On September 20, 2021 iBio, Inc. (NYSEA:IBIO) ("iBio" or the "Company"), a developer of next-generation biopharmaceuticals and pioneer of the sustainable, plant-based FastPharming Manufacturing System, reported that it will report its fiscal fourth quarter and full year 2021 financial results before market open on Monday, September 27, 2021 (Press release, iBioPharma, SEP 20, 2021, View Source [SID1234587950]). iBio management will host a webcast and conference call at 8:30 a.m. Eastern Time to discuss the results and provide a corporate update.

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The live and archived webcast may be accessed on the Company’s website at www.ibioinc.com under "News and Events" in the Investors section. The live call can be accessed by dialing (833) 672-0651 (domestic) or (929) 517-0227 (international) and referencing conference code: 7159935.

On September 20, 2021 Triumvira Immunologics ("Triumvira") reported that the first patient has been dosed as part of the TACTIC-2 trial evaluating the company’s lead candidate, TAC01-HER2, an autologous T cell therapy for the treatment of human epidermal growth factor receptor 2 (HER2) positive solid tumors (Press release, Triumvira Immunologics, SEP 20, 2021, View Source [SID1234587969]). Triumvira, a clinical-stage company, is developing novel, targeted autologous and allogeneic T cell therapeutics that co-opt the natural biology of T cells to treat patients with solid and liquid tumors. The company’s proprietary T cell Antigen Coupler (TAC) platform technology activates natural T cell functions differently from other cell therapies such as Chimeric Antigen Receptor T cell (CAR-T) and engineered T cell receptor therapies.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"Despite advances with CAR-T cell therapies in hematological malignancies, there remains a substantial patient population within solid tumors in need of treatments that can demonstrate prolonged safety and efficacy," said Paul Lammers, M.D., M.Sc., President and CEO of Triumvira. "The initiation of our TACTIC-2 trial represents a significant milestone for Triumvira and an opportunity to establish clinical proof of concept for our TAC technology. We look forward to sharing our progress with this program as we build out a pipeline of candidates targeting solid tumors."

Triumvira’s TAC technology has the potential to empower T cells to locate and destroy tumor cells by activating the natural T cell receptor for maximal and controlled anti-tumor responses. Triumvira’s HER2-TAC engineered T cells have demonstrated superior anti-cancer properties and more favorable safety profiles in preclinical studies when compared to both CAR-T cell and standard-of-care therapies.

Triumvira’s TAC01-HER2 was manufactured using Lonza’s Cocoon Platform, a state-of-the-art, automated and self-contained manufacturing system that offers an elegant solution to address many of the challenges of manufacturing autologous cell therapies. With this trial, Triumvira is the first company in the U.S. to dose a patient with a therapy manufactured with Lonza’s Cocoon Platform. As previously announced, Triumvira and Lonza have established a collaboration to expand the use of the Cocoon as an elegant manufacturing solution for TAC-T cell therapeutics.

TACTIC-2 is a Phase 1/2 multicenter, open-label trial designed to evaluate the safety, tolerability and efficacy of TAC01-HER2 in people with HER2-positive metastatic, advanced, unresectable solid tumors such as breast, gastric and many other cancers. The clinical trial is actively enrolling participants at MD Anderson Cancer Center in Houston, Texas, and Dana Farber Cancer Institute in Boston, Mass., and University of Chicago, Ill. and plans to enroll approximately 70 participants.

In addition to TAC01-HER2, Triumvira intends to bring multiple TAC programs directed at other promising targets in solid and liquid cancers into clinical development in the coming years. More information on Triumvira’s pipeline and programs can be found at www.triumvira.com and details on the this clinical trial can be found at clinicaltrials.gov using ClinicalTrials.gov Identifier NCT04727151.

On September 20, 2021 Verastem Oncology (Nasdaq:VSTM), a biopharmaceutical company committed to advancing new medicines for patients battling cancer, reported a clinical collaboration agreement with Amgen to evaluate the combination of VS-6766, Verastem Oncology’s investigational dual RAF/MEK inhibitor, with Amgen’s KRAS G12C inhibitor LUMAKRASTM (sotorasib) in KRAS G12C-mutant non-small cell lung cancer (NSCLC) (Press release, Verastem, SEP 20, 2021, View Source [SID1234588006]).

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The Phase 1/2 trial will evaluate the safety, tolerability and efficacy of VS-6766 in combination with LUMAKRASTM in patients with KRAS G12C-mutant NSCLC who have not been previously treated with a KRAS G12C inhibitor as well as in patients who have progressed on a KRAS G12C inhibitor. The study will therefore investigate the potential benefits of a more complete vertical blockade of the RAS pathway with the combination of VS-6766 (RAF/MEK blockade) with LUMAKRASTM (G12C inhibition) in KRAS G12C-mutant locally advanced or metastatic NSCLC.

"Recent data indicate that acquired resistance to KRAS G12C inhibitors in patients occurs predominantly through additional mutations in the RAS pathway, many of which may be addressed with a downstream inhibitor such as VS-6766,"1 said Ramaswamy Govindan, M.D., Professor, Department of Medicine, Oncology Division at Washington University School of Medicine and lead investigator of the study. "This clinical study of VS-6766 and LUMAKRASTM will build on preclinical data showing synergy between these two agents, including tumor regression through deeper blockade of ERK pathway signaling."2

"We are pleased to partner with Amgen on this important research that could potentially expand treatment options for patients with KRAS G12C-mutant NSCLC," said Brian Stuglik, CEO of Verastem Oncology. "This collaboration advances our strategy to fully explore the potential of VS-6766 as a backbone of therapy to treat RAS pathway-driven cancers."

Verastem Oncology expects to initiate the clinical trial with VS-6766 and LUMAKRASTM by the end of 2021.

About KRAS Mutant Non-Small Cell Lung Cancer (NSCLC)

Approximately 85% of lung cancers are non-small cell lung cancer (NSCLC), which are the single leading cause of cancer deaths worldwide.3 KRAS mutation occurs in approximately 25% of NSCLC adenocarcinoma patients.4 Two of the most common types of KRAS mutations are G12C, which occurs in approximately 13% of patients with NSCLC adenocarcinoma, as well as G12V, which is present in approximately 7% of NSCLC.5,6 Currently, there is a high unmet need in the second-line treatment of KRAS mutant NSCLC.3,7

About VS-6766

VS-6766 (formerly known as CH5126766 and RO5126766) is a unique inhibitor of the RAF/MEK signaling pathway. In contrast to other MEK inhibitors in development, VS-6766 blocks both MEK kinase activity and the ability of RAF to phosphorylate MEK. This unique mechanism allows VS-6766 to block MEK signaling without the compensatory activation of MEK that appears to limit the efficacy of other inhibitors. The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for the combination of Verastem Oncology’s investigational RAF/MEK inhibitor VS-6766, with defactinib, its FAK inhibitor, for the treatment of all patients with recurrent low-grade serous ovarian cancer (LGSOC) regardless of KRAS status after one or more prior lines of therapy, including platinum-based chemotherapy.8

Verastem Oncology has initiated Phase 2 registration-directed trials of VS-6766 with defactinib in patients with recurrent LGSOC and in patients with recurrent KRAS-G12V mutant NSCLC as part of its RAMP (Raf And Mek Program) clinical trials.

On September 20, 2021 miR Scientific reported that Data presented from a cross-validation study at the American Urological Association’s (AUA) 2021 Annual Meeting confirms that the miR Sentinel Prostate Cancer Test can detect and risk-classify prostate cancer at the molecular level with predictive accuracy of over 90%, based on a single urine sample (Press release, miR Scientific, SEP 20, 2021, View Source [SID1234588048]). This validation study follows and confirms the data on more than 1,400 patients published in The Journal of Urology in September 2020.

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When comparing the results of the miR Sentinel Prostate Cancer Test to systematic core needle biopsy in men presenting with initial suspicion of prostate cancer, the latest validation study demonstrated a 93% concordance between the two methods of screening and detection regarding the classification of clinically significant cancer. This 93% sensitivity of the miR Sentinel Prostate Cancer Test sets a new bar for detecting and classifying prostate cancer. The data further demonstrate the strong negative predictive value of the miR Sentinel Prostate Cancer Test with results showing the test correctly identified 96% (371/387) of men as having non-clinically significant cancer.

"Our mission to inclusively transform cancer management is further validated in this prospective study, demonstrating that the miR Sentinel Prostate Cancer Test is able to provide an accurate non-invasive means to identify the presence or absence of any prostate cancer and classify the molecular risk of disease becoming metastatic, and thereby lethal, prior to biopsy" says Sam Salman, Chairman and CEO of miR Scientific. "We believe that the accuracy, accessibility, and non-invasive features of our award-winning technology will impact the lives of millions of men and forever positively evolve the standard of care for urological cancers."

Cross-Validation Study Results

The data reported in this late-breaking abstract and presented by Laurence Klotz, MD, FRCSC at the AUA, is based on a study of 763 men over 45 years old, eligible for their first core needle biopsy. Pathology based on the core needle biopsy showed 354 (46%) were biopsy negative and 409 (54%) were biopsy positive. Of those 409 men found to have pathologic evidence of disease, 189 (25%) were classified as Grade Group 1 (GG1) representing non-clinically significant cancer, and 220 were classified as Grade Group 2 (GG2) or higher representing clinically significant cancer.

With just a urine liquid biopsy, the miR Sentinel Prostate Cancer Test identified 204 men with clinically significant cancer (intermediate or high risk), demonstrating 93% sensitivity (204/220) with the core needle biopsy. When evaluating men with non-clinically significant cancer, the miR Sentinel Prostate Cancer Test identified 371 out of 387 men, delivering 96% (371/387) sensitivity.

The data further examined the apparent false positive rate for clinically significant cancer by analyzing the sub-set of men who underwent both systematic biopsy and MRI-fusion biopsy, and who were negative on systematic biopsy. The data demonstrates >95% concordance been the positive MRI-guided biopsy and the miR Sentinel Prostate Cancer Test, indicating that the discordance between systematic biopsy results and the miR Sentinel Prostate Cancer Test are largely attributable to false negatives of biopsy.

Laurence Klotz, MD, FRCSC, Professor of Surgery at the University of Toronto, and Chief Medical Officer of miR Scientific LLC, said, "The key features of the test are the very high negative predictive value and the very high accuracy [in] identifying cancer. In addition to its quick turnaround, the test is highly scalable: the company will be able to perform a very large number of these tests right away."

Innovative Urine-based Liquid Biopsy

The miR Sentinel Prostate Cancer Test, which already received the Breakthrough Device Designation by the FDA, is a non-invasive molecular test based on the analysis of small non-coding RNAs (sncRNA) isolated from non-DRE urinary exosomes. It provides an innovative method to analyze sncRNAs derived from a simple, non-invasive urine specimen from age-eligible men. Using only the expression dynamics of these sncRNAs, a proprietary Statistical Classification Algorithm derives scores that classify patients according to the likelihood of being in the following four possible groups: no molecular evidence of prostate cancer; low-risk; intermediate-risk; or high-risk prostate cancer.

The miR Sentinel Prostate Cancer Test is expected to be commercially available in the United States and Puerto Rico at the end of this year.

On September 20, 2021 The US Oncology Network (The Network), the largest organization of its kind dedicated to advancing local cancer care and better patient outcomes, reported that it has appointed Jason Hammonds as its new president (Press release, US Oncology, SEP 20, 2021, View Source [SID1234590268]).

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Hammonds has supported The Network for more than 13 years in a range of leadership roles and brings deep industry experience and a stellar track record of accomplishments. Most recently, he served as senior vice president of operations for Texas Oncology, a member of The Network and the largest integrated, community-based oncology practice in the nation.

Previously, Hammonds held roles in both strategy and business development at McKesson , which supports The Network. There, he executed numerous growth activities that added more than 500 physicians to The Network during his tenure.

"I am excited and humbled to lead this phenomenal organization, which is dedicated to empowering physicians and practices to provide the highest quality of care possible to the cancer patients who need them," said Hammonds. "We will stay focused on what is best for the patient by evolving our approach to value-based care, supporting our research capabilities, advancing our operational excellence, and modernizing our technology infrastructure. My goal is to continue supporting The US Oncology Network to the best of our ability so its legacy of exceptional, compassionate care for patients in the community will thrive and move forward in an ever-changing industry."

"Jason has played an instrumental role in helping to grow and evolve The Network for over a decade, and his wide-ranging expertise and achievements make him the perfect fit to lead the organizations," said Kirk Kaminsky, president, U.S. Pharmaceutical, McKesson. "I look forward to working with him as we continue to grow The Network and our oncology ecosystem, aligning with McKesson’s mission of advancing health outcomes for all."