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.

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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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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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.

On October 5, 2020 Foghorn Therapeutics reported that it is aiming for a $100 million IPO, but don’t be surprised it if goes the way of many other biotech listings and shoots far north of that (Press release, Foghorn Therapeutics, OCT 5, 2020, View Source [SID1234568133]).

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The Cambridge, Massachusetts-based biotech launched in March 2018 to develop drugs for cancer as well as other serious diseases based on insights into the chromatin regulatory system.

Out of this has come the "gene traffic control" platform, which enticed Merck into a $425 million deal in the summer to discover and develop new meds against a transcription factor target "believed to be relevant to a broad range of cancer patients."

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Foghorn likens chromatin regulation, which directs gene expression in cells, to air traffic control: "Just as airports need an air traffic control system to direct which planes move and when, where, and in what order, our bodies need a system to control which genes our cells express, and when, where, in what order, and what quantity."

A breakdown in chromatin regulation is a "major, unexplored cause" of many diseases, including more than 20% of cancers, the company said. It was first launched by life science VC shop Flagship Pioneering.

While still in the early stages, new research is shining a light on how this system might work.

In a study published in the journal Science Advances earlier this year, a Northwestern University team pinpointed the role of chromatin, which is the DNA, RNA and proteins that make up the chromosome. They reported that the way chromatin is packed in the nucleus can cause diverse DNA transcriptional features among cells and control how they respond to stress.

Cancer cells with disordered packing are more likely to adapt to treatments, they reported. The researchers believe targeting chromatin could inhibit cancer cells’ ability to adjust and therefore help boost responses to traditional therapies.

According to its Securities and Exchange Commission filing, its furthest along assets are FHD-286, a selective allosteric ATPase inhibitor, and FHD-609, a protein degrader, which are being tapped for blood cancers and solid tumors.

"Our approach is to identify and drug genetically determined dependencies within the chromatin regulatory system," it said in its filing. "Our initial focus is in cancer with a precision oncology approach. Every program we pursue is based on a genetic dependency on the chromatin regulatory system."

Foghorn plans to file investigational new drug applications for FHD-286 and FHD-609 in the fourth quarter and first half of next year. The biotech is plotting to list on the Nasdaq under the symbol "FHTX."