On November 7, 2017 SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company delivering innovative anti-infective therapies for difficult-to-treat and often life-threatening infections, reported financial results for the quarter ended September 30, 2017, and provided an update on recent operational and clinical developments (Press release, Scynexis, NOV 7, 2017, View Source [SID1234521717]).

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"During the quarter, we continued to advance the clinical development of the SCY-078 platform in multiple indications and expanded the body of evidence supporting the versatility of SCY-078 and its activity against a wide variety of fungal diseases," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "We’ve made significant progress in our lead studies, the DOVE study and the FURI study, and we look forward to continuing this momentum with the initiation of a new clinical study (the CARES study) in the fourth quarter to evaluate oral SCY-078 as a treatment for Candida auris infections, an increasingly urgent global health threat. We remain committed to advancing our vision of providing a novel treatment option to patients suffering from difficult-to-treat and often life-threatening infections."

SCY-078 Clinical and Regulatory Advancement

Dosing in Two Ongoing Clinical Studies Evaluating Oral SCY-078 Continues as Planned
Phase 2 dose-finding study (DOVE study) for the treatment of Vulvovaginal Candidiasis (VVC). Patient enrollment in this U.S.-based study is proceeding as planned with top-line results expected in mid-2018. This randomized, multicenter, double-blind, active-controlled, dose-finding Phase 2 study is designed to evaluate the safety and efficacy of five dosing regimens of oral SCY-078 compared to oral fluconazole, the standard of care.
Global, open-label study for the treatment of patients with invasive fungal infections that are refractory to or intolerant of standard antifungal agents (FURI study). Patient enrollment has started in this global study. It provides access to oral SCY-078 for patients battling invasive fungal infections, including multi-drug resistant, azole-resistant- or echinocandin-resistant Candida infections, who have failed other therapies and for whom treatment options are limited.
Global, Open-Label Candida auris Study (CARES Study) Opening for Patient Enrollment in the Fourth Quarter. Candida auris is a pathogen that is often multidrug-resistant, and systemic infections caused by Candida auris are associated with high mortality. The CARES study is designed to provide rapid access to oral SCY-078 for patients suffering from this life-threatening infection.
Clinical Development Status of Intravenous (IV) Formulation of SCY-078. Based on previous discussions with the U.S. Food and Drug Administration (FDA), SCYNEXIS is in the process of gathering the required data that will enable the submission of a complete response supporting the Company’s request to lift the clinical hold on the IV formulation of SCY-078. Upon lifting of the clinical hold, SCYNEXIS plans to test the intended IV dose regimen first in healthy volunteers before initiating a Phase 2 study for treatment of patients with invasive Candida infections. Commencement of this Phase 2 study is expected to occur in 2018.
Preclinical Data Support Clinical Activity of SCY-078

All recent scientific publications can be found at: View Source Based on promising in vitro and in vivo data of SCY-078 against Aspergillus infections, both as a single agent and in combination with standard of care, described in the first two data reports below, SCYNEXIS is evaluating potential clinical development steps for this indication.

Reported Data Further Showing SCY-078’s Activity in Numerous Potential Indications
IDWeek 2017 – SCY-078 as a potential treatment for Aspergillus and Candida infections. In October 2017, SCYNEXIS presented results from three studies supporting the potent and broad antifungal activity of SCY-078 against Candida and Aspergillus species. These results showed SCY-078’s potent activity against wild-type (WT) and azole-resistant strains of A. fumigatus, as well as against WT, azole-resistant and echinocandin-resistant strains of C. parapsilosis. In addition, SCY-078 showed significant and clinically-meaningful penetration into tissues relevant for the targeted indications, including lung, vaginal mucosa and kidney, following oral and IV administration in rats and mice.
TIMM 2017 – SCY-078 as a potential agent for combination therapy against Aspergillus spp. In October 2017, SCYNEXIS presented preliminary in vivo results of a study conducted by Thomas J. Walsh, M.D., Professor of Medicine in Microbiology and Immunology at Weill Cornell Medical College, and his team. SCY-078 was evaluated alone and in combination with isavuconazole in a neutropenic rabbit model of pulmonary aspergillosis. Preliminary results showed that SCY-078, when administered with isavuconazole, led to better outcomes than single agents.
IDSOG Annual Meeting – SCY-078 as a potential treatment of VVC. In August 2017, SCYNEXIS presented results highlighting SCY-078’s high penetration into vaginal tissue after oral administration and its potent anti-Candida activity in acidic pH conditions, characteristic of the vaginal setting, supporting the use of SCY-078 as a novel treatment of VVC.
Third Quarter 2017 Financial Results
Cash, cash equivalents and short-term investments totaled $47.7 million as of September 30, 2017, with net working capital of $42.0 million. We believe that our existing cash and cash equivalents and short-term investments will enable us to fund our operating expenses and capital expenditure requirements into the second quarter of 2019.

Research and development, net expenses, decreased to $4.5 million in the third quarter of 2017, compared with $4.9 million in the third quarter of 2016. The decrease of $0.4 million, or 8.8%, for the three months ended September 30, 2017, was primarily driven by a decrease of $0.3 million in both clinical and preclinical development and a net increase of $0.2 million in other research and development expenses.

Selling, general and administrative expenses increased to $2.0 million in the third quarter of 2017, compared with $1.9 million in the third quarter of 2016. The increase of $0.1 million, or 6.6%, was primarily driven by an increase of $0.1 million in stock-based compensation, a $0.1 million decrease in professional services and a $0.1 million net increase in other selling, general and administrative expenses.

Total other expense decreased to $2.0 million in the third quarter of 2017, compared with $4.5 million in the third quarter of 2016. The decrease of $2.5 million, or 55.7%, was primarily driven by a decrease of $2.9 million in the non-cash loss recorded on the adjustment in the fair value of the warrant liability, offset in part by a $0.4 million increase in interest expense.

Net loss for the third quarter of 2017 was $8.4 million, or $0.31 per share. This compares with a net loss for the third quarter of 2016 of $11.2 million, or $0.48 per share.

About SCY-078
SCY-078 is an antifungal agent in clinical and preclinical development for the treatment of fungal infections caused by Candida and Aspergillus species. SCY-078, a semi-synthetic derivative of the natural product enfumafungin, is the first representative of a family of triterpenoids—a structurally distinct and novel class of glucan synthase inhibitors. SCY-078 combines the well-established activity of glucan synthase inhibitors with the potential flexibility of having IV and oral formulations. By belonging to a chemical class distinct from other antifungals, SCY-078 has shown in vitro and in vivo activity against multi-drug resistant pathogens, including azole- and echinocandin-resistant strains. The FDA granted Fast Track, Qualified Infectious Disease Product and Orphan Drug Designations for the formulations of SCY-078 for the indications of invasive candidiasis (including candidemia) and invasive aspergillosis.On

On November 7, 2017 Cellectar Biosciences, Inc. (Nasdaq: CLRB), an oncology-focused, clinical stage biotechnology company (the "company"), reported that the ongoing median overall survival (mOS) from Cohort 1 of the Phase 1 study of its lead PDC compound, CLR 131 has reached 26.2 months in patients with multiple myeloma (Press release, Cellectar Biosciences, NOV 7, 2017, View Source [SID1234521672]). While no head-to-head studies have been conducted to date with CLR 131, for comparison, the median overall survival benefit seen with the three most recently FDA-approved third line therapies for multiple myeloma ranges from 11.9 – 18.6 months in separate trials.

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In the first cohort, the 26.2-month mOS benefit was observed following a single 30-minute infusion of 12.5mCi/m2 in heavily pretreated patients who had an average of 5.8 prior lines of therapy. The second cohort, which received a single dose of 18.75 mCi/m2 has experienced a mOS of 15.4 months to date, and the third cohort, which received a single dose of 25 mCi/m2 has experienced 10 months of mOS to date. It is important to note that the trial remains ongoing, and the median overall survivals for all cohorts could continue to increase over time.

As previously disclosed, Cohorts 2 and 3 were initiated approximately 10 and 18 months after the initiation of Cohort 1, thus accounting for the difference in mOS between the cohorts. Even though the mOS in each cohort remains ongoing, the values in all cohorts already compare favorably with the historic survival benefit seen with standard chemotherapy in a relapsed/refractory multiple myeloma setting. The company continues to collect overall survival data on all evaluable trial participants and expects to provide timely updates as the data mature.

"The ongoing median overall survival from the first cohort exceeding two years, and the second cohort’s mOS surpassing 15 months underscore the clinical potential of our CLR 131 program in multiple myeloma," said Jim Caruso, president and CEO of Cellectar Biosciences. "These observations taken together with the recently reported partial response from Cohort 3 leave us very optimistic with regard to advancing this compound through the clinic."

AVEO has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, AVEO, 2017, NOV 7, 2017, View Source [SID1234521622]).

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Novavax has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Novavax, 2017, NOV 7, 2017, View Source [SID1234521665]).

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On November 7, 2017 Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer reported that initial data from the ongoing trial of CB-839 in combination with Opdivo in patients with melanoma, renal cell carcinoma and non-small cell lung cancer will be presented Saturday, November 11th, 2017, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting (Press release, Calithera Biosciences, NOV 7, 2017, View Source [SID1234535250]). Calithera also announced it has expanded its existing clinical collaboration with Bristol-Myers Squibb, evaluating CB-839 in combination with Opdivo. CB-839 is an orally bioavailable glutaminase inhibitor currently in Phase 2 trials, and Opdivo is a PD-1 immune checkpoint inhibitor designed to overcome immune suppression.

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"This trial is designed to include patients who are currently receiving checkpoint inhibitor therapy and experiencing disease progression at the time of enrollment. There is significant unmet need among these patients, and the responses observed would not be expected with treatment with Opdivo alone in this population," said Susan M. Molineaux, Ph.D., founder, Chief Executive Officer and President of Calithera Biosciences. "The expanded clinical collaboration with Bristol-Myers Squibb will help us pursue our strategy of developing CB-839 in combination with Opdivo with the hope of improving treatment options for patients with cancer."

Calithera is conducting a Phase 1/2 trial (NCT02771626) in collaboration with Bristol-Myers Squibb designed to evaluate the safety, tolerability and efficacy of CB-839 in combination with Opdivo in patients with renal cell carcinoma, melanoma or non-small cell lung cancer. The study will be expanded to enroll additional melanoma patients. As part of the expanded collaboration, melanoma development costs will be shared, and a joint development committee will be established to guide the development and regulatory strategy.

The ongoing study enrolled three cohorts of patients who have received a checkpoint inhibitor (PD-1/PD-L1) in the most recent line of therapy.

Among 16 evaluable melanoma patients, all of whom were progressing on a checkpoint inhibitor at study entry, one patient achieved a complete response and two patients achieved partial responses. The overall response rate in this cohort was 19%, and the overall disease control rate was 44%.
Among six evaluable non-small cell lung cancer patients, all of whom were progressing on a checkpoint inhibitor at study entry, 67% experienced stable disease.
Among eight evaluable renal cell carcinoma patients, 75% were progressing and 25% had stable disease at study entry.

Stable disease was achieved in 75%, all of whom were progressing on a checkpoint inhibitor at study entry. The study enrolled one cohort of renal cell carcinoma patients who have received a checkpoint inhibitor in any prior line of therapy, but never achieved a response to checkpoint therapy.

Among seven evaluable checkpoint inhibitor experienced renal cell carcinoma patients, with a median of four prior lines of therapy, 57% experienced stable disease.

The study enrolled one cohort of renal cell carcinoma patients who were previously treated with VEGF inhibiting therapy, and were naïve to checkpoint inhibitors. Among 19 evaluable checkpoint inhibitor naïve renal cell carcinoma patients, four patients (21%) achieved a partial response and disease control rate was 74%. Fifty percent of the enrolled patients remain on study treatment.

An analysis of all safety evaluable patients demonstrated that CB-839 was well tolerated when combined with Opdivo in melanoma, renal cell carcinoma and non-small cell lung cancer patients. During dose escalation of the combination therapy, there was one report of dose limiting Grade 3 ALT increase, however no maximum tolerated dose was reported. The majority of adverse events reported have been mild to moderate with the most common being fatigue, nausea and photophobia. With 3.7% immune-related adverse events Grade ≥ 3, the data suggest there was no apparent increase in the rate or severity of immune related events compared to historical rates.

Dr. Funda Meric-Bernstam from MD Anderson Cancer Center will present the results on Saturday, November 11, 2017, in an oral and poster session (Abstract #O16), "A phase 1/2 study of CB-839, a first-in-class glutaminase inhibitor, combined with nivolumab in patients with advanced melanoma, renal cell carcinoma or non-small cell lung cancer." The oral presentation slides and the poster will be available on the Company’s website in the publication section at View Source

Calithera will webcast a clinical update on CB-839 on Saturday, November 11th at 3:30 p.m. Pacific Time/ 6:30 p.m. Eastern Time. The call can be accessed by dialing (855) 783-2599 (domestic) or (631) 485-4877 (international), and referring to conference ID 1878409. To access the live audio webcast or the subsequent archived recording, visit the Investors section of the Calithera website at www.calithera.com. The webcast will be recorded and available for replay on Calithera’s website for 30 days.

About CB-839
Calithera’s lead product candidate, CB-839, is a potent, selective, reversible and orally bioavailable inhibitor of glutaminase. CB-839’s onco-metabolism activity takes advantage of the unique metabolic requirements of tumor cells and cancer-fighting immune cells such as cytotoxic T-cells. It is currently being evaluated in Phase 2 clinical trials in multiple tumor types, in combination with standard of care agents.