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Johnson & Johnson Announces Quarterly Dividend for Fourth Quarter 2019

On October 17, 2019 Johnson & Johnson (NYSE: JNJ) reported that its Board of Directors has declared a cash dividend for the fourth quarter of 2019 of $0.95 per share on the company’s common stock (Press release, Johnson & Johnson, OCT 17, 2019, View Source;johnson-announces-quarterly-dividend-for-fourth-quarter-2019-300940675.html [SID1234542345]). The dividend is payable on December 10, 2019 to shareholders of record at the close of business on November 26, 2019. The ex-dividend date is November 25, 2019.

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Penumbra, Inc. Schedules Third Quarter 2019 Earnings Release and Conference Call for November 7, 2019

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.

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.

The Lancet Respiratory Medicine Published Study Shows Ensartinib Holds Promise as a New Treatment Option for ALK-positive Non-Small Cell Lung Cancer (NSCLC)

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.

"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.

Immunomic Therapeutics to Present at Precision Lung Cancer World R&D Summit

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.

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.

Teneobio and Selexis Expand Relationship with Three Commercial License Agreements for Multi-specific Antibody Candidates in Oncology

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.

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.