On April 2, 2018 SELLAS Life Sciences Group Inc., (Nasdaq:SLS) (SELLAS), a clinical-stage biopharmaceutical company focused on novel cancer immunotherapies for a broad range of cancer indications, reported positive interim data from the prospective, randomized, single-blinded, controlled Phase 2b independent investigator-sponsored clinical trial (IST) of trastuzumab (Herceptin) +/- nelipepimut-S (NeuVax) in HER2 1+/2+ breast cancer patients in the adjuvant setting to prevent recurrences (Press release, Sellas Life Sciences, APR 2, 2018, View Source [SID1234525120]).

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A pre-specified interim analysis, conducted by an independent Data Safety Monitoring Board (DSMB) of the efficacy and safety data for the study in an overall population of 275 patients as well as the two primary study target patient populations (node-positive and TNBC) after a median follow-up of 19 months, demonstrated a clinically meaningful difference in median disease-free survival (DFS) in favor of the active arm (NeuVax + Herceptin), a primary endpoint of the study, with hazard ratios of 0.67 and 0.61 in the intent to treat (ITT) and modified ITT (mITT) populations (i.e., those who received at least one dose of vaccine or control) as well as a 34.9% and 39.5% reduction in relative risk of recurrence in the active versus control arms in the ITT and mITT populations, respectively.

A clinically meaningful and also statistically significant difference was found between the two arms in the cohort of patients (n= 98) with triple-negative breast cancer (TNBC), with a hazard ratio of 0.26 and a p-value of 0.023 in favor of the NeuVax + Herceptin combination with a 70.4% reduction in relative risk of recurrence in the active arm versus control. Similarly, a clinically meaningful and statistically significant difference was found between the two arms in favor of the combination in the cohort of patients not receiving hormonal therapy (n = 110), with a hazard ratio of 0.24 and a p-value of 0.009 with a 74.1% reduction in relative risk of recurrence in the active arm versus control. This pre-specified interim analysis also showed an adverse event profile with no notable differences between treatment arms. The addition of NeuVax to Herceptin did not result in any additional cardiotoxicity compared to Herceptin alone.

"We are indeed excited about these compelling results and believe NeuVax + Herceptin has the potential to become an important therapeutic option for TNBC patients. The positive NeuVax phase 2b data underscores the innovative science and approach we have taken to investigate this agent’s potential to address this persistent therapeutic challenge. We plan to immediately engage with the FDA and EMA, as per the recommendation of the DSMB, to identify the optimal path forward in this particular patient group, while advancing the drug through a partnership or other strategic collaboration," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "These are indeed unique and exciting clinical data for TNBC patients, and I would like to extend my sincere gratitude to all patients who have participated in this clinical trial, as well as the study teams."

The NeuVax + Herceptin combination was found to be generally well-tolerated. The majority of treatment-emergent adverse events (TEAE) were of mild or moderate (G1/G2) severity and the majority of G3 systemic TEAEs were unrelated to NeuVax. Treatment-related adverse events consisted primarily of manageable local injection site reactions, skin induration, pruritus and fatigue.

Additionally, in the NeuVax + Herceptin arm, in vivo HER2-specific T-cell immune responses (IRs), assessed by delayed type hypersensitivity (DTH) skin testing, showed a time-dependent increase in IR potency compared to the earliest tested datapoint (p=0.000023), while no such increase was observed in the control arm.

Based on the results above, the DSMB has recommended to expeditiously seek regulatory guidance by the FDA for further development of the combination of NeuVax + Herceptin in TNBC, considering the statistically significant benefit of the combination therapy seen in this population with large unmet medical need.

"We are very pleased with these findings, which suggest that NeuVax + Herceptin may provide a clinically meaningful benefit to breast cancer patients with low-to-intermediate HER2-expression, especially given the recent report of the NSABP B-47 trial showing no benefit in these patients with Herceptin alone. Furthermore, our trial has shown a significantly improved disease-free survival in women with TNBC. The favorable findings for this cohort are particularly promising, given the limited treatment options for these patients with high risk of recurrence and death," commented COL (ret) George E. Peoples, MD, FACS, the study director and sponsor-investigator of the IST. "We look forward to presenting these data at an upcoming major medical conference and to supporting SELLAS in the regulatory and developmental pathway for NeuVax."

Herceptin is a registered trademark of Genentech, Inc. and is not a trademark of SELLAS. The manufacturer of this brand is not affiliated with and does not endorse SELLAS or its products.

About the NeuVax + Herceptin study

This Phase 2b trial is a multi-center, randomized, single-blinded, placebo-controlled trial in 275 HER2 1+/2+ breast cancer patients with positive nodes and/or TNBC. The study combines NeuVax and trastuzumab (Herceptin) in the adjuvant setting aiming to prevent recurrence or death. Tumors in these women show low levels of expression of HER2, as measured by immunohistochemistry (IHC), i.e., at a level of either 1+ or 2+ and, hence, these patients are not considered candidates for Herceptin. Patients who are hormone receptor-negative and HER2 1+/2+ by IHC are currently defined as ‘triple-negative’ breast cancer (TNBC) patients. NeuVax (nelipepimut-S) is a potentially first-in-class, HER2-directed cancer immunotherapy and is the immunodominant peptide derived from the extracellular domain of the HER2 protein, a well-established target for therapeutic intervention in breast carcinoma. The nelipepimut-S sequence stimulates specific CD8+ cytotoxic T lymphocytes (CTLs) following binding to specific HLA molecules on antigen presenting cells (APC) and destroy HER2 expressing cancer cells.

On April 2, 2018 OncoCyte Corporation (NYSE American:OCX), a developer of novel, non-invasive liquid biopsy tests for the early detection of cancer, reported financial results for the fourth quarter and full year ended December 31, 2017 (Press release, BioTime, APR 2, 2018, View Source;p=RssLanding&cat=news&id=2340629 [SID1234525312]).

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"Since our last quarterly update to investors in November, the team at OncoCyte has been busy making substantial progress on several fronts," commented William Annett, President and Chief Executive Officer. "OncoCyte has upgraded its management team, brought additional talent to its Board of Directors, strengthened its balance sheet, expanded its patent estate, and continued to advance the development of DetermaVu to be ready for potential commercialization by the end of 2018. So far in 2018 we have continued to be deeply engaged in a number of activities that we believe should create significant value for our shareholders over time by bringing innovative technologies to market that have the potential to save and improve the lives of cancer patients."
Recent Highlights

Strengthened balance sheet through a $10 million private placement of common shares with two current investors.

Discovered and filed patent applications for 190 novel lung cancer biomarkers that may enhance OncoCyte’s lung cancer test and enable better differentiation of malignant from benign lung nodules for improved lung cancer diagnosis.

Reported positive data from a small study using a preliminary algorithm incorporating a combination of existing and newly discovered biomarkers. The study demonstrated at least equivalent accuracy for DetermaVu in diagnosing lung cancer on three different commercial molecular diagnostic platforms. These results need to be verified in a larger confirmation study to confirm the potential utility of the new biomarker panel. The Company is currently conducting that study and expects that it will be completed during the second quarter of 2018.

Announced the appointment of Cavan Redmond, a director of the Company since 2015, as Chairman of the Board of Directors.

Continued to enhance our abilities to rapidly prototype, evaluate, and develop lung cancer diagnostic products through the continued growth of our well-characterized lung cancer clinical sample bank.

Upcoming Milestones in 2018
First half:
Complete DetermaVu confirmation study.
Second half:
Select final commercial platform for DetermaVu.

Conduct R&D Validation Study of DetermaVu

Conduct and report results of Analytical Validation Study of DetermaVu.

Conduct CLIA Validation Study of DetermaVu.

Conduct and report results of Clinical Validation Study of DetermaVu.

Fourth Quarter 2017 Financial Results

For the quarter ended December 31, 2017, OncoCyte incurred a net loss of $4.0 million, or ($0.13) per share, compared to a net loss of $3.1 million, or ($0.11) per share, in the fourth quarter of 2016.
Operating expenses for the three months ended December 31, 2017, were $3.9 million as reported, and were $3.3 million, on an as adjusted basis.

Research and development expenses for the fourth quarter of 2017, as reported, were $1.5 million compared to $1.4 million for the same period in 2016. The increased costs include outside laboratory and clinical trial expenses, salaries and payroll related expenses, stock-based compensation expenses, and charges to OncoCyte by its former parent company BioTime, Inc. for continued shared facilities and services provided to OncoCyte.

General and administrative expenses for the fourth quarter of 2017, as reported, were $1.8 million compared to $1.1 million for the same period in 2016. The $0.7 million increase was mainly attributable to increased legal and patent related costs, consulting, salaries and payroll related expenses, including stock-based compensation, as we upgraded our management team with additional key hires made in 2017.

Sales and marketing expenses for the fourth quarter of 2017, as reported, were $0.6 million, relatively unchanged from $0.5 million for the same period in 2016.

At December 31, 2017, OncoCyte had cash and cash equivalents of $7.6 million and available-for-sale securities valued at $0.8 million.

Fiscal 2017 Financial Results

For 2017, OncoCyte reported a net loss of $19.4 million, or ($0.64) per share, compared to $11.2 million, or ($0.42) per share, in 2016.

Operating expenses for 2017 were $18.8 million, as reported, and were $12.6 million, on an as adjusted basis.
Research and development expenses for 2017, as reported, were $7.2 million, compared to $5.7 million during 2016. The $1.5 million increase was primarily due to the certification and maintenance costs related to the Company’s CLIA laboratory and the cost of the DetermaVu program. The increased costs include outside laboratory and clinical trial expenses, salaries and payroll related expenses, including stock-based compensation, and charges to OncoCyte by its former parent company, BioTime, Inc., for continued shared facilities and services provided to OncoCyte.

General and administrative expenses for 2017, as reported, were $9.2 million compared to $4.3 million during 2016. The $4.9 million increase was mainly attributable to a $4.1 million noncash charge for the issuance of warrants to certain investors who exercised stock purchase warrants, $0.4 million in legal and patent related expenses, $0.3 million in personnel costs and related benefits, including stock-based compensation expenses, and $0.2 million in insurance expense.

Sales and marketing expenses for 2017, as reported, were $2.4 million compared to $1.2 million during 2016. The $1.2 million increase was mainly attributable to increases of $0.7 million in salaries and payroll related expenses, including stock-based compensation, $0.2 million in consulting expenses, and $0.2 million in amounts charged to OncoCyte by BioTime for continued shared facilities and services provided to OncoCyte.
Conference Call

OncoCyte will host a conference call today, April 2, 2018, at 4:30 p.m. ET / 1:30 p.m. PT to discuss financial results.
The dial-in number in the U.S./Canada is 800-281-7973, for international participants the number is 323-794-2093. For all callers, refer to Conference ID 4101947. To access the live webcast, go to the investor relations section on the company’s website, View Source
A replay of the conference call will be available for seven business days beginning about two hours after the conclusion of the live call, by calling 888-203-1112 toll-free (from U.S./Canada); international callers dial 719-457-0820. Use the Conference ID 4101947. Additionally, the archived webcast will be available View Source

On April 2, 2018 Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH) a clinical stage biopharmaceutical company developing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, reported that company management will give a corporate presentation at the H. C. Wainwright Annual Global Life Sciences Conference on Monday, April 9 at 10:40 a.m. CEST at Le Meridien Beach Plaza Hotel in Monte Carlo, Monaco (Press release, Tetraphase, APR 2, 2018, View Source [SID1234525121]).

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Live audio webcasts of the presentation will be available on the company’s website at View Source Archived presentations will be available for 30 days.

On April 2, 2018 Merck (NYSE:MRK), known as MSD outside the United States and Canada, reported that it will hold its first-quarter 2018 sales and earnings conference call with institutional investors and analysts at 8:00 a.m. EDT on Tuesday, May 1 (Press release, Merck & Co, FEB 2, 2018, View Source [SID1234525122]). During the call, company executives will provide an overview of Merck’s performance for the quarter.

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Institutional investors and analysts can participate in the call by dialing (706) 758-9927 or (877) 381-5782 and using ID code number 9499465. Members of the media are invited to monitor the call by dialing (706) 758-9928 or (800) 399-7917 and using ID code number 9499465. Journalists who wish to ask questions are requested to contact a member of Merck’s Media Relations team at the conclusion of the call.

On March 31, 2018 Shanghai Huaota Biopharmaceutical reported that its first category I biological product HB002 injection, IND number ‘CXSL1600123’, was approved by the CDE on June 20th 2017 (Press release, Huabo Biopharm, MAR 31, 2018, View Source [SID1234656061]). It marks Huaota’s first innovative biological drug has officially entered the stage of commercial clinical research.

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HB002 is a new type of recombinant human vascular endothelial growth factor receptor-antibody fusion protein ophthalmic injection, mainly used for the treatment of age-related macular degeneration (AMD). The drug is also known as ‘HB002.1T’, It can inhibit vascular endothelial growth as well as tumor activity. Its second indication application is intended to treat bowel cancer and gastric cancer.

the recombinant human vascular endothelial growth factor receptor-antibody fusion protein ophthalmic injection (HB002.1M) will start clinical trial in July 2017.