Halozyme Therapeutics To Participate In Upcoming Healthcare Conferences

On November 15, 2017 Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies reported that it will participate in two upcoming investor conferences (Press release, Halozyme, NOV 15, 2017, View Source [SID1234522087]).

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Dr. Helen Torley, president and chief executive officer will represent Halozyme in a question and answer session at the 29th Annual Piper Jaffray Healthcare Conference in New York on Wednesday, November 29 at 8:00 a.m. ET / 5:00 a.m. PT.

On Thursday, December 14, Jim Mazzola, vice president corporate communication and investor relations will present a company overview at the BMO Capital Markets 2017 Prescriptions for Success Healthcare Conference in New York at 3:30 p.m. ET / 12:30 p.m. PT.

Webcasts of both sessions can be accessed through the "Investors" section of www.halozyme.com, and a recording will be made available for 90 days following each event. To access a live webcast, please visit Halozyme’s website approximately 15 minutes prior to the presentation to register and download any necessary audio software.

Abeona Reports Third Quarter 2017 Financial Results and Recent Business Highlights

On November 15, 2017 Abeona Therapeutics Inc. (NASDAQ:ABEO), a leading clinical-stage biopharmaceutical company focused on developing novel gene therapies for life-threatening rare diseases, reported financial results for the third quarter and recent business highlights (Press release, Abeona Therapeutics, NOV 15, 2017, View Source;p=RssLanding&cat=news&id=2317120 [SID1234522085]). The Company will provide investors an update on recent and ongoing business activities and an overview of its 3Q17 financials on Monday, November 20th, at 10:00 am (Eastern). Interested parties are invited to participate in the call by dialing 877-269-7756 (toll free domestic) or 201-689-7817 (international).

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"The third quarter was marked with achievements across multiple clinical programs, including initiating enrollments at our global clinical sites for ABO-102 for MPS IIIA and reporting additional data that underscored the durability and clinical benefit of the gene therapy. Our Epidermolysis Bullosa program achieved FDA Breakthrough Therapy designation, completed its Phase 1/2 clinical trial and continues to advance as we finalize the clinical protocol before initiating the pivotal Phase 3 trial next year. We were pleased to have recently initiated screening in our MPS IIIB program and look forward to commencing enrollments shortly," stated Timothy J. Miller, Ph.D., President and CEO. "In addition, work in optimizing our AIM vector platform demonstrated exciting progress, including enhanced tissue tropisms compared to naturally occurring AAV capsids."

3rd Quarter Summary Financial Results:

Cash position: Cash and cash equivalents as of September 30, 2017 were $56.5 million, compared to $58.3 million as of June 30, 2017. Net cash used in operating activities in the nine months ended September 30, 2017 was $17.6 million as compared to $9.6 million in the same period in 2016. Cash and cash equivalents includes approximately $5 million from exercised warrants in the third quarter. Subsequent to the end of the third quarter, the Company closed a public offering of common stock with gross proceeds of $92 million. Total cash as of October 31, 2017 was $142.6 million.
Revenues: Revenues were $219 thousand for the third quarter of 2017, compared to $184 thousand in the third quarter of 2016. Revenues consisted of a combination of royalties from marketed products, primarily MuGard, and recognition of deferred revenues related to upfront payments from early license agreements.
Loss per share: Loss per share was $0.13 for the third quarter of 2017, compared to a loss per share of $0.08 in the comparable period in 2016.
Abeona Recent Highlights:

November 9, 2017: Enrolled First Subject at Spain Clinical Site in Ongoing Phase 1/2 Clinical Trial in MPS IIIA
October 19, 2017: Announced Closing of $92 Million Underwritten Public Offering and Full Exercise of Underwriters’ Option to Purchase Additional Shares
October 16, 2017: Announced a Grant of up to $13.85 Million from Leading Sanfilippo Syndrome Foundations for Clinical Development of MPS III Gene Therapies
October 11, 2017: Hosted inaugural R&D day and announced enrollment of First Two Patients in Global Expansion of Phase 1/2 Clinical Trial in MPS IIIA
October 6, 2017: Announced Top-Line One Year Data from ABO-102 MPS IIIA Trial at ARM’s Cell & Gene Meeting on the Mesa
Gene therapy demonstrated durable and significant reduction of underlying disease pathology across multiple clinical measures in Cohort 1 (n=3) compared to a natural history control group (n=8-12)
Systemic biopotency demonstrated time- and dose-dependent reductions of disease causing Heparan Sulfate in the Cerebrospinal fluid (CSF) and liver volumes
Preservation of deep brain architecture observed after intravenous administration
Stabilization of neurocognitive assessment scores at one year post-injection
October 4, 2017: Announced Dedication of Commercial Gene Therapy Manufacturing Facility in Cleveland, Ohio
September 28, 2017: Announced Collaboration with Brammer Bio for Commercial Translation of ABO-102
August 29, 2017: Received FDA Breakthrough Therapy Designation for EB-101 Autologous Cell Therapy in Epidermolysis Bullosa
July 25, 2017: Announced Appointment of Juan Ruiz, M.D., Ph.D. as Chief Medical Officer
July 18, 2017: Received Guidance from FDA to Commence Pivotal Phase 3 for EB-101 Gene Therapy for Patients with Epidermolysis Bullosa

"We have made great progress in the quarter towards becoming a key player in the development of novel breakthrough gene and cell therapies for rare genetic diseases," stated Steven H. Rouhandeh, Executive Chairman. "The recent investment from high-quality investors and leading foundations is another achievement that demonstrates our internal capabilities and commitment to the advancement of our robust pipeline and next generation vector platform, including MPS III gene therapy products. We look forward to further strengthening our efforts with key hires, advancing clinical capabilities, and commercial expansion in the coming quarters."

West Announces Upcoming Investor Conference

On November 15, 2017 West Pharmaceutical Services, Inc. (NYSE: WST), a global leader in innovative solutions for injectable drug administration, reported that management will be presenting a West business overview at the upcoming Jefferies 2017 London Healthcare Conference, at the Waldorf Hilton Hotel in London, UK, at 8:40 a.m. GMT on Thursday, November 16, 2017 (Press release, West Pharmaceutical Services, NOV 15, 2017, View Source;p=RssLanding&cat=news&id=2317078 [SID1234522080]).

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A live audio webcast of the presentation and a copy of the presentation will be accessible from the Company’s website at www.westpharma.com/en/investors.

Third quarter 2017 report

On November 15, 2017 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH) reported its revenues and cash position for the first nine months of 2017 (Press release, Innate Pharma, NOV 15, 2017, View Source [SID1234522077]).

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Mondher Mahjoubi, Chief Executive Officer of Innate Pharma, commented: "Our robust cash position as of September 30 2017, provides us with the ability to further invest in our proprietary discovery and development portfolio of first-in-class immuno-oncology programs, including our lead product candidates IPH4102 and IPH5401. Clinical development plans for both candidates are in the process of being shaped and we expect to provide an update early in 2018. Following the promising results for IPH4102 presented at the 2017 EORTC meeting, Innate Pharma remains committed to bringing IPH4102 to patients on our own as quickly as possible, in line with our strategy of becoming an independent, fully integrated biopharmaceutical company."

Cash, cash equivalents and financial assets of the Company amounted to €195.7 million at September 30, 2017, including current and non-current financial assets (€239.6 million at September 30, 2016). At the same date, its financial liabilities amounted to €4.9 million (€5.6 million at September 30, 2016).

The net consumption of cash, cash equivalents and financial assets* amounted to €8.4 million for the third quarter of 2017. This includes the collection during the period of the research tax credit relating to the year 2016 (€8.8 million).

For the nine-month period ended September 30, 2017, revenue results from the co-development and commercialization agreement with AstraZeneca, corresponding to the recognition over the period of the initial payment received in April 2015 (€27.2 million for the same period in 2016).

The nine-month period ended September 30, 2016 included a €0.7 million amount resulting from the collaboration and licensing agreement with Bristol-Myers Squibb corresponding to the recognition of the upfront payment received in July 2011.

Regarding the co-development and commercialization agreement with AstraZeneca, the Company recognizes the initial payment of $250 million over the period during which the Company is committed to complete the studies and based on actual expenses incurred. The measurement of progress has been based on actual expenses incurred compared to the total estimated amount of expenses to be incurred for these studies.

ADC Therapeutics to Present New Clinical Data for ADCT-402 and ADCT-301 at the American Society of Hematology 2017 Annual Meeting

On November 15, 2017 ADC Therapeutics (ADCT), an oncology drug discovery and development company that specializes in the development of proprietary Antibody Drug Conjugates (ADCs) targeting major cancers, reported that five abstracts, including one oral presentation, have been accepted for presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting taking place December 9-12, 2017 in Atlanta, USA (Press release, ADC Therapeutics, NOV 15, 2017, View Source [SID1234522071]). The presentations will highlight the clinical data from ADCT-402 and ADCT-301, the two most advanced programs in its portfolio of ADCs targeting haematological and solid tumours.

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"Interim data from a phase 1 study evaluating pyrrolobenzodiazepine-based antibody drug conjugate ADCT-402 (Loncastuximab tesirine) targeting CD19 for relapsed or refractory B-Cell acute lymphoblastic leukemia."
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ADCT-402 and ADCT-301 are currently in four Phase Ia/Ib clinical studies, and incorporate a novel class of highly potent pyrrolobenzodiazepine (PBD)-based warheads with a unique mode of action. ADCT-402 is an ADC targeting CD19 for the treatment of non-Hodgkin lymphoma (NHL) and acute lymphoblastic leukemia (ALL). ADCT-301 is an ADC targeting CD25 for the treatment of Hodgkin and non-Hodgkin lymphoma (HL/NHL), as well as acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL).

"We are excited by the clincal data we are presenting at ASH (Free ASH Whitepaper) this year. The presentation and posters cover two clinical stage programs where we have seen considerable single agent clinical activity, in relapsed and refractory disease settings, in patients who have undergone multiple prior therapies, and have very limited treatment options," said Dr. Chris Martin, CEO of ADC Therapeutics. "We look forward to further developing our ADC pipeline and are pleased that our ADCs continue to demonstrate encouraging clinical activity across multiple tumor types."

The titles for the oral presentation and poster presentations are as follows, including date and time:

Oral presentation:

ADCT-402 (Abstract #187):

– "Encouraging early results from the first-In-human clinical trial of ADCT-402 (Loncastuximab tesirine), a novel pyrrolobenzodiazepine-based antibody drug conjugate, in relapsed/refractory B-cell lineage non-Hodgkin lymphoma." Session 626 Saturday, December 9, 2017 at 2:00pm to 3:30 pm, Bldg A, Lvl 4, A411-A412

Poster presentations:

ADCT-402 (Abstract #1321)

– "Interim data from a phase 1 study evaluating pyrrolobenzodiazepine-based antibody drug conjugate ADCT-402 (Loncastuximab tesirine) targeting CD19 for relapsed or refractory B-Cell acute lymphoblastic leukemia." Session 614 Saturday, December 9, 2017 from 5:30pm to 7:30pm, Bldg A, Lvl 1, Hall A2

ADCT- 402 (Abstract #2543):

– "Elucidating exposure-response (safety and efficacy) of ADCT-402 (Loncastuximab tesirine), a novel pyrrolobenzodiazepine-containing antibody drug conjugate, for recommended phase 2 dose determination in patients with relapsed or refractory non-Hodgkin lymphoma." Session 614 Sunday, December 10, 2017 from 6:00pm to 8:00pm, Bldg A, Lvl 1, Hall A2

ADCT-301 (Abstract #1510):

– "Interim results from a phase 1 study of ADCT-301 (Camidanlumab tesirine) show promising activity of a novel pyrrolobenzodiazepine-based antibody drug conjugate in relapsed/refractory Hodgkin/non-Hodgkin lymphoma." Session 624 Saturday, December 9, 2017 from 5:30pm to 7:30pm, Bldg A, Lvl 1, Hall A2

ADCT-301 (Abstract #2662):

– "Results from an ongoing phase 1 Study indicate ADCT-301 (Camidanlumab tesirine) is well tolerated in patients with relapsed or refractory CD25-positive acute leukemia." Session 616 Sunday, December 10, 2017 from 6:00pm to 8:00pm, Bldg A, Lvl 1, Hall A2

Learn more about the ADC programs at the ADC Therapeutics Booth #323 in the Exhibition Hall B2

About ADCT-402 ADCT-402 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-expresing 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 certain CD19-expressing 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 two ongoing Phase Ia/Ib clinical trials in patients with relapsed or refractory B-cell lineage non-Hodgkin lymphoma and relapsed or refractory B-cell lineage acute lymphoblastic leukemia. (www.adct-402.com)

About ADCT-301 ADCT-301 is an antibody-drug conjugate (ADC) composed of a monoclonal antibody that binds to CD25 (HuMax(R)-TAC, licensed from Genmab A/S), conjugated through a linker to a pyrrolobenzodiazepine (PBD) dimer toxin. Once bound to a CD25-expresing cell, ADCT-301 is internalized into the cell where enzymes release the PBD-based warhead. CD25 is an attractive target for an ADC approach as it is expressed in a wide range of hematological malignancies, including certain forms of lymphomas and leukemias, while its expression in healthy organs is restricted. ADCT-301 is being evaluated in two ongoing phase Ia/Ib clinical trials in patients with relapsed or refractory Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL), and in patients with relapsed or refractory CD25-positive acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). (www.adct-301.com)