Masaryk Memorial Cancer Institute

DDF continues to provide critical resources and support to those affected by stomach cancer. FORT LAUDERDALE, Fla., Dec. 22, 2022 /PRNewswire/ -- Debbie's Dream Foundation: Curing Stomach Cancer (DDF) celebrates a successful year of providing critical resources and support to the stomach cancer community. Much of the organization's success is due to the generosity of its 2022 industry partners. In 2022, DDF secured just over $1.6 million in support grants. As a result, the foundation has continued to serve patients, their families, and caregivers through its Patient Resource Education Program (PREP), National and International Symposia, Nutrition Program, and Health Equity Program. This year's PREP Sponsors include Title Sponsors Amgen and Daiichi Sankyo, Silver Sponsor Lilly Oncology, and Copper Sponsors Bristol Myers Squibb, Merck, and Taiho Oncology. Through PREP, the foundation provides support and resources through peer-to-peer mentorship, clinical trial matching services, and monthly support groups in partnership with Memorial Cancer Institute. DDF also expanded its Health Equity Program, launched in 2021, to include in-person workshops in collaboration with local community groups such as United Way and YMCA to help educate minority communities on the healthcare disparities that disproportionately affect populations of color. The expansion of this program was supported by Amgen, Bristol Myers Squibb, Genentech, Lilly Oncology, Merck, and Taiho Oncology. "We could not have made such strides and pivots without the generous support of our industry partners who understand our vision and commit to helping us make it a reality," said Chief Executive Officer Andrea Eidelman. "We are fortunate to have their support as we continue to make an impact in the communities we serve." DDF's 2022 Nutrition Program consisted of a LIVE Cooking Demonstration series hosted by Emmy-nominated chef Nathan Lyons and Mary-Eve Brown, a clinical oncology dietician at Johns Hopkins. The series featured delicious seasonal recipes modified for gastric cancer patients and included a recipe book for those who registered throughout the year. Sponsors of this program are Daiichi Sankyo, Merck, and Bristol Myers Squibb. All episodes of the program can be viewed on DDF's Facebook page, YouTube channel, and website at . DDF hosted nine Stomach Cancer Educational Webinars, three National Symposia, and one International Symposium in partnership with the Korean Cancer Association. DDF worked with experts from some of the world's top institutions through these programs to share their latest findings in gastric cancer research. Supporters of the 2022 webinars include Platinum Sponsors Amgen, Daiichi- Sankyo, Merck, Silver Sponsor Bristol Myers, and Seagen. This year's National Symposium series also featured partnerships with Rutgers Cancer Institute of New Jersey and the Miami Cancer Institute of Baptist Health South Florida. Sponsors for the 2022 National and International symposia include DDF's National Title Sponsors Amgen, Bristol Meyers Squibb, and Daiichi Sankyo, Title Sponsor Taiho Oncology, National Platinum Sponsor Merck, National Gold Sponsor Astellas, and Gold Sponsor Lilly Oncology. All symposia and webinars can be viewed at . For more information about DDF, visit . About Debbie's Dream Foundation: Curing Stomach Cancer DDF is a 501(c)(3) non-profit organization dedicated to raising awareness about gastric cancer, advancing funding for research, and providing education and support internationally to patients, families, and caregivers. DDF seeks as its ultimate goal to make the cure for stomach cancer a reality. DDF was founded in 2009 by Debbie Zelman after she was diagnosed with stage IV incurable gastric cancer in 2008 and given only weeks to live. Debbie is considered a pioneer by many for bringing awareness to the plight of stomach cancer patients worldwide and the lack of federal funding for stomach cancer research. She did all of this while receiving hundreds of rounds of chemo in addition to daily oral treatments. Debbie passed away on December 23, 2017, at 50, almost a decade later. As a result of her leadership, DDF now has a Scientific and Medical Advisory Board of world-renowned doctors and chapters throughout the United States, Canada, and Germany. DDF strives to continue Debbie's mission and to make her dream a reality. To learn more about DDF, please visit us at . Media Contact: Brittnay Starks Communications Director Debbie's Dream Foundation: Curing Stomach Cancer (954) 475-1200 [email protected] SOURCE Debbie's Dream Foundation: Curing Stomach Cancer

Every week, there are dozens of clinical trial updates and announcements. Here’s a look at some of the more interesting news. Seagen and Astellas Pharma announced positive topline results from the Phase Ib/II EV-103 trial (KEYNOTE-869) Cohort K of Padcev (enfortumab vedotin-ejfv) in combination with Merck’s anti-PD-1 checkpoint inhibitor Keytruda (pembrolizumab) as first-line treatment in patients with unresectable locally advanced or metastatic urothelial cancer who are ineligible to receive cisplatin-based chemotherapy. In patients receiving the combination, the data demonstrated a 64.5% confirmed objective response rate (ORR), the primary endpoint of Cohort K. The median duration of response (DOR) per the independent central review was not reached. SOTIO Biotech announced it had dosed the first patient in its Phase II AURELIO-04 combination trial of SOT101 and Merck’s Keytruda in patients with selected advanced/refractory solid tumors. SOT101 is an anti-IL-15 superagonist. The first patient was dosed at the Masaryk Memorial Cancer Institute in Brno, Czech Republic. Diffusion Pharmaceuticals plans to initiate a Phase II trial of trans sodium crocetinate (TSC) in newly diagnosed glioblastoma multiforme patients after reaching an agreement with the U.S. Food and Drug Administration on the study design. It will be designated Study 200-208. TSC is being evaluated to enhance oxygen diffusion to tissues with low oxygen levels (hypoxia), including hypoxic solid tumors. InMed Pharmaceuticals provided an update on its Phase II trial of INM-755 for patients with epidermolysis bullosa. INM-775 is a cannabinol cream. Epidermolysis bullosa is a group of rare genetic skin diseases marked by fragile skin that can lead to extensive blistering and wounding, as well as mucous membranes in the GI tract and genitourinary and respiratory systems. Based on safety data from the first five adults in the Phase II trial, an independent Data Monitoring Committee gave the go-ahead to enroll adolescent patients with EB, defined as people 12 to 17 years of age. Philogen SpA enrolled 214 patients in its Phase III European trial of Nidlegy in locally advanced melanoma. The trial will read when 95 events have occurred. The therapy is being tested via intratumoral injections as neoadjuvant therapy followed by standard-of-care treatment compared to standard-of-care alone, in melanoma with locally advanced, fully resectable metastatic disease, accessible to intralesional injection. Nidlegy is a combination of immunocytokines L19IL2 and L19TNF. Acasti Pharma initiated its planned pharmacokinetic (PK) bridging study to evaluate the relative bioavailability of GTX-101 compared to the reference listed drug bupivacaine in 48 healthy patients. GTX-101 is a novel formulation of bupivacaine hydrochloride (HCl) for topical administration via a bio-adhesive, film-forming polymer for relief of pain associated with Postherpetic Neuralgia (PHN). PHN is a persistent and often debilitating nerve pain caused by nerve damage from shingles, resulting from a varicella zoster viral infection. Celularity treated the first patient in its Phase I/IIa trial for CYNK-101. CYNK-101 is a novel allogeneic off-the-shelf human placental CD34+ stem cell-derived NK cell therapeutic candidate that is genetically engineered to express a high-affinity and cleavage-resistant CD16 variant to improve antibody-dependent cell-mediated cytotoxicity (ADCC). The therapy is being developed for advanced HER2-positive gastric and gastroesophageal junction (G/GEJ) cancers. NewAmsterdam Pharma dosed the first patient in a pivotal Phase III trial of obicetrapib in adults with a history of heterozygous familial hypercholesterolemia (HeFH), whose LDL-C is not adequately controlled despite being on maximally tolerated lipid-modifying therapies. The drug is a next-generation oral, low-dose, once-a-day cholesteryl ester transfer protein (CETP) inhibitor. It is in development for patients with a high risk of cardiovascular disease with the highest-tolerated doses of statins, both as a monotherapy and in a fixed-dose combination with ezetimibe. Ionis Pharmaceuticals announced positive topline results from its Phase IIb RE-THINC ESRD trial of fesomersen in end-stage renal disease (ESRD) patients on hemodialysis. Fesomersen hit the primary outcome measure of no increase in the incidence of major bleeding and clinically relevant non-major bleeding compared to placebo. Fesomersen is an investigational antisense drug engineered to decrease the production of Factor XI, a clotting factor produced in the liver that is a major component of the coagulation pathway. ACM Biolabs dosed the first patient in a Phase I trial of a second-generation adjuvanted COVID-19 vaccine as part of Operation Nasal Vaccine. The vaccine is being evaluated as a booster, comparing intramuscular versus intranasal administration of various doses of antigen and adjuvant in healthy adult volunteers who have previously received three doses of approved COVID-19 vaccines.

AURELIO-04 will enroll up to 320 patients and test the combination in multiple solid tumor indications Clinical collaborator, MSD (Merck & Co., Inc., Rahway, NJ, USA), will supply KEYTRUDA for the study that is being conducted in Europe and the US BASEL, Switzerland, July 26, 2022 (GLOBE NEWSWIRE) -- SOTIO Biotech, a clinical stage immuno-oncology company owned by PPF Group,announced today that the first patient was dosed in its Phase 2, AURELIO-04 combination trial of SOT101, anIL-15 superagonistand MSD’s (Merck& Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab), in patients with selected advanced/refractory solid tumors. “The initiation of this Phase 2 study is a significant milestone for the clinical development of SOT101,” said Richard Sachse, M.D., Ph.D., Chief Medical Officer of SOTIO and Managing Director of SOTIO Biotech in Switzerland. “IL-15 has been widely favored as a promising cytokine in oncology, but IL-15-based approaches to date have fallen short of realizing this promise due to aberrant targeting and adverse events. SOT101 in combination with KEYTRUDA has shown encouraging early clinical efficacy in the AURELIO-03 phase 1 study and we look forward to building upon our findings to advance this innovative therapy for the potential benefit of patients battling cancer.” The Phase 2 trial (NCT05256381) is an open-label, single-arm, multicenter study of SOT101 in combination with pembrolizumab to evaluate efficacy and safety in patients with selected advanced/refractory solid tumors. The initiation of AURELIO-04 is based on encouraging data from the Phase 1/1b AURELIO-03 study of SOT101 which showed encouraging early efficacy signals in combination with pembrolizumab, and as single-agent treatment. The Phase 2 trial will enroll up to 320 patients targeting multiple solid tumor indications across 55 trial sites in Europe and the US. SOTIO entered into a clinical trial collaboration and supply agreement with MSD (a tradename of Merck & Co., Inc., Rahway, NJ, USA) last year in December. MSD will supply KEYTRUDA for the study. The first patient was dosed at the Masaryk Memorial Cancer Institute, Brno, Czech Republic, under the supervision of Peter Grell, M.D., Ph.D., as principal investigator. Stéphane Champiat, M.D., Ph.D., Head of the Inpatient Unit at the Drug Development of Gustave Roussy Cancer Center and coordinating investigator of AURELIO-04 trial commented: “The continued clinical development of SOT101 is crucial as we still face a significant need to provide more effective therapeutic options for patients with solid tumors. Validated by promising Phase 1/1b AURELIO-03 data, AURELIO-04 will aim to confirm safety and demonstrate efficacy of SOT101 in combination with pembrolizumab in additional indications.” KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. About SOT101 and IL-15 Superagonist Technology: SOT101 is the lead candidate from SOTIO’s technology platform. SOT101 (SO-C101) is a subcutaneously administered IL-15R superagonist that is fused to the sushi+ domain of the IL-15 receptor α chain. SOT101 has demonstrated strong preclinical in vivo efficacy in various tumor models showing increased long-term survival and tumor regression, as well as a favorable toxicology profile. SOT101 has been shown in pre-clinical models to synergize with checkpoint inhibitors and antibody therapies exerting ADCC. Along with Interleukin-2 (IL-2), IL-15 activity increases the number of cytotoxic T cells and NK cells, the two most important cells for driving an anti-cancer immune response. This T and NK cell expansion is the result of IL-15 binding to its IL-15 alpha chain receptor in conjunction with binding to its shared IL-2/IL-15 beta gamma receptor on the surface of T and NK cells. SOT101 has been precisely designed and optimized for its use as a potent immunotherapy by addressing two important design issues that limit current IL-2 and IL-15 approaches. These include selectively binding only to cytotoxic T and NK cells, while avoiding other cell types that are associated with adverse events and stimulating T and NK cells through pulses in cytokine concentrations rather than tonic stimulation. Company contact: Media contact: Richard Kapsa Michael Tattory Head of Communication LifeSci Communications T: (+420) 224 174 448 T: (+1) 609-802-6265 M: (+420) 603 280 971 mtattory@lifescicomms.com kapsa@sotio.com About SOTIO Biotech SOTIO Biotech is shaping the future of cancer immunotherapies by translating compelling science into patient benefit. The robust SOTIO clinical pipeline includes a differentiated superagonist of the attractive immuno-oncology target IL-15, SOT101, currently being tested in phase II clinical trials. SOT102, a next generation Claudin18.2-targeted antibody-drug conjugate (ADCs) has recently entered clinical phase. Two programs will enter phase I clinical testing within 2022, including SOT201, an IL-15-based immunocytokine and BOXR1030, a GPC3-targeted CAR-T based on proprietary technology designed to improve on the efficacy of CAR T therapies in the tumor microenvironment. SOTIO is a member of the PPF Group. For more information, please visit the company’s website at . SOTIO is a registered trademark of SOTIO Biotech a.s. in selected countries.