On October 17, 2019 Selexis SA and Teneobio, Inc. reported that they have signed three commercial license agreements (CLAs) for the development of Teneobio’s Human Heavy-Chain Antibodies (UniAbs), a new class of multi-specific biologics, for the treatment of multiple myeloma, lymphoma and prostate cancer (Press release, TeneoBio, OCT 17, 2019, View Source [SID1234542339]). The CLAs expand the companies’ previously established relationship, including a service agreement signed between Teneobio and Selexis in December 2018.

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Through each new CLA, Selexis will provide Teneobio with access to high performance research cell banks (RCBs) developed using the Selexis SUREtechnology Platform, with each expressing a unique UniAb product candidate.

"Today, new generations of biologically engineered antibody therapies are reaching the clinic with Selexis technologies that are specifically engineered to address the challenges of achieving high expression levels for and quality thresholds of bi- and multi-specific antibodies. Teneobio’s multi-specific UniAbs represent an exciting opportunity to leverage our capabilities," said Yemi Onakunle, PhD, MBA, Selexis senior vice president, licensing and business development. "We’re pleased that the SUREtechnology Platform has positively impacted the trajectory of Teneobio’s pipeline and we look forward to working with their team to bring these exciting new oncology biologics to the clinic."

Bi- and multi-specific antibodies represent one of the fastest-growing classes of molecules offering new therapeutic perspectives. A bi/multi-specific antibody is a recombinant, engineered protein that can simultaneously bind to two or more different types of antigens, often on two or more different types of cells. For cancer therapies, one-half of a bispecific recognizes an antigen on an immune cell, typically a T-cell, and the other half recognizes an antigen on the tumor. By binding both antigens simultaneously, a bispecific brings T-cells in close proximity to tumor cells where they can kill them.

"Since we began working with Selexis two years ago, we’ve seen firsthand the benefits of its cell line expression technologies – high-yield, speed, stability, flexibility and applicability for use with our differentiated, multi-specific platform – all of which are essential for bringing our innovative UniAbs to patients," said Omid Vafa, PhD, MBA, chief business officer at Teneobio, Inc. "We look forward to continuing our important work together."

Selexis’ modular SUREtechnology Platform facilitates the rapid, stable, and cost-effective production of virtually any recombinant protein and provides seamless integration of the biologics development continuum, spanning discovery to commercialization.

On October 17, 2019 Immunomic Therapeutics, Inc. reported a presentation at the Precision Lung Cancer World R&D Summit in Boston (Press release, Immunomic Therapeutics, OCT 17, 2019, View Source [SID1234542340]). On Tuesday, October 22, Business Development Advisor at Immunomic, Yan Su, will present a talk entitled "Current & Future Application of the UNITE Platform in Cancer Immunotherapy," highlighting Immunomic’s investigational UNiversal Intracellular Targeted Expression (UNITE) platform and its application in immuno-oncology.

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Immunomic’s UNITE technology platform has the potential to utilize the body’s natural biochemistry to develop a broad immune response, including antibody production, cytokine release and critical immunological memory, a method that could put UNITE at the crossroads of immunotherapies in a number of illnesses, including cancer. The investigational UNITE technology is currently being applied as a cancer immunotherapy in a Phase II clinical trial targeting glioblastoma multiforme (GBM). Su’s presentation will explore the broader potential of UNITE through discussion of the LAMP-based immunotherapy technology, VAC2. VAC2 is an allogeneic cancer immunotherapy being developed by Lineage Cell Therapeutics, Inc. in collaboration with Cancer Research UK and is currently in a Phase 1 clinical trial for treatment of non-small cell lung cancer. In addition, the presentation will discuss the potential application of the UNITE Platform in Cancer targeting shared neoantigens.

Who: Yan Su, Business Development Advisor at Immunomic Therapeutics, Inc.

What: Presentation on Current & Future Application of the UNITE Platform in Cancer Immunotherapy

When: Tuesday, October 22 at 4:00 p.m. ET

Where: Wyndham Boston Beacon Hill, 5 Blossom St., Boston, MA 02114

About UNITE

ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, works by fusing pathogenic antigens with the Lysosomal Associated Membrane Protein, an endogenous protein in humans, for immune processing and MHC-II presentation to helper T-cells. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach could put UNITE technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. UNITE is currently being employed in Phase II clinical trials as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of UNITE in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for UNITE therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.

On October 17, 2019 ArsenalBio reported that its debut backed by $85 million Series A financing to build a programmable cell therapy company to create highly effective and accessible immune cell therapies (Press release, Arsenal Bio, OCT 17, 2019, View Source [SID1234567863]). The company will integrate technologies such as CRISPR-based genome engineering, scaled and high throughput target identification, synthetic biology, and machine learning to advance a new paradigm to discover and develop immune cell therapies, initially for cancer. ArsenalBio’s foundation stems from the contributions of scientific leaders from a consortium of academic medical and research institutions.

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Investors include Westlake Village BioPartners, the Parker Institute for Cancer Immunotherapy (PICI), Kleiner Perkins, the University of California, San Francisco (UCSF) Foundation Investment Company, Euclidean Capital, and Osage Venture Partners.

"Our goal is to address the unmet need and suffering of patients with cancer, and ultimately other diseases, by developing and advancing a new paradigm of human immune cell therapy design and treatment," said Ken Drazan, MD, ArsenalBio’s founding Chief Executive Officer. "The integrated technology approach we’re embarking upon will create a new arsenal of tools and medicines for researchers, patients and their physicians to reduce cancer morbidity and mortality."

Today’s commercialized, first-generation T cell therapies are designed and manufactured with the goal of inserting into T cells a single cell-targeting transgene, a chimeric antigen receptor or a new T cell receptor through viral delivery. ArsenalBio seeks to exponentially advance this process by precisely inserting, without viral vectors, significantly larger DNA payloads, designed with proprietary tools and encoding a broader set of biological "software" instructions to enable immune cells to effectively target and destroy solid organ and hematologic cancers. ArsenalBio’s approach will move beyond the current model of tumor-targeting strategies to enable the rewiring of immune cell circuitry through computationally driven design. The company aspires to evolve critical metrics of success for immune cell therapies, including enhanced and broader efficacy, increased patient safety, reduced provider costs, and expanded market access.

"The technology ArsenalBio is developing represents a significant advance in how cancer could be treated. The experience leaders such as Jane Grogan, Michael Kalos and Tarjei Mikkelsen bring, combined with Dr. Drazan’s results-oriented management approach, will help rapidly advance this transformational platform to benefit patients," added Beth Seidenberg, MD, co-founding Managing Director of Westlake Village BioPartners, a Los Angeles area-based venture capital firm focused on incubating and building life sciences companies.

"ArsenalBio is taking different approaches to gene editing, target selection, cell circuit engineering, and computation to reimagine dosing, delivery, persistence, and affordability of cell therapy. The networks of pharma, science, and talent relationships of PICI, Westlake and Kleiner Perkins is a booster to ArsenalBio’s remarkable team and R&D progress," said Brook Byers, Founding Partner of Kleiner Perkins of Menlo Park, CA.

"ArsenalBio allows us to rewrite vast stretches of code to give T cells dramatic new functions–that means they can be made to be more effective at killing cancer and a broad spectrum of other diseases," said Sean Parker, founder and Chairman of PICI. "It’s also very rewarding to see ArsenalBio born from the deep collaboration of PICI investigators—who worked together across research centers, hospitals and universities on the science behind these technologies. The company’s very existence demonstrates how much faster and better we can get therapies from bench to bedside when we collaborate and put patients first."

Experienced Management Team

ArsenalBio’s management team includes seasoned industry executives who bring immuno-oncology, cell therapy and genomic expertise:

Ken Drazan, MD, who most recently served as President of GRAIL, Inc.
Jane Grogan, PhD, Chief Scientific Officer (formerly Principal Scientist, Head of Adaptive Tumor Immunity and Cell Therapy, Genentech)
Michael Kalos, PhD, Executive Vice President, Head of Research & Development (formerly Vice President, Immuno-Oncology and Cell Therapies, Janssen Oncology)
Tarjei Mikkelsen, PhD, Chief Technology Officer (formerly Vice President, Biology at 10x Genomics)
Board of Directors with Proven Track Record

ArsenalBio’s board brings together industry leaders who have proven track records building successful companies:

Ken Drazan, MD, Founding CEO, ArsenalBio
Beth Seidenberg, MD, Managing Director, Westlake Village BioPartners
Brook Byers, Founding Partner, Kleiner Perkins
Sean Parker, Chairman and Founder, PICI
Alexander Marson, MD, PhD, Associate Professor of Microbiology/Immunology, UCSF and PICI Investigator
Scientific Founders

The company’s scientific founders comprise a bi-coastal, multi-disciplinary consortium of leading academic researchers:

Bradley Bernstein, MD, PhD, Professor of Pathology, Massachusetts General Hospital / Broad Institute
W. Nicholas Haining, BM BCh, Vice President, Discovery Oncology at Merck Research Laboratories, previously Associate Professor of Pediatrics, Dana-Farber Cancer Institute
Alexander Marson, MD, PhD, Associate Professor of Immunology, UCSF and PICI Investigator
Theodore Roth, PhD, UCSF School of Medicine, ArsenalBio’s founding interim Chief Scientific Officer
Kole Roybal, PhD, Assistant Professor of Immunology, UCSF and PICI Investigator
E. John Wherry, PhD, Chairman and Distinguished Presidential Professor of Systems Immunology, UPenn and PICI Investigator, Chair Arsenal Science Advisory Board

On October 17, 2019 Xcovery Holdings, Inc., an oncology-focused biopharmaceutical company, reported that ensartinib, the company’s lead drug candidate, demonstrated efficacy and safety in patients with crizotinib-refractory, anaplastic lymphoma kinase (ALK) positive non-small cell lung cancer (NSCLC), including those with brain metastases (Press release, Xcovery, OCT 17, 2019, View Source [SID1234542341]). The peer-reviewed manuscript of the study, "Efficacy, safety, and biomarker analysis of ensartinib in crizotinib-resistant, ALK-positive non-small-cell lung cancer: a multicentre, phase 2 trial" was published online in The Lancet Respiratory Medicine.

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"These results from the ensartinib China registration trial are very encouraging. They support our ongoing global phase 3 efforts in evaluating ensartinib’s efficacy and safety in the first line setting," said Li Mao, M.D., Chief Executive Officer of Xcovery, "Our company is dedicated to developing drugs to help cancer patients and we believe ensartinib has the potential to be the best-in-class first line therapy for ALK-positive NSCLC patients."

The multicenter phase 2 registration study analyzed the efficacy and safety of ensartinib in ALK-positive NSCLC patients that failed prior crizotinib treatment. The study also explored the associations between ensartinib efficacy and crizotinib-resistant mutations.

Ensartinib showed very promising activity in patients with ALK-positive NSCLC whose disease had progressed on previous crizotinib therapy. 52% (95% CI 43–60) of patients had a systemic objective response, whereas 70% (53–83) had an intracranial objective response, as assessed by an independent review committee.

In the study, most treatment-related adverse events were grade 1 or 2 and low proportions of patients required dose modifications or discontinued. Ensartinib also demonstrated activity against a broad array of ALK mutations, including G1202R, G1269A, F1174, C1156Y, and T1151.

D. Ross Camidge, M.D., from the University Of Colorado Department Of Medicine provided the Editorial Comment for the Lancet published study. "The median progression-free survival associated with ensartinib (9.6 months) was remarkably similar to that reported for the same drug at the same dose in a separate US study (9.2 months)," noted Dr. Camidge. "Cross-trial comparison would suggest that ensartinib’s activity is thus likely to be similar, if not marginally superior, to that of alectinib."

"This data set supports ensartinib as a new option for ALK-positive NSCLC patients in a refractory setting," said Giovanni Selvaggi, M.D., Chief Medical Officer at Xcovery and co-author of the study. "The high efficacy against brain metastases and the encouraging signal in resistant mutations, including G1202R, make ensartinib a promising treatment in an area where there is still significant unmet medical need."

To view the article, please visit https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(19)30252-8/fulltext.

For more information on the ensartinib phase 3 clinical trial, please visit clinicaltrials.gov.

About Ensartinib

Ensartinib (X-396) is a potent anaplastic lymphoma kinase (ALK) inhibitor currently in a global phase 3 trial for ALK-positive NSCLC in the first line.

On October 17, 2019 Penumbra, Inc. (NYSE: PEN) reported that it will host a conference call to discuss financial results for the third quarter 2019 after market close on Thursday, November 7, 2019 at 4:30 PM Eastern Time (Press release, Penumbra, OCT 17, 2019, View Source [SID1234542342]). A press release with third quarter 2019 financial results will be issued after market close that day.

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Webcast & Conference Call Information
The conference call can be accessed live over the phone by dialing (833) 227-5837 for domestic callers or (647) 689-4064 for international callers (conference id: 4746448), or the webcast can be accessed on the "Events" section under the "Investors" tab of the Company’s website at: www.penumbrainc.com. The webcast will be available on the Company’s website for at least two weeks following the completion of the call.