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Daiichi Sankyo Initiates Clinical Development of Sixth DXd ADC DS-6000 with Sarah Cannon Research Institute

On February 2, 2021 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and Sarah Cannon Research Institute (Sarah Cannon reported that the first patient has been dosed in the first-in-human phase 1 study evaluating DS-6000, a CDH6 directed antibody drug conjugate (ADC), in patients with advanced renal cell carcinoma or ovarian cancer with disease progression following standard treatment (Press release, Daiichi Sankyo, FEB 2, 2021, https://www.businesswire.com/news/home/20210202005385/en/Daiichi-Sankyo-Initiates-Clinical-Development-of-Sixth-DXd-ADC-DS-6000-with-Sarah-Cannon-Research-Institute [SID1234574508]).

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Despite recent advances in targeted treatment, five-year survival rates for both renal cell carcinoma and ovarian cancer remain low and new therapeutic strategies are needed for tumors that continue to progress on currently available medicines.1,2 CDH6 is a cadherin family protein overexpressed in several cancers, particularly renal cell and ovarian.3 CDH6 overexpression is associated with tumor growth and proliferation and has been correlated with poor prognosis in renal cell carcinoma.4 No CDH6 directed cancer therapies are currently approved.

"With DS-6000, we have applied our innovative DXd ADC technology to a promising molecular target, CDH6, and it has potential to serve as a new treatment modality for patients with renal cell or ovarian cancer," said Arnaud Lesegretain, Vice President Oncology R&D and Head, Alpha Portfolio, Daiichi Sankyo. "We are pleased to continue our successful collaboration with Sarah Cannon, working together on advancing the development of another novel ADC with first-in-class potential."

DS-6000 is the sixth DXd ADC from the oncology pipeline of Daiichi Sankyo to enter clinical development and the third being developed in collaboration with Sarah Cannon Research Institute.

"We look forward to developing DS-6000 as a potential treatment option for people facing renal cell carcinoma or ovarian cancer," says Erika Hamilton, MD, Director, Breast Cancer and Gynecologic Cancer Research Program, Sarah Cannon Research Institute at Tennessee Oncology. "In partnership with Daiichi Sankyo, we will further evaluate whether DS-6000 may serve as a new and effective therapy for patients who have progressed on standard treatments."

About the Study
The two-part, multicenter, open-label, first-in-human phase 1 trial will evaluate the safety and efficacy of DS-6000 in adult patients with advanced renal cell carcinoma or ovarian cancer resistant or refractory to standard of care therapy.

The first part of the study (dose escalation) will assess the safety and tolerability of increasing doses of DS-6000 to determine the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) in approximately 46 patients with advanced renal cell carcinoma or ovarian tumors. The second part of the study (dose expansion) will further evaluate the safety and efficacy of DS-6000 at the RDE in two cohorts including approximately 30 patients with advanced renal cell carcinoma in cohort 1 and 25 patients with advanced ovarian cancer in cohort 2.

The study will evaluate safety endpoints including dose-limiting toxicities and adverse events and efficacy endpoints including overall response rate, duration of response, disease control rate, clinical benefit rate, time to response and progression-free survival. Pharmacokinetic and exploratory biomarker endpoints will also be assessed.

A total of approximately 102 patients are expected to be enrolled in this study at multiple sites in the U.S. For more information, please visit Clinicaltrials.gov.

About Renal Cell Carcinoma and Ovarian Cancer
Renal cell carcinoma accounts for 90 percent of all kidney cancer.5 There were approximately 431,000 new cases of kidney cancer and over 179,000 deaths reported worldwide in 2020.6 Ovarian cancer is one of the three most common gynecological malignancies.7 There were approximately 313,000 new cases of ovarian cancer and over 207,000 deaths reported worldwide in 2020.8 The five-year survival rate is 13 percent and 30 percent, respectively, for patients diagnosed with metastatic renal cell carcinoma and ovarian cancer.9,10

About DS-6000
DS-6000 is a potential first-in-class CDH6 directed antibody drug conjugate (ADC). Designed using Daiichi Sankyo’s proprietary DXd ADC technology, DS-6000 is the sixth ADC in the Daiichi Sankyo oncology pipeline to enter clinical development.

DS-6000 is comprised of a humanized anti-CDH6 IgG1 monoclonal antibody attached to a topoisomerase I inhibitor payload, an exatecan derivative, via a tetrapeptide-based cleavable linker. Preclinical research shows that DS-6000 binds to CDH6 on the surface of cancer cells, and it is proposed that DS-6000 is then brought inside the cell where lysosomal enzymes break down the linker and release the DXd payload to destroy the cell. In preclinical studies, DS-6000 inhibited tumor growth and induced tumor regression in CDH6 expressing renal cell and ovarian tumors.

DS-6000 is an investigational agent that has not been approved for any indication in any country. Safety and efficacy have not been established.

About Daiichi Sankyo Cancer Enterprise
The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by our DXd antibody drug conjugate (ADC) technology, our powerful research engines include biologics, medicinal chemistry, modality and other research laboratories in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA. For more information, please visit: www.DSCancerEnterprise.com.

Exicure Announces Presentation at 2021 BIO CEO & Investor Digital Conference

On February 2, 2021 Exicure, Inc. (Nasdaq: XCUR), a pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) constructs, reported that David Giljohann, CEO, will present at the 2021 BIO CEO & Investor Digital Conference, February 16-18, 2021 (Press release, Exicure, FEB 2, 2021, View Source [SID1234574507]).

The presentation will be available to registered conference attendees for on-demand viewing beginning February 15, 2021 at 9:00AM ET via the virtual conference link.

Registered conference attendees may schedule a 1×1 meeting with Exicure via the conference scheduling link.

Replays of the presentation will be available on Exicure’s website for 30 days following the presentation.

Genomic Testing Cooperative Establishes a Program to Address Cancer Disparity by Offering Molecular Profiling to Minority Patients without Adequate Insurance Coverage and Facilitating Access to Precision Medicine and Enrollment in Clinical Trials

On February 2, 2021 Genomic Testing Cooperative, LCA (GTC) reported that they are establishing a program offering comprehensive molecular profiling (DNA+RNA) testing to patients with cancer who are affected by cancer disparity and unable to pay due to lack of insurance or lack of coverage of this type of testing (Press release, Genomic Testing Cooperative, FEB 2, 2021, View Source [SID1234574506]). Ethnic and racial minorities, impoverished people, sexual and gender minorities (LGBTQ) are typically affected more negatively with cancer. One of the reasons for this disparity is poor access to precision medicine and exclusion from clinical trials or studies evaluating the potential differences in the biology of their cancer.

GTC molecular profiling will provide the treating physicians and patients with proper diagnosis and classification of the tumor, help in determining prognosis, selecting therapy and in developing a strategy for treatment that is specific for the patient. The molecular profiling report provides information regarding potential clinical trials that will help the patients evaluate their options to participate and be treated in these clinical trials. Participation in this program will increase access of underserved patients and reduce disparity within community-based cancer care. In addition, the data generated from this program will be de-identified and made available to appropriate academic and scientific groups for the purpose of developing more personalized cancer treatment for minority groups of patients.

GTC is committed to donating 5% of its annual testing volume to this program. GTC is also establishing a donation fund allowing others to support this program and to increase the number of patients benefiting from this program. Individual donors and organizations can contribute to this program with 100% of the raised funds being used to pay for the actual cost of testing.

Patients must be nominated for this program by their physicians. Patients with solid tumors or hematologic neoplasms are eligible for testing. Hematologists/Oncologists can download a simple nomination form from the GTC website, fill in the required information and fax or e-mail to GTC. Patients can mention this program to their hematologists/oncologists and request nomination for this program.

Dr. Maher Albitar, GTC Chief Executive Officer and Chief Medical Officer, stated "GTC is committed to making cancer molecular profiling available to all patients with cancer. We all know that patients seen in academic centers are different from real-world patients. Minority patients are not adequately represented in the process for developing innovative medicine nor in the implementation of state-of-the-art medicine. As a diagnostic company, we are doing our part by defining the precise molecular abnormalities that can be targeted but having access to the expensive targeted therapy is a different struggle. We are hoping that pharmaceutical companies will join our effort and do their part in providing the appropriate drugs to these patients and will develop a mechanism to recruit them in their clinical trials."

A recent study reported that one-third of disparities in survival between white and black patients with stage IV colorectal cancer is a product of treatment gaps (HemOnctoday, January 21/2021).

Moleculin Announces 100% Survival Achieved in Osteosarcoma Lung Metastases Animal Model

On February 2, 2021 Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported that a preclinical study in animals demonstrated a potentially significant therapeutic benefit of Annamycin against metastatic osteosarcoma (Press release, Moleculin, FEB 2, 2021, View Source [SID1234574505]). This appears to be the result of the high cytotoxic potential of Annamycin previously demonstrated in vitro against sarcoma cells in combination with its high uptake by the lungs where the tumors in this study are localized. Computerized tomography (CT) scans demonstrated that animals treated with Annamycin exhibited significant suppression of tumor growth and not a single death was observed in the treated animals, whereas significant tumor burden contributed to the rapid death of 90% of untreated animals. While the study continues, as of day 130, the survival rate for animals treated with Annamycin was 100%, compared with only 10% for untreated animals.

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. (PRNewsfoto/Moleculin Biotech, Inc.)

Osteosarcoma is among a class of tumors that initiate in the bone of patients, with bone-related sarcomas representing the second most common form of sarcoma after soft tissue sarcoma. While many bone sarcomas can be addressed through surgical removal, it is estimated that as many as 40% of bone sarcomas will eventually metastasize to the lungs, where treatment can become more problematic. Researchers have more recently referred to the lungs and certain other vital organs as "sanctuary sites" for cancer where tumors can develop out of reach from conventional chemotherapies.

Once metastasized to the lungs, if tumors cannot be surgically removed, the primary chemotherapy regimen is the anthracycline doxorubicin (also known as Adriamycin). While 10% to 30% of patients with sarcoma lung metastases may initially respond to doxorubicin, most will relapse leaving the majority of these patients without an alternative chemotherapy. Moleculin recently announced findings from its sponsored research showing that doxorubicin has a limited ability to accumulate in the lungs of animals, which may help explain its limited efficacy in this sanctuary site. Treatment options are further limited because of the inherent cardiotoxicity of currently approved anthracyclines, including doxorubicin, which limits the amount of anthracycline that can be given to patients.

Annamycin is a "next generation" anthracycline that has recently been shown in animal models to accumulate in the lungs at up to 34 times the level of doxorubicin, which may account for the 100% survival rate attained in this most recent osteosarcoma lung metastases study. Importantly, Annamycin has also demonstrated a lack of cardiotoxicity in recently conducted human clinical trials of Annamycin for the treatment of acute myeloid leukemia, so the use of Annamycin may not face the same dose limitations imposed on doxorubicin.

Moleculin recently announced that the FDA has allowed the Company’s request for investigational new drug (IND) status in order to study Annamycin for the treatment of soft tissue sarcoma metastasized to the lungs. In addition, the FDA granted Orphan Drug Designation for Annamycin for the treatment of soft tissue sarcomas.

"Our ongoing sponsored research continues to expand the potential uses for Annamycin," commented Walter Klemp, Chairman and CEO of Moleculin. "We expect that one, and potentially two, clinical trials in sarcoma lung metastases should be up and running this year."

BIO-TECHNE RELEASES SECOND QUARTER FISCAL 2021 RESULTS

On February 2, 2021 Bio-Techne Corporation (NASDAQ:TECH)reported its financial results for the second quarter ended December 31, 2020 (Press release, Bio-Techne, FEB 2, 2021, View Source [SID1234574504]).

Second Quarter FY2021 Snapshot

Second quarter organic revenue increased by 19% (21% reported) to $224.3 million and 15% (16% reported) in the first half of fiscal 2021 to $428.5 million.
GAAP EPS was $1.15 versus $3.02 one year ago primarily relating to a non-recurring gain of approximately $121 million in our ChemoCentryx investment in the second quarter of fiscal 2020. Delivered record adjusted earnings per share (EPS) of $1.62 versus $1.08 one year ago.
Adjusted Operating Margin increased to 38.7% in the second quarter of fiscal 2021 compared to 33.4% in the second quarter of fiscal 2020.
Excellent commercial execution in both the Protein Sciences and Diagnostics and Genomics segments, with each delivering record organic growth of 19%.
Delivered record operating cash flows in the first half of fiscal 2021 while paying down approximately $125 million in outstanding debt.
The Company’s financial statements are prepared in accordance with accounting principles generally accepted in the United States (GAAP). Adjusted EPS, adjusted earnings, adjusted gross margin, adjusted operating income, organic growth, and adjusted operating margin are non-GAAP measures that exclude certain items detailed later in this press release under the heading "Use of non-GAAP Adjusted Financial Measures." A reconciliation of GAAP to non-GAAP financial measures is included in this press release.

"I would like to thank the entire global Bio-Techne team for delivering such a stellar quarter," said Chuck Kummeth, President and Chief Executive Officer of Bio-Techne. "To achieve 19% organic growth, with only 3% attributed to Covid tailwinds, attests to the strong execution of our strategy we have implemented in recent years. It’s great to see this planning succeed in virtually all areas of our business. We delivered this organic growth with a continued focus on profitability, as our adjusted operating margin improved over 500 basis points year over year to 38.7%."

Kummeth added, "The continued ramp of our high-growth platforms including Exosome Dx, Cell and Gene Therapy, GMP Proteins, proteomics instrumentation and genomics will be exciting to watch as we strive for continued double-digit organic growth. Our expanded digital platform, increased global brand presence, and world class customer relationships has brought our renowned protein and antibody products (as well as our new platforms) to the forefront of the life science tools and diagnostics industry."

Second Quarter Fiscal 2021

Revenue

Net sales for the second quarter increased 21% to $224.3 million. Organic growth was 19% compared to the prior year, with foreign currency exchange having a favorable impact of 2% and acquisitions contributing an immaterial amount to revenue growth.

GAAP Earnings Results

GAAP EPS decreased to $1.15 per diluted share, versus $3.02 in the same quarter last year. GAAP EPS was favorably impacted by a non-recurring gain of approximately $121 million on our ChemoCentryx investment in the second quarter of fiscal 2020. GAAP operating income for the second quarter of fiscal 2021 increased 37.9% to $51.0 million, compared to $37.0 million in the second quarter of fiscal 2020. GAAP operating margin was 22.7%, compared to 20.0% in the second quarter of fiscal 2020. GAAP operating margin compared to prior year was positively impacted by volume leverage and cost management.

Non-GAAP Earnings Results

Adjusted EPS increased to $1.62 per diluted share, versus $1.08 in the same quarter last year, an increase of 50%. Adjusted EPS increased due to revenue growth and operating margin expansion. Adjusted operating income for the second quarter of fiscal 2021 increased 40% compared to the second quarter of fiscal 2020. Adjusted operating margin was 38.7%, compared to 33.4% in the second quarter of fiscal 2020. Adjusted operating margin compared to the prior year was favorably impacted by volume leverage and cost management.

Segment Results

Management uses adjusted operating results to monitor and evaluate performance of the Company’s business segments, as highlighted below.

Protein Sciences Segment

The Company’s Protein Sciences segment is one of the world’s leading suppliers of specialized proteins such as cytokines and growth factors, immunoassays, antibodies and reagents, to the biotechnology and academic research communities. Additionally, the segment provides an array of platforms useful in various areas of protein analysis. Protein Sciences segment’s second quarter fiscal 2021 net sales were $172.2 million, an increase of 22% from $141.5 million for the second quarter of fiscal 2020. Organic growth for the segment was 19%, with foreign currency exchange having a favorable impact of 3% on revenue growth and acquisitions contributing an immaterial amount to revenue growth. Protein Sciences segment’s operating margin was 46.6% in the second quarter of fiscal 2021 compared to 43.0% in the second quarter of fiscal 2020. The segment’s operating margin compared to the prior year was positively impacted by volume leverage and cost management.

Diagnostics and Genomics Segment

The Company’s Diagnostics and Genomics segment provides blood chemistry and blood gas quality controls, hematology instrument controls, immunoassays and other bulk and custom reagents for the in vitro diagnostic market. The Diagnostics and Genomics segment also develops and provides in situ hybridization products as well as exosome-based diagnostics for various pathologies, including prostate cancer. The Diagnostics and Genomics segment’s second quarter fiscal 2021 net sales were $52.5 million, an increase of 20% from $43.8 million for the second quarter of fiscal 2020. Organic growth for the segment was 19% with foreign currency exchange having a 1% impact on revenue. The Diagnostics and Genomics segment’s operating margin was 15.5% in the second quarter of fiscal 2021 compared to 2.2% in the second quarter of fiscal 2020. The segment’s operating margin was favorably impacted by volume leverage and cost management.

Conference Call

Bio-Techne will host an earnings conference call today, February 2, 2021 at 8:00 a.m. CST. To listen, please dial 1-877-407-9208 or 1-201-493-6784 for international callers, and reference conference ID 13715028. The earnings call can also be accessed via webcast through the following link View Source

A recorded rebroadcast will be available for interested parties unable to participate in the live conference call by dialing 1-844-512-2921 or 1-412-317-6671 (for international callers) and referencing Conference ID 13715028. The replay will be available from 11:00 a.m. CST on Tuesday, February 2, 2021 until 11:00 p.m. CST on Tuesday, March 2, 2021.

Use of non-GAAP Adjusted Financial Measures:

This press release contains financial measures that have not been calculated in accordance with accounting principles generally accepted in the U.S. (GAAP). These non-GAAP measures include:

Organic growth
Adjusted diluted earnings per share
Adjusted net earnings
Adjusted gross margin
Adjusted operating income
Adjusted operating margin
We provide these measures as additional information regarding our operating results. We use these non-GAAP measures internally to evaluate our performance and in making financial and operational decisions, including with respect to incentive compensation. We believe that our presentation of these measures provides investors with greater transparency with respect to our results of operations and that these measures are useful for period-to-period comparison of results.

Our non-GAAP financial measure of organic growth represents revenue growth excluding revenue from acquisitions within the preceding 12 months as well as the impact of foreign currency. Excluding these measures provides more useful period-to-period comparison of revenue results as it excludes the impact of foreign currency exchange rates, which can vary significantly from period to period, and revenue from acquisitions that would not be included in the comparable prior period.

Our non-GAAP financial measures for adjusted gross margin, adjusted operating margin, and adjusted net earnings, in total and on a per share basis, exclude the costs recognized upon the sale of acquired inventory, amortization of acquisition intangibles, acquisition related expenses inclusive of the changes in fair value of contingent consideration, and other non-recurring items including non-recurring costs and gains. The Company excludes amortization of purchased intangible assets, purchase accounting adjustments, including costs recognized upon the sale of acquired inventory and acquisition-related expenses inclusive of the changes in fair value contingent consideration, and other non-recurring items including gains or losses on legal settlements and one-time assessments from this measure because they occur as a result of specific events, and are not reflective of our internal investments, the costs of developing, producing, supporting and selling our products, and the other ongoing costs to support our operating structure. Additionally, these amounts can vary significantly from period to period based on current activity.

The Company’s non-GAAP adjusted operating margin and adjusted net earnings, in total and on a per share basis, also excludes stock-based compensation expense, which is inclusive of the employer portion of payroll taxes on those stock awards, restructuring, impairments of equity method investments, gain and losses from investments, and certain adjustments to income tax expense. Stock-based compensation is excluded from non-GAAP adjusted net earnings because of the nature of this charge, specifically the varying available valuation methodologies, subjective assumptions, variety of award types, and unpredictability of amount and timing of employer related tax obligations. Impairments of equity investments are excluded as they are not part of our day-to-day operating decisions. Additionally, gains and losses from other investments that are either isolated or cannot be expected to occur again with any predictability are excluded. Costs related to restructuring activities, including reducing overhead and consolidating facilities, are excluded because we believe they are not indicative of our normal operating costs. For the Eminence acquisition, amortization expense and costs of acquired inventory were adjusted in the net earnings calculation based on the Company’s ownership percentage to calculate the adjusted net earnings per share attributable to Bio-Techne. The Company independently calculates a non-GAAP adjusted tax rate to be applied to the identified non-GAAP adjustments considering the impact of discrete items on these adjustments and the jurisdictional mix of the adjustments. In addition, the tax impact of other discrete and non-recurring charges which impact our reported GAAP tax rate are adjusted from net earnings. We believe these tax items can significantly affect the period-over-period assessment of operating results and not necessarily reflect costs and/or income associated with historical trends and future results.

Investors are encouraged to review the reconciliations of adjusted financial measures used in this press release to their most directly comparable GAAP financial measures as provided with the financial statements attached to this press release.