On February 28, 2019 Sensei Biotherapeutics, Inc., a clinical-stage biopharmaceutical company developing precision immuno-oncology therapies, reported that it will present novel preclinical data on SNS-723, a first-in-class CAR-T cell therapy and additional Phase 1 data on the long-term effects of SNS-301, a first-in-class cancer immunotherapy, both targeting a novel tumor specific embryonic antigen, human aspartate β-hydroxylase (ASPH), at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Atlanta, Georgia March 29 – April 3, 2019 (Press release, Sensei Biotherapeutics, FEB 28, 2019, View Source [SID1234533832]).

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Poster Session Details:

Poster Title: CAR-T cell therapies targeting aspartyl β-hydroxylase (ASPH)
Session Date and Time: Monday, April 1: 1:00-5:00pm ET
Session Title: Adoptive Cell Therapy 2
Location: Exhibit Hall B, Poster Section 22, Poster Board 5
Abstract Number: 2306

Poster Title: Long-term immunogenicity results from a first-in-human study evaluating the anti-ASPH cancer vaccine, SNS-301
Session Date and Time: Monday April 1: 8:00am – 12:00pm ET
Session Title: Cancer Vaccines and Intratumoral Immunomodulation
Location: Exhibit Hall B, Poster Section 22, Poster Board 9
Abstract Number: 1454

About SNS-723

SNS-723 is a first-in-class CAR-T cell therapy that is currently in preclinical development targeting human aspartate β-hydroxylase (ASPH), a cell surface enzyme that is normally expressed during fetal development. The recognition domain of the CAR is the scFv portion of a high affinity anti-ASPH mAb. SNS-723 is designed to overcome one of the major hurdles in T-cell therapy, the identification of antigens that permit effective targeting of tumors in the absence of non-tolerable and/or off-target toxicities to essential tissues and organs. Experiments to further characterize ASPH-targeted CAR-T cells are ongoing with the goal of moving these promising therapeutics into clinic.

About SNS-301

SNS-301 is a first-in-class cancer immunotherapy targeting human aspartate β-hydroxylase (ASPH), a cell surface enzyme that is normally expressed during fetal development. Following fetal development, the protein is no longer expressed. Expression of ASPH is uniquely upregulated in more than 20 different cancer types and promotes cancer cell growth, cell motility and invasiveness. ASPH expression levels in various tumors are inversely correlated with tumor resistance and patient survival. Through enhanced antigen presentation and other engineered immunotherapeutic features, SNS-301 is designed to overcome self- tolerance and induce robust and durable ASPH-specific humoral and cellular immune responses. SNS-301 is paired with a companion diagnostic to select antigen-positive patients and is delivered intradermally for ease of administration.

On February 28, 2019 Novocure (NASDAQ: NVCR) reported financial results for the quarter and year ended December 31, 2018, highlighting continued revenue growth, anticipated clinical and regulatory milestones and a strong cash position (Press release, NovoCure, FEB 28, 2019, View Source [SID1234533831]). Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer through the development and commercialization of its innovative therapy, Tumor Treating Fields.

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An "active patient" is a patient who is on Optune under a commercial prescription order as of the measurement date, including patients who may be on a temporary break from treatment and who plan to resume treatment in less than 60 days.

A "prescription received" is a commercial order for Optune that is received from a physician certified to treat patients with Optune for a patient not previously on Optune. Orders to renew or extend treatment are not included in this total.

"2018 was an extremely productive year for Novocure," said William Doyle, Novocure’s Executive Chairman. "Highlights included annual revenue growth of 40 percent, the presentation of our STELLAR data in mesothelioma, the first patient enrollment in our PANOVA-3 phase 3 trial for pancreatic cancer and our collaboration agreement with Zai Labs in China. We continued to grow our glioblastoma business globally and invested more than $50 million in research and development in 2018."

"At Novocure, we are working to extend survival in some of the most aggressive forms of cancer by developing and commercializing Tumor Treating Fields," continued Mr. Doyle. "With 2018 revenues approaching $250 million, four indications in our late stage pipeline and significant cash on hand, we believe we enter 2019 well-positioned to deliver both continued near-term growth and significant long-term value."

Fourth quarter 2018 operating statistics and financial update

There were 2,383 active patients on Optune at December 31, 2018, representing 30 percent growth compared to December 31, 2017, and 6 percent growth compared to September 30, 2018. The increase in active patients was driven by increased commercial adoption and by continued growth in prescriptions for patients with newly diagnosed GBM, who typically have a longer duration of treatment with Optune.

In the United States, there were 1,637 active patients on Optune at December 31, 2018, representing 24 percent growth compared to December 31, 2017.
In Germany and other EMEA markets, there were 654 active patients on Optune at December 31, 2018, representing 28 percent growth compared to December 31, 2017.
In Japan, there were 92 active patients on Optune at December 31, 2018, representing significant growth in the first year with reimbursement approval for Optune in Japan.
There were 1,315 prescriptions received in the quarter ended December 31, 2018, representing 21 percent growth compared to the same period in 2017, and 6 percent growth compared to the quarter ended September 30, 2018. Prescriptions for newly diagnosed GBM continued to grow, with approximately 950 Optune prescriptions in the fourth quarter written for patients with newly diagnosed GBM.

In the United States, 941 prescriptions were received in the quarter ended December 31, 2018, representing 16 percent growth compared to the same period in 2017.
In Germany and other EMEA markets, 322 prescriptions were received in the quarter ended December 31, 2018, representing 15 percent growth compared to the same period in 2017.
In Japan, 52 prescriptions were received in the quarter ended December 31, 2018, representing significant growth in the first year with reimbursement approval for Optune in Japan.
For the three months ended December 31, 2018, net revenues were $69.7 million, representing 30 percent growth versus the same period in 2017 and 8 percent growth versus the three months ended September 30, 2018. This growth was primarily driven by an increase in active patients.

For the three months ended December 31, 2018, cost of revenues was $23.0 million compared to $15.6 million for the same period in 2017, representing an increase of 47 percent. The increase was primarily driven by the cost of shipping transducer arrays to a higher volume of commercial patients and a one-time increase of $2.7 million in non-recoverable indirect taxes.

Research, development and clinical trials expenses for the three months ended December 31, 2018, were $15.0 million compared to $10.0 million for the same period in 2017, representing an increase of 50 percent. This was primarily due to an increase in clinical trial and personnel expenses for our METIS, LUNAR, and PANOVA-3 trials and an increase in personnel costs associated with regulatory and medical affairs.

Sales and marketing expenses for the three months ended December 31, 2018, were $21.2 million compared to $16.0 million for the same period in 2017, representing an increase of 32 percent. This was primarily due to increased marketing expenses, increases in personnel costs associated with a larger sales force globally and increased share-based compensation expense.

General and administrative expenses for the three months ended December 31, 2018, were $19.1 million compared to $16.5 million for the same period in 2017, representing an increase of 16 percent. This was primarily due to an increase in share-based compensation and an increase in professional services.

Personnel costs for the three months ended December 31, 2018, included $10.6 million in non-cash share-based compensation expenses, comprised of $0.4 million in cost of revenues; $1.3 million in research, development and clinical trials; $2.1 million in sales and marketing; and $6.9 million in general and administrative expenses. Total non-cash share-based compensation expenses for the fourth quarter 2017 were $6.4 million.

Net loss for the three months ended December 31, 2018, was $15.6 million compared to net loss of $10.9 million for the same period in 2017.

At December 31, 2018, we had $140.6 million in cash and cash equivalents and $105.3 million in short-term investments, for a total balance of $245.9 million in cash, cash equivalents and short-term investments. This represents an increase of $18.2 million in cash and investments since September 30, 2018.

Anticipated clinical and regulatory milestones

FDA approval for unresectable malignant pleural mesothelioma (2019)
Initiation of phase 3 pivotal trial in recurrent ovarian cancer (2019)
Zai Labs initiation of phase 2 pilot trial in gastric cancer (2019)
Data from phase 2 pilot HEPANOVA trial in advanced liver cancer (2020)
Interim analysis of phase 3 pivotal LUNAR trial in non-small cell lung cancer (2020)
Data from phase 3 pivotal METIS trial in brain metastases (2021)
Interim analysis of phase 3 pivotal PANOVA-3 trial in locally advanced pancreatic cancer (2021)
Final data from phase 3 pivotal LUNAR trial in non-small cell lung cancer (2021)
Interim analysis of phase 3 pivotal INNOVATE-3 trial in recurrent ovarian cancer (2022)
Conference call details

Novocure will host a conference call and webcast to discuss fourth quarter and full year 2018 financial results today, Thursday, Feb. 28, 2019 at 8 a.m. EDT. Analysts and investors can participate in the conference call by dialing 855-442-6895 for domestic callers and 509-960-9037 for international callers, using the conference ID 3956899.

The webcast, earnings slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for at least 14 days following the call.

Contractor advisory committee meeting details

The durable medical equipment Medicare administrative contractors (DME MACs) plan to host a contractor advisory committee on March 6, 2019 from 9 a.m. to 4 p.m. EDT to discuss the scientific evidence underlying Novocure’s local coverage decision reconsideration request.

The meeting agenda is available on the DME MAC web sites. Morning and afternoon sessions of the contractor advisory committee meeting can be viewed live on the Centers for Medicare and Medicaid Services YouTube channel. A recording of the meeting will also be posted on the DME MAC web sites following the meeting.

On February 28, 2019 Coherus BioSciences, Inc. (Nasdaq: CHRS), reported financial results for the quarter and full year ended December 31, 2018 (Press release, Coherus Biosciences, FEB 28, 2019, View Source [SID1234533827]).

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Fourth Quarter 2018 and Recent Corporate Highlights Include:

On November 2, 2018, the U.S. Food and Drug Administration (FDA) approved UDENYCA (pegfilgrastim-cbqv) for patients with non-myeloid cancer receiving myelosuppressive chemotherapy associated with a clinically significant incidence of febrile neutropenia. UDENYCA is Coherus’ first drug to receive FDA and European Commission approval.

In November 2018, Coherus received Q-Code medical billing status for UDENYCA from the Centers for Medicare and Medicaid Services, which became effective January 1, 2019.

On January 3, 2019, Coherus launched UDENYCA commercially in the U.S.

On January 7, 2019, Coherus entered into a $75 million senior secured credit facility agreement with Healthcare Royalty Partners.

In January 2019, Coherus entered into settlement and license agreements with AbbVie Inc. that grant the company global, royalty-bearing, non-exclusive license rights under AbbVie’s intellectual property to commercialize CHS-1420 (adalimumab (Humira) biosimilar).

Fourth Quarter and Full Year 2018 Financial Results:

Research and development (R&D) expenses for the fourth quarter of 2018 were $26.7 million, as compared to $31.5 million for the same period in 2017. R&D expenses for the fiscal year 2018 were $110.2 million, as compared to $162.4 million for the same period in 2017. The decreases in R&D expenses were mainly due to the completion of the clinical trials and related manufacturing for the immunology biosimilar drug candidates, CHS-0214 (etanercept (Enbrel) biosimilar) and CHS-1420. These cost decreases were partially offset by increased costs associated with the manufacturing of UDENYCA. Coherus had approximately 330,000 cumulative units of UDENYCA released as of December 31, 2018.

Selling, general and administrative (SG&A) expenses for the fourth quarter of 2018 were $33.8 million, as compared to $15.0 million for the same period in 2017. SG&A expenses for the fiscal year 2018 were $94.2 million, as compared to $71.3 million for the same period in 2017. The increases in SG&A expenses in 2018 were mainly attributable to the costs associated with hiring a sales force and completing the commercial functions and infrastructure to launch and sell UDENYCA in the U.S.

Cash and cash equivalents and investments in marketable securities for the fourth quarter totaled $72.4 million as of December 31, 2018, before receiving $73.1 million in net proceeds from the senior secured credit facility in January 2019, or a pro forma total of $145.5 million, as compared to $117.2 million as of September 30, 2018. Cash used in operations was $47.4 million during the fourth quarter of 2018, as compared to $42.8 million during the third quarter of 2018.

Net loss attributable to Coherus for the fourth quarter of 2018 was ($62.6) million, or ($0.92) per share, compared to a net loss of ($49.1) million, or ($0.84) per share, for the same period in 2017. Net loss attributable to Coherus for 2018 was ($209.3) million, or ($3.22) per share, compared to a net loss of ($238.2) million, or ($4.48) per share, for 2017.

Guidance for the Next Twelve Months from December 31, 2018:

UDENYCA (pegfilgrastim-cbqv), Neulasta (pegfilgrastim) biosimilar

Secure receipt of transitional pass-through status in 340-B hospitals in April 2019.

Increase penetration of patient and provider support programs and access portals.

Secure parity payment status with all national and local payers.

CHS-1420 (adalimumab (Humira) biosimilar)

Pursue manufacturing objectives in support of the anticipated filing of a 351(k) biologic license application (BLA) in the U.S.

CHS-3351 (ranibizumab (Lucentis) biosimilar) and CHS-2020 (aflibercept (Eylea) biosimilar)

Complete manufacturing technology transfer to support clinical development of CHS-3351.

Continue preclinical development of CHS-2020.

Conference Call Information

When: Thursday, February 28, 2019 starting at 4:30 p.m. ET

Dial-in: (844) 452-6826 (toll free) or (765) 507-2587 (International)

Conference ID: 3398069

Webcast: View Source

Please join the conference call at least 10 minutes early to register. The webcast will be archived on the Coherus website.

Fourth quarter and full year 2018 financial results, are posted on the Coherus website at View Source.

On February 28, 2019 OncoSec Medical Incorporated (OncoSec) (NASDAQ:ONCS), a company developing novel cancer immunotherapies, reported it will present pre-clinical data regarding its new anti-tumor product candidate during a poster presentation at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, which will be held March 29 – April 3, 2019 at the Georgia World Congress Center in Atlanta, Georgia (Press release, OncoSec Medical, FEB 28, 2019, View Source [SID1234533816]).

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The poster is entitled, "Intratumoral administration of plasmid IL-12 and CXCL9 with membrane-bound anti-CD3 elicits robust anti-tumor immunity," and outlines pre-clinical data demonstrating that IL-12, in concert with CXCL9, inflames tumors. This leads to a brisk T cell infiltrate and anti-tumor activity, which when combined with anti-CD3 stimulation, drives a robust systemic T cell response. A link to the abstract of the presentation can be found here.

OncoSec’s clinical studies have demonstrated that plasmid IL-12 (tavokinogene telseplasmid) delivered intratumorally (TAVO) induces local expression of IL-12, converting immunologically cold tumors into inflamed immunogenic lesions, which is fundamental to generating objective responses in both treated and untreated distant tumors. In order to identify the key immunological components associated with an effective therapy, OncoSec’s research laboratory used immunological findings made from previously treated TAVO patients to design its new, second product candidate.

"This new product candidate builds upon our plasmid-based cancer immunotherapy platform by amplifying the power of intratumoral IL-12 through the addition of both CXCL9, a critical T cell chemokine, along with a membrane bound pan T cell stimulator, anti-CD3," noted Christopher Twitty, Ph.D., Chief Scientific Officer of OncoSec. "Importantly, this new product candidate integrates three key immunotherapeutic elements into a single novel, multi-gene expression platform that we believe has broad applicability across a number of tumor targets. We look forward to filing an Investigational New Drug application for this promising new product."

Presentation details are as follows:

Session Category:

Immunology

Session Title:

Combination Immunotherapies

Presenter:

Anandaroop Mukhopadhyay, PhD, Principal Scientist

Session Date and Time:

April 2, 2019 8:00 A.M – 12:00 P.M.

Poster Board Number:

5

Abstract Number

3195

Location:

Georgia World Congress Center, Exhibit Hall B, Poster Session 23

About

On February 28, 2019 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq:SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that it will release its fourth quarter 2018 financial results on Thursday, March 7, after the close of the U.S. financial markets (Press release, Syndax, FEB 28, 2019, View Source [SID1234533815]).

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In connection with the earnings release, Syndax’s management team will host a conference call and live audio webcast at 4:30 p.m. ET on Thursday, March 7, to discuss the Company’s financial results and provide a general business update.

The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company’s website at www.syndax.com. Alternatively, the conference call may be accessed through the following:

Conference ID: 8252397
Domestic Dial-in Number: (855) 251-6663
International Dial-in Number: (281) 542-4259
Live webcast: View Source

For those unable to participate in the conference call or webcast, a replay will be available for 30 days on the Investors section of the Company’s website, www.syndax.com.