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."

On October 5, 2020 Cancer Research UK reported that Earlier detection of cancer offers arguably the single biggest opportunity to save lives from the disease, but there are many challenges of seeing this a reality for patients in the NHS, according to Cancer Research UK’s Roadmap for the Early Detection and Diagnosis of Cancer report, and highlighted in a commentary in the Lancet Oncology (Press release, Cancer Research UK, OCT 5, 2020, View Source [SID1234568131]).

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Cancer Research UK’s consultation of over 100 experts highlights the siloed early detection research and development ecosystem, from academia and industry to the health services and policy makers, which is hampering progress. It proposes a series of tangible recommendations to unite these sectors, address these challenges and deliver a future where early detection of cancer is a routine reality.

Critically, it calls for the significant investment in diagnostic equipment and technologies, along with NHS staff, to support new ways of working and drive the paradigm shift to diagnose more cancers at an earlier stage, and ultimately save lives. The Roadmap also calls to attention a market failure in early detection of cancer, with too few innovative technologies making into the health system.

By having the right investments and policies in place, the UK has the potential to become a world leader in early detection and diagnosis of cancer, unlocking a major economic growth opportunity for the UK.

The authors hope that the prioritisation of early detection and diagnosis of cancer by scientists, companies, health services and government will create a thriving multidisciplinary ecosystem, focussed on proactively managing patients’ health and wellbeing before symptoms arise.

Dr David Crosby, head of prevention and early detection research at Cancer Research UK and co-author of the Roadmap said: "All too often, patients are being diagnosed at a late stage, where their cancer is deeply rooted and requires significant intervention, often with poor outcomes.

"This is a human tragedy, not just in terms of lives lost, but it also means more expensive treatments, hospital stays and monitoring. If we can turn this on its head and find cancer at its earliest stages when it’s easier to treat, not only will we be able to save lives on a vast scale, but we will be saving our NHS millions of pounds that would otherwise be needed for costly late stage treatments.

"For the first time, the Roadmap shows us how we can bring together the entire research, commercial and health ecosystem to create a future where lives are not needlessly lost due to late diagnosis."

Terry Kavanagh, who was diagnosed with lung cancer and took part in the consultation said: "I still remember the surgeon’s words after waking from surgery to remove half of my left lung, "Well Terry, I’m satisfied we caught it early". It’s why I’m still here. Taking part in the roadmap really opened my eyes to the number of disciplines that have to come together in a bigger plan to help other cancer patients. Hopefully one day, early detection will be a reality for every cancer."