On January 31, 2019, Gritstone Oncology, Inc. (the "Company") reported that it has entered into an Office/Laboratory Lease (the "New Lease"), effective as of January 28, 2019, with Emery Station West, LLC (the "Landlord") to lease approximately 34,469 square feet of office and laboratory space located at 5959 Horton Street, Emeryville, California 94608 (the "Premises") for the Company’s new principal executive offices (Press release, Gritstone Oncology, FEB 5, 2019, View Source [SID1234533086]).

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The term of the New Lease (the "Lease Term") commences on the earlier of (i) the date on which the Landlord delivers the newly constructed Premises, substantially completed, and tenders possession to the Company of, the Premises or (ii) the date upon which the Company, with the Landlord’s consent, takes possession of any portion of the Premises to commence construction of certain tenant improvements (the "Commencement Date"). Beginning on the earlier of (x) 270 days after the Commencement Date or (y) the date on which the Company opens for business in any portion of the Premises (the "Rent Commencement Date"), the New Lease provides for annual base rent of approximately $1.7 million, which increases on a yearly basis up to approximately $2.6 million for the final 12 months of the initial Lease Term (the "Initial Lease Term"). In addition, the Company deposited with the Landlord a security deposit of approximately $0.6 million, equal to three months base rent.

The Initial Lease Term terminates on the last day of the 120th calendar month following the Rent Commencement Date, unless terminated earlier in accordance with the New Lease. The Company has the option to extend the Lease Term for two consecutive additional five year terms (the "Renewal Terms"). The New Lease provides for the base rent during the applicable Renewal Term to be calculated based on the fair market rental value of the Premises at such time, as described in the New Lease. The Company will also be obligated to pay to the Landlord for certain costs, taxes and operating expenses related with the New Lease and the Premises, subject to certain exclusions.

Under the New Lease, the Landlord will provide the Company with an improvement allowance of up to approximately $4.0 million in the aggregate for costs relating to the design, permitting and construction of improvements that are permanently affixed to the Premises.

Lease Termination Agreement

On January 31, 2019, the Company also entered into a Lease Termination Agreement (the "Termination Agreement"), effective as of January 28, 2019, with Emery Station Joint Venture, LLC (the "Current Landlord"), pursuant to which the Company and the Current Landlord agreed to early terminate the Company’s lease, dated November 23, 2015, as subsequently amended (the "Current Lease"), of the premises located at 5858 Horton Street, Emeryville, California 94608 (the "Current Premises"). Pursuant to the Termination Agreement, the Current Lease will terminate effective no later than 60 days after the Rent Commencement Date under the New Lease. In the event that the Company is deemed to hold over in possession of the Current Premises, the Company will be liable for 150% of the monthly base rent under the Current Lease and 100% of any increases for rent adjustments, as reasonably determined by the Current Landlord.

The foregoing descriptions of the New Lease and the Termination Agreement do not purport to be complete and are subject to, and qualified in their entirety by reference to, the full terms of the New Lease and the Termination Agreement, copies of which are filed as Exhibits 10.1 and 10.2 to this Current Report on Form 8-K, and are incorporated by reference herein.

On February 5, 2019 MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX & MDAX; NASDAQ: MOR) reported the appointment of David R. Trexler as President and member of the Board of Directors of MorphoSys US Inc., effective February 6, 2019 (Press release, MorphoSys, FEB 5, 2019, View Source [SID1234533085]). Mr. Trexler will lead the ongoing build-up of MorphoSys’s U.S. subsidiary with a focus on establishing the company’s commercial capabilities in preparation for the planned commercialization of MOR208 in the U.S.

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"I am delighted to welcome David Trexler to MorphoSys. With his experience and proven track record in establishing commercial organizations for international pharmaceutical companies as well as successfully executing oncology product launches in the U.S., he is ideally qualified to lead MorphoSys US Inc. We very much look forward to working with him," said Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG and Chairman of the Board of Directors of MorphoSys US Inc. "I would like to thank Jim Hussey for his outstanding contribution as interim president of our U.S. subsidiary over the last five months. Jim will now resume his position as special advisor to me in my role as Chairman of MorphoSys US Inc."

Mr. Trexler has built his career in leadership positions for branded pharmaceuticals in marketing, sales, business development and general management. He joins MorphoSys from EMD Serono, a business of Merck KGaA, Darmstadt, Germany, where he held positions of increasing seniority including most recently positions as Global Brand Lead, Bavencio and Senior Vice President US Oncology Commercial. At EMD Serono, he was responsible for building Merck KGaA’s first commercial oncology footprint in the U.S. and for the successful launch of Bavencio (avelumab) for metastatic Merkel cell carcinoma (mMCC). Prior to EMD Serono, Mr. Trexler worked for 10 years in various marketing roles in oncology for Eisai Inc., in particular as Senior Vice President Americas Oncology, where he was responsible for sales and marketing of Eisai’s oncology portfolio across the U.S. and supported efforts in Canada, Mexico and Brazil. Mr. Trexler previously held leadership roles at Mylan Bertek Pharmaceuticals (2004-2005) and Sanofi-Aventis Pharmaceuticals (1986-2004).

"I am enthused to join MorphoSys US Inc. at this exciting time in the Company’s development," commented David Trexler. "I look forward to working closely with the entire MorphoSys team to build our U.S. organization to enable a successful launch of MOR208 in this country, subject of course to prior FDA approval."

On February 5, 2019 Taiho Pharmaceutical Co., Ltd. and Cullinan Oncology, LLC reported on February 5 an agreement to develop TAS6417, a novel EGFR (epidermal growth factor receptor) tyrosine kinase inhibitor discovered by Taiho Pharmaceutical (Press release, Taiho, FEB 5, 2019, View Source [SID1234533083]).

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Under the terms of the agreement, Taiho Pharmaceutical will grant an exclusive, global license ex-Japan for the development and commercialization of TAS6417 to Cullinan Pearl, a newly formed USbased company under the Cullinan Oncology umbrella. Taiho Pharmaceutical will receive an upfront payment, regulatory and sales milestones, as well as royalties based on net sales. Taiho Ventures, LLC, a strategic corporate venture arm of Taiho Pharmaceutical, alongside Cullinan Oncology, will provide funding for Cullinan Pearl’s Series A.

"The Taiho’s drug research team created a unique molecule targeting EGFR Exon 20 insertion mutation using proprietary drug discovery platform technology. This alliance, one of the first of its kind at Taiho Pharmaceutical, allows our organization to optimize its R&D resource allocation and accelerate global development by accessing external talent and resources. We are pleased to partner with Cullinan Oncology and its experienced management team in bringing this novel treatment to NSCLC patients," said Teruhiro Utsugi, Managing Director of Taiho Pharmaceutical.

Cullinan Pearl will utilize Cullinan Oncology’s shared service platform to develop TAS6417, which relies on a central management team and a network of integrated collaborators to help drive the development of preclinical and clinical assets.

"We are excited to partner with Taiho Pharmaceutical and Taiho Ventures in exploring the utility of this novel drug in a patient population with limited options to date. We are thankful for Taiho’s trust in our team’s ability to execute the clinical development of this exciting asset," stated Owen Hughes, CEO of Cullinan Oncology.

About TAS6417

TAS6417 is an orally available tyrosine kinase inhibitor designed to target activating mutations in EGFR. The molecule was engineered to inhibit EGFR variants with exon 20 insertion mutations, while sparing wild-type EGFR. TAS6417 is a clinical candidate for NSCLC driven by EGFR exon 20 insertion mutations and is expected to be a novel therapeutic option for the patients with highly unmet medical needs

On February 5, 2019 GlaxoSmithKline plc (LSE/NYSE: GSK) and Merck KGaA, Darmstadt, Germany reported that they have entered into a global strategic alliance to jointly develop and commercialise M7824 (bintrafusp alfa*). M7824 is an investigational bifunctional fusion protein immunotherapy that is currently in clinical development, including potential registration studies, for multiple difficult-to-treat cancers (Press release, GlaxoSmithKline, FEB 5, 2019, View Source [SID1234533081]). This includes a Phase II trial to investigate M7824 compared with pembrolizumab as a first-line treatment in patients with PD-L1 expressing advanced non-small cell lung cancer (NSCLC).

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M7824 is designed to simultaneously target two immuno-suppressive pathways, transforming growth factor-β (TGF-β) trap and an anti-programmed cell death ligand-1 (PD-L1), that are commonly used by cancer cells to evade the immune system. Bifunctional antibodies aim to increase efficacy above and beyond that achieved with individual therapies or combinations of individual therapies.1 M7824 has the potential to offer new ways to fight difficult-to-treat cancers beyond the established PD-1/PD-L1 class. In addition to use as a single agent, M7824 is also being considered for use in combination with other assets from the pipelines of both companies.

Dr Hal Barron, Chief Scientific Officer and President R&D, GSK, said: "Despite recent medical advances, many patients with difficult-to-treat cancers don’t currently benefit from immuno-oncology therapies leaving them with limited treatment options. M7824 brings together two different biological functions in a single molecule and we have observed encouraging clinical results in treating certain cancer patients, particularly those people with non-small cell lung cancer. I’m excited by the potential impact this first-in-class immunotherapy could have on the lives of cancer patients."

Dr Belén Garijo, Member of the Executive Board and CEO Healthcare of Merck KGaA, Darmstadt, Germany said: "Our bifunctional fusion protein M7824 has the potential to bring new answers to patients living with cancer. Together with GSK we aim to drive a paradigm shift in the treatment of cancer as the leader in this novel class of immunotherapies. GSK clearly emerged as the ideal partner due to their strong commitment to oncology, and the complementary talent and capabilities they will bring to our alliance. We now look forward to harnessing the full potential of M7824 across a broad range of cancer indications as we continue to advance our oncology portfolio."

Merck KGaA, Darmstadt, Germany will receive an upfront payment of €300 million (£260 million) and is eligible for potential development milestone payments of up to €500 million (£440 million) triggered by data from the M7824 lung cancer programme. Merck KGaA, Darmstadt, Germany will also be eligible for further payments upon successfully achieving future approval and commercial milestones of up to €2.9 billion (£2.5 billion). The total potential deal value is up to €3.7 billion (£3.2 billion). Both companies will jointly conduct development and commercialisation with all profits and costs from the collaboration being shared equally on a global basis.

For GSK, this alliance is a further step in the company’s priority to strengthen its pharmaceuticals pipeline. This follows the company’s recent acquisition of TESARO, an oncology-focused company based in Waltham, Massachusetts. GSK’s approach to oncology is focused on innovation in the areas of immuno-oncology, cell therapy, cancer epigenetics and, most recently, genetic medicine.

This alliance reflects Merck KGaA, Darmstadt, Germany’s strategic approach to oncology R&D, identifying those opportunities that can progress the company’s highly promising clinical stage assets as efficiently and rapidly as possible, whether through internal expertise and capabilities or external collaborations.

With this alliance, both companies have the leadership position in this new class of immunotherapies, specifically leveraging TGF-β biology.

*Bintrafusp alfa is the proposed International Nonproprietary Name (INN) for the bifunctional immunotherapy M7824. Bintrafusp alfa is currently under clinical investigation and not approved for any use anywhere in the world.

About M7824 (also now known as bintrafusp alfa)
M7824 is an investigational bifunctional immunotherapy that is designed to combine a TGF-β trap with the anti-PD-L1 mechanism in one fusion protein. M7824 is designed to combine co-localised blocking of the two immuno-suppressive pathways – targeting both pathways aims to control tumour growth by potentially restoring and enhancing anti-tumour responses. M7824 is currently in Phase I studies for solid tumours, as well as a randomised Phase II trial to investigate M7824 compared with pembrolizumab as a first-line treatment in patients with PD-L1 expressing advanced NSCLC. The multicentre, randomised, open-label, controlled study is evaluating the safety and efficacy of M7824 versus pembrolizumab as a monotherapy treatment.

To-date, nearly 700 patients have been treated with M7824 across more than 10 tumour types in Phase I studies. Encouraging data from the ongoing Phase I studies indicates M7824’s potential safety and clinical anti-tumour activity across multiple types of difficult-to-treat cancers, including advanced NSCLC, human papillomavirus-associated cancers, biliary tract cancer (BTC) and gastric cancer. In addition, in pre-clinical studies M7824 demonstrated superior anti-tumour activity, compared with anti-PD-L1 alone or with anti-PD-L1 and TGF-β trap when co-administered. In total, eight high priority immuno-oncology clinical development studies are ongoing or expected to commence in 2019, including studies in non-small cell lung and biliary tract cancers.

On February 5, 2019 Leap Therapeutics, Inc. (Nasdaq: LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported the closing of an underwritten public offering of 6,571,428 shares of its common stock and warrants to purchase up to 6,571,428 shares of its common stock, as well as an additional 985,714 shares of its common stock and warrants to purchase up to 985,714 shares of its common stock pursuant to the full exercise of the underwriters’ option to purchase additional securities (Press release, Leap Therapeutics, FEB 5, 2019, View Source [SID1234533078]). Total gross proceeds to Leap from this offering were approximately $13,225,000, before deducting underwriting discounts and offering expenses payable by Leap, and excluding any proceeds Leap may receive upon exercise of the warrants.

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Raymond James & Associates, Inc. and Ladenburg Thalmann acted as book-running managers for the offering.

The shares were offered pursuant to an effective shelf registration statement on Form S-3 (File No. 333-223419) that was previously filed by Leap with the Securities and Exchange Commission (the "SEC") on March 2, 2018 and was declared effective by the SEC on March 16, 2018. A prospectus supplement and the related prospectus have been filed with the SEC and are available, for free, on the SEC’s website at View Source Copies of the prospectus supplement and the accompanying prospectus may be obtained from: Raymond James & Associates, Inc., Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, Florida 33716, or by telephone at (800) 248-8863, or e-mail at [email protected]; or from Ladenburg Thalmann, 277 Park Ave, 26th Floor, New York, NY 10172, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.