On January 13, 2022 Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage biopharmaceutical company developing potential new medicines for patients with sarcomas, pediatric cancers, and other cancers, reported a definitive agreement with DeuteRx, LLC to acquire an oral, small molecule targeted protein degradation portfolio (Press release, Salarius Pharmaceuticals, JAN 13, 2022, View Source [SID1234605477]). The acquisition includes a lead drug candidate that Salarius has renamed SP-3164 (formerly DRX-164), the related patent family, including issued composition of matter patents, and the opportunity to develop additional undisclosed cancer-fighting assets in the targeted protein degradation space. Targeted protein degradation takes advantage of the body’s own degradation system to promote the selective elimination of disease-causing proteins.

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"This strategic acquisition is a transformative event for Salarius that significantly expands our development pipeline while building upon the momentum of our lead clinical-stage candidate, seclidemstat, our existing infrastructure and our scientific expertise," stated David Arthur, Chief Executive of Salarius Pharmaceuticals. "SP-3164 provides entry into the exciting field of protein degradation, a fast-growing area of cancer drug research that is attracting substantial interest from some of the world’s largest pharmaceutical companies because of the potential advantages of protein degraders, including the ability to go after previously undruggable cancer-promoting targets."

SP-3164 is a next-generation cereblon-binding molecular glue. Molecular glues are small molecules that commandeer the body’s normal protein-degradation processes and induce selective elimination of cancer-causing proteins. Derived from avadomide, SP-3164 was developed by using deuterium-enabled chiral switching (DECS), a unique strategy that utilizes deuterium to stabilize the preferred, active (S)-enantiomer from the first-generation compound, avadomide. This creates a new molecular entity with the potential for increased efficacy and improved safety. Salarius plans to develop SP-3164 as a potential treatment for hematological cancers and solid tumors and plans to begin the first clinical trial in 2023.

Mr. Arthur continued, "In addition to advancing seclidemstat, our goal at Salarius is to develop a multiprong internal pipeline and advance cancer therapies that address the unmet needs of patients and, by doing so, generate value for patients and shareholders. With SP-3164, Salarius plans to enter the protein degradation space which generated global sales of over $15 billion dollars in 2020. Funded with existing financial resources, this acquisition capitalizes on our strong cash position and our seclidemstat momentum."

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As part of the agreement, Salarius and DeuteRx will collaborate to complete SP-3164 development activities and collaborate on the research and development of future products.

Under the terms of the agreement, DeuteRx will receive from Salarius an upfront payment consisting of $1.5 million in cash and 1 million shares of restricted stock. Based upon the success of SP-3164, DeuteRx is also entitled to receive up to $53 million in future clinical and regulatory event-driven milestone payments and sales achievement milestone payments of up to $135 million, as well as escalating royalties on net sales. Additionally, DeuteRx is eligible to receive event-driven clinical, regulatory and sales achievement milestone payments of up to $84 million, as well as escalating royalties on net sales, for each of two future products.
"DeuteRx is excited to collaborate with the team at Salarius to advance SP-3164 and additional programs for the benefit of patients in need of better treatment options," said Sheila DeWitt, Ph.D., President and CEO of DeuteRx. "Our agreement with Salarius aligns with our goal to partner with innovative companies to unlock the value of our DECS technology platform and our differentiated drug candidates. I look forward to seeing this exciting new therapy advance through the clinic."
Conference Call Information:
Salarius Pharmaceuticals will host a conference call and live audio webcast on Thursday, January 13, 2022, at 8:30 a.m. EST, to discuss the asset acquisition agreement with DeuteRx. Interested participants and investors may access the conference call by dialing:
(833) 423-0481 (U.S.) or (918) 922-2375 (international)
Conference ID: 6528776
Investors may submit questions to Salarius prior to the conference call by e-mail to [email protected]. Please use the e-mail subject heading "Salarius/DeuteRx Acquisition" to ensure that the information is received. Salarius’ management will respond to select questions during the conference call.
An audio webcast will be accessible via the Investors Events and Presentations section of the Company’s website View Source An archive of the webcast will remain available for 90 days beginning at approximately 8:30 a.m. ET, on January 13, 2022.

About SP-3164
SP-3164, formerly DRX-164, is the next-generation, deuterium-stabilized (S)-enantiomer of avadomide. DRX-164 was developed by DeuteRx LLC. Avadomide is one of the most extensively studied molecular glues, a class of targeted protein degraders. It has been studied in more than 400 subjects across 10 clinical trials for patients with hematological cancers and solid tumors and has demonstrated efficacy when used as a single agent and when used in combination

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therapy. SP-3164 is a patent-protected new molecular entity with the potential for increased efficacy and improved safety compared to avadomide.
Avadomide is a 1:1 mixture of two mirror-image compounds ((R)- and (S)-enantiomers) that interconvert in vitro and in vivo. Using deuterium, DeuteRx stabilized each enantiomer and characterized their dramatically different pharmacological properties. In in vitro studies, SP-3164, the deuterium-stabilized (S)-enantiomer, has been shown to be the active enantiomer as it is primarily responsible for the cereblon-binding and the anti-inflammatory activity of avadomide1. As a result, in a preclinical efficacy model, SP3164 exhibited the anti-tumorigenic activity while the (R)-enantiomer appears to promote tumor growth2. Based upon preclinical results to date, SP-3164 has the potential to exhibit a better therapeutic profile than avadomide and will be the first stabilized, single enantiomer cereblon-binding protein degradation agent to enter the clinic.

On January 13, 2022 Galapagos NV (Euronext & NASDAQ: GLPG) reported that its supervisory board created 30,000 subscription rights under a new employee subscription right plan (Press release, Galapagos, JAN 13, 2022, View Source [SID1234605476]).

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On 13 January 2022, the supervisory board of Galapagos approved a subscription right plan intended for an employee of a subsidiary of the Company (not intended for members of the management board of the Company), within the framework of the authorized capital. Under this subscription right plan, 30,000 subscription rights were created (subject to acceptance). The subscription rights have an exercise term of eight years as of the date of the offer and an exercise price of €46.18 (the closing price of the Galapagos share on Euronext Amsterdam and Brussels on the day preceding the date of the offer). Further details are available on the Galapagos website.

Galapagos’ total share capital currently amounts to €354,582,005.11; the total number of securities conferring voting rights is 65,552,721, which is also the total number of voting rights (the "denominator"), and all securities conferring voting rights and all voting rights are of the same category. The total number of rights to subscribe to not yet issued securities conferring voting rights is (i) 8,579,287 subscription rights under several outstanding employee subscription right plans, which equals 8,579,287 voting rights that may result from the exercise of those subscription rights, and (ii) one subscription right issued to Gilead Therapeutics to subscribe for a maximum number of shares that is sufficient to bring the shareholding of Gilead and its affiliates to 29.9% of the actually issued and outstanding shares after the exercise of the subscription right. This excludes the 30,000 subscription rights of the newly issued subscription right plan, which were created subject to acceptance. Galapagos does not have any convertible bonds or shares without voting rights outstanding.

On January 13, 2022 On Target Laboratories, Inc., a privately-held biotechnology company developing intraoperative molecular imaging agents to target and illuminate cancer during surgery, reported the completion of the Phase 3, randomized, multi-center, single dose, open-label ELUCIDATE (Enabling LUng Cancer IDentification Using FolATE Receptor Targeting) Trial, which investigated the use of CYTALUX (pafolacianine) injection in patients scheduled to undergo thoracic surgery for confirmed or suspected cancer in the lung (Press release, On Target Laboratories, JAN 13, 2022, View Source [SID1234605473]).

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The study (NCT04241315) assessed the efficacy of CYTALUX and near-infrared imaging (NIR) to intraoperatively identify pulmonary nodules and detect positive margins. It also evaluated the safety and tolerability of single intravenous doses of CYTALUX. The trial successfully achieved its primary endpoint and full results will be shared in the future.

"Lung cancer is the number one cancer killer of men and women globally," said Inderpal (Netu) Sarkaria, MD, MBA, FACS Associate Professor of Cardiothoracic Surgery and Chair in Minimally Invasive Thoracic Surgery and Director of Thoracic Robotic Surgery at UPMC and ELUCIDATE trial investigator. "There is opportunity for emerging technologies to enhance our ability to find and remove cancer during surgery to improve the lives of lung cancer patients."

CYTALUX was approved by FDA on November 29, 2021 for adult patients with ovarian cancer as an adjunct for intraoperative identification of malignant lesions. CYTALUX is the first targeted molecular imaging agent that illuminates ovarian cancer intraoperatively, enabling the detection of more cancer for removal. CYTALUX, administered by standard IV prior to surgery, binds to folate receptors that are overexpressed in most epithelial ovarian cancersi and illuminates intraoperatively under near-infrared light.

"ELUCIDATE was completed ahead of schedule, which was a monumental achievement during a pandemic," said Chris Barys, President and Chief Executive Officer of On Target. "We are grateful to the trial patients, the Investigators and their teams who helped us move yet another step closer to bringing CYTALUX to more patients fighting cancer."

About Intraoperative Molecular Imaging

To date, there have been limited ways for surgeons to confidently assess the location and full extent of cancerous tissue while operating. Intraoperative Molecular Imaging (IMI) is an emerging category of technology for surgical oncology in which targeted imaging agents are injected into patients to highlight cancer cells making them visible during surgery.

On January 13, 2022 Bold Therapeutics, a clinical-stage biopharmaceutical company developing BOLD-100, reported an extension of the option agreement with an undisclosed publicly traded South Korean biopharmaceutical company, originally executed in May 2020, for development and commercialization rights to BOLD-100 in South Korea (Press release, Bold Therapeutics, JAN 13, 2022, View Source [SID1234605472]). The extension is expected to further solidify cooperation between these companies, as well as support the addition of five clinical trial sites in South Korea: Seoul National University Hospital (PI: Do-Youn Oh); Samsung Medical Center (PI: Joon Oh Park); Severance Hospital (PI: Sun Young Rha); National Cancer Center (PI: Yongjun Cha); and Kangbuk Samsung Hospital (KBSMC) (PI: Dong-Hoe Koo).

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Bold Therapeutics’ BOLD-100 is a first-in-class ruthenium-based small molecule therapeutic that (1) alters the unfolded protein response (UPR) through selective GRP78 inhibition; and (2) induces reactive oxygen species (ROS) which causes DNA damage and cell cycle arrest. Collectively, these effects result in cell death in both sensitive and resistant cancers, giving BOLD-100 the potential to significantly improve outcomes in a wide range of both solid and liquid tumors in combination with other anti-cancer therapies ranging from traditional chemotherapies to targeted therapies to immuno-oncology agents. BOLD-100 has been granted Orphan Drug Designations (ODDs) by the FDA in both gastric (stomach) and pancreatic cancers, and Bold Therapeutics expects to receive one or more Breakthrough Therapy Designations (BTDs) for BOLD-100 in 2022. Preclinical experiments have repeatedly shown that BOLD-100 improves outcomes in combination with a wide range of existing anti-cancer therapies, with particular synergy evident in drug-resistant cell lines.

"As our partner is one of the fastest growing and most respected pharmaceutical companies in South Korea, we are honored to extend this option agreement that allows us to further leverage their substantial expertise in oncology development," said E. Russell McAllister, CEO of Bold Therapeutics. "We expect to complete our Phase 1b trial of BOLD-100 in combination with FOLFOX in the treatment of advanced gastrointestinal cancers imminently and immediately transition into a Phase 2a study at six sites in Canada, two sites in the U.S., and now five sites in South Korea. We look forward to continuing to work with our partner’s team to advance this revolutionary cancer therapy."

On January 13, 2022 SK Life Science, Inc., a subsidiary of SK Biopharmaceuticals Co., Ltd., an innovative global pharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application to study SKL27969 as a potential treatment of advanced solid tumors (Press release, SK biopharmaceuticals, JAN 13, 2022, View Source [SID1234605471]).

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SK life science will conduct a Phase 1/2 open-label, non-randomized, multicenter, dose escalation and expansion study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of SKL27969 in adult patients with solid tumors.

"We look forward to learning more about the potential of SKL27969 as a treatment option for a range of advanced solid tumors," said Marc Kamin, MD, chief medical officer at SK life science. "We are excited to expand our R&D efforts into discovering potential new therapies for cancer."

"This milestone enables SK life science and SK Biopharmaceuticals to explore and begin to address unmet medical needs in oncology," said Jeong Woo Cho, PhD, President and CEO of SK Biopharmaceuticals and SK life science. "We look forward to advancing the development of this novel candidate using our already established clinical development capabilities in an effort to deliver a potential therapy to patients."

About SKL27969
SKL27969 is a protein arginine methyltransferase 5 (PRMT5) inhibitor candidate that has shown activity in preclinical models of solid tumors, such as glioblastoma (GBM), non-small cell lung cancer (NSCLC), and triple negative breast cancer (TNBC).