On November 8, 2018 BioTime, Inc. (NYSE American and TASE: BTX), and Asterias Biotherapeutics, Inc. ("Asterias") (NYSE American: AST), reported that they have entered into a definitive merger agreement whereby BioTime will acquire all of the remaining outstanding common stock of Asterias that are not currently owned by BioTime (Press release, BioTime, NOV 8, 2018, View Source [SID1234531159]). Asterias stockholders will receive 0.71 shares of BioTime common shares for every share of Asterias common stock and will own approximately 16.2% of the combined company. Subject to customary closing conditions, including approval by the respective shareholders of BioTime and Asterias, the transaction is expected to be completed in the first quarter of 2019.

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"Our vision is to build BioTime into a premier cell therapy company and this acquisition can support that transformation as it not only diversifies our pipeline with two additional clinical-stage assets addressing high unmet medical needs, but also adds partnerships with notable institutions such as the California Institute for Regenerative Medicine and Cancer Research UK," stated Brian M. Culley, Chief Executive Officer of BioTime. "We believe this merger is an exciting opportunity for BioTime’s shareholders to benefit from the potential future value of a more differentiated pipeline as well as the opportunity to impact disease areas that are in desperate need of innovative therapeutic approaches."

"This transaction can create substantial value for our stockholders, employees and our clinical programs," stated Michael Mulroy, Chief Executive Officer of Asterias. "The stock merger structure provides Asterias stockholders the ability to continue their investment in our clinical programs in spinal cord injury and non-small cell lung cancer as part of a larger, more diversified company with greater resources."

Asterias’ Pipeline

OPC1 – Innovative Phase 2 Program for the Treatment of Severe Spinal Cord Injury

OPC1 is a cellular therapy utilizing oligodendrocyte progenitor cells (OPCs), which in preclinical testing has demonstrated potentially reparative functions that address the complex pathologies observed in demyelination disorders such as spinal cord injury and multiple neurodegenerative diseases, including multiple sclerosis and white matter stroke. The potential reparative functions of OPC1 include the production of neurotrophic factors, the stimulation of vascularization, and the induction of remyelination of denuded axons, all of which are critical for survival, regrowth, and conduction of nerve impulses through axons at the injury site.

Asterias is currently completing a Phase 1/2a clinical trial (the "SCiStar Study") for severe spinal cord injury where there currently are no approved therapies. The results from the SCiStar Study have been promising:

Safety Profile: Results-to-date for the SCiStar Study have shown no evidence of adverse changes in any of the subjects treated with OPC1. To date, there have been no serious adverse events (SAEs) related to the OPC1 cells.
Cell Engraftment: Over 95% of subjects in the SCiStar Study have magnetic resonance imaging (MRI) scans consistent with the formation of a tissue matrix at the injury site, which is encouraging evidence that OPC1 cells have engrafted at the injury site and helped to prevent cavitation.
Motor Function Recovery: Many of the patients in the SCiStar Study have shown promising upper extremity motor recovery in their arms, hands, and fingers.

An independent data review meeting was held recently to discuss the latest results from the SCiStar Study and positive feedback was received from the outside medical and scientific experts on the panel.
A meeting with the FDA under OPC1’s RMAT designation is scheduled for later this year to discuss the trial design of the next OPC1 study.
A final update on the SCiStar Study results is expected in the first quarter of 2019.
The SCiStar Study has been partially funded by a $14.3 million grant from the California Institute for Regenerative Medicine (CIRM) and there is the potential to obtain additional non-dilutive funding in 2019 to partially offset the cost of OPC1’s next phase of clinical development.

VAC2 – Phase 1 Program for the Treatment of Non-Small Cell Lung Cancer (NSCLC) Partnered with Cancer Research UK

VAC2 is a non-patient-specific, or "allogeneic," cancer immunotherapy candidate. VAC2 cells are engineered to express a protein widely expressed in tumor cells but rarely found in normal cells. The VAC2 antigen presenting dendritic cells instruct the immune system to generate responses against tumor cells.
VAC2 currently is being investigated in a Phase 1 study for the treatment of NSCLC and is sponsored and conducted by Cancer Research UK.

The safety data from the first three subjects has been reviewed by the study’s Safety Review Committee which found VAC2 to be safe and well-tolerated in those subjects.
The study currently is enrolling subjects in the advanced disease cohort of the study and immune response and survival data are expected during 2019 and 2020. The study design also includes a cohort of less advanced patients where tumors have been resected.

VAC2 is potentially complementary and synergistic with other immune therapies such as immune checkpoint inhibitors.
In addition to being investigated in NSCLC, a leading cause of cancer deaths, VAC2 is a platform technology that has the potential to be applied to other solid and liquid tumors and to deliver additional or different antigens depending on the cancer type.

About the Proposed Merger

Under the terms of the merger agreement, Asterias stockholders will receive 0.71 common share of BioTime for each share of common stock of Asterias they own upon closing of the merger. The merger agreement, the merger and the other transactions contemplated in the merger agreement have been approved by the board of directors of Asterias (by unanimous vote of the disinterested members of the Asterias board of directors, acting upon the recommendation of a special committee comprised of only disinterested and independent members of the board of directors of Asterias). The merger agreement, the merger, the issuance of the BioTime shares in the merger and the other transactions contemplated in the merger agreement have been approved by the board of directors of BioTime (by unanimous vote of the disinterested members of the BioTime board of directors acting upon the unanimous recommendation of the disinterested members of a special committee comprised of only independent directors of BioTime). The merger is expected to close during the first quarter of 2019, subject to approval of the merger by the BioTime and Asterias stockholders, and other customary closing conditions.

The combined company will be led by Brian M. Culley, President and Chief Executive Officer of BioTime. It is expected that, following closing of the transaction, BioTime’s Board of Directors will consist of nine members, with Don Bailey, Chairman of Asterias’ Board of Directors, joining the BioTime Board of Directors and Mr. Mulroy, Asterias’ Chief Executive Officer, remaining on the BioTime Board.

Pursuant to the terms of a "go-shop" provision in the merger agreement, between the date of the merger agreement and December 3, 2018, Asterias and its representatives may solicit, discuss or negotiate alternative proposals from third parties for the acquisition of Asterias. Following the expiration of this go-shop period, Asterias will become subject to customary "no shop" restrictions on its and its representatives’ ability to solicit, discuss or negotiate alternative acquisition proposals from third parties, subject to exceptions for acquisition proposals that the Asterias board of directors and the Asterias special committee has determined constitutes or is reasonably expected to constitute a Superior Proposal (as defined in the merger agreement), and further subject to compliance with certain conditions.

BioTime’s financial advisor in the transaction is Maxim Group LLC. Raymond James is acting as financial advisor to Asterias. Cooley LLP is serving as legal counsel to BioTime and Dentons LLP is serving as legal counsel to Asterias.

On November 8, 2018 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading genome editing company focused on developing curative therapeutics using CRISPR/Cas9 technology both in vivo and ex vivo, reported that it will participate in the following upcoming healthcare conferences in November (Press release, Intellia Therapeutics, NOV 8, 2018, View Source [SID1234531157]):

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Tuesday, November 13, 2018
Credit Suisse Healthcare Conference
Location: Scottsdale, Arizona
Time: 2:50pm MT (4:50pm ET)

Thursday, November 15, 2018
Jefferies London Healthcare Conference
Location: London, United Kingdom
Time: 12:40pm GMT (7:40am ET)

Thursday, November 29, 2018
Barclays Gene Editing and Gene Therapy Summit
Location: New York, NY
Time: 3:00pm ET

A live webcast of Intellia’s presentations at the Credit Suisse Healthcare Conference and Jefferies London Healthcare Conference will be accessible through the Events and Presentations page of the Investor Relations section of the company’s website at www.intelliatx.com. To access the webcasts, please log on to the Intellia website approximately 15 minutes prior to the start time to ensure adequate time for any software downloads that may be required. A replay of the webcasts will be available on Intellia’s website for approximately 14 days following each conference.

On November 8, 2018 ChemoCentryx, Inc., (Nasdaq:CCXI), reported financial results for the third quarter ended September 30, 2018 and provided an overview of the Company’s recent corporate highlights (Press release, ChemoCentryx, NOV 8, 2018, View Source [SID1234531155]).

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"We embark now upon exciting times. Looking forward to the coming year, we have set the stage for a sequence of key top-line data readouts from multiple clinical programs; readouts which could change the treatment landscape in woefully underserved orphan diseases," said Thomas J. Schall, Ph. D., President and Chief Executive Officer of ChemoCentryx. "We completed enrollment of our landmark ADVOCATE Phase III pivotal trial in ANCA-associated vasculitis in the third quarter, and plan to report top-line data in the fourth quarter of this coming year. We have clinical trials of avacopan in C3G and another unique asset, CCX140 in FSGS underway, and we stand on the brink of launching our definitive clinical trial of avacopan in Hidradenitis Suppurativa, our first foray into orphan dermatological disease. Our momentum grows ever stronger, enabled by a robust balance sheet that allows us to conduct multiple registration-supporting trials simultaneously."

Recent Highlights

Completed enrollment of the Company’s pivotal Phase III ADVOCATE trial of avacopan for the treatment of ANCA-associated vasculitis; top line data expected in the fourth quarter of 2019.

Submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the Phase IIb clinical development of avacopan in HS, a chronic and inflammatory skin disease. The Company expects to launch a comprehensive, randomized, double-blind, placebo-controlled clinical trial with avacopan in HS by the end of 2018. The study is expected to enroll approximately 390 patients with moderate to severe HS in the United States. The primary endpoint will be proportion of patients with a clinical response as assessed by the Hidradenitis Suppurativa Clinical Response (HiSCR) score compared to placebo after 12 weeks of treatment.

Advanced the Company’s clinical trial of avacopan in patients with C3 Glomerulopathy (C3G); enrollment now at 61% of the initial cohort of 44 patients; 35% of the expanded study targeting a combined 88 patients. C3G is a rare disorder that often affects the young, requiring dialysis and often kidney transplant with relapsing disease common. There is no approved effective treatment.

Received orphan drug designation from the FDA for CCR2 inhibitor CCX140 for the treatment of FSGS, a rare kidney disease. Clinical trials are underway in two FSGS sub-populations: nephrotic syndrome primary FSGS and sub-nephrotic primary FSGS.

Began active enrollment of patients with FSGS at multiple sites in the U.S. and Europe.

Presented at the American Society of Nephrology and American College of Rheumatology annual meetings on the avacopan ADVOCATE Phase III trial design and the potential new role of CCR2 in the treatment of FSGS with the first demonstration of CCR2 presence on renal progenitor cells destined to be podocytes.

Maintained a very strong balance sheet with reported cash and investments of approximately $186.0 million at September 30, 2018.

Third Quarter 2018 Financial Results

Cash and investments totaled approximately $186.0 million at September 30, 2018. ChemoCentryx was cash flow positive for the nine months ended September 30, 2018 (driven by cash receipts from milestone and upfront payments and credit facility advances), and reported a net increase of $50.8 million in cash and investments for period then ended. Excluding cash receipts from milestone and upfront payments and credit facility advances, the Company utilized cash and investments of approximately $40.7 million for the first nine months of the year and expects to end 2018 with approximately $170 million.

Revenue was $9.0 million for the third quarter of 2018, consistent with the same period in 2017. Revenue recognized represents amortization of the upfront license fee commitments, milestone payments and collaboration funding from Vifor pursuant to the Avacopan Agreement, Avacopan Amendment and CCX140 Agreement.

Research and development expenses were $15.1 million for the third quarter of 2018, compared to $12.3 million for the same period in 2017. The increase from 2017 to 2018 was primarily due to the advancement of the avacopan ADVOCATE Phase III pivotal trial which completed enrollment in July 2018.

General and administrative expenses were $5.4 million for the third quarter of 2018, compared to $3.6 million for the same period in 2017. The increase from 2017 to 2018 was primarily due to higher employee-related expenses, including those associated with our commercialization planning efforts, and increased professional fees.

Net loss for the third quarter of 2018 was $10.9 million, compared to $6.6 million for the same period in 2017.

Total shares outstanding at September 30, 2018 were approximately 50.4 million shares.

Conference Call and Webcast

The Company will host a conference call and webcast today, November 8, 2018 at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time. To participate by telephone, please dial 877-303-8028 (Domestic) or 760-536-5167 (International). The conference ID number is 4672117. A live and archived audio webcast can be accessed through the Investors section of the Company’s website at www.ChemoCentryx.com. The archived webcast will remain available on the Company’s website for fourteen (14) days following the conference call.

On November 8, 2018 OncBioMune Pharmaceuticals, Inc. (OTCQB:OBMP) ("OncBioMune" or the "Company"), a clinical-stage biopharmaceutical company engaged in the development of a proprietary therapeutic cancer vaccine immunotherapy and targeted cancer therapies, reported its upcoming Phase 2 clinical trials of ProscaVax for prostate cancer and other corporate developments (Press release, Oncbiomune, NOV 8, 2018, http://oncbiomune.com/2018/11/08/oncbiomune-phase-2-clinical-trial-to-begin-enrollment-company-announces-other-development-and-corporate-milestones/ [SID1234531154]).

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Phase 2 Trial, Early-Stage Prostate Cancer

The Company’s lead Phase 2 trial of ProscaVax for prostate cancer (View Source) is being hosted by Beth Israel Deaconess Medical Center (BIDMC), a teaching hospital of Harvard University, and its affiliate hospital. The Company reported that the trial will commence on or about December 17, 2018. Enrollment is scheduled for 120 patients (80 in the ProscaVax arm, 40 in active surveillance arm).

This study will evaluate the safety and efficacy of ProscaVax, OncBioMune’s prostate cancer vaccine (a combination of prostate cancer associated prostate specific antigen (PSA) with the biological adjuvants interleukin-2 (IL-2) and granulocyte-macrophage colony-stimulating factor (GM-CSF)) in patients with low-risk localized prostate cancer. The goal of the study is to determine if vaccine administration results in a change in the rate of prostate cancer progression when compared to a no-treatment control group of active surveillance patients. Active surveillance is a frequently used disease management option for patients with localized prostate cancer that elect to work with their doctor to monitor the disease for progression before taking more drastic intervention measures, such as surgery or radiotherapy that are often accompanied by unpleasant side effects, including impotence and urinary incontinence.

In the ProscaVax arm of the study, during the first 4 months of induction treatment, 6 doses of the Proscavax vaccine will be administered intradermally at weeks 1, 2, 3, 7, 11, and 15, followed by maintenance booster injections once every month which will alternate between low dose IL-2 alone (at weeks 19, 27 and 35) and Proscavax vaccine (at weeks 23, 31, 39) for 6 months.

Primary outcomes for the study are:

Prostate cancer progression measured by PSA test (Time Frame: At pre-study, every 3 months until 2 years starting at week 7 for the ProscaVax arm and at study entry for the active surveillance arm)
Prostate cancer progression measured by digital rectal examination (Time Frame: At pre-study and then every 6 months for 2 years)
Prostate cancer progression measured by prostate biopsy (Time Frame: At pre-study and then every 12-months for 2 years)
Secondary Outcomes for the study are:

PSA doubling time (Time Frame: At pre-study, and then every 3 months until 2 years, starting at week 7 for ProscaVax arm and at study entry for active surveillance arm)
Assessment of Adverse Events (Time Frame: From first injection until 30 days past the 24-month assessments)
Management anticipates providing interim results throughout the trial as they are available, tentatively beginning during the second quarter of 2019.

Phase 2 Trial, Late-Stage Prostate Cancer

This study, which is expected to get the FDA green light in the coming weeks, is being hosted by Urology Clinics of North Texas, a preeminent 10-center urology group in Texas serving the Dallas, Fort Worth, Collin, Rockwall and Tarrant County areas. The trial is similar in design to and builds upon the successfully completed Phase 1a trial of ProscaVax and will treat hormone-naïve recurrent prostate cancer patients with increasing PSA that have failed previous conventional therapies. Per protocol, following FDA approval, the trial is scheduled to enroll 30 biochemically progressing prostate cancer patients. The study is anticipated to take three years to complete.

As previously announced, OncBioMune has signed a work order with the leading Contract Research Organization Theradex Oncology for its services throughout this clinical trial. An independent Institutional Review Board (IRB) is being used for this trial, which is expected to reduce IRB review times. Once approved by the FDA and IRB, the clinical trial information will be submitted to clinicaltrials.gov, where the summary of the clinical trial will then be publicly available.

In the completed Phase 1a clinical trial, at 19 weeks post-therapy, 80 percent of the patients (n=20) treated with ProscaVax demonstrated stable disease/no prostate cancer progression. At 43 weeks post-therapy, overall survival was 100% for all 20 patients and 12 of the 17 evaluable patients (70.6%) continued to live with stable, progression-free disease.

As with the BIDMC Phase 2 trial, OncBioMune anticipates releasing interim data as available detailing the safety and efficacy data from ProscaVax therapy.

Corporate Developments

Dr. Jonathan Head, Chief Executive Officer and Chairman at OncBioMune, last week spoke about the development of ProscaVax at Oncology Meeting Innovations’ 2018 Global Summit on Genitourinary Malignancies in Banff, Alberta, Canada. Dr. Head’s presentation was well received and sparked interest in ProscaVax as a compelling experimental immunotherapeutic vaccine targeting prostate cancer at the earliest stage, where no current therapies exist, and in the late stage, where the limited number of FDA-approved therapies frequently fail. Dr. Head’s presentation will be available this week on the Company’s website on the "Investors" > "Events and Presentations" tab.

The Company recently made a significant improvement to its balance sheet with the retirement of $900,000 in debt. The Company continues to focus on improving its liquidity and strengthening its balance sheet in support of the clinical trials and additional continued development of ProscaVax. In furtherance of these efforts, OncBioMune reported that it is planning to host a shareholder conference call in December 2018. The Company expects to disclose details on the call in connection with the filing of its Form 10-Q for the quarter ended September 30, 2018.

"Our team and stakeholders have worked vigilantly to make 2018 a milestone year at OncBioMune. We believe that our concerted efforts have built considerable momentum as we look ahead to 2019," commented Dr. Head. "There is still much work to be done to meet our goal of developing the world’s first therapeutic prostate cancer vaccine, but all that we have accomplished so far this year with positioning for two significant clinical trials certainly gives us reason to be very optimistic about where we are heading for our company, our shareholders and the oncology community."

Sign up for OncBioMune email alerts at: View Source

About Prostate Cancer

According to the American Cancer Society (ACS), prostate cancer is the most common type of cancer in men other than skin cancer, with about 1 in 9 men diagnosed during their lifetime. ACS estimates that about 164,690 new cases of prostate cancer will be diagnosed during 2018 and approximately 29,430 men will die from the disease this year. Prostate cancer is the second leading cause of cancer death in men, trailing only lung cancer. Approximately 2.9 million men are living with prostate cancer today. The average age of diagnosis is 66, with the disease considered rare in men under the age of 40.

On November 8, 2018 Sorrento Therapeutics, Inc. (NASDAQ: SRNE), a clinical-stage immunotherapy biotech company, reported the closing of a debt financing for up to $150 million (Press release, Sorrento Therapeutics, NOV 8, 2018, View Source [SID1234531151]). The financing is being provided by funds and accounts managed by Oaktree Capital Management, L.P. ("Oaktree"), a leading global investment firm. An affiliate of Oaktree is the sole administrative agent and collateral agent for the financing and Morgan Stanley & Co. LLC served as the sole placement agent for the transaction.

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"With this financing, we believe we now have adequate funding for up to the next two years, enabling us to bring several of our key clinical programs in the CAR-T and non-opioid pain management space to FDA approvals and potential commercialization", said Henry Ji, Ph.D., Chairman, President and Chief Executive Officer. "Additionally, with encouraging data readout from our ongoing Anti-CEA trial for liver metastases among pancreatic cancer patients and our recently initiated Anti-CD38 CAR-T trial for multiple myeloma cancer patients, we are optimistic about potential collaborations with strategic partners."

Building off its industry-leading fully human antibody G-MAB library, a wide array of innovative technologies such as the Sofusa lymphatics delivery system, and multi-site multi-modality cGMP facilities, Sorrento continues to expand and advance its robust clinical product pipeline.

The financing is a senior secured five-year term loan, with the first tranche of $100 million already funded and an additional tranche of $50 million available subject to Sorrento’s achievement of certain business milestones in the next nine to twelve months.