1234507803]). ImmunoGen also provided an update on product programs and reiterated its guidance for its 2016 fiscal year.

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"We believe mirvetuximab soravtansine has the potential to make an important difference for many patients with FRα-positive cancers and look forward to the upcoming data presentations at AACR (Free AACR Whitepaper)-NCI-EORTC," commented Daniel Junius, President and CEO. "Of particular note are the findings suggesting that the level of FRα expression on patient tumors has a marked impact on response to mirvetuximab soravtansine. As noted in the abstract that became public yesterday, the response rate was 53% for the patients reported at ASCO (Free ASCO Whitepaper) and 80% in the subset with the highest expression – about half of the 22 patients treated. Updated response data, including duration, for these patients will be reported at AACR (Free AACR Whitepaper)-NCI-EORTC."

Mr. Junius continued, "We are successfully executing on all of our product programs – completing enrollment in the 40-patient ovarian cancer Phase 1 expansion cohort well ahead of plan, moving forward with combination strategies for our two ADCs for B-cell malignancies, and submitting the IND for our fourth wholly owned program, IMGN779, to the FDA on schedule. There also has been notable progress by a number of our partners."

Updates on Product Programs

Mirvetuximab soravtansine (formerly IMGN853) – for FRα-positive cancers including ovarian cancer.

Data presentations at the upcoming AACR (Free AACR Whitepaper)-NCI-EORTC conference will feature:
Findings from an analysis of the relationship between level of FRα expression on patient tumor cells and response to treatment with mirvetuximab soravtansine (abstract C47). This analysis indicates patients with higher levels of target expression on their tumors are more likely to respond to treatment with mirvetuximab soravtansine. The findings helped inform that FORWARD I would enroll patients with medium or high levels of expression, with stratification by expression level.

Preclinical evaluation of mirvetuximab soravtansine combination therapy (abstract C170) provides findings on mirvetuximab soravtansine used in combination with bevacizumab (Avastin) and the other agents to be assessed in FORWARD II.
Clinical progress: patient enrollment completed – ahead of plan – in the Phase 1 40-patient expansion cohort assessing mirvetuximab soravtansine monotherapy for FRα-positive platinum-resistant ovarian cancer. Patient enrollment is also ahead of plan in the 20-patient ovarian cancer cohort examining biomarkers using biopsies taken before and on treatment, and is progressing in the endometrial cancer expansion cohort. Data presentation for each of these cohorts is targeted for 2Q2016. Cohorts for additional types of FRα-positive cancers are expected to be added to this Phase 1 trial.

Phase 2 testing: ImmunoGen remains on track to initiate its FORWARD I and FORWARD II trials by year end. FORWARD I evaluates mirvetuximab soravtansine used alone to treat patients with FRα-positive ovarian cancer previously treated with 3-4 regimens and could potentially support an Accelerated Approval pathway. FORWARD II assesses doublet combinations of mirvetuximab soravtansine and bevacizumab (Avastin), carboplatin, and pegylated liposomal doxorubicin (Doxil) in less pretreated FRα-positive ovarian cancer.

IMGN529 and coltuximab ravtansine (formerly SAR3419) – for diffuse large B-cell lymphoma (DLBCL) and potentially other B-cell malignancies.

Data presentations at upcoming ASH (Free ASH Whitepaper) conference: preclinical findings with each compound used in combination with approved anticancer therapies.

Clinical progress, Phase 2 testing: maximum tolerated dose identified in single agent, Phase 1 assessment of IMGN529 for B-cell non-Hodgkin lymphoma. Company on track to start Phase 2 assessments of IMGN529 and of coltuximab ravtansine in combination regimens by the end of 2015 and in 2016, respectively.

IMGN779 – CD33-targeting ADC for acute myeloid leukemia and myelodysplastic syndrome; utilizes the first of ImmunoGen’s new DNA-acting payload agents.

Data presentation at upcoming ASH (Free ASH Whitepaper) conference: mechanism of action findings.
Clinical progress: IND submitted to FDA; on track for initiation of patient dosing in early 2016.
Partner compounds – Recent highlights include:

Promising single-agent activity in recurrent mesothelioma from a Phase 1b trial was reported with Bayer’s anetumab ravtansine (BAY 94-9343) at the 16th World Conference on Lung Cancer.
Eli Lilly and Company advanced its FGFR3-targeting ADC, LY3076226, into clinical testing in September, triggering a milestone payment to ImmunoGen. Additionally, ImmunoGen earned a milestone payment from Amgen with its advancement of a new ADC.
Patient dosing began with Sanofi’s LAMP1-targeting ADC, SAR428926, in October, also triggering a milestone payment to ImmunoGen.
There are now seven companies with novel anticancer compounds in the clinic utilizing ImmunoGen’s technology: Amgen, Bayer, Biotest, Genentech/Roche, Lilly, Novartis and Sanofi. Companies advancing earlier-stage ADCs include CytomX and Takeda.

Financial Results

For the Company’s quarter ended September 30, 2015 (1QFY2016), ImmunoGen reported a net loss of $33.7 million, or $0.39 per basic and diluted share, compared to a net loss of $22.3 million, or $0.26 per basic and diluted share, for the same quarter last year (1QFY2015).

Revenues for 1QFY2016 were $14.9 million, compared to $13.2 million for 1QFY2015. They include $6.1 million of license and milestone fees, comprised principally of a $5 million milestone earned from Lilly and a $1 million milestone earned from Amgen with the advancement by each of an ADC with ImmunoGen technology. Revenues also include $5.7 million of non-cash royalties on Roche sales of Kadcyla for the three-months ended June 30, 2015. Additionally, revenues for 1QFY2016 include $2.3 million of clinical materials revenue and $0.8 million of research and development support fees. The level of research support and the number of batches of clinical materials produced and released to partners varies on a quarter-to-quarter basis.

Operating expenses in 1QFY2016 were $43.5 million, compared to $35.1 million in 1QFY2015. Operating expenses in 1QFY2016 include research and development expenses of $35.1 million, compared to $28.0 million in 1QFY2015. This change is primarily due to increased third-party costs related to the advancement of our wholly owned product candidates, increased clinical trial costs, primarily related to our expansion of the mirvetuximab soravtansine development program, and increased personnel expenses, principally due to recent hiring. Operating expenses include general and administrative expenses of $8.3 million in 1QFY2016, compared to $7.1 million in 1QFY2015. This increase is primarily due to increased personnel expenses and professional services.

ImmunoGen had approximately $247.8 million in cash and cash equivalents as of September 30, 2015, compared with $278.1 million as of June 30, 2015, and had no debt outstanding in either period. Cash used in operations was $31.4 million in the first three months of FY2016, compared with $18.9 million in the same period in FY2015. Capital expenditures were $3.4 million and $1.7 million for the first three months of FY2016 and FY2015, respectively.

Financial Guidance for Fiscal Year 2016

ImmunoGen’s financial guidance remains unchanged from that issued in July 2015. ImmunoGen expects: its revenues to be between $70 million and $80 million; its operating expenses to be between $175 million and $180 million; its net loss to be between $120 million and $125 million; its cash used in operations to be between $100 million and $105 million; and its capital expenditures to be between $13 million and $15 million. Cash and marketable securities at June 30, 2016 are anticipated to be between $165 million and $170 million.

On October 26th, 2015 PharmaMar reported that for the next few days, thousands of oncology experts in gynecologic cancers are gathering during the 19th Biennial Meeting of the European Society of Gynecological Oncology (ESGO 2015), which is taken place from October 24-27, 2015 in Nice, France. ESGO is the European leading organization that aims to advance gynecologic cancer care and is strongly committed to help women in Europe with this disease. This forum is an excellent opportunity for clinicians, researchers, patient associations and drug developers to learn about the most exciting developments in the field of gynecologic cancers, which include ovarian, cervical, uterine, vaginal and vulvar cancers.

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The initial standard treatment for ovarian cancer implies a platinum-based combination therapy. However, after recurrence, leading oncologists in the field recommend evaluating patients on a case-by-case basis to identify the best therapeutic option for each patient. In this scenario, platinum-free therapies keep gaining traction among clinicians.

"Making the most of every option in the treatment of ovarian cancer. Choosing the optimal sequency" is the title of the satellite symposium organized by PharmaMar, which gathered more than 600 oncologists, during ESGO 2015 to bring together
national and international oncologists and discuss the different aspects that need to be considered from a clinical standpoint to treat women with recurrent ovarian cancer. Among the most crucial topics to be discussed are the best approaches to
manage and overcome platinum hypersensitivity and the clinical benefit of platinum-free therapies after recurrence.

One of the participants, Nicoletta Colombo, MD, European Oncology Institute, University of Milan-Bicocca, Milan, has pointed how certain platinum sensitive tumors can also respond to other therapies and said "among the benefits of switching from a platinum-based therapy to a non-platinum treatment you can find two important aspects of the management of these patients; the probable recovery from neurotoxicity that is associated to platinum, and the potential to reduce and even prevent the hipersensitivity often found during treatment of these women with platinum".

When a patient is partially sensitive to platinum, that is the patient relapses within 6 to 12 months after treatment with platinum, among the recommended therapeutic options, oncologists and the most recent ESMO (Free ESMO Whitepaper) Clinical Practice Guidelines suggest a treatment combining YONDELIS (trabectedin) with pegylated liposomal doxorubicin followed by a platinum-based therapy. Dr. Colombo explained that with this sequential treatment, an overall survival of 6 months and a 41 percent reduction in the risk of death can be obtained. Also, the treated patient can recover from the toxicity caused by platinum-based therapiesi". The hypothesis to explain the benefit of this sequential treatment is that such approach could enhance the sensitivity of the tumor to a next platinum therapy, thus increasing the survival of the patient.

Studies highlighted at ESGO 2015
PharmaMar introduces several posters to show clinical data about the treatment combining YONDELIS with PLD in different patient profiles.

YONDELIS (trabectedin)

 Complete response to trabectedin in combination with pegylated liposomal doxorubicin (PLD) in heavily pre-treated BRCA-2 mutated platinum-sensitive intermediate epithelial ovarian cancer (EOC)
Poster: Saturday 24th, October, e-poster station
Lead author: P. Biondani, Hôpital Tenon 4 Rue de la chine 75020 Paris

 BRCA mutated ovarian cancer complete remission following second line treatment with trabectedin and lposomal Adriamycin
Poster: Saturday 24th, October, e-poster station
Lead author: Dr. Raffaella Bracci, Clinica di Oncologia Medica
Centro Regionale Genetica Oncologica, Azienda Ospedaliero-Universitaria
Ospedali Riuniti, Italy

 Extending the platinum-free interval (PFI) with trabectedin plus pegylated liposomal doxorubicin (PLD) in a patient with partially
platinum-sensitive (PPS) recurrent ovarian cancer (ROC)
Poster: Saturday 24th, October, e-poster station
Lead autor: Dr.ssa Sara Giovannoni, U.O.C.Oncologia B, Policlinico Umberto
I Roma

 Long-lasting complete response with trabectedin plus pegylated liposomal doxorubicin (PLD) in a young BRCA-mutated woman with platinum-sensitive relapsed ovarian cancer (ROC): a case report
Poster: Saturday 24th, October, e-poster station
Lead autor: Dr.ssa Sara Giovannoni, U.O.C.Oncologia B, Policlinico Umberto
I Roma

 Prolonged treatment with trabectin plus pegylated liposomal doxorubicin (PLD) combination in a heavily pretreated patient with
metastatic relapsed ovarian cancer (ROC)
Poster: Saturday 24th, October, e-poster station
Lead author: Dr Pierre Guillet, Centre Hospitalier Sainte Musse, Toulon

 Trabectedin in combination with pegylated liposomal doxorubicin to treat heavily-treated patient with relapsed ovarian cancer
Poster: Saturday 24th, October, e-poster station
Lead author: Professor Dr Saad Tahir. Broomfield Hospital. Chelmsford

 Trabectedin in monoteraphy, a therapeutic option
Poster: Saturday 24th, October, e-poster station
Lead autor: Dr S. Rego, Hospital da Arrábida, Portugal

 METASTATIC OVARIAN CANCER – CHRONIC DISEASE?
Poster: Saturday 24th, October, e-poster station
Lead autor: Dr S. Rego, Hospital da Arrábida, Portugal

 Multicenter retrospective study to analyze the effectiveness and safety of trabectedin (T) + PLD in recurrent ovarian cancer (ROC)
patients according to SMPC. GEICO-1402r study
Poster: Saturday 24th, October, e-poster station
Lead author: Dr L. Vidal, Hospital Universitari Clinic de Barcelona

 Trabectedin in advanced gynaecological carcinosarcomas – a single institution series (abstract #57)
Poster: Sunday 25th, October, poster area (endometrial cancer)
Laed author: Dr. J. Gounaris, Department of Oncology, Addenbrooke´s
Hospital, Cambridge, UK

PM1183 (lurbinectedina)
The Company also shows another poster about PM1183, a novel transcription inhibitor and DNA repair, to treat relapsed platinum-sensitive ovarian cancer

 LURBINECTEDIN (PM01183) EFFICACY IN PLATINUMRESISTANT/REFRACTORY OVARIAN CANCER (PRROC) PATIENTS CORRELATES WITH DRUG EXPOSURE USING
PHARMACOKINETIC/PHARMACODYNAMIC (PK/PD) MODELLING
(abstract #157)
Poster: Monday 26th, October, poster area
Lead author: C. Fernandez-Teruel

On October 26, 2015 Agios Pharmaceuticals (NASDAQ:AGIO), a leader in the fields of cancer metabolism and rare genetic metabolic disorders, reported that the first results from the Phase 1 study of AG-120 in patients with IDH1-mutant positive advanced solid tumors will be presented in an oral presentation and featured in the press program at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) taking place November 5-9, 2015, in Boston (Press release, Agios Pharmaceuticals, OCT 26, 2015, View Source;p=RssLanding&cat=news&id=2102387 [SID:1234507791]).

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"We look forward to sharing the first clinical data for AG-120 in patients with advanced solid tumors as we continue to understand the potential of this investigational medicine," said Chris Bowden M.D., chief medical officer at Agios. "This is an important step toward our long-term vision of making a difference for people with a broad range of hematologic and solid tumor cancers that harbor IDH mutations."

Title: The First Reported Results of AG-120, a First-in-class, Potent Inhibitor of the IDH1 Mutant Protein, in a Phase 1 Study of Patients with Advanced IDH1-Mutant Solid Tumors, Including Gliomas

Plenary Session Date & Time: Sunday, November 8, 2015, at 8:00 a.m. ET

Session: Advances in Targeted Therapy

Press Program Date & Time: Sunday, November 8, 2015, at 10:30 a.m. ET

Presenter: Howard A. Burris, III, M.D., Sarah Cannon Cancer Center, Nashville, Tennessee

Location: Hynes Convention Center

Investor Lunch and Webcast Information

Agios will host an investor lunch on Sunday, November 8, 2015 in Boston to review data presented at the conference, additional event details to come. The event will be webcast live and can be accessed under "Events & Presentations" in the Investors and Media section of the company’s website at www.agios.com. A replay of the webcast will be archived on the Agios website for approximately 30 days following the presentation.