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NEW EFTILAGIMOD ALPHA (LAG-3Ig or IMP321) DATA FOR PRESENTATION AT THE SOCIETY FOR IMMUNOTHERAPY OF CANCER (SITC) 2017 ANNUAL MEETING

On November 9, 2017 Prima BioMed Ltd (ASX: PRR; NASDAQ: PBMD) ("Prima") reported the presentation of new data from its TACTI-mel Phase I clinical trial in Australia investigating the use of eftilagimod alpha (LAG-3Ig or IMP321), the Company’s lead product candidate, in combination with pembrolizumab (KEYTRUDA) in unresectable or metastatic melanoma patients (Press release, Prima Biomed, NOV 9, 2017, View Source [SID1234521897]).

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The data will be presented in the poster titled "Pushing the accelerator and releasing the brake: testing the soluble LAG-3 protein (IMP321), an antigen presenting cell activator, together with pembrolizumab in unresectable or metastatic melanoma" (Poster Number P259) for the first time at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2017 Annual Meeting, to be held on November 10-12, 2017 at the Gaylord National Hotel & Convention Center in National Harbor, Maryland. Eftilagimod alpha, which is a soluble LAG-3Ig fusion protein, is an APC activator boosting T cell responses.

"The data to be presented at the SITC (Free SITC Whitepaper) meeting is very encouraging and demonstrates that anti-tumor activity was observed in patients following the administration of eftilagimod alpha in combination with pembrolizumab. Furthermore, it is important to note that prior to coming into this study, these patients were treated with pembrolizumab monotherapy and did not achieve a meaningful therapeutic benefit from this treatment," stated Dr. Frédéric Triebel, Prima’s Chief Scientific Officer and Medical Officer.
The patients eligible to participate in the TACTI-mel Phase 1 clinical trial are those that have either had a suboptimal response or had disease progression with KEYTRUDA monotherapy as a first-line of treatment. 12 patients from the first two cohorts of the trial were treated with 1 and 6mg doses of eftilagimod alpha respectively. The third cohort of patients, being treated with 30 mg doses, is ongoing.

Dr. Frédéric Triebel further commented, "The data also supports the hypothesis that there is a therapeutic synergy when administering an APC activator, which enhances anti-tumor T cell production, in combination with a checkpoint inhibitor, which releases the brake on the T cells."

The presentation at the SITC (Free SITC Whitepaper) conference includes the following results:

• Combination of eftilagimod alpha (1 and 6 mg) and pembrolizumab in advanced metastatic melanoma patients is safe and well tolerated;
• Anti-tumor activity (tumor reduction) was observed in 7/12 patients (58 %) in this study; prior to the study all of these patients either had a suboptimal response or had disease progression when treated with the pembrolizumab monotherapy;

• Data presented supports the hypothesis that combining an APC activator (IMP321) with a checkpoint inhibitor (pembrolizumab) results in a therapeutic synergy and a potential clinical benefit over a checkpoint inhibitor monotherapy;

• Data presented supports further investigation of IMP321 in combination with PD-1/ PD-L1 checkpoint inhibitors in different tumor types.

Marc Voigt, Prima’s Chief Executive Officer, added, "We believe the positive data, taken together with the excellent safety profile of eftilagimod alpha and data from our ongoing clinical trial in metastatic breast cancer, further validate the therapeutic utility of modulating the LAG-3 immune control mechanism. We are very pleased with the clinical progress of eftilagimod alpha and look forward to presenting additional data from the TACTI-mel clinical trial and exploring the potential therapeutic benefit of combining it with other checkpoint inhibitors in other solid tumors."
A copy of this SITC (Free SITC Whitepaper) poster presentation is available on Prima’s website in the Presentations section of the Investors tab at View Source

Supernus to Present at Three November Healthcare Conferences

On November 9, 2017 Supernus Pharmaceuticals, Inc. (NASDAQ: SUPN), a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases, reported that the Company’s management will present an overview and update for the Company, and host investor meetings at the following three conferences (Press release, Supernus, NOV 9, 2017, View Source [SID1234521905]):

Stifel 2017 Healthcare Conference
Date: Tuesday, November 14, 2017
Time: 11:45 a.m. EST
Place: Lotte New York Palace Hotel, New York

Jefferies 2017 London Healthcare Conference
Date: Thursday, November 16, 2017
Time: 4:40 p.m. GMT (11:40 a.m. EST)
Place: Waldorf Hilton, London, U.K.

Piper Jaffray 29th Annual Healthcare Conference
Date: Wednesday, November 29, 2017
Time: 8:00 a.m. EST
Place: Lotte New York Palace Hotel, New York

Investors interested in arranging a meeting with the Company’s management during these conferences should contact the conference coordinator.

A live webcast of the presentation can be accessed by visiting ‘Events & Presentations’ in the Investors Section on the Company’s website at www.supernus.com. An archived replay of these webcasts will be available for 60 days on the Company’s website after each conference.

TRACON Pharmaceuticals Presents Updated Data from Phase 1b/2 Study of TRC105 and Votrient® in Patients with Soft Tissue Sarcoma Including Angiosarcoma

On November 9, 2017 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, wet age-related macular degeneration and fibrotic diseases, reported updated data from the Company’s Phase 1b/2 study of TRC105 and Votrient (pazopanib) in patients with angiosarcoma at the Connective Tissue Oncology Society (CTOS) annual meeting taking place in Maui, Hawaii (Press release, Tracon Pharmaceuticals, NOV 9, 2017, View Source;p=RssLanding&cat=news&id=2315809 [SID1234521907]).

In poster presentation 2804349 entitled, "Every Other Week Dosing of TRC105 (Endoglin Antibody) in Combination with Pazopanib in Patients with Advanced Soft Tissue Sarcoma," updated data were presented from 18 angiosarcoma patients treated with the combination of TRC105 and Votrient, and an additional cohort of six soft tissue sarcoma patients treated with a hybrid dosing schedule of TRC105 and Votrient. Key results included:

TRC105 target concentrations previously shown to saturate endoglin receptors were achieved continuously using a TRC105 hybrid dosing schedule of 10 mg/kg weekly for four weeks followed by 15 mg/kg every other week.
Median progression-free survival (PFS) was 7.8 months in 13 VEGF inhibitor naïve angiosarcoma patients treated with the combination of TRC105 and Votrient using either 10 mg/kg weekly dosing or the hybrid dosing schedule of TRC105. This compares favorably to the median PFS of 3 months reported in a retrospective study of single agent Votrient in patients with angiosarcoma.
In the 17 patients who received prior treatment of metastatic disease, treatment duration on TRC105 and Votrient exceeded the duration of the most recent prior therapy in 7 of 12 VEGF naïve angiosarcoma patients and 2 of 5 patients who received a prior VEGF inhibitor as part of their most recent prior therapy.
Treatment with the combination of TRC105 and Votrient continued to be well-tolerated and allowed for dosing of the combination for more than two years in patients who experienced complete responses to treatment.

"The combination of TRC105 and Votrient continues to demonstrate the potential to deliver meaningful benefits to angiosarcoma patients. We continue to achieve important progress with the clinical development of this compelling product candidate, as our pivotal Phase 3 TAPPAS trial is now open at more than 20 sites in the U.S., and European sites are expected to open by year-end," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "We also continue to evaluate every other week dosing of TRC105 in other indications, including lung and liver cancers."

The poster is available on TRACON’s website at www.traconpharma.com.

About Carotuximab (TRC105)

TRC105 is a novel, clinical stage antibody to endoglin, a protein overexpressed on proliferating endothelial cells that is essential for angiogenesis, the process of new blood vessel formation. TRC105 is currently being studied in a pivotal Phase 3 trial in angiosarcoma and multiple Phase 2 clinical trials, in combination with VEGF inhibitors. TRC105 has received orphan designation for the treatment of soft tissue sarcoma in both the U.S. and EU. The ophthalmic formulation of TRC105, DE-122, is currently in a randomized Phase 2 trial for patients with wet AMD. For more information about the clinical trials, please visit TRACON’s website at www.traconpharma.com/clinical_trials.php.

Histogenics Corporation Announces Third Quarter 2017 Financial and Operating Results

On November 9, 2017 Histogenics Corporation (Histogenics) (Nasdaq:HSGX), a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function, reported financial and operational results for the quarter ended September 30, 2017 (Press release, Histogenics, NOV 9, 2017, View Source;p=RssLanding&cat=news&id=2315740 [SID1234521909]).

"With enrollment in the NeoCart Phase 3 clinical trial complete, we are focused on preparing for the top- line, superiority data and potential BLA filing for NeoCart in the third quarter of 2018. In the third quarter of 2017, we enhanced Histogenics’ operational capabilities and expanded our portfolio of data supporting the unique mechanism of action of NeoCart," stated Adam Gridley, President and Chief Executive Officer of Histogenics. "We believe that the data published in the Journal of Biomechanics in October 2017 provide additional evidence that Histogenics’ proprietary cell therapy platform produces cartilage that may accelerate recovery time and reduce pain. These data support the potential of NeoCart to replace microfracture as the standard of care for the treatment of knee cartilage defects, as well as the future development of additional product candidates from the NeoCart product platform. Histogenics’ priorities are now focused on preparing for our upcoming Biologics License Application (BLA) submission, further defining our commercial strategies for our launch of NeoCart, and our ongoing partnering activities for NeoCart in Japan and Asia."

Recent Highlights

Peer Reviewed Publication Further Strengthens NeoCart Data Portfolio. In October 2017, Histogenics announced the publication of a study, "In Vitro Culture Increases Mechanical Stability of Human Tissue Engineered Cartilage Constructs by Prevention of Microscale Scaffold Buckling" in the online version of the peer-reviewed Journal of Biomechanics. The study analyzes the compressive properties of engineered cartilage tissue grown with chondrocytes seeded in a porous scaffold. Histogenics intends to include the results of this study to provide additional data to the U.S. Food and Drug Administration (FDA) as part of a potential BLA for NeoCart, subject to a successful outcome in the ongoing NeoCart Phase 3 clinical trial.

Enhancement of Executive Team in Advance of Potential Approval and Commercialization of NeoCart. In October 2017, Histogenics promoted Stephen Kennedy from Chief Technology Officer to Executive Vice President & Chief Operating Officer. The promotion is consistent with Mr. Kennedy’s focus on the manufacturing scale-up of NeoCart to supply the U.S. market, if approved. Mr. Kennedy has more than 30 years of executive product development, manufacturing, technology assessment and commercialization experience at leading biotechnology companies, which includes extensive experience overseeing product technologies from development through commercial launch.

Financial Results for the Third Quarter of 2017

Loss from operations was $(5.7) million in the third quarter of 2017, compared to $(6.6) million in the third quarter of 2016. The decrease in operating expenses was primarily driven by a reduction in research and development expenses that was offset by an increase in general and administrative expenses.

Research and development expenses were $3.5 million in the third quarter of 2017, compared to $4.9 million in the third quarter of 2016. The decrease was primarily due to reductions in collaboration, consulting and temporary labor expenses and clinical trial-related costs. General and administrative expenses were $2.2 million in the third quarter of 2017, compared to $1.8 million in the third quarter of 2016. The increase was primarily due to activities related to a potential BLA submission and commercialization of NeoCart, if approved.

Net loss attributable to common stockholders was $(5.1) million in the third quarter of 2017, or $(0.23) per share, compared to $(9.2) million, or $(0.70) per share, in the third quarter of 2016. The decrease in net loss attributable to common stockholders is primarily due to lower operating expenses in the third quarter of 2017, $3.1 million in expenses related to the private placement completed in the third quarter of 2016 and an increase in weighted average shares outstanding, also resulting from the 2016 private placement.

As of September 30, 2017, Histogenics had cash, cash equivalents and marketable securities of $12.6 million, compared to $31.9 million at December 31, 2016. Histogenics believes its current cash position will be sufficient to fund its operations into the middle of 2018.

Conference Call and Webcast Information

Histogenics’ management will host a conference call on Thursday, November 9, 2017 at 8:30 a.m. ET. A question-and-answer session will follow Histogenics’ remarks. To participate on the live call, please dial 877-930-8064 (domestic) or 253-336-8040 (international) and provide the conference ID: 89009539 five to ten minutes before the start of the call.

A live audio webcast of the presentation will be available via the "Investor Relations" page of the Histogenics website, www.histogenics.com, or by clicking here. A replay of the webcast will be archived on Histogenics’ website for approximately 45 days following the presentation.

VistaGen Therapeutics Reports Second Fiscal Quarter 2018 Financial Results and Provides Business Update

On November 9, 2017 VistaGen Therapeutics Inc. (NASDAQ: VTGN), a clinical-stage biopharmaceutical company focused on developing new generation medicines for depression and other central nervous system (CNS) disorders, reported its financial results for its second fiscal quarter ended September 30, 2017 (Press release, VistaGen Therapeutics, NOV 9, 2017, View Source [SID1234521908]).

The Company also provided an update on its corporate progress and recently achieved milestone for AV-101, its oral CNS drug candidate in Phase 2 development, initially as a new generation adjunctive treatment for major depressive disorder (MDD).

"The FDA’s recent authorization to proceed under our AV-101 IND application is a significant milestone in our Phase 2 program focused on MDD," commented Shawn Singh, Chief Executive Officer of VistaGen. "With that authorization, we are now one step closer towards our goal of commencing our 180-patient, multi-center, double-blind, placebo-controlled Phase 2 adjunctive treatment study in the first quarter of 2018."

Milestones achieved during the quarter:
In October 2017, the U.S. Food and Drug Administration (FDA) authorized the Company to proceed under its Investigational New Drug (IND) application with its planned 180-patient, multi-center, double-blind, placebo-controlled Phase 2 study to assess the safety, tolerability and efficacy of AV-101 as an orally administered adjunctive treatment for adult MDD patients with an inadequate response to standard, FDA-approved antidepressants. Dr. Maurizio Fava of Harvard Medical School will be the Principal Investigator of this study, expected to begin in the first quarter of 2018 with completion expected at the end of 2018.

Recent Operational Highlights:
Intellectual Property Accomplishments

The European Patent Office granted a European Patent for AV-101 relating to the treatment of depression, Parkinson’s disease levodopa-induced dyskinesia (PD LID) and use of multiple dosage forms to treat these CNS disorders. The patent has been validated in Belgium, Denmark, France, Germany, Ireland, Italy, Portugal, Spain, Switzerland and the United Kingdom. It will be in effect until January 2034.
The Company received a Notice of Allowance from the U.S. Patent and Trademark Office for U.S. Patent Application No. 14/775,287 related to certain methods of production for AV-101.
The corresponding patent application related to methods of production for AV-101 was also granted in China.
Bolstered Clinical Team with Industry Expert

The Company appointed David Rotella, Ph.D. to the Scientific Advisory Board of VistaStem Therapeutics, the Company’s wholly owned subsidiary focused on utilizing the Company’s stem cell technology, to assist in advancing VistaStem’s small molecule drug rescue objectives and in evaluating other CNS-focused programs intended to expand VistaGen’s drug development pipeline. Dr. Rotella has extensive academic research and pharmaceutical industry experience in both medicinal chemistry and drug discovery, including key leadership roles on teams at Wyeth, Pfizer and Bristol-Meyers focused on drug candidates to fight cancer, cardiovascular disease, metabolic disorders, and neurodegenerative diseases.
Financial Results for the Fiscal Quarter Ended September 30, 2017:
Net loss for the fiscal quarter ended September 30, 2017 was approximately $5.0 million, including non-cash expenses of approximately $2.1 million, compared to $3.1 million for the fiscal quarter ended September 30, 2016, which included non-cash expenses of approximately $0.7 million.

Research and development expense totaled approximately $2.4 million for the fiscal quarter ended September 30, 2017, compared with approximately $1.6 million for the fiscal quarter ended September 30, 2016. The increase in year-over-year research and development expense was attributable to the Company’s increased focus on the continuing nonclinical and clinical development of AV-101 and ongoing preparations to launch its AV-101 MDD Phase 2 adjunctive treatment study.

General and administrative expense was approximately $2.6 million in the fiscal quarter ended September 30, 2017, compared to approximately $1.5 million in the fiscal quarter ended September 30, 2016, reflecting increased professional services expenses and noncash expense attributable to the grant of common stock for services, noncash warrant modification expense and, to a lesser extent, salary and benefits and noncash stock compensation expenses.

At September 30, 2017, the Company had cash of approximately $1.76 million, compared to approximately $1.63 million as of June 30, 2017. In September 2017, the Company completed an underwritten public offering of shares of its common stock and warrants. The gross proceeds from this offering were approximately $2.4 million, resulting in net proceeds of $2.0 million, after deducting the underwriting discount and offering expenses.

About VistaGen
VistaGen Therapeutics, Inc. (NASDAQ: VTGN) is a clinical-stage biopharmaceutical company focused on developing new generation medicines for depression and other CNS disorders. VistaGen’s lead CNS product candidate, AV-101, is in Phase 2 development, initially as a new generation oral antidepressant drug candidate for MDD. AV-101’s mechanism of action is fundamentally different from all FDA-approved antidepressants and atypical antipsychotics used adjunctively to treat MDD, with potential to drive a paradigm shift towards a new generation of safer and faster-acting antidepressants. AV-101 is currently being evaluated by the NIMH in a small Phase 2 monotherapy study in MDD being fully funded by the NIMH and conducted by Dr. Carlos Zarate Jr., Chief, Section on the Neurobiology and Treatment of Mood Disorders and Chief of Experimental Therapeutics and Pathophysiology Branch at the NIMH. VistaGen is preparing to launch a 180-patient Phase 2 study of AV-101 as an adjunctive treatment for MDD patients with an inadequate response to standard, FDA-approved antidepressants, with Dr. Maurizio Fava of Harvard University as Principal Investigator. AV-101 may also have the potential to treat multiple CNS disorders and neurodegenerative diseases in addition to MDD, including neuropathic pain, epilepsy, Huntington’s disease, PD LID and other disorders where modulation of the NMDA receptors, activation of AMPA pathways and/or key active metabolites of AV-101 may achieve therapeutic benefit.