On September 28, 2023 Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, reported that it will be presenting at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 38th Annual Meeting (SITC 2023) taking place in San Diego, CA and virtually November 1-5, 2023 (Press release, Gamida Cell, SEP 28, 2023, View Source [SID1234635522]).

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Details about the poster presentations are as follows:

Title: GDA-201, nicotinamide (NAM) expanded NK cells derived from peripheral apheresis, show unique culture kinetics and increased expansion
Abstract number: 401
Presenter: Avner Yeffet, Ph.D.
Time: Friday, November 3, 2023, 9:00 a.m. – 7:00 p.m. PDT
Location: Exhibit Halls A and B1

Title: Significant myeloid and dendritic cellular enrichment of omidubicel graft suggests fast homeostatic proliferation of lymphoid populations
Abstract number: 336
Presenter: Dima Yackoubov
Time: Saturday, November 4, 2023, 9:00 a.m. – 8:30 p.m. PDT
Location: Exhibit Halls A and B1

About GDA-201
GDA-201 is an intrinsic NK cell therapy candidate being investigated for the treatment of hematologic malignancies. A multicenter Phase 1 study of GDA-201 for the treatment of non-Hodgkin lymphoma is ongoing (NCT05296525). Results are expected in Q1 2024.

GDA-201 is an investigational cell therapy candidate, and its safety and efficacy have not been established by the FDA or any other health authority.

Omisirge (omidubicel-onlv) Indication

Omisirge is a nicotinamide modified allogeneic hematopoietic progenitor cell therapy derived from cord blood indicated for use in adults and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection.

Important Safety Information for Omisirge

BOXED WARNING: INFUSION REACTIONS, GRAFT VERSUS HOST DISEASE, ENGRAFTMENT SYNDROME, AND GRAFT FAILURE

Infusion reactions may be fatal. Monitor patients during infusion and discontinue for severe reactions. Use is contraindicated in patients with known allergy to dimethyl sulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin or bovine material.
Graft-versus-Host Disease may be fatal. Administration of immunosuppressive therapy may decrease the risk of GvHD.
Engraftment syndrome may be fatal. Treat engraftment syndrome promptly with corticosteroids.
Graft failure may be fatal. Monitor patients for laboratory evidence of hematopoietic recovery.
Contraindications

OMISIRGE is contraindicated in patients with known hypersensitivity to dimethyl sulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin, or bovine products.

Warnings and Precautions

Hypersensitivity Reactions
Allergic reactions may occur with the infusion of OMISIRGE. Reactions include bronchospasm, wheezing, angioedema, pruritis and hives. Serious hypersensitivity reactions, including anaphylaxis, may be due to DMSO, residual gentamicin, Dextran 40, human serum albumin (HSA) and bovine material in OMISIRGE. OMISIRGE may contain residual antibiotics if the cord blood donor was exposed to antibiotics in utero. Patients with a history of allergic reactions to antibiotics should be monitored for allergic reactions following OMISIRGE administration.

Infusion Reactions
Infusion reactions occurred following OMISIRGE infusion, including hypertension, mucosal inflammation, dysphagia, dyspnea, vomiting, and gastrointestinal toxicity. Premedication with antipyretics, histamine antagonists, and corticosteroids may reduce the incidence and intensity of infusion reactions. In patients transplanted with OMISIRGE in clinical trials, 47% (55/117) patients had an infusion reaction of any severity. Grade 3-4 infusion reactions were reported in 15% (18/117) patients. Infusion reactions may begin within minutes of the start of infusion of OMISIRGE, although symptoms may continue to intensify and not peak for several hours after the completion of the infusion. Monitor patients for signs and symptoms of infusion reactions during and after OMISIRGE administration. When a reaction occurs, pause the infusion and institute supportive care as needed.

Graft-versus-Host Disease
Acute and chronic GvHD, including life-threatening and fatal cases, occurred following treatment with OMISIRGE. In patients transplanted with OMISIRGE Grade II-IV acute GvHD was reported in 58% (68/117). Grade III-IV acute GvHD was reported in 17% (20/117). Chronic GvHD occurred in 35% (41/117) of patients. Acute GvHD manifests as maculopapular rash, gastrointestinal symptoms, and elevated bilirubin. Patients treated with OMISIRGE should receive immunosuppressive drugs to decrease the risk of GvHD, be monitored for signs and symptoms of GvHD, and treated if GvHD develops.

Engraftment Syndrome
Engraftment syndrome may occur because OMISIRGE is derived from umbilical cord blood. Monitor patients for unexplained fever, rash, hypoxemia, weight gain, and pulmonary infiltrates in the peri-engraftment period. Treat with corticosteroids as soon as engraftment syndrome is recognized to ameliorate symptoms. If untreated, engraftment syndrome may progress to multiorgan failure and death.

Graft Failure
Primary graft failure occurred in 3% (4/117) of patients in OMISIRGE clinical trials. Primary graft failure, which may be fatal, is defined as failure to achieve an absolute neutrophil count greater than 500 per microliter blood by Day 42 after transplantation. Immunologic rejection is the primary cause of graft failure. Monitor patients for laboratory evidence of hematopoietic recovery.

Malignancies of Donor Origin
Two patients treated with OMISIRGE developed post-transplant lymphoproliferative disorder (PTLD) in the second-year post-transplant. PTLD manifests as a lymphoma-like disease favoring non-nodal sites. PTLD is usually fatal if not treated. The etiology is thought to be donor lymphoid cells transformed by Epstein-Barr virus (EBV). Serial monitoring of blood for EBV DNA may be warranted in patients with persistent cytopenias. One patient treated with OMISIRGE developed a donor-cell derived myelodysplastic syndrome (MDS) during the fourth-year post-transplant. The natural history is presumed to be the same as that for de novo MDS. Monitor life-long for secondary malignancies. If a secondary malignancy occurs, contact Gamida Cell at (844) 477-7478.

Transmission of Serious Infections
Transmission of infectious disease may occur because OMISIRGE is derived from umbilical cord blood. Disease may be caused by known or unknown infectious agents. Donors are screened for increased risk of infection, clinical evidence of sepsis, and communicable disease risks associated with xenotransplantation. Maternal and infant donor blood is tested for evidence of donor infection. See full Prescribing Information, Warnings and Precautions, Transmission of Serious Infections for list of testing performed. OMISIRGE is tested for sterility, endotoxin, and mycoplasma. There may be an effect on the reliability of the sterility test results if the cord blood donor was exposed to antibiotics in utero. Product manufacturing includes bovine-derived reagents. All animal-derived reagents are tested for animal viruses, bacteria, fungi, and mycoplasma before use. These measures do not eliminate the risk of transmitting these or other transmissible infectious diseases and disease agents. Test results may be found on the container label and/or in accompanying records. If final sterility results are not available at the time of use, Quality Assurance will communicate any positive results from sterility testing to the physician. Report the occurrence of transmitted infection to Gamida Cell at (844) 477-7478.

Transmission of Rare Genetic Diseases
OMISIRGE may transmit rare genetic diseases involving the hematopoietic system because it is derived from umbilical cord blood. Cord blood donors have been screened to exclude donors with sickle cell anemia, and anemias due to abnormalities in hemoglobins C, D, and E. Because of the age of the donor at the time cord blood collection takes place, the ability to exclude rare genetic diseases is severely limited.

ADVERSE REACTIONS

The most common adverse reactions (incidence > 20%) are infections, GvHD, and infusion reaction.

Please see full Prescribing Information, including Boxed Warning.

On September 28, 2023 Synthekine Inc., a leader in engineered cytokine therapeutics, reported that the company has completed phase 1a dose escalation and dosed the first patient in the Phase 1b portion of a clinical trial evaluating its α/β biased IL-2, STK-012, for the treatment of solid tumors (Press release, Synthekine, SEP 28, 2023, View Source [SID1234635521]).

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STK-012 is engineered to selectively stimulate antigen-activated T cells, which are associated with potent anti-tumor activity, and avoid broad stimulation of other lymphocytes, such as NK cells, which are associated with IL-2 toxicity. Synthekine recently completed the Phase 1a dose-escalation portion of the study in patients with various advanced solid tumors, with results suggesting a differentiated safety profile and monotherapy efficacy. The Phase 1b portion of the study will include dose expansion cohorts to evaluate STK-012 as monotherapy at the candidate recommended phase 2 dose (RP2D) in selected solid tumor types, including renal cell carcinoma (RCC) and non-small cell lung cancer (NSCLC).

"IL-2 is critical for T cell activation and promoting antitumor immunity," said Naiyer Rizvi, M.D., chief medical officer of Synthekine. "However, to date, no one has been able to unravel the pleiotropic nature of IL-2 and develop a drug that truly expands therapeutic index. STK-012 is built from unique insights into IL-2 biology and is the first α/β biased IL-2 with clinical results. We have observed encouraging single-agent activity with STK-012 in dose escalation and are excited to begin our cohort expansion studies."

"High-dose (HD) IL-2 has brought durable benefits to patients, even remissions for patients with metastatic melanoma and kidney cancer. But its significant toxicity and limited efficacy have prevented HD IL-2 from fulfilling its transformative potential in devastating cancers like non-small cell lung cancer," said David McDermott, M.D., a study investigator and Chief of Medical Oncology at Beth Israel Deaconess Medical Center, and Professor of Medicine at Harvard Medical School. "STK-012 represents a promising new approach in the field of cancer immunotherapy, offering a highly selective strategy for targeting IL-2 pathways that could potentially transform the treatment paradigm for these and other solid tumor indications."

The Phase 1b dose expansion portion of the clinical trial is an open-label, nonrandomized multi-center study currently enrolling patients. In addition to assessing the anti-tumor activity of STK-012 monotherapy, this study will continue to evaluate safety, tolerability and pharmacokinetics. For additional information about the trial, please visit www.clinicaltrials.gov using the identifier NCT05098132.

Results from the Phase 1a portion of the study will be presented at a future medical meeting.

On September 15, 2023 Oncoinvent AS, a clinical stage company advancing alpha emitter therapy across a variety of solid cancers, reported the presentation of initial safety data from the ongoing Phase 1 clinical trial evaluating the recommended dose, safety and tolerability of Radspherin in patients with recurrent ovarian cancer at the 24th Congress of the European Society of Gynaecological Oncology (ESGO) being held at the Istanbul Congress Center in Istanbul, Türkiye from September 28 – October 1, 2023 (Press release, Oncoinvent, SEP 28, 2023, View Source [SID1234635520]). The presentation, titled "First Experience With Intra-Abdominal 224Radium-Labelled Microparticles (Radspherin) After Cytoreductive Surgery For Peritoneal Metastasis In Recurrent Epithelial Ovarian Cancer (Phase 1 Study)" will be presented on September 30, 2023 from 9:24 a.m. to 9:32 a.m. local time (5:24 a.m. ET).

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"Oncoinvent is proud to present safety data from our lead candidate, Radspherin at a major congress of the global gynecological cancer community. We believe this is an important first step as we advance the development of Radspherin as a new treatment for patients with advanced ovarian cancer," says CEO Anders Månsson.

Details of the presentation are as follows:

Session: MO3 Mini Oral Session – Ovarian Cancer
Presentation Title: First Experience With Intra-Abdominal 224Radium-Labelled Microparticles (Radspherin) After Cytoreductive Surgery For Peritoneal Metastasis In Recurrent Epithelial Ovarian Cancer (Phase 1 Study)
Presentation Board Number: 850
Presenting Author: Els Van Nieuwenhuysen, MD
Presentation Date and Time: September 30th, 2023, from 9:24 a.m. to 9:32 a.m. local time (5:24 a.m. ET)

The ongoing Phase 1 study is designed to evaluate the recommended dose, safety and tolerability of Radspherin injected intraperitoneally following secondary cytoreductive surgery. The safety interim analysis after completion of the dose-limiting toxicity (DLT) period demonstrated that Radspherin was well tolerated. The highest dose of 7 MBq was recommended following the completion of dose escalation of 1-2-4-7 MBq, as no DLT was observed.

On September 28, 2023 RefleXion Medical, a therapeutic oncology company, reported that the company will showcase the RefleXion X1 with SCINTIX biology-guided radiotherapy at the American Society for Radiation Oncology (ASTRO) Annual Meeting, Oct. 1-4, 2023 in San Diego (booth #2831) (Press release, RefleXion Medical, SEP 28, 2023, View Source [SID1234635519]). Researchers from multiple clinical programs will present new scientific evidence in 20 presentations, including two oral presentations, supporting the potential of SCINTIX therapy, which is delivered only through the X1 platform.

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"We’re thrilled to see a robust and growing body of evidence about SCINTIX therapy as we commence patient treatments at multiple sites in the U.S. following FDA clearance of our technology earlier this year," said Shervin "Sean" Shirvani, M.D., M.P.H., chief medical officer at RefleXion. "Highlights from these presentations explore critical aspects of X1 performance in dosimetric accuracy, workflow, FDG uptake, and exquisite kVCT image quality.

"Furthermore, we are now developing PSMA-targeted and FAP-targeted PET radiotracers as SCINTIX bioguides and are excited about the emerging results that will be presented at this meeting," continued Shirvani.

The following oral and panel presentations highlight some of the new research being presented at ASTRO 2023. Detailed information on all 20 presentations may be found here.

Oral Presentations:

Monday, Oct 2, 5:30-5:37 pm, Room 31 – Prognostic Significance of Positron Emission Tomography Delta Radiomics Following Bridging Therapy in Patients with Large B-Cell Lymphoma Undergoing CAR T-Cell Therapy
Tuesday, Oct. 3, 4:20-4:25 pm, Room 4 – Mitigation of IMRT/SBRT Treatment Planning Errors on the First Biology-guided Radiotherapy System Using FMEA within Six Sigma Framework
Featured Posters:

Monday, Oct. 2, 5:00-6:00 pm, Hall B2 – Evaluation of 68Ga-Fibroblast Activation Protein Inhibitor (FAP) vs. 18F-FDG as a Novel Radiotracer for Biologically-guided Radiation Therapy
Tuesday, Oct. 3, 12:30-1:45 pm, Hall B2 – Dosimetric Accuracy of Multi-Target Biology-guided Radiotherapy Treatments in a Single Session
Tuesday, Oct. 3, 2:30-3:45 pm, Hall B2 – Pilot Study of a Novel Ring Gantry-Based PET/CT Linear Accelerator in Patients with Prostate Cancer Receiving [18F]-DCFPyl for PSMA PET Imaging
Wednesday, Oct. 4, 12:30-1:45 pm, Hall B2 – Imaging Performance of the PET scan on a Novel Ring Gantry-based PET/CT Linear Accelerator System in the First-in-Human Study of Biology-guided Radiotherapy
Wednesday, Oct. 4, 12:30-1:45 pm, Hall B2 – Reproducibility and Repeatability of Pelvic Radiomics Features with Daily Imaging on a Novel Biology-guided Radiotherapy Machine Compared to Daily Imaging on Other Radiotherapy Delivery Systems
RefleXion will host in-booth presentations discussing their first patient treatments delivered in patients with lung tumors. Registration for these small-group presentations is recommended, and the schedule can be found here. The RefleXion booth will also feature a multi-target SCINTIX technology interactive demonstration and SCINTIX treatment planning demonstrations.

On September 28, 2023 Verastem Oncology, (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, reported the presentation of scientific background and clinical trial updates on the avutometinib and defactinib programs at the 5th Annual RAS-Targeted Drug Development Summit in Boston, Massachusetts (Press release, Verastem, SEP 28, 2023, View Source [SID1234635518]). The updates are part of two oral presentations by Jonathan Pachter, PhD, Chief Scientific Officer and Louis Denis, MD, Chief Medical Officer at Verastem Oncology. The first presentation titled "Vertical Inhibition of RAS, RAF & MEK: Enhancing Antitumor Efficacy of KRAS G12C & G12D Inhibitors with RAF/MEK Clamp Avutometinib", includes scientific rationale for clinical combinations with avutometinib and defactinib in various RAS pathway-driven cancers. The second presentation titled, "Introducing Rational Combinations of RAF/MEK Clamp Avutometinib: Breakthrough Therapy Designation & Beyond," discusses novel combination treatment approaches and provides an overview of the avutometinib and defactinib clinical development program.

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The clinical presentation includes updated FRAME study efficacy data showing an overall response rate (ORR) of 42% (11 of 26) in evaluable patients with low grade serous ovarian cancer (LGSOC) (n=26). Among patients with KRAS mutant LGSOC (n=12), the ORR was 58% (7 of 12), compared to patients with KRAS wild-type LGSOC (n=12), the ORR was 33% (4 of 12). Across all LGSOC patients, the median duration of response was 26.9 months (95% CI: 8.5-47.3) while median progression free survival (PFS) was 20.0 months (95% CI: 11.1-31.2). As of the July 2023 data cutoff date, 19% of patients (5 of 26) were still on study treatment with a minimum follow-up of 17 months.

"We are encouraged that the high rate and long duration of objective responses in the recurrent LGSOC cohort of the FRAME study continue to provide foundational proof-of-concept supporting Breakthrough Therapy Designation for the combination of avutometinib and defactinib," said Dan Paterson, President and Chief Executive Officer of Verastem Oncology.

The FRAME study, led by Professor Udai Banerji, MBBS, MD, DNB, PhD, FRCP, Deputy Director of the Drug Development Unit at The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust, is an ongoing investigator-sponsored trial evaluating avutometinib in combination with defactinib among patients with advanced solid tumors, including recurrent LGSOC. The Company recently reported results of Part A of RAMP 201 in recurrent LGSOC including confirmed ORR by blinded independent central review of 45% (13/29; 95% CI: 26%,64%) with a tolerable safety profile at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2023 Annual Meeting. The median duration of response and median PFS from RAMP 201 Part A were not yet reached at the time of the ASCO (Free ASCO Whitepaper) 2023 presentation.