XENCOR,INC. (NASDAQ:XNCR) Files An 8-K Other Events
Item 8.01. Other Events.
On November13, 2016, Xencor,Inc. (the Company) announced
preliminary data from XmAb5871-03, an ongoing, open-label, pilot
Phase 2 study of XmAb5871 in patients with active IgG4-RD. Data
show that 82% of patients achieved an initial response to therapy
within two weeks of their first dose. The data was presented by
John H. Stone, M.D., MPH, director of rheumatology at
Massachusetts General Hospital, at the American College of
Rheumatology 2016 Annual Meeting in the Miscellaneous Rheumatic
and Inflammatory Disease session on November13, 2016.
As of a data cutoff of October31, 2016, 12 patients with active
IgG4-RD have been enrolled and dosed with XmAb5871 (median number
of infusions = 7, range 1-12). Patients had a median IgG4-RD
responder index (RI) of 10 (range 2-30) with a median of four
organs involved (range 1-10) at the time of study entry. Organ
site involvement occurring at a frequency of greater than or
equal to 50% included lymph nodes, submandibular glands, parotid
glands and lacrimal glands.
Preliminary Safety Data:
Every other week intravenous administration of XmAb5871 has been
well tolerated. As of October31, 2016, no serious adverse events
(AEs) have been reported. Treatment-related AEs have occurred in
five patients (42%). Treatment-related AEs that occurred in more
than one patient were abdominal pain/discomfort in three patients
(25%), occurring as part of Grade 1 (mild) infusion-related
gastrointestinal symptoms (nausea and/or vomiting and/or
diarrhea) during the first infusion, and Grade 1 (mild) headaches
in two patients (16.7%). One patient discontinued the study as
the result of an AE. The patient developed a Grade 2 (moderate)
hypersensitivity reaction with rash and arthritis, commonly
referred to as serum sickness, following the fifth infusion. The
event resolved quickly without the need for medical management.
This patient was subsequently found to have developed anti-drug
antibodies.
Preliminary Efficacy Data:
11 of the 12 patients dosed with XmAb5871 have had at least one
IgG4-RD RI performed following dosing as of the data cutoff date.
Nine of 11 patients (82%) have had an initial response to
XmAb5871 therapy of at least a three-point reduction in the
IgG4-RD RI within two weeks of the first dose. Five patients
attained disease remission (an IgG4-RD RI of 0) during the study.
Two patients entering the study on corticosteroids have been able
to taper and discontinue steroid use during the study.
In addition to the patient with early study termination due to an
AE, two other patients have discontinued treatment prior to
receipt of all 12 planned infusions. One patient had a response
to therapy (IgG4-RD RI reduction of six points), but lost
response following the sixth infusion, at which point this
patient discontinued treatment. One patient had no response to
therapy as defined by a greater than or equal to two-point
decrease in the IgG4-RD RI. This patient had an atypical
presentation of larynx involvement as the only organ involved.
The patient discontinued the study after six infusions. Neither
of these two patients have responded to subsequent rituximab
treatment.
On November29, 2016, the Company updated the slide presentation
to be used by the Company at investor meetings by adding a slide
presenting data from XmAb5871-03. A copy of that revised slide is
attached hereto as Exhibit99.1 and is incorporated herein by
reference.
The Company is filing certain information for the purpose of
updating descriptions of the Companys risk factors contained in
the Companys other filings with the Securities and Exchange
Commission. A copy of this additional disclosure is attached as
Exhibit99.2 to this report and incorporated herein by reference.
Forward Looking Statements:
Statements contained in this Current Report on Form8-K
regarding matters that are not historical facts are
forward-looking statements within the meaning of applicable
securities laws, including expectations relating to the
Companys business, research and development programs, including
ongoing clinical trials of XmAb5871, and the immune inhibitory
Fc domain technology, partnering efforts or the Companys
capital requirements. Such statements involve known and unknown
risks, uncertainties and other factors that may cause actual
results, performance or achievements, including those of the
complete clinical trial of XmAb5871, and the timing of events
to be materially different from those implied by such
statements, and therefore these statements should not be read
as guarantees of future performance or results. Such risks
include, without limitation, the risks associated with the
process of discovering, developing, manufacturing and
commercializing drugs that are safe and effective for use as
human therapeutics and other risks described in the Companys
public securities filings. All forward-looking statements are
based on the Companys current information and belief as well as
assumptions made by the Company. Readers are cautioned not to
place undue reliance on such statements and the Company
disclaims any intention or obligation to update or revise any
forward-looking statements, whether as a result of new
information, future events or otherwise.
Item 9.01 Financial Statements and Exhibits.
(d)Exhibits.
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ExhibitNo. |
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Description |
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99.1 |
Slide presenting data from XmAb5871-03 from Xencor,Inc. |
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99.2 |
Risk Factors |
About XENCOR, INC. (NASDAQ:XNCR)
Xencor, Inc. is a clinical-stage biopharmaceutical company. The Company is focused on discovering and developing engineered monoclonal antibodies to treat severe and life threatening diseases. Its segment is related to the development of pharmaceutical products. It uses its XmAb technology platform to create antibody product candidates designed to treat autoimmune and allergic diseases, cancer and other conditions. Its clinical stage product candidates include XmAb5871, which is being developed for autoimmune disease, and XmAb7195, which is being developed for asthma and allergic diseases. Its oncology product candidates are in preclinical stage, which include XmAb14045 and XmAb13676. In addition to its compounds in clinical development, the Company uses its XmAb technology to create antibody compounds which are licensed to other pharmaceutical and biotechnology companies for further development, which include XmAb5574/MOR208 and XmAb13551. XENCOR, INC. (NASDAQ:XNCR) Recent Trading Information
XENCOR, INC. (NASDAQ:XNCR) closed its last trading session down -0.78 at 25.56 with 231,518 shares trading hands.
