On June 2, 2022 ESSA Pharma Inc. ("ESSA", or the "Company") (NASDAQ: EPIX), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported that the Company will be presenting at the 2022 Jefferies Healthcare Conference in New York City on Thursday, June 9, 2022 at 3:00 p.m. Eastern Time (Press release, ESSA, JUN 2, 2022, View Source [SID1234615478]).

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David. R. Parkinson, President and Chief Executive Officer of ESSA Pharma, will participate in and host one-on-one meetings. David S. Wood, ESSA’s Chief Financial Officer, will also be participating in the one-on-one meetings.

On June 2, 2022 ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported that Angelos Stergiou, MD, ScD. h.c, President and Chief Executive Officer of SELLAS, will present at the JMP Securities Life Sciences Conference to be held at the Lotte New York Palace in New York City on Wednesday, June 15, 2022, at 11:00 a.m. ET (Press release, Sellas Life Sciences, JUN 2, 2022, View Source [SID1234615445]).

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For more information about the conference, or to schedule a one-on-one meeting with SELLAS management, please contact your JMP Securities representative directly, or send an email to KCSA Strategic Communications at [email protected].

On June 2, 2022 InterVenn Biosciences, a clinical technology company leveraging glycoproteomics to transform the future of healthcare, reported new data showing that its new DAWN IO Melanoma test accurately assesses and classifies advanced melanoma patients as likely or unlikely to benefit from immune checkpoint inhibitor therapies: either pembrolizumab alone or ipilimumab in combination with nivolumab (Press release, InterVenn Biosciences, JUN 2, 2022, View Source [SID1234615461]). This test was developed on InterVenn’s perspectIV platform, which can directly interrogate the blood glycoproteome, for its own development or on behalf of partners.

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InterVenn conducted the validation study of the new DAWN IO Melanoma test in collaboration with Mass General Hospital (MGH), on a cohort of 205 advanced melanoma patients. The company was able to develop a signature based on the blood glycoproteome. The test is designed to guide clinicians in accurately assessing individual likelihood of benefit to the commonly used therapies nivolumab and ipilimumab, given in combination, or pembrolizumab. The test showed strong discriminatory power with a hazard ratio of 4.93 and high statistical significance.

DAWN IO Melanoma is the first in a series of liquid biopsy-based assays that InterVenn plans to develop under the DAWN IO brand to address a variety of cancers. InterVenn is building a robust pipeline of liquid biopsy tests to unlock the untapped, rich layer of biology called the glycoproteome, which is, in simple terms, the entire set of sugars on proteins. Because of the essential roles glycoproteins play in physiological functions, the glycoproteome has the potential to be highly significant for real-time clinical decision-making.

"Immune checkpoint inhibitors simply don’t work on everyone. The launch of DAWN IO Melanoma helps physicians and patients with advanced melanoma plan the best treatment path based on their likelihood to benefit from these therapies," said Aldo Carrascoso, CEO of InterVenn. "The DAWN IO Melanoma validation study confirms that the perspectIV platform can identify glycoproteomic biomarkers that perform consistently and accurately, with the potential to support oncologists treating patients with advanced melanoma and other complex cancers."

The Problem that DAWN IO Melanoma Solves

Approximately 100,000 cases of melanoma are diagnosed a year in the United States, with 5% of those diagnosed at a late stage. While cancer immune therapies are powerful treatments for many types of cancer, including melanoma, they are effective only in subsets of patients. Reliable tests to assess a patient’s likelihood of benefit before starting immunotherapy are limited, which can lead to sub-optimal clinical decisions.

Patients who gain no health benefit miss out on alternative options for treatment, losing valuable time. As a result, there is a significant unmet medical need for tests that can guide physician selection of the appropriate treatment, including the recommendation to enroll in an appropriate clinical trial.

Built to meet clinical requirements, DAWN IO Melanoma interrogates the blood glycoproteome at an unprecedented speed and scale. Unlike other non-invasive methods, it does not depend on detecting material shed by tumors, and it requires a significantly lower blood sample volume than conventional methods. In addition, the groundbreaking ability to process significantly large amounts of highly complex post-translational information enables clinical applications of glycosylation in ways that clinicians have not previously seen.

The Validation Study

Results of the retrospective validation study demonstrated a glycoproteomic biomarker signature successfully identified metastatic melanoma patients as likely or not to benefit from ICIs, where the "Unlikely to Benefit" group displayed a median progression-free survival of 2.5 months versus 17.34 months for the Likely to Benefit group, p<1.29 x 10-5. The study’s results confirm that DAWN IO Melanoma determined 12% of patients were "Unlikely to Respond" while 10% were classified as "Indeterminate."

"Our validation study is an important milestone in InterVenn’s ongoing efforts to build high-quality clinical tests and the supporting clinical evidence that its innovative glycoproteomic biomarkers can enable," said Tillman Pearce, M.D., Chief Medical Officer at InterVenn.

InterVenn’s clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists (CAP). The DAWN IO Melanoma test was developed, and its performance characteristics were determined by InterVenn. The DAWN IO Melanoma test has not been cleared or approved by the U.S. Food and Drug Administration. InterVenn’s clinical laboratory is regulated under CLIA to perform high-complexity testing. The DAWN IO Melanoma test is intended for clinical purposes.

Lung Registry: Enrollment Begins

To further support clinical evidence for DAWN IO, InterVenn is starting recruitment for its HEaLth through I/O therapy Success Registry (HELIOS-001), focused on individuals diagnosed with advanced malignancies who will begin ICI treatment. The HELIOS-001 Registry will support current and future discovery of InterVenn’s DAWN IO product portfolio. Individuals who consent to participate will be asked to provide an initial blood sample, as well as clinical data pertaining to their diagnosis and treatment. For more information about the Registry, please contact [email protected].

Poster Presentation at ASCO (Free ASCO Whitepaper) 2022

The validation results will be presented in a poster session on June 6 at 1:15-4:15 p.m. CT in Hall A, Abstract # 9545, Poster #138 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting at McCormick Place in Chicago.

Additional Information

For more information about DAWN IO Melanoma, go to www.intervennoncology.com. InterVenn will also have a stand at the ASCO (Free ASCO Whitepaper) conference and will be available for in-person meetings during the event.

On June 2, 2022 Intensity Therapeutics, Inc. ("Intensity"), a clinical-stage biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, reported that data from its ongoing phase 1/2 clinical trial in refractory patients demonstrating the efficacy and tolerability of INT230-6, either as monotherapy or in combination with ipilimumab in patients with relapsed, refractory and metastatic sarcomas, will be presented on June 5, at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held in Chicago and virtually from June 3-7, 2022 (Press release, Intensity Therapeutics, JUN 2, 2022, View Source [SID1234615479]).

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Abstract Title: INT230-6 monotherapy and in combination with ipilimumab (IPI) across a broad spectrum of refractory soft tissue sarcomas (STS) [Intensity IT-01; BMS#CA184-592].
Presenter/First Author: Matthew Ingham, MD
Session Type/Title: Poster Discussion Session/Sarcoma
Poster Discussion Session Date and Time: Sunday, June 5, 2022, 12:30 PM – 2:00 PM EDT
Location: In-Person & On Demand | S404
Abstract Number: 11515
Poster: 420 (9:00 am to 12:00 am EDT)

Copies of the presentation materials will also be available on the Intensity Therapeutics website on the publications and posters page, following completion of the live presentation.

"Sarcoma has been a very challenging cancer to treat and has proven resistant to checkpoint blockade. Novel immunotherapy-based approaches are needed, and sarcoma is an attractive cancer for intratumoral injection," stated Matthew Ingham, M.D., assistant professor of medicine in the Division of Hematology and Oncology, Columbia University Vagelos College of Physicians and Surgeons, and a principal investigator for the trial. "The results from this ongoing study are maturing and showing compelling early signs of efficacy with this intratumoral approach as monotherapy. Preliminary data from this study also show immune cell infiltration with INT230-6 alone, in sarcoma, which is normally a non-immunogenic cancer type, that may be enhanced by combination with ipilimumab."

We are excited to have had our abstract, 11515, selected for both a poster and a podium discussion at ASCO (Free ASCO Whitepaper) this year," stated Lewis H. Bender, President and Chief Executive Officer of Intensity Therapeutics. "The biomarker and clinical data generated in sarcoma patients provide strong proof-of-concept evidence for our approach and underscore the potential of this new, potential treatment. As recent data readout events in the field of oncology have shown, there remains a high unmet need for novel therapeutic approaches in this deadly disease. With the strength of this data and following a meeting with FDA, we are in the process of designing a phase 3 clinical study."

The presentations report the mOS and disease control rate (DCR: CR + PD + SD per the Response Evaluation Criteria in Solid Tumors (RECIST)). However, RECIST metrics (sum of longest diameters) to gauge efficacy are only validated for use with systemically delivered therapies. Data generated in the study suggests that RECIST is inadequate with intratumorally (IT) administered INT230-6. In this study, RECIST response is complicated by the amount of INT230-6 repeatedly injected and retained in the tumors prior to the first radiographic scan. Biomarker findings suggest immune infiltration into the tumor microenvironment is occurring that could also increase tumor size. Additionally, results in a neoadjuvant setting (see ASCO (Free ASCO Whitepaper) 2022 Abstract Number: 605, Poster: 376) show a single injection of INT230-6 can cause near complete necrosis of the tumor without change in diameter. Finally, data reported shows that tumor volume, when calculated using all three dimensions, can be decreasing while the longest diameter of the corresponding tumor is increasing or stable. The lack of correlation between longest diameter and actual volume illustrates that RECIST may be unreliable for use as an efficacy endpoint for IT INT230-6.

As of the April 21, 2022 cutoff, the phase 1/2 clinical trial evaluated 27 patients with a heterogenous mix of several sarcoma subtypes including leiomyosarcoma, liposarcoma, pleomorphic sarcoma, chondrosarcoma, sacral chordoma, undifferentiated, connective tissue, osteosarcoma (chondroid syringoma), myofibroblastic, Kaposi, myxoid spindle cell, Langerhans and fibrosarcoma. The preliminary efficacy and safety of either INT230-6 alone (n=15) or in combination with the anti-CTLA-4 antibody, ipilimumab (n=12) were evaluated. Patients were treated with and progressed following a median of three prior therapies in the monotherapy group and five prior treatments receiving the combination. INT230-6 was administered intratumorally every two weeks for five doses either alone or with 3 mg/kg of ipilimumab dosed every three weeks for four doses. Preliminary efficacy measured DCR and mOS. Additional outcome measures included safety/tolerability, response in the injected tumor and the pharmacokinetic profile. The DCR rate >50 days for monotherapy in sarcoma (excluding chordoma) was 56% and the DCR for INT230-6+IPI was 57%.

Study IT-01 is a single arm study; however, published clinical phase 1/2 basket trials in sarcoma report mOS, ranging from 7.6 to 9.6 months (Jones et. al., Cancer Chemother Pharmacol (2011) 68:423–429; Cassier et. al., Annals of Oncology 25: 1222–1228, 201; vi. Subbiah et. al., Scientific Reports | 6:35448 2016,). Using the Subbiah study data set and the RMHI scores from the IT-01 study sarcoma patients, a synthetic control group Kaplan Meier (KM) survival curve was generated. The overall survival of the control, all INT230-6 patients in sarcoma and those receiving a cumulative dose of greater than 40% of their total tumor burden (TTB), are shown in the below table. Subjects receiving combination with ipilimumab have not yet reached median survival with 297 days median follow-up. There has been only 1 death reported in the combination group as of data cut-off. The Hazard Ratio (HR) for monotherapy patients to the control was 0.290 CI (0.173, 0.494), whereas the HR for monotherapy patients receiving INT230-6 at a dose great than or equal to 40% of the TTB was 0.236 CI (0.130, 0.423). Data is encouraging though the sample size is small. Sarcoma subtypes may differ between groups and data is still early.

The pharmacokinetic profile for the individual drug components of INT230-6 (cisplatin and vinblastine sulfate) was measured and ~95% of the active agents remaining in the tumor. Additional outcome measures included overall safety. INT230-6, either as monotherapy or in combination with ipilimumab, was well tolerated. The most common treatment related adverse events (TRAEs) were localized tumor-related pain, nausea, fatigue, decreased appetite and vomiting in the monotherapy group. TRAEs were mild to moderate, with 20% grade 3 in the monotherapy group and 11% in combination with ipilimumab. There were no Grade 4 or 5 AEs.

About INT230-6
INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug is composed of two proven, potent anti-cancer agents, cisplatin and vinblastine, and a penetration enhancer molecule that helps disperse potent cytotoxic drugs throughout tumors for diffusion into cancer cells. These agents remain in the tumor resulting in a favorable safety profile. In addition to local disease control, direct killing of the tumor by INT230-6 releases a bolus of neoantigens specific to the patient’s malignancy, leading to engagement of the immune system and systemic anti-tumor effects. Importantly, these effects are mediated without the immunosuppression of concomitant systemic chemotherapy.

About Intensity Therapeutics’ Clinical Studies
INT230-6 is currently being evaluated in several phase 2 cohorts (NCT03058289) in patients with various advanced solid tumors as part of Study IT-01. In 2019, the Company signed a clinical collaboration agreement with Merck Sharpe & Dohme (Merck) to evaluate the combination of INT230-6, Intensity’s lead product candidate, and KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 (programmed death receptor-1) therapy, in patients with advanced pancreatic, colon, squamous cell and bile duct malignancies. In 2020, the Company executed a clinical collaboration agreement with Bristol-Myers Squibb to evaluate the combination INT230-6 with Bristol-Myers Squibb’s anti-CTLA-4 antibody, Yervoy (ipilimumab), in patients with advanced liver, breast and sarcoma cancers. Intensity is managing the individual combination arms separately with each respective partner via a joint development committee. In 2021, the Company executed agreements with the Ottawa Hospital Research Institute (OHRI) and the Ontario Institute of Cancer Research (OICR) to study INT230-6 in a randomized controlled neoadjuvant phase 2 study in women with early stage breast cancer (the INVINCIBLE study) (NCT04781725).

ON June 2, 2022 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported that management will participate in the Jefferies Healthcare Conference being held June 8-10, 2022 (Press release, Oncternal Therapeutics, JUN 2, 2022, View Source [SID1234615412]).

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James Breitmeyer, M.D, Ph.D., Oncternal’s President and Chief Executive Officer, will present a corporate overview on Wednesday, June 8th at 9:30am (ET), and the Company will be available for one-on-one meetings.