SELECTA BIOSCIENCES, INC. (NASDAQ:SELB) Files An 8-K Regulation FD Disclosure
Item 7.01. Regulation FD Disclosure.
On June 15, 2017, Selecta Biosciences, Inc. (the Company) issued
a press release announcing additional data from the Companys
ongoing Phase 2 company-sponsored trial, which is assessing
single ascending dose safety, pharmacokinetic and
pharmacodynamics of SEL-212 in patients with elevated uric acid
levels.
a press release announcing additional data from the Companys
ongoing Phase 2 company-sponsored trial, which is assessing
single ascending dose safety, pharmacokinetic and
pharmacodynamics of SEL-212 in patients with elevated uric acid
levels.
The full text of the press release is furnished as Exhibit 99.1
to this Current Report on Form 8-K. In connection with the
issuance of the press release, the Company is holding a public
conference call and webcast on June 15, 2017, at 8:30 a.m. ET,
during which the Company will provide the investor presentation
attached as Exhibit 99.2 to this Current Report on Form 8-K. The
Company undertakes no obligation to update, supplement or amend
the materials attached hereto as Exhibit 99.2.
to this Current Report on Form 8-K. In connection with the
issuance of the press release, the Company is holding a public
conference call and webcast on June 15, 2017, at 8:30 a.m. ET,
during which the Company will provide the investor presentation
attached as Exhibit 99.2 to this Current Report on Form 8-K. The
Company undertakes no obligation to update, supplement or amend
the materials attached hereto as Exhibit 99.2.
The information furnished under this Item 7.01 (including
Exhibits 99.1 and 99.2 attached hereto) shall not be deemed filed
for purposes of Section 18 of the Securities Exchange Act of 1934
(the Exchange Act), or otherwise subject to the liabilities of
that section, nor shall it be deemed incorporated by reference
into any filing under the Securities Act of 1933, as amended, or
the Exchange Act, except as expressly provided by specific
reference in such a filing.
Exhibits 99.1 and 99.2 attached hereto) shall not be deemed filed
for purposes of Section 18 of the Securities Exchange Act of 1934
(the Exchange Act), or otherwise subject to the liabilities of
that section, nor shall it be deemed incorporated by reference
into any filing under the Securities Act of 1933, as amended, or
the Exchange Act, except as expressly provided by specific
reference in such a filing.
Item 8.01. Other Events.
On June 15, 2017, the Company issued a press release announcing
additional data from the Companys ongoing Phase 2
company-sponsored trial, which is assessing single ascending dose
safety, pharmacokinetic and pharmacodynamics of SEL-212 in
patients with elevated uric acid levels.
additional data from the Companys ongoing Phase 2
company-sponsored trial, which is assessing single ascending dose
safety, pharmacokinetic and pharmacodynamics of SEL-212 in
patients with elevated uric acid levels.
Key observations and findings based upon the clinical data
generated through June 12, 2017 from the 60 patients currently
enrolled in this open-label, dose ranging Phase 2 trial include:
generated through June 12, 2017 from the 60 patients currently
enrolled in this open-label, dose ranging Phase 2 trial include:
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Mitigated anti-drug antibodies (ADAs) after repeat monthly
administrations of SEL-212>->The prevention of ADAs in a dose-dependent manner resulted in a durable control of serum uric acid (sUA) levels (defined as sUA 6 mg/dl). The clinical data demonstrate a correlation between the prevention of ADAs and the maintenance of pegsiticase activity and serum uric acid control. |
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Demonstrated induction of immune tolerance>- A majority
of patients in the minimum effective dose group maintained sUA control following three monthly injections of SEL-212 and two monthly challenge injections of pegsiticase alone. Maintenance of sUA in the challenge portion of the trial provides evidence at this stage that the use of SVP-Rapamycin is enabling immune tolerance, meaning a prevention of ADAs to pegsiticase, which is typically immunogenic when administered alone. |
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Reduced rate of gout flares with SEL-212>- In the
control cohorts receiving pegsiticase alone, within the first month of treatment, 50% of patients reported experiencing a gout flare, which is a sudden and severe attack of pain, inflammation and tenderness of the joints. By comparison, only 15% of patients receiving SEL-212 reported a gout flare in the first month of treatment, with reports declining further in subsequent months. These data also appear to be in contrast with the increased incidence of flares reported in clinical trials involving other urate lowering therapies. |
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Identified minimum effective dose of SEL-212>- A key
objective of the Phase 2 trial was to determine a minimum effective monthly dose of the two components of SEL-212 (i.e. pegsiticase and SVP-Rapamycin) through an ascending dose matrix design. A majority of the initial patients dosed with 0.4 mg/kg of pegsiticase in combination with 0.08 mg/kg of SVP-Rapamycin maintained sUA control beyond five treatments. As a result, the Company has determined this to be a minimum monthly effective dose of SEL-212. Additional patients are now being added to this cohort, and higher dose levels of SVP-Rapamycin are being tested to further determine the dose regimens that may be taken forward into Phase 3. |
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SEL-212 generally well tolerated>- Consistent with the
expected reduction in immunogenicity of pegsiticase when SVP-Rapamycin doses increase, SEL-212 has been generally well tolerated at clinically active doses. There have been a total of eight serious adverse events (SAEs) reported in the trial through June 12, 2017. Seven were infusion reactions, four of which occurred in the cohorts receiving pegsiticase alone or the lowest dose of SVP-Rapamycin and two of which were due to dosing errors. One additional SAE, cholecystitis, was determined to not be related to the study drug. All of the SAEs were successfully treated and resolved without further issues. |
Following an End of Phase 2 Meeting with the U.S. Food and Drug
Administration, the Company expects to initiate its Phase 3
program in 2018.
Administration, the Company expects to initiate its Phase 3
program in 2018.
Forward-Looking Statements Disclaimer
This Current Report on Form 8-K (the Current Report) contains
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. All statements
contained in this Current Report that do not relate to matters of
historical fact should be considered forward-looking statements,
including without limitation statements regarding our ability to
determine appropriate SEL-212 dose regimens for our Phase 3
program and our expectations surrounding the initiation of our
Phase 3 program. These forward-looking statements are based on
managements current expectations. These statements are neither
promises nor guarantees, but involve known and unknown risks,
uncertainties and other important factors that may cause our
actual results, performance or achievements to be materially
different from any future results, performance or achievements
expressed or implied by the forward-looking statements,
including, but not limited to, the following: the uncertainties
inherent in the initiation, completion and cost of clinical
trials including their uncertain outcomes;>the unproven
approach of our SVP technology; undesirable side effects of our
product candidates; our reliance on third parties to manufacture
our product candidates and to conduct our clinical trials; our
inability to maintain our existing or future collaborations or
licenses; our inability to protect our proprietary technology and
intellectual property; potential delays in regulatory approvals;
and availability of funding sufficient for our foreseeable and
unforeseeable operating expenses and capital expenditure
requirements. These and other important factors discussed under
the caption Risk Factors in our Quarterly Report on Form 10-Q
filed with the Securities and Exchange Commission, or SEC, on May
11, 2017, and our other reports filed with the SEC could cause
actual results to differ materially from those indicated by the
forward-looking statements made in this Current Report. Any such
forward-looking statements represent managements estimates as of
the date of this Current Report. While we may elect to update
such forward-looking statements at some point in the future, we
disclaim any obligation to do so, even if subsequent events cause
our views to change. These forward-looking statements should not
be relied upon as representing our views as of any date
subsequent to the date of this Current Report.
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. All statements
contained in this Current Report that do not relate to matters of
historical fact should be considered forward-looking statements,
including without limitation statements regarding our ability to
determine appropriate SEL-212 dose regimens for our Phase 3
program and our expectations surrounding the initiation of our
Phase 3 program. These forward-looking statements are based on
managements current expectations. These statements are neither
promises nor guarantees, but involve known and unknown risks,
uncertainties and other important factors that may cause our
actual results, performance or achievements to be materially
different from any future results, performance or achievements
expressed or implied by the forward-looking statements,
including, but not limited to, the following: the uncertainties
inherent in the initiation, completion and cost of clinical
trials including their uncertain outcomes;>the unproven
approach of our SVP technology; undesirable side effects of our
product candidates; our reliance on third parties to manufacture
our product candidates and to conduct our clinical trials; our
inability to maintain our existing or future collaborations or
licenses; our inability to protect our proprietary technology and
intellectual property; potential delays in regulatory approvals;
and availability of funding sufficient for our foreseeable and
unforeseeable operating expenses and capital expenditure
requirements. These and other important factors discussed under
the caption Risk Factors in our Quarterly Report on Form 10-Q
filed with the Securities and Exchange Commission, or SEC, on May
11, 2017, and our other reports filed with the SEC could cause
actual results to differ materially from those indicated by the
forward-looking statements made in this Current Report. Any such
forward-looking statements represent managements estimates as of
the date of this Current Report. While we may elect to update
such forward-looking statements at some point in the future, we
disclaim any obligation to do so, even if subsequent events cause
our views to change. These forward-looking statements should not
be relied upon as representing our views as of any date
subsequent to the date of this Current Report.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
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Exhibit
No.
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Description
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99.1
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Press Release issued on June 15, 2017
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99.2
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Corporate slide presentation of Selecta Biosciences,
Inc. dated June 15, 2017 |
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About SELECTA BIOSCIENCES, INC. (NASDAQ:SELB)
Selecta Biosciences, Inc. is a clinical-stage biopharmaceutical company. The Company using its synthetic vaccine particle (SVP) technology to discover and develop targeted therapies that are designed to modulate the immune system to treat rare and serious diseases. The Company is engaged in the research and development of nanoparticle immunomodulatory drugs for the treatment and prevention of human diseases. The Company’s product candidates are in development. The Company’s SVP technology encapsulates an immunomodulator in biodegradable nanoparticles to induce antigen-specific immune tolerance to mitigate the formation of anti-drug antibodies (ADAs) in response to life-sustaining biologic drugs. The Company’s technology allows for the design of SVP therapies that can stimulate immune responses against a range of relevant antigens. Its initial immune-stimulating product candidate is a synthetic vaccine against nicotine for the market of smoking cessation and relapse prevention.
