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New Cologuard® Modeling Data Show Patient Navigation Matters When Reaching Underserved Populations for Colorectal Cancer (CRC) Screening

On October 25, 2021 Exact Sciences Corp. (NASDAQ: EXAS) reported that data from modeling analyses that demonstrate Cologuard (mt-sDNA), with its included patient navigation system, provides a greater reduction in incidence and mortality from colorectal cancer (CRC) compared to annual fecal immunochemical test (FIT), when it included outreach, with or without a mailed annual FIT, using real world adherence rates in a simulated Medicaid population (Press release, Exact Sciences, OCT 25, 2021, View Source [SID1234591899]). Cologuard remained cost-effective in all the real-world adherence scenarios modeled. The modeling analyses were consistent with the CISNET Colorectal Working Group models when using 100% adherence rates.

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Cologuard Data Models Impact on CRC Incidence, Mortality and Cost Effectiveness in a Medicaid Population
The Exact Sciences Laboratories Patient Navigation Program features on-demand phone support, reminder phone calls, texts and emails at no additional cost with each Cologuard test ordered.

These new data, generated from the CRC-AIM microsimulation model, will be presented in an ACG Presidential Award-winning poster titled, "Cost-Effectiveness of Stool-Based Colorectal Cancer Screening Using Reported Real-World Adherence Rates in a Medicare Population." (P1181)

"Colorectal cancer screening rates need improvement, and they are particularly low in vulnerable populations,"1 said Paul Limburg, M.D., Chief Medical Officer, Screening at Exact Sciences. "Exact Sciences Laboratories’ patient navigation program answers any question around sample collection and offers phone and text reminders to complete the testing process. It is a way to help all patients, including vulnerable patients, prioritize their health and get up to date with CRC screening."

Colorectal cancer is the second deadliest cancer impacting both men and women in the U.S. Earlier detection of colorectal cancer through effective screening has been shown to improve clinical outcomes.2,3

All abstracts and posters presented at the meeting can be accessed through this link. Additional Cologuard abstracts accepted for presentation include:

Adherence to colorectal cancer screening and associated healthcare resource utilization, a longitudinal analysis in US Medicare population with ten years follow-up (PO246)

Colorectal cancer screening rates and associated characteristics among US Medicare beneficiaries aged 66-75 years old in 2016-2018 (PO245)

Impact of mt- sDNA in a colorectal cancer screening clinical practice: a real-world survey (PO247)

Multitarget stool DNA testing has a high positive predictive value for colorectal neoplasia on the second round of testing (P1318)

Initial colorectal cancer screenings after turning 50-year-old and follow-up screening patterns after positive FIT or multitarget stool DNA testing among average-risk population (P1330)

Colorectal cancer screening and adherence rates among average-risk population enrolled in a national health insurance provider during 2009-2018 (P2345)

Entry Into a Material Definitive Agreement.

On October 25, 2021, AnaptysBio, Inc. ("AnaptysBio") reported that it entered into a Royalty Purchase Agreement (the "Royalty Purchase Agreement") with Sagard Healthcare Royalty Partners, LP ("Sagard") to monetize a portion of AnaptysBio’s future JEMPERLI royalties and milestones under AnaptysBio’s Collaboration and Exclusive License Agreement, as amended (the "Collaboration Agreement"), with Tesaro, Inc. and Tesaro Development, Ltd., each a wholly-owned subsidiary of GlaxoSmithKline ("GSK") (Filing, 8-K, AnaptysBio, OCT 25, 2021, View Source [SID1234591898]).

Upon closing of the transaction with Sagard, which is anticipated by the end of 2021, Sagard will pay AnaptysBio $250 million upfront in exchange for royalties payable to AnaptysBio under the Collaboration Agreement on annual global net sales of JEMPERLI below $1 billion starting October 2021. The royalty rate applicable below the $1 billion annual net sales threshold is 8%. Sagard may also receive up to a total of $105 million in potential cash milestones, of which $15 million are subject to certain future JEMPERLI regulatory filing and approval milestones and up to $90 million are subject to certain commercial sales milestones due prior to JEMPERLI achieving the $1 billion in annual global net sales threshold.

Royalties payable above $1 billion JEMPERLI annual global net sales, which are paid by GSK at 12% to 25%, and certain milestones payable on annual sales at or above $1 billion are retained by AnaptysBio and are not subject to the Royalty Purchase Agreement. Royalties and milestones due upon development and commercialization of the AnaptysBio-generated anti-TIM-3 antagonist (cobolimab) or anti-LAG-3 antagonist (GSK4074386) antibodies under the Collaboration Agreement, including in combination with JEMPERLI, are also not subject to the Royalty Purchase Agreement. In addition, royalties due to AnaptysBio from GSK’s global net sales of ZEJULA (niraparib) are excluded from the Royalty Purchase Agreement. The closing of the transaction is subject to the satisfaction of customary closing conditions.

The aggregate JEMPERLI royalties and milestones to be received by Sagard under this Agreement is capped at certain fixed multiples of the upfront payment based upon time. Once Sagard receives an aggregate of either $312.5 million (125% of the upfront) by the end of 2026, or $337.5 million (135% of the upfront) during 2027 or $412.5 million (165% of the upfront) at any time after 2027, the Royalty Purchase Agreement will expire resulting in AnaptysBio regaining all subsequent JEMPERLI royalties and milestones.

The foregoing summary of the Royalty Purchase Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Royalty Purchase Agreement and the Collaboration Agreement. A copy of the Collaboration Agreement is available as Exhibit 10.10 to AnaptysBio’s Registration Statement on Form S-1, as amended, filed on May 10, 2016 and as Exhibit 10.16 to AnaptysBio’s Annual Report on Form 10-K for the year ended December 31, 2020. A copy of the Royalty Purchase Agreement will be filed as an exhibit to AnaptysBio’s Annual Report on Form 10-K for the year ended December 31, 2021.

Ultragenyx to Present at Jefferies Gene Therapy/Editing Summit

On October 25, 2021 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel therapies for serious rare and ultra-rare genetic diseases, reported that Emil D. Kakkis, M.D., Ph.D., the company’s Chief Executive Officer and President, will present at the Jefferies Gene Therapy/Editing Summit on October 28, 2021 at 3:30 PM ET (Press release, Ultragenyx Pharmaceutical, OCT 25, 2021, View Source [SID1234591897]).

The live and archived webcast of the presentation will be accessible from the company’s website at View Source The replay of the webcast will be available for 90 days.

Iovance Biotherapeutics to Host Third Quarter Financial Results Conference Call and Webcast on Thursday, November 4, 2021

On October 25, 2021 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported that it will report its third quarter financial results on Thursday, November 4, 2021 (Press release, Iovance Biotherapeutics, OCT 25, 2021, View Source [SID1234591895]). Management will host a conference call and live audio webcast to discuss these results and provide a corporate update at 4:30 p.m. ET.

To participate in the conference call, please dial 1-844-646-4465 (domestic) or 1-615-247-0257 (international) and reference the access code 7286232. The live webcast can be accessed in the Investors section of the Company’s website at www.iovance.com. The archived webcast will also be available for one year in the Investors section at www.iovance.com.

Invitation to presentation of Q3 2021 results

On October 25, 2021 ArcticZymes Technologies reported for the third quarter 2021 on Thursday, 28. October 2021 at 08.30 a.m (Press release, Biotec Pharmacon, OCT 25, 2021, View Source [SID1234591894])

The company will host an online presentation for investors, analysts, and media at 08:30 a.m on Thursday, 28 October 2021, which will be followed by a Q&A session.

CEO, Jethro Holter and CFO, Børge Sørvoll will hold the presentation.

Participants who want to participate in the live webcast are asked to send an email to [email protected] for a separate invitation, which will be distributed 1 day prior to the meeting. Participants who want to participate by telephone should dial in on +47 21 40 24 87 with conference id: 220 624 781#. It will be possible to post questions through the webcast and over the phone after the presentation is finished.

The report for the third quarter 2021 will be available on www.newsweb.no and on the company’s homepage www.arcticzymes.com from 07.00 a.m. on Thursday, 28. October 2021.