On April 3, 2017 Ipsen reported that it has completed its acquisition of global oncology assets from Merrimack Pharmaceuticals, in Cambridge, MA., focusing on ONIVYDE (irinotecan liposome injection) for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy, in combination with fluorouracil and leucovorin (Press release, Ipsen, APR 3, 2017, View Source [SID1234518434]).1,[1] Ipsen has gained exclusive commercialization rights for the current and potential future indications for ONIVYDE in the U.S., as well as the current licensing agreements with Shire for commercialization rights ex-U.S. and PharmaEngine for Taiwan. The acquisition also includes the Merrimack commercial and manufacturing infrastructure for Onivyde, and generic doxorubicin HCl liposome injection.

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"The addition of ONIVYDE to Ipsen’s Oncology portfolio is very important, first and foremost for patients with pancreatic cancer across the U.S., as there are limited approved therapies," said Cynthia Schwalm, Executive Vice President and President, North American Commercial Operations, Ipsen. "Together with our experienced commercial and medical teams and the legacy we have gained through the acquisition of ONIVYDE, we are confident in our ability to meet the growing needs of these patients."

Along with this acquisition, Ipsen will continue to advance the clinical development program for ONIVYDE.

Financial terms of the acquisition include an upfront cash payment of $575 million to Merrimack Pharmaceuticals, and up to $450 million upon the approval of potential additional indications for ONIVYDE in the U.S.

About Pancreatic Cancer

Pancreatic cancer is a rare and deadly disease with approximately 338,000[2] new patients diagnosed globally each year, approximately 50,000 of which are in the United States[3]. More than half are diagnosed with metastatic disease, which has an overall 5-year survival rate of less than three percent4, and often rapidly progresses during or shortly after receiving chemotherapy[4]. Pancreatic cancer is the 3rd leading cause of cancer-related death in the United States, surpassing breast cancer.4 It is expected to become the 2nd leading cause of cancer-related death in the U.S. by the year 2030, surpassing colorectal cancer.4,[5]

About ONIVYDE

ONIVYDE is an encapsulated formulation of irinotecan. This long-circulating liposomal form is designed to increase length of tumor exposure to both irinotecan and its active metabolite, SN-38. ONIVYDE was approved by the U.S. FDA in combination with fluorouracil and leucovorin for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. For full prescribing information, including Boxed WARNING, please visit www.ONIVYDE.com.

On April 3, 2017 ONCODESIGN (FR0011766229 – ALONC), a biotechnology company serving the pharmaceutical industry in the discovery of new therapeutic molecules to fight cancer and other serious illnesses with no known effective treatment, reported that it will present its latest scientific developments at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2017 held on April 1-5, in Washington DC, USA (Press release, Oncodesign, APR 3, 2017, View Source [SID1234518433]).

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The AACR (Free AACR Whitepaper) is the largest global organisation that brings together public and private actors involved in cancer research. Its annual meetings attract every year over 18,000 researchers from the industry and academia.

On this occasion, Oncodesign will present several of its recent scientific developments:

As part of the IMODI project, Oncodesign will present a poster on one of the more important collections of extensively characterised predictive models for pancreatic cancer in the world. The collection of breast cancer models, particularly documented and representative of the human disease, caught the attention of the organisers of the AACR (Free AACR Whitepaper) meeting and will be presented during a dedicated conference on April 4, 2017. According to the INCA study, breast cancer is the cancer with highest incidence in women, with over 54,000 new cases each year in France.
As part of the IMAkinib project, Oncodesign will present the preclinical, cellular and in vivo imaging results obtained with its first PET-tracer generated by the Nanocyclix technology, currently in phase 1 of its development in patients with non-small cell lung cancer.
Oncodesign will also present the results of its Experimentation’s research activities on a new immunotherapy formulation conducted for the US company Checkmate Pharmaceuticals (Cambridge, MA). Remarkable efficacy results have been obtained, in combination with immune checkpoint modulators, in several cancer indications.
Finally, Oncodesign will describe in a fourth poster Experimentation’s internal research conducted on the resistance to PD-11 blockade. Antibodies targeting PD-1 have been recently approved as second line treatments for several types of cancer (urethra, kidney, head and neck, Hodgkin’s lymphoma), or as first line treatment for metastatic melanoma and metastatic non-small cell lung cancer. In spite of the positive response rates and increased survival in the majority of treated patients, a resistance phenomenon develops in certain patients. The Oncodesign research presented at the AACR (Free AACR Whitepaper) meeting aims to develop combination strategies to overcome such resistance and to identify biomarkers. This research showcases complex data analyses, such as cytokine profiles studied in syngeneic models.
Jan Hoflack, Ph.D., Chief Scientific Officer of Oncodesign, said: "Being represented in this way in one of the largest global medical meetings on oncology is a privilege, which provides unparalleled visibility to Oncodesign. This reinforces further the reputation of Oncodesign in terms of its research quality, upheld by the commitment of all our teams to promote the discovery of more effective new drugs."

Full details on Oncodesign presentations during the AACR (Free AACR Whitepaper) meeting:

Abstract n°5169: "Overcoming pd1 targeting antibody resistance using combination strategies"
Presentation: Dr. Jean-François Mirjolet (Oncodesign, Dijon, France)
Poster session/Section: Poster Section 28
Date: April 3, 2017
Time: 8:00am – 12:00pm EDT
Venue: Convention Center, Halls A-C

Abstract n°52217: "Preclinical proof of concept for the first Nanocyclix TKI-PET radiotracer targeting activated EGFR positive lung tumors"
Presentation: Dr. Francis Bichat (Oncodesign, Dijon, France)
Poster session/Section: Poster Section 39
Date: April 3, 2017
Time: 8:00am – 12:00pm EDT
Venue: Convention Center, Halls A-C

Abstract n°28: "Antitumor activity of the CMP-001 (TLR9 agonist) alone or combined with immune modulators in syngeneic tumor models"
Presentation: Dr. Aaron Morris (Checkmate Pharmaceuticals, Boston, US) and
Dr Sylvie Maubant (Oncodesign, Dijon, France)
Poster session/Section: Poster Section 26
Date: April 3, 2017
Time:
1:00pm – 5:00pm EDT
Venue: Convention Center, Halls A-C

Abstract n°3846: "Imodi initiative: A novel holistic and integrative approach with patient-derived tumor models against pancreatic cancer"
Presentation: Dr. Juan Iovanna (Inserm U1068, Marseille, France)
Poster session/Section: Poster Section 37
Date: April 4, 2017
Time: 8:00am – 12:00pm EDT
Venue: Convention Center, Halls A-C

Abstract n°5015: "Innovative and predictive models against breast cancer"
Presentation: Dr. S. Tabonne (Leon Berard clinical center, Lyon, France)
Section: Tumor biology Minisymposium session
Date: April 4, 2017
Time:
3:00pm – 5:00pm EDT

On April 3, 2017 OncoSec Medical Incorporated ("OncoSec") (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, reported a poster titled "Intratumoral Delivery of a P2A-linked Bicistronic IL-12 Construct Leads to High Intratumoral Expression and Systemic Anti-tumor Response" (Abstract ID # 1614) at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, in Washington, D.C (Press release, OncoSec Medical, APR 3, 2017, View Source [SID1234518431]). The poster included preclinical data demonstrating the latest developments of OncoSec’s gene delivery platform in a murine melanoma model.

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Previous studies have shown the use of immunomodulatory cytokines is effective in the regression of a wide range of tumors. However, systemic delivery of recombinant cytokines has often resulted in life-threatening adverse effects. Intratumoral gene electrotransfer of plasmid encoded interleukin-12 (IL-12) has shown acceptable safety and efficacy profiles in regressing tumors, both preclinically and clinically.

"We sought to optimize the anti-tumor immune response of our IL-12 immunotherapy platform that combines intratumoral injection of plasmid DNA coding for IL-12 and electroporation. Using a mouse model of melanoma, we were able to demonstrate that the changes made to plasmid design and to electroporation parameters can significantly increase production of IL-12, leading to an improved anti-tumor effect," said Punit Dhillon, OncoSec President and CEO. "The new IL-12 construct is the backbone of our next generation combination molecules."

Copies of the abstract are available and can be viewed on the AACR (Free AACR Whitepaper) website at View Source!/4292/presentation/6375. The poster is available in the Publications section of OncoSec’s website.

On April 3, 2017 Seattle Genetics, Inc. (Nasdaq: SGEN), a global biotechnology company, reported multiple data presentations that support the company’s advancing antibody-drug conjugate (ADC) and immuno-oncology programs at the upcoming 108th Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) being held April 1-5, 2017, in Washington, D.C (Press release, Seattle Genetics, APR 3, 2017, View Source [SID1234518430]). The presentations describe the ability of ADCETRIS (brentuximab vedotin) to activate antitumor immune responses, supporting continued clinical evaluation in combination with checkpoint inhibitors. Additionally, preclinical data feature two immuno-oncology agents, SEA-CD40 and SGN-2FF, both of which are in phase 1 trials. Seattle Genetics and Unum Therapeutics are presenting preclinical data evaluating combination treatment with Antibody-Coupled T cell Receptor (ACTR) engineered autologous T cells and an antibody targeting B-cell maturation antigen (BCMA), SEA-BCMA, for multiple myeloma. Further data highlight clinical biomarker analyses for vadastuximab talirine (SGN-CD33A; 33A), an ADC under evaluation in the global phase 3 CASCADE trial for acute myeloid leukemia (AML).

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"Our expertise in empowered-antibody innovation drives a substantial, advancing pipeline of more than a dozen clinical and preclinical programs, both ADCs and immuno-oncology agents," said Jonathan Drachman, M.D., Chief Medical Officer and Executive Vice President, Research and Development, at Seattle Genetics. "Preclinical data presented at AACR (Free AACR Whitepaper) support multiple ongoing clinical studies evaluating combination treatment of ADCETRIS and nivolumab (Opdivo) in relapsed Hodgkin and non-Hodgkin lymphoma and phase 1 trials of two proprietary immuno-oncology agents, SEA-CD40 and SGN-2FF, in solid tumors. Seattle Genetics is transforming into a global, multi-product oncology company through dedication to scientific innovation and the needs of patients."

Multiple presentations are being featured at AACR (Free AACR Whitepaper) that highlight advances with Seattle Genetics’ ADC and empowered antibody pipeline programs. Abstracts can be found at www.aacr.org and include the following:

Preclinical data evaluating the ability of brentuximab vedotin (ADCETRIS) to induce immunogenic cell death will be presented in a poster presentation on Wednesday, April 5, 2017 (Abstract #5588). These data demonstrate that ADCETRIS-treated tumor cells initiate an antitumor immune response alone and, to a greater extent, in combination with anti-PD-1 agents, and support combination strategies with immuno-oncology regimens, such as the ongoing phase 1/2 clinical trials evaluating ADCETRIS and nivolumab (Opdivo) in relapsed Hodgkin and non-Hodgkin lymphoma.
Preclinical data supporting the ongoing phase 1 study of SGN-2FF for patients with advanced solid tumors, including non-small cell lung cancer, were highlighted in an oral presentation at the New Drugs on the Horizon symposium on Sunday, April 2, 2017 (Session #DDT02-02). SGN-2FF is an oral, small molecule immuno-oncology agent that has been shown in preclinical models to inhibit fucosylation of proteins and thereby stimulate the immune system to slow the growth and spread of cancer cells.
SEA-CD40 preclinical data will be presented in a poster on Tuesday, April 4, 2017 (Abstract #3647), focusing on mechanism of action through activation of antitumor immune response and potential for combination with checkpoint inhibitors. This innovative immuno-oncology agent being developed by Seattle Genetics targets the protein CD40 using Seattle Genetics’ proprietary sugar-engineered antibody (SEA) technology to produce a non-fucosylated antibody. SEA-CD40 is under evaluation in a phase 1 trial for the treatment of blood cancers and solid tumors.
An analysis of CD33 target binding by vadastuximab talirine from a phase 1 monotherapy study in AML will be highlighted in a poster presentation on Tuesday, April 4, 2017 (Abstract #CT120). Vadastuximab talirine is being broadly evaluated across multiple lines of therapy in patients with myeloid malignancies, including the ongoing global phase 3 CASCADE study in newly diagnosed, older AML patients and phase 1/2 trial in patients with newly diagnosed myelodysplastic syndrome (MDS).
A novel preclinical program evaluating SEA-BCMA antibody in combination with ACTR T cells in multiple myeloma, developed in collaboration with Unum Therapeutics, will be highlighted in a poster presentation on Tuesday, April 4, 2017 (Abstract #4605). The ACTR engineered T cell technology enables programming of a patient’s immune system to attack tumor cells when co-administered with tumor-specific therapeutic antibodies. The cell surface protein BCMA is expressed on cells of several cancer types, including multiple myeloma and other B cell malignancies. The preclinical data support clinical evaluation of SEA-BCMA and ACTR T cell combination treatment in multiple myeloma patients.

On April 3, 2017 Celgene Corporation (NASDAQ:CELG) reported that it has received a Paragraph IV Notice Letter advising that Teva Pharmaceuticals USA, Inc. submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) seeking authorization from the FDA to manufacture and market a generic version of POMALYST (pomalidomide) 1 mg, 2 mg, 3 mg and 4 mg in the United States (Press release, Celgene, APR 3, 2017, View Source [SID1234518427]).

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The Notice Letter contains Paragraph IV certifications against certain patents related to POMALYST. Celgene is assessing the notice. Celgene intends to vigorously defend its extensive intellectual property rights related to POMALYST.

About POMALYST

In the U.S., POMALYST (pomalidomide) is indicated for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.