Bio-Techne Announces Expanded Simple Plex Immunoassay Cartridge Portfolio

On February 3, 2021 Bio-Techne Corporation (NASDAQ: TECH) reported that ProteinSimple, a Bio-Techne brand, has expanded its Simple PlexTM immunoassay cartridge portfolio to include nine new cartridge formats (Press release, Bio-Techne, FEB 3, 2021, View Source [SID1234574534]). These new cartridge offerings provide Simple Plex users with increased flexibility in the number of samples and biomarker assays run on each cartridge. Simple Plex assay cartridges, run on the EllaTM platform, utilizing state-of-the-art microfluidics to deliver a fully automated immunoassay solution. Researchers can customize cartridge lots from a menu of over 200 validated assays. Until now, Simple Plex assay cartridges were only available in formats delivering one, four, or eight assays run simultaneously. The expanded portfolio of cartridge offerings provides users new options to better align their assay panels with the throughput requirements of their studies.

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Dave Eansor, President of Bio-Techne’s Protein Sciences Segment commented, "This expanded selection of Simple Plex cartridges offers researchers the flexibility to automate their immunoassay workflow for projects of any scope or size using the Ella platform."

The Ella platform allows users to perform high-quality immunoassays with no manual intervention, enabling sub-picogram level sensitivity, 4+ logs of dynamic range and a high level of reproducibility. Ella’s innovative immunoassay workflow decreases the potential for user error and empowers staff to spend their time on higher value activities. Factory calibration of each Simple Plex assay cartridge eliminates the need to generate standard curves. Setting up an assay simply requires loading diluted samples into the cartridge. Once loaded, the Ella instrument performs every step of the immunoassay automatically, from wash steps to final quantification of results in just 90 minutes.

Cannabics Pharmaceutical’s Interim in-vivo Study Results Show a 27% Lower Tumor Volume in Mice Treated with Company’s Proprietary Drug Candidate for Colorectal Cancer

On February 3, 2021 Cannabics Pharmaceuticals Inc. (OTCQB: CNBX), a global leader in the development of cancer related cannabinoid-based medicines, reported that it has obtained interim results for its ongoing in-vivo study evaluating the efficacy of the company’s proprietary drug candidate RCC-33 for Colorectal cancer in nude-mice (Press release, Cannabics Pharmaceuticals, FEB 3, 2021, View Source [SID1234574553]). The interim results show a 27% reduction in tumor volume in mice exposed to RCC-33 in comparison with sham control mice. Both groups were
inoculated with colorectal cancer cells. Daily doses of intraperitoneal (IP) delivery of RCC-33 or sham were initiated on day 5. Differences in tumor volume between the
two groups were first observed after 5 days of treatment (day 10). Interim results of a 27% reduction in tumor volume were recorded after 12 days of treatment (day 17),
with p-value=0.022. Study is ongoing.

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Effect of Cannbics TM RCC-33 on Tumor Development in Mice Inoculated with Human Colorectal Cancer Cells

Effect of Cannbics TM RCC-33 on Tumor Development in Mice Inoculated with Human Colorectal Cancer Cells
Gabriel Yariv, Cannabics Pharmaceuticals’ President and COO said: "Developing innovative formulations to combat colorectal cancer is a worthy cause. Colorectal cancer is the third most diagnosed cancer worldwide and the second most lethal. That said, 67% of colorectal cancer patients undergoing currently available treatments survive for 5 years or longer. Accordingly, our objective with RCC-33 is to be able to demonstrate its efficacy and enter an official FDA track, eventually reaching a position where we can potentially help a large group of people get better and live longer; this is our ultimate goal and today marks an important step in the right direction."

Dr. Eyal Ballan, Cannabics Pharmaceuticals Co-founder and CTO said: "Today’s interim results mark an important milestone for the company. Seeing our formulation cause attenuation in tumor growth, in-vivo, and already within 12 days of treatment, is a clear indicator and an encouragement for us to continue with our focus and efforts in the direction we chose and believe in."

Affimed Announces Collaboration with Roche to Study AFM24 in Combination with PD-L1 Checkpoint Inhibitor in EGFR Expressing Solid Tumors

On February 3, 2021 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that it has entered into a clinical research collaboration with Roche to explore the combination of Affimed’s innate cell engager (ICE) AFM24 with Roche’s PD-L1 checkpoint inhibitor atezolizumab (Tecentriq) (Press release, Affimed, FEB 3, 2021, View Source [SID1234574571]).

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Under the terms of the agreement, Affimed will fund and conduct a Phase 1/2a clinical trial to investigate the combination of AFM24 and atezolizumab for the treatment of advanced solid epidermal growth factor receptor (EGFR) expressing malignancies in patients whose disease has progressed after treatment with previous anticancer therapies. Roche will supply Affimed with atezolizumab for the clinical trial. The Phase 1/2a study will establish a dosing regimen for the combination therapy and assess safety and potential activity.

"AFM24 is a first-in-class innate cell engager that we believe has the potential to bring benefit to a broad set of patients as monotherapy and in combination with other I/O therapies to address disease states where co-activation of the innate and adaptive immune systems is beneficial," said Dr. Adi Hoess, CEO of Affimed. "This collaboration with Roche is an important step in our continued execution of AFM24’s clinical development strategy. Importantly, preclinical and clinical studies indicate that ICE and PD-(L)1 checkpoint inhibition therapy could act synergistically, which drives our optimism about the combination of AFM24 with atezolizumab and its promise as a possible treatment option for patients with EGFR expressing solid tumors."

AFM24 is a novel tetravalent, bispecific EGFR- and CD16A-binding innate cell engager that activates innate immunity by inducing both antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). AFM24 has shown an acceptable safety profile and antitumor activity in preclinical studies. AFM24 is currently being evaluated as monotherapy in adult patients with advanced solid malignancies known to be EGFR-positive in an open-label, non-randomized, multi-center, multiple ascending dose escalation/expansion study.

GEMoaB Announces UniCAR-T-CD123 Data from its Ongoing Phase I Study in Patients with Relapsed/Refractory AML (rrAML) to be Presented at Virtual 3rd EHA-EBMT European CAR T-Cell Meeting

On February 3, 2021 GEMoaB, a biopharmaceutical company focused on the development of next-generation immunotherapies for hard-to-treat cancers, reported interim data from the ongoing Phase I study of their lead asset UniCAR-T-CD123 in relapsed/refractory acute myeloid leukemia (rrAML) at the Virtual 3rd EHA (Free EHA Whitepaper)-EBMT European CAR-T-Cell Meeting, which is held from February 04-06, 2021 (Press release, GEMoaB, FEB 3, 2021, View Source [SID1234574588]). The data are being presented as oral presentation by Dr. Martin Wermke, University Hospital Dresden, Germany (February 05, 12:20 CET) and as a poster presentation by Dr. Sabrina Kraus, University Hospital Würzburg, Germany (Abstract 68).

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"These clinical results present a promising step forward as we continue to evaluate the safety and efficacy of UniCAR-T-CD123," said Professor Gerhard Ehninger, Chief Medical Officer of GEMoaB. "We are highly encouraged by the fact that UniCAR-T-CD123 has demonstrated a favorable safety and efficacy profile in rrAML. The clinical data nicely confirm our UniCAR key platform claims and provide the clinical proof of UniCAR’s rapid switch on/off and re-activation capability. We look forward to progressing our study and positioning UniCAR as a potentially superior cellular immunotherapy platform for patients with hard-to-treat advanced hematologic malignancies and solid tumors."

Data highlights for the oral presentation titled: "Proof-of-Concept for Rapidly Switchable Universal CAR-T Platform with UniCAR-T-CD123 in Relapsed/Refractory AML" include:

UniCAR-T-CD123 has been well tolerated to date with CRS (cytokine release syndrome) grade 1-2; no ICU admissions or dose limiting toxicities have been observed by the cut-off date; UniCAR-T-CD123 dose escalation is ongoing
Robust expansion of UniCAR-T-CD123 in peripheral blood and bone marrow, comparable to conventional CD123-targeting CAR-T products
Rapid recovery of neutrophils after stop of treatment with targeting module TM123 in all treated patients
Encouraging efficacy signals in the first 3 fully treated patients, with 1 PR (partial remission) and 2 CRi (complete remission with incomplete hematologic recovery) observed
The poster named "Re-activation of UniCAR-T-Cells with 2nd Cycle of Targeting Module TM123 in a Patient with Relapsed/Refractory AML" is summarizing data obtained on re-activation and re-expansion of UniCAR-T cells, leading to a CRi in the respective patient.

Both presentations will be available on the GEMoaB website following the congress.

About the UniCAR-T-CD123 Phase IA Study

This first-in-human phase I study is an open-label, non-randomized, dose-finding study designed to evaluate the safety and activity of UniCAR-T-CD123 in up to 16 CD123 positive patients with relapsed/refractory AML. Its purpose is to determine the maximum tolerated dose (MTD) as well as Dose limiting toxicities (DLT) of the combined application of a single dose of UniCAR-T and the continuous infusion of TM123 over 25 days. Application follows post bridging therapy and lymphodepletion. The study also investigates response rates, response duration, persistence of UniCAR-T cells over time as well as the ability to rapidly switch UniCAR-T cells on and off in case of side effects through stopping TM infusion. The study takes place at selected Phase I, Acute Leukemia and CAR-T experienced University centers in Germany. The study is supported by a grant from the German Federal Ministry for Education and Research (project "TurbiCAR"). To learn more about the trial, please visit clinicaltrials.gov.

About UniCAR

GEMoaB is developing a rapidly switchable universal CAR-T platform, UniCAR, to improve the therapeutic window and increase efficacy and safety of CAR-T cell therapies in challenging cancers, including acute leukemias and solid tumors. Conventional CAR-T cells depend on the presence and direct binding of cancer antigens for activation and proliferation. An inherent key feature of the UniCAR platform is a rapidly switchable on/off mechanism (less than 4 hours after interruption of TM supply) enabled by the short pharmacokinetic half-life and fast internalization of soluble adaptors termed TMs. These TMs provide the antigen-specificity to activate UniCAR gene-modified T-cells (UniCAR-T) and consist of a highly flexible antigen binding moiety, linked to a small peptide motif recognized by UniCAR-T.

Veracyte to Acquire Decipher Biosciences

On February 3, 2021 Veracyte, Inc. (Nasdaq: VCYT) and Decipher Biosciences, Inc., a commercial-stage precision oncology company focused on urologic cancers, reported they have entered into a definitive agreement through which Veracyte will acquire Decipher, further solidifying Veracyte’s global leadership in the genomic cancer diagnostics market while accelerating revenue growth (Press release, Veracyte, FEB 3, 2021, View Source [SID1234574535]).

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"By combining Decipher Biosciences’ leadership in urologic cancers with our comprehensive genomic testing menu, Veracyte will be able to serve patients across the clinical care continuum in 7 of the 10 most prevalent cancers in the United States with highly differentiated and clinically impactful tests, significantly accelerating revenue growth and driving shareholder value. Further, with our best-in-class nCounter diagnostics platform, we are well-positioned to deliver comprehensive genomic cancer testing to physicians and their patients worldwide," said Bonnie Anderson, Veracyte’s chairman and chief executive officer. "I am also delighted that Dr. Tina Nova, Decipher’s president and CEO, and a veteran diagnostics industry leader, will join Veracyte as general manager, urologic cancers, and that Decipher’s talented employees will also join our team."

Dr. Nova has been a member of Veracyte’s board since 2015, but was not involved in Veracyte’s deliberations regarding the transaction and is resigning from the Veracyte board in connection with the transaction.

Decipher has established a market-leading position for its comprehensive portfolio of tests in urologic cancers, which leverage whole transcriptome analysis and proprietary machine learning algorithms to improve patient decision-making across the clinical care continuum and accelerate adoption of new therapies. Collectively, Decipher’s genomic tests have been used by more than 3,200 urologists and radiation oncologists, including at all 28 National Comprehensive Cancer Network (NCCN) centers in the United States. The Decipher Prostate Biopsy and post-radical prostatectomy (RP) tests are included in NCCN guidelines and the Decipher Prostate RP test is the only genomic molecular diagnostic test recommended in NCCN guidelines for use in patients with localized prostate cancer. They are also broadly reimbursed by Medicare and private payers and included in practice-changing clinical trials, with growing adoption within the urology community. Further, the company’s Decipher Bladder test is expected to launch commercially in 2021 and its kidney cancer test is in development. Decipher GRID, a large, well-annotated urologic cancer database, is fueling the company’s biopharmaceutical partnerships and product innovation.

"Our goal is to enable better treatment decisions and patient outcomes in urologic cancers by providing valuable information about the underlying biology of a patient’s tumor," said Dr. Nova. "Our team has made significant progress in advancing our mission and is thrilled to join Veracyte to benefit from their expertise and infrastructure, accelerating commercial expansion of our tests in the United States and globally."

Global Leadership in Genomic Diagnostics for Cancer

Veracyte currently offers high-value advanced genomic tests that address unmet clinical needs at multiple points in the care continuum for lung cancer, breast cancer, thyroid cancer and interstitial lung diseases, and its lymphoma subtyping test is in development. With the addition of Decipher’s genomic tests in prostate, bladder and kidney cancers, Veracyte will provide an expanded comprehensive testing menu and, with the nCounter system, is uniquely positioned to make its tests available to physicians and their patients in global markets, where hospitals and laboratories can perform them locally. Veracyte estimates that approximately 1.1 million patients in the United States alone, based on cancer incidence, will potentially be able to benefit from the company’s comprehensive menu of advanced genomic tests.

In addition, the Decipher GRID is expected to augment Veracyte’s extensive biorepositories, further positioning Veracyte to advance biopharmaceutical company partnerships and its pipeline development efforts.

The transaction will also provide Veracyte with increased operational flexibility by including Decipher Bioscience’s state-of-the-art facilities in Southern California and its highly qualified team.

Revenue Growth Acceleration

Decipher Biosciences grew its 2020 total revenue by more than 130% to approximately $39 million to $40 million, compared to $16.5 million in 2019. This included total revenue between $11.75 million and $12.25 million for the three months ended December 31, 2020. Decipher’s genomic test volume for 2020 was between 15,500 and 16,500. The annualized total revenue for the combined company based on the midpoint of the total revenue that each company expects to report for the three months ended December 31, 2020 is approximately $186 million. Veracyte expects the acquisition of Decipher Biosciences to significantly accelerate its revenue growth in 2021 and to expand the near-term addressable market for Veracyte’s current and pipeline genomic tests from approximately $10 billion to an estimated $12 billion. Veracyte estimates that the acquisition will further expand its long-term addressable market beyond approximately $50 billion. The transaction is also expected to be accretive to Veracyte’s gross margins and accelerate its path to profitability.

The foregoing revenue amounts are preliminary, have not been audited and are subject to change in connection with the completion of each company’s financial statements for the year ended December 31, 2020.

Transaction Terms and Other Information

Under the terms of the definitive agreement, Decipher Biosciences will become a wholly-owned subsidiary of Veracyte. At closing, Veracyte will pay $600 million in total consideration to Decipher security holders, consisting of $250 million in cash and up to $350 million in stock consideration, subject to customary purchase price adjustments. The number of Veracyte shares issued at the closing will be based on a fixed price of $54.30 per share, resulting in a maximum issuance of 6.4 million common shares. However, without changing the total consideration paid at closing, Veracyte has the option, at its sole discretion, until the earlier of March 15, 2021 and the fourth business day following the closing of any potential equity financing, to substitute cash in lieu of shares in any amount up to the entire stock consideration or $350 million. The transaction, which has been unanimously approved by Veracyte’s board of directors and by an independent special committee appointed by the Decipher Biosciences board of directors, is expected to close by May 2021, subject to regulatory approval and the satisfaction of other customary conditions.

Upon finalization of the transaction, Dr. Nova will become general manager of Veracyte’s urologic cancer business unit. Prior to the signing of the transaction, Dr. Nova resigned from Veracyte’s board of directors. Decipher Bioscience’s laboratory and other operations will remain in San Diego.

Advisors

Goldman Sachs & Co. LLC is serving as financial advisor to Veracyte, and Fenwick & West LLP is serving as legal advisor. Evercore Group, LLC is serving as financial advisor to Decipher Biosciences, and Cooley LLP is serving as legal advisor.

Conference Call and Webcast Details

In a separate press release issued today, Veracyte announced its preliminary financial results for the fourth quarter and full year ended December 31, 2020.

The company will host a conference call and webcast today at 8:00 a.m. Eastern Time to discuss the transaction, as well as its preliminary fourth quarter and full-year 2020 financial results. The conference call will be webcast live from the company’s website and will be available via the following link: View Source The webcast should be accessed 10 minutes prior to the conference call start time. A replay of the webcast will be available for one year following the conclusion of the live broadcast and will be accessible on the company’s website at View Source