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AI-Guided Cancer Therapy Platform from SRI International Identifies Novel Molecular Targets for Aggressive Form of Breast Cancer

On April 16, 2018 A proprietary,precision cancer therapy platform from SRI International has reported that identified new molecular targets for the treatment and prevention of an aggressive and difficult-to-treat type of breast cancer (Press release, SRI International, APR 16, 2018, View Source [SID1234525359]). Subarna Sinha, Ph.D., bioinformatics program leader at SRI, presented new data describing the platform and the validated target today during a minisymposium at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.

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Identification of new molecular targets for drug therapy is an area of active investigation and continued need in oncology. The Mining Synthetic Lethals (MiSL) platform offered by SRI may accelerate the discovery of new targeted oncology drugs by integrating a computational approach that mines patterns from primary tumor data with pre-clinical validation of potential targets.

The MiSL platform works by "looking" for synthetic lethal (SL) partners among primary tumor data and then validating them in vivo. Synthetic lethality offers a new approach to finding targeted therapies for previously "undruggable" tumor mutations. In SL interactions, a diseased cell with a mutation is dependent on a second gene for cell survival. Inhibiting activity of the second gene in these cells leads to cell death.

"If you can inhibit the SL partner, you can very exquisitely kill cancer cells," said Dr. Sinha. "MiSL overcomes the limitations of cell line screening methods such as shRNA and CRISPR, and has previously demonstrated ability to identify valid SL partners in multiple tumor types, including acute myeloid leukemia and kidney cancer. Today we presented the first data demonstrating the platform’s ability to identify new targets in triple-negative breast cancer."
BRCA1 is mutated in 15 to 20 percent of triple negative breast cancer (TNBC). SRI researchers used MiSL to identify and predict 22 SL partners of the BRCA1 mutation in TNBC, including XRCC6. To test the prediction that XRCC6 is an SL partner of BRCA1 in TNBC, SRI researchers examined the effect of inhibiting XRCC6 in a BRCA1-mutated TNBC cell line. The researchers found that this XRCC6 "knockdown" significantly increased cell death (37.3 percent) and reduced viability (50 percent reduction, p < 0.0001) as compared to controls. SRI researchers are testing the remaining SL partners identified by MiSL in an effort to expand the set of available molecular targets that may become the focus of new drug discovery projects.

"This platform opens the door for discovering new options to treat BRCA1-mutated breast cancers and could lead to new chemo-prevention strategies for individuals carrying germline BRCA1 mutations," added Dr. Sinha.

JHL Biotech’s Clinical Trial Application Accepted by China for Bevacizumab Biosimilar to Treat Colorectal, Lung, and Ovarian Cancers

On April 16, 2018 JHL Biotech reported that the China Food and Drug Administration (CFDA) has accepted for review JHL’s Clinical Trial Application for a proposedbevacizumab biosimilar, JHL1149, to treat cancer (Press release, JHL Biotech, APR 16, 2018, http://www.jhlbiotech.com/press-release/jhl-biotechs-clinical-trial-application-accepted-by-china-for-bevacizumab-biosimilar-to-treat-colorectal-lung-and-ovarian-cancers/ [SID1234525358]).
JHL1149 is a biosimilar to bevacizumab and would provide an affordable alternative to treat several cancers, the most common of which are metastatic colorectal cancer, non-small cell lung cancer, andovarian cancer, as well as cervical cancer, renal cell carcinoma, and glioblastoma.

JHL is planning to conduct a Phase 1 pharmacokinetic study in healthy volunteers in China followed by a multinational Phase 3 efficacy study in non-small cell lung cancer patients. Currently, a Phase I clinical trial for JHL1149 is ongoing in Europe. The data from these trials will support the global registration and commercialization of JHL1149. Once approved, JHL1149 will be manufactured at JHL’s facility in Wuhan, China, the world’s largest biopharmaceutical manufacturing plant based on single-use technologies, which will provide a high-quality supply of products worldwide.
JHL1149 is an anti-vascular endothelial growth factor (anti-VEGF) monoclonal antibody. The reference biologic, bevacizumab, is marketed by Roche under the trade name, Avastin. In 2017, bevacizumabgenerated worldwide revenues of approximately US$7 billion.

"JHL 1149 has been demonstrating a high level of similarity to the innovator product in physicochemcial and biological characteristics and in comparative preclinical studies," said Dr. Rong Chen, Chief Medical Officer, JHL Biotech. "Clinical trial for JHL1149 in China is a milestone in delivering quality and accessible products to patients worldwide who suffer from high unmet medical needs."

"Bevacizumab is an important biologic that is unfortunately very expensive for patients suffering from certain cancers, and JHL1149 would provide an affordable treatment for these patients," said Mr. Racho Jordanov, CEO, JHL Biotech. "JHL’s clinical trial in China is a step forward in our mission to become a global leader in developing, manufacturing, and commercializing biologics."

In addition to JHL1149, JHL has several other biosimilars currently in or expected to be in clinical trials. These include:
Rituximab biosimilar, JHL1101, to treat rheumatoid arthritis and non-Hodgkin lymphoma. Currently in Phase I trial in Europe.
Dornase alfa biosimilar, JHL1922, to manage symptoms of cystic fibrosis. Currently in Phase I trial in Europe.
Trastuzumab biosimilar, JHL1188, to treat breast cancer.
JHL1211, to treat asthma and chronic idiopathic urticaria.
JHL1199, to treat breast cancer.
JHL1266, to treat osteoporosis.
Media Contact:
Ellis Chu: [email protected] phone: +886 3-658-3899
Jill Liu: [email protected] phone: +886 3-658-3899
Amber Chen: [email protected] phone: +886 3-658-3899

Personalis, Inc. to Present New Data at the American Association for Cancer Research (AACR) Annual Meeting 2018

On April 16, 2018 Personalis, Inc., a provider of advanced genomic sequencing and analytics for immuno-oncology, reported that the company will present four posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting being held this year in Chicago, Illinois from April 14-18, 2018 (Press release, Personalis, APR 16, 2018, View Source [SID1234525356]).

Following is a list of abstracts that will be presented at the meeting.

Session ID / Poster Number

Title & Presenter
Day & Time
Location
PO.BSB01.01
1292
Methods of improving accuracy of neoantigen identification for therapeutic and diagnostic use in immuno-oncology
Presenter: Sean Michael Boyle
April 16
8am-12pm
Poster section
12
PO.BSB01.02
2245
Deconvolution of diverse immune cell populations within tumors using ACE Transcriptome
Presenter: Eric Levy
April 16
1-5pm
Poster section
12
PO.MCB09.08
5385
Supporting neoantigen discovery and monitoring in plasma through analytical validation of a deep Augmented Content Enhanced (ACE) exome
Presenter: Ravi Alla
April 18
8am-12pm
Poster section
17
PO.IM02.04
5710
Molecular profiling of anti-PD-1 treated melanoma patients reveals importance of assessing neoantigen burden and tumor escape mechanisms for clinical treatment
Presenter: Sean Michael Boyle

OncoSec Provides Highlights from Research Reception at AACR Annual Meeting 2018

On April 16, 2018 OncoSec Medical Incorporated (OncoSec) (NASDAQ: ONCS), a company developing intratumoral cancer immunotherapies, today provided highlights from its Research Reception held on Sunday, April 15, 2018, during the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2018.

The Research Reception was organized to provide industry experts gathered at the AACR (Free AACR Whitepaper) with a comprehensive overview of OncoSec’s ongoing and anticipated clinical programs involving ImmunoPulse IL-12 (or Intratumoral tavo-EP) in metastatic melanoma and triple-negative breast cancer (TNBC), including an overview of a poster presented at AACR (Free AACR Whitepaper) regarding a Phase 1 pilot study of ImmunoPulse IL-12 in TNBC ("Intratumoral plasmid IL-12 and electroporation in pre-treated inoperable locally advanced or recurrent triple-negative breast cancer (TNBC)" – Poster 055 / Abstract CT022).

ImmunoPulse IL-12 is currently being used in several ongoing clinical trials, with the technology demonstrating evidence of anti-tumor activity in the treatment of various solid tumors, the potential to initiate a systemic immune response, and a favorable safety profile. ImmunoPulse IL-12 combines intratumoral plasmid IL-12 with electroporation to produce a controlled, localized expression of IL-12 in the tumor microenvironment, which in turn, enables the immune system to target and attack tumors throughout the body.
The full webcast and presentation slides from the Research Reception can be accessed via OncoSec’s website: View Source

The following is a recap of key highlights from the event:
Melanoma Data Update: OMS-I100 Monotherapy Study & OMS-I102 Pembrolizumab Combination Study
Led by Alain Algazi, MD of the UCSF Helen Diller Family Comprehensive Cancer Center, the first presentation provided data from the OMS-I100 Phase 2 clinical trial, which demonstrated that ImmunoPulse IL-12 delivered as a monotherapy promoted innate and adaptive immune responses, importantly driving increased CD8+ TIL frequency.
Updated clinical data from the OMS-I100 study demonstrated that, in addition to peripheral immune responses, regression of distal, non-treated lesions were observed on average in 45% of the patients
Also, the treatment-related reshaping of the tumor microenvironment points to amplification of the IFN-γ/IL-12 feedforward loop, which in addition to supporting anti-tumor immunity, triggers adaptive immune resistance (PD-L1 expression) and provides the basis for a combination with IL-12 and anti-PD-1 therapy
Updated data from the OMS-I102 Phase 2 clinical trial (ImmunoPulse IL-12 in combination with pembrolizumab) demonstrated a 57% progression free survival (PFS) rate at 21 months with 100% (11/11) duration of response and median PFS/OS not yet reached

OMS-I140 Protocol; Review of Intratumoral IL-12 Data in TNBC Presented at AACR (Free AACR Whitepaper)
Led by Melinda Telli, MD of the Stanford University Medical Center, the following presentation provided a review of the OMS-I140 Phase 1 pilot study of ImmunoPulse IL-12 in TNBC, including an analysis of initial findings from the study, which were presented as a poster during AACR (Free AACR Whitepaper). The Phase 1 pilot study was designed to determine whether intratumoral plasmid IL-12 with electroporation (ImmunoPulse IL-12) would elicit a pro-inflammatory molecular and histological signature in treated as well untreated sites. Following administration of ImmunoPulse IL-12 on Days 1, 5 and 8 of a single 28-day cycle, data was obtained from five patients of the 10-patient study.
Treatment-related increase in CD8+ TIL density was observed by intratumoral chromogenic staining in 2 of 5 patient tumors (1 treated /1 untreated tumor)
NanoString analysis suggests that 1 cycle of Intratumoral tavo-EP did not globally impact intratumoral immune-related gene expression
Evidence of a treatment-related productive systemic immune response was seen in reduced gMDSCs and increased SLECs in the peripheral blood
Reported treatment-related adverse events included transient pain associated with electroporation and fatigue (both grade 1)

These results suggest that Intratumoral tavo-EP is a safe and tolerable TIL-stimulating therapy of skin and subcutaneous TNBC tumors

Further study of this therapy in combination with anti-PD-1 antibody therapy is warranted
OMS-I141 Protocol; Upcoming Anti-PD-1 Combination Clinical Trial in TNBC
A presentation given by Pamela Munster, MD of the UCSF Helen Diller Family Comprehensive Cancer Center, provided a review of OncoSec’s proposed Phase 2 trial in TNBC involving a combination of ImmunoPulse IL-12 (intratumoral tavo-EP) and an anti-PD-1 antibody therapy. The future Phase 2 trial will be a Simon 2-stage minimax design, non-comparative, open-label, single-arm, multicenter study of ImmunoPulse IL-12 plus an anti-PD-1 antibody therapy.
The study is expected to enroll approximately 25 patients (15 in Stage 1, and, if appropriate, 10 in Stage 2) with TNBC and electroporation accessible cutaneous / subcutaneous tumors

The proposed primary endpoint is to assess efficacy as measured by objective response rate (ORR) by independent central review (ICR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 of intratumoral tavo-EP in combination with an anti-PD-1 antibody therapy in subjects with inoperable locally advanced or metastatic TNBC
OncoSec expects to initiate this proposed study in 2018

PISCES/KEYNOTE-695 Operational Update
Led by OncoSec’s Chief Clinical and Regulatory Officer, Sharron Gargosky, PhD, the final presentation offered an operational assessment of PISCES/KEYNOTE-695, a global, multicenter Phase 2b, open-label trial of ImmunoPulse IL-12 in combination with pembrolizumab in patients with stage III/IV melanoma who have progressed or are progressing on either pembrolizumab or nivolumab treatment. OncoSec expects to report preliminary data at an upcoming medical meeting in 2018.

Navidea Biopharmaceuticals to Present at 2nd Annual NASH Summit

On April 16, 2018 Navidea Biopharmaceuticals (NYSE MKT: NAVB) ("Navidea" or "the Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported it will present at the 2nd Annual NASH Summit in Boston, MA being held April 23-25, 2018 (Press release, Navidea Biopharmaceuticals, APR 16, 2018, View Source [SID1234525353]). Michael Goldberg, President and Chief Executive Officer, will be giving a new presentation focused on Navidea’s NASH research; the presentation will be available on Navidea’s website following the conference.

Event: 2nd Annual NASH Conference
Presentation Date: Wednesday, April 25th
Presentation Time: 11:30am EST
Location: Revere Hotel Boston Common, Boston, MA
To schedule a meeting with Navidea management at the conference, please contact Navidea Investor Relations at [email protected].