On November 15, 2017 Arvinas LLC, a private biotechnology company creating a new class of drugs based on protein degradation, reported it has expanded its ongoing license agreement with Genentech, a member of the Roche Group, for the development of new therapeutics using Arvinas’ novel PROTAC technology (Press release, Arvinas, NOV 15, 2017, View Source [SID1234558785]). The multi-year strategic license agreement, initiated in October 2015, will encompass additional disease targets and expand the collaboration.

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Under the revised terms of the agreement, Arvinas is eligible to receive development and commercialization milestone payments in excess of $650 million based on achievement of certain predetermined milestones. In addition, Arvinas is eligible to receive tiered-royalties on sales of products resulting from the license agreement. Full financial terms have not been disclosed.

"Genentech’s decision to expand our original agreement to include additional disease targets shows the promise seen in our first two years together and further supports our targeted protein degradation platform as a novel drug modality to treat a broad array of diseases," said John Houston, Ph.D., President and Chief Executive Officer of Arvinas. "This expansion also supports our initial decision to work with Genentech in 2015 and we look forward to this growing collaboration."

The PROTAC Platform offers potential improvements over traditional small molecule inhibitors using the ubiquitin and proteasome system within a cell to degrade disease causing proteins. By removing target proteins directly rather than inhibiting them, PROTACs can provide multiple advantages over small molecule inhibitors, which can require high systemic exposure to achieve sufficient inhibition, often resulting in toxic side effects and eventual drug resistance.

On November 15, 2017 Prima BioMed Ltd (ASX: PRR; NASDAQ: PBMD) ("Prima") reported that it held a Pre-Investigational New Drug Application (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) in November to discuss the regulatory pathway for the development of Eftilagimod Alpha (LAG-3Ig or IMP 321) in the United States (Press release, Prima Biomed, NOV 15, 2017, View Source [SID1234522106]).

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The FDA addressed Prima’s questions related to preclinical, nonclinical, and clinical data and design of clinical trials of Eftilagimod Alpha in a chemo-immunotherapy setting and in an immuno-oncology combination trial. Prima intends to file an investigational new drug application (IND) in the first half of calendar year 2018. After having successfully started clinical development of Eftilagimod Alpha in Australia and Europe, an IND would provide Prima with the opportunity to commence clinical studies and regulatory interactions in the United States.
"The U.S. is the largest pharmaceutical market in the world, so the pre-IND meeting regarding Eftilagimod Alpha was an important milestone. Our meeting with the FDA was very productive and their guidance will be most valuable in assessing the appropriate U.S. clinical and regulatory strategies for Eftilagimod Alpha," said Marc Voigt, Prima’s Chief Executive Officer.

On November 15, 2017 LabCorp (NYSE: LH) a leading global life sciences company, reported the U.S. availability of the PD-L1 IHC 28-8 pharmDx assay as a complementary diagnostic for two newly approved indications in connection with the use of Bristol-Myers Squibb’s OPDIVO (nivolumab) to treat patients with metastatic urothelial carcinoma, also referred to as bladder cancer, and squamous cell carcinoma of the head and neck (Press release, LabCorp, NOV 15, 2017, View Source;p=RssLanding&cat=news&id=2317135 [SID1234522109]). The PD-L1 IHC 28-8 pharmDx assay was developed by Agilent’s Dako pathology division. While OPDIVO is approved for these indications without use of the test, the test provides physicians with important information about those patients who are most likely to respond positively to OPDIVO. LabCorp’s Center for Molecular Biology and Pathology laboratory performed testing for the clinical studies that supported approval of the new indications for the assay.

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The PD-L1 IHC 28-8 pharmDx assay was previously approved for use as a complementary diagnostic with OPDIVO to treat certain patients with non-squamous non-small cell lung cancer (NSCLC) and melanoma. LabCorp’s central clinical trials laboratory was the sole provider of testing to support the clinical trial for the 2015 approval of the non-squamous NSCLC treatment indication, reflecting how the combined capabilities of LabCorp’s clinical laboratory infrastructure and Covance’s central clinical trials laboratory provide integrated support for clinical trials.

"The expanded use of this PD-L1 test as a complementary diagnostic for two new cancer indications, as well as our collaboration in the studies that supported regulatory approval, demonstrate the unique solutions that only LabCorp can provide for the development and commercialization of new tests and therapies, particularly complementary and companion diagnostics," said David P. King, chairman and chief executive officer of LabCorp. "The combined expertise of LabCorp Diagnostics and Covance Drug Development makes us the industry leader in precision medicine, including the exciting area of immuno-oncology. With our extensive experience performing this test, physicians can have high confidence that the results we deliver will help them identify the most appropriate treatment for their patients and will improve the delivery of care."

The PD-L1 IHC 28-8 pharmDx assay is approved for use with patients diagnosed with advanced or metastatic bladder cancer, or recurrent or metastatic squamous cell carcinoma of the head and neck, whose cancers have returned or progressed after prior treatment with platinum-based chemotherapy. OPDIVO is an immunotherapy that helps the immune systems of certain individuals detect and kill cancer cells. The PD-L1 IHC 28-8 pharmDx assay identifies a tumor’s expression of the PD-L1 protein, which may be associated with an increased likelihood of positive immune system response to treatment with OPDIVO; however, OPDIVO is approved for use regardless of PD-L1 status.

Squamous cell carcinoma of the head and neck is the most common form of head and neck cancer, and urothelial carcinoma is the most common type of bladder cancer, accounting for approximately 90 percent of diagnoses. These cancers are often difficult to treat using traditional therapies, and immunotherapies like OPDIVO offer the hope of enhanced survival for appropriate patients.

The PD-L1 IHC 28-8 pharmDx assay is available from LabCorp and its Integrated Oncology specialty laboratory.

OPDIVO is a registered trademark of Bristol-Myers Squibb Company.

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)

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.