On November 6, 2019 Cellular Biomedicine Group Inc. (NASDAQ: CBMG) ("CBMG" or the "Company"), a biopharmaceutical firm engaged in the drug development of immunotherapies for cancer and stem cell therapies for degenerative diseases, reported its financial results and business highlights for the third quarter of 2019 (Press release, Cellular Biomedicine Group, NOV 6, 2019, View Source [SID1234550512]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"During the third quarter of 2019, we made great strides in both corporate and clinical progress. We started our U.S. expansion for research and clinical development in a new 22,000 square foot facility in Rockville, Maryland in October 2019. This milestone will allow us to foster strategic partnerships, develop new innovations and support continued development of CBMG’s cell therapy-based immune-oncology assets that have shown promise in early proof-of-concept trials in China," said Tony (Bizuo) Liu, Chief Executive Officer for the Company.

"We also had continued progress on the clinical side, with the initiation of our Phase II clinical trial in China of AlloJoin therapy for knee osteoarthritis (KOA). Additionally, our autologous stem cell therapy program for KOA, ReJoin, was accepted by the NMPA in China to begin a Phase II clinical trial. We are excited about our regenerative medicine programs as we are currently the only company that has received two clinical trial acceptances for any stem cell program in China."

Mr. Liu continued, "Presentations of our pre-clinical and clinical data at upcoming medical conferences later this year will demonstrate continued focus on our immune-oncology pipeline and we are proud to provide an update of our commitment to cancer immunotherapy."

Third Quarter 2019 and Other Recent Corporate Developments

New facility to expand research and development and to support clinical development in Rockville, MD
Initiation of AlloJoin therapy for multiple-site Knee Osteoarthritis Phase II clinical trial
ReJoin therapy received stem cell drug application acceptance for Phase II clinical trial by NMPA
Upcoming Clinical and Preclinical Presentations:

Society of Immunotherapy in Cancer ("SITC") 34th Annual Meeting
Poster Presentation
The Next Generation "Off-The-Shelf" Universal CAR For Adoptive Immunotherapy (Abstract ID: P229)
Friday, November 8, 2019 – 7:00 AM – 8:00 AM ET
Gaylord National Hotel & Convention Center, National Harbor, MD
American Society of Hematology ("ASH") 61st Annual Meeting and Exposition
Oral Presentation
Developing a Novel Anti-BCMA CAR-T For Relapsed or Refractory Multiple Myeloma (Submission ID: 125372)
Saturday, December 7, 2019 – 7:45 AM – 8:00 AM ET
Orange County Convention Center (OCCC), Orlando, FL
Financial Results for the Third Quarter of 2019

Net loss allocable to common stock holders for the quarter and nine months ended September 30, 2019 was $15.9 million and $37.3 million respectively, compared to $12.7 million and $30.4 million for the same periods in 2018.
General and administrative expenses for the quarter and nine months ended September 30, 2019 were $3.3 million and $10.0 million, respectively, compared to $3.3 million and $9.6 million for the same periods in 2018.
Research and development expenses for the quarter and nine months ended September 30, 2019 were $13.1 million and $28.2 million respectively, compared $6.5 million and $18.0 million for the same periods in 2018.
Net cash used in operating activities for the nine months ended September 30, 2019 was $28.1 million, compared to $19.4 million for the same period in 2018.
Cash balance was $29.0 million as of September 30, 2019, compared to $39.7 million as of June 30, 2019.
Conference Call and Webcast Information
The Company will host a conference call and webcast with the investment community on Wednesday, November 6th at 4:30 p.m. Eastern Time featuring remarks by Tony Liu, Executive Director, CEO and CFO of CBMG.

Live Call:

Toll-Free: 1-855-327-6838

International: 1-604-235-2082

Webcast:

View Source

Replay:

Toll-Free: 1-844-512-2921

International: 1-412-317-6671

Conference ID: 10007976

(Available approximately two hours after the completion of the live call until 11:59 p.m. ET on November 20, 2019)

On November 6, 2019 Akoya Biosciences, Inc., The Spatial Biology Company, reported that data generated with its CODEX and Phenoptics multiplex immunofluorescence platforms will be presented at the 34th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), taking place in National Harbor, MD, from November 6th to 9th (Press release, Akoya Biosciences, NOV 6, 2019, View Source [SID1234550542]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Cancer immunotherapy is a transformative treatment modality, but mounting evidence indicates that current biomarkers do not reliably predict treatment response for the majority of patients. As noted in a recent publication, multiplex immunofluorescence and multiplex immunohistochemistry, which preserve critical spatial data about cell proximity and interaction in the tumor microenvironment, offers higher predictive power than traditional immunohistochemistry and emerging genomic biomarkers. The CODEX and Phenoptics Solutions provide industry leading highly multiplexed, spatially resolved biomarker detection for basic, translational, and clinical research.

At SITC (Free SITC Whitepaper) 2019, Akoya and its customers will present results from the latest immuno-oncology studies enabled by these platforms. A sponsored dinner symposium entitled "High-plex Spatial Analysis of the Tumor Microenvironment: Advancements and Applications," will take place at 6:30 pm on Friday, November 8th, at the Gaylord National Convention Center. The featured speakers include Dr. Robert Pierce from the Fred Hutchinson Cancer Research Center as well as Victoria Duckworth, Cliff Hoyt, and Dr. Julia Kennedy-Darling from Akoya. In addition to presenting new workflow innovations, Akoya’s presenters will also share a cross-platform comparison of the CODEX and Vectra Polaris systems that will simplify the translation of biomarkers from discovery to high-throughput validation. Further details can be found at www.akoyabio.com/sitc2019.

Conference attendees can also get hands-on experience with the CODEX and Vectra Polaris systems at the Akoya booth (#330). In-booth software demos will take place during the Friday and Saturday lunch sessions covering these tools:

A preview of the soon-to-be launched Proxima Solution to meet researchers’ data storage, image management and data analysis needs
Akoya’s inForm TissueFinder and phenoptrReports for analyzing and visualizing complex phenotypes and reporting spatial metrics with ease
Visiopharm APP for automated immune infiltrate analysis of unmixed multiplex immunofluorescence imagery
IndicaLab HALO for whole-slide analysis of unmixed multiplex immunofluorescence imagery
The company and its collaborators will also highlight new applications and validation data through the following poster presentations:

#P31: Applying Multispectral Unmixing and Spatial Analyses to Explore Tumor Heterogeneity with a Pre-Optimized 7-Color Immuno-Oncology Workflow
#P34: A Fully Optimized End-To-End Solution for I/O Multiplex Immunofluorescence Staining Using Opal Polaris 7-Color PD1/PD-L1 Panel Kits for Lung Cancer and Melanoma
#P43: A Novel Platform for Highly Multiplexed, Single-Cell Imaging of Cell Suspensions
#P54: Development of a 9-Color Immunofluorescence Assay Using Tyramide Signal Amplification and Multispectral Imaging for High-Throughput Studies on FFPE Tissue Sections
#P59: Highly Consistent Automated Multiplex Immunofluorescence for Immunoprofiling of Solid Tumors in Clinical Trials: Assay Validation Study Using Multispectral Imaging and Digital Analysis.
#P64: Highly Multiplexed Single-Cell Spatial Analysis of FFPE Tumor Tissues Using Codex
Brian McKelligon, Chief Executive Officer of Akoya, commented: "We are excited to share our latest innovations in multiplex immunofluorescence and their application to immunotherapy studies with the SITC (Free SITC Whitepaper) community."

On November 6, 2019 VBL Therapeutics (Nasdaq: VBLT) reported that an investigational new drug (IND) application has received clearance from the U.S. Food and Drug Administration (FDA) (Press release, VBL Therapeutics, NOV 6, 2019, View Source [SID1234550558]). The IND is for a Phase 2 randomized, controlled, clinical trial of VB-111 in rGBM patients undergoing a second surgery. In this new study, VB-111 will be administrated either before and after the surgery (neo-adjuvant and adjuvant therapy) or just after the surgery (adjuvant therapy) and will be compared to a standard of care control cohort. The IND was submitted by Patrick Wen, M.D., Director, Center for Neuro-Oncology, Dana-Farber Cancer Institute, on behalf of a group of top neuro-oncology US medical centers.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"MRI analysis conducted at UCLA of the VB-111 Phase 2 and GLOBE Phase 3 studies demonstrated objective responses to VB-111 monotherapy. Importantly, VB-111 responders had a survival advantage. These clinically meaningful findings suggest that VB-111 should be furthered explored in rGBM," said Timothy Cloughesy, M.D., Director and Professor, UCLA Neuro-Oncology Program and a co-principal investigator of the upcoming study.

A prior Phase 2 study demonstrated a survival benefit for patients with rGBM primed with VB-111 monotherapy that was continued upon progression with a combination of VB-111 and bevacizumab. The primary endpoint of this new study in participants with surgically accessible rGBM is to investigate whether administration of VB-111 as a neo-adjuvant treatment prior to surgery can result in an increase in tumor infiltrating T lymphocyte (TIL) within the tumor and enhance systemic tumor-specific T cell responses. Secondary endpoints will include progression free survival at 6 months (PFS-6) and overall survival (OS).

"This study builds upon our previous positive Phase 2 trial of VB-111 in rGBM and it incorporates lessons learned from the GLOBE study, aiming to optimize the regimen for VB-111 in this deadly tumor," said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. "We look forward to exploring the potential of neo-adjuvant treatment with VB-111 to turn immunologically ‘cold’ GBM tumors ‘hot’."

Additional details about the study will be presented at the 2019 Society for Neuro-Oncology annual meeting, to be held on November 20 – 24, 2019 in Phoenix, Arizona.

On November 2019 ADC Therapeutics SA, a clinical-stage oncology-focused biotechnology company pioneering the development of highly potent antibody drug conjugates (ADCs) for patients suffering from hematological malignancies and solid tumors, reported that two abstracts on ADCT-402 (loncastuximab tesirine) have been selected for an oral and poster presentation at the upcoming 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, which is being held December 7-10, 2019, in Orlando, FL (Press release, ADC Therapeutics, NOV 6, 2019, View Source [SID1234596052]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Jay Feingold, MD, PhD, Senior Vice President, Chief Medical Officer and Head of Oncology Clinical Development at ADC Therapeutics, said, "We look forward to sharing updated interim efficacy data from our pivotal Phase 2 clinical trial of ADCT-402 in relapsed or refractory diffuse large B-cell lymphoma (DLBCL), which demonstrate its encouraging single-agent clinical activity and manageable toxicity in a difficult-to-treat patient population and support our plans to submit a Biologics License Application to the U.S. Food and Drug Administration in the second half of 2020. In addition, we are pleased to share information about our Phase 1 trial evaluating ADCT-402 plus durvalumab. These presentations at the ASH (Free ASH Whitepaper) Annual Meeting validate the potential of ADCT-402 to fill a significant unmet medical need for heavily pretreated patients with B-cell non-Hodgkin lymphomas, both as a single agent and in combination with approved therapies."

Oral Presentation

Title: Interim Futility Analysis of a Phase 2 Study of Loncastuximab Tesirine, a Novel Pyrrolobenzodiazepine-Based Antibody-Drug Conjugate, in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Abstract Number: 757

Session: 626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas)—Results from Prospective Clinical Trials: Novel Therapies in Relapsed/Refractory Disease

Date and Time: Monday, December 9, 2019; 2:45 p.m. ET

Location: Orange County Convention Center, W304ABCD

Presenter: Carmelo Carlo-Stella, MD, Humanitas Cancer Center, Humanitas University

Poster Presentation

Title: Safety and Anti-Tumor Activity Study of Loncastuximab Tesirine and Durvalumab in Diffuse Large B-Cell, Mantle Cell, or Follicular Lymphoma

Abstract Number: 2807

Session: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster II

Date and Time: Sunday, December 8, 2019; 6 – 8 p.m. ET

Location: Orange County Convention Center, Hall B

Presenter: Craig Moskowitz, MD, Sylvester Comprehensive Cancer Center, University of Miami Health System

For more information about the ASH (Free ASH Whitepaper) Annual Meeting, visit View Source

ADC Therapeutics to Host Event ADC Therapeutics will host an investor and analyst event beginning at 8 p.m. ET on Sunday, December 8, 2019. This event will not be webcast.

About ADCT-402

ADCT-402 (loncastuximab tesirine) is an antibody drug conjugate (ADC) composed of a humanized monoclonal antibody directed against human CD19 and conjugated through a linker to a pyrrolobenzodiazepine (PBD) dimer cytotoxin. Once bound to a CD19-expressing cell, ADCT-402 is designed to be internalized by the cell, following which the warhead is released. The warhead is designed to bind irreversibly to DNA to create highly potent interstrand cross-links that block DNA strand separation, thus disrupting essential DNA metabolic processes such as replication and ultimately resulting in cell death. CD19 is a clinically validated target for the treatment of B-cell malignancies. ADCT-402 is being evaluated in a pivotal Phase 2 clinical trial in patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) (NCT03589469), a Phase 1b trial in combination with ibrutinib in patients with R/R DLBCL or mantle cell lymphoma (MCL) (NCT03684694) and a Phase 1b trial in combination with durvalumab in patients with R/R DLBCL, MCL or follicular lymphoma (NCT03685344). The U.S. Food and Drug Administration granted orphan drug designation to ADCT-402 for the treatment of relapsed or refractory DLBCL and MCL.

On November 6, 2019 Mersana Therapeutics, Inc. (NASDAQ:MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported financial results and a business update for the third quarter ended September 30, 2019 (Press release, Mersana Therapeutics, NOV 6, 2019, View Source [SID1234550405]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We continue to execute on our 2019 goals and remain on track for near-term proof of concept and the potential for multiple data readouts in 2020. In the third quarter, we made important progress with the initiation of the XMT-1536 expansion study in patients with platinum resistant ovarian cancer and non-small cell lung cancer adenocarcinoma at a dose of 36 mg/m2 as well as the continuation of the dose escalation cohorts," said Anna Protopapas, President and CEO of Mersana Therapeutics. "We are pleased to report that the first three patients in the 43 mg/m2 dose escalation cohort have experienced no dose limiting toxicities. We are encouraged that the safety and efficacy profile of XMT-1536 continues to be promising."

Recent Highlights and Updates

Clinical Program

Expansion portion of the XMT-1536 Phase 1 study initiated. In August 2019, Mersana announced that it had dosed the first patient in the expansion study on the 36 mg/m2 once-every-four-week dose regimen. The Company continues to add sites and enroll platinum-resistant ovarian cancer patients who have failed standard therapy and non-small cell lung cancer (NSCLC) adenocarcinoma patients who have failed front line platinum-based chemotherapy with anti-PD-1 or anti-PD-L1 therapy or have exhausted targeted therapies.

Phase 1 dose escalation of XMT-1536 remains ongoing. In August 2019, Mersana announced that the 36 mg/m2 once-every-four-week dosing cohort cleared safety review and the Company initiated a 43 mg/m2 once-every-four-week dose escalation cohort. The Safety Review Committee has evaluated three patients on the 43 mg/m2 dose level and concluded that no patients experienced dose limiting toxicities and the dose has been well-tolerated to date. The Company plans to continue to enroll and evaluate additional patients at this dose level before deciding next steps for dose escalation and expansion.

Discovery Pipeline Progress

Mersana presented preclinical data from a research collaboration that investigated NaPi2b expression in NSCLC emphasizing correlations to histology. In a poster titled "NaPi2b expression in a large surgical non-small cell lung cancer cohort," investigators

concluded that in a large early-stage surgical NSCLC cohort, a high level of NaPi2b expression was seen with adenocarcinoma subtypes and tumors harboring EGFR and KRAS mutations.

Mersana remains on track to disclose its next ADC clinical candidate around year end, further strengthening its scientific leadership in ADC development. The Company is targeting the filing of its next Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) in the first half of 2020.

Mersana presented preclinical data from the Company’s novel Immunosynthen platform at the 10th Annual World ADC conference. Data supports the potential for the development of a STING agonist ADC that can address the challenge of systemic delivery and tolerability of immunomodulatory payloads.

Upcoming Events

The Company will present preclinical data from its novel Immunosynthen platform in a poster session at the 34th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) from November 6 – 10, 2019, in National Harbor, MD. Details of the poster session are as follows:

Poster Title: "Tumor targeting of a STING agonist with an antibody drug conjugate elicits potent anti-tumor immune responses"

Date/Time: November 8, 2019 from 8 AM – 8 PM

Abstract/Poster #: P695

2019 Financial Results

Cash, cash equivalents and marketable securities as of September 30, 2019, were $112.0 million, compared to $70.1 million as of December 31, 2018. On March 5, 2019 the Company completed a public equity offering with gross proceeds of $97.8 million. On May 8, 2019, the Company completed a non-dilutive debt financing with Silicon Valley Bank (SVB) that provides Mersana with the ability to draw up to $20.0 million. The Company drew $5.0 million upon the execution of the agreement. The Company used net cash of $16.3 million in operations in the third quarter of 2019. The Company expects that its cash, cash equivalents and marketable securities will enable it to fund its operating plan into at least mid-2021.

Third Quarter 2019

Collaboration revenue for the third quarter 2019 was approximately $0.8 million, compared to $2.2 million for the same period in 2018. The decrease in collaboration revenue was primarily as a result of a decrease in services performed in support of partner’s programs.

Research and development expenses for the third quarter 2019 were approximately $13.7 million, compared to $15.2 million for the same period in 2018. The decrease was primarily due to decreased manufacturing costs for XMT-1536 and XMT-1522, offset by increased manufacturing costs for preclinical studies and discovery efforts associated with the Company’s next ADC clinical candidate, advancement of companion diagnostics development efforts for the NaPi2b biomarker and a milestone paid on the initiation of the expansion cohort.

General and administrative expenses for the third quarter 2019 remained flat at $4.4 million, compared to the same period in 2018.

Net loss for the third quarter 2019 was $16.8 million, or $0.35 per share, compared to a net loss of $17.1 million, or $0.74 per share, for the same period in 2018. Weighted average common shares outstanding for the quarters ended September 30, 2019 and September 30, 2018, were 47,833,607 and 23,152,019 respectively.

Conference Call

Mersana Therapeutics will host a conference call and webcast today at 8:00 a.m. ET to report financial results for the third quarter of 2019 and provide certain business updates. To access the call, please dial 877-303-9226 (domestic) or 409-981-0870 (international) and provide the Conference ID 459394. A live webcast of the presentation will be available on the Investors & Media section of the Mersana website at www.mersana.com.

About XMT-1536

XMT-1536 is a first-in-class ADC targeting the sodium-dependent phosphate transport protein (NaPi2b) and utilizing the Dolaflexin platform to deliver an average of 10-15 DolaLock payload molecules per antibody. The NaPi2b antigen is broadly expressed in non-small cell lung cancer (NSCLC) adenocarcinoma and ovarian cancer. XMT-1536 is in Phase 1 clinical trials in patients with tumors expressing NaPi2b, including ovarian cancer and NSCLC adenocarcinoma. More information on the ongoing Phase 1 clinical trial can be found at clinicaltrials.gov (NCT03319628).