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AbCheck and Pierre Fabre Pharmaceuticals Enter Into Strategic Research Partnership

On June 17, 2015 AbCheck s.r.o, a wholly owned subsidiary of Affimed N.V., Heidelberg, Germany, and Pierre Fabre Pharmaceuticals reported that they have expanded their ongoing collaboration into a strategic research partnership in the field of human antibody discovery and optimization (Press release, Pierre Fabre, JUN 17, 2015, View Source [SID:1234505451]).

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AbCheck is recognized for its expertise in human antibody discovery and optimization throughout the US and Europe. Pierre Fabre, the third largest French pharmaceutical company, has a long-standing commitment to oncology and immunology. The Pierre Fabre Immunology Centre (CIPF) in Saint-Julien-en-Genevois, France, is dedicated to the identification, development and manufacturing of therapeutic monoclonal antibodies in focused therapeutic areas.

Under the expanded agreement, AbCheck will use its proprietary human antibody discovery and optimization platform technologies, AbSieve and AbAccel, to deliver antibodies against two or more targets provided by Pierre Fabre per year over a period of three years. This period can be extended to up to five years. Pierre Fabre has secured full rights to all antibodies selected in exchange for discovery fees and milestone payments to AbCheck. Additional deal terms as well as financial details were not disclosed.

"We are extremely pleased that our technology platform, performance and business attitude has encouraged Pierre Fabre to select AbCheck as its main provider for therapeutic antibodies," said Dr. Volker Lang, Managing Director of AbCheck. "This validation once more proves our ability to efficiently address the needs of our partners, which is instrumental to AbCheck’s future development."

"At Pierre Fabre Immunology Center, we are working on a wide range of new promising targets and are always looking to reinforce our capabilities through collaborations with world-class platforms. This strategic partnership with AbCheck will support and accelerate our antibody discovery," said Dr. Nathalie Corvaïa, Managing Director of the Pierre Fabre Immunology Center.

"Pierre Fabre is deeply committed to bringing targeted therapies to patients that need them as quickly as possible. This partnership with AbCheck coupled with our internal capabilities provides us with a platform to achieve this objective," added Prof. Laurent Audoly, Head of R&D, Pierre Fabre Pharmaceuticals.

ImmunoGen’s IMGN529 for B-Cell Malignancies Demonstrates Synergistic Activity with Rituximab in Preclinical Models of Non-Hodgkin Lymphoma

On June 17, 2015 ImmunoGen reported the first presentation of findings with the Company’s CD37-targeting ADC, IMGN529, in combination with the CD20-targeting antibody, rituximab (Rituxan), in preclinical assessments (Press release, ImmunoGen, JUN 17, 2015, View Source [SID:1234505446]). These data are being presented in a poster at the 13th International Conference on Malignant Lymphoma taking place in Lugano, Switzerland (abstract #P-274).

Among the findings being presented are:

IMGN529 exhibits strong synergy with rituximab and other CD20-targeting antibodies in cell lines representative of an array of non-Hodgkin lymphoma (NHL) subtypes, including both GCB and ABC diffuse large B-cell lymphoma (DLBCL);

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Consistent with the in vitro findings, the combination of IMGN529 and rituximab was highly active against DLBCL models in vivo;

Synergy also was seen in vitro in a model representative of "double hit" lymphoma, a particularly difficult-to-treat type of DLBCL characterized by deregulation of two different genes, BCL2 (or BCL6) and MYC; and

Both IMGN529’s antibody component and its DM1 payload contributed to its synergistic activity with rituximab.

"Rituximab is a standard of care in the treatment of B-cell malignancies, and thus it is highly exciting that IMGN529 and rituximab demonstrate synergistic activity in combination in these models," commented Dr. Charles Morris, EVP and Chief Development Officer of ImmunoGen. "We plan to initiate clinical testing of IMGN529 in combination with rituximab later this year to assess the potential benefit of such a regimen for patients with DLBCL."

IMGN529 is currently in Phase I clinical testing for the treatment of NHL, used as a single agent in patients with heavily pre-treated disease. It has demonstrated encouraging evidence of activity, particularly for patients with relapsed/refractory DLBCL.1 Later this year, ImmunoGen plans to begin assessing IMGN529 used in combination with rituximab for the treatment of relapsed/refractory DLBCL in addition to assessing it as a single agent in DLBCL and chronic lymphocytic leukemia disease-specific patient populations.

About IMGN529

IMGN529 is a CD37-targeting ADC created by ImmunoGen for the treatment of B-cell malignancies. It consists of a CD37-binding antibody with one of the Company’s potent cancer cell-killing agents, DM1, attached. The antibody serves to deliver the DM1 specifically to B cells to kill them and, based on preclinical research, also contributes anticancer activity.

About Diffuse Large B-cell Lymphoma (DLBCL)

More than 70,000 people will be diagnosed with non-Hodgkin lymphoma (NHL) in the US in 2014.2 DLBCL is an aggressive lymphoma that represents approximately one third of the new NHL cases diagnosed annually.2 GCB, or Germinal Center B-cell like, and ABC, or Activated B-cell like, are prevalent sub-types of DLBCL which can differ markedly in their responses to treatment.

Eli Lilly and Company Enters Into Strategic Partnership with Sarah Cannon Research Institute to Develop Investigational Oncology Therapy

On June 17, 2015 Eli Lilly and Sarah Cannon Research Institute reported a strategic partnership to co-develop an investigational oncology compound, LY3023414, a PI3K/mTOR dual inhibitor (Press release, Eli Lilly, JUN 17, 2015, View Source [SID:1234505445]). Under the agreement, SCRI will collaborate with Lilly to provide clinical development expertise and program design, as well as medical oversight and trial management. Patient enrollment for the initial Phase II clinical trial is underway.

"Lilly has a long history of leading innovation in cancer therapy with the goal to offer patients improved treatment outcomes," said Christopher A. Slapak, M.D., vice president, early phase clinical research for Lilly. "This strategic partnership is an exciting step to foster further collaboration with SCRI in advancing the field of cancer research."

The partnership supports the development of this novel targeted cancer therapy, including flexible and efficient program design and implementation, as well as more rapid patient enrollment to clinical trials by accessing SCRI’s large network of patients.

"Our clinical trial management capabilities and scientific leadership, combined with Lilly’s leading drug development expertise, furthers our mission to advance therapies for patients seeking novel cancer medicines," said Dee Anna Smith, CEO of SCRI. "Through partnerships like this one, we can accelerate the time it takes to bring clinical trials into communities for those fighting cancer."

Nymox Announces $850,000 Financing

On June 16, 2015 Nymox Pharmaceutical reported that it has recently completed financing for a total of $850,000 at prices of $1.25-$1.66 (Press release, Nymox, JUN 16, 2015, View Source;fvtc=4&fvtv=6907 [SID:1234505443]). The financing consisted of a private placement of 400,000 shares with a European investor at $1.25 per share and an equity line drawdown from the Company’s existing facility consisting of 217,122 shares priced at $1.66 per share. There were no warrants attached to the transactions.

The Company’s lead product NX-1207 is in Phase 3 development for benign prostatic hyperplasia (BPH). Nymox recently announced that the Company is conducting Phase 3 NX-1207 BPH pivotal studies long-term follow-up extension data capture that is expected to be completed and results reported in late Q2 or early Q3 2015.

Nymox has also recently reported a successful Phase 2 long-term outcome study in 147 men of NX-1207 at higher dosage for low grade localized prostate cancer.

BPH is one of the most commonly diagnosed diseases in middle aged and older men. The condition has negative impacts on men’s health and quality of life and often leads to need for surgery. It is estimated that 50% of men in their 50’s have pathological signs of prostatic hyperplasia and one quarter to one half of men over 40 suffer from moderate to severe urinary symptoms associated with BPH.

The American Cancer Society estimates that in 2012 more than 240,000 men in the United States will be newly diagnosed with prostate cancer and more than 28,000 men will die from the disease. Most cases are detected via prostate-specific antigen (PSA) screening and usually found to have localized tumors. Surgical removal of the prostate (radical prostatectomy) and radiation therapy with or without androgen deprivation therapy are the most common active treatment options for localized prostate cancer but have significant short and long-term adverse effects, including impotence, urinary dysfunction, and other complications.

– See more at: View Source;fvtc=4&fvtv=6907#sthash.gnhqulFg.dpuf

8-K – Current report

On June 16, 2015 Provectus Biopharmaceuticals reported that the Society of Surgical Oncology (SSO) has published an abstract describing preliminary research into use of the Company’s investigational agent, PV-10, in murine models of colon cancer (Filing, 8-K, Provectus Pharmaceuticals, JUN 16, 2015, View Source [SID:1234505440]). A poster based on the published abstract was presented at the SSO’s 68th Annual Cancer Symposium.
Titled, "Intralesional Injection of Rose Bengal Induces an Anti-tumor Immune Response and Potent Tumor Regressions in a Murine Model of Colon Cancer," the abstract detailed research by K. Pardiwala, G. Qiao, J. Sundararajan, B. Prabhakar, and A.V. Maker at the University of Illinois at Chicago, Chicago, IL.
Based on their findings, the researchers concluded, "Rose Bengal induced potent cell death in human and murine colon cancer cells in vitro. Intralesional injection in established tumors induced an anti-tumor immune response and significant tumor regressions in vivo. These studies establish that intralesional PV-10 therapy warrants further study as a potential immunotherapeutic agent in colorectal cancer and metastases."
The SSO has made available all the abstracts from the Symposium in an electronic supplement to Annals of Surgical Oncology, its house journal. The abstract on PV-10 can be found on page S86 of the book, View Source