On October 17, 2019 Plexium reported the launch of the company with the closing of a $28 million Series A financing (Press release, Plexium, OCT 17, 2019, View Source [SID1234542338]). The financing was led by DCVC Bio and The Column Group, with participation from M Ventures, CRV, and Neotribe Ventures. The company’s proprietary platform, DELPhe, enables cell-based phenotypic screening of DNA-encoded libraries in nanoliter volumes.

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Proceeds from the financing will be used to further advance Plexium’s DELPhe platform and build a pipeline of small molecules that modulate E3 ligases to selectively enhance and degrade protein targets. Disease-specific profiles of desired protein modulation are informed by human clinical and translational biomarker observations. By screening millions of small molecules, simultaneously, for their impact on cellular RNA and protein levels, compounds with the desired activity profiles will be selected and advanced as therapeutic candidates in oncology and neurodegenerative diseases.

"Inducing protein degradation by redirecting E3 ligases is an exciting therapeutic modality with immense potential to create safe and effective new medicines," said Kandaswamy (Swamy) Vijayan, Ph.D., founder and CEO of Plexium. "The levels of a vast majority of proteins in the cell are modulated by E3 ligases, including disease targets considered ‘undruggable.’ DELPhe can efficiently identify therapeutic small molecules for the precise manipulation of E3 ligases, unlocking control of disease-modifying pathways."

Plexium’s strategy employing the DELPhe platform is unlike other approaches to targeted protein degradation. While other strategies require a small molecule known to bind a protein target to be degraded, the DELPhe platform utilizes target-specific degradation assays and phenotypic screens to find small molecules that reduce levels of the target protein in cells. This creates an opportunity to identify small molecules to undruggable protein targets through screening approaches that do not require prior knowledge of molecules that bind the target.

In conjunction with the financing, Kiersten Stead, Ph.D., managing partner of DCVC Bio, and Tim Kutzkey, Ph.D., managing partner of The Column Group, have joined Plexium’s board of directors.

"Plexium is replacing the complex infrastructure around drug discovery with an ultra-high-throughput microfluidic platform while reducing assay complexity and supercharging chemical diversity," said Kiersten Stead. "The richness and scale of data that can be generated from the DELPhe platform are poised to transform drug development. We are thrilled to support Plexium in its mission to develop the ultimate tool for drugging undruggable proteins."

"Plexium is an interesting amalgam of cutting-edge engineering coupled with the latest advances in chemistry and biology," said Tim Kutzkey. "We are impressed with the vision of the DELPhe platform and its applicability to E3 ligase modulation. We believe tuning E3 ligases opens up immense opportunities for first-in-class therapeutics, and we are excited to be supporting the novel approaches and therapeutic opportunities being pursued at Plexium."

Plexium will be presenting at the Targeted Protein Degradation Summit in Boston on October 23.

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 16, 2019 4SC AG (4SC, FSE Prime Standard: VSC) reported a collaboration with the Netherlands Cancer Institute (Stichting Het Nederlands Kanker Instituut (NKI) – Antoni van Leeuwenhoek Ziekenhuis) in Amsterdam to evaluate domatinostat in combination with checkpoint blockade in a "Multicenter Phase 1b Study testing the Neoadjuvant Combination of Domatinostat, Nivolumab, and Ipilimumab, in RECIST 1.1-measurable Stage III Cutaneous or Unknown Primary Melanoma – DONIMI" (Press release, 4SC, OCT 16, 2019, View Source [SID1234542306]).

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Immunotherapy, and particularly checkpoint inhibitors like anti-PD-1 (e.g. Nivolumab) and anti-CTLA4 (Ipilimumab), are increasingly investigated not only in the advanced unresectable or metastatic setting but also in earlier stages of disease. The rationale for such treatment is to activate the immune system before resection of the tumor to generate an immune memory and prevent recurrence of the disease. On the basis of some encouraging data published by the International Neoadjuvant Melanoma Consortium (INMC; View Source), innovative combination approaches will now be tested to optimize the treatment in a more personalized manner where domatinostat is a promising combination partner.

Jason Loveridge, Ph.D., CEO of 4SC: "It is getting clearer and clearer that immunotherapy for cancer is most effective when used early in disease progression and we believe the neoadjuvant setting offers a great potential for protecting patients from recurrence of their malignancy after resection, potentially leading to a much higher number of cured patients with resectable, high-risk melanoma. Prof. Blank and his collaborators within the INMC have already made remarkable progress in this highly innovative field in melanoma and the NKI is a worldwide leading cancer center in the treatment of melanoma and other indications in the neoadjuvant setting. We are grateful entering such collaboration with the NKI and looking forward to the initiation of the DONIMI study in the near future."

Prof. Dr. Christian Blank, NKI: "It is exciting to see what we have achieved with neoadjuvant immunotherapy in melanoma within the INMC during the last few years. However there´s still a way to go to implement a standard neoadjuvant treatment in melanoma. Additional combination approaches to modulate the tumor microenvironment and the patients´ immune system remains a priority so as to optimize and personalize treatment for patients with melanoma, and potentially impact the treatment of patients with other cancers. For example, we do not know yet which patients require double neoadjuvant checkpoint inhibition and who can be treated with neoadjuvant PD-1 blockade alone. Based on preclinical and early clinical data, epigenetic modulation with domatinostat in combination with checkpoint blockade might be a promising approach in the neoadjuvant setting. In the DONIMI study, Domatinostat will be one of the first compounds tested in a personalized neoadjuvant combination trial implemented by INMC researchers from Sydney and Amsterdam. We are much looking forward to enroll the first patients later this year."

On October 16, 2019 Abbott (NYSE: ABT) reported financial results for the third quarter ended Sept. 30, 2019 (Press release, Abbott, OCT 16, 2019, View Source [SID1234542323]).

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Third-quarter worldwide sales of $8.1 billion increased 5.5 percent on a reported basis and 7.6 percent on an organic* basis.
Reported diluted EPS from continuing operations under GAAP was $0.53 in the third quarter. Adjusted diluted EPS from continuing operations, which excludes specified items, was $0.84, an increase of 12.0 percent versus prior year1.
Abbott narrowed its full-year 2019 outlook for diluted EPS from continuing operations on a GAAP basis to $2.06 to $2.08, and full-year adjusted diluted EPS from continuing operations to $3.23 to $3.25, reflecting 12.5 percent growth versus the prior year at the midpoint of the range2.
FreeStyle Libre achieved worldwide sales of $496 million in the quarter, an increase of 63.1 percent on a reported basis and 67.6 percent on an organic basis versus the prior year.
During the third quarter, FreeStyle Libre obtained public reimbursement coverage in Ontario and Quebec, becoming the first and only sensor-based glucose monitoring system to be listed by any provincial health plan in Canada.
Worldwide sales of MitraClip were $176 million in the quarter, an increase of 30.4 percent on a reported basis and 31.9 percent on an organic basis, including U.S. growth of 45.7 percent versus the prior year. During the third quarter, Abbott announced U.S. FDA approval of its next-generation MitraClip device, which offers enhancements and more sizes to offer doctors further options.
In September, Abbott announced data from its COAPT Trial that shows that MitraClip is projected to increase life-expectancy and quality of life compared to guideline-directed medical therapy alone in heart failure patients with secondary mitral regurgitation, or a leaky mitral heart valve.
During the third quarter, Abbott received U.S. FDA approval for its Alinity-S diagnostics system, the latest technology for screening and protecting the U.S. blood and plasma supply.
"We’re performing exceptionally well across several areas," said Miles D. White, chairman and chief executive officer, Abbott. "We’re right on track to achieve ongoing EPS and organic sales growth at the upper-end of our initial guidance ranges for the year."

* See note on organic growth below.

THIRD-QUARTER BUSINESS OVERVIEW
Note: Management believes that measuring sales growth rates on an organic basis is an appropriate way for investors to best understand the underlying performance of the business.

Organic sales growth:

Excludes the prior year first, second and third-quarter results for a non-core business within U.S. Adult Nutrition, which was discontinued during the third quarter 2018; and
Excludes the impact of foreign exchange.

Third-quarter 2019 worldwide sales of $8.1 billion increased 5.5 percent on a reported basis. On an organic basis, worldwide sales increased 7.6 percent. Refer to tables titled "Non-GAAP Reconciliation of Adjusted Historical Revenue" for a reconciliation of adjusted historical revenue.

Worldwide Nutrition sales increased 2.0 percent on a reported basis in the third quarter. On an organic basis, sales increased 3.8 percent. Refer to tables titled "Non-GAAP Reconciliation of Adjusted Historical Revenue" for a reconciliation of adjusted historical revenue.

Worldwide Pediatric Nutrition sales increased 0.5 percent on a reported basis in the third quarter, including an unfavorable 0.9 percent effect of foreign exchange, and increased 1.4 percent on an organic basis. In the U.S., sales growth was led by Abbott’s market-leading toddler brands, PediaSure and Pedialyte. International sales declined 2.4 percent on a reported basis and 0.7 percent on an organic basis, driven by challenging market dynamics in Greater China, partially offset by growth across several countries in Southeast Asia and Latin America.

Worldwide Adult Nutrition sales increased 3.9 percent on a reported basis in the third quarter and increased 6.9 percent on an organic basis. International Adult Nutrition sales increased 7.5 percent on a reported basis and 10.4 percent on an organic basis in the third quarter. Sales performance in the quarter was led by strong growth of Ensure, Abbott’s market-leading complete and balanced nutrition brand, and Glucerna, Abbott’s market-leading diabetes-specific nutrition brand.

Worldwide Diagnostics sales increased 4.7 percent on a reported basis in the third quarter, including an unfavorable 1.9 percent effect of foreign exchange, and increased 6.6 percent on an organic basis.

Core Laboratory Diagnostics sales increased 8.3 percent on a reported basis and 10.6 percent on an organic basis in the third quarter. Sales performance was led by above-market growth in the U.S. and internationally, where Abbott is achieving continued strong adoption of its Alinity family of innovative and highly differentiated diagnostic instruments. During the third quarter, Abbott received U.S. FDA approval for its Alinity-S blood and plasma screening diagnostics instrument and several testing assays.

Molecular Diagnostics sales decreased 7.8 percent on a reported basis in the third quarter, including an unfavorable 1.4 percent effect of foreign exchange, and decreased 6.4 percent on an organic basis. Internationally, sales growth in the quarter was negatively impacted by lower non-governmental organization purchases in Africa.

Point of Care Diagnostics sales increased 6.3 percent on a reported basis in the third quarter, including an unfavorable 0.4 percent effect of foreign exchange, and increased 6.7 percent on an organic basis. Sales growth was led by Abbott’s market-leading i-STAT handheld system in the U.S. and internationally.

Rapid Diagnostics sales decreased 0.7 percent on a reported basis in the third quarter, including an unfavorable 1.5 percent effect of foreign exchange, and increased 0.8 percent on an organic basis. Organic sales growth was led by infectious disease testing in developed markets and cardio-metabolic testing globally, partially offset by lower than expected infectious disease testing sales in Africa.

Established Pharmaceuticals sales increased 4.4 percent on a reported basis in the third quarter, including an unfavorable 3.5 percent effect of foreign exchange, and increased 7.9 percent on an organic basis.

Key Emerging Markets include India, Brazil, Russia and China along with several additional emerging countries that represent the most attractive long-term growth opportunities for Abbott’s branded generics product portfolio. Sales in these geographies increased 2.8 percent on a reported basis in the third quarter and increased 6.8 percent on an organic basis, which excludes an unfavorable 4.0 percent effect of foreign exchange. Organic sales growth was led by strong growth across several geographies, including India, China and Brazil.

Other sales increased 9.2 percent on a reported basis in the third quarter, including an unfavorable 1.7 percent effect of foreign exchange, and increased 10.9 percent on an organic basis.

Worldwide Medical Devices sales increased 8.9 percent on a reported basis in the third quarter and increased 10.6 percent on an organic basis, led by double-digit growth in Electrophysiology, Heart Failure, Structural Heart and Diabetes Care.

In Electrophysiology, growth was led by strong performance in cardiac diagnostic and ablation catheters, which are used to help physicians accurately and effectively treat atrial fibrillation, a form of irregular heartbeat.

In Heart Failure, strong double-digit growth was driven by market adoption of Abbott’s HeartMate 3 left ventricular assist device, which has been shown to improve survival and clinical outcomes in patients with advanced heart failure.

Growth in Structural Heart was led by MitraClip, Abbott’s market-leading device for the minimally invasive treatment of mitral regurgitation, or a leaky mitral heart valve. In the third quarter, Abbott announced U.S. FDA approval of its next-generation MitraClip device, MitraClip G4, which offers an expanded range of clip sizes, an alternative leaflet grasping feature and facilitation of procedure assessment in real time to offer doctors further options when treating mitral valve disease.

In Diabetes Care, sales increased 29.6 percent on a reported basis and 33.1 percent on an organic basis in the third quarter. Sales growth in the quarter was led by FreeStyle Libre, Abbott’s revolutionary continuous glucose monitoring system, with worldwide sales of $496 million, an increase of 63.1 percent on a reported basis and 67.6 percent on an organic basis versus the prior year. During the third quarter, FreeStyle Libre obtained public reimbursement coverage in Ontario and Quebec, becoming the first and only sensor-based glucose monitoring system to be listed by any provincial health plan in Canada.

ABBOTT’S GUIDANCE FOR 2019
Abbott is narrowing its guidance for 2019 diluted earnings per share from continuing operations under Generally Accepted Accounting Principles (GAAP) to $2.06 to $2.08. Abbott forecasts net specified items for the full year 2019 of $1.17 per share. Specified items include intangible amortization expense, acquisition-related expenses, charges associated with cost reduction initiatives and other expenses. Excluding specified items, projected adjusted diluted earnings per share from continuing operations would be $3.23 to $3.25 for the full year 2019.

Abbott is issuing fourth-quarter 2019 guidance for diluted earnings per share from continuing operations under GAAP of $0.59 to $0.61. Abbott forecasts specified items for the fourth quarter 2019 of $0.35 per share primarily related to intangible amortization, acquisition-related expenses, cost reduction initiatives and other expenses. Excluding specified items, projected adjusted diluted earnings per share from continuing operations would be $0.94 to $0.96 for the fourth quarter.

ABBOTT DECLARES 383RD CONSECUTIVE QUARTERLY DIVIDEND
On Sept. 12, 2019, the board of directors of Abbott declared the company’s quarterly dividend of $0.32 per share. Abbott’s cash dividend is payable Nov. 15, 2019, to shareholders of record at the close of business on Oct. 15, 2019.

Abbott has increased its dividend payout for 47 consecutive years and is a member of the S&P 500 Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years.