On November 6, 2018 Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led biopharmaceutical company focused on identifying, developing, and commercializing innovative therapies to address significant unmet needs in aesthetic and medical dermatology and immunology, reported financial results for the third quarter of 2018 and provided an update on its clinical development and commercial programs (Press release, Aclaris Therapeutics, NOV 6, 2018, View Source [SID1234530841]).

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In October, Aclaris entered into a definitive asset purchase agreement with Allergan Sales, LLC to acquire worldwide rights to RHOFADE (oxymetazoline hydrochloride) cream, 1% and additional intellectual property. The acquisition includes an exclusive license to certain intellectual property for RHOFADE, which is approved in the United States for the topical treatment of persistent facial erythema (redness) associated with rosacea in adults. Aclaris expects this acquisition to close in the fourth quarter of 2018.

During the third quarter of 2018, total net revenue was $1.6 million, which consisted of net sales of ESKATA (hydrogen peroxide) Topical Solution, 40% (w/w) of $0.5 million and contract research revenue of $1.1 million.

In September, Aclaris initiated the Phase 3 program for A-101 45% Topical Solution (A-101 45%) for the treatment of common warts (verruca vulgaris).

Aclaris has completed enrollment in the ongoing AA-201 topical formulation trial of ATI-502 in patients with patchy alopecia areata (AA), a less severe phenotype of AA, data from which is expected in the first half of 2019.

"This is an exciting time for Aclaris. With the anticipated closing of the acquisition of RHOFADE in the fourth quarter, we will take another major step toward establishing ourselves as a fully integrated biopharmaceutical company with multiple commercial products, a robust clinical-stage pipeline and drug discovery engine," said Dr. Neal Walker, President and Chief Executive Officer of Aclaris.

Clinical Pipeline Update:

A-101 45% Topical Solution –

Initiated Phase 3 program (THWART-1 and THWART-2) for the treatment of common warts in September 2018. Topline data are expected in the second half of 2019.

Plan to commence an open-label safety extension trial investigating A-101 45% for the treatment of common warts in 2019.

JAK Inhibitor Trials:

AA-202 Topical –

An ongoing Phase 2 clinical trial of ATI-502, a topical JAK 1/3 inhibitor, for the treatment of AA.

Data from the full cohort of patients expected before year end.

After completing the 28-day portion of the trial, patients entered a 6-month open-label extension during which all continuing patients will receive drug. Treatment period extended in August 2018 for an additional 6 months to allow for full year of drug exposure.

Evidence of hair regrowth in the open-label extension portion of this trial has been observed.

Safety results – generally well-tolerated; no treatment related serious adverse events reported to date.

AUATB-201 Topical –

An ongoing Phase 2 open-label clinical trial of ATI-502 for the topical treatment of AA in Australia.

In this trial, Aclaris is evaluating the safety and efficacy of ATI-502 on the regrowth of eyebrows in patients with AA, including patients with alopecia totalis (AT) and alopecia universalis (AU). Interim update:

12 patients have been enrolled; 5 continue in the trial. Patients will also enroll in a 12 month extension phase of the trial after completing 6 months.

Evidence of eyebrow hair regrowth has been observed in two patients.

Safety results – generally well-tolerated; no treatment-related serious adverse events reported to date.

AA-201 Topical –

Completed enrollment of this ongoing Phase 2 clinical trial of ATI-502 for the topical treatment of AA.

This randomized, double-blinded, parallel-group, vehicle-controlled trial will evaluate the safety, efficacy and dose response of two concentrations of ATI-502 on the regrowth of hair in approximately 120 patients with AA. This trial is being conducted in the United States and data are expected in the first half of 2019.

VITI-201 Topical – Completed enrollment of this ongoing Phase 2 open-label clinical trial of ATI-502 for the topical treatment of vitiligo. This trial will evaluate the safety and efficacy of ATI-502 on the repigmentation of facial skin in 33 patients with vitiligo, and data are expected in 2019.

AGA-201 Topical – Completed enrollment of this ongoing Phase 2 open-label clinical trial of ATI-502 for the topical treatment of androgenetic alopecia (AGA), also known as male/female pattern hair loss. This trial will evaluate the safety and efficacy of ATI-502 on the regrowth of hair in 31 patients with AGA, and data are expected in the first half of 2019.

AD-201 Topical – an ongoing Phase 2 open-label clinical trial of ATI-502 in patients with atopic dermatitis (AD). This trial will evaluate the safety and efficacy of ATI-502 applied twice daily to affected skin for four weeks in approximately 30 adult patients with moderate-to-severe AD, and data are expected in mid-2019.

AUAT-201 Oral – an ongoing Phase 2 dose ranging trial of ATI-501, an oral JAK 1/3 inhibitor for the treatment of AA. This randomized, double-blinded, parallel-group, placebo-controlled trial will evaluate the safety, efficacy and dose response of three concentrations of ATI-501 on the regrowth of hair in approximately 80 patients with AA, and data are expected in the second half of 2019.

ATI-450 (MK-2 Inhibitor) – Investigational New Drug application on track for submission to the FDA in mid-2019.

Recent Corporate Highlights:

In October, Aclaris entered into a Loan and Security Agreement with Oxford Finance LLC. The Loan Agreement provides for up to $65 million in term loans. Of the $65 million, Aclaris borrowed $30 million on October 31, 2018. The remaining $35 million will become available for draw beginning on the closing date of the RHOFADE acquisition and ending on the earlier of March 31, 2019 or an event of default.

In October, Aclaris closed an underwritten public offering of 9,941,750 shares of Aclaris’ common stock at a price to the public of $10.75 per share, which includes the full exercise of the underwriters’ option to purchase 1,296,750 additional shares, for total gross proceeds of $106.9 million. Aclaris paid underwriting discounts and commissions of $6.4 million. All of the common stock in the offering was sold by Aclaris.

Issued US Patent # 10,098,910 – In October, Aclaris was issued a U.S. patent with 18 claims directed to an applicator containing a formulation of high concentration hydrogen peroxide and methods of using such an applicator to treat seborrheic keratosis (SK), warts and other indications, which is scheduled to expire in 2035. Orange Book listed.

Co-authored an article titled: "Inhibition of the Stromal p38MAPK/MK2 Pathway Limits Breast Cancer Metastases and Chemotherapy-Induced Bone Loss" in the journal Cancer Research. ATI-450, an investigational drug, is a selective inhibitor of p38 mitogen-activated protein kinase-activated protein kinase 2 (p38MAPK/MK2) interface and an attractive candidate for stromal-targeted therapy.

Commercial Update:

Over 1,050 ESKATA accounts opened to date.

Sales force focused on driving clinical and business integration in existing ESKATA accounts in addition to expanding account base.

National DTC campaign initiated on October 1.

Financial Highlights:

Third Quarter 2018 Financial Results

For the quarter ended September 30, 2018, total net revenues were $1.6 million, which consisted of net sales of ESKATA of $0.5 million and contract research revenue of $1.1 million, compared to $0.7 million for the quarter ended September 30, 2017, all of which was contract research revenue. For the nine months ended September 30, 2018, total net revenues were $6.4 million, which consisted of net sales of ESKATA of $2.0 million, contract research revenue of $3.4 million, and other revenue of $1.0 million, compared to $0.7 million for the nine months ended September 30, 2017, all of which was contract research revenue. Cost of revenues for the quarter and nine months ended September 30, 2018 were $1.2 million and $3.3 million, respectively, compared to $0.5 million for both the quarter and nine months ended September 30, 2017.

For the quarter ended September 30, 2018, total operating expenses were $33.9 million, compared to $19.0 million for the third quarter of 2017. For the nine months ended September 30, 2018, total operating expenses were $99.5 million, compared to $47.2 million for the same period in 2017.

Research and development (R&D) expenses for the quarter and nine months ended September 30, 2018 were $15.9 million and $43.5 million, respectively, compared to $10.9 million and $26.6 million, for the same periods of 2017. The increases of $5.0 million and $16.9 million were mainly the result of the expansion of Aclaris’ JAK inhibitor and common wart programs, as multiple Phase 2 trials of ATI-501 and ATI-502 and Phase 3 trials of A-101 45% are ongoing in 2018. There were also increases in medical affairs activities related to ESKATA and costs associated with drug discovery programs as a result of the acquisition of Confluence in August 2017. Personnel expenses, including stock-based compensation, increased due to increased headcount to support these programs and as a result of the acquisition of Confluence in August 2017. These increases were offset by a decrease in costs related to the development of ESKATA leading to Aclaris’ NDA submission in February 2017 following the completion of the clinical trials.

Sales and marketing (S&M) expenses for the quarter and nine months ended September 30, 2018 were $11.4 million and $35.0 million, respectively, compared to $3.6 million and $7.2 million, for the same periods of 2017. The increases of $7.8 million and $27.8 million were mainly the result of increases in direct marketing and professional fees, as well as other commercial expenses incurred to support the launch of ESKATA in May 2018. Personnel

expenses, including stock-based compensation, increased as Aclaris completed the hiring of its field sales force in the first quarter of 2018.

General and administrative (G&A) expenses for the quarter and nine months ended September 30, 2018 were $6.6 million and $21.0 million, respectively, compared to $4.6 million and $13.4 million, for the same periods of 2017. The increases of $2.0 million and $7.6 million were mainly the result of higher personnel expenses, including stock-based compensation, due to increased headcount to support the commercial launch of ESKATA, and as a result of the acquisition of Confluence in August 2017. G&A expenses for the nine months ended September 30, 2018 also included a $1.5 million ESKATA-related milestone payment, whereas the nine months ended September 30, 2017 included a $1.0 million ESKATA-related milestone payment.

For the quarter ended September 30, 2018, net loss was $32.7 million, or $1.06 per basic and diluted share, as compared to $18.2 million, or $0.63 per basic and diluted share, for the third quarter of 2017. For the nine months ended September 30, 2018, net loss was $94.2 million, or $3.04 per basic and diluted share, as compared to $45.6 million, or $1.68 per basic and diluted share, for the same period of 2017.

Liquidity and Capital Resources

As of September 30, 2018, Aclaris had aggregate cash, cash equivalents and marketable securities of $134.3 million compared to $208.9 million as of December 31, 2017.

Aclaris anticipates that its cash, cash equivalents and marketable securities balances, including the proceeds from the public offering of common stock in October and the initial drawdown from the loan facility with Oxford, will be sufficient to fund its operations into the second half of 2020, without giving effect to any potential new business development transactions or financing activities.

2018 Financial Outlook

Aclaris has updated its expected 2018 GAAP R&D expenses to be in the range of $62 to $64 million, including estimated stock-based compensation of $7 million.

Aclaris updated its expected 2018 GAAP selling, general and administrative (SG&A) expenses, which combine its Sales and marketing and General and administrative line items, to be in the range of $77 to $79 million, including estimated stock-based compensation of $14 million.

Company to Host Conference Call

Management will conduct a conference call at 5:00 PM ET today to discuss Aclaris’ financial results and provide a general business update. The conference call will be webcast live over the Internet and can be accessed by logging on to the "Investors" page of the Aclaris Therapeutics website, www.aclaristx.com, prior to the event. A replay of the webcast will be archived on the Aclaris Therapeutics website for 30 days following the call.

On November 6, 2018 Purdue Pharma L.P. reported that the first patient has been enrolled in a Phase 1 investigator-initiated clinical trial of tinostamustine, an investigational treatment, in patients with newly-diagnosed unmethylated O6-Methylguanine-DNA-methyltransferase (MGMT) glioblastoma multiforme (unmethylated nGBM),1 the most common and aggressive type of primary malignant brain tumor.2 Now open at The University of Texas MD Anderson Cancer Center, the open-label, non-randomized trial will investigate the safety profile, maximum tolerated dose (MTD), and efficacy of tinostamustine (Press release, Purdue Pharma, NOV 6, 2018, View Source [SID1234530936]).

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Glioblastoma is an incurable cancer with a very poor prognosis.2 Median overall survival is only 15 months and survival rates have shown no notable improvement in the past 30 years.3,4 The current standard of care for the disease includes surgery and postoperative radiation therapy with concurrent and adjuvant chemotherapy using temozolomide.5-7 Prognosis is significantly worse for patients with the unmethylated MGMT form of glioblastoma because that tumor type is less likely to respond to currently available treaments.8 Under current standard of care, the two-year overall survival rate was 46 percent in patients with MGMT-methylated nGBM versus 14 percent in patients with unmethylated nGBM.8

"We are excited to see tinostamustine advance into a Phase 1 study in patients with unmethylated glioblastoma multiforme, an extremely aggressive and fatal form of brain tumor," said John Renger, PhD, vice president, Head of Research & Development and Regulatory Affairs, Purdue Pharma. "The limited brain penetration of some medications across the blood-brain barrier contributes to the poor prognosis of this disease, however, preclinical data suggest tinostamustine may have the potential to cross the blood-brain barrier to deliver therapeutic central nervous system concentrations."

The dual-acting therapy candidate tinostamustine, previously known as EDO-S101, is a novel and potentially first-in-class alkylating deacetylase inhibitor (AK-DACi) therapy. Clinical research is underway to evaluate its ability to improve access to and break the DNA strands within cancer cells, and counteract the cancer cells’ attempts to repair the DNA damage.9-12

The potential utility of tinostamustine in the treatment of glioblastoma is supported by various pre-clinical data, and the molecule has shown anti-tumor activity in multiple in-vitro models of glioblastoma. In a pharmacokinetic analysis of tinostamustine administered to murine models by IV bolus and continuous IV infusion (CIVI), tinostamustine crossed the blood-brain barrier with central nervous system (CNS) penetration of 16.5 percent and 13.8 percent for IV bolus and CIVI administrations, respectively.13 CNS penetration with adequate therapeutic CNS concentration is essential for the treatment of brain tumors.

Tinostamustine is an investigational treatment and it is not approved for use in glioblastoma patients. Tinostamustine is also in development for a range of rare or difficult-to-treat blood cancers and advanced solid tumors. The completion of the first-in-human Phase 1 dose escalation study of tinostamustine in patients with relapsed or refractory (difficult-to-treat) hematological malignancies for which there are no available therapies was announced recently, and a Phase 1/2 study in advanced solid tumors was initiated in 2017. Tinostamustine is being developed in the US by Mundipharma EDO on behalf of Purdue Pharma.

To find out more about the study, visit clinicaltrials.gov.

This release discusses an investigational new drug under development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such investigational drug will successfully complete clinical development or receive regulatory approval.

On November 6, 2018 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported its third quarter 2018 financial results and provided a corporate update (Press release, Iovance Biotherapeutics, NOV 6, 2018, View Source;p=RssLanding&cat=news&id=2375637 [SID1234530753]).

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"We have made tremendous progress in the last several months. Following our recent end of Phase 2 meeting with the FDA, we released information about the meeting outcome and our US registration path, receipt of RMAT designation for metastatic melanoma, an abbreviated set of our latest clinical data, and conducted a successful round of financing. The company is now in a very strong financial position which will allow us to pursue our registration program to commercialize our TIL therapy," said Dr. Maria Fardis, Ph.D., MBA, president and chief executive officer of Iovance Biotherapeutics. "We intend to recruit a new cohort of patients in the C-144-01 study to support registration of lifileucel, build a commercial manufacturing facility as well as a commercial team to support our plans to bring lifileucel to patients, while we continue advancing our existing clinical programs and expand our TIL therapy into new indications."

Recent Achievements

Regulatory

Iovance received the Regenerative Medicine Advanced Therapy (RMAT) designation for lifileucel, the company’s adoptive cell therapy using its TIL technology for the treatment of patients with metastatic melanoma from the U.S. Food and Drug Administration (FDA).
Iovance held an end of Phase 2 meeting with FDA during which the agency acknowledged that a single-arm cohort as part of the C-144-01 study could be supportive of initial registration and conduct of a randomized Phase 3 trial in the patient population being enrolled may not be feasible.
Clinical

Enrollment in Cohort 2 of the global Phase 2 lifileucel metastatic melanoma study, C-144-01, reached the predefined sample size and was therefore closed.
— As announced today, new data from Cohort 2 will be presented in a poster and as an oral presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 33rd Annual Meeting in Washington, D.C. on November 10-12. The presentation will include 47 consecutively dosed patients with an objective response rate (ORR) of 38%, with a median duration of response (DOR) of 6.4 months and range of 1.3+ to 14+ months. The ORR includes one complete response and 17 partial responses, four of which are unconfirmed and pending patient’s upcoming second assessments. Patients in the study had a mean of 3.3 prior systemic therapies and all the patients had received anti-PD-1 immunotherapy.
— The most common treatment emergent adverse events observed in this cohort to date include chills, febrile neutropenia, anaemia, decreased platelet count, pyrexia, and hypophosphataemia. There were two grade 5 events reported.
— Patient enrollment in a new cohort, Cohort 4, will be initiated in early 2019. This will be a single-arm cohort for registration in metastatic melanoma in a patient population that is post PD-1 blocking antibody and, if BRAF mutation positive, a BRAF inhibitor or BRAF inhibitor with MEK inhibitor. Iovance expects to fully enroll the necessary patients into this cohort by late 2019/early 2020. Cohort 4 is expected to enroll 80-100 patients. The primary endpoint for the study is ORR as determined by Blinded Independent Central Review (BIRC).
Patient dosing continues in the C-145-04 study for cervical carcinoma. The company recently dosed its first patient in Europe. This study design is based on a Simon’s two-stage design. The first stage has been completed and enrollment in the study continues with target enrollment of 47. Preliminary data for 15 patients yielded an ORR of 27% with an early look at the DOR ranging from 2.4 to 2.5+ months. Patients in the study had a median of five prior therapies. The safety findings from this study remain consistent with previous reports. The protocol for this study has been amended to limit the number of prior therapies to no more than three and to exclude patients who have been treated with prior immunotherapy. Iovance anticipates providing an update on this study at an upcoming medical meeting in 2019.
In the C-145-03 study for head and neck cancer, to date, preliminary data for 13 patients has yielded an ORR of 31% with the DOR ranging from 2.8 to 7.6 months. The safety findings from this study is also consistent with previous reports. Patients in the study had a median of three prior therapies.
For the study in NSCLC, IOV-LUN-201, in collaboration with MedImmune, the company amended the protocol to eliminate the TIL monotherapy cohort and patients will now be enrolled for treatment with LN-145 and durvalumab. There are currently nine sites active for this trial.
The study in PD-1 naïve melanoma and head and neck patients with TIL in combination with pembrolizumab, and LN-145 as monotherapy in NSCLC patients (IOV-COM-202) is open to enrollment with two sites active.
As of October 2018, Iovance has expanded to over 90 clinical sites for its five company-sponsored studies.
Manufacturing

Iovance announced a new three-year Manufacturing Services Agreement with MaSTherCell S.A., a cell therapy-dedicated Contract Development and Manufacturing Organization (CDMO). MaSTherCell will manufacture TIL for Iovance’s European late-stage clinical trials in its commercial-ready cGMP manufacturing suites and increases Iovance’s capacity for manufacturing TIL in Europe.
Research

Under a collaboration with Ohio State University, Iovance has developed a product candidate called peripheral blood lymphocytes (PBLs). A clinical program to administer PBLs in chronic lymphocytic leukemia (CLL) patients is expected to begin in 2019.
Data from PD-1 selected TIL, one of the next generation TIL products at Iovance, will also be presented at SITC (Free SITC Whitepaper).
Corporate

In October 2018, the company closed an underwritten public offering of 25,300,000 shares of its common stock at a public offering price of $9.97 per share, before underwriting discounts. The shares sold at closing included 3,300,000 shares issued upon the exercise in full by the underwriter of its option to purchase additional shares at the public offering price less the underwriting discount. The net proceeds from the offering, after deducting the underwriting discounts and commissions and other offering expenses payable by the company, were $236.6 million.
Two U.S. patent applications covering therapeutic methods based upon Generation 2 manufacturing, which was developed at Iovance, were recently allowed.
Third Quarter 2018 Financial Results

Net loss for the third quarter ended September 30, 2018 was $33.8 million, or $0.36 per share, compared to a net loss of $22.1 million, or $0.35 per share for the same period ended September 30, 2017.

Research and development expenses were $27.9 million for the third quarter ended September 30, 2018, an increase of $11.3 million compared to $16.7 million for the third quarter ended September 30, 2017. The increase was primarily attributable to a $4.8 million increase in clinical trial costs due to; higher patient enrollment and an increase in the number of sites in the clinical trial of lifileucel for the treatment of metastatic melanoma, increased enrollment in the cervical and head and neck LN-145 clinical trials and the initiation of clinical trials in 2018 for new indications. Further, payroll and related expenses, including stock-based compensation expenses increased by $4.4 million due to a higher number of full time employees and dedicated consultants as the company expanded its internal research efforts and clinical development programs. In addition, research and alliance costs increased by $1.4 million for clinical trials run by Iovance’s alliance partners and new research initiatives and $0.7 million for the expansion of manufacturing capacity at the company’s Clinical Manufacturing Organizations (CMOs).

General and administrative expenses were $7.1 million for the third quarter ended September 30, 2018, an increase of $1.4 million compared to $5.7 million for the third quarter ended September 30, 2017. The increase was primarily attributable to a $1.5 million increase in stock-based compensation expenses due to an increase in the number of full time employees and higher stock prices during the quarter as compared to the same period in 2017.

Nine Months Ended September 30, 2018 Financial Results

Net loss for the nine months ended September 30, 2018 was $91.0 million, or $1.01 per share, compared to a net loss of $66.2 million, or $1.06 per share for the same period ended September 30, 2017.

Research and development expenses were $72.4 million for the nine months ended September 30, 2018, an increase of $21.5 million compared to $50.9 million for the same period ended September 30, 2017. The increase was primarily attributable to a $11.9 million increase in the company’s clinical trial costs for ongoing and newly initiated studies and a $10.1 million increase in payroll and related expenses, including stock-based compensation expenses, for a higher number of full time employees and expenses for services performed by third parties in support of the company’s clinical studies. Further, research and research alliance costs increased by $1.1 million as Iovance expanded its research efforts and the number of clinical development programs run by its collaborators. These increases were partially offset by a $1.5 million decrease in manufacturing costs due to higher costs in 2017 related to technical transfer activities.

General and administrative expenses were $20.9 million for the nine months ended September 30, 2018, an increase of $5.0 million compared to $15.9 million for the same period ended September 30, 2017. The increase was primarily attributable to a $4.3 million increase in payroll and related expenses, including stock-based compensation expenses, due to a higher number of full time employees and higher stock prices during 2018 and a $0.6 million increase in professional service and legal expenses.

At September 30, 2018, the company held $260 million in cash, cash equivalents, and short-term investments compared to $276.1 million at June 30, 2018. During the third quarter the company used $28.2 million for operating-related activities and received $12.1 million of proceeds from the exercise of warrants and stock options. In October 2018 the company received $236.6 in net proceeds from the issuance of common stock. The company anticipates that the year-end balance of cash, cash equivalents and short-term investments may be between $460 to $465 million.

Webcast and Conference Call
Iovance will host a conference call today at 4:30 p.m. ET to discuss these third quarter 2018 results and provide a corporate update. The conference call dial-in numbers are 1-844-646-4465 (domestic) or 1-615-247-0257 (international). The conference ID access number for the call is 8718039. The live webcast can be accessed under "News & Events" in the "Investors" section of the company’s website at View Source or you may use the link: View Source

A replay of the call will be available from November 6, 2018 at 7:30 p.m. ET to November 13, 2018 at 8:30 p.m. ET. To access the replay, please dial 1-855-859-2056 (domestic) or 1-404-537-3406 (international) and reference the access code 8718039. The archived webcast will be available for thirty days in the Investors section of Iovance Biotherapeutics’ website at View Source.

On November 6, 2018 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company developing highly selective medicines for patients with genomically defined cancers, reported that company management will participate in fireside chats at the following upcoming investor conferences (Press release, Loxo Oncology, NOV 6, 2018, View Source [SID1234530773]):

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Stifel Healthcare Conference in New York City on November 13, 2018 at 8:45 a.m. ET
Piper Jaffray Healthcare Conference in New York City on November 28, 2018 at 10:30 a.m. ET
Live webcasts of the fireside chats will be available at View Source

On November 6, 2018 Verastem, Inc. (Nasdaq: VSTM) (Verastem Oncology or the Company), focused on developing and commercializing medicines to improve the survival and quality of life of cancer patients, reported a poster presentation of preclinical data by Jonathan Pachter, Ph.D., the Company’s Chief Scientific Officer, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 33rd Annual Meeting being held November 7-11, 2018, in Washington, D.C (Press release, Verastem, NOV 6, 2018, View Source;p=irol-newsArticle&ID=2375552 [SID1234530795]).

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"We have assessed the activity of duvelisib, our orally-administered dual inhibitor of PI3K-delta and PI3K-gamma, in combination with either immune checkpoint or co-stimulatory antibodies in syngeneic antitumor models," said Dr. Pachter. "Results to be presented at SITC (Free SITC Whitepaper)’s 33rd Annual Meeting demonstrated that duvelisib shows strong anti-tumor synergy with PD-1 or OX40 antibodies. As a dual PI3K-delta/gamma inhibitor, duvelisib was found to reduce both immunosuppressive Tregs and myeloid cells in tumors more strongly than PI3K-delta, or PI3K-gamma only inhibitors, suggesting that it could be a highly-differentiated PI3K inhibitor for combination with immuno-oncology therapeutics. These preclinical results support clinical investigation of duvelisib in combination with immunotherapies for treatment of patients with hematological or solid tumor malignancies."

Details for the poster presentation are as follows:

Title: Synergistic efficacy of duvelisib with checkpoint or co-stimulatory antibodies in a B cell lymphoma model: Advantages of dual inhibition of PI3K-delta and PI3K-gamma

Abstract poster number: P373

Date and time: Friday, November 9, 2018 from 12:45-2:15 PM and 6:30 – 8:00 PM ET

Location: Hall E

A copy of the poster will be available here following its presentation at the meeting