Trieza Therapeutics is a new company developing immunomodulatory oncolytic viruses for the treatment of cancer (Company Web Page, MPM Capital, MAY 1, 2017, View Source [SID1234518761]). Founded as a spin-out from Potenza Therapeutics, Trieza has a portfolio containing multiple pre-clinical candidates.

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On May 1, 2017 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that the results from a Phase 1 dose-escalation study evaluating mirvetuximab soravtansine (IMGN853) in patients with folate receptor alpha (FRα)-positive solid tumors were published in the journal Cancer (Press release, ImmunoGen, MAY 1, 2017, View Source [SID1234518773]). The previously disclosed data demonstrated encouraging clinical activity and a manageable safety profile for mirvetuximab soravtansine (IMGN853), and informed the dose that was used in Phase 1 expansion cohorts and the ongoing Phase 3 FORWARD I trial of patients with platinum-resistant ovarian cancer.

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"These Phase 1 results have played an important role in determining the appropriate dose for mirvetuximab soravtansine in the recently initiated Phase 3 FORWARD I trial of patients with platinum-resistant ovarian cancer," said Kathleen Moore, M.D., Associate Professor, Department of Obstetrics and Gynecology at the Stephenson Cancer Center at the University of Oklahoma. "The combination of these data and the recent data published in the Journal of Clinical Oncology further support the dose that has been chosen and patients who have been selected for FORWARD I."

The open-label, Phase 1 dose-escalation study treated a total of 44 patients with recurrent ovarian (52%) or endometrial cancer (25%), along with renal cell carcinoma and non-small cell lung cancer (11% and 9%, respectively). Patients received mirvetuximab soravtansine on day 1 of a 21-day cycle (Q3W dosing) with cycles repeated until dose-limited toxicity or progression, concluding the recommended dose for future trials is 6.0 mg/kg of mirvetuximab (based on adjusted ideal body weight) dosed once every three weeks. On the basis of the study findings, and additional data that demonstrated the importance of FRα expression levels for optimal mirvetuximab sorvatansine activity, the Company designed the Phase 3 FORWARD I trial utilizing this dose in patients with platinum-resistant ovarian cancer, along with a Phase 1b trial evaluating mirvetuximab in combination with standard-of-care chemotherapy and targeted agents.1

Mirvetuximab soravtansine exhibited a manageable safety profile and encouraging preliminary clinical activity. Adverse events (AEs) were generally mild with the majority being grade 1 or grade 2 (least severe grades). The most commonly observed AEs were fatigue, blurred vision and diarrhea.1

The publication, "Phase I dose-escalation study of mirvetuximab soravtansine (IMGN853), a folate receptor alpha-targeting antibody-drug conjugate, in patients with solid tumors," is available on the Cancer website.

About Mirvetuximab Soravtansine

Mirvetuximab soravtansine (IMGN853) is the first FRα-targeting ADC. It uses a FRα-binding antibody to target the ADC specifically to FRα-expressing cancer cells and a potent anti-tumor agent, DM4, to kill the targeted cancer cells.

Mirvetuximab soravtansine is ImmunoGen’s lead program and is in Phase 3 testing as a single agent for the treatment of platinum-resistant ovarian cancer. The candidate is also being assessed in combination regimens for both platinum-resistant and platinum-sensitive disease in Phase 1b/2 FORWARD II trial.

About Ovarian Cancer and FRα

In 2016, approximately 22,300 new cases of ovarian cancer will be diagnosed in the U.S. and more than 14,200 women will die from the disease.2 ImmunoGen estimates that 60% of ovarian cancer cases have medium or high FRα expression.

Standard first-line therapy for ovarian cancer is a platinum-based regimen. Once the cancer becomes platinum-resistant, treatment options include single-agent cytotoxic therapies such as pegylated liposomal doxorubicin, paclitaxel, or topotecan.

On May 1, 2017 Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS) (the "Company") reported that the ZoptEC Phase 3 clinical study of Zoptrex (zoptarelin doxorubicin) in women with locally advanced, recurrent or metastatic endometrial cancer did not achieve its primary endpoint of demonstrating a statistically significant increase in the median period of overall survival of patients treated with Zoptrex as compared to patients treated with doxorubicin (Press release, AEterna Zentaris, MAY 1, 2017, View Source [SID1234518774]).

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Dr. Richard Sachse, the Company’s Chief Scientific Officer, stated, "The median overall survival period for patients treated with Zoptrex was 10.9 months compared to 10.8 months for patients treated with doxorubicin. This is not a statistically significant, clinically meaningful increase in overall survival and thus the ZoptEC Phase 3 clinical study did not meet its primary endpoint. In addition, Zoptrex generally performed no better than the comparator drug with respect to the secondary efficacy endpoints. For example, the median period of progression-free survival of the patients in the Zoptrex arm of the study was identical to that for patients in the doxorubicin arm. Finally, there was no meaningful difference between the two arms with respect to safety; the number of patients with cardiac disorders was similar – eight in the Zoptrex arm and nine in the doxorubicin arm. Therefore, the results of the study are not supportive to pursue regulatory approval."

David A. Dodd, the President and Chief Executive Officer of the Company, stated, "We are very disappointed with the outcome of the ZoptEC Phase 3 clinical study. Based on this outcome, we do not anticipate conducting clinical trials of Zoptrex with respect to any other indications. I would like to thank my colleagues within Aeterna Zentaris and our external team of clinical investigators for their dedication to and contributions on this project." Commenting on the Company’s plans, Mr. Dodd continued, "Our focus has now shifted entirely to filing our new drug application for Macrilen and, if the product is approved, to its commercial launch as soon as possible. We will also optimize our resources to be consistent with our focus on Macrilen-related efforts. We continue to believe in the potential that Macrilen provides for us to become a focused specialty pharmaceutical company. Our intention is to submit the Macrilen NDA in the third quarter of 2017 and, if the product receives FDA approval, to commercially launch the product in the first quarter of 2018."

On May 1, 2017 SignalRx Pharmaceuticals Inc., a clinical-stage company developing novel small-molecules therapeutics to inhibit key orthogonal and synergistic oncotargets for the treatment of cancer, reported the presentation last week of its novel approach to immune-oncology treatments (Press release, SignalRx, MAY 1, 2017, http://www.ireachcontent.com/news-releases/signalrx-discloses-its-novel-immuno-oncology-program-approach-at-the-12th-annual-drug-discovery-chemistry-2017-meeting-620879733.html [SID1234527322]). The presentation by Donald L. Durden, MD, PhD, senior scientific advisor for SignalRx, occurred at 10:30 am on Thursday April 27th, 2017, at the Drug Discovery Chemistry 2017 meeting in San Diego, CA.

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The presentation was entitled"Dual PI3K/BRD4 inhibitor (SF2523) for immuno-oncology to suppress MYC and the MQ immunosuppressive environment". SignalRx’s program provides a novel approach to immune-oncology and is summarized below:

SF2523 is the only known nM potent dual PI3K/BET bromodomain inhibitor; this provides maximal suppression of the oncogenic transcription factor MYC via enhanced MYC degradation (PI3K inhibition) coupled with decreased production of MYC by inhibiting BRD4 which inhibits transcription of MYC.
MYC has been shown by others to regulate the antitumor immune response through immune-oncology checkpoint receptors CD47 and PD-L1; we have demonstrated that SF2523 reduces the expression of PD-L1 in hepatocellular carcinoma cells, likely through the suppression of MYC.
SF2523 inhibits PI3K isoforms shown by others to regulate the immune suppression found in the tumor microenvironment
SF2523 blocks the transition of M1 macrophages to the immune-suppressing M2 macrophage stage which is expected to augment antitumor immunity
SF2523 is the only dual PI3K/BRD4 inhibitor with demonstrated in vivo antitumor, antimetastatic and immune activating activity.
SignalRx is also seeking partnering opportunities to accelerate the development of its programs and advance novel anticancer therapeutics into first-in-man clinical trials based on the promising profile and mode of action of its inhibitors. Since these are single molecules with a single PK/PD and toxicity profile, there is a great opportunity to streamline their development alone and in combination therapies.

(Filing, Annual, Kitov Pharmaceuticals , 2016, MAY 1, 2017, View Source [SID1234518764])

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