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BioTime Acquires Two Clinical-Stage Cell Therapy Product Candidates Addressing Significant Unmet Needs in Spinal Cord Injury and Immuno-Oncology
Asterias Stockholders to Receive 0.71 Shares of
“Our vision is to build
“This transaction can create substantial value for our stockholders,
employees and our clinical programs,” stated
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
- 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
FDAunder 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 milliongrant 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
- 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
The combined company will be led by
Pursuant to the terms of a “go-shop” provision in the merger agreement,
between the date of the merger agreement and
BioTime’s financial advisor in the transaction is
BioTime is a clinical-stage biotechnology company focused on the
development and commercialization of novel therapies for the treatment
of degenerative diseases. BioTime’s pipeline is based on two platform
technologies which encompass cell replacement and cell/drug delivery.
BioTime’s lead cell replacement product candidate is OpRegen®,
a retinal pigment epithelium transplant therapy in Phase 2 development
for the treatment of dry age-related macular degeneration, the leading
cause of blindness in the developed world. BioTime’s lead cell delivery
clinical program is Renevia®, an investigational medical
device being developed as an alternative for whole adipose tissue
transfer procedures. BioTime also has significant equity holdings in two
publicly traded companies,
BioTime common stock is traded on the NYSE American and TASE under the
symbol BTX. For more information, please visit www.biotime.com or
connect with the company on Twitter,
Additional Information and Where to Find It
This communication is being made in respect of the proposed business
No Offer or Solicitation
This document does not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.
Certain statements in this communication, including statements relating
to the Merger Agreement, the Merger and the other transactions
contemplated by the Merger Agreement and the combined company’s future
financial condition performance and operating results, strategy and
plans, including the design, status, funding and timing of the clinical
trials and further development and potential of the product candidates
are “forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995 giving BioTime’s and Asterias’
expectations or predictions of future financial or business performance
or conditions. These forward-looking statements are subject to numerous
assumptions, risks and uncertainties which change over time.
Forward-looking statements speak only as of the date they are made and
we assume no duty to update forward-looking statements. In addition to
factors previously disclosed in BioTime’s and Asterias’ reports filed
BioTime Inc. IR
Ioana C. Hone, 510-871-4188
Solebury Trout IR
Gitanjali Jain Ogawa, 646-378-2949
Asterias Biotherapeutics IR
Investor Relations, 510-456-3892
EVC Group LLC
Michael Polyviou, 732-232-6914