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]).

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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.

Palleon to Present Preclinical Data on Lead Immuno-Oncology Program, E-602, at SITC Annual Meeting

On October 25, 2021 Palleon Pharmaceuticals, a company pioneering the field of glyco-immunology to treat cancer and inflammatory diseases, reported it will present new preclinical data on the company’s lead immuno-oncology program, E-602, at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in Washington, D.C., from November 10-14, 2021 (Press release, Palleon Pharmaceuticals, OCT 25, 2021, View Source [SID1234591914]).

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Palleon’s poster highlights recent preclinical data from in vitro and in vivo studies of the company’s most advanced therapeutic candidate, E-602 (formerly known as Bi-Sialidase). E-602 is part of the company’s novel cancer immunotherapy platform, EAGLE (Enzyme-Antibody Glycan-Ligand Editing), which utilizes engineered human sialidase to degrade immunosuppressive sialoglycans.

In addition to the poster presentation, Palleon will be hosting a hybrid (live and virtual) scientific symposium at SITC (Free SITC Whitepaper) on November 11th featuring Palleon Scientific Co-Founder Carolyn Bertozzi, Ph.D., Scientific Advisor James Paulson, Ph.D., and Chief Medical Officer David Feltquate, M.D., Ph.D. The session will review the most recent state of the science of sialoglycan-mediated immune regulation and its potential relevance for immuno-oncology therapeutics. To learn more and register to attend, visit this link.

"We’re looking forward to sharing more about the development of our EAGLE platform and the lead program E-602, which we believe is a uniquely powerful way to reverse the immunosuppressive effect of cell-surface sialoglycans," said Li Peng, Ph.D., Chief Scientific Officer. "These data will inform our upcoming Phase 1 clinical trial of E-602, as well as our growing pipeline of EAGLE therapeutic candidates in oncology."

Details of the poster presentation are as follows:

Title: Development and engineering of human sialidase for degradation of immunosuppressive sialoglycans to treat cancer

Number: 843

Presenter: Li Peng, Ph.D., Chief Scientific Officer

Details of the symposium are as follows:

Title: Sialoglycan-Mediated Immune Regulation: Glycobiology Meets Immuno-Oncology

Timing: November 11, 2021, 6:30 p.m. – 8:00 p.m. EST

Registration Link

Presenters:

Carolyn Bertozzi, Ph.D.

Anne T. and Robert M. Bass Professor of Chemistry at Stanford University; Baker Family Director of Stanford ChEM-H; Scientific Co-Founder, Palleon Pharmaceuticals

James Paulson, Ph.D.

Cecil H. and Ida M. Green Professor and Co-Chair, Department of Molecular Medicine, and Professor, Department of Immunology and Microbiology, Scripps Research Institute; Scientific Advisor, Palleon Pharmaceuticals

David Feltquate, M.D., Ph.D.

Chief Medical Officer, Palleon Pharmaceuticals

Gritstone Announces Presentations during Five Upcoming Investor Conferences and Events

On October 25, 2021 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company developing the next generation of cancer and infectious disease immunotherapies, reported that Gritstone management will participate in five upcoming investor conferences in October, November and December (Press release, Gritstone Oncology, OCT 25, 2021, View Source [SID1234592018]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Conference: B. Riley Fall Best Ideas in Oncology Panel Series – Overcoming Checkpoint Resistance in Solid Tumors
Date and Time: Thursday, October 28, 2021 at 11:00 a.m. ET
Presenter: Andrew Allen, M.D., Ph.D., co-founder, president and chief executive officer

Conference: Stifel 2021 Virtual Healthcare Conference
Date and Time: Monday, November 15, 2021 at 1:20 p.m. ET
Presenter: Andrew Allen, M.D., Ph.D., co-founder, president and chief executive officer

Conference: Cowen’s 5th Annual IO Next Virtual Summit
Date and Time: Monday, November 15, 2021 at 4:15 p.m. ET
Presenter: Andrew Allen, M.D., Ph.D., co-founder, president and chief executive officer

Conference: Evercore ISI 4th Annual Health CONx Virtual Conference
Date and Time: Wednesday, December 1, 2021 at 10:05 a.m. ET
Presenter: Andrew Allen, M.D., Ph.D., co-founder, president and chief executive officer

Conference: Piper Sandler 33rd Annual Healthcare Conference
Date and Time: November 30-December 2, 2021
Presenter: Andrew Allen, M.D., Ph.D., co-founder, president and chief executive officer

A live webcast of the presentations will be accessible via the Investors & Media section of the company’s website at View Source An archived replay will be accessible for 30 days following each event.

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)

Angel Pharmaceuticals Announces Approval of IND Application in China for ITK Inhibitor CPI-818

On October 25, 2021 Angel Pharmaceuticals Co., Ltd. ("Angel Pharma") reported that its IND application for CPI-818, a small molecule ITK inhibitor, has been approved by the Center for Drug Evaluation (CDE) to initiate clinical trials in patients with relapsed/refractory T-cell lymphomas (TCL) in China (Press release, Angel Pharmaceuticals, OCT 25, 2021, prnewswire.com/news-releases/angel-pharmaceuticals-announces-approval-of-ind-application-in-china-for-itk-inhibitor-cpi-818-301407424.html [SID1234591915]).

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CPI-818, the first-and-only ITK inhibitor in clinical development, has been shown to selectively inhibit ITK (interleukin-2-inducible T-cell kinase) without effect on related kinases such as RLK (resting lymphocyte kinase) and BTK (Bruton’s tyrosine kinase). Angel Pharma licensed the rights to CPI-818 from Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS) for development, manufacturing and commercialization in China. Corvus is studying CPI-818 in a multi-center Phase 1b/2 clinical trial in patients with several types of TCL in the U.S. and Asia. Overall, CPI-818 has been shown to be well-tolerated, and has shown anti-tumor activity in peripheral T-cell lymphomas (PTCL) and in cutaneous T-cell lymphomas. As reported at the annual meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in December 2020, 2 of 7 patients with refractory PTCL experienced responses to treatment with CPI-818; one complete response and one partial response.

"This marks an important milestone in our efforts to bring this potential first-in-class innovative drug to patients in China. We are excited about working with top lymphoma experts in China to accelerate the development of CPI-818 to address unmet clinical need." said Richard A. Miller, M.D., co-founder and chairman of Angel Pharmaceuticals.

Professor Song Yuqin, Director of the Chinese Society of Clinical Oncology (CSCO), Secretary-General of the Anti-Lymphoma Alliance of the CSCO, and Deputy Director of Lymphoma Department at Peking University Cancer Hospital, said: "Relapsed/refractory T-cell lymphoma is a challenging group of non-Hodgkin’s lymphoma. Current five-year overall survival rates for the majority of patients are 10-30%. We are very pleased that Angel Pharmaceuticals brought the only clinical phase ITK inhibitor to China. We hope that the clinical development of the product in China progress successfully to benefit patients with relapsed/refractory T-cell lymphoma."

About CPI-818

CPI-818 is an investigational small molecule drug given orally that has selectively inhibited ITK (interleukin-2-inducible T-cell kinase) in preclinical studies. It was designed to possess dual properties: to block malignant T-cell growth and to modulate immune responses. ITK, an enzyme, is expressed predominantly in T-cells and plays a role in T-cell and natural killer (NK) cell lymphomas and leukemias, as well as in normal immune function. Interference with ITK signaling can modulate immune responses to various antigens. The Company believes the inhibition of specific molecular targets in T-cells may be of therapeutic benefit for patients with T-cell lymphomas and in patients with autoimmune diseases. Corvus is conducting a Phase 1b/2 trial in patients with refractory T-cell lymphomas in the U.S. and Angel Pharmaceuticals, which has rights to CPI-818 in China, is leading a global trial in patients with relapsed/refractory (R/R) T-cell lymphomas.