On November 14, 2018 Agendia, Inc., a world leader in precision oncology, reported new data from the I-SPY 2 study, presented at the European Organization for Research and Treatment of Cancer (EORTC), the National Cancer Institute (NCI) and the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Symposium (Press release, Agendia, NOV 14, 2018, View Source [SID1234531318]). The two presentations demonstrate both the prognostic, and the predictive role of the MammaPrint 70-Gene Breast Cancer Risk of Recurrence and BluePrint 80-Gene Molecular Subtyping tests in determining which patients are likely to respond to therapies. Dr. Laura van’t Veer, chief research officer and co-founder at Agendia, and Professor of Laboratory Medicine at the University California San Francisco, will present the results at the 30th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium at 15:00 GMT on Wednesday, Nov. 14, 2018.

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MammaPrint High1/High2 risk class as a pre-specified biomarker of response to nine different targeted agents plus standard neoadjuvant therapy for ~1000 breast cancer patients in the I-SPY 2 TRIAL (Abstract 2)1

A new analysis from the I-SPY 2 trial showed that a subgroup of "Ultra-High Risk" patients identified by MammaPrint respond better to certain targeted therapies and treatment combinations. Patients were classified as either MammaPrint High Risk (MP1), indicating less aggressive disease, or MammaPrint Ultra-High Risk (MP2), indicating more aggressive disease. Nearly 50 percent of patients were classified as MP2 and had higher rates of pathological complete response (pCR) compared to MP1 patients.

In addition, MP2 patients had a higher chance of achieving pCR if they received veliparib/carboplatin, neratinib, ganitumab, TDM1/pertuzumab or pembrolizumab in addition to the standard paclitaxel treatment alone or in combination with trastuzumab. Together, these findings support the use of the MammaPrint High Risk or Ultra-High Risk result as a predictive biomarker of treatment response.

BluePrint basal subtype predicts neoadjuvant therapy response in ~400 HR+HER2- patients across 8 arms in the I-SPY 2 TRIAL (Abstract 3)2

A second analysis of the I-SPY 2 trial evaluated neoadjuvant chemotherapy response in different subgroups of patients with HR+/HER2- disease. Using the BluePrint Molecular Subtyping test, patients were classified as having either basal, luminal or HER2 subtypes. Patients with the basal subtype were four times more likely to achieve pCR with neoadjuvant therapy than patients with the luminal subtype, and this association was independent of the type of treatment they received. Additionally, more than three-quarters of patients with the HR+/HER2- basal subtype of cancer were classified as having MP2 Ultra-High Risk disease, suggesting that genetic and molecular risk signatures can be used to predict treatment response in similar subgroups of patients.

Dr. Laura van ‘t Veer, Chief Research Officer and Co-founder at Agendia said:

"The results presented at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium demonstrate that MammaPrint is not just a prognostic test, it is also a predictive test. When used in conjunction with BluePrint, it can stratify patients into different subgroups to help identify which are more likely to respond to new treatments or to neoadjuvant chemotherapy and which are not likely to respond and should be given an alternative treatment. We need to further investigate the clinical implications, but this is an important milestone with significant value for women with breast cancer."

Dr. William Audeh, Chief Medical Officer at Agendia said:

"The new studies stemming from the I-SPY 2 trial are very encouraging and highlight the continuing and constantly expanding utility of MammaPrint and BluePrint to identify which patients will respond to specific treatments based on the genomic signatures of their tumors. In discovering the MammaPrint signature with her colleague Dr. Rene Bernards, Dr. van ‘t Veer harnessed the power of genomics to provide a platform capable of yielding continuous new discoveries to further understand and personalize the treatment of breast cancer. As the landmark I-SPY 2 trial further evolves, we anticipate future findings that will continue to bolster the value of precision oncology."

MammaPrint High1/High2 risk class as a pre-specified biomarker of response to nine different targeted agents plus standard neoadjuvant therapy for ~ 1000 breast cancer patients in the I-SPY 2 TRIAL. Poster presented at EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper). November 2018; Dublin, Ireland.
BluePrint basal subtype predicts neoadjuvant therapy response in ~400 HR+HER2- patients across 8 arms in the I-SPY 2 TRIAL. Poster presented at EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper). November 2018; Dublin, Ireland.
About MammaPrint

MammaPrint is an in vitro diagnostic medical device, performed as a testing service in a central laboratory, using the 70-gene expression profile of breast cancer tissue samples to assess a patient’s risk for distant metastasis. The device is FDA-cleared and CE-marked, enabling use in the European Union. MammaPrint is indicated for use by physicians as a prognostic marker only, along with other clinical-pathological factors. It is not intended to determine the outcome of disease, nor to suggest or infer an individual patient’s response to therapy. MammaPrint is the only test of its kind recommended for lymph node-negative and lymph node-positive patients by both the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and National Comprehensive Cancer Network (NCCN). The test is also recommended by many other national and international clinical practice guidelines.

About BluePrint

BluePrint is an 80-gene complementary test provided with MammaPrint which allows functional molecular subtyping of a breast cancer sample into three distinct subtypes: Luminal-type, HER2-type and Basal-type, each with marked differences in long-term outcome and response to neoadjuvant chemotherapy.

About I-SPY 2

I-SPY 2 is an interventional, randomized neoadjuvant Phase II clinical trial that is evaluating the efficacy of new targeted drug agents in combination with standard chemotherapy compared to standard therapy alone. The goal of the trial is to identify more treatment regimens for different subsets of breast cancer patients based on the molecular characteristics of their tumors and by learning about which early indicators of response are predictors of treatment success. A MammaPrint High Risk result is a prerequisite for patients included in the trial.

On November 14, 2018 Cytori Therapeutics (NASDAQ: CYTX) ("Cytori" or the "Company") reported Q3 2018 financial results and provided updates on corporate activities (Press release, Cytori Therapeutics, NOV 14, 2018, View Source [SID1234531481]).

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Q3 2018 net loss was $2.3 million, or $0.27 per share. Operating cash burn for Q3 was approximately $2.6 million. Cytori ended Q3 with approximately $6.8 million of cash and cash equivalents.

Cytori is developing its lead chemotherapy drug, ATI-0918, a generic version of pegylated liposomal doxorubicin hydrochloride, with the goal of submitting a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) next year. We previously completed a bioequivalence study against the European reference drug and are in the process of completing manufacturing-related activities to support the MAA. The Company also continues to evaluate potential commercial partnering opportunities for ATI-0918 with a focus on Europe, which has a current estimated market size of over $120 million.

Cytori is also developing another chemotherapy drug, ATI-1123, a patented, albumin-stabilized pegylated liposomal docetaxel. The Company recently received an orphan drug designation from the U.S. FDA for small cell lung cancer and intends to pursue FDA’s 505(b)(2) new drug application (NDA) pathway in the U.S. which may offer accelerated and lower cost development.

In the first half of 2019, Cytori expects a 1-year data readout from the 45 patient, multi-center, potential pivotal clinical trial in stress urinary incontinence conducted in Japan called ADRESU.

Later in 2018, Cytori expects a 6-month data readout from the 40 patient, French SCLERADEC II clinical trial in scleroderma patients.

Cytori is actively conducting the U.S. Phase I RELIEF trial in thermal burn injury trial sponsored by BARDA. Cytori completed a successful In-Process Review meeting with BARDA this past June.

Commercially, Cytori is focusing its efforts in Japan and continues to see favorable growth trends in the use of its cell therapy products approved under the Regenerative Medicine Law in the aesthetic and orthopedic markets. The Company remains on track to see continued double digit year-over-year growth in Celution System consumable utilization.

Finally, Cytori recently received the first $1.0 million royalty milestone from Bimini Technologies, LLC (Bimini). In 2013, Cytori divested the Puregraft product line that includes periodic royalty payments of up to $10.0 million and certain other economic benefits based on Bimini achieving gross profits milestones.

"A key corporate objective is to complete manufacturing support activities and seek European marketing authorization for ATI-0918, our lead oncology drug product. Furthermore, we have recently expanded development activities for the ATI-1123 phase II oncology program and its potential 505(b)(2) acceptability," said Dr. Marc Hedrick, President and Chief Executive Officer of Cytori. "In cell therapy, we are focused on continued revenue growth based on positive quarter-over-quarter and year-over-year consumable utilization trends. In the meantime, we are awaiting pivotal clinical data from our Japanese stress urinary incontinence trial."

Q3 2018 and year-to-date Financial Performance

Q3 2018 and year-to-date operating cash burn was $2.6 million and $9.5 million, compared to $4.0 million and $13.9 million for the same periods in 2017, respectively.
Q3 2018 and year-to-date product revenues were $0.9 million and $2.2 million, compared to $0.5 million and $2.0 million for the same periods in 2017, respectively.
Q3 2018 and year-to-date contract revenues were $0.5 million and $2.3 million, compared to $1.3 million and $2.9 million for the same periods in 2017, respectively.
Q3 2018 and year-to-date consumable utilization in Japan grew by approximate 90% and 70%, when comparing to the same periods in 2017, respectively.
Cash and debt principal balances at September 30, 2018 were approximately $6.8 million and $13.0 million, respectively.
Q3 2018 adjusted net loss was $4.0 million or $0.45 per share, compared to a net loss of $4.8 million or $1.39 per share for the same period in 2017. The adjusted net loss excludes a non-cash beneficial conversion feature (a non gaap measure) related to the issuance of our Series C convertible preferred shares in the third quarter of 2018 of $2.5 million, as well as a credit of $1.7 million related to a change in fair value of warrant liability (a non gaap measure). Q3 2018 net loss allocable to common stockholders was $4.8 million, or $0.55 per share.
Year-to-date 2018 adjusted net loss was $12.1 million or $1.73 per share, compared to $18.4 million or $6.22 per share for the same period in 2017. The adjusted net loss excludes a non-cash beneficial conversion feature (a non gaap measure) related to the issuance of our Series C convertible preferred shares in the third quarter of 2018 of $2.5 million, as well as a credit of $1.7 million related to a change in fair value of warrant liability (a non gaap measure). Year-to-date 2018 net loss allocable to common stockholders was $12.9 million, or $1.85 per share.
Selected Key Anticipated Milestones:

Complete ATI-0918 development and manufacturing required to prepare and file a MAA with the EMA.
Seek FDA 505(b)(2) pathway applicability for ATI-1123 product.
Obtain Japan MHLW Class III approval for Celution System consumables.
Report 1-year Japanese ADRESU pivotal clinical trial data for post-surgical male stress urinary incontinence.
Enrollment update in the BARDA-funded U.S. RELIEF clinical trial.
Report French investigator initiated SCLERADEC II clinical trial data in scleroderma hand dysfunction.
Management Conference Call Webcast

Cytori will host a management conference call at 5:30 p.m. Eastern Time today to further discuss its progress. The webcast will be available live and by replay two hours after the call and may be accessed under "Webcasts" in the Investor Relations section of Cytori’s website. If you are unable to access the webcast, you may dial in to the call at +1.877.402.3914, Conference ID: 9699923.

On November 14, 2018 ADC Therapeutics, an oncology drug discovery and development company that specializes in the development of proprietary antibody drug conjugates (ADCs), reported that data from Phase I clinical trials of ADCT-402 (loncastuximab tesirine) and ADCT-301 (camidanlumab tesirine) have been selected for oral and poster presentations at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, which is being held December 1-4 in San Diego (Press release, ADC Therapeutics, NOV 14, 2018, View Source [SID1234596073]).

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Jay Feingold, MD, PhD, Chief Medical Officer and Senior Vice President of Clinical Development at ADC Therapeutics, said, "We look forward to sharing updated data from our first-in-human clinical trials of ADCT-402 and ADCT-301 in multiple subtypes of lymphoma at the 2018 ASH (Free ASH Whitepaper) Annual Meeting. Interim data show that ADCT-402, which targets CD19, has demonstrated durable single-agent anti-tumor activity in patients with diffuse large B-cell lymphoma, follicular lymphoma and mantle cell lymphoma who have failed other therapies or have no available treatment options. In addition, new data on ADCT-301 highlight the CD25-targeting ADC’s impressive overall and complete response rates in heavily pretreated patients with classical Hodgkin lymphoma, as well as its encouraging clinical activity in T-cell lymphoma."

Oral Presentations

Title: Interim Results from the First-in-Human Clinical Trial of Adct-402 (Loncastuximab Tesirine), a Novel Pyrrolobenzodiazepine-Based Antibody Drug Conjugate, in Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Abstract Number: 398
Session: 626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas)—Results from Prospective Clinical Trials: New Agents
Date and Time: Sunday, December 2, 2018; 12:15 p.m. PT
Location: Marriott Marquis San Diego Marina, Pacific Ballroom 20
Presenter: John Radford, MD, FRCP, Manchester Academic Health Centre, The University of Manchester and The Christie NHS Foundation Trust, Manchester, UK

Title: Phase 1 Study of Adct-301 (Camidanlumab Tesirine), a Novel Pyrrolobenzodiazepine-Based Antibody Drug Conjugate, in Relapsed/Refractory Classical Hodgkin Lymphoma
Abstract Number: 928
Session: 624. Hodgkin Lymphoma and T/NK Cell Lymphoma—Clinical Studies: Hodgkin Lymphoma: Chemotherapy and Response Adapted Approaches
Date and Time: Monday, December 3, 2018; 5:15 p.m. PT
Location: San Diego Convention Center, Room 6F
Presenter: Mehdi Hamadani, MD, Division of Hematology and Oncology, Medical College of Wisconsin, Milwaukee, WI

Poster Presentations

Title: Safety and Efficacy of Adct-402 (Loncastuximab Tesirine), a Novel Antibody Drug Conjugate, in Relapsed/Refractory Follicular Lymphoma and Mantle Cell Lymphoma: Interim Results from the Phase 1 First-in-Human Study
Abstract Number: 2874
Session: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster II
Date and Time: Sunday, December 2, 2018; 6-8 p.m. PT
Location: San Diego Convention Center, Hall GH
Presenter: Paolo Caimi, MD, Case Western Reserve University, University Hospitals Cleveland Medical Center, Cleveland, OH

Title: Adct-301 (Camidanlumab Tesirine), a Novel Pyrrolobenzodiazepine-Based CD25-Targeting Antibody Drug Conjugate, in a Phase 1 Study of Relapsed/Refractory Non-Hodgkin Lymphoma Shows Activity in T-Cell Lymphoma
Abstract Number: 1658
Session: 624. Hodgkin Lymphoma and T/NK Cell Lymphoma—Clinical Studies: Poster I
Date and Time: Saturday, December 1, 2018; 6:15-8:15 p.m. PT
Location: San Diego Convention Center, Hall GH
Presenter: Graham P. Collins, MB, BS, DPhil, Oxford University Hospitals, NHS Trust, Oxford, UK

ADCT-402 is currently being evaluated in three clinical trials, including a pivotal trial in patients with relapsed or refractory diffuse large B-cell lymphoma. ADCT-301 is being evaluated in three clinical trials. To learn more about the company’s ADC programs, visit ADC Therapeutics’ Booth #117 located in the Exhibit Hall of the San Diego Convention Center.

For more information about the ASH (Free ASH Whitepaper) Annual Meeting, please visit View Source

About ADCT-402

ADCT-402 (loncastuximab tesirine) is an antibody drug conjugate (ADC) composed of a humanized monoclonal antibody that binds to human CD19, conjugated through a linker to a pyrrolobenzodiazepine (PBD) dimer toxin. Once bound to a CD19-expressing cell, ADCT-402 is internalized into the cell where enzymes release the PBD-based warhead. CD19 is a clinically validated target for the treatment of B-cell malignancies. The PBD-based warhead has the ability to form highly cytotoxic DNA interstrand cross-links, blocking cell division and resulting in cell death. ADCT-402 is being evaluated in a pivotal Phase II clinical trial in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) (NCT03589469). The U.S. Food and Drug Administration granted orphan drug designation to ADCT-402 for the treatment of DLBCL and mantle cell lymphoma.

About ADCT-301

ADCT-301 (camidanlumab tesirine) is an antibody drug conjugate (ADC) composed of a monoclonal antibody that binds to CD25 (HuMax-TAC, licensed from Genmab A/S), conjugated to the pyrrolobenzodiazepine (PBD) dimer payload tesirine. Once bound to a CD25-expressing cell, ADCT-301 is internalized into the cell where enzymes release the PBD-based warhead. The intra-tumor release of its PBD warhead may cause bystander killing of neighboring tumor cells. In addition, the PBD warhead will

trigger immunogenic cell death, which in turn will strengthen the immune response against tumor cells. ADCT-301 is being evaluated in ongoing Phase Ia/Ib clinical trials in patients with relapsed or refractory Hodgkin lymphoma and non-Hodgkin lymphoma (NCT02432235), as well as a Phase Ib clinical trial in solid tumors (NCT03621982).

On November 14, 2018 Sutro Biopharma, Inc. (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation oncology therapeutics, reported its financial results for the third quarter ended September 30, 2018 (Press release, Sutro Biopharma, NOV 14, 2018, View Source [SID1234531319]).

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"This has been an outstanding third quarter for Sutro. We have completed our initial public offering and achieved multiple milestones in the development of our own clinical programs for treatment of multiple myeloma and ovarian cancer," said Bill Newell, Sutro’s Chief Executive Officer. "We look forward to working with our newest partners and collaborators as the Sutro team continues to execute at a high level to advance our vision of transforming the lives of patients."

Business Highlights and Recent Developments

STRO-001 Clinical Program

STRO-001 granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of multiple myeloma.
The Leukemia & Lymphoma Society (LLS) agreed to contribute clinical development funding for STRO-001 through its Therapy Acceleration Program, which forges collaborations with biotechnology companies to help bring innovative therapies to patients faster.
Potential first-in-class antibody-drug conjugate (ADC) directed against CD74 is currently being studied in a Phase 1 clinical trial enrolling separate dose escalation cohorts for myeloma and B-cell lymphoma.
STRO-002 Clinical Program

The FDA has concluded their 30-day review of Sutro’s Investigational New Drug (IND) application for STRO-002, a targeted antibody-drug conjugate directed against folate receptor-alpha. Sutro expects to commence a Phase 1 clinical trial focused on ovarian and endometrial cancers in early 2019.
Corporate Highlights

Collaboration and licensing agreement signed with Merck to discover and develop novel immune-modulating therapies for cancer and autoimmune disorders.
Sutro is primarily responsible for preclinical research and Merck will obtain exclusive worldwide rights to therapeutic candidates derived from the collaboration.
Sutro received from Merck an upfront payment of $60 million, a $20 million investment in its Series E preferred stock, and $10 million investment in a private placement of common stock concurrent with the IPO.
Sutro is eligible for milestone payments totaling up to $1.6 billion, assuming the development and sale of all therapeutic candidates and all possible indications identified under the collaboration, as well as tiered royalties ranging from mid-single digit to low teen percentages on worldwide sales of commercial products that may result from the collaboration.
The initial public offering (IPO) that closed on October 1, 2018, provided Sutro with gross proceeds of $85.0 million, before deducting underwriting discounts and commissions and offering expenses. Additionally, Sutro received proceeds of $10.0 million from Merck in a private placement of common stock concurrent with the IPO.
Appointment of Stephen Worsley as Chief Business Officer and Linda Fitzpatrick as Chief People and Communications Officer.
Third Quarter 2018 Financial Highlights

Cash, Cash Equivalents and Marketable Securities

As of September 30, 2018, Sutro had cash, cash equivalents and marketable securities of $123.0 million.

In October 2018, Sutro announced the closing of its IPO of 5,667,000 shares of its common stock at a price of $15.00 per share. The gross proceeds to Sutro from the IPO, before deducting underwriting discounts and commissions and offering expenses, were $85.0 million. In addition to the IPO, Sutro concurrently sold in a private placement to Merck Sharp & Dohme Corp. (Merck) additional shares of common stock at the IPO offering price for gross proceeds of $10.0 million. Proceeds from the IPO and the concurrent private placement are not reflected in Sutro’s September 30, 2018 balance sheet.

Revenue

Revenue was $7.8 million for the third quarter of 2018, which included collaboration revenue of $6.9 million recognized primarily from Merck, Celgene and EMD Serono, in addition to other revenue of $0.9 million. During the third quarter of 2018, Sutro began recording revenue from Merck primarily from the $60.0 million upfront payment received by Sutro under the July 2018 collaboration and licensing agreement, for which revenue is being recognized ratably over an approximate four-year period. Future collaboration revenue from Merck, Celgene and EMD Serono, and from any future collaboration partners, will fluctuate as a result of the timing and amount of upfront, milestones and other collaboration agreement payments.

Operating Expenses

Total operating expenses for the third quarter of 2018 were $18.0 million, comprised of research and development expenses of $12.6 million and general and administrative expenses of $5.4 million. Total operating expenses for the quarter included non-cash stock-based compensation expense of $0.3 million and depreciation and amortization expense of $1.1 million. In future quarters, Sutro expects to incur additional general and administrative expenses as it operates as a public company following its IPO that closed on October 1, 2018.

Net Loss Per Share Calculation

The financial statements as of September 30, 2018, including share and per share amounts, do not give effect to the IPO, or the conversion of the redeemable convertible preferred stock, as the IPO and such conversions were completed on October 1, 2018. Relatedly, the weighted-average shares used in calculating net loss per share for the third quarter of 2018 include only common stock outstanding prior to the IPO.

On November 14, 2018 GamaMabs Pharma, a biotechnology company developing optimized therapeutic antibodies targeting the Anti-Müllerian Hormone Receptor II (AMHRII) for the treatment of cancer, reported its presentation of new data regarding its First-In-Class GM102 antibody at two upcoming conferences (Press release, GamaMabs Pharma, NOV 14, 2018, View Source [SID1234531457]).

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Clinical data for 20 Granulosa Cell Tumor patients treated with GM102 in the C101 clinical study, will be presented at the EORTC–NCI–AACR 2018 Symposium, Dublin (Ireland), on November 13-16, 2018. The poster describes safety and hints of activity of GM102 in this orphan disease with high unmet need and no approved therapy.

"Following the first results of the C101 study in gynecological cancers published at ASCO (Free ASCO Whitepaper) this year, we will present additional clinical data for the subset of granulosa ovarian cancer patients who do not have therapeutic alternatives at this stage in their disease," said Dr. Isabelle Tabah-Fisch, Chief Medical Officer at GamaMabs Pharma

Unveiled activation of T-cells by GM102 following macrophage activation and synergy with immune-checkpoint inhibitors targeting T-cells, will be presented at the AACR (Free AACR Whitepaper) 2018 Conference on Tumor Immunology and Immunotherapy, Miami (Florida) on November 27-30.

"We are looking forward to presenting new data on T-cell activation induced by GM102, confirming the potential of our mAb as a single agent and in combination with immune-checkpoint inhibitors," said Jean-François Prost, Chief R&D Officer at GamaMabs.

The presentation details are:

EORTC–NCI–AACR Symposium 2018
Title: ‘GM102, a first-in-class monoclonal glyco-engineered antibody (Ab) targeting Anti-Mullerian-Hormone-Receptor II (AMHRII): safety and hints of activity in Granulosa Cell Tumors (GCT)’, Leary A.
Session: Late Breaking Poster Presentation
Abstract number: 15LBA
Date and time: November 16, 2018, 10am ­– 2pm
Location: Exhibition Hall, The Convention Centre, Dublin (CCD)
AACR Conference on Tumor Immunology and Immunotherapy
Title: ‘GM102, a low fucosylated anti-Müllerian Hormone type II Receptor (AMHRII) antibody, promotes in vitro antitumoral activities of innate (macrophages) and adaptative (CD4+ and CD8+ T cells) immune cells’
Poster number: B77
Date and time: Thursday, November 29, 5pm – 7pm (EST)
Session category/title: Poster Session B
Location: Loews, Miami Beach, rooms Americana 3 and 4
GM102 is a first-in-class glyco-engineered (low-fucose) monoclonal antibody selectively targeting AMHRII-expressing tumors. AMHRII, an embryonic receptor involved in the regression of the Müllerian ducts in the male embryo, is constitutively expressed in ovarian granulosa tumors (GCT) and is re-expressed in a majority of tumor samples in a wide range of gynecological and non-gynecological tumors such as colorectal and lung cancers, hepatocarcinoma or renal cell carcinoma. GM102 is currently being studied in two clinical trials, a phase 1b in recurrent gynecological cancers and a phase 2 in advanced or metastatic colorectal cancers.

GM102 exerts its anti-tumor activity through NK cell and macrophage engagement in the tumor microenvironment, resulting in enhanced tumor phagocytosis and subsequent T cell activation.

Following presentation, the two posters will be available on the publication page of GamaMabs’ website