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)

Seres Therapeutics, MD Anderson Cancer Center, and the Parker Institute for Cancer Immunotherapy Announce a Collaboration to Support the Investigation of Microbiome Therapeutics for Immuno-Oncology

On November 14, 2017 Seres Therapeutics, Inc. (NASDAQ:MCRB), The University of Texas MD Anderson Cancer Center (MD Anderson), and the Parker Institute for Cancer Immunotherapy (Parker Institute) reported a collaboration to evaluate the potential of Seres’ microbiome therapies to improve the outcomes of cancer patients treated with currently-available immunotherapy (Press release, Seres Therapeutics, NOV 14, 2017, View Source [SID1234530894]).

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The collaborators plan to initiate a randomized, placebo-controlled clinical study at MD Anderson, sponsored by the Parker Institute, in patients with advanced metastatic melanoma. The clinical trial will evaluate the impact of an anti-PD-1 checkpoint inhibitor with adjunctive microbiome therapy on patient outcomes. Seres is developing SER-401, a preclinical stage oral microbiome therapy comprising a rationally-designed consortium of live bacteria, to improve the efficacy and safety of immunotherapy.

Published studies provide preclinical and clinical evidence demonstrating that the composition of bacteria in the gastrointestinal microbiome may impact response to checkpoint inhibitor therapy.1 On Nov. 2, 2017, Science published research by Jennifer Wargo, M.D. and colleagues from MD Anderson indicating that the composition of the gut microbiome may influence checkpoint inhibitor response in melanoma patients.2 This research also demonstrated that the favorable microbiome properties found in checkpoint inhibitor responder patients are able to be transferred to mice. The results provide support for the clinical study of microbiome therapeutics to augment the clinical benefit of cancer immunotherapy.

Seres also received an exclusive option, with pre-defined financial terms, to license intellectual property rights from MD Anderson related to the use of bacteria in combination with checkpoint inhibitors.

"MD Anderson, and in particular Dr. Wargo’s laboratory, is leading the charge to better understand the microbiome and the response to immune checkpoint inhibitors," said Roger J. Pomerantz, M.D., President, CEO and Chairman of Seres. "We look forward to combining our insights and capabilities with both MD Anderson and the Parker Institute to advance microbiome therapies to augment Immunotherapy in cancer patients toward the clinic, with the ultimate goal of improving outcomes for patients facing life-threatening tumors with significant unmet medical need."

"Immunotherapy has represented an important advance for melanoma and other cancers. However, in the majority of patients, the response is not adequate to durably control disease," said Jennifer Wargo, M.D., Associate Professor of Genomic Medicine and Surgical Oncology at MD Anderson. "Modulation of the microbiome is a promising approach that may improve the therapeutic benefit of checkpoint therapy."

"This collaboration between the Parker Institute, Seres and MD Anderson exemplifies the mission of the Parker Institute for Cancer Immunotherapy to unlock the promise of immunotherapy by rapidly progressing next generation treatments into clinical trials," said Fred Ramsdell, Ph.D., Vice President of Research at the Parker Institute of Cancer Immunotherapy. "If this novel approach is successful at altering the microbiome and more importantly, also leads to better cancer patient responses to immunotherapy, this would mark an important milestone for the entire field."

References

1. Chen C. and Mellman I., Elements of cancer immunotherapy and the cancer-immune set point, Nature, 2017
2. Wargo J. et al., Gut Microbiome Impacts Response to Anti-PD-1 Immunotherapy in Melanoma Patients, Science, 2017

10-Q – Quarterly report [Sections 13 or 15(d)]

AmpliPhi Biosciences has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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10-Q – Quarterly report [Sections 13 or 15(d)]

AmpliPhi Biosciences has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, AmpliPhi Biosciences, 2017, NOV 14, 2017, View Source [SID1234522079]).

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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

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