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BioTime Board of Directors Approves Distribution of AgeX Therapeutics Shares to BioTime Shareholders

On September 25, 2017– BioTime, Inc. (NYSE American: BTX), a clinical-stage biotechnology company focused on developing and commercializing products addressing degenerative diseases, reported that its Board of Directors has approved a distribution of some or all of the shares of AgeX Therapeutics, Inc. owned by BioTime to BioTime’s shareholders (Press release, BioTime, SEP 25, 2017, View Source;p=RssLanding&cat=news&id=2302486 [SID1234520622]). The Board also authorized management to work with investment banks and other financial institutions to finalize and implement the strategy for taking AgeX public, which may include a tax-free distribution.

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"Asterias BioTherapeutics and OncoCyte Corporation, two companies founded by BioTime, were successfully transitioned into independent, publicly-traded companies that created significant value for BioTime and its shareholders," said Alfred Kingsley, BioTime’s Chairman of the Board. "We believe the formation and independent funding of AgeX, and a subsequent distribution to BioTime shareholders, will similarly unlock the significant value of the previously embedded BioTime assets related to the treatment of aging and age-related diseases, such as diabetes, obesity, heart disease, stroke and cancer."

AgeX Therapeutics focuses on technologies relating to cellular immortality and the regenerative biology of aging. Aging and age-related diseases have recently garnered significant investor interest, as evidenced by the formation of companies such as Calico, Human Longevity Inc., Unity Biotechnology, and Samumed, as well as others. These companies have attracted major financial supporters, many of whose investments were made at multibillion-dollar market valuations. AgeX’s initial investors similarly include institutions and accomplished business leaders, whose support creates a foundation for the company’s potential future success.

AgeX closed its initial $10 million equity financing in August of 2017 with a post-money valuation of approximately $68 million. BioTime currently owns approximately 85% of the outstanding shares of AgeX, with a post-money valuation of approximately $58 million, or 50 cents per BioTime share. The equity financing is expected to fund AgeX’s general operations and product development well into 2019, while saving BioTime more than $5 million annually on these programs and associated operational expenses.

Building on the recent success of the formation, funding and launch of AgeX, BioTime’s management and Board are now exploring all options for making AgeX a publicly-traded company, including a potential tax-free distribution of all AgeX shares to BioTime shareholders. Once BioTime’s management completes its discussions with investment banks and other financial firms, and its analysis of remaining tax, legal, commercial and regulatory issues, BioTime will announce further details of the resulting plan.

SignalRx Presents in silico Design of Dual PI3K/BRD4 Inhibitors for Combinatorial Activation of Anti-tumor Immunity in Treating Cancer

On September 25, 2017 SignalRx Pharmaceuticals Inc. reported the presentation of scientific data on the company’s in silico platform technology for the rational design of dual small-molecule PI3K/BRD4 inhibitor for immune-oncology relative to activating anti-tumor immunity (Press release, SignalRx, SEPT 25, 2017, http://www.ireachcontent.com/news-releases/signalrx-presents-in-silico-design-of-dual-pi3kbrd4-inhibitors-for-combinatorial-activation-of-anti-tumor-immunity-in-treating-cancer-647615323.html [SID1234527320]). The presentation by Dr. Donald L. Durden, MD, PhD, senior scientific advisor for SignalRx, was made at the Immunomodulatory Small Molecules section of the 15th Annual Discovery on Target meeting in Boston, MA on September 25, 2017 at 8:40 a.m.

The presentation was entitled "A Novel Dual PI3K/BRD4 Inhibitor, SF2523 for Combinatorial Activation of Anti-Tumor Immunity in Cancer via the Orthogonal Inhibition of MYCN and MYC" and highlighted advancements in the development of single small-molecules that simultaneously inhibit both PI3 kinase (PI3K) and the new epigenetic cancer target BRD4 in vivo.

Key highlights presented are:

Dual inhibitory chemotype disclosed which blocks MYC via two orthogonal independent pathways.
Synergistic anticancer effects of dual inhibition: PI3K inhibition induces MYCN degradation and BRD4 inhibition blocks MYCN transcription.
Dual PI3K/BRD4 inhibitor SF2523 blocks MYCN transcription and induces MYCN degradation
SF2523 shown to block tumor growth, metastasis, and PI3K/BRD4 signaling in vivo.
Demonstrated that SF2523 abrogates the macrophage immunosuppressive effects on tumor immunity via the blockade of the M1- M2 transition in vivo, and activates the adaptive T cell immune response against the tumor.
Data also was also presented related to the recent discovery of SRX3207, a novel dual inhibitor which inhibits PI3K and a recently discovered new immune checkpoint kinase. This inhibitor has potent immunostimulatory properties and blocks the immunosuppressive macrophage compartment.
SignalRx, focused on developing more effective oncology drugs through molecular design imparting multiple target-selected inhibition, is also announcing that it is seeking partnerships to accelerate the development of their novel small molecules into first-in-man clinical trials. These molecules include single-targeted novel BRD4 inhibitors and CDK inhibitors with picomolar potencies.

CombiMatrix Sets Record Date and Special Stockholders Meeting Date Regarding Proposed Merger with Invitae

On September 25, 2017 CombiMatrix Corporation (NASDAQ: CBMX) (“CombiMatrix” or the “Company”), a family health molecular diagnostics company specializing in DNA-based reproductive health and pediatric testing services, reported it has set important dates for a special meeting of its stockholders to vote on matters related to the proposed merger with Invitae Corporation (“Invitae”) (Filing, 8-K, CombiMatrix, SEP 25, 2017, View Source [SID1234520629]).

The special meeting of stockholders will be held at 1:00 pm, local time, on November 10, 2017, at the offices of Stradling Yocca Carlson & Rauth, P.C., 660 Newport Center Drive, Suite 1600, Newport Beach, California. CombiMatrix’s stockholders of record as of the close of business on September 26, 2017 are entitled to receive notice of, and to vote at, the special meeting.

The merger has been unanimously approved by the boards of directors of both companies. The proposed merger is expected to close in the fourth quarter of 2017 (subject to the approval of the stockholders of CombiMatrix and acceptance by at least 90% of CombiMatrix’s holders of Series F warrants to tender their warrants in exchange for Invitae common stock in the Series F warrants tender exchange offer that will be conducted simultaneously with the CombiMatrix merger proxy solicitation).

Immune Design Announces Four Upcoming Presentations at the SITC 32nd Annual Meeting

On September 25, 2017 Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company focused on oncology, reported that four abstracts have been accepted for presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 32nd Annual Meeting, November 8-12, 2017 in National Harbor, Maryland.

The oral and poster presentation information are as follows:

Novel Biomarkers in Next-generation Cancer Vaccines

Public NY-ESO-1 specific TCRs as novel biomarkers for immune monitoring of NY-ESO-1 positive cancer patients

Oral Presentation/ SITC (Free SITC Whitepaper) Pre-Conference Program
Session title: Immuno-Oncology Biomarkers: Today’s Imperatives for Tomorrow’s Needs
Date: November 8, 2017
Time: 8 a.m. to 12:30 p.m.
Presenter: Hailing Lu, MD, PhD, Principal Scientist, Immune Design

Poster Presentation:
Poster Number: P58
Date: Saturday, November 11, 2017
Time: 12:30 — 2 p.m. and 6:30 — 8 p.m.
Presenter: Hailing Lu, MD, PhD, Principal Scientist, Immune Design

Combination Therapy (Cancer Vaccine + Intratumoral Immunization):

G100 and ZVex-based combination immunotherapy induces near complete regression of established glioma tumors in mice

Poster Number: P256
Date: Saturday, November 11, 2017
Time: 12:30 — 2 p.m. and 6:30 — 8 p.m.
Presenter: Tina Chang Albershardt, PhD, Scientist II, Immune Design

Multi-Target Cancer Vaccines:

Transduction of MAGE-A1, A3, A4, A10 and IL-12 by ZVex, a dendritic cell targeting platform induces robust multi-antigen T-cell immune responses without antigenic interference or immunodominance

Poster Number: P127
Date: Friday, November 10, 2017
Time: 12:30 — 2 p.m. and 6:30 — 8 p.m.
Presenter: Jardin Leleux, Postdoctoral Researcher, Immune Design

Next-Generation Intratumoral Vaccination Using ZVex:

Intratumoral expression of IL12 using the ZVex dendritic cell-targeting lentiviral vector exerts potent anti-tumor effects via induction of multiple immune effectors, including CD8 T cell responses

Poster Number: P401
Date: Friday, November 10, 2017
Time: 12:30 — 2 p.m. and 6:30 — 8 p.m.
Presenter: Tina Chang Albershardt, PhD, Scientist II, Immune Design

NewLink Genetics Announces Clinical Collaboration to Evaluate IO-Based Combination Therapies in Pancreatic Cancer

On September 25, 2017 NewLink Genetics Corporation (Nasdaq: NLNK) reported that it has entered into a clinical collaboration agreement with AstraZeneca to evaluate the combination of indoximod, NewLink Genetics’ small molecule IDO pathway inhibitor, and durvalumab, AstraZeneca’s anti-PD-L1 monoclonal antibody, along with standard of care chemotherapy for patients with metastatic pancreatic cancer (Press release, NewLink Genetics, SEP 25, 2017, View Source [SID1234520626]).

The primary objective for this randomized placebo-controlled, Phase 2 study is to evaluate the efficacy and safety of the immuno-oncology-based combination compared to gemcitabine/ABRAXANE alone. Patients will also be enrolled into a smaller cohort evaluating the combination of durvalumab with gemcitabine/ABRAXANE.

The Phase 2 trial will be funded equally by both companies, with NewLink Genetics serving as the study sponsor. NewLink Genetics’ share of the aggregate expense of the trial is not expected to have a material effect on its financial position.

“We are pleased to initiate a joint immuno-oncology clinical collaboration with AstraZeneca,” said Dr. Charles J. Link, Jr., Chairman, Chief Executive Officer and Chief Scientific Officer of NewLink Genetics. “As recent data have indicated, indoximod combinations with immunotherapy and chemotherapy show promise of improving outcomes for patients with multiple tumor types.”

About Durvalumab

Durvalumab (Imfinzi), a human monoclonal antibody directed against PD-L1, blocks PD-L1 interaction with PD-1 and CD80 on T cells, countering the tumour’s immune-evading tactics and inducing an immune response.

Durvalumab is being assessed in Phase III trials as a monotherapy in various stages of NSCLC, in small-cell lung cancer (SCLC), in metastatic urothelial cancer (mUC) and in head and neck squamous cell carcinoma (HNSCC). The combination of durvalumab and tremelimumab is being assessed in Phase III trials in NSCLC, SCLC, mUC and HNSCC and in Phase I/II trials in hepatocellular carcinoma and haematological malignancies.

Imfinzi received accelerated approval from the US Food and Drug Administration for previously treated patients with advanced bladder cancer and is under review in Canada and Australia for similar use.

About Indoximod

Indoximod is an investigational, orally available small molecule targeting the IDO pathway. The IDO pathway is one of the key immuno-oncology targets involved in regulating the tumor microenvironment and immune escape.

NewLink Genetics is currently evaluating indoximod in multiple combination studies for patients with various types of cancer including melanoma, acute myeloid leukemia, pancreatic cancer and prostate cancer.

About Metastatic (Stage IV) Pancreatic Cancer1

Approximately 53,670 new cases of pancreatic cancer in the US will be diagnosed in 2017 according to the National Cancer Institute (NCI), and a little over 43,000 people will die of the disease this year. Pancreatic cancer is difficult to detect in its early stages. Because of this, approximately 52% of all pancreatic cancers are metastatic, or advanced, in nature and are associated with a poor prognosis. The 5-year survival rate for pancreatic cancer overall is only 8.2%, and drops to a low of 2.7% for individuals whose pancreatic cancer has metastasized to farther regions of the body.

1National Cancer Institute: Pancreas Cancer