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.

On September 28, 2023 SkylineDx, an innovative diagnostics company focused on research & development of molecular diagnostics for oncology and inflammatory diseases, reported that a new peer-reviewed publication will be presented during the International Myeloma Society 20th Annual Meeting and Exposition by Dr. Martin F. Kaiser ‘Defining high risk and ultra-high risk MM (Press release, SkylineDx, SEP 28, 2023, View Source [SID1234635515]).’ The publication highlights the significant impact of SKY92 in identifying high-risk multiple myeloma patients who will benefit from an intensified treatment combination with improved survival [1].

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Identification and treatment of newly diagnosed patients with high-risk myeloma remains a global challenge. Diagnostically, there is currently an unmet need as high-risk patients could remain unidentified and experience an early relapse on standard of care treatment. Identifying aggressive disease correctly and early is therefore paramount for risk-stratified treatment approaches in myeloma.

The independent prospective multi-center UK OPTIMUM trial published in the Journal of Clinical Oncology by the UK collaborative trial group, offered patients from nearly 40 hospitals across the UK extended molecular risk screening over standard of care, by combining SKY92 with standard genetic testing for two or more high-risk markers, also termed Ultra high-risk MM (UHRMM). Patients identified as having UHRMM by either marker, or those with plasma cell leukemia (PCL), were offered intensified treatment with Dara-CVRd before and for 18 cycles after autologous stem cell transplant (ASCT). In this unique prospective molecular screening and treatment trial, SKY92 identified about 10% of NDMM patients with UHRMM who otherwise could not be identified with standard of care genetic risk markers, and vice versa, confirming prior retrospective results [2]. These patients would have effectively been missed with traditional diagnostics methods alone. In addition, the majority of PCL patients were identified by SKY92, suggesting that a wider aggressive group of disease could be diagnosed with this test in the future. Importantly, outcome of UHRMM patients treated with intensified Dara-CVRd in OPTIMUM was markedly improved over that of a digital comparator group of trial patients identified by SKY92 or standard of care genetics from the UK Myeloma XI trial: at 30 months, progression free survival (PFS) was 77% in OPTIMUM vs. 39.8% for Myeloma XI treatment. This Myeloma XI treatment is similar to standard of care. At 30 months follow up, the overall survival (OS) rate was 83.5%, vs. 73.5% using the conventional method.

"Everyone recognizes that myeloma is a highly heterogeneous disease and we now see, for the first time, markedly improved outcomes for the patients with highest unmet need, those with high-risk myeloma, with new treatment combinations. However, if we want to help and direct patients toward their best possible treatment options, we urgently need access to better molecular diagnostics as well. The sense that we are currently missing patients with aggressive disease at diagnosis is very real and confirmed by both retrospective and, with OPTIMUM, prospective evidence," said Dr. Martin F. Kaiser, Consultant Hematologist at The Institute of Cancer Research; Royal Marsden Hospital Sutton, England, United Kingdom.

"Dr. Kaiser set up a unique and innovative study design focused on a patient group in high need of new treatment strategies. The initial results, showing improved PFS and OS for the UHRMM, is an important step towards personalized treatment protocols," said Jvalini Dwarkasing, Chief Scientific Officer at SkylineDx. "We are appreciative that our SKY92 test was able to support this study by identifying UHRMM patients, indicating its utility in clinical application."

About MMprofiler with SKY92

The clinical course of MM can vary significantly between patients. This variability is related to unique characteristics of each patient’s disease. There are many treatment options available, in numerous combinations. Choosing the right treatment at the right time, while planning for future lines, is essential and can be very challenging. MMprofiler with SKY92 helps navigating these complexities. SKY92 measures the activity of 92 genes in the malignant myeloma plasma cells, and determines how aggressive the myeloma is. When myeloma is more aggressive (high-risk disease) it is less likely to respond to conventional treatments and the patient might benefit from intensification of therapy. MMprofiler with SKY92 is CE-IVD registered in Europe and available as laboratory developed test (LDT) from SkylineDx’s CAP/CLIA lab in San Diego (CA, USA).

On September 28, 2023 ProfoundBio, a clinical-stage biotechnology company focused on the development of novel antibody-drug conjugate (ADC) therapeutics for cancer, reported four upcoming poster presentations on its ADC platform and lead clinical assets, rinatabart sesutecan (Rina-S) and PRO1160, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 38th Annual Meeting (SITC 2023), to be held at the San Diego Convention Center and virtually November 1-5, 2023 (Press release, ProfoundBio, SEP 28, 2023, View Source [SID1234635514]).

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Presentation Details

Abstract #708: A Phase 1/2 Study of Rinatabart Sesutecan (PRO1184), a Novel Folate Receptor Alpha-Directed Antibody-Drug Conjugate, in Patients with Locally Advanced and/or Metastatic Solid Tumors
Date and Location: Saturday, November 4, 2023, Exhibit Halls A and B1, 9 a.m. to 8:30 p.m. PDT

Abstract #718: Phase 1/2 Study of PRO1160, a CD70-Directed Antibody-Drug Conjugate, in Patients with Advanced Solid Tumors and Hematologic Malignancies
Date and Location: Saturday, November 4, 2023, Exhibit Halls A and B1, 9 a.m. to 8:30 p.m. PDT

Abstract #1406: A Novel PTK7-Directed Antibody-Drug Conjugate (ADC) PRO1107 Demonstrated Broad Antitumor Activity with a Promising Safety Profile in Preclinical Models
Date and Location: Saturday, November 4, 2023, Exhibit Halls A and B1, 9 a.m. to 8:30 p.m. PDT

Abstract #1407: Expanding the Therapeutic Index of MMAE-Based Antibody-Drug Conjugates (ADCs) with a Novel Linker System (LD343)
Date and Location: Friday, November 3, 2023, Exhibit Halls A and B1, 9 a.m. to 7:00 p.m. PDT

On September 28, 2023 Deka Biosciences ("Deka") reported that it has successfully closed a USD $20 Million Series B2 financing with a syndicate of life science investors led by MPM BioImpact, and joined by additional investors including Leaps by Bayer, Lumira Ventures, O-Bio (Echo Investment Capital), Viva BioInnovator, Alexandria Venture Investments, Amana Investments, Plains Ventures, ATEM Capital and CEO John Mumm (Press release, Deka Biosciences, SEP 28, 2023, View Source [SID1234635513]). The proceeds of the financing will support the advancement of Deka’s pipeline and drug product manufacturing as they continue clinical trials following the receipt of a notice to proceed letter from the FDA for their investigational new drug (IND) application to evaluate DK210 (EGFR). Additionally, Detlev Biniszkiewicz, Ph.D. of MPM-BioImpact, will join the Deka board.

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"This financing round is a significant milestone. We appear to be the only company that has dissociated IL-2 potency from toxicity," said Dr. John Mumm, CEO of Deka. "It is gratifying to be supported by investors who recognize the potential of our innovative science to radically improve immunotherapy treatments by evaluating each patient’s immune system and combining biology with the power of precision medicine.

We have only raised $55 million to date and are already proceeding to dose our third cohort in our Phase 1 clinical trial. Thus far, we have established safety and clear signs of immune activation in our first 2 cohorts. We are encouraged by these results and believe that this combined approach will result in safer, more efficacious, and cost-effective immunotherapies."

"Deka’s unique vision of rationally combining multiple cytokines in a single therapeutic, and the potential impact this could have for patients suffering from cancer and autoimmunity, was deeply intriguing to the MPM BioImpact team," said Dr. Detlev Biniszkiewicz, Managing Director at MPM BioImpact. "We are impressed by the ability of DK210 to improve the safety parameters of IL-2 while maintaining potent anti-tumor responses in cancer patients, and we are thrilled to be working with the Deka team in developing their innovative approach."

The funding follows the seed round investment of USD $5 million led by CEO John Mumm, Series A financing of USD $20 million announced in November 2021, co-led by Leaps by Bayer and ECHO Investment Capital, and a USD $21.5 million Series B1 co-led by Lumira and Leaps by Bayer in 2022. The previous financings have enabled Deka to advance a pipeline of multiple DiakinesTM, conduct critical IND enabling experiments, manufacture drug substance/drug product with Cytovance Biologics, start the first Phase I clinical trial, as well as to expand into a new facility.