1stOncology™: Cancer Intelligence Service – Page 17984 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

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).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

Schedule Your 30 min Free Demo!

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);

Know more, wherever you are:
Latest on Antibodies in Oncology, book your free 1stOncology demo here.

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

OncoSec Medical Enrolls First Patient in Squamous Cell Carcinoma of the Head and Neck Phase II Clinical Trial

On June 16, 2015 OncoSec Medical reported that the company has enrolled the first patient into OMS-I130, a Phase II clinical trial of ImmunoPulse IL-12 in patients with treatment-refractory, metastatic and unresectable squamous cell carcinoma of the head and neck (HNSCC) (Press release, OncoSec Medical, JUN 16, 2015, View Source [SID:1234505441]).

ImmunoPulse IL-12, which employs intratumoral electroporation to enhance delivery of DNA-based interleukin-12 (IL-12), is designed to promote an anti-tumor immune response.

"This study will address one of the great unmet medical needs in oncology today: the number of patients who do not respond to anti-PD-1 treatment," said Mai H. Le, MD, Chief Medical Officer of OncoSec. "As we expand the application of ImmunoPulse IL-12 beyond cutaneous cancer indications, we anticipate that it will augment the anti-tumor immune response in HNSCC and increase the number of patients who will respond to anti-PD-1 therapy."

Robert H. Pierce, MD, Chief Scientific Officer of Oncosec and a member of the anti-PD-1 Biomarker Team while at Merck, added, "Key biomarker data was recently presented at the 2015 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, showing that a specific NanoString-based gene expression profile characterizes anti-PD-1 response in HNSCC. Importantly, at OncoSec, we have observed the ability of ImmunoPulse IL-12 to promote this NanoString gene expression signature in melanoma, and we anticipate that this will be observed in HNSCC as well."

The lead investigators for OMS-I130 are Tanguy Seiwert, MD, from the University of Chicago and lead author of the presentation outlining the key gene signature for anti-PD-1 responders with HNSCC, and Alain Algazi, MD, from the University of California, San Francisco.

"Median overall survival in recurrent and metastatic HNSCC is less than one year even with aggressive, multi-agent chemotherapy. Immune checkpoint inhibitors, including anti-PD-1 antibodies, can achieve durable remissions in some patients, but these therapies are ineffective in the majority of patients because tumor-fighting immune cells and signals are missing from the tumor," said Dr. Algazi. "ImmunoPulse IL-12 allows tumors to produce key immune signals and attract these immune cells, which can potentially provide the missing link that will allow the majority of patients to achieve long-term remission."

OMS-I130 is a single-arm, open-label study evaluating the safety and anti-tumor activity of intratumoral DNA-based IL-12 with electroporation in approximately 30 patients with treatment-refractory metastatic and unresectable HNSCC. The key endpoints include: objective response evaluations by RECIST v1.1 and immune-related Response Criteria (irRC); biomarker comparisons of pre- and post-treatment tumor biopsies, including NanoString gene expression profiling and immunohistochemistry for tumor-infiltrating lymphocytes (TILs); duration of response to treatment; overall survival; progression-free survival; and safety.

To learn more about the trial, visit www.oncosec.com. Additional details can also be found at www.clinicaltrials.gov.

About Squamous Cell Carcinoma of the Head and Neck
Squamous cell carcinoma (SCC) of the head and neck is one of most common causes of cancer-associated mortality worldwide. While the incidence of SCC of the head and neck (HNSCC) that is attributable to traditional risk factors, smoking and alcohol abuse, is declining, the incidence of SCC of the oropharynx due to HPV infection is on the rise.1

HNSCC can be treated with surgery, radiation, or chemoradiation in 60-90 percent of patients, but a substantial number of patients will develop recurrent or distant metastatic disease after locoregional therapy. These recurrences are associated with a poor overall prognosis2, and the median overall survival in patients with metastatic HNSCC is under a year even with intensive combination chemotherapy.3

The limited efficacy of standard of care treatment options means that 11,500 patients die every year from squamous cell carcinoma of the oral cavity and the oropharynx in the United States alone.1 There is a clear medical need in head and neck cancers for more effective treatment options to minimize toxicity and improve efficacy.