On September 7, 2022 SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported that it has entered into an expanded global, non-exclusive license and collaboration agreement with GSK plc (LSE/NYSE: GSK) for nirogacestat, SpringWorks’ investigational oral gamma secretase inhibitor, in combination with Blenrep (belantamab mafodotin-blmf), GSK’s antibody-drug conjugate targeting B-cell maturation antigen (BCMA) (Press release, SpringWorks Therapeutics, SEP 7, 2022, View Source [SID1234619139]).

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Under the terms of the expanded agreement, SpringWorks will receive a $75 million equity investment from GSK, with shares of common stock priced at a premium to the 30-day volume-weighted average share price on September 2, 2022. SpringWorks will also be eligible to receive up to $550 million in additional payments based on reaching certain development and commercial milestones. SpringWorks will retain full commercial rights to nirogacestat and will be responsible for global commercialization of nirogacestat.

"We are very pleased to expand our relationship with GSK to enable potential additional studies of Blenrep and nirogacestat," said Saqib Islam, Chief Executive Officer of SpringWorks. "Our goal is to maximize the clinical impact of nirogacestat as a potentiator of BCMA targeted therapies and today’s announcement advances our opportunity to serve patients with multiple myeloma across lines of therapy."

"We look forward to continuing our relationship with SpringWorks for the potential expanded development of Blenrep with nirogacestat and are encouraged by the early clinical data emerging from the combination," said Hesham A. Abdullah, M.D., M.Sc., Senior Vice President, Global Head of Oncology Development at GSK. "Blenrep in combination with novel therapies, such as nirogacestat, could prove to be an impactful therapeutic option for patients with multiple myeloma, as these combination regimens may further optimize the benefit-risk profile of Blenrep, especially in earlier lines of therapy."

SpringWorks and GSK first entered into a clinical trial collaboration and supply agreement in June 2019, later amended in October 2021, to cover the initial clinical development of nirogacestat in combination with Blenrep in patients with relapsed or refractory multiple myeloma. The new agreement expands the original collaboration to include the potential for continued development and commercialization of the combination of nirogacestat and Blenrep in earlier lines of treatment, including newly diagnosed multiple myeloma. SpringWorks and GSK will expand their previously established governance structures to add a new Joint Steering Committee and Joint Commercialization Committee to their existing Joint Development Committee. GSK will continue funding all development costs, except for those related to the supply of nirogacestat and certain expenses related to intellectual property rights.

On September 7, 2022 Celsion Corporation (NASDAQ: CLSN), a clinical-stage drug development company reported that Dr. Corinne Le Goff, President and Chief Executive Officer will present a company overview and be available for 1×1 meetings at the upcoming H.C. Wainwright 24th Annual Global Investment Conference (Press release, Celsion, SEP 7, 2022, View Source [SID1234619138]). The hybrid conference will be held from September 12-14 with in-person participation held at the Lotte New York Palace Hotel.

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Dr. Le Goff will present in person on Tuesday, September 13th at 4:00 pm ET. A replay of the presentation will available under "Financial Events" in the Investors section of the Company’s website at: View Source

On September 7, 2022 Viracta Therapeutics, Inc. (Nasdaq: VIRX), a precision oncology company targeting virus-associated malignancies, reported that the European Commission has granted an orphan drug designation (ODD) to nanatinostat and valganciclovir (Nana-val), the company’s all-oral combination product candidate, for the treatment of peripheral T-cell lymphoma (PTCL) (Press release, Viracta Therapeutics, SEP 7, 2022, View Source [SID1234619137]). This represents Nana-val’s first ODD in Europe and fifth globally. The U.S. Food and Drug Administration previously granted Nana-val ODD for the treatment of T-cell lymphoma, post-transplant lymphoproliferative disorder, plasmablastic lymphoma, and Epstein-Barr virus-positive (EBV+) diffuse large B-cell lymphoma, not otherwise specified.

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"This orphan drug designation acknowledges the high unmet medical need of this patient population as well as the potential of Nana-val to offer therapeutic benefit to patients with recurrent peripheral T-cell lymphoma," said Lisa Rojkjaer, M.D., Chief Medical Officer of Viracta. "Patients with peripheral T-cell lymphoma have few effective treatment options, particularly those with relapsed/refractory disease. Of note, Epstein-Barr virus is frequently associated with peripheral T-cell lymphoma, and reportedly confers a worse overall survival for patients. Following the conclusion of our Phase 1b/2 study, we are now continuing the evaluation of Nana-val in patients with relapsed/refractory Epstein-Barr virus-positive lymphoma in our global Phase 2 NAVAL-1 trial, which is actively enrolling at sites across Europe, North America and Southeast Asia."

ODD in the European Union (EU) is granted by the European Commission based on a positive opinion issued by the European Medicines Agency (EMA) Committee for Orphan Medical Products (COMP). To qualify for ODD from the European Commission, a product candidate must be intended to treat, prevent, or diagnose a life-threatening or chronically debilitating disease that does not affect more than 5 in 10,000 people across the EU. In addition, there must be sufficient clinical or non-clinical data to suggest the product candidate may produce clinically relevant outcomes, and grounds to indicate it can provide a significant benefit over any currently authorized products. Receiving an orphan drug designation from the European Commission provides companies with certain benefits and incentives including clinical protocol assistance, access to a centralized marketing authorization procedure valid in all EU member states, reduced regulatory fees, and ten years of market exclusivity upon receipt of marketing authorization in the EU. The availability of market exclusivity is intended to encourage the development of medicines for rare diseases by protecting them from competition from similar medicines with similar indications, which cannot be marketed during the exclusivity period.

About NAVAL-1
NAVAL-1 (Nanatinostat in Combination with Valganciclovir) is a global, multicenter, open-label Phase 2 basket trial. The trial, which will include patients with multiple subtypes of relapsed/refractory EBV-positive (EBV+) lymphoma, is designed to evaluate the anti-tumor activity of Nana-val and enroll approximately 140 patients. The primary endpoint of the trial is objective tumor response rate as assessed by an independent review committee. If successful, Viracta believes this trial could potentially support multiple new drug application filings across various EBV+ lymphoma subtypes. The study employs a Simon two-stage design where a limited number of patients are enrolled into each cohort in Stage 1 and, if a pre-specified activity threshold is reached, additional patients will be enrolled in Stage 2. During Stage 2, Viracta anticipates discussing the preliminary results with the FDA and may amend the protocol to include additional patients as necessary to enable registration.

About Nana-val (Nanatinostat and Valganciclovir)
Nanatinostat is an orally available histone deacetylase (HDAC) inhibitor being developed by Viracta. Nanatinostat is selective for specific isoforms of Class I HDACs, which is key to inducing viral genes that are epigenetically silenced in Epstein-Barr virus (EBV)-associated malignancies. Nanatinostat is currently being investigated in combination with the antiviral agent valganciclovir as an all-oral combination therapy, Nana-val, in various subtypes of EBV-associated malignancies.

On September 7, 2022 Good Therapeutics, a privately held company, reported it has entered into a definitive merger agreement to be acquired by Roche (SIX: RO, ROG; OTCQX: RHHBY) (Press release, Good Therapeutics, SEP 7, 2022, View Source [SID1234619136]). With this acquisition, Roche will gain rights to Good Therapeutics’ innovative, conditionally active, PD-1-regulated IL-2 program and an exclusive right to the platform technology for the development of PD-1-regulated IL-2 receptor agonist therapeutics.

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Under the terms of the merger agreement, Roche will make an upfront cash payment of $250 million for the shares on a fully diluted basis and additional payments based on the achievement of predetermined development, regulatory, and commercial milestones. The transaction is conditioned upon clearance under the Hart-Scott-Rodino Antitrust Improvements Act and is expected to close in the third quarter of 2022.

Following the close of the Roche acquisition, the Good Therapeutics team plans to apply the technology for the design of conditionally active therapeutics to other targets in immuno-oncology and beyond in a new company, Bonum Therapeutics.

"Good Therapeutics was founded to create a new class of conditionally active therapeutics that will be more effective and avoid the problem of systemic immune activation seen with previous versions of such drugs. We have focused on PD-1-IL-2 as a biology that has great potential for benefiting patients," said John Mulligan, Ph.D., Founder and CEO of Good Therapeutics. "Roche is a leader in immuno-oncology and has pioneered the field of engineered PD-1-targeted IL-2 therapeutics. Given their expertise in this field and broad capabilities in oncology, we believe they are a perfect choice for taking this important program forward."

"We are excited to bring Good’s innovative PD-1-regulated IL-2 program into our existing oncology pipeline, which nicely complements our efforts on next-generation PD-1-targeted IL-2 therapeutics and our broader oncology strategy of providing cancer patients with innovative solutions and improving health outcomes," said James Sabry, M.D., Ph.D., Global Head of Pharma Partnering at Roche. "With our proven track record in cancer immunotherapy, we are well-positioned to leverage our deep discovery, development, clinical, and manufacturing capabilities and worldwide reach to potentially bring innovative products from this program to patients as fast as possible."

On September 7, 2022 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immune-oncology technologies for the treatment of hard to treat cancers, reported that Jeffrey F. Eisenberg, Chief Executive Officer of Xenetic will present at the H.C. Wainwright 24th Annual Global Investment Conference being held in New York, NY and virtually on September 12-14, 2022 (Press release, Xenetic Biosciences, SEP 7, 2022, https://ir.xeneticbio.com/news/detail/126/xenetic-biosciences-inc-to-present-at-the-h-c-wainwright-24th-annual-global-investment-conference [SID1234619132]).

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Xenetic Biosciences, Inc., Wednesday, September 7, 2022, Press release picture
In addition to the presentation, management will be available to participate in virtual one-on-one meetings with qualified members of the investor community who are registered to attend the conference. For more information, please visit the conference website.

A video webcast of the presentation will be accessible for viewing on-demand beginning on Monday, September 12 at 7:00 AM ET for those registered for the event and will be available on the Events page in the Investors section of the Company’s website (www.xeneticbio.com). The webcast replay will be archived for 90 days following the event.