CHINOOK THERAPEUTICS CLOSES MERGER WITH ADURO BIOTECH AND COMPLETES $115 MILLION PRIVATE PLACEMENT FINANCING

On October 5, 2020 Chinook Therapeutics, Inc. (NASDAQ: KDNY), a clinical-stage biotechnology company focused on the discovery, development and commercialization of precision medicines for kidney diseases, reported the closing of its merger with Aduro Biotech, Inc. and $115 million private placement financing (Press release, Aduro Biotech, OCT 5, 2020, View Source [SID1234569772]). The combined company, now known as Chinook Therapeutics, will commence trading October 6, 2020 on the Nasdaq Global Select Market under the trading symbol "KDNY."

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As previously announced, the $115 million private placement financing includes participation from new investors EcoR1 Capital, OrbiMed Advisors, funds managed by Rock Springs Capital, Fidelity Management and Research Company LLC, Avidity Partners, Surveyor Capital (a Citadel company), Ally Bridge Group, Monashee Investment Management LLC, Northleaf Capital Partners, Janus Henderson Investors, Sphera Biotech and other top-tier healthcare investors. As part of the financing, Chinook’s existing investors, Versant Ventures, Apple Tree Partners and Samsara BioCapital, purchased $25 million in Chinook common stock on the same terms as the new investors. Effective as of the closing of the merger, Chinook has over $275 million in operating capital to advance its kidney disease programs.

"Chinook’s merger with Aduro and entry into the public market is a transformative event that will propel the development of our atrasentan, BION-1301 and CHK-336 programs, and drive forward our research and discovery programs for other rare, severe chronic kidney diseases with large unmet medical needs," said Eric Dobmeier, president and chief executive officer of Chinook Therapeutics. "With a strong cash position, a promising pipeline and our dedication to treating patients with debilitating kidney diseases, we are well positioned to achieve value-generating milestones and build a leading company in the kidney disease space."

Chinook will focus on advancing its product candidates for kidney disease, including:

Planned Phase 3 and Phase 2 trials of atrasentan, an investigational selective endothelin receptor antagonist, in development for the treatment of IgA nephropathy and other primary glomerular diseases;
An ongoing Phase 1b and future clinical trials of BION-1301, an investigational humanized monoclonal antibody that blocks APRIL binding to both the BCMA and TACI receptors, in development for the treatment of IgA nephropathy;
A planned Phase 1 trial of CHK-336, an investigational small molecule, in preclinical development for the treatment of an ultra-rare orphan kidney disease; and
Advancement of additional research and discovery programs focused on the treatment of rare, severe chronic kidney diseases.
In connection with the closing of the merger, Aduro effected a 1:5 reverse split of its common stock. Post-merger and post-reverse split, Chinook has approximately 42 million shares of common stock outstanding. Prior Chinook stockholders collectively own approximately 39.5% of the combined company, prior Aduro stockholders collectively own approximately 39.9% of the combined company and investors in the Chinook private placement financing collectively own approximately 20.6% of the combined company.

Effective as of the closing of the merger, the board of directors of Chinook will be comprised of seven directors: Eric Dobmeier, president and chief executive officer of Chinook Therapeutics; Jerel Davis, Ph.D., managing director at Versant Ventures; Srini Akkaraju, M.D., Ph.D., managing general partner at Samsara BioCapital; William M. Greenman, president and chief executive officer of Cerus Corporation; Ross Haghighat, founder, chairman and managing partner of Triton Systems, Inc.; Michelle Griffin, director and audit committee chair for Adaptive Biotechnologies, Acer Therapeutics and HTG Molecular Diagnostics, Inc.; and Dolca Thomas, M.D., chief medical officer of Principia Biopharma, Inc.

MTS Health Partners acted as exclusive financial advisor to Chinook and Fenwick & West LLP served as legal counsel to Chinook for the merger. SVB Leerink acted as exclusive financial advisor to Aduro and Latham & Watkins LLP served as legal counsel to Aduro for the merger. SVB Leerink acted as lead placement agent and Evercore Group L.L.C. and William Blair acted as co-placement agents for the private placement financing.

Zai Lab Announces First Patient Dosed in China in a Global Phase 3 Study of Retifanlimab in Patients with NSCLC

On October 5, 2020 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), an innovative commercial stage biopharmaceutical company, reported dosing of the first patient in China in the global Phase 3 POD1UM-304 study evaluating retifanlimab, an investigational anti-PD-1 antibody, in combination with platinum-based chemotherapy in patients with first-line metastatic non-small-cell lung cancer (NSCLC) (Press release, Zai Laboratory, OCT 5, 2020, View Source [SID1234568280]).

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"Non-small cell lung cancer is the most common tumor type and represents a significant unmet medical need in China," said Dr. Samantha Du, Founder, Chairwoman and Chief Executive Officer of Zai Lab. "Anti-PD-1 therapies are the backbone to many current and future immuno-oncology therapy combinations and we are excited to contribute patients to the POD1UM-304 Phase 3 registrational study and join Incyte in its endeavor to bring this potential new therapy to patients globally."

POD1UM-304 is a Phase 3, randomized, multicenter, double-blind study evaluating retifanlimab in combination with platinum-based chemotherapy in patients with first-line metastatic squamous and non-squamous non-small cell lung cancer. The study is expected to enroll approximately 530 adult patients randomized to receive retifanlimab or placebo in combination with standard therapy of platinum-based chemotherapy. Zai Lab and its partner, Incyte, will cooperate in conducting the study in Greater China with Zai Lab taking the operational lead by conducting the screening, enrollment and treatment of patients in Greater China. The primary endpoints of the study are overall survival (OS) and progression-free survival (PFS) as determined by blinded independent central review using RECIST v1.1. Key secondary endpoints include objective response rate (ORR), duration of response (DOR), safety and pharmacokinetics.

About NSCLC

Lung cancer is the most commonly diagnosed cancer type and the leading cause of cancer death in China. There were approximately 774,000 new cases and 690,500 deaths of lung cancer in China in 2018, respectively. NSCLC accounts for approximately 85 percent of lung cancer, and approximately 70 percent of NSCLC is locally advanced or metastatic at initial diagnosis.

About Retifanlimab (INCMGA0012)

Retifanlimab (formerly INCMGA0012), an investigational anti-PD-1 antibody, is currently under evaluation in registration-directed studies as a monotherapy for patients with microsatellite instability-high endometrial cancer, Merkel cell carcinoma and squamous cell carcinoma of the anal canal (SCAC); and in combination with platinum-based chemotherapy for patients with non-small cell lung cancer and SCAC.

Retifanlimab has been granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of anal cancer.

In 2019, Incyte and Zai Lab announced a collaboration and license agreement for the development and commercialization of retifanlimab in Greater China.

Entry into a Material Definitive Agreement

On October 5, 2020, Scholar Rock, Inc. (the "Sublandlord"), a wholly-owned subsidiary of Scholar Rock Holding Corporation (collectively, the "Company") reported entered into a Sublease Agreement (the "Sublease") with Orna Therapeutics, Inc. (the "Subtenant") to sublease approximately 20,751 square feet of office and laboratory space located at the Company’s primary headquarters at 620 Memorial Drive, Cambridge, Massachusetts (the "Premises") (Filing, 8-K, Scholar Rock, OCT 5, 2020, View Source [SID1234568264]). The Sublease is subordinate to that certain Indenture of Lease, dated March 5, 2015, by and between 620 Memorial Leasehold LLC and the Sublandlord, as subsequently amended on February 22, 2016 and February 22, 2018.

The Sublease term will commence on a date to be determined between January 1 and March 15, 2021, and ends on August 31, 2023, unless terminated earlier. As previously disclosed on the Company’s Form 10-Q filed on November 12, 2019, the Company entered into a facility lease at 301 Binney Street in Cambridge, Massachusetts ("New Facility"), and upon completion of its move into the New Facility, the New Facility will become the Company’s new corporate headquarters.

The Sublease provides for initial annual base rent of approximately $1.9 million. The Subtenant will also be obligated to pay the Sublandlord for certain costs, taxes and operating expenses related to the Premises, subject to certain exclusions.

The Subtenant is obligated to provide a security deposit to the Sublandlord in the form of a letter of credit in the amount of approximately $0.8 million, subject to adjustments, which may be applied by the Sublandlord for certain purposes upon the Subtenant’s breach of any provisions under the Sublease.

The Sublease contains customary provisions allowing the Sublandlord to terminate the Sublease if the Subtenant fails to remedy a breach of any of its obligations within specified time periods, or upon bankruptcy or insolvency of the Subtenant.

The foregoing description of the Sublease does not purport to be complete and is qualified in its entirety by reference to such Sublease, which the Company intends to file as an exhibit to its Form 10-K for the year ending December 31, 2020.

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WindMIL Therapeutics to Present at 2020 Virtual Cell & Gene Meeting on the Mesa

On October 5, 2020 WindMIL Therapeutics reported that Chairman and Chief Executive Officer Don Hayden will present at the annual Cell & Gene Meeting on the Mesa to be held virtually Monday, October 12 – Friday, October 16, 2020 (Press release, WindMIL Therapeutics, OCT 5, 2020, View Source [SID1234568181]). Company presentations will be available to view on-demand throughout the entirety of the conference.

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Y-mAbs Provides Regulatory Update on Omburtamab for the Treatment of Patients with Neuroblastoma

On October 5, 2020 -mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that Y-mAbs has received a Refusal to File letter from the U.S. Food and Drug Administration ("FDA") regarding the Biologics License Application ("BLA") for omburtamab for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma, which was submitted in August 2020 (Press release, Y-mAbs Therapeutics, OCT 5, 2020, View Source [SID1234568144]).

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Upon preliminary review, the FDA determined that certain parts of the Chemistry, Manufacturing and Control ("CMC") module and the Clinical module of the BLA require further detail. No additional non-clinical data have been requested or are required.

Y-mAbs is confident that it can address all points raised by the FDA, including providing the requested additional CMC information and supplementary data from Study 101, which will include tumor response data from patients with evaluable disease among the first 24 patients included in the protocol.

The Company will request a Type A meeting with the FDA as soon as possible, and plans to work in close dialog with the Agency in order to amend the BLA with the goal of resubmitting the BLA before the end of 2020.

Investor Call and Webcast

Y-mAbs will hold an investor conference call to discuss this update on October 6, 2020 at 9:00 a.m. EDT.

Investors are invited to listen to a live webcast of the call by dialing 877-407-0792 in the U.S. or 201-689-8263 for international callers, Conference ID: 13711563. To access a live webcast of the update, please use the following link: View Source

Researchers at Memorial Sloan Kettering Cancer Center ("MSK") developed omburtamab, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests in the compound and in Y-mAbs.