On November 7, 2018 Tocagen Inc. (Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy company, reported that Marty Duvall, chief executive officer, reported that it will present at the following upcoming investor conferences (Press release, Tocagen, NOV 7, 2018, View Source;p=RssLanding&cat=news&id=2375950 [SID1234531165]):

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Wednesday, November 14, 11:00-11:40 a.m. ET in New York City
Stifel Nicolaus Healthcare Conference

Tuesday, November 27, 4:35-4:55 p.m. ET in Boston
Evercore ISI Biopharma Catalyst/Deep Dive Conference

The live audio webcasts from the conferences and subsequent replay may be accessed by visiting the "Events & Presentations" page in the investors section of Tocagen’s website. The webcasts will be available shortly after conclusion of the presentation and archived on the company’s website for 90 days following the presentation.

On November 7, 2018 Achieve Life Sciences, Inc. (Nasdaq: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation, reported third quarter 2018 financial results (Press release, OncoGenex Pharmaceuticals, NOV 7, 2018, View Source [SID1234531181]).

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Recent Highlights

The United States Adopted Name Council, or USAN, adopted cytisinicline as the nonproprietary (generic) name for the substance also known as cytisine

Announced initiation of the first trial in the ORCA (Ongoing Research of Cytisinicline for Addiction) Program. This Phase 2b optimization study will evaluate approximately 250 smokers in the U.S.

Reported results of a clinical study evaluating the effect of food on the bioavailability of a new formulation for cytisinicline

Closed registered direct offering for gross proceeds of $5.6 million

Announced positive cytisinicline data published in the International Journal of Drug Policy

Rick Stewart, Chairman and Chief Executive Officer of Achieve Life Sciences commented, "We are pleased with our continued progress made in the third quarter, particularly the initiation of the ORCA-1 trial that will provide critical insights to inform our Phase 3 program expected to initiate in the second-half of 2019."

"Cytisinicline" Designated as New Generic Name for Cytisine

The United States Adopted Names (USAN) Council adopted cytisinicline as the nonproprietary (generic) name in Q3 2018. USAN is responsible for selecting simple, informative, and unique generic drug names. The USAN Council establishes logical nomenclature classifications based on pharmacological and/or chemical relationships.

Initiated Phase 2b "ORCA-1"Optimization Trial

ORCA-1 is the first in Achieve’s ORCA (Ongoing Research of Cytisinicline for Addiction) Program that aims to evaluate the effectiveness of cytisinicline for smoking cessation and potentially other indications. This Phase 2b trial will evaluate both the 1.5mg and 3mg doses of cytisinicline on a declining titration schedule over 25 days, as well as three times daily dosing. The trial is randomized and blinded to compare the effectiveness of the cytisinicline doses and schedules to respective placebo groups. The primary efficacy endpoint is reduction in the number of cigarettes smoked during treatment with secondary analyses to be conducted on smoking cessation rates, safety, and compliance. ORCA-1 is being conducted at eight centers across the U.S. and results are expected in mid-2019.

Announced Study Results for New Formulation

The study evaluated the bioavailability of a new formulation of cytisinicline under fed and fasted conditions in 12 healthy volunteer smokers. Results demonstrated bioequivalence when cytisinicline was administered with or without food and that the 3mg dose of this new formulation was well tolerated.

Completed $5.6M Financing

Achieve announced the closing of a registered direct offering that raised total gross proceeds of $5.6 million and after deducting approximately $0.6 million in placement agent fees and offering expenses, receiving net proceeds of $5.0 million.

Publication of New Cytisinicline Data in the International Journal of Drug Policy

Results of an observational study comparing the effectiveness of cytisinicline and nicotine replacement therapy (NRT) as an aid to smoking cessation in the Russian Federation determined that smokers in the cytisinicline group were approximately three times more likely to achieve 90-days abstinence compared to those who attempted to quit with NRT (p=0.011). The authors concluded the findings support previous trial evidence indicating that cytisinicline is superior to NRT for achieving short- and long-term abstinence and should be considered a first-line pharmacologic treatment for smoking cessation.

Financial Results

As of September 30, 2018, the company’s cash, cash equivalents, short-term investments and restricted cash were $13.2 million. Total operating expenses for the three and nine months ended September 30, 2018 were $3.3 million and $9.1 million, respectively. Total net loss for the three and nine months ended September 30, 2018 was $3.2 million and $9.1 million, respectively

As of November 7, 2018 Achieve had 6,721,103 shares outstanding.

Conference Call Details

Achieve will host a conference call at 4:30 p.m. Eastern time today, Wednesday, November 7, 2018, to provide an update on the cytisinicline clinical development program and announce third quarter 2018 financial results. To access the webcast, log on to the Investor Relations page of the Achieve website at View Source Alternatively, you may access the live conference call by dialing (877) 472-9809 (U.S. & Canada) or (629) 228-0791 (International) and referencing conference ID 9922429. A webcast replay will be available approximately two hours after the call and will be archived on the website for 90 days.

On November 7, 2018 OncoSec Medical Incorporated (OncoSec) (NASDAQ:ONCS), a company developing intratumoral cancer immunotherapies, reported that the first patient has been treated in KEYNOTE-890, a Phase 2 clinical trial for the treatment of late-stage triple negative breast cancer (TNBC) with TAVO (intratumoral plasma encoded IL-12, or tavokinogene telseplasmid, plus electroporation) in combination with Merck’s KEYTRUDA (pembrolizumab) (Press release, OncoSec Medical, NOV 7, 2018, View Source [SID1234530901]).

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KEYNOTE-890 is designed as a multicenter Phase 2 open-label trial focusing on patients with a histologically confirmed diagnosis of inoperable locally advanced or metastatic TNBC and at least 1 prior line of approved systemic chemotherapy or immunotherapy. 25 patients are expected to be enrolled. Each patient will undergo 3-week treatment cycles with pembrolizumab administered as a 30-minute IV infusion day 1 of every cycle (flat dose of 200 mg) and treated with TAVO on days 1, 5 and 8 every six weeks.

"Treating the first patient in our KEYNOTE-890 clinical trial is an important milestone for OncoSec as we seek to rapidly advance this program," said Kellie Malloy Foerter, Chief Clinical Development Officer of OncoSec. "Additionally, this study is important for patients with metastatic triple negative breast cancer given the lack of treatment options currently available. Prior clinical observations suggest that TAVO in combination with pembrolizumab is a valid therapeutic approach for TNBC. Based on the outcome of the study and feedback from FDA, we may choose to expand the study and seek accelerated approval with the FDA for this patient population."

Breast cancer cells that test negative for estrogen receptors (ER-), progesterone receptors (PR-), and HER2 (HER2-) means the cancer is triple negative.1 Approximately 10-20 percent of U.S. breast cancer cases are triple negative breast cancer (TNBC),1 which disproportionately affects younger women, as well as African-American women,2 followed by Hispanic women.3

TNBC remains a poor-prognosis breast cancer subtype,2 with limited treatment options for patients with advanced, recurrent disease. In the recurrent disease setting, chemotherapy remains the standard of care, and median survival is approximately 13 months from the time of disease recurrence.4 Emerging evidence shows immunotherapy options may play an important role in the treatment paradigm for TNBC.5-8 Preliminary data from early-phase studies demonstrated the anti-PD-1 antibody pembrolizumab led to an objective response in 18 to 19 percent of TNBC patients;5-7 and median overall survival was 8.9 months in a pretreated cohort.6 The anti-PD-L1 antibody atezolizumab (MPDL3280A) achieved an objective response in 25 percent of patients in the first-line and 11 percent of patients in the second-line setting.8 There is increasing evidence that tumors need TILs for anti-PD-1/PD-L1 therapies to be most effective.9-12 Data also show TILs promote better responses to chemotherapy and improve clinical outcomes in breast cancer, including TNBC.13-17

On November 7, 2018 Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, reported financial results for the three and nine months ended September 30, 2018 and highlighted recent corporate progress (Press release, Heron Therapeutics, NOV 7, 2018, View Source [SID1234530918]).

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Recent Corporate Progress

Pain Management Franchise

Submitted NDA for HTX-011. On October 31, 2018, the Company announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for HTX-011. HTX-011 is an investigational, long-acting, extended-release formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for the management of postoperative pain.
CINV Franchise

CINV Sales. Chemotherapy-induced nausea and vomiting (CINV) franchise net product sales for the three and nine months ended September 30, 2018 were $19.8 million and $48.6 million, respectively, compared to $8.6 million and $20.7 million for the same periods in 2017, respectively. Heron has increased full-year 2018 CINV franchise net product sales guidance to $70 million to $72 million.
CINVANTI Sales. Net product sales of CINVANTI (aprepitant) injectable emulsion for the three months ended September 30, 2018 were $16.4 million. This compares to $11.2 million for the three months ended June 30, 2018 and $5.2 million for the three months ended March 31, 2018. CINVANTI was approved by the FDA on November 9, 2017 and became commercially available in the U.S. on January 4, 2018. Net product sales for CINVANTI were $32.8 million for the nine months ended September 30, 2018.
SUSTOL Sales. Net product sales of SUSTOL (granisetron) extended-release injection for the three and nine months ended September 30, 2018 were $3.4 million and $15.8 million, respectively. The entry of generic palonosetron in the first quarter of 2018 has had, and is expected to have, a several-quarter negative impact on provider demand for SUSTOL.

Permanent J-Code Assigned for CINVANTI. On November 5, 2018, a product-specific billing code, or permanent J-code, for CINVANTI was assigned with an effective date of January 1, 2019. The new J-code was assigned by the Centers for Medicare and Medicaid Services (CMS) and will help simplify the billing and reimbursement process for prescribers of CINVANTI.
"We are pleased with the advances made during the third quarter of 2018 in both our pain management and CINV franchises, highlighted by our recent NDA submission for HTX-011 and the increase in our full-year 2018 CINV franchise net product sales guidance," said Barry D. Quart, Pharm.D., Chief Executive Officer of Heron Therapeutics. "We look forward to preparing to launch HTX-011 in the U.S. for postoperative pain management, if approved, in 2019 and achieving our increased full-year 2018 CINV franchise net product sales guidance of $70 million to $72 million."

Financial Results

Net product sales for the three and nine months ended September 30, 2018 were $19.8 million and $48.6 million, respectively, compared to $8.6 million and $20.7 million for the same periods in 2017, respectively.

Heron’s net loss for the three and nine months ended September 30, 2018 was $38.3 million and $129.3 million, or $0.49 per share and $1.81 per share, respectively, compared to $41.9 million and $135.0 million, or $0.77 per share and $2.55 per share, for the same periods in 2017, respectively. Net loss for the three and nine months ended September 30, 2018 included non-cash, stock-based compensation expense of $8.1 million and $23.6 million, respectively, compared to $7.5 million and $23.6 million, for the same periods in 2017, respectively.

As of September 30, 2018, Heron had cash, cash equivalents and short-term investments of $364.8 million, compared to $172.4 million as of December 31, 2017. Net cash used for operating activities for the three and nine months ended September 30, 2018 was $35.9 million and $158.3 million, respectively, compared to $40.5 million and $123.2 million for the same periods in 2017, respectively.

About HTX-011 for Postoperative Pain

HTX-011, which utilizes Heron’s proprietary Biochronomer drug delivery technology, is an investigational, long-acting, extended-release formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for the management of postoperative pain. By delivering sustained levels of both a potent anesthetic and a local anti-inflammatory agent directly to the site of tissue injury, HTX-011 was designed to deliver superior pain relief while reducing the need for systemically administered pain medications such as opioids, which carry the risk of harmful side effects, abuse and addiction. HTX-011 has been shown to reduce pain significantly better than placebo or bupivacaine alone in five diverse surgical models: hernia repair, abdominoplasty, bunionectomy, total knee arthroplasty and breast augmentation. HTX-011 was granted Fast Track designation from the FDA in the fourth quarter of 2017 and Breakthrough Therapy designation in the second quarter of 2018. Heron recently submitted an NDA to the FDA for HTX-011.

About CINVANTI (aprepitant) injectable emulsion

CINVANTI, in combination with other antiemetic agents, is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin and nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). CINVANTI is an intravenous formulation of aprepitant, a substance P/neurokinin-1 (NK1) receptor antagonist. CINVANTI is the first intravenous (IV) formulation to directly deliver aprepitant, the active ingredient in EMEND capsules. Aprepitant (including its prodrug, fosaprepitant) is the only single-agent NK1 receptor antagonist to significantly reduce nausea and vomiting in both the acute phase (0 – 24 hours after chemotherapy) and the delayed phase (24 – 120 hours after chemotherapy). CINVANTI is the only IV formulation of an NK1 receptor antagonist indicated for the prevention of acute and delayed nausea and vomiting associated with HEC and nausea and vomiting associated with MEC that is free of polysorbate 80 or any other synthetic surfactant. Pharmaceutical formulations containing polysorbate 80 have been linked to hypersensitivity reactions, including anaphylaxis and irritation of blood vessels resulting in infusion-site pain. FDA-approved dosing administration included in the United States prescribing information for CINVANTI is a 30-minute infusion.

Please see full prescribing information at www.CINVANTI.com.

About SUSTOL (granisetron) extended-release injection

SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. SUSTOL is an extended-release, injectable 5-HT3 receptor antagonist that utilizes Heron’s Biochronomer drug delivery technology to maintain therapeutic levels of granisetron for ≥5 days. The SUSTOL global Phase 3 development program was comprised of two, large, guideline-based clinical studies that evaluated SUSTOL’s efficacy and safety in more than 2,000 patients with cancer. SUSTOL’s efficacy in preventing nausea and vomiting was evaluated in both the acute phase (0 – 24 hours after chemotherapy) and delayed phase (24 – 120 hours after chemotherapy).

On November 7, 2018 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported the first patient was dosed in a global Phase 3 clinical trial of its investigational BTK inhibitor zanubrutinib compared with ibrutinib in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) (Press release, BeiGene, NOV 7, 2018, View Source;p=RssLanding&cat=news&id=2375817 [SID1234531033]).

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"We continue to be encouraged by data on zanubrutinib in various B-cell malignancies and are excited to further expand the development program for zanubrutinib in CLL and SLL with this Phase 3 trial, which represents the second Phase 3 study directly comparing zanubrutinib to ibrutinib," said Jane Huang, M.D., Chief Medical Officer, Hematology, at BeiGene.

The global Phase 3 open-label trial is expected to enroll approximately 400 patients with relapsed/refractory CLL or SLL across approximately 150 study centers in the U.S., China, Europe, Australia and New Zealand. Patients will be randomized in a one-to-one manner to either zanubrutinib (160 mg orally twice daily) or ibrutinib (420 mg orally once daily). The primary endpoint is overall response rate, as determined by independent central review. Key secondary endpoints include progression-free survival, duration of response, overall survival, patient-reported outcomes, and safety.

Zanubrutinib was recently granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with Waldenström macroglobulinemia (WM). New drug applications (NDAs) in China for zanubrutinib as a treatment for patients with mantle cell lymphoma (MCL) and for patients with relapsed/refractory CLL or SLL, have been accepted for review by the National Medical Products Administration of China (NMPA, formerly known as CFDA or CDA).

Zanubrutinib is being studied in a broad registration program. In addition to this newly initiated Phase 3 trial, it is also being evaluated in a fully enrolled, global Phase 3 clinical trial in patients with WM comparing zanubrutinib to ibrutinib, a global Phase 3 clinical trial in patients with previously untreated CLL, and a pivotal Phase 2 trial in combination with GAZYVA (obinutuzumab) in patients with relapsed/refractory follicular lymphoma. In China, in addition to the MCL and CLL filings, BeiGene has completed enrollment in another pivotal Phase 2 clinical trial of zanubrutinib in patients with WM.

For more information about the trial, patients and physicians should email BeiGene at [email protected].

About Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are forms of non-Hodgkin lymphoma, a type of blood cancer, that arise from B lymphocytes. CLL and SLL are essentially the same disease, with the only difference being the location where the cancer primarily occurs.1 When most of the cancer cells are located in the bloodstream and the bone marrow, the disease is referred to as CLL, although the lymph nodes and spleen are often involved. When the cancer cells are located mostly in the lymph nodes, the disease is called SLL.2

About Zanubrutinib
Zanubrutinib (BGB-3111) is an investigational small molecule inhibitor of Bruton’s tyrosine kinase (BTK) that is currently being evaluated in a broad pivotal clinical program globally and in China as a monotherapy and in combination with other therapies to treat various B-cell malignancies.