On February 1, 2022 GlaxoSmithKline plc (LSE/NYSE: GSK) reported that ViiV Healthcare, the global specialist HIV company majority-owned by GSK, with Pfizer Inc. and Shionogi & Co. Limited (Shionogi) as shareholders, has agreed to settle the global patent infringement litigation between GSK, Shionogi and Gilead Sciences, Inc. (Gilead) concerning ViiV Healthcare’s patents relating to dolutegravir, an antiretroviral medication used, together with other medicines, to treat human immunodeficiency virus (HIV) (Press release, GlaxoSmithKline, FEB 1, 2022, View Source [SID1234607572]).

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ViiV Healthcare, GSK and Shionogi alleged that Gilead’s Biktarvy, a triple combination HIV medicine containing the HIV integrase inhibitor bictegravir, tenofovir alafenamide and emtricitabine, infringed certain of their patents relating to dolutegravir. As a result of the settlement, patent infringement cases in the US, UK, France, Ireland, Germany, Japan, Korea, Australia, and Canada will be discontinued.

ViiV Healthcare, GSK, Shionogi and Gilead have entered into a global settlement agreement and a patent license agreement under which Gilead has been granted a worldwide licence to certain ViiV Healthcare patents relating to dolutegravir and a covenant not to enforce any patents controlled by ViiV Healthcare, GSK or Shionogi against Gilead in connection with any past or future claims of infringement relating to Biktarvy. ViiV Healthcare, GSK and Shionogi have also agreed not to enforce their patents against any future product containing bictegravir, to the extent that the patent enforcement relates to the bictegravir component of the product.

Financial Considerations
Under the terms of the global settlement and licensing agreement, Gilead will make an upfront payment of $1.25 billion to ViiV Healthcare which is expected in the first quarter of 2022. In addition, Gilead will also pay a 3% royalty on all future US sales of Biktarvy ($6.09 billion in 2020) and in respect of the bictegravir component of any other future bictegravir-containing products sold in the US. These royalties will be payable by Gilead to ViiV Healthcare from 1 February 2022 until the expiry of ViiV Healthcare’s U.S. Patent No. 8,129,385 on 5 October 2027. Gilead’s obligation to pay royalties does not extend into any period of regulatory paediatric exclusivity, if awarded. Regulatory paediatric exclusivity would extend the period of exclusivity after the expiry of the ‘385 patent by six months from 5 October 2027 to 5 April 2028.

The upfront payment and royalty income will be distributed in proportion to the ordinary shareholding in ViiV Healthcare (GSK 78.3%, Pfizer 11.7%, Shionogi 10%) net of the contingent consideration liability (CCL) to Shionogi and applicable tax.

The upfront payment of $1.25 billion will be recorded in GSK’s financial results as an adjusting item in the income statement for the first quarter of 2022. The future royalty income will be recorded in total and adjusted results in the income statements for 2022 to 2027 inclusive. Both the settlement and the future royalty income increase the fair value of the CCL to Shionogi, and the Pfizer put option.* These increases in fair value will be reflected in GSK’s 2021 full-year and fourth-quarter results, and the associated charges will be recorded within adjusting items.

Cash in-flows from the upfront payment and future royalty income and cash out-flows from the CCL will be recorded in cash generated from operations. The resulting increased dividends to Shionogi and Pfizer will be included within financing cashflows. Full details of the operational accounting of the CCL can be found on pages 52-53 of GSK’s 2020 Annual Report.

On February 1, 2022 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS’’ or the "Company"), a late-stage clinical biopharmaceutical company focused on developing novel cancer immunotherapies for a broad range of indications, reported the completion of enrollment in the Phase 1/2 clinical trial of the Company’s lead asset, galinpepimut-S (GPS), in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in second or third line Wilms Tumor-1 (WT1)(+) relapsed or refractory metastatic ovarian cancer (Press release, Sellas Life Sciences, FEB 1, 2022, View Source [SID1234607571]). The endpoints of the study include safety, overall response rate, progression-free survival, overall survival and immune response correlates. The clinical trial is being conducted under a Clinical Trial Collaboration and Supply Agreement with Merck & Co., Inc., Kenilworth, N.J. USA (known as MSD outside of the United States and Canada).

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The total expected enrolled and evaluable number of patients is 17. Data from 15 patients will be examined by mid-2022, with final data analysis for all evaluable patients expected by the end of 2022. SELLAS and Merck will jointly perform applicable analyses of the study, including survival, immune-biological and any other analyses of interest, to assess the safety and efficacy profile of the combination of GPS and pembrolizumab in this difficult-to-treat metastatic ovarian cancer indication.

"Completion of enrollment is an important milestone as we work diligently to evaluate a much-needed therapeutic treatment option for second or third line relapsed or refractory metastatic ovarian cancer patients," said Angelos Stergiou, MD, ScD. h.c., President and Chief Executive Officer of SELLAS. "Our ability to complete enrollment timely, especially given the challenges related to COVID, is a tremendous accomplishment. We greatly appreciate the level of commitment Merck has given to this collaboration and are deeply grateful to all patients and their families, as well as investigators and study staff involved."

About Ovarian Cancer
Ovarian cancer is one of the most common gynecologic malignancies and the fifth most frequent cause of cancer death in women in the United States. Over 22,000 cases are diagnosed annually, resulting in an estimated 15,500 deaths per year. The majority of patients have widespread disease at presentation, and the five-year survival for the advanced-stage disease remains less than 30 percent. Combining GPS with the checkpoint inhibitor pembrolizumab, which beneficially and profoundly alters the tumor microenvironment (TME), is hypothesized to increase the proportion of patients who develop an immune response against their cancer and potentially improve their clinical outcome over pembrolizumab monotherapy, without the burden of additional toxicities in macroscopically measurable malignancies.

On February 1, 2022 Massive Bio reported that New York City Health Business Leaders (NYCHBL), the organization that serves as the gateway to New York’s healthcare ecosystem, has recognized the company on its NYC Digital Health 100, showcasing the most exciting and innovative health start-ups in New York (Press release, Massive Bio, FEB 1, 2022, View Source [SID1234607570]).

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"We are very excited and honored to be included among many other great startups in the healthcare industry. Massive Bio has been headquartered in New York City since being founded in 2015, so being selected to this list is especially rewarding. We will continue connecting cancer patients in New York City and around the world to leading edge therapies in clinical trials" said Massive Bio Co-Founder and CEO Selin Kurnaz.

"This year, the NYC Digital Health 100 is comprised of an incredibly diverse set of companies and leaders who are working to innovate and solve some of the most complex challenges across all facets of the healthcare ecosystem," said Bunny Ellerin, co-founder and CEO, NYCHBL. "We are delighted to recognize these companies and celebrate and support their growth in the New York area."

Massive Bio’s mission of providing cancer patients with access to new therapies and clinical trials combined with an artificial intelligence (AI) powered platform can give patients new opportunities to treat their cancer. With over 18,000 actively recruiting cancer clinical trials, Massive Bio’s Clinical Trial Matching System (CTMS) provides improved outcomes for cancer patients as well as contributes to faster drug development in cancer research.

The NYC Digital Health 100 was released in conjunction with the NYCHBL Healthcare Innovation Report 2022, an in-depth look at the data, trends and insights that define the healthcare industry in NY. In 2021, 182 companies raised an historic high of $9.0B, a 150% increase from 2020 ($3.6B) and 87% of the investments went to start-ups in areas including virtual care, patient engagement and mental health. View the full report here.

NYC Digital Health 100 Methodology
To compile the NYC Digital Health 100, NYCHBL used its dynamic database of digital health companies in the region and then invited companies to complete applications with quantitative and qualitative data to broaden the consideration set. A company qualified for consideration if it maintained headquarters or an office (over 10 people) in the New York region. Companies were judged on a number of factors, including but not limited to: strength of leadership, number of employees, funding (if known), revenue (if known), market fit, differentiated offerings, approach to diversity and equity, and community engagement.

On February 1, 2022 Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, reported that management will participate in a virtual fireside chat at the Guggenheim Healthcare Talks 2022 Oncology Conference on February 9, 2022 at 4:00 PM ET (Press release, Protara Therapeutics, FEB 1, 2022, View Source [SID1234607569]).

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A live webcast of the fireside chat can be accessed by visiting the Events and Presentations section of the Company’s website: View Source The webcast will be archived on the Company’s website for 90 days following the presentation.

On February 1, 2022 Rubius Therapeutics, Inc. (Nasdaq: RUBY), a clinical-stage biopharmaceutical company that is biologically engineering red blood cells to create an entirely new class of cellular medicines called Red Cell Therapeutics for the treatment of cancer and autoimmune diseases, reported that the executive management team will present and host meetings with investors at the virtual Guggenheim Healthcare Talks and SVB Leerink Global Healthcare Conference in February (Press release, Rubius Therapeutics, FEB 1, 2022, View Source [SID1234607568]).

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Pablo J. Cagnoni, M.D., president and chief executive officer, will provide a corporate update through fireside chats at Guggenheim Healthcare Talks | Idea Forum | Oncology Day on February 10, 2022, 08:00 a.m. EST and at the 11th Annual SVB Leerink Global Healthcare Conference on February 18, 2022, 1:00 p.m. EST. Live audio webcasts for these events will be available within the Investors & Media section of the Rubius Therapeutics website. Archived replays will be accessible for 90 days following the events.