Cellular Biomedicine Group (CBMG) Announces the Addition of a Second Clinical Site in the Expansion of its Chimeric Antigen Receptor T-cell (CAR-T) Phase I Clinical Trial for Its CARD-1 Trial in Patients with Non-Hodgkin Lymphoma (NHL)

On May 15, 2017 Cellular Biomedicine Group Inc. (NASDAQ: CBMG) ("CBMG" or the "Company"), a clinical-stage biopharmaceutical firm engaged in the development of effective immunotherapies for cancer and stem cell therapies for degenerative diseases, reported the addition of a new independent Phase I clinical trial of the Company’s ongoing CARD-1 study in patients with chemorefractory and aggressive DLBCL (Press release, Cellular Biomedicine Group, MAY 15, 2017, View Source [SID1234519124]). The Company and Shanghai Tongji Hospital (Tongji) are conducting a single arm, non-randomized study to evaluate the safety and efficacy of C-CAR011 (Anti-CD19 single-chain variable fragment (scFv) (41BB-CD3f)) therapy in relapsed or refractory B cell Non-Hodgkin Lymphoma (NHL). The trial will enroll 15 patients comprised of DLBCL, Primary Mediastinal Large B-Cell Lymphoma (PMBCL) and Follicular Lymphoma (FL).

"Driven by Shanghai’s regional demand, Tongji’s CAR-T expertise, the requirement to confirm site to site consistency and our need to prepare for the next phase of a confirmatory clinical trial, the new trial will benefit patients in Shanghai and provide CBMG with incremental data in safety and tolerability of C-CAR011 in more chemorefractory and aggressive DLBCL patients comprised of unique histogenesis and those with the most common indolent form of non-Hodgkin lymphoma (NHL). " said Mr. Tony Liu, Chief Executive Officer for CBMG.

Mr. Tony Liu added, "Due to our robust clinical pipeline, we believe the Company’s stock is currently undervalued. The management and our scientific team are committed to delivering long-term clinical benefits to patients that have the potential to address very large cancer and knee osteoarthritis markets and create long-term value for shareholders. We believe that CBMG has one of the very few leading integrated chemistry, manufacturing, and controls (CMC) facilities in the world for a cell therapy company, which when fully built out in China, will have the manufacturing capacity to support the treatment of 10,000 cancer and 10,000 knee osteoarthritis patients per year. With a healthy balance sheet and an efficient deployment of capital that will enable CBMG to execute on its clinical developments over the next twelve months, we are well equipped to further our clinical trials including the addition of new cancer indications by adding more top cancer centers in China for DLBCL and ALL trials using our C-CAR011 product. As a reminder, each year China has approximately five million new cancer patients, which far surpasses the U.S. We are pleased with our CAR-T patient screening and trial enrollment progress thus far and are on track to share our topline clinical data in the fourth quarter of this year as it becomes available. We look forward to evaluating new interests in expanding our clinical development and CAR-T partnerships with leading hospitals in major cities in China."

2017 Business & Technology Highlights

● In 2016, commenced patient enrollment in China for its CARD-1 ("CAR-T Against DLBCL") Phase I clinical trial utilizing CBMG’s optimized proprietary C-CAR011 construct of CD19 chimeric antigen receptor T-cell (CAR-T) therapy for the treatment of patients with refractory Diffuse Large B-cell Lymphoma (DLBCL);

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● Announced addition of second clinical trial site for its Chimeric Antigen Receptor T-cell (CAR-T) Phase I Clinical Trial for its CARD-1 Trial in patients with refractory Diffuse Large B-cell Lymphoma (DLBCL) in Shanghai with Tongji Hospital;

● Commenced CALL-1 ("CAR-T against Acute Lymphoblastic Leukemia") Phase I clinical trial in China utilizing its optimized proprietary C-CAR011 construct of CD19 chimeric antigen receptor T-cell (CAR-T) therapy for the treatment of patients with relapsed or refractory (r/r) CD19+ B-cell Acute Lymphoblastic Leukemia (ALL);

● Received the first disbursement of $1.2 million in the $2.29 million grant by California Institute for Regenerative Medicine (CIRM), California’s stem cell agency, to support pre-clinical studies of AlloJoinTM, CBMG’s "Off-the-Shelf" Allogeneic Human Adipose-derived Mesenchymal Stem Cells for the treatment of Knee Osteoarthritis in the United States;

● Completed expansion of its 30,000 square foot facility in Huishan High Tech Park in Wuxi, China, with 20,000 square feet of the Wuxi GMP facility dedicated to advanced stem cell culturing, centralized plasmid and viral vector production, cell banking and development of reagents;

● Began construction of a new GMP facility in "Pharma Valley" in Shanghai Zhangjiang High-Tech Park, which will consist of 40,000 square feet dedicated to advanced cell manufacturing;

● Established a strategic research collaboration with GE Healthcare Life Sciences China to co-develop certain high-quality industrial control processes in Chimeric Antigen Receptor T-cell (CAR-T) and stem cell manufacturing, and form a joint laboratory within CBMG’s new Shanghai Zhangjiang GMP-facility dedicated to the joint research and development of a functionally integrated and automated immunotherapy cell preparation system.

Preclinical data for reversible BTK inhibitor RXC005 presented at the 17th International Workshop of Chronic Lymphocytic Leukemia

On May 15, 2017 Redx Pharma Plc reported that preclinical efficacy data inmouse-models for its development candidate, RXC005, a reversible BTK inhibitor, has been presented in a poster session at the 17th International Workshop of Chronic Lymphocytic Leukemia (iwCLL) biennial meeting in New York City, U.S. on 14 May, 2017 (Press release, Redx Pharma, MAY 15, 2017, View Source [SID1234524749]).

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The poster, entitled "RXC005, a Potent and Selective, Reversible BTK Inhibitor Targeting both Wild-type and Mutant C481S BTK with Potent Efficacy in ABC-DLBCL Xenograft Mouse Models", demonstrated that RXC005 successfully inhibits wild-type BTK and C481S mutant BTK, as well as B-CellReceptor signalling in ABC-DLBCL cell lines and importantly primary CLL cells.

RXC005 was also shown to be highly selective and exhibits improved target specificity against other Tec and Src kinase family members. RXC005 demonstrated significant efficacy in ABC-DLBCL xenograft mouse models such as TMD8 and OCI-Ly10 cell lines. The poster can be found at View Source

Dr Neil Murray, Chief Executive Officer of Redx Pharma, commented: We are delighted to have presented further potent efficacy data for one of our lead development candidates, RXC005, at the prestigious iwCLL event in front of our peers and contemporaries.

Dr Richard Armer, Chief Scientific Officer of Redx Pharma, commented: The data presented is further validation of RXC005’s potential to target both wild-type and mutant BTK, an important emerging resistance mechanism in patients with CLL progression following ibrutinib treatment. With good target engagement demonstrated in the PK/PD studies and efficacy in mouse-models, we look forward to filing an IND/CTA in late 2017 to take RXC005 into the clinic.

Further Details:
XVII International Workshop of Chronic Lymphocytic Leukemia web site: View Source
Poster title: RXC005, a Potent and Selective, Reversible BTK Inhibitor Targeting both Wild-type and Mutant C481S BTK with Potent Efficacy in ABC-DLBCL Xenograft Mouse Models
Download the presentation poster: RXC005, a Potent and Selective, Reversible BTK Inhibitor

OSE Immunotherapeutics Presents New Data on Anti-SIRPa (Effi-DEM), the Checkpoint Inhibitor blocking Pro-Tumor and Suppressor Myeloid Cells at “Advances in Immuno-Oncology Congress”, London, May 15-16, 2017

On May 15, 2017 OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnémo: OSE) reported that the Company presented in oral session significant data on Selective Anti-SIRP a OSE-172 (Effi-DEM), at the "2 nd Annual Advances in Immuno-Oncology Congress" in London on May 15, 2017 (Press release, OSE Immunotherapeutics, MAY 15, 2017, View Source [SID1234519637]).

OSE-172 (Effi-DEM) is a humanized monoclonal antibody targeting SIRPa, expressed on suppressive myeloid cells (Myeloid Derived Suppressor Cells, MDSC and Tumor Associated Macrophages, TAM) as well as effector myeloid cells (anti-tumoral macrophages) involved in the Tumor Micro-Environment. As a selective antagonist of SIRPa, OSE-172 promotes recruitment of effector over suppressive myeloid cells, in particular it inhibits M 2 pro-tumorigenic macrophage cells and increases M1 anti-tumorigenic cells, whilst increasing effector memory CD8 T-cells resurrecting key immune defenses.

OSE-172 does not bind to red blood cells and platelets constituting a potential hematologic safety advantage. Moreover OSE-172 i s very selective as it antagonizes SIRPa and does not bind human T-cells (no SIRP- binding, receptor of the SIRP famil y expressed on T-cells), allow ing for a strong human effector T cell proliferation in parallel with a blockade of suppressive myeloid cells. This original mechanism of action provides reduction of tumor growth in various solid tumor models through a straight transformation in the Tumor Micro-Environment: When used as monotherapy or com bined with activators of the T-cell response, anti-PD-L1 (checkpoint inhibitor) and anti-41BB (costimulatory receptor), OSE-172 was very effective allowing effector macrophages and T-cells to work together with significant tumor shrinkage. In parallel with the transformation of suppressive into effector myeloid cells, T umor Micro-Environment was also dramatically modified allowing i ntra-tumoral accumulation of cytolytic natural killer (NK) and of effector B cells. A particular interest is a significant decrease of peripheral regulatory T-cells (suppressive Treg s). " Our myeloid checkpoint inhibitor OSE-172 demonstrate s its strong impact on the Tumor Micro-Environment beyond myeloid cells, tackling cancer through a specific blockade of SIRPa," said Nicolas Poirier, Chief Scientific Officer of OSE Immunotherapeutics. FOR MORE INFOR M ATION ON 2ND ANNUAL ADVANCES IN IMMUNO-ONCOLOGY C ONGRESS View Source 15-16 May 2017, London Session: Discove ry of Immuno-Oncology Therapies: Selective Anti-SIRPa: Next Generation Checkpoint Inhibitor Targeting Pro-Tumors And Suppressors Myeloid Cells Nicolas Poirier, Ph.D., C S O, OSE Immunotherapeutics

Sophiris Bio Reports First Quarter Financial Results and Key Corporate Highlights

On May 15, 2017 Sophiris Bio Inc. (NASDAQ: SPHS) (the “Company” or “Sophiris”), a late stage clinical biopharmaceutical company developing topsalysin (PRX302) for the treatment of patients with urological diseases, today reported first quarter financial results and key corporate highlights (Press release, Sophiris Bio, MAY 15, 2017, View Source [SID1234519162]).

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Key Corporate Highlights:

Update on Phase 2b Localized Prostate Cancer Study. In March 2017, the Company initiated its Phase 2b open-label localized prostate cancer study with investigational sites in both the UK and US. Five clinical trial sites have been initiated and additional sites are in the process of being initiated.

The Company is currently awaiting final regulatory clearance for the diluent (the medium in which topsalysin is diluted prior to dosing), which is anticipated this month, at which point the investigational sites will begin dosing patients.

The Company expects to receive the six-month biopsy data for all patients in the first quarter of 2018 assuming enrollment is completed as expected. The Company expects to have complete data on all patients who receive a second dose by the fourth quarter of 2018.

Presented Proof-of-Concept and Phase 2a Data at Global Urological Meetings. The Company presented positive data from its Phase 2a clinical trial of topsalysin for the focal treatment of localized prostate cancer at the 112th American Urological Association Annual Meeting and at the 32nd European Association of Urology Congress. Copies of the posters are available on the Company’s website at www.sophirisbio.com.

“We now have five clinical trial sites fully trained with additional sites coming onboard,” said Randall E. Woods, president and CEO of Sophiris. “The regulatory approval of the diluent is the last remaining box to check in the administrative work that enables the dosing of patients which we anticipate being able to do in the very near future.”

Financial Results:

At March 31, 2017, the Company had cash, cash equivalents and securities available-for-sale of $25.7 million and working capital of $25.6 million. The Company expects that its cash and cash equivalents will be sufficient to fund its operations through the end of 2018. The Company is currently not planning on pursuing a second Phase 3 trial in BPH, unless the Company can secure a development partner to fund a new clinical trial or the Company obtains other financing.

The Company reported a net loss of $2.6 million ($0.09 per share) for the three months ended March 31, 2017 compared to a net loss of $2.2 million ($0.13 per share) for the three months ended March 31, 2016.

Research and development expenses were $1.2 million for the three months ended March 31, 2017, compared to $0.9 million for the three months ended March 31, 2016. The increase in research and development expenses was primarily attributable to an increase in the costs associated with the Company’s on-going Phase 2b clinical trial for the focal treatment of localized prostate cancer which was initiated in March 2017 and, to a lesser extent, an increase in costs associated with manufacturing activities for topsalysin. These increases were partially offset by a decrease in costs associated with our completed Phase 2a proof of concept clinical trial for low to intermediate risk prostate cancer.

General and administrative expenses were $1.4 million for the three months ended March 31, 2017 compared to $1.2 million for the three months ended March 31, 2016. The increase in general and administrative expenses was primarily due to an increase in non-cash stock-based compensation expense which was offset by a reduction in legal and professional services.

Aeolus Announces Second Quarter Financial Results for Fiscal Year 2017

On May 15, 2017 Aeolus Pharmaceuticals, Inc. (OTCQB: AOLS), a biotechnology company developing compounds to protect against fibrosis, inflammation, nerve damage and infection reported financial results for the three months ended March 31, 2017 (Press release, Aeolus, MAY 15, 2017, View Source [SID1234519167]).

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The company reported net loss of $1,035,000 or $0.01 per share for the three months ended March 31, 2017. This compares to a net loss (before extraordinary items) of $629,000 or $0.01 per share for the three months ended March 31, 2016. The increase in net loss was primarily attributable to pre-IND work on AEOL 11114, the Company’s compound in development for the treatment of Parkinson’s disease and lower revenues from the Biomedical Advanced Research and Development Authority ("BARDA").

"During the quarter, we initiated a Phase 1 safety study of AEOL 10150 in healthy volunteers, completed manufacturing optimization and oral formulation development work on AEOL 11114 for Parkinson’s disease, and reported positive results in an animal model of Cystic Fibrosis with inhaled AEOL 20415," stated John L. McManus, President and Chief Executive Officer. "Although we were disappointed with BARDA’s notification in March that it had elected not to exercise additional options under the contract at this time, we are continuing work in process under the contract through its expiration in May 2019. In addition, we are submitting proposals to and have received indications of interest from other government agencies to expand the funding of AEOL 10150 as a medical countermeasure against the pulmonary effects of radiation exposure and sulfur mustard gas exposure."

Results of Operations for the Three Months Ended March 31, 2017

Revenue for the three months ended March 31, 2017 was $129,000, which compares to $565,000 for the three months ended March 31, 2016. The revenue is from the BARDA Contract and the decline in revenue is primarily attributable to a lower level of activity under that contract.

Research and Development ("R&D") expenses increased $93,000, or 19%, to $594,000 for the three months ended March 31, 2017 from $501,000 for the three months ended March 31, 2016. The increase is primarily attributable to manufacturing optimization and oral formulation development work for AEOL 11114.

General and administrative ("G&A") expenses decreased $123,000, or 18%, to $570,000 for the three months ended March 31, 2017 from $693,000 for the three months ended March 31, 2016. The decrease is primarily attributable to lower accounting and legal fees related to SEC filing requirements.

Results of Operations for the Six Months Ended March 31, 2017

Revenue for the six months ended March 31, 2017 was $212,000, which compares to $870,000 for the six months ended March 31, 2016. The revenue is from the BARDA Contract and the decline in revenue is primarily attributable to a lower level of activity under that contract.

Research and Development ("R&D") expenses increased $89,000, or 9%, to $1,082,000 for the six months ended March 31, 2017 from $993,000 for the six months ended March 31, 2016. The increase is primarily attributable to manufacturing optimization and oral formulation development work for AEOL 11114.

General and administrative ("G&A") expenses decreased $2,000 to $1,252,000 for the six months ended March 31, 2017 from $1,254,000 for the six months ended March 31, 2016. The decrease is primarily attributable to lower investor relations fees.

As of March 31, 2017, the Company had approximately $981,000 in cash and cash equivalents and 152,085,825 common shares outstanding. The Company had accounts receivable of $603,000 and accounts payable of $638,000 on March 31, 2017.

Aeolus has filed today with the SEC its Quarterly Report on Form 10-Q for the quarter ended March 31, 2017. Aeolus urges its investors to read this quarterly filing as well as its Annual Report on Form 10-K, also filed with the SEC, for further details concerning the Company. The Quarterly Report on Form 10-Q and the Annual Report on Form 10-K are also available on the Company’s website, at www.aolsrx.com.

About AEOL 10150

AEOL 10150 is a superoxide dismutase (SOD) mimic being developed for the treatment/mitigation of lung damage from exposure to chemical and radiological insults and to reduce/prevent lung damage in patients with Idiopathic Pulmonary Fibrosis (IPF) and in cancer patients receiving radiation therapy. AEOL 10150 protects tissue from damage and increases survival in animal models of lung damage after exposure to radiation toxic chemicals, agents that induce inflammation, and trauma by mitigating and/or preventing cell death, inflammation and fibrosis through its action on oxidative stress (Reactive Oxygen Species, or "ROS") and regulation of growth factors and chemokines including PTEN, TGF-β1, HIF-1α, TNF-α and IL-6, as well as impacting subsequent signaling pathways associated with ROS production, apoptosis and fibrosis such as NADPH-oxidase (Nox-4), PTEN, PI3K/p-Akt and p53/Bax. AEOL 10150 has been shown to improve survival and mitigate pulmonary damage in rodent models of SMG, chlorine gas and radiation exposure and in a nonhuman primate (NHP) model of whole thorax lung irradiation (WTLI). Given these promising results, Aeolus is developing AEOL10150 for the mitigation and/or treatment of pulmonary injury resulting from SMG exposure.

AEOL 10150 has performed well in animal safety studies, was well tolerated in two human clinical trials and is currently being tested in a third human study. Aeolus has received "Orphan Drug" designation for use in treating Lung ARS, Idiopathic Pulmonary Fibrosis and Amyotrophic Lateral Sclerosis and has active IND’s for the Lung ARS and ALS indications. Preparations are currently underway to make IND filings for Idiopathic Pulmonary Fibrosis, Cancer Radiation Therapy and Pulmonary Effects of Sulfur Mustard Gas Exposure.