On February 4, 2016 ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that develops novel anticancer therapeutics using its ADC technology, and Merck, known as MSD outside the United States and Canada, reported that they have entered into a clinical research collaboration for the assessment of ImmunoGen’s mirvetuximab soravtansine in combination with Merck’s anti-PD-1 therapy, Keytruda (pembrolizumab), for the treatment of patients with FRα-positive ovarian cancer (Press release, ImmunoGen, FEB 4, 2016, View Source [SID:1234508972]). Schedule your 30 min Free 1stOncology Demo! Mirvetuximab soravtansine is an experimental ADC for FRα-positive cancers that has shown notable activity for FRα-positive ovarian cancer in early clinical testing. Mirvetuximab soravtansine contains a monoclonal antibody that enables it to bind to FRα-positive tumor cells with ImmunoGen’s DM4, a maytansinoid cancer-killing agent, attached to kill these cells. In preclinical research conducted by ImmunoGen and academics, ADCs with maytansinoids have been found to enhance the maturation and activation of the dendritic cells of the immune system that stimulate antitumor responses.1,2 Keytruda is a humanized monoclonal antibody that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. Keytruda blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T-lymphocytes, which may affect both tumor cells and healthy cells.
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"We look forward to evaluating our mirvetuximab soravtansine ADC in combination with Merck’s anti-PD-1 therapy, Keytruda," said Daniel Junius, ImmunoGen President and Chief Executive Officer. "In early clinical testing, mirvetuximab soravtansine has demonstrated notable activity as a single agent for FRα-positive ovarian cancer, and we are aggressively advancing it for this use. At the same time, we believe mirvetuximab soravtansine should be evaluated in different combination regimens to potentially provide the greatest benefit to the most patients. Keytruda has a different mechanism of action than the other agents being assessed."
"Fully realizing the potential for Keytruda to help patients with cancer requires strategic collaborations, such as this agreement with ImmunoGen, that explore how complementary approaches might result in improved outcomes for patients," said Dr. Eric Rubin, vice president and therapeutic area head, oncology early-stage development, Merck Research Laboratories. "We look forward to evaluating the data from this combined approach in patients with FRα-positive ovarian cancer."
ImmunoGen is conducting a Phase 1b/2 clinical trial, FORWARD II, that evaluates mirvetuximab soravtansine for FRα-positive ovarian cancer used in doublet combination with other anticancer agents. The assessment of mirvetuximab soravtansine with Keytruda will be added to this trial, with Merck supplying the Keytruda. ImmunoGen expects this cohort to open for patient enrollment in the second half of 2016.
The agreement is between ImmunoGen and Merck, through a subsidiary. The agreement includes a provision for potential expansion of the collaboration to include a subsequent Phase 3 clinical trial. Additional details were not disclosed.
About Mirvetuximab Soravtansine
ImmunoGen developed mirvetuximab soravtansine as a potential treatment for ovarian cancer and other FRα-positive solid tumors. In early clinical testing, mirvetuximab soravtansine demonstrated notable activity when used as a single agent to treat platinum-resistant FRα-positive ovarian cancer.3 ImmunoGen is assessing the ADC used as a single agent for pretreated FRα-positive ovarian cancer in its Phase 2 trial, FORWARD I, which is intended to support an Accelerated Approval pathway. Mirvetuximab soravtansine is also now being assessed in separate combinations with pegylated liposomal doxorubicin (Doxil), bevacizumab (Avastin), and carboplatin in the Phase 1b/2 trial, FORWARD II.
About Ovarian Cancer
Each year there are approximately 240,000 new cases of ovarian cancer diagnosed and 140,000 deaths from the disease on a global basis.4 Among all gynecologic cancers, ovarian cancer accounts for the most deaths on an annual basis.
Year: 2016
Ignyta Announces Initiation of Phase 1/1b Clinical Trial of Taladegib in Combination with Paclitaxel by Cancer Research UK
On February 4, 2016 Ignyta, Inc. (Nasdaq: RXDX), a precision oncology biotechnology company, reported that Cancer Research UK has initiated a new, investigator-sponsored Phase 1/1b clinical trial of a combination of paclitaxel with taladegib – the company’s novel, orally available, hedgehog/smoothened inhibitor – in patients with platinum-resistant, recurrent ovarian cancer or recurrent, advanced solid tumors (Press release, Ignyta, FEB 4, 2016, View Source [SID:1234508971]). Schedule your 30 min Free 1stOncology Demo! This clinical trial is an open label dose-escalation and expansion study designed to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), tolerability, pharmacokinetics and preliminary clinical activity of the combination of taladegib and weekly paclitaxel in this patient population. The lead investigator will be Dr. Rosalind Glasspool of the Beatson West of Scotland Cancer Centre, Glasgow, Scotland.
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"We are excited that Cancer Research UK has expanded the clinical investigation of taladegib through the initiation of this combination study"
"We are excited that Cancer Research UK has expanded the clinical investigation of taladegib through the initiation of this combination study," said Jonathan Lim, M.D., Chairman and CEO of Ignyta. "We look forward to supporting Cancer Research UK in this trial, and to evaluating the data, including potentially identifying the impact of this therapeutic intervention on the hedgehog pathway at both the mRNA and protein levels and correlating these changes with the patients’ disease and potential clinical response."
About Taladegib
Taladegib, which Ignyta exclusively licensed from Eli Lilly and Company in November 2015, is a potent, orally bioavailable small molecule hedgehog/smoothened antagonist that has achieved clinical proof-of-concept and a recommended Phase 2 dose based on results from prior clinical studies. Ignyta believes taladegib represents a potential first-in-class hedgehog/smoothened inhibitor for second-line treatment of locally advanced or metastatic basal cell carcinoma, as well as a potential best-in-class hedgehog/smoothened inhibitor for first-line treatment of these patients. In addition, Ignyta believes taladegib alone or in combination has the potential to treat selected patients with solid tumors outside of basal cell carcinoma that are driven by hedgehog pathway alterations. Ignyta also granted back to Lilly exclusive rights for Lilly to develop and commercialize taladegib-containing products in combination with certain Lilly compounds.
10-Q – Quarterly report [Sections 13 or 15(d)]
(Filing, 10-Q, Immunomedics, FEB 3, 2016, View Source [SID:1234508966])
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10-K – Annual report [Section 13 and 15(d), not S-K Item 405]
(Filing, 10-K, Biogen, FEB 3, 2016, View Source [SID:1234508961])
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8-K – Current report
On February 3, 2016 OXiGENE, Inc. (Nasdaq:OXGN), a clinical-stage biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of cancer, reported it will present a company overview on February 8, 2016 at 11:30 a.m. Eastern time at the 2016 BIO CEO & Investor Forum (Filing, 8-K, OXiGENE, FEB 3, 2016, View Source [SID:1234508979]).
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OXiGENE also announced that the U.S. Food and Drug Administration (FDA) has approved the protocol for FOCUS, OXiGENE’s phase 2/3 study of CA4P for the treatment of platinum-resistant ovarian cancer. FOCUS will test whether CA4P, the company’s lead investigational drug, improves progression-free survival (PFS) when combined with bevacizumab (Avastin) and chemotherapy. If the trial is successful, data from FOCUS would be used as the basis for a new drug application to the FDA.
"I am pleased that we have approval from the FDA to proceed with FOCUS, our planned clinical trial in platinum-resistant ovarian cancer," stated William D. Schwieterman, M.D., President and Chief Executive Officer of OXiGENE. "We have engaged a well-qualified clinical research organization to assist us with this trial, and intend to begin patient enrollment in the second quarter of this year. While we continue to develop and plan for a similar study in glioblastoma multiforme, and continue to see this as an outstanding opportunity to expand our pipeline, we will not initiate this study in 2016 as most of our current efforts for developing CA4P will be on FOCUS."
FOCUS is a randomized double-blind placebo-controlled study divided into two parts to maximize the speed of data collection. During stage 1 (n= up to 80 patients), serial interim analyses will be conducted to initially assess the efficacy and safety of the combination regimen when compared to standard-of-care. Stage 2 (n= approximately 356 patients) is a confirmatory phase 3 study which would begin immediately after evidence of safety and efficacy are initially demonstrated in stage 1.
FOCUS is designed to build upon data from the GOG-0186I study, first announced in 2014, which demonstrated that CA4P improves PFS in women with recurrent ovarian cancer when combined with bevacizumab compared to bevacizumab alone. The treatment effect observed in this study was strongest in the subgroup of ovarian cancer patients with platinum-resistant disease.
To listen to a live version of the audio webcast of the 2016 BIO CEO & Investor Forum, please visit the Company’s website, www.oxigene.com. Under the "Investors" tab, select the link to "Events & Presentations." A replay of the webcast will be available at this same location approximately one hour after the conclusion of the live event.