On August 15, 2018 RXi Pharmaceuticals Corporation (NASDAQ: RXII) a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (sd-rxRNA) therapeutic platform reported that it has entered into a research collaboration with the Karolinska Institutet in Stockholm, Sweden (Press release, RXi Pharmaceuticals, AUG 15, 2018, View Source [SID1234528886]). This collaboration will explore RXi’s sd-rxRNA compounds against targets involved in T cell and NK cell differentiation and/or in the immune cell tumor-induced stress response with the aim of producing anti-tumor adoptive cell therapy grafts with improved functionality and persistence.

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This work will expand on the recently published results from the Kiessling group demonstrating that an sd-rxRNA targeting PD-1 can enhance TIL antitumor activity against melanoma cells in vitro, further showing that ex vivo treatment with the sd-rxRNA compounds was easily incorporated into a clinically relevant rapid expansion protocol for TILs.1

Dr. Gerrit Dispersyn, Chief Development Officer of RXi Pharmaceuticals, stated: "We are pleased to expand our collaboration with Dr. Kiessling’s group, to further harness their expertise in oncology and to expand on the successful research they have previously done with our sd-rxRNA technology platform in immuno-oncology. The combination of their prior results and the anticipated research results from this new collaboration are critical elements for a rapid advancement of sd-rxRNA immuno-oncology therapeutics into the clinic, further supported by our prior clinical experience with sd-rxRNA in other indications."

Rolf Kiessling, MD, PhD, Senior Professor in Experimental Oncology at the Karolinska Institutet, Senior Chief Physician at the Oncology clinic at the Karolinska University Hospital and member of RXi’s Scientific Advisory Board stated: "Our results to date provide direct clinical relevance for the use of sd-rxRNA technology to improve ACT. In this collaboration, we look forward to exploring using sd-rxRNA to modulate targets outside of checkpoints to improve efficacy of immune effector cells such as T cells and NK cells."

Immunotherapy of cancer has become increasingly important in clinical practice over the recent decade. By activating the patient’s immune system, immunotherapy treatments have shown remarkable promise in extending the lifespan of previously untreatable cancer patients. Adoptive cell therapy is an emerging immunotherapy approach which uses immune cells, such as T-lymphocytes or NK cells that are isolated from the patient or retrieved from allogeneic immune cell banks, and then expanded and in some cases processed to express tumor-binding receptors.

A new and important step in this ex-vivo processing of the immune cells is in development where self-delivering RNAi compounds (sd-rxRNA) are used to eliminate the expression of immunosuppressive receptors or proteins from the therapeutic immune cells, thereby making them less sensitive to tumor resistance mechanisms and improving their ability to destroy tumor cells. In this way, sd-rxRNA therapeutic compounds can be used to weaponize therapeutic immune cells to attack cancer and ultimately provide patients battling terminal cancers with a powerful new treatment option that goes beyond current treatment modalities.

About RXi Pharmaceuticals

RXi Pharmaceuticals Corporation (NASDAQ: RXII) is a biotechnology company developing the next generation of immuno-oncology therapeutics based on its self-delivering RNAi (sd-rxRNA) therapeutic platform. The Company’s discovery and research efforts are focused on developing sd-rxRNA therapeutic compounds to be used with an Adoptive Cell Transfer (ACT) approach. This process uses immune cells, such as T-lymphocytes that are isolated from the patient or retrieved from allogeneic immune cell banks, and then expanded and in some cases processed to express tumor-binding receptors. Our approach introduces a new and important step in ex-vivo processing of the immune cells where sd-rxRNA is used to eliminate the expression of immunosuppressive receptors or proteins from the therapeutic immune cells, making them less sensitive to tumor resistance mechanisms and thus improving their ability to destroy the tumor cells. Essentially, we aim to maximize the power of our sd-rxRNA therapeutic compounds by weaponizing therapeutic immune effector cells to attack cancer and ultimately provide patients battling terminal cancers with a powerful new treatment option that goes beyond current treatment modalities.

On August 15, 2018 Neuralstem, Inc. (Nasdaq:CUR), a biopharmaceutical company focused on the development of nervous system therapies based on its neural stem cell and small molecule compound technologies, reported its financial results for the second quarter ended June 30, 2018 (Press release, Neuralstem, AUG 15, 2018, View Source [SID1234528876]).

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"We are pleased to report a productive second quarter of 2018 as we continue to advance our pipeline of innovative neural stem cell and small molecule therapies," said Jim Scully, interim Chief Executive Officer of Neuralstem. "We are especially excited about the advancement of our lead stem cell therapy candidate, NSI-566, into a Phase 2 trial in ischemic stroke, as well as its potential application to other areas of unmet medical need. Additionally, based on encouraging preclinical data, we look forward to exploring our small molecule NSI-189’s potential treatment applications, including Angelman Syndrome and Alzheimer’s Disease."

Clinical Highlights

NSI-566, is a spinal cord-derived neural stem cell line that is being evaluated to treat paralysis associated with stroke, Amyotrophic Lateral Sclerosis (ALS) and chronic spinal cord injury (cSCI). NSI-566 is Neuralstem’s lead stem cell therapy candidate.

In July, Neuralstem announced initiation of a Phase 2 clinical trial evaluating NSI-566 as a potential treatment for ischemic stroke. This trial, which will be a randomized, double-blind, controlled study, is based on the positive results from the open-label Phase 1 safety study and is intended to further test the safety and efficacy of NSI-566 to reverse paralysis in stroke patients where half of their body has been partially paralyzed. James Li, Ph.D., Executive Vice President of Asia Operations of Suzhou Neuralstem Ltd, will be managing this trial which will be taking place at Bayi Brain Hospital in Beijing, China, and commenced on August 1, 2018. In Phase 1, NSI-566 treatment of 9 chronically hemiparetic stroke patients resulted in statistically significant improvement from baseline of motor functioning and clinical status.

In June, the Company announced the results from a study published in Cell Stem Cell that support the potential therapeutic application of transplanted NSI-566 in patients with chronic spinal cord injury (cSCI). The manuscript, entitled "A First-in-Human, Phase I Study of Neural Stem Cell Transplantation for Chronic Spinal Cord Injury," presented a detailed analysis of motor and sensory function and electrophysiology results which showed improvement in three of the four patients after NSI-566 transplantation. The study’s primary objective was to evaluate the safety of NSI-566 transplantation in subjects with stable thoracic spinal cord injury, and additional endpoints measured included changes in neurologic deficits, neurophysiology, and neuropathic pain.

In May, the Company announced the results from a study published in the Annals of Clinical and Translational Neurology in a manuscript entitled "Long-term Phase 1/2 Intraspinal Stem Cell Transplantation Outcomes in Amyotrophic Lateral Sclerosis" that support the potential of transplanted human spinal cord-derived neural stem cells (HSSC) to stabilize functioning of ALS patients. The study evaluated the impact of HSSC transplantation on functional outcomes, as measured using the ALSFRS-R scale, and on a composite statistic that combined functional and survival outcomes. Results were evaluated against matched controls derived from two historical datasets and showed significantly better ALSFRS-R scores at 24 months, as well as the composite functional/survival score in subjects receiving HSSC. The ALS Functional Rating Scale-Revised (ALSFRS-R) is a validated questionnaire that measures physical function in performing activities of daily living (ADLs).
NSI-189, is a small molecule benzylpiperazine-aminopyridine, in clinical development for MDD and in preclinical development for Angelman syndrome, irradiation-induced cognitive impairment, Type 1 and Type 2 diabetes, and stroke.

In August, the Company announced it had been granted orphan drug designation by the FDA for the treatment of Angelman Syndrome. In pre-clinical models, NSI-189 has demonstrated the ability to restore long term potentiation (LTP), a measure of synaptic plasticity and an in vitro biomarker of memory. Angelman Syndrome (AS) is a rare congenital genetic disorder caused by a lack of function in the UBE3A gene on the maternal 15th chromosome. It affects approximately one in 15,000 people – about 500,000 individuals globally. Symptoms of AS include developmental delay, lack of speech, seizures, and walking and balance disorders. Patients with AS may never walk or speak and require life-long care. Life expectancy is normal which places a significant burden on patients and caregivers. There are currently no FDA-approved therapies for the treatment of Angelman syndrome. The FDA’s orphan-drug designation program provides special status and incentives to encourage the development of drugs for diseases affecting fewer than 200,000 people in the U.S. Orphan drug designation confers seven years of market exclusivity upon FDA approval, as well as other development incentives, such as tax credits related to clinical trial expenses, an exemption from the FDA-user fee and FDA assistance in clinical trial design.

In July, the Company presented preclinical data at the Alzheimer’s Association International Conference in Chicago, Illinois, demonstrating that oral administration of NSI-189 in a mouse model of Alzheimer’s Disease leads to a significant amelioration and/or improvement in cognition measures and anxiety. Results were presented in a poster titled ‘Effect of Neurogenic Compound NSI-189 on Indices of Cognition and Anxiety in a Mouse Model (5XFAD) of Alzheimer’s Disease.’ The study was carried out by Dr. Corinne Jolivalt’s laboratory at the University of California, San Diego, and found that treatment with NSI-189 significantly improved learning ability as well as retention, short-term memory and anxiety levels of mice.
Corporate Highlights

Effective August 1, Jim Scully was appointed as interim chief executive officer by the Board of Directors. Mr. Scully succeeds Mr. Rich Daly, former Neuralstem president and chief executive officer. Mr. Scully brings to Neuralstem a wealth of experience from a range of senior executive roles in the pharmaceutical and broader healthcare industry, including leadership roles in financial and strategic planning, global business development and general management at Takeda Pharmaceuticals, Astellas Pharmaceuticals, Abbott Laboratories and Walgreens.

Also, effective August 1, the Board of Directors appointed William Oldaker as Chairman of the Board. Mr. Oldaker has served as a director of Neuralstem since April 2007. Additionally, he is a founder and partner in the Washington, D.C. law firm, Oldaker & Willison PLLP, and is a member of the Colorado, D.C. and Iowa Bar Associations, the Bar Association for the Court of Appeals, D.C., and the Bar of the United States Supreme Court.
Financial Results for the Quarter Ended June 30, 2018

Cash Position and Liquidity: At June 30, 2018, cash and investments was $7.1 million as compared to $9.7 million at March 31, 2018. The $2.6 million decrease reflects a $0.6 million loss for the period adjusted for certain non-cash items including a $1.4 million gain related to the change in fair value of our liability classified warrants, $760,000 net cash outflows related to changes in operating assets and liabilities, and $200,000 of share-based compensation. The Company expects its existing cash, cash equivalents and short-term investments to fund its operations based on its current operating plans, into the first quarter of 2019.

Operating Loss: Operating loss for the second quarter ended June 30, 2018 was $2.0 million compared to a loss of $4.2 million for the comparable period of 2017. Operating loss for the six months ended June 30, 2018 was $4.4 million compared to a loss of $8.5 million for comparable period of 2017.

The decrease in operating loss for both the three- and six-month periods was primarily related to decreases in clinical trial and related costs due to the completion of the NSI-189 Phase 2 clinical trial, decreases in personnel, facility and related expenses due to ongoing corporate restructuring and cost reduction efforts offset by revenues from a milestone-based royalty and reimbursements under a National Institute of Health (NIH) grant.

Net Loss: Net loss for the second quarter ended June 30, 2018 was $0.6 million, or $0.04 per share (basic), compared to a loss of $4.6 million, or $0.39 per share (basic), for the comparable period of 2017. The decrease in net loss was primarily due to a decrease in operating loss and the non-cash charges related to the change in the fair value of liability classified warrants.

Net loss for the six months ended June 30, 2018 was $2.8 million, or $0.18 per share (basic), compared to a loss of $12.2 million, or $1.06 per share (basic), for the comparable period of 2017. The decrease in net loss was primarily due to a decrease in operating loss and the non-cash charges related to the change in the fair value of liability classified warrants and warrant inducement expenses in the 2017 period and a decrease in interest expense related to our long-term debt which matured in April 2017.

Research and Development Expenses: The $1.0 million of research and development expenses for the quarter ended June 30, 2018 represents a $1.6 million, or 61% decrease over the comparable period of 2017. This decrease was primarily attributable to a $710,000 decrease in personnel and facility expenses due to ongoing corporate restructuring and cost reduction efforts, a $310,000 decrease in clinical trial and related costs due to the completion of our NSI-189 Phase 2 clinical trial and a $410,000 decrease in non-cash share-based compensation expense along with $90,000 of reimbursements under a NIH grant.

The $2.2 million of research and development expenses for the six months ended June 30, 2018 represents a $3.3 million, or 60% decrease over the comparable period of 2017. This decrease was primarily attributable to a $1.8 million decrease in personnel and facility expenses due to ongoing corporate restructuring and cost reduction efforts, a $540,000 decrease in clinical trial and related costs due to the completion of the NSI-189 Phase 2 clinical trial, a $720, 000 decrease in our non-cash share-based compensation expense along with $180,000 of reimbursements under a NIH grant.

General and Administrative Expenses: The $1.3 million of general and administrative expenses for the second quarter ended June 30, 2018 represents a $380,000, or 23% decrease over the comparable period of 2017. This decrease was primarily attributable to a $400,000 decrease in payroll and related expenses due to corporate restructuring and cost reduction efforts coupled with a $40,000 decrease in non-cash share-based compensation expense partially offset by a $70,000 increase in tax and insurance expenses.

The $2.4 million of general and administrative expenses for the six months ended June 30, 2018 represents a $530,000, or 18% decrease over the comparable period of 2017. This decrease was primarily attributable to a $560,000 decrease in payroll and related expenses coupled with a $40,000 decrease in consulting and professional service expenses due to corporate restructuring and cost reduction efforts partially offset by a $90,000 increase in our tax and insurance expenses.

On August 15, 2018 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, reported a favorable review of safety data from the second dose cohort of patients who received one billion transduced SPEAR T‑cells targeting MAGE-A4 in the ongoing basket study in nine solid tumor indications (Press release, Adaptimmune, AUG 15, 2018, View Source;p=RssLanding&cat=news&id=2363723 [SID1234528864]). Based on these data, the Safety Review Committee (SRC) has endorsed dose escalation to the third dose cohort of 1.2 to 6 billion cells.

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To date, three patients have received 100 million transduced MAGE‑A4 SPEAR T-cells in the first dose cohort, and three patients received one billion cells in the second cohort. No evidence of toxicity related to off-target binding or alloreactivity has been reported. Most adverse events were consistent with those typically experienced by cancer patients undergoing cytotoxic chemotherapy or other cancer immunotherapies.

"In Cohorts 1 and 2, we have observed cell expansion consistent with the doses administered. We are initiating dosing with 1.2 to 6 billion cells in the MAGE-A10 and MAGE-A4 studies. We have a number of patients whose cell products have been manufactured and these cells can be used when patients are ready for therapy. We remain on track to deliver initial data on response assessments from these cohorts during the second half of 2018," said Rafael Amado, Adaptimmune’s President of Research & Development.

Overview of Study Design MAGE-A4 Pilot Study

This is a first-in-human, open-label study utilizing a modified 3+3 design in up to 36 patients with escalating doses of 100 million (Cohort 1), 1 billion (Cohort 2), and 1.2‑6 billion (Cohort 3) transduced SPEAR T-cells to evaluate safety, including dose limiting toxicities (DLTs) followed by a possible expansion phase with doses of up to 10 billion SPEAR T-cells
This active trial is being evaluated across nine solid tumor indications including urothelial, melanoma, head and neck, ovarian, NSCLC, esophageal, and gastric cancers; as well as synovial sarcoma and myxoid/round cell liposarcoma (MRCLS)
Patients are screened under a separate protocol (Screening Protocol: NCT02636855) to identify those who have the relevant HLA-A*02 alleles and MAGE-A4 tumor expression
There was a 21-day stagger between patients in Cohort 1, with this stagger dropping to 7 days in Cohorts 2, and 3. There is no pre-determined stagger in the potential expansion phase
Cohorts 1-3 were intended to enroll 3 patients each with an expansion to 6 patients if DLTs were observed
The expansion phase can enroll up to 30 patients
The lymphodepletion regimen are:
Cohorts 1 and 2 – fludarabine (flu) (30mg/m2/day) and cyclophosphamide (cy) (600 mg/m2/day) for 3 days
Cohorts 3 and expansion phase – flu (30mg/m2/day) for 4 days and cy (600 mg/m2/day) for 3 days
Efficacy is assessed by overall response rate, time to response, duration of response, progression-free survival, and overall survival at weeks 4, 8, and 12, month 6, and then every 3 months until confirmation of disease progression
Adaptimmune’s Pipeline
Adaptimmune’s proprietary technology enables the Company to consistently generate affinity enhanced T-cell receptors (TCRs) that address intracellular targets on solid tumors that may not be accessible to certain other immunotherapy treatment modalities. Adaptimmune has three wholly owned SPEAR T‑cells in active clinical trials, with additional first and next generation SPEAR T‑cells being evaluated by means of Adaptimmune’s proprietary preclinical testing platform in advance of proceeding to the clinic.

Adaptimmune’s wholly owned SPEAR T-cells targeting MAGE‑A10, MAGE‑A4, and AFP are being evaluated in four active clinical trials across ten solid tumor indications:

MAGE-A10: Two active trials, one in NSCLC, and a triple tumor study in urothelial (bladder), melanoma, and head & neck cancers
MAGE-A4: One active trial across nine solid tumor indications including urothelial, melanoma, head and neck, ovarian, NSCLC, esophageal, and gastric cancers; as well as synovial sarcoma and myxoid/round cell liposarcoma (MRCLS)
AFP: One active study in hepatocellular (liver) cancer
Patients are receiving doses of 1.2-6 billion SPEAR T-cells across all the MAGE-A4 and MAGE‑A10 trials as there has been no evidence of off-target toxicity, to date, which has supported dose escalation

On August 14, 2018 GT Biopharma Inc. (OTCQB: GTBP) and (Euronext Paris: GTBP.PA), an immuno-oncology biotechnology company focused on innovative treatments based on the company’s proprietary platforms, reported the Chief Executive Officer, Dr. Raymond W. Urbanski, will present at the Wedbush PacGrow Healthcare Conference on Wednesday, August 15, at 1:50pm (Press release, GT Biopharma , AUG 14, 2018, View Source [SID1234539525]).

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Dr. Urbanski’s presentation will provide a corporate overview and highlight the company’s proprietary technology platforms. These innovative platforms include the tri- and tetra-specific natural killer cell engagers (TriKEs and TetraKEs) as well as their bi-specific antibody drug conjugates. In addition, Dr. Urbanski will provide an update to their current clinical and preclinical programs.

Dr. Urbanski said, "We are very excited to present at the Wedbush PacGrow Healthcare Conference. Conferences such as this gives us the opportunity to engage with leading institutional investors and interact with other global companies. It also allows us to further demonstrate that GT Biopharma is at the forefront of immune-oncology therapeutics."

A webcast of the conference presentation will be available on the company website at gtbiopharma.com after the conference.

On August 14, 2018 Cytori Therapeutics (NASDAQ: CYTX) ("Cytori" or the "Company") reported Q2 2018 financial results and provided updates on corporate activities (Press release, Cytori Therapeutics, AUG 14, 2018, View Source [SID1234529752]).

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Q2 2018 net loss was $3.7 million, or $0.59 per share. Operating cash burn for Q2 was approximately $2.7 million. Cytori ended Q2 with approximately $3.1 million of cash and cash equivalents, or approximately $8.8 million pro-forma at June 30, 2018, when considering $5.7 million in net cash proceeds received from a public rights offering which closed on July 25, 2018.

Cytori is developing for manufacture its lead chemotherapeutic drug, ATI-0918, a generic version of pegylated liposomal doxorubicin hydrochloride, with the goal of demonstrating bioequivalence to the European reference drug. Our Nanomedicine team in San Antonio, Texas continues to complete activities in support of a Marketing Authorization Application (MAA) to be filed with the European Medicines Agency (EMA) next year. The Company also continues to engage potential commercial partners for ATI-0918 in Europe, Middle East, North Africa, North America, and Asia Pacific. Furthermore, for Cytori’s ATI-1123 chemotherapy drug product candidate, an albumin-stabilized pegylated liposomal docetaxel, the Company has requested an orphan drug designation from FDA for small cell lung cell cancer and is evaluating the FDA’s 505(b)(2) new drug application (NDA) pathway in the U.S. which may offer accelerated and lower cost development.

Our Cell Therapy team is awaiting data readouts from clinical trials in scleroderma and urinary incontinence and is actively conducting a clinical trial in thermal burns. 6 month data from the 40 patient, French SCLERADEC II clinical trial (scleroderma) is expected before the end of 2018 and 1 year data from the 45 patient, Japanese ADRESU clinical trial (urinary incontinence) is expected in early 2019. Finally, U.S. FDA has approved a protocol amendment for the RELIEF thermal burn injury trial sponsored by BARDA intended to facilitate enrollment. Cytori completed a successful In-Process Review meeting with BARDA this past June. Thus far, Cytori and BARDA have initiated 2 of 8-10 anticipated U.S. clinical sites.

In Japan, Cytori continues to see favorable growth trends in the use of its commercially approved cell therapy products in the aesthetic and orthopedic markets. The Company remains on track to see continued double digit year over year growth in consumable utilization.

"Our primary corporate objective is to file for European market approval for ATI-0918, our lead oncology drug product. We have also expanded the development of our pipeline drug, ATI-1123, in the U.S. and we are priming it for phase II evaluation." said Dr. Marc Hedrick, President and Chief Executive Officer of Cytori. "We are also pleased with the quarter-over-quarter and year-over-year results of our commercial Cell Therapy efforts in Japan that are primarily focused on consumable utilization. This provides a growing business and infrastructure in anticipation of the SCLERADEC-II and ADRESU trials, in 2018 and 2019, respectively."

Q2 2018 and year-to-date Financial Performance

Q2 2018 and year-to-date operating cash burn was $2.7 million and $6.8 million, compared to $5.0 million and $9.9 million for the same periods in 2017, respectively.
Q2 2018 and year-to-date total revenues were $1.6 million and $3.2 million, compared to $1.5 million and $3.1 million for the same periods in 2017, respectively.
Q2 2018 and year-to-date consumable utilization in Japan grew by over 70% and 60%, when comparing to the same periods in 2017, respectively.
Cash and debt principal balances at June 30, 2018 were approximately $3.1 million and $13.0 million, respectively.
Q2 2018 net loss was $3.7 million or $0.59 per share, compared to a net loss of $6.0 million or $1.94 per share for Q2 2017.
Year-to-date net loss was $8.1 million or $1.32 per share, compare to an adjusted net loss of $13.6 million or $5.04 per share for the same period in 2017, respectively.
Selected Key Anticipated Milestones:

Complete ATI-0918 development and manufacturing required to prepare and file a MAA with the EMA.
Receive Orphan Drug Designation and 505(b)(2) pathway feedback from the U.S. FDA for ATI-1123.
Enroll burn patients in BARDA-funded U.S. RELIEF clinical trial.
Report 3 and 6 month French SCLERADEC II clinical trial data for scleroderma hand dysfunction.
Report 1 year Japanese ADRESU clinical trial data for post-surgical male stress urinary incontinence.
Management Conference Call Webcast

Cytori will host a management conference call at 5:30 p.m. Eastern Time today to further discuss its progress. The webcast will be available live and by replay two hours after the call and may be accessed under "Webcasts" in the Investor Relations section of Cytori’s website. If you are unable to access the webcast, you may dial in to the call at +1.877.402.3914, Conference ID: 4075028.