On January 11, 2016 Sanofi and Warp Drive Bio, a privately held biotechnology company using the molecules and mechanisms of nature to discover and develop transformative medicines, reported that they have extended and reshaped their existing collaboration utilizing Warp Drive’s proprietary SMART(TM) (Small Molecule Assisted Receptor Targeting) and Genome Mining platforms to discover novel oncology therapeutics and antibiotics (Press release, Sanofi, JAN 10, 2016, View Source [SID:1234508727]).

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Sanofi, who has been a major investor and strategic partner since Warp Drive’s inception in 2012, and Warp Drive have entered into a research collaboration and exclusive license focused on the development of drugs targeting important human oncogenes including RAS, which has one of the highest mutation rates in cancer – and new antibiotics targeting Gram-negative bacteria. Warp Drive Bio retains the rights to deploy its platforms to pursue discovery and development against all other targets, both alone and in collaboration with other companies.

The collaboration is an outgrowth of Sanofi’s Sunrise initiative, a strategic partnership model that seeks to invest in early stage opportunities that align with Sanofi’s expert development and commercialization abilities.

"Our partnership with Warp Drive is a perfect example of open innovation which allows Sanofi to collaborate with innovative companies and combine unique areas of expertise to advance drug development in a meaningful way", said Elias Zerhouni, M.D., President, Sanofi, Global R&D. "This is an exciting collaboration for Sanofi as it could yield potentially lifesaving oncology and antibiotic therapies for patients by utilizing cutting-edge technology platforms."

"This reshaped alliance enables joint and independent product development by Warp Drive, an important step in our evolution as we advance a therapeutic pipeline using our proprietary platforms," said Laurence Reid, Ph.D., Chief Executive Officer, Warp Drive Bio. "Since our inception, Sanofi has been highly supportive of our progress and we are very pleased to reshape our strategic collaboration to focus on novel therapeutics in areas of great unmet need."

Under the terms of the Agreement, Warp Drive will lead the research collaboration for a period of five years and Sanofi will receive worldwide exclusive licenses to develop and commercialize the candidates discovered during the research term.

Warp Drive is eligible to receive from Sanofi cumulative payments in excess of $750 million across four successful collaboration programs, including an equity investment by Sanofi, research, clinical, and regulatory milestones, and research and development services.

The companies will initially focus on three defined oncology programs targeting different mutants and states of the RAS oncogenic protein. Warp Drive has the option to lead development of the therapeutic candidates from post IND filing up to phase 2 clinical studies, with Sanofi leading development through the filing of new drug applications. Sanofi will lead global commercial activities on product(s) resulting from the collaboration and Warp Drive has the option to co-commercialize oncology therapeutics in the U.S. market. Sanofi will manage all ex-US commercial activities and Warp Drive will receive commercial milestones and tiered royalties on product sales.

The antibiotic collaboration will focus on the discovery and development of novel Gram-negative therapeutics and Sanofi will lead all development activities. Sanofi will be responsible for global commercialization of the antibiotic products and will pay Warp Drive research, clinical, and regulatory milestones, plus tiered royalties and commercial milestones based on global sales.

A review of Warp Drive’s SMART platform and its application to RAS and other important disease targets was discussed in a plenary session at the recent AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper). Warp Drive believes that novel therapeutics targeting RAS will represent a significant advance in the future of oncology drug development. Moreover, creating a new modality for currently undruggable targets by deploying the company’s SMART platform has the potential to open up new avenues for additional therapeutics in oncology and other important disease areas.

On January 11, 2016 Novartis reported that it is adding to its diverse and deep immuno-oncology pipeline through a strategic alliance and licensing agreement with Surface Oncology (Press release, Novartis, JAN 10, 2016, View Source [SID:1234508724]). The agreement gives Novartis access to four pre-clinical programs that target regulatory T cell populations, inhibitory cytokines, and immunosuppressive metabolites in the tumor microenvironment. These programs will be explored as monotherapies and in combination with other complementary therapies in Novartis’ immuno-oncology and targeted therapy portfolios.

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"We have several programs now in the clinic that aggressively address the complexities of the tumor microenvironment," said Mark Fishman, President of the Novartis Institutes for BioMedical Research. "This alliance with Surface Oncology is another building block in our strategy to develop a portfolio of programs that we believe will lead the next wave of immuno-oncology medicines."

At the start of 2015 Novartis launched a new immuno-oncology research team led by cancer vaccine pioneer Glenn Dranoff. In a short period of time, this team has rapidly built a broad portfolio of clinical and pre-clinical programs focused on stimulating the body’s immune system to combat cancers through targeting critical regulatory steps in the anti-tumor immune response. Today the company’s immuno-oncology portfolio includes novel checkpoint inhibitors, chimeric antigen receptor T-cell (CART) technology, myeloid cell targeting agents, the T cell stimulating factor IL-15, STING agonists that enhance immune recognition of cancers, and adenosine receptor antagonists and TGF-beta blocking antibodies that overcome immunosuppression in the tumor microenvironment.

Seven of these candidates are already in clinical trials and five more are expected to enter the clinic individually and as combinations by the end of 2016. Novartis’ myeloid cell targeting program (MCS110), anti-TIM-3 program (MGB453), IL-15-agonist (NIZ985) checkpoint inhibitors targeting PD-1 (PDR001) and LAG-3 (LAG525), and a small molecule adenosine receptor antagonist (NIR178) are now in phase 1 clinical trials. The CART program (CTL019) is in phase 2 clinical trials. A STING agonist (MIW815), a GITR agonist, and an anti-TGF-beta antibody are progressing toward first-in-human clinical trials in 2016.

This rich immuno-oncology pipeline together with a deep targeted therapy portfolio provides Novartis with the opportunity to attack cancer in powerful and complementary ways: through enhancing immune-mediated tumor destruction and promoting direct tumor cell killing. Together, these synergistic approaches may accomplish more durable clinical benefits for a larger proportion of cancer patients.

On January 10, 2015 Innate Pharma and OREGA Biotech reported that they have entered into an exclusive licensing agreement by which OREGA Biotech grants Innate Pharma full worldwide rights to its program of first-in-class anti-CD39 checkpoint inhibitors (Press release, Innate Pharma, JAN 10, 2016, View Source [SID:1234508721]). This license agreement arose from a fruitful research collaboration between the two companies initiated in 2014.

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CD39, initially discovered as a checkpoint inhibitor by OREGA Biotech’s cofounder Dr. Armand Bensussan in collaboration with INSERM, is expressed on both regulatory T cells and tumor cells. It plays a major role in promoting immunosuppression through the pathway degrading adenosine triphosphate (ATP) into adenosine. Within the tumor microenvironment, ATP promotes immune cell-mediated killing of cancer cells. In contrast, adenosine accumulation causes immune suppression and dysregulation of immune cell infiltrates resulting in tumor spreading.

Blockade of CD39 may therefore stimulate anti-tumor immunity across a wide range of tumors by preventing the production of adenosine and by promoting the accumulation of ATP in the tumor microenvironment . OREGA Biotech’s program to develop a CD39-blocking antibody thus aims at restoring a pro-inflammatory micro-environment. It is currently in preclinical development.

Yannis Morel, Chief Business Officer of Innate Pharma, said: "CD39 is an exciting target to counteract the immunosuppressive tumor microenvironment and may complement other therapies that act to boost anti-tumor activities of T cells and NK cells". He added: "We are very pleased of the work we have done with OREGA Biotech. Their scientific expertise was key to this collaboration. It was a very efficient and successful way to advance this new first-in-class antibody program, which could become part of the next generation of checkpoint inhibitors. In the very competitive field of immuno-oncology, this kind of agreement is important to further strengthen our unique position in the field and our long term development perspectives".

Jeremy Bastid, Chief Operating Officer of OREGA Biotech, added: "We are delighted to enter into this licensing agreement with Innate Pharma. The involvement of this pathway in human tumors is broad and we believe that this CD39-blocking agent could become a valuable immune checkpoint inhibitor in the future". Gilles Alberici, Chief Executive Officer and cofounder of OREGA Biotech, further commented: "It is a major step forward for OREGA Biotech as it represents the accomplishment of our business model, which relies on our capacity to discover novel immune checkpoint inhibitors and partner early with larger biotech or pharma companies for the preclinical development. We have been impressed by Innate Pharma’s expertise and we are convinced that they will successfully bring this program to the clinic".

Innate Pharma and OREGA Biotech will present data on this program at an upcoming scientific meeting.

Under the terms of the agreement, OREGA Biotech will receive undisclosed upfront payment, milestone payments for preclinical, clinical and regulatory achievements as well as royalties on net sales.

On January 10, 2016 ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that develops targeted anticancer therapeutics using its antibody-drug conjugate (ADC) technology, reported recent product program advancements and anticipated 2016 events in advance of the 34th Annual J.P. Morgan Healthcare Conference (Press release, ImmunoGen, JAN 10, 2016, View Source [SID:1234508718]).

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"ImmunoGen made significant progress in 2015 that is anticipated to lead to a number of meaningful events in 2016 and beyond," commented Daniel Junius, President and CEO. "For mirvetuximab soravtansine, our lead program, these include completing patient enrollment in three disease-specific cohorts that can provide informative data in 2016. They also include putting in place the FORWARD I trial intended to support an Accelerated Approval pathway as well as the FORWARD II combination trial. Additionally, we put in place a trial to assess our IMGN529 in combination with rituximab, established a development strategy for coltuximab ravtansine, and submitted an IND for IMGN779, the first ADC to utilize one of our new DNA-acting cancer-killing agents."

Mr. Junius continued, "Our partners, too, made important progress, with Roche reporting global growth in Kadcylasales, encouraging initial clinical findings reported with Bayer’s anetumab ravtansine, Novartis, Lilly, Sanofi, and Amgen all advancing ADCs with ImmunoGen technology into the clinic, and a new collaboration established with Takeda. We expect several key partner events in 2016, including the advancement of two programs into trials designed to support product registration."

Mirvetuximab soravtansine – the first folate receptor α (FRα)-targeting ADC.

2015 accomplishments include:

Presentation of the first clinical data from assessment in a disease-specific patient population that demonstrated the potential of mirvetuximab soravtansine, used alone, to make a meaningful difference for patients with heavily pretreated FRα-positive ovarian cancer.
Activity was most notable among patients with high or medium amounts of FRα on their cancer cells, the majority of the patients.
Completion of patient enrollment in three disease-specific Phase I cohorts (enrollment target):
Patients with platinum-resistant FRα-positive ovarian cancer (40 patients);
Patients with platinum-resistant FRα-positive ovarian cancer consenting to the required biopsies (20 patients); and
Patients with relapsed/refractory FRα-positive endometrial cancer (20 patients).
Establishment of a development strategy that includes:
Assessment as single-agent therapy for patients with FRα-positive ovarian cancer treated with 3-4 prior regimens. This Phase 2 trial, FORWARD I, is intended to support an Accelerated Approval pathway.

In December, ImmunoGen and the GOG Foundation, Inc. entered into a partnership designed to help patients with ovarian cancer learn about FORWARD I and, if appropriate, enroll in the study. Patient dosing in trial is poised to start.
Assessment for FRα-positive ovarian cancer in three doublet combinations – with either pegylated liposomal doxorubicin (Doxil), bevacizumab (Avastin), or carboplatin; additional cohorts are possible. ImmunoGen is conducting this Phase 1b/2 trial, FORWARD II, to potentially expand the number of patients able to benefit from mirvetuximab soravtansine. Patient dosing is underway.
Preclinical evaluation of additional types of cancers for potential clinical assessment.
Events anticipated in 2016 include:

Meeting with regulators in 1H2016 on the mirvetuximab soravtansine development program, including the design of the second stage of the FORWARD I trial.
Presentation of clinical data from the 40-patient ovarian cancer cohort at a medical meeting in 2Q2016.
Presentation of clinical data from additional expansion cohorts.
Advancing FORWARD I and FORWARD II. ImmunoGen plans to ultimately have more than 50 centers open in the US, Canada, and Western Europe for FORWARD I patient enrollment.
IMGN529 – CD37-targeting ADC for diffuse-large B-cell lymphoma (DLBCL) and potentially other non-Hodgkin lymphoma (NHL) subtypes.

2015 accomplishments include:

Completion of dosing-finding Phase 1 evaluation of IMGN529 used as monotherapy. IMGN529 demonstrated encouraging single-agent activity in patients with heavily pretreated NHL, particularly ones with DLBCL.
Establishment of strategy to evaluate IMGN529 in combination with rituximab (Rituxan) in a Phase 2 trial based on distinctive synergy seen in preclinical models.
Design and start of implementation of this Phase 2 trial, with patient dosing expected to start shortly.

Anticipated in 2016:

Advancing Phase 2 combination trial.
Potentially other program updates.
Coltuximab ravtansine – CD19-targeting ADC for DLBCL and potentially other NHL subtypes.

2015 accomplishments include:

Regaining coltuximab ravtansine rights from Sanofi.
Establishment of strategy to advance in a combination regimen.
Preclinical evaluation of alternatives for selection of regimen to be assessed clinically.

Events anticipated in 2016 include:

Disclosure of combination regimen to be assessed in 1H2016.
Initiation of Phase 2 combination study midyear.
IMGN779 – Novel CD33-targeting ADC for acute myeloid leukemia (AML) and potentially other malignancies. IMGN779 is the first ADC utilizing one of ImmunoGen’s new DNA-acting IGNs as the cancer-killing agent.

2015 accomplishments include:

IND submitted and active, ImmunoGen’s fourth IND in four years.
Events anticipated in 2016 include:

Initiation of Phase 1 testing for the treatment of AML in 1H2016.
Partner Programs – ImmunoGen has a distinctive record of successful partnerships.

There are now ten novel anticancer compounds, including Kadcyla, in the clinic for a broad range of solid and liquid cancers through ImmunoGen partnerships with Amgen, Bayer, Biotest, Lilly, Novartis, Roche and Sanofi.

2015 accomplishments include:

Amgen, Lilly, Novartis and Sanofi each advanced a novel ADC with ImmunoGen technology into clinical testing.
Study investigators presented encouraging Phase 1 clinical findings with Bayer’s anetumab ravtansine in pretreated mesothelioma.
A collaboration was established with Takeda in early 2015, and in December, Takeda took its first license for the exclusive right to develop ADCs to an undisclosed target using ImmunoGen technology. The taking of this license triggers ImmunoGen recognition of approximately $8.6 million of (non-cash) revenue in its quarter ending December 31, 2015.
In December, CytomX announced it is advancing a novel anticancer agent targeting CD166 using its ProbodyTM technology and ImmunoGen’s ADC technology under a strategic collaboration established between the companies in early 2014. This event does not impact ImmunoGen financial results.
Events anticipated in 2016 include:

Two partner compounds begin testing in trials designed to support product registration.
At least one additional partner compound disclosed and/or advances into clinical testing.
Cash Position

ImmunoGen will report the financial results for the quarter ended December 31, 2015 on January 29, 2016. The Company noted that it ended the quarter with approximately $212 million in cash and cash equivalents and had no debt.

(Filing, 10-K, Advaxis, JAN 8, 2016, View Source [SID:1234508711])

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