On November 7, 2018 Supernus Pharmaceuticals, Inc. (NASDAQ: SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases, reported that the Company’s management will present an overview and Company update as well as host investor meetings, at the following three conferences (Press release, Supernus, NOV 7, 2018, View Source [SID1234531188]):

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Stifel 2018 Healthcare Conference
Date: Tuesday, November 13, 2018
Time: 3:30 p.m. EST
Place: Lotte New York Palace Hotel, New York

Jefferies 2018 London Healthcare Conference
Date: Thursday, November 15, 2018
Time: 2:40 p.m. GMT (9:40 a.m. EST)
Place: Waldorf Hilton, London, U.K.

Piper Jaffray 30th Annual Healthcare Conference
Date: Tuesday, November 27, 2018
Time: 12:00 p.m. EST
Place: Lotte New York Palace Hotel, New York

Investors interested in arranging a meeting with the Company’s management during these conferences should contact the respective conference coordinators.

A live webcast of the respective presentations can be accessed by visiting ‘Events & Presentations’ in the Investor Relations section on the Company’s website at www.supernus.com. An archived replay of these webcasts will be available for 60 days after the respective conferences on the Company’s website.

On November 7, 2018 SpringWorks Therapeutics, a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for nirogacestat, an investigational, oral, small molecule, selective gamma-secretase inhibitor, for the treatment of adult patients with progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis (Press release, SpringWorks Therapeutics, NOV 7, 2018, View Source [SID1234538851]).

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Desmoid tumors are rare and debilitating soft-tissue tumors that can occur in both children and adults. Depending on their size and location, desmoid tumors can cause severe morbidities such as pain, internal bleeding, disfigurement, and limited range-of-motion. In some cases, desmoid tumors can be fatal if they impact vital organs.1 It is estimated that 900 to 1,500 new cases of desmoid tumors are diagnosed each year in the United States.2

"The Fast Track designation recognizes that desmoid tumors have a substantial impact on the lives of patients, and that nirogacestat has the potential to address the significant needs faced by this community who currently do not have an FDA-approved treatment," said Saqib Islam, Chief Executive Officer of SpringWorks Therapeutics. "We look forward to continuing to work closely with the FDA throughout our development program with the hope of ultimately bringing this important medicine to patients."

The FDA’s Fast Track program is designed to expedite the development and review of drugs with the potential to treat serious or life-threatening conditions, and with nonclinical or clinical data that demonstrate the potential to address unmet medical needs. Fast Track designation enables a company to have frequent communication with the FDA throughout the drug development and review process.3

In June 2018, the U.S. FDA granted Orphan Drug designation for nirogacestat for the treatment of desmoid tumors. SpringWorks expects to initiate the DeFi Study, a global Phase 3, double-blind, randomized, placebo-controlled, trial in patients with desmoid tumors in the first half of 2019.

About Desmoid Tumors
Desmoid tumors (also referred to as aggressive fibromatosis or desmoid-type fibromatosis) are rare, non-metastatic tumors of connective tissue cells that can arise in any part of the body, with the most common sites being the upper and lower extremities, abdominal walls, thoracic areas, and the head and neck. The severity of desmoid tumors and associated symptoms varies based on their size and location. Desmoid tumors can cause severe morbidities such as pain, internal bleeding, disfigurement, limited range of motion, and in some cases, fatality if they impact vital organs. While they can affect children and adults, desmoid tumors are more commonly diagnosed in young adults between 20-30 years of age, with a two-to-three-fold predominance in females. 1,4 It is estimated that desmoid tumors affect 2 to 4 per million people worldwide, and that there are 900 to 1,500 new cases diagnosed per year in the United States.2 Historically, desmoid tumors were treated with surgical resection or in severe cases, amputation, but even with these interventions, high rates of tumor regrowth have been observed.5 There are currently no FDA-approved therapies for the treatment of desmoid tumors.

About Nirogacestat
Nirogacestat is an investigational, oral, small molecule, selective gamma-secretase inhibitor. Gamma secretase is an integral membrane protein that cleaves multiple different transmembrane protein complexes, including Notch, which is believed to play a role in activating pathways that contribute to desmoid tumor growth. Nirogacestat has been investigated in 24 patients with desmoid tumors across Phase 1 and Phase 2 clinical trials.

On November 7, 2018 Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory, cancer and other diseases, reported financial results for the third quarter of 2018 ended September 30, 2018 and provided an update on the Company’s recent and future developments (Press release, Pieris Pharmaceuticals, NOV 7, 2018, View Source [SID1234530848]).

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"We are pleased to announce that PRS-060, an IL-4 receptor alpha antagonist for moderate-to-severe asthma, was safe and well-tolerated by healthy volunteers in a single ascending dose Phase I study. This is the first clinical use of an inhaled Anticalin protein and marks an important development milestone for the Company. We continue to enroll subjects with mild asthma in a multiple ascending dose Phase I study. Along with our partner AstraZeneca, we anticipate reporting the data from the Phase I studies at an upcoming medical meeting. For PRS-343, our 4-1BB/HER2 bispecific, we now intend to report initial data from a Phase I study in the first half of next year, after completing the dose escalation, to provide a more comprehensive data set," said Stephen S. Yoder, President and CEO of Pieris. "We look forward to providing updates on our progress as we head into 2019."

PRS-060: PRS-060, an inhaled IL-4 receptor alpha antagonist for moderate-to-severe asthma, was tested in 48 healthy volunteers at dose levels ranging from 0.25 mg to 400 mg in a single ascending dose Phase I study. The drug candidate was safe and well-tolerated in this study. Pieris continues to enroll subjects with mild asthma and elevated levels of fractional exhaled nitric oxide (FeNO) in a multiple ascending dose Phase I study. This study will evaluate the safety, tolerability and FeNO-reducing potential of PRS-060 versus placebo. The data from the PRS-060 Phase I studies will be presented at an upcoming medical meeting. PRS-060 is the lead candidate in Pieris’ respiratory collaboration with AstraZeneca. Pieris is sponsoring the Phase I studies and AstraZeneca is funding the costs. AstraZeneca will conduct and fund the Phase IIa study, after which Pieris will have separate options to co-develop and co-commercialize the drug candidate.

PRS-343: The Company continues to enroll and treat patients in a Phase I dose-escalation study of PRS-343, a 4-1BB/HER2 bispecific for HER2-positive solid tumors, and now intends to report initial data from the study in the first half of 2019, after completing the dose escalation, in order to provide a more comprehensive data set. Our objective for the remaining enrollment will be to favor patient selection across a range of immunotherapy-responsive tumor types. The Company is screening patients for the 11th cohort of the study, a dose level comparable to approved dose levels of trastuzumab. In August, Pieris initiated a trial with PRS-343 in combination with atezolizumab, and the Company intends to report data from this trial in 2019.

PRS-080: Pieris is planning to enroll and complete dosing of the final patient in its Phase IIa multiple ascending dose study of PRS-080, a half-life-optimized hepcidin antagonist for anemia, by year end. In the ongoing trial, PRS-080 at both doses (4mg/kg and 8mg/kg) has not generated any observed drug-related serious adverse events and has demonstrated substantial iron mobilization and transferrin saturation (TSAT) increases versus placebo. To date, there has been no conclusive change in hemoglobin at either dose versus placebo. We remain committed to completing the study and sharing the data with ASKA and other potential partners for continued development. We intend to report the full data set from the study in the first half of 2019.

PRS-344: Pieris will present preclinical data for PRS-344, a PD-L1/4-1BB antibody-Anticalin bispecific in IND-enabling studies, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2018 Annual Meeting in Washington, D.C. The poster, P375, will be presented on November 9–10, 2018. PRS-344 is one of five development programs in Pieris’ immuno-oncology alliance with Servier.

Board Appointments: In September 2018, Pieris appointed Peter Kiener, D.Phil. to the Company’s Board of Directors. Dr. Kiener served in several executive roles, most recently as the Chief Scientific Officer at Sucampo. In October 2018, Pieris also appointed Matthew L. Sherman, M.D. to the Company’s Board of Directors. Dr. Sherman most recently served as Executive Vice President and Chief Medical Officer at Acceleron Pharma.

Preclinical Pipeline: Pieris remains committed to advancing several early-stage programs into the clinic and is on track to file two immuno-oncology INDs, one for a proprietary drug candidate and one as part of its collaboration with Servier, in 2019. The Company has also initiated two proprietary respiratory programs.
Third Quarter Financial Update:

Cash Position – Cash, cash equivalents and investments totaled $137.3 million as of September 30, 2018, compared to a cash, cash equivalents and investments balance of $82.6 million as of December 31, 2017. The increase was driven primarily by the $47.2 million in net proceeds from the Company’s February 2018 equity financing, the $30.0 million in upfront payments received as part of the Seattle Genetics immuno-oncology collaboration, and the $12.5 million milestone payment from AstraZeneca that was triggered during the fourth quarter of 2017 and received during the first quarter of 2018. The increase was partially offset by $35.7 million of operating cash expenditures during the year.

R&D Expense – R&D expenses were $11.4 million for the three months ended September 30, 2018, compared to $6.3 million for the three months ended September 30, 2017. R&D expenses were $28.5 million for the nine months ended September 30, 2018, compared to $17.0 million for the nine months ended September 30, 2017. The Company’s increase in R&D expenses reflects preparation for and advancement of clinical studies as well as advancement across its pipeline of preclinical programs.

G&A Expense – G&A expenses were $4.7 million for the three months ended September 30, 2018, compared to $2.9 million for the three months ended September 30, 2017. G&A expenses were $13.9 million for the nine months ended September 30, 2018, compared to $11.2 million for the nine months ended September 30, 2017. The Company’s increase in G&A expenses reflects higher personnel costs and professional services costs for audit and legal, as well as an increase in general administrative costs to support the growing business of the Company. On a nine-month basis, the increase was partially offset by lower transaction fees for license and collaboration agreements compared to amounts recorded in the first half of 2017.

Interest Income – Interest income was $0.5 million and $1.5 million for the three and nine months ended September 30, 2018, respectively, compared to no interest income earned in the comparable 2017 periods. The Company began investing cash received from the collaboration agreements signed in 2017 in the fourth quarter of 2017.

Other Income – Other income was $1.1 million and $1.5 million for the three and nine months ended September 30, 2018, respectively, compared to other expense of $1.7 million and $3.1 million for the three and nine months ended September 30, 2017, respectively. The Company began investing cash received from the collaboration agreements signed in 2017 in the fourth quarter of 2017. The increase in income for the three- and nine-month periods is a result of net foreign currency transaction gains due to the strengthening of the U.S. dollar against the euro, positively impacting the remeasurement of U.S. dollar denominated monetary assets held in Germany.

Net Loss – Net loss was $6.2 million or $(0.11) per share for the three months ended September 30, 2018, compared to a net loss of $7.1 million or $(0.16) per share for the three months ended September 30, 2017. Net loss was $15.1 million or $(0.29) per share for the nine months ended September 30, 2018, compared to a net loss of $25.1 million or $(0.58) per share for the nine months ended September 30, 2017.

Conference Call:

Pieris management will host a conference call beginning at 8:00 AM Eastern Standard Time on Wednesday, November 7, 2018, to discuss the third quarter of 2018 financial results and provide a corporate update. Individuals can join the call by dialing +1-877-407-8920 (US & Canada) or +1-412-902-1010 (International). An archived replay of the call will be available by dialing +1-877-660-6853 (US & Canada) or +1-201-612-7415 (International) and providing the Conference ID #: 13661472.

On November 7, 2018 BioInvent International AB (OMXS: BINV), focused on the discovery and development of novel and first-in-class immuno-regulatory antibodies to treat cancer, and Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies, reported they will be presenting two back-to-back posters featuring positive data supporting their ongoing collaboration to develop a novel oncolytic virus encoding for an anti-CTLA-4 antibody at the annual meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) to be held November 7-11 in Washington, D.C (Press release, Transgene, NOV 7, 2018, View Source [SID1234530909]).

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This novel oncolytic virus combines a Transgene Invir.IO Vaccinia virus (VV)-based oncolytic vector, with BioInvent’s human anti-CTLA-4 antibody (IgG1) and a human cytokine.

BioInvent and Transgene are together creating a novel armed oncolytic virus that will be able to infect and selectively replicate within the tumor, inducing cancer cell destruction, and to elicit a strong immune response that is further enhanced by the local expression of the immune checkpoint inhibitor and the cytokine. This novel oncolytic virus is expected to deliver better treatment outcomes with an improved safety profile as the patient is not exposed to the potential systemic toxicity of the anti-CTLA-4 antibody.

In the posters, Transgene and BioInvent provide further details on the strengths and advantages of their respective technologies:

Transgene’s VV is a highly oncolytic and immunogenic viral vector that has demonstrated its ability to ensure the expression of a fully functional, full-length antibody in the tumor and trigger a massive immune infiltration into the tumor with low systemic exposition to the molecule;
BioInvent has developed a potent anti-CTLA-4 antibody, selected and characterized for its improved FcγR-dependent Treg depleting efficacy. FcγR-dependent Treg depletion was recently found to play a key role in the anti-CTLA-4 antibody’s efficacy in vivo.
Björn Frendéus, Chief Scientific Officer of BioInvent said: "Having identified a lead human anti-CTLA-4 antibody candidate with improved Treg-depleting activity compared with ipilimumab, we are looking forward to advancing the program presented at the SITC (Free SITC Whitepaper) in collaboration with Transgene, and develop a potentially safe and more efficacious strategy to combine anti-CTLA-4 and anti-PD-1/PDL1 checkpoint inhibition in the context of oncolytic virotherapy."

Eric Quéméneur, Pharm.D., Ph.D., Executive VP, Chief Scientific Officer of Transgene, said: "We are very pleased with the progress of our collaboration with BioInvent. The data that both companies present at SITC (Free SITC Whitepaper) underline the potential of combining our synergistic expertise to generate a novel oncolytic virus capable of delivering a potent anti-CTLA-4 antibody directly into the tumor micro-environment. The concept of combining the merits of our respective technologies was already demonstrated in preclinical experiments and we look forward to demonstrating its potential in the clinic."

The posters will be on display both Friday, November 9 and Saturday, November 10 in the Poster Hall (Hall E). They will also be available after the conference on the companies’ respective websites, www.transgene.fr and www.bioinvent.com.

Antibody-armed oncolytic Vaccinia virus to block immunosuppressive pathways in the tumor microenvironment – Poster P615

Authors: Marchand JB, Semmrich M, Fend L, Tornberg UC, Silvestre N, Frendéus B, Quéméneur E
Generation and characterization of a CTLA-4 antibody with improved FcγR-dependent

Treg deletion for tumor microenvironment-targeted oncolytic virotherapy of cancer – Poster 602

Authors: Semmrich M, Marchand JB, Holmkvist P, Mårtensson L, Tornberg UC, Fend L, Kovacek M, Teige I, McAllister A, Quéméneur E, Frendéus B

On November 7, 2018 Clovis Oncology, Inc. (Nasdaq: CLVS) reported that Patrick J. Mahaffy, Chief Executive Officer and President, will present at the 27th Annual Healthcare Conference on Wednesday, November 14, 2018 at 11:30 AM Mountain Time (Press release, Clovis Oncology, NOV 7, 2018, View Source [SID1234530945]). The conference will be held at the Phoenician in Scottsdale.

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A live webcast of the presentation can be accessed through the investor relations section of the Company’s website at www.clovisoncology.com. Following the live presentation, a replay of the webcast will be available on the Company’s website for 30 days.