On September 29, 2020 Sema4, a patient-centered health intelligence company, reported that it has entered into a research agreement with Janssen Research & Development, LLC (Janssen) to optimize oncology clinical trials (Press release, Sema4, SEP 29, 2020, View Source [SID1234567751]). Together, Sema4 and Janssen will utilize genomic testing and advanced data analytics to more efficiently and accurately identify patients diagnosed with cancer who may be candidates for oncology clinical trials.

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Approximately 1.8 million people are expected to be diagnosed with cancer in the US in 2020, yet only a small percentage of adult patients participate in oncology clinical trials each year, despite clinical trials evaluating promising investigational therapies. Suboptimal patient recruitment is a significant rate-limiting factor in clinical trials that can lead to studies using excessive resources and time, and being underpowered or even abandoned.

To address this problem, Sema4 will provide Janssen access to two of the company’s key assets: industry-leading genomic testing and its proprietary Centrellis health intelligence platform. Centrellis utilizes automated natural language processing capabilities, complemented by PhD oncology curators, to extract critical information regarding patient characteristics from electronic medical record (EMR) data.

Sema4 will deploy its advanced analytics capabilities to apply Janssen’s clinical trial recruitment criteria to Sema4’s large pool of deidentified clinical and genomic patient data to evaluate if a patient may benefit from one of Janssen’s clinical trials.

"Sema4 is passionate about improving patient care through its work with patients, providers, and biopharmaceutical companies," said Eric Schadt, PhD, Founder and Chief Executive Officer of Sema4. "We are delighted to collaborate with Janssen to utilize our technology and digital expertise and market-leading science experience to potentially accelerate trial recruitment times, with the goal of more treatment options becoming available to patients more quickly."

The collaboration with Janssen follows several other significant developments for Sema4 since the beginning of 2020. Earlier in the year, Sema4 released several software solutions to enable biopharmaceutical partners to rapidly find patients matching clinical trial recruitment criteria and effectively and efficiently design new clinical trials. The company also announced an alliance with artificial intelligence informatics company VieCure, provider of an oncology EMR and point-of-care decision support system, to further enable its national clinical trial support capabilities.

Additionally, Sema4 this year launched its Sema4 Signal Whole Exome/Transcriptome Sequencing (WES/WTS) offering, which is available to biopharmaceutical companies, and became the first commercial laboratory to be approved by the New York State Department of Health (NYSDOH) for WES/WTS for solid and hematologic malignancies utilizing tumor-normal analysis. NYSDOH review represents one of the most rigorous levels of validation nationally for such testing.

On September 29, 2020 Genosity Inc., and Olink Proteomics AB reported that they have entered into a strategic services and collaboration agreement within the United States (Press release, Genosity, SEP 29, 2020, View Source [SID1234567749]). This will allow Olink to further expand its innovative protein biomarker discovery services for the U.S. market, while enabling Genosity to add high throughput proteomics to its repertoire of available technologies.

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Genosity is a biotechnology company that currently offers many genomic assays based on DNA and RNA analysis to its pharmaceutical customers for both clinical research and clinical trials applications. Through the collaboration, Genosity will provide wider access to the Olink high-multiplex protein biomarker discovery portfolio by utilizing Genosity’s cutting edge CLIA/GCP/GLP laboratory. Beyond offering the Olink technology within the Genosity laboratory, Genosity will also provide Olink with a path towards further decentralization and commercialization through inclusion of the Olink technology inside the Genosity Integrated Genomics Toolkit (IGT) software solution. The Genosity comprehensive sample to result report system is operational at a number of institutions within the United States that are potential customers for the Olink technology and allows for easier adoption and implementation of innovative and new testing solutions.

"We are excited to introduce another cutting-edge omics platform into our Genomic ecosystem. As we continue to advance precision medicine, we are always looking for new technologies to add to our laboratory service offering. The ability to perform such highly multiplexed, proteomic profiling experiments with the same sequencers we use to sequence Genomes is revolutionary," said Robert Daber, CTO and cofounder of Genosity.

"We are delighted to enter into this strategic partnership with Genosity, which we are confident will broaden the access to our protein biomarker solutions for the wider scientific community in the U.S. We have been greatly impressed during our discussions with Genosity, from their well-established entrepreneurial history in the biotechnology arena, to their clear understanding of precision medicine and Olink’s contribution to this area. Our conversations with Genosity’s existing customers have only strengthened this impression, and they are clearly at the forefront of genomics, bioinformatics and precision oncology. We are genuinely excited about the opportunity to add proteomics to their offering in order to expand and accelerate precision medicine towards clinical applications and patient care," said Erik Pettersson, Head of Business Development, Olink Proteomics.

"Proteomics is becoming an area of increasing interest for research and clinical research applications. Olink’s unique approach has clearly made it the market leader in this innovative area of biomarker discovery. The key to any biomedical innovation is how it will eventually answer a relevant clinical question for patient care. Proteomics and especially Olink have only scratched the surface of their applications, we look forward to working with them as they expand their footprint across this country and beyond," says Marc Grodman MD, cofounder and CEO, Genosity Inc.

About the technology

Olink’s Proximity Extension Assay (PEA) technology utilizes pairs of antibodies linked to complementary oligonucleotides, which are brought into proximity when the antibody binds to the target protein. The proximity results in formation of PCR Target sequence which can be further amplified, detected, and quantified using standard methodologies. The Olink Explore platform currently enables 1536 proteins to measured using less than 3 µL of sample using Next Generation Sequencing (NGS) readout, producing up to 1.3 million protein data measurements per week per Illumina NovaSeq system. Olink’s technology is superior to other immunoassays because using specific DNA oligos prevents any cross-reactivity as a result of unspecific antibody binding, and enables sensitive, rapid, high throughput protein measurements at very high multiplexing levels, consuming minimal sample.

On September 29, 2020 Kuur Therapeutics, a leader in the development of off-the-shelf CAR-NKT cell immunotherapies for the treatment of hematological and solid malignancies, reported the treatment of the first patients in its ANCHOR phase 1 study of KUR-502, an allogeneic CAR-NKT therapy (Press release, Kuur Therapeutics, SEP 29, 2020, View Source [SID1234567747]).

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"This is an important day, as the initiation and dosing of the first patients in the ANCHOR phase 1 clinical study marks the first time that patients have been treated with an allogeneic engineered CAR-NKT cell therapy," said Dr. Carlos Ramos, Principal Investigator of the ANCHOR study, Professor of Medicine in the Center for Cell and Gene Therapy (CAGT) at Baylor College of Medicine and member of the Dan L Duncan Comprehensive Cancer Center. "CAR-NKT cells have the potential to offer a distinct set of advantages over other lymphocytes commonly used for cell therapy, such as T cells. We are pleased to be advancing this ground-breaking first-in-human clinical study and anticipate that CAR-NKT cells could be an important treatment option for patients with both hematological and solid tumors in the future."

"With the initiation of the ANCHOR study of KUR-502 in CD19 positive hematological malignancies, we are able to turn our focus to exploring the effects of off-the-shelf CAR-NKT cells," said Kevin S. Boyle, Sr., Kuur’s Chief Executive Officer. "This study will allow us to evaluate our platform technology with a validated target in CD19 and validated indications, generating critical data to advance our allogeneic efforts. Together with the results from our proof of concept GINAKIT2 study of KUR-501 in neuroblastoma, the forthcoming data from the ANCHOR study will guide future development of our next generation platform technology."

KUR-502 is built on Kuur’s next-generation CAR-NKT platform, with novel engineering capabilities that harness and enhance the unique tumor-homing properties of NKT cells. This NKT platform technology was developed in the CAGT Lab of Dr. Leonid Metelitsa, Professor of Pediatrics-Oncology at Baylor College of Medicine and Texas Children’s Hospital and member of the Dan L Duncan Comprehensive Cancer Center, and KUR-502 was produced by the CAGT cGMP facility. One of the challenges with allogeneic therapies is that infusing a patient with donor-derived lymphocytes can induce graft versus host disease (GvHD), a potentially life-threatening condition in which the infused cells recognize the patient’s tissues as foreign. The NKT cells used in Kuur’s CAR-NKT platform have an invariant T cell receptor that does not distinguish between self- and non-self tissues, making the cells unlikely to induce GvHD when given to another person. Preclinical data generated by Baylor College of Medicine indicate that while human CAR-T cells cause severe GvHD, CAR-NKT cells from the same donor do not.

The ANCHOR (NCT03774654) study is a phase 1, first-in-human, dose escalation evaluation of KUR-502 in adults with R/R CD19 positive malignancies, including B cell lymphomas, acute lymphoblastic leukemia (ALL) and chronic lymphocytic leukemia (CLL). The single arm study will evaluate three dose levels, with patients receiving lymphodepletion chemotherapy consisting of cyclophosphamide and fludarabine followed by infusion with KUR-502.

Patients with R/R CD19 positive malignancies have limited effective treatment options. While CD19-directed autologous CAR-T cells are now available for these patients, they are limited by delays to get treatment, a requirement for patient leukapheresis, and issues with inferior quality leukapheresis starting material due to prior treatment. Off-the-shelf KUR-502 is designed to overcome these limitations.

The ANCHOR study is being sponsored and conducted by Kuur’s collaborator, Baylor College of Medicine.

About KUR-502

KUR-502 is an innovative allogeneic (off-the-shelf) product in which natural killer T cells are engineered with a chimeric antigen receptor targeting CD19. KUR-502 is engineered with a CD19-specific CAR construct that is additionally designed to secrete the cytokine IL-15, which has been shown in nonclinical studies to increase the persistence of CAR-NKT cells and improve their efficacy within the immunosuppressive tumor microenvironment. In addition, the CAR-NKT cells express short hairpin RNA (shRNA) designed to downregulate HLA class I and class II expression, which may minimize rejection by the patient’s immune system and further enhance persistence. The CAR, IL-15 and shRNAs are effectively expressed in NKT cells via a single gammaretroviral vector, allowing for one-hit generation of off-the-shelf CAR-NKT cells. In contrast to off-the-shelf CAR therapy with conventional alpha-beta T cells, gene editing to remove the TCR to prevent GvHD is not required for off-the-shelf CAR-NKT therapy. KUR-502 is manufactured from healthy donors, from whom cell therapy products can be prepared in large quantities from a single procedure and used to treat many different patients.

On September 29, 2020 Novocure (NASDAQ: NVCR) reported that it will host a virtual Research & Development Day for analysts and investors from 7:30 a.m. to 9:30 a.m. EDT on Thursday, November 12, 2020, to highlight progress across its clinical and product development pipelines and to introduce areas of internal and external focus in its translational research (Press release, NovoCure, SEP 29, 2020, View Source [SID1234567746]). The event will include presentations from various leaders of Novocure’s research and development teams as well as from key opinion leaders from across the global scientific community who are conducting research on Tumor Treating Fields.

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The event will be webcast live and can be accessed from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations. The webcast will be available for replay for at least 14 days following the event. Novocure has used, and intends to continue to use, its investor relations website, as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

On September 29, 2020 AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, reported financial results for the first quarter of fiscal year 2021, which ended August 31, 2020 (Press release, AngioDynamics, SEP 29, 2020, View Source [SID1234567744]).

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"We had a strong first quarter, as our customers continued to show signs of recovery from the disruption of COVID-19," commented Jim Clemmer, President and Chief Executive Officer of AngioDynamics, Inc. "While customer demand has not yet returned to pre-COVID levels, the team is clearly executing in this challenging environment. Our key technology platforms performed well during the quarter, including strong sales growth of our AngioVac platform and more than $1 million in sales of our Auryon platform. We’re still seeing the impact of COVID, particularly in our Oncology business, but, despite the unique challenges presented by this environment, we remain confident in our ability to efficiently manage the business while growing our key technology platforms."

First Quarter 2021 Financial Results

Net sales for the first quarter of fiscal 2021 were $70.2 million, an increase of 6.3% compared to the prior-year quarter. Net sales in the first quarter continued to be impacted by the disruption to procedure volumes resulting from the COVID-19 global pandemic. Foreign currency translation did not have a significant impact on the Company’s sales in the quarter.

Oncology net sales were $12.3 million, a decrease of 12.3% from $14.0 million a year ago, with growth in microwave ablation and U.S. NanoKnife probe sales more than offset by lower sales in international markets.
Vascular Interventions and Therapies ("VIT") net sales were $29.9 million, an increase of 3.3%, compared to $29.0 million a year ago. Sales of AngioVac grew 46% over the previous year and were partially offset by a decline in sales of Venous products as a result of lower elective procedure volumes. Auryon sales during the quarter were $1.1 million, and the Company announced the full commercial launch of this platform on September 21, 2020.
Vascular Access net sales were $28.1 million, an increase of 21.4% from $23.2 million a year ago, which includes the impact of a previously disclosed sale in the UK through our distributor partner to the NHS. Excluding the impact of this sale, Vascular Access sales declined approximately 1.2% year over year.
U.S. net sales in the first quarter of fiscal 2021 were $54.1 million, an increase of 2.2% from $52.9 million a year ago, and International net sales were $16.1 million, including the one-time sale to NHS, an increase of 22.9% from $13.1 million a year ago.

Gross margin for the first quarter of fiscal 2021 was 50.9%, a decline of 700 basis points compared to the first quarter of fiscal 2020. The gross margin decline was primarily attributable to the Company’s previously discussed COVID-related operating plan, which included COVID-related operating protocols designed to ensure supply-chain security and employee safety. Additionally, during the first quarter, inventory was reduced by $7.2 million when compared to inventory levels on May 31, 2020.

The Company recorded a net loss of $4.3 million, or loss per share of $0.11, in the first quarter of fiscal 2021. This compares to net loss of approximately $1.3 million, or loss per share of $0.03, a year ago.

Excluding the items shown in the non-GAAP reconciliation table below, adjusted net income for the first quarter of fiscal 2021 was $0.6 million or adjusted earnings of $0.02 per share, compared to adjusted net income of $3.2 million, or adjusted earnings per share of $0.08, in the first quarter of fiscal 2020.

Adjusted EBITDA in the first quarter of fiscal 2021, excluding the items shown in the reconciliation table below, was $4.5 million, compared to $7.3 million in the first quarter of fiscal 2020.

In the first quarter of fiscal 2021, the Company used $5.4 million in operating cash and had capital expenditures of $1.8 million. As of August 31, 2020, the Company had $47.9 million in cash and cash equivalents compared to $54.4 million in cash and cash equivalents at the end of the fourth quarter of fiscal 2020. As of August 31, 2020, the Company had $40.0 million in debt outstanding, consistent with its debt balance on May 31, 2020. Management remains focused on cash preservation amid the current environment.

Fiscal Year 2021 Financial Guidance

The Company expects fiscal year 2021 net sales to be in the range of $278 to $284 million and fiscal year 2021 adjusted earnings per share to be in the range of $0.00 to $0.05.

Conference Call

The Company’s management will host a conference call today at 8:00 a.m. ET to discuss its fiscal 2021 first quarter results.

To participate in the conference call, dial 1-877-407-0784 (domestic) or +1-201-689-8560 (international) and refer to the passcode 13710506.

This conference call will also be webcast and can be accessed from the "Investors" section of the AngioDynamics website at www.angiodynamics.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A recording of the call will also be available from 11:00 a.m. ET on Tuesday, September 29, 2020, until 11:59 p.m. ET on Tuesday, October 6, 2020. To hear this recording, dial 1-844-512-2921 (domestic) or +1-412-317-6671 (international) and enter the passcode 13710506.

Use of Non-GAAP Measures

Management uses non-GAAP measures to establish operational goals and believes that non-GAAP measures may assist investors in analyzing the underlying trends in AngioDynamics’ business over time. Investors should consider these non-GAAP measures in addition to, not as a substitute for or as superior to, financial reporting measures prepared in accordance with GAAP. In this news release, AngioDynamics has reported adjusted EBITDA, adjusted net income, adjusted earnings per share, and free cash flow. Management uses these measures in its internal analysis and review of operational performance. Management believes that these measures provide investors with useful information in comparing AngioDynamics’ performance over different periods. By using these non-GAAP measures, management believes that investors get a better picture of the performance of AngioDynamics’ underlying business. Management encourages investors to review AngioDynamics’ financial results prepared in accordance with GAAP to understand AngioDynamics’ performance taking into account all relevant factors, including those that may only occur from time to time but have a material impact on AngioDynamics’ financial results. Please see the tables that follow for a reconciliation of non-GAAP measures to measures prepared in accordance with GAAP.