On July 22, 2021 Synaffix B.V., a biotechnology company focused on commercializing its clinical-stage platform technology that enables antibody-drug conjugates (ADCs) with best-in-class therapeutic index, reported the signature of a license and option agreement with ProfoundBio, an emerging oncology biotherapeutics company (Press release, Synaffix, JUL 22, 2021, View Source [SID1234585075]).

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The deal provides access to multiple novel linker-payload technologies developed by Synaffix and includes access to the GlycoConnect glycan conjugation and HydraSpace polar spacer technologies, both of which are known to optimize the therapeutic properties (efficacy and safety) of ADCs. Upon signature, ProfoundBio was granted non-exclusive license rights to deploy the above technologies for one therapeutic program that targets an undisclosed specific tumor associated antigen (TAA). Additionally, ProfoundBio retains license option rights to a second TAA that can be nominated later.

Under the terms of the agreement, Synaffix is eligible to receive upfront and potential milestone payments worth up to $246 million, plus tiered royalties­­ on net sales. No further financial details are disclosed.

ProfoundBio will be responsible for the research, development, manufacturing and commercialization of the ADC products. Synaffix will closely support ProfoundBio’s research activities and be responsible for the manufacturing of components that are specifically related to its proprietary GlycoConnect, and HydraSpace technologies.

Baiteng Zhao, CEO of ProfoundBio said:

"Selecting the right linker-payload for each ADC is critical for success. Through our collaboration with Synaffix, we can access multiple potent ADC linker-payloads and efficiently optimize the competitive position of our therapeutic pipeline."

"With the solid experience and track record of our founding management team and a strong venture capital syndicate behind us, we are well positioned to rapidly progress multiple best-in-class and first-in-class ADC candidates to the clinic. We look forward to working closely with Synaffix to achieve this."

Peter van de Sande, CEO of Synaffix said:

"This collaboration is another example of Synaffix’ proprietary technologies helping biotech and pharma companies optimize the competitive positions of their ADC pipelines."

"The ProfoundBio team brings multiple decades of valuable ADC development experience from Seattle Genetics (now Seagen) and MSD. into our collaboration. We are looking forward to continuing our close collaboration with ProfoundBio on their emerging ADC portfolio and supporting the development of multiple ADCs into the clinic and beyond."

On July 22, 2021 Eli Lilly and Company (NYSE: LLY) reported its second-quarter 2021 financial results on Tuesday, August 3, 2021 (Press release, Eli Lilly, JUL 22, 2021, View Source [SID1234585074]). Lilly will also conduct a conference call on that day with the investment community and media to further detail the company’s financial performance.

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The conference call will begin at 9 a.m. Eastern time. Investors, media and the general public can access a live webcast of the conference call through a link that will be posted on Lilly’s website at View Source A replay will also be available on the website following the conference call.

On July 22, 2021 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported that it will host a conference call and webcast on Friday, August 6, 2021, at 8:00 a.m. ET to discuss a corporate update and financial results for the second quarter 2021 (Press release, Oncolytics Biotech, JUL 22, 2021, View Source [SID1234585073]).

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Conference Call & Webcast

A webcast of the call will also be available on the Investor Relations page of Oncolytics’ website, available by clicking here, and will be archived for three months. A dial in replay will be available for one week and can be accessed by dialing (888) 390-0541 (North America) or (416) 764-8677 (International) and using reference code: 148-191#.

On July 22, 2021 GlycoMimetics, Inc. (Nasdaq: GLYC) reported that clinicians have treated the first patient in a Phase 1b/2 study evaluating the company’s lead drug candidate, uproleselan, added to cladribine plus low dose cytarabine (LDAC) in patients with treated secondary AML (ts-AML) (Press release, GlycoMimetics, JUL 22, 2021, View Source [SID1234585072]). The investigator-sponsored trial is being led by Tapan Kadia, M.D., associate professor of Leukemia at The University of Texas MD Anderson Cancer Center.

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According to Eric Feldman, M.D., GlycoMimetics’ Chief Medical Officer, "Patients with treated secondary AML have an extremely poor prognosis. Despite new drug approvals in the field, subgroups of patients with limited options still exist, especially those whose disease has progressed following treatment with a hypomethylating agent. Our previous preclinical and clinical research supports the potential for these patients to benefit from the addition of uproleselan. If the new study demonstrates that targeting E-selectin with uproleselan could help to overcome resistance to other therapies, this would be a significant achievement that underscores the broad potential of our drug candidate."

About the Phase 1b/2 Clinical Trial

The Phase 1b/2 single-arm trial is enrolling patients 18 years or older, with a diagnosis of ts-AML who have not received therapy for their AML. Considered a distinct high-risk subset of AML with an adverse prognosis, ts-AML is defined as AML arising from a previously treated antecedent myeloid neoplasm (myelodysplastic syndrome or myeloproliferative neoplasm). Clinicians plan to enroll approximately 25 patients in the trial.

GlycoMimetics is providing uproleselan for the investigator-sponsored trial. The study is designed to evaluate both the safety and tolerability of the combination therapy, as well as to identify a recommended Phase 2 dose of the uproleselan triple combination approach in patients with ts-AML. Among the trial’s secondary objectives are efficacy assessments including overall response rate, complete response, complete response without blood count recovery, and other measures. The rate of minimal residual disease negativity will also be evaluated by flow cytometry at response. Exploratory endpoints include examination of biomarkers of response and resistance and the correlation of the expression of E-selectin ligand-forming glycosylation genes of leukemic blasts with clinical outcome.

About Uproleselan

Discovered and developed by GlycoMimetics, uproleselan is an investigational, first-in-class, targeted antagonist of E-selectin. Uproleselan (yoo’ pro le’ sel an), currently in a comprehensive Phase 3 development program in AML, has received Breakthrough Therapy designation from the U.S. Food and Drug Administration and the Chinese Health authority for the treatment of adult AML patients with relapsed or refractory disease. Uproleselan is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance.

On July 22, 2021 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that financial results for the second quarter ended June 30, 2021 (Press release, Quest Diagnostics, JUL 22, 2021, View Source [SID1234585064]).

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"We had another strong quarter, with a faster than expected recovery in our base business," said Steve Rusckowski, Chairman, CEO and President. "This was the first quarter since 2019 that organic base testing revenues grew in the quarter, driven by contributions from new hospital lab management contracts as well as people returning to the healthcare system. We are well-positioned to continue our momentum and support the return to health care in the coming months, which is reflected in the outlook we have provided for the remainder of 2021."

For further details impacting the year-over-year comparisons related to operating income, operating income as a percentage of net revenues, net income attributable to Quest Diagnostics, and diluted EPS, see note 2 of the financial tables attached below.

The sum of reported and adjusted diluted EPS for the first two quarters of 2021 did not equal the totals for the six months ended June 30, 2021 due to both quarterly fluctuations in the company’s earnings and in the weighted average common shares outstanding throughout the period as a result of the impact of accelerated share repurchase agreements ("ASRs") that the company entered into during April 2021.

Note on Non-GAAP Financial Measures

As used in this press release the term "reported" refers to measures under accounting principles generally accepted in the United States ("GAAP"). The term "adjusted" refers to non-GAAP operating performance measures that exclude special items such as restructuring and integration charges, certain financial impacts resulting from the COVID-19 pandemic, amortization expense, excess tax benefits ("ETB") associated with stock-based compensation, costs associated with donations, contributions, and other financial support through Quest for Health Equity, the company’s initiative with the Quest Diagnostics Foundation to reduce health disparities in underserved communities, a gain on sale of an ownership interest in a joint venture, and other items.

Non-GAAP adjusted measures are presented because management believes those measures are useful adjuncts to GAAP results. Non-GAAP adjusted measures should not be considered as an alternative to the corresponding measures determined under GAAP. Management may use these non-GAAP measures to evaluate our performance period over period and relative to competitors, to analyze the underlying trends in our business, to establish operational budgets and forecasts and for incentive compensation purposes. We believe that these non-GAAP measures are useful to investors and analysts to evaluate our performance period over period and relative to competitors, as well as to analyze the underlying trends in our business and to assess our performance. The additional tables attached below include reconciliations of non-GAAP adjusted measures to GAAP measures.

Conference Call Information

Quest Diagnostics will hold its quarterly conference call to discuss financial results beginning at 8:30 a.m. Eastern Time today. The conference call can be accessed by dialing 888-455-0391 within the U.S. and Canada, or 773-756-0467 internationally, passcode: 7895081; or via live webcast on the company’s website at www.QuestDiagnostics.com/investor. The company suggests participants dial in approximately 10 minutes before the call.

A replay of the call may be accessed online at www.QuestDiagnostics.com/investor or, from approximately 10:30 a.m. Eastern Time on July 22, 2021 until midnight Eastern Time on August 5, 2021, by phone at 866-360-3307 for domestic callers or 203-369-0162 for international callers. Anyone listening to the call is encouraged to read the company’s periodic reports, on file with the Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.