On June 21, 2022 OncoHost, a global leader in next-generation precision oncology for improved personalized cancer therapy, reported a peer-reviewed article published in Journal for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (JITC), a BMJ oncology journal (Press release, OncoHost, JUN 21, 2022, View Source [SID1234616144]). The study highlights the role of blood plasma proteomic profiling for assessing resistance in non-small cell lung cancer (NSCLC) patients being treated with immune checkpoint inhibitors (ICIs).

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Over the last decade, ICIs targeting the PD-1/PD-L1 axis have emerged as standard-of-care treatments for NSCLC. Although ICI therapy achieves impressive long-term survival in some, the overall response rate is modest, ranging from 20-30 percent in NSCLC patients. A significant proportion of patients display innate resistance to ICIs, and many of those who derive initial clinical benefit experience disease progression at a later stage. The mechanisms underlying innate and acquired resistance to ICIs are not yet fully understood.

The study, Longitudinal plasma proteomic profiling of non-small cell lung cancer patients undergoing immune checkpoint blockade, focuses on how ICI resistance can be predicted in NSCLC patients through proteomic profiling. The analysis was done using PROphet, OncoHost’s first-of-its-kind diagnostic platform that combines proteomic analysis with AI to predict patient response to immunotherapy and identify resistance associated processes.

"While ICIs have played a major role in revolutionizing cancer therapy, we are still lacking clear biomarkers to predict resistance in patients being treated with these modalities," said Dr. Michal Harel, Director of Science and Innovation at OncoHost. "In this study, we have analyzed the largest and deepest plasma proteome dataset for NSCLC patients receiving ICI-based treatment published so far, revealing a predictive signature for response to treatment comprised of two proteins and two clinical parameters using our AI-powered PROphet platform. In addition, using bioinformatic tools, we have identified 3 subtypes of patients based on their plasma proteome, each subtype with distinct clinical and functional characteristics. Altogether, these results have the power to create a paradigm shift in truly understanding and overcoming resistance to cancer by characterizing systemic proteomic changes along ICI-based therapy."

The paper was authored by a team of Israeli and international scientists and oncologists, including Dr. Michal Harel, Prof. Yuval Shaked, co-founder and Chief Scientific Advisor at OncoHost, and professor of cell biology and cancer science at the Technion – Israel Institute of Technology, and Prof. Adam Dicker, a leading radiation oncologist at Thomas Jefferson University and Chief Medical Officer at OncoHost. Additional key investigators included Dr. David Carbone, professor of internal medicine and director of the James Thoracic Center, Prof. Jair Bar, Deputy Director, Institute of Oncology at Sheba Medical Center, and Dr. Alona Zer, Head, Department of Medical Oncology at Rambam Health Care Campus.

"This paper highlights continued success in our clinical trial initiatives as we prepare for the upcoming U.S. launch of PROphet," said Dr. Ofer Sharon, CEO of OncoHost. "We are finally making significant headway in overcoming the long-standing issue in clinical oncology of patient resistance to treatment. The knowledge that PROphet can provide clinicians with is an industry game-changer, and we are excited to be playing a part in transforming cancer patient care. I am proud of our team and look forward to what lies ahead."

On June 21, 2022 Race Oncology Limited ("Race") reported that two peer reviewed research poster abstracts detailing new preclinical data on the anti-cancer uses of Zantrene (also known as bisantrene or CS1) have been published in the prestigious scientific journal, Cancer Research, following their recent presentation at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Conference in New Orleans, from April 8 – 13, 2022 (Press release, Race Oncology, JUN 21, 2022, View Source [SID1234616227]).

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The two posters were presented by researchers from the City of Hope Hospital and Chicago University, including Race’s Scientific Advisory Board member, Professor Jianjun Chen. They describe the use of Zantrene as a potent inhibitor of FTO – the Fat Mass and Obesity-associated protein.

The first abstract describes preclinical data demonstrating Zantrene’s ability to inhibit FTO and suppress pancreatic carcinogenesis via targeting cancer stem cell maintenance. Pancreatic cancer has few effective treatment options and patients need better treatments for this devastating disease.

The second abstract explores the use of Zantrene as an adjunctive treatment able to overcome colorectal cancer resistant to 5-FU based chemotherapy via inhibition of FTO in both cell and mouse models. Resistance to 5-FU is a significant clinical issue as this drug remains a backbone of colorectal cancer treatment.

This important research exploring Zantrene utility in pancreatic cancer and colorectal cancer complements Race’s own recent findings that Zantrene can inhibit FTO in AML, melanoma and clear cell renal cell carcinoma.

On June 21, 2022 NKGen Biotech, a biotechnology company harnessing the power of the body’s immune system through the development of Natural Killer (NK) cell therapies, reported that senior management will be hosting one-on-one meetings at the Truist Securities Cell Therapy Symposium – symposia-cel being held in person in New York City on Tuesday, June 28, 2022 (Press release, NKGEN Biotech, JUN 21, 2022, View Source [SID1234616129]). Details on the symposium can be found below.

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Truist Securities Cell Therapy Symposium – symposia-cel (in person)
Format: Symposium and 1 x 1 meetings
Date: Tuesday, June 28, 2022
Meeting Times: 12:30 pm – 5:00 pm EDT
Location: New York, NY
Registration: Event website

If you are interested in arranging a 1 x1 meeting with NKGen Biotech, please contact your Truist representative.

On June 21, 2022 Aethlon Medical, Inc. (Nasdaq: AEMD), a company developing medical technology to treat cancer and life-threatening infectious disease, reported that it will issue financial results for its fiscal year ended March 31, 2022, at 4:15 p.m. EST on Tuesday, June 28, 2022 (Press release, Aethlon Medical, JUN 21, 2022, https://www.prnewswire.com/news-releases/aethlon-medical-to-release-fiscal-year-end-financial-results-and-host-conference-call-on-june-28-2022-301571954.html [SID1234616145]).

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Management will host a conference call on Tuesday, June 28, 2022 at 4:30 p.m. EST to review financial results and recent corporate developments. Following management’s formal remarks, there will be a question and answer session.

Interested parties can register for the conference by navigating to View Source Please note that registered participants will receive their dial in number upon registration.

A replay of the call will be available approximately one hour after the end of the call through July 28, 2022. The replay can be accessed via Aethlon Medical’s website or by dialing 1-877-344-7529 (domestic) or 1-412-317-0088 (international) or Canada toll free at 1-855-669-9658. The replay conference ID number is 4234353.

On June 21, 2022 Celsion Corporation (NASDAQ: CLSN), a clinical-stage company focused on DNA-based immunotherapy and next-generation vaccines, reported that following a pre-planned interim safety review of 87 as treated patients (46 patients in the experimental arm and 41 patients in the control arm) randomized in the Phase I/II OVATION 2 Study with GEN-1 in advanced (Stage III/IV) ovarian cancer, the Data Safety Monitoring Board (DSMB) has unanimously recommended that the OVATION 2 Study continue treating patients with the dose of 100 mg/m2 (Press release, Celsion, JUN 21, 2022, View Source [SID1234616112]). The DSMB also determined that safety is satisfactory with an acceptable risk/benefit, and that weekly doses of GEN-1 were well tolerated during a course of treatment that is given over six months in combination with standard neoadjuvant chemotherapy. No dose-limiting toxicities were reported.

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The OVATION 2 Study combines GEN-1, the Company’s IL-12 gene-mediated immunotherapy, with standard-of-care neoadjuvant chemotherapy (NACT) in patients newly diagnosed with Stage III/IV ovarian cancer. NACT is designed to shrink the cancer as much as possible for optimal surgical removal after three cycles of chemotherapy. Following NACT, patients undergo interval debulking surgery, followed by three additional cycles of chemotherapy to treat any residual tumor.

The OVATION 2 Study is designed with an 80% confidence interval to show an approximate 33% improvement in risk for cancer progression, Progression Free Survival, when comparing the treatment arm (NACT + GEN-1) with the control arm (NACT only). GEN-1 is an immunotherapy that produces safe and durable local levels of IL-12, a pluripotent cytokine associated with the stimulation of innate and adaptive immune response against cancer. The GEN-1 nanoparticle comprises a DNA plasmid encoding IL-12 gene and a synthetic polymer facilitating plasmid delivery vector. Cell transfection is followed by persistent, local secretion of the IL-12 protein at therapeutic levels.

The Company also announced that more than 87% of the projected 110 patients have been enrolled in the OVATION 2 Study. Interim clinical data from patients who have undergone interval debulking surgery showed that the GEN-1 treatment arm is showing improvement in R0 surgical resection rates and CRS 3 chemotherapy response scores over the control arm. A complete tumor resection (R0) is a microscopically margin-negative resection in which no gross or microscopic tumor remains in the tumor bed. The chemotherapy response score is a three-tier standardized scoring system for histological tumor regression into complete/near complete (CRS 3), partial (CRS 2) and no/minimal (CRS 1) response based on omental examination.

"Findings from our OVATION 2 study show a consistent favorable trend in both surgical outcome and tumor response, which is further supported by translational data of the tumor microenvironment," noted Nicholas Borys, M.D., Celsion’s executive vice president and chief medical officer. "We are encouraged by the current rate of patient recruitment and expect to complete enrollment by the third quarter of 2022. The primary endpoint for the study is progression-free survival (PFS) which we expect to report approximately 12 months after patient enrollment is completed."

In February 2021, the Company announced that GEN-1 received FDA Fast Track Designation in advanced ovarian cancer. Celsion plans to request FDA Breakthrough Therapy Designation for GEN-1 based on the encouraging clinical data.

"We again want to thank the DSMB members for their work and advice," said Michael H. Tardugno, Celsion’s chairman, president and chief executive officer. "Preclinical and clinical data gives us every reason to believe in GEN-1’s promise for ovarian cancer patients along with the support from leading medical researchers of the Gynecological Oncology Group (GOG). FDA Fast Track Designation for GEN-1 in advanced ovarian cancer coupled with the GOG’s interest in forging a partnership to develop GEN-1 in ovarian cancer will assist Celsion in its plans for an accelerated registrational program."

About GEN-1 Immunotherapy

GEN-1, designed using Celsion’s proprietary TheraPlas platform technology, is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anti-cancer immunity acting through the induction of T-lymphocyte and natural killer (NK) cell proliferation. The Company previously reported positive safety and encouraging Phase I results with GEN-1 given as monotherapy or a combination therapy in patients with advanced peritoneally metastasized primary or recurrent ovarian cancer, and recently completed a Phase Ib dose-escalation trial (OVATION 1 Study) of GEN-1 in combination with carboplatin and paclitaxel in patients with newly diagnosed ovarian cancer.

About Epithelial Ovarian Cancer

Epithelial ovarian cancer (EOC) is the fifth deadliest malignancy among women in the United States. There are approximately 22,000 new cases of ovarian cancer every year and the majority (approximately 70%) are diagnosed in advanced stages III and IV. EOC is characterized by dissemination of tumor in the peritoneal cavity with a high risk of recurrence (75%, stage III and IV) after surgery and chemotherapy. Since the five-year survival rates of patients with stages III and IV disease at diagnosis are poor (41% and 20%, respectively), there remains a need for a therapy that not only reduces the recurrence rate but also improves overall survival. The peritoneal cavity of advanced ovarian cancer patients contains the primary tumor environment and is an attractive target for regional approach to immune modulation.