Envisagenics wins another SBIR grant from the National Cancer Institute to enhance their AI/ML platform for Immunotherapy development

On October 23, 2019 Envisagenics, Inc., a New York-based biotechnology company leveraging artificial intelligence (AI) and RNA-splicing analytics for discovery and development of disease specific therapeutics, reported that it was awarded a Small Business Innovation Research (SBIR) Phase I grant from the National Cancer Institute (NCI), part of the National Institutes of Health (NIH) (Press release, Envisagenics, OCT 23, 2019, View Source [SID1234542459]). This grant will provide $300,000 over 1 year to expand Envisagenics’ proprietary drug discovery platform, SpliceCore, for the discovery of novel targets for immuno-oncology (IO) therapeutic development.

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This is Envisagenics’ third SBIR grant and the first from the NCI. Envisagenics was previously awarded Phase I and Phase II grants from the National Institute of General Medical Sciences (NIGMS, NIH) to develop the SpliceCore software platform. SpliceCore generates actionable insights using AI to drive development of splicing-based therapeutics. Using the SpliceCore platform, Envisagenics developed its first therapeutic asset pipeline for triple negative breast cancer (TNBC). Its lead compound targets a novel isoform that is present in 65% of TNBC patients and is currently undergoing pre-clinical studies at Envisagenics’ laboratory located at Johnson & Johnson Innovation, JLABS at New York City (JLABS @ NYC).

"What makes SpliceCore truly unique is its exon-centric view of the transcriptome. While mainstream transcriptomics is all about genes, we focus on exons because they are the minimal and most powerful informative unit for RNA-therapeutics development. This grant proposal aims to extend the value of SpliceCore for the identification of tumor-associated ectodomains (TAEs), which are small protein domains encoded by three exons or less," said Martin Akerman, co-founder and CTO of Envisagenics. TAEs are peptides present on cell membranes that can elicit an immune response. They may serve as novel targets for IO therapeutics or diagnostic biomarkers. IO therapies represent a major advancement in the treatment of cancers. However, existing IO treatments remain ineffective for a significant number of patients. Current methods to detect TAEs utilize antibody- and/or proteomic-based techniques, which are costly and time-consuming approaches that rely on previous domain knowledge and are limited in their ability to identify novel TAEs. Envisagenics’ RNA-based approach utilizes high-throughput sequencing data from patient samples and takes advantage of the high sensitivity of RNA-seq data to uncover novel TAE isoforms. Isoform viability and immunogenicity is then predicted using a set of machine learning algorithms.

Envisagenics will be collaborating in this research with Dr. Omar Abdel-Wahab, an expert in the field of splicing and hematologic malignancies. Dr. Abdel-Wahab is currently an Associate Member in Human Oncology and Pathogenesis Program (HOPP) and an Associate Attending Physician on the Leukemia Service in the Department of Medicine at Memorial Sloan Kettering Cancer Center (MSKCC). "I am excited to collaborate on this grant," said Dr. Abdel-Wahab. "This software represents an opportunity for cancer and immunology research, allowing for the discovery and profiling of transmembrane proteins using RNA-seq data instead of lower throughput proteomics methods."

"This is a very exciting moment for Envisagenics. While we focus on developing our TNBC assets, this grant will allow us to further explore and develop innovative applications of our platform for therapeutic development, with the ultimate goal of helping patients in need," said Maria Luisa Pineda, co-founder and CEO.

Amyris to Announce Third Quarter Financial Results on Thursday, November 7, 2019

On October 23, 2019 Amyris, Inc. (Nasdaq:AMRS) reported that it will report financial results for the third quarter ended September 30, 2019 after market close on Thursday, November 7, 2019 (Press release, Amyris Biotechnologies, OCT 23, 2019, View Source [SID1234542460]).

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The company will hold its quarterly conference call to discuss these results, as well as provide an update on the company’s business and outlook, at 4:30 p.m. ET (1:30 p.m. PT) on Thursday, November 7, 2019.

Conference Call:
Thursday, November 7, 2019, 4:30 p.m. ET/1:30 p.m. PT

Dial-in Number:
(877) 870-4263 (U.S. & International)

Participants should ask to be joined to the Amyris, Inc. call.

Audio Webcast:
A live webcast of the call will be available online on the Amyris website. To listen via live webcast, please visit: View Source A replay of the webcast will be available on the Investor Relations section of the company’s website approximately two hours after the conclusion of the call.

AIM ImmunoTech to Present at the Dawson James Securities 5th Annual Small Cap Growth Conference

On October 23, 2019 AIM ImmunoTech Inc. (NYSE American:AIM), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, reported that it will be presenting at the Dawson James Securities 5th Annual Small Cap Growth Conference being held on October 28-29, 2019 at the Wyndham Grand Hotel in Jupiter, Florida (Press release, AIM ImmunoTech, OCT 23, 2019, View Source;id=184460&p=2170068&I=1206939-c7Z3G6f3m8 [SID1234542444]).

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Thomas K. Equels, Chief Executive Officer of AIM ImmunoTech, is scheduled to present on Tuesday, October 29th at 1:10 p.m. Eastern Time, in Track 2 – Preserve Ballroom B, with one-on-one meetings to be held throughout the conference.

About Dawson James Securities

Dawson James Securities, Inc., a member of FINRA/SIPC, is a full-service investment bank headquartered in Boca Raton, FL. View Source

Insmed to Host Third Quarter 2019 Financial Results Conference Call on Wednesday, October 30, 2019

On October 23, 2019 Insmed Incorporated (Nasdaq: INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, reported that it will release its third quarter 2019 financial results on Wednesday, October 30, 2019 (Press release, Insmed, OCT 23, 2019, View Source [SID1234542462]).

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Insmed management will host a conference call for investors beginning at 8:30 a.m. ET on Wednesday, October 30, 2019 to discuss the financial results and provide a business update.

Shareholders and other interested parties may participate in the conference call by dialing (888) 317-6003 (domestic) or (412) 317-6061 (international) and referencing conference ID number 6042526. The call will also be webcast live on the company’s website at www.insmed.com.

A replay of the conference call will be accessible approximately one hour after its completion through November 6, 2019 by dialing (877) 344-7529 (domestic) or (412) 317-0088 (international) and referencing replay access code 10136134. A webcast of the call will also be archived for 90 days under the Investor Relations section of the company’s website at www.insmed.com.

BioInvent Signs Manufacturing Agreement With Cancer Research UK Expected to Generate Approximately SEK 30 Million (~$3 Million)

On October 23, 2019 BioInvent International AB (publ) (OMXS: BINV) reported it has concluded a production agreement with Cancer Research UK, the world’s largest independent funder of cancer research, for the production of Hummingbird Bioscience’s anti-HER3 antibody drug HMBD-001 for use within a clinical partnership formed between Cancer Research UK and Hummingbird Bioscience to test the agent in a phase I trial (Press release, BioInvent, OCT 23, 2019, View Source [SID1234542445]).

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Under the agreement, which is expected to generate revenue of approximately SEK 30 million (~$3 million), mostly in 2020, BioInvent will provide HMBD-001 to Cancer Research UK. It includes process, analytical and formulation development, process scale up and manufacturing of toxicology and clinical grade material in 200- and 1,000-liters scale.

"We are very pleased to have concluded an agreement to provide this service to Cancer Research UK and are looking forward to producing Hummingbird’s drug candidate for clinical trials. The fact that BioInvent has its own production facility gives us added flexibility, meaning we can develop our proprietary immuno-oncology programs more efficiently, and also generate revenue from our services to help fund our pipeline," says Martin Welschof, CEO of BioInvent.

Dr Nigel Blackburn, Cancer Research UK’s director of drug development, says: "We are delighted to be partnering with BioInvent who will produce Hummingbird Bioscience’s anti-HER3 antibody, ready to be tested in clinical trials. Our clinical development partnerships fast track promising new treatments like this through one of the most difficult stages of drug development, benefitting people with cancer much sooner."

Cancer Research UK’s Centre for Drug Development entered into a partnership with Hummingbird Bioscience to manufacture clinical grade anti-HER3 antibody and conduct a Phase I clinical trial to evaluate drug safety, toxicity and efficacy. HMBD-001 is the only anti-HER3 antibody in development that binds to the most critical region involved in HER3 activation, turning off this signal completely. If successful, this new antibody could be used in the treatment of multiple cancers and be effective against drug resistant cancers.

BioInvent’s manufacturing capabilities
The BioInvent manufacturing facility is compliant with Current Good Manufacturing Practice (cGMP) regulations and is fully based on disposable technology and can produce batches in sizes from 40 L to 1,000 L. The platform process ensures rapid and efficient process development and spans everything from cell line development to final release of drug substance for clinical trials. BioInvent offers a range of cell line development options that include a royalty free GS knocked CHO K1 cell line.