Shares of XOMA Corp (NASDAQ:XOMA) ended Friday session in red amid volatile trading. The shares closed down -0.101 points or –15.13% at $0.566 with 4.45 million shares getting traded. Post opening the session at $0.60, the shares hit an intraday low of $0.53 and an intraday high of $0.60 and the price vacillated in this range throughout the day. The company has a market cap of $68.30 million and the numbers of outstanding shares have been calculated to be 120.59 million shares.
XOMA Corp (XOMA) on Sept. 15, 2016 provided an update on its ongoing XOMA 358 Phase 2 studies in patients with severe hypoglycemia due to congenital hyperinsulinism (CHI) and post-bariatric surgery (PBS), two rare conditions resulting from abnormal insulin function.
“The initial data from the XOMA 358 Phase 2 clinical studies confirms that our first-in-class allosteric antibody is exhibiting an inhibition on insulin signaling, the desired mechanism-of-action. This means that for patients who are not able to properly regulate their high insulin levels and experience severe bouts of hypoglycemia, such as those diagnosed with congenital hyperinsulinism and certain post-bariatric surgery patients, XOMA 358 could provide benefit in preventing hypoglycemic episodes,” stated John Varian, Chief Executive Officer of XOMA. “When we consider the totality of preclinical and clinical evidence, which demonstrates that XOMA 358 down-regulates insulin signaling by binding to the insulin receptor in an allosteric manner, we believe XOMA 358 is ready for advancement into Phase 2b multi-dose studies.
“I want to thank these patients for their willingness to participate in these studies,” Mr. Varian concluded.
XOMA 358 Initial Combined Phase 2 Clinical Data
Patients act as their own control. To confirm their baseline status and participate in the ongoing Phase 2 studies, each patient must have two documented hypoglycemic events, captured by continuous glucose monitoring (CGM) or by supervised provocation by fast, protein challenge or meal test.
The ongoing CHI study is designed to evaluate the safety, pharmacokinetic, pharmacodynamics and biological activity of escalating doses of XOMA 358. Preliminary data from seven patients showed reduced duration and number of hypoglycemic episodes with increasing dose.
In the Phase 2 PBS study, XOMA 358 showed some effect on glucose and insulin tolerance in the face of a meal challenge at the initial dose of 3 mg/kg in two patients.
“We believe the most relevant efficacy measures are the duration of hypoglycemia and the number of hypoglycemic episodes. Although the number of patients dosed with XOMA 358 is small, both time spent in a hypoglycemic state, and number of hypoglycemic episodes decreased in a dose-dependent manner. We will continue to further confirm this type of drug effect in additional patients,” commented Paul Rubin, MD, Senior Vice President Research and Development and Chief Medical Officer of XOMA. “The data from our ongoing Phase 2 study is helping us define the parameters that will give us the best opportunity for demonstrating efficacy in future studies, such as the use of continuous glucose monitoring to track glycemic profile on a continuous basis over days and weeks.”
Shares of ImmunoGen, Inc. (NASDAQ:IMGN) ended Friday session in green amid volatile trading. The shares closed up +0.05 points or 1.80% at $2.83 with 4.40 million shares getting traded. Post opening the session at $2.81, the shares hit an intraday low of $2.75 and an intraday high of $2.87 and the price vacillated in this range throughout the day. The company has a market cap of $251.58 million and the numbers of outstanding shares have been calculated to be 87.33 million shares.
ImmunoGen, Inc. (IMGN) on August 4, 2016 provided an update on the Company’s progress.
Mirvetuximab soravtansine is a well-differentiated experimental therapy for the treatment of ovarian cancer and potentially other tumor types that express its target, folate receptor alpha (FRα). This ADC is being evaluated in clinical trials as a single-agent therapy for platinum-resistant ovarian cancer and in combination regimens for both platinum-resistant and platinum-sensitive disease.
- Held Type B meeting with the U.S. Food and Drug Administration (FDA) to review the path to registration for mirvetuximab soravtansine and the proposed FORWARD I study protocol. With the benefit of the agency’s guidance, ImmunoGen is moving forward with initiating this Phase 3 trial as previously outlined, including with the primary endpoint of progression-free survival (PFS).
- Reported data from 46 patients with FRα-positive platinum-resistant ovarian cancer at the American Society of Clinical Oncology (ASCO) meeting in June. Mirvetuximab soravtansine demonstrated robust single-agent activity in these patients, with the greatest response rates and PFS reported in patients with high or medium levels of FRα expression on their tumors and who had received up to three prior regimens, the patient population eligible for enrollment in FORWARD I.
Strategic Combination Regimens
- Initiated the 35-patient Phase 2 assessment in FORWARD II of mirvetuximab soravtansine in combination with Avastin following successful completion of dose finding.
- Continued enrollment in the FORWARD II cohorts assessing the ADC used with pegylated liposomal doxorubicin (PLD) and, separately, with carboplatin, with the cohort assessing the combination with Keytruda® on track to open this summer.
Exploring Additional Opportunities
- Through ImmunoGen’s collaboration with the National Comprehensive Cancer Network (NCCN), grants were awarded for clinical assessment of mirvetuximab soravtansine in combination with gemcitabine and as a treatment of triple negative breast cancer as well as for preclinical studies on mechanisms of resistance, sensitivity, and biomarkers.
IMGN779 / IMGN632
IMGN779 and IMGN632 deploy ImmunoGen’s new ultra-potent, DNA-acting payload agents that alkylate DNA without crosslinking it. In preclinical studies, these agents have been found to avoid the sustained toxicity seen with DNA-crosslinking agents.
- Initiated Phase 1 clinical testing of IMGN779, a CD33-targeting ADC, for the treatment of AML. Initial clinical data from this trial are expected to be presented in 2017.
- Advanced CD123-targeting IMGN632 into IND-enabling testing. The first preclinical findings with this novel ADC were presented at the European Hematology Association annual meeting, with additional data on its distinctive activity and tolerability expected to be presented in late 2016.
IMGN529 deploys ImmunoGen’s validated maytansinoid payload technology and recently gained orphan drug status in diffuse large B-cell lymphoma (DLBCL).
- Initiated Phase 2 clinical testing of IMGN529 used in combination with Rituxan® for patients with B-cell malignancies including DLBCL based on marked synergy in preclinical testing.