On December 8, 2022 Agendia, Inc., a leader in gene expression profiling for early-stage breast cancer, reported that it will present late-breaking research at the 2022 San Antonio Breast Cancer Symposium (SABCS) that proves MammaPrint is the first FDA-cleared gene expression profiling test to predict an early-stage breast cancer patient’s benefit from extended endocrine therapy (EET) (Press release, Agendia, DEC 8, 2022, View Source [SID1234624976]). The study, which analyzed MammaPrint results of over 500 patients enrolled in the IDEAL trial, proved MammaPrint test results can effectively identify which post-menopausal, hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer patients will benefit from five years of EET. This research highlights the value of advanced gene expression profiling tests to gather personalized insights that inform a patient’s treatment plan beyond solely predicting their response to chemotherapy.

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Prescribing EET with more precision can not only help avoid unnecessary patient suffering, but also give those who are most likely to benefit from EET the encouragement to remain adherent. Agendia’s research found MammaPrint can identify which HR+ post-menopausal patients are at risk of late distant metastasis and would benefit most from EET, and for whom treatment compliance is important. Additionally, MammaPrint helps identify those who will realize minimal to no benefit, offering patients the power of choice when discussing their treatment plan with their provider.

Laura van ‘t Veer, PhD, Co-Inventor of MammaPrint and a Professor of Laboratory Medicine and Director of Applied Genomics at the University of California San Francisco’s Helen Diller Family Comprehensive Cancer Center, will present during SABCS on December 9th at 12pm CT. She will highlight the following findings among HR+ post-menopausal women with early-stage breast cancer:

Tumors classified with a MammaPrint Low Risk result exhibited the largest benefit of five additional years of EET compared to 2.5 years, with 9.8% improvement for distant metastasis, 9.8% improvement for recurrence free interval, and 8.8% improvement for breast cancer free interval.
In contrast, tumors with a MammaPrint High Risk result do not benefit from five additional years of EET because they exhibit an early recurrence risk profile, and therefore have reduced sensitivity to the therapy after the initial 5 years of treatment.
Tumors with a MammaPrint UltraLow Risk result also do not benefit from EET due to their excellent prognosis and low risk of late recurrence.
MammaPrint test results have now been used in level 1B evidence for extended endocrine treatment decisions, providing high confidence of its net benefit that providers and patients can rely on when making EET treatment decisions.
"The results of this study reaffirm the critical role MammaPrint plays in guiding treatment decisions with the unprecedented precision that patients deserve. Physicians and patients need to be equipped with gene expression profiling solutions that can offer a comprehensive view of their tumor’s predicted response to various therapies, not just chemotherapy," said Dr. Laura van ‘t Veer. "No patient should have to be on a difficult therapy longer than necessary, and those who will benefit from a longer duration need encouragement to stay on track. Agendia is empowering women with need-to-know answers and physicians with tools to guide shared decision-making."

"Genomic information continues to transform the way we deliver cancer care, and this latest research is no exception. Being able to decipher which patients see a significant benefit and which can forgo EET is a monumental accomplishment in our aim toward precision medicine," said Dr. Gerrit-Jan Liefers, surgeon and head of the Geriatric Oncology Group at Leiden University Medical Center, and lead author of the study.

To learn more about Agendia’s solutions being showcased at booth #315 at SABCS, visit View Source Follow Agendia on Twitter, Facebook and LinkedIn for updates throughout the conference.

On December 8, 2022 Dana-Farber Cancer Institute reported that Multiple myeloma is a cancer of the plasma cells in bone marrow that affects more than 30,000 new patients in the United States each year (Press release, Dana-Farber Cancer Institute, DEC 8, 2022, View Source [SID1234624975]). Today, multiple myeloma is still considered incurable.

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Nearly all people with multiple myeloma have early warning signs called "precursor conditions." Health leaders like the Dana-Farber Cancer Institute, one of the world’s leading centers of cancer research and treatment, can better treat this condition if it is detected early, and therefore reduce mortality. Now with their recent announcement about the ambitious PROMISE study, Dana-Farber aims to make multiple myeloma a cancer that is preventable.

By collecting and analyzing data from people who test positive for the early precursor conditions, Dana-Farber will be able to study people before they develop the condition, in order to discover how to better treat – and ultimately prevent – this deadly cancer.

A study of this magnitude requires extensive data collection, as well as an approach to enroll and engage participants from communities traditionally under-represented in biomedical and clinical research. To achieve these aims, Dana-Farber chose to collaborate with Vibrent Health, a digital technology company known for its innovation in precision medicine research solutions and providing researchers a better way to provide eConsent and collect data across electronic medical records, genomics, wearables, surveys, and more.

Dana-Farber will use Vibrent’s platform for informed eConsent to enroll a highly diverse pool of research participants nationwide. Dana-Farber study staff will also use Vibrent’s platform to perform novel data collection through virtual methods and computer-assisted telephone interviewing (CATI).

The Research Institute will implement patient engagement through Vibrent’s robust privacy-protecting participant portal and comprehensive researcher tools, as well as provide educational content that can be personalized to the patient’s specific and unique needs.

"Using this technology to interact directly with our study participants is so powerful," said the study’s principal investigator Irene Ghobrial, MD, of Dana-Farber. "Not only will this improve the quality of the research we are able to conduct, but it puts the tools in our participants hands to help us make multiple myeloma a preventable disease."

For Vibrent Health, this partnership builds on the company’s commitment to improving research data and health outcomes for traditionally underrepresented populations in clinical research.

"Clinical research has long faced limitations because of the available participants," said Vibrent Health CEO Praduman "PJ" Jain. "Our solutions remove the barriers – whether they are a person’s location, internet connectivity, or physical limitations – so they can contribute to the important work of researchers. By including their data, researchers can create health outcomes that better help these populations."

The PROMISE Study is currently enrolling participants with a target goal of 30,000 individual participants nationwide, in order to identify 3,000 with the precursor conditions. The resulting dataset will help Dana-Farber to identify the factors that are associated with disease progression and develop potential methods for prevention.

"Five years ago, we told people with precursor conditions of the disease to watch and wait until they experienced symptoms," said Ghobrial. "By empowering our community, we are understanding who is most likely to develop multiple myeloma in their lifetime and where early interception can be most effective".

On December 8, 2022 PDC*line Pharma, a clinical stage biotech company developing a new class of potent and scalable active immunotherapies for cancers, reported the first immunological results of its PDC-LUNG-101 phase I/II clinical trial (NCT03970746) with PDC*lung01, the company’s therapeutic off-the-shelf cancer vaccine candidate for Non-Small Cell Lung Cancer (NSCLC) (Press release, PDC Line Pharma, DEC 8, 2022, View Source [SID1234624974]). The preliminary data was presented today at a poster display session at the ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress 2022 (ESMO-IO) in Geneva (Switzerland). Results showed that in a large proportion of subjects PDC*lung01, in monotherapy and combined with pembrolizumab, induces a significant expansion of effector memory CD8+ T-cells specific to the tumor peptides carried by PDC*lung01.

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"We are very pleased to demonstrate that our innovative immunotherapy platform can induce a strong immune response in humans. These first results illustrate the potential targeted mechanism of action of PDC*lung01 to prime naive anti-tumor specific T-Cells and trigger effector memory T-cells in humans."

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The objectives of the phase I/II trial (PDC-LUNG-101) are to assess the safety, tolerability, immunogenicity and preliminary clinical activity of the drug candidate PDC*lung01, associated or not with anti-PD-1 treatment in NSCLC patients. PDC*lung01 will be administered to a total of 64 evaluable HLA-A*02:01 positive NSCLC patients, at two dose levels in two different settings:

As a single agent to patients in the adjuvant setting (A1: Low Dose, A2: High Dose)
Added to standard of care anti-PD-1 monotherapy to patients with first-line stage IV (metastatic) NSCLC disease with a PD-L1 tumor proportion score of ≥50% and no targetable driver mutation (B1: Low Dose, B2: High Dose)
PDC*lung01 is made of irradiated human Plasmacytoid Dendritic Cells (PDC*line), loaded with HLA-A*02:01-restricted peptides, derived from NY-ESO-1, MAGE-A3, MAGE-A4, Multi-MAGE-A, MUC1 and Survivin tumor antigens. It is administered weekly by a subcutaneous and intravenous route, in six consecutive doses. Safety and clinical activity of the product were presented at ESMO (Free ESMO Whitepaper) 2022 in September 2022 in Paris (France). PDC*line is a potent professional antigen-presenting cell line that is able to prime and boost the patient’s antitumor cytotoxic CD8+ T-cells and is synergistic in vitro with anti-Programmed Death-1 (PD-1) treatment. The poster presented the analysis of the immune responses of the first three cohorts of patients.

"We are very pleased that PDC*lung01 is found to be biologically active to trigger an antitumor immune response, detectable without any in vitro restimulation, in a significant number of patients in our NSCLC clinical trial. The first signal of correlation between immune and clinical responses in six metastatic patients from the B1 cohort is encouraging," said Dr. Joël Plumas, co-founder and chief scientific officer of PDC*line Pharma.

"Presenting the first immunological data set from our lead candidate, PDC*lung01, for the treatment of NSCLC at ESMO (Free ESMO Whitepaper)-IO, a major immuno-oncology conference, is an important milestone for the company," added Eric Halioua, CEO of PDC*line Pharma. "We are very pleased to demonstrate that our innovative immunotherapy platform can induce a strong immune response in humans. These first results illustrate the potential targeted mechanism of action of PDC*lung01 to prime naive anti-tumor specific T-Cells and trigger effector memory T-cells in humans."

Key highlights from the poster display

Poster title: The therapeutic cancer vaccine PDC*lung01 induces immune responses with or without anti-PD-1 treatment in patients with non-small cell lung cancer.

Several circulating immune parameters were monitored at different times before and after PDC*lung01 administrations using assays developed by PDC*line Pharma
Leukocyte count and determination of peptide-specific CD8+ T-cells, for which a Limit Of Quantification (LOQ) was defined to better assess the fold changes of the cell expansion. Assays allow evaluation of circulating antitumor specific CD8+ T-cells pre and post treatment, ex vivo with an LOQ of 0.003%, without prior in vitro restimulation

PDC*lung01 is found to be biologically active to trigger an antitumor immune response in a significant number of patients
23 of the 25 patients included received at least four doses and were evaluable. No major changes in circulating lymphocyte frequencies (B cells, NK cells, CD4+, CD8+, or Treg T-cells) were observed during treatment. In contrast, a specific and memory CD8+ T-cell response was induced against the antigens from which are derived the peptides loaded on PDC*lung01 in 33%, 45% and 67% of evaluable patients in, respectively, A1 (six patients), A2 (eleven patients) and B1 (six patients) cohorts

First signal of correlation observed between immune and best overall clinical responses in metastatic patients treated with pembrolizumab

The best overall response in six evaluable patients of the B1 cohort, according to RECIST criteria, included four partial responses, one stable disease and one progressive disease. CD8+ T-cells for at least one of the six lung antigens were observed in the majority of the partial and stable disease patients. In contrast, no immune response was detected in the progressive disease patient.

On December 8, 2022 Intensity Therapeutics, Inc. ("Intensity"), a clinical-stage biotechnology company focused on the discovery and development of proprietary, first-in-class immune-based cancer therapies designed to kill tumors and increase immune system recognition of cancers, reported new data from the INVINCIBLE study in a live Spotlight Session Poster Presentation at the San Antonio Breast Cancer Symposium (SABCS) Annual Meeting being held at the Henry B. Gonzalez Convention Center, San Antonio, TX, from December 6-10, 2022 (Press release, Intensity Therapeutics, DEC 8, 2022, View Source [SID1234624973]).

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The INVINCIBLE study (NCT 04781725), a phase 2, randomized study that enrolled 91 women with newly diagnosed, operable early-stage intermediate or high-grade T1-T2 invasive breast cancers 2 to 5 weeks prior to surgery (lumpectomy or mastectomy). Drug dose was set by the diameter of the tumor. Subjects were randomly allocated (2:1) prior to resection to 1 to 3 IT injections of INT230-6 versus no treatment (part 1 n=29) or saline sham injection (part 2 n=58).

INT230-6 demonstrated the ability to cause up to 100% necrosis of presurgical breast cancer tumors in the window period from diagnosis to surgery. Pathway enrichment analysis demonstrated changes in T cell activation, lymphocyte activation and inflammatory response. Analysis is ongoing for part 2 of the clinical trial for changes in Ki67 and other parameters. Adverse events were mostly grade 1 with expected pain at the breast injection site; there were very few systemic adverse effects.

"A diagnosis of breast cancer is a traumatic experience for a patient. There is a waiting period prior to surgery that can last for several weeks, which is a stressful time. For the majority of surgical candidates, there are currently no therapeutic options during the waiting period. Surgeons and patients can feel powerless," said Angel Arnaout, M.D., Scientist and Surgical Oncologist at the Ottawa Hospital, Professor of Surgery at the University of Ottawa and Co-lead of the Ontario Institute for Cancer Research (OICR) Window-of-Opportunity (WOO) Network. "INT230-6 a new drug approach where the drug is directly injected into the tumor. The technology uses a dispersion enhancer that can cause high levels of tumor cell death and necrosis in multiple breast cancer subtypes. The ability to use just one or two doses of this agent to elicit a rapid and marked cytotoxic and immune induction response within the tumor during the surgical waiting period, all without an increase in postoperative complications, is very novel and highly desirable. Patient feedback and acceptance of this new approach has been quite positive. We are excited about how this new approach may fundamentally change the treatment for pre-surgical cancer patients. We look forward to completing our INVINCIBLE study data analysis and new studies to demonstrate that this new agent can make a long-term, positive impact in patients with breast cancer."

"The cell death activates an anti-cancer immune response as we see a relative increase in the abundance of CD4 T naïve, B and NK cells, post treatment when comparing drug treated with control samples within the tumor," said Dr. Melanie Spears, Co-Director, Diagnostic Development for OICR and Co-lead of the WOO Network. "This effect could be systemic and further work is in process to determine whether a global immune activation has occurred."

"The demonstration of 100% tumor necrosis in a tumor on a single dose of INT230-6 is unique," said Lewis H. Bender, President, and Chief Executive Officer of Intensity Therapeutics. "These new results from the INVINCIBLE study, coupled with our previously reported data in metastatic patients, provide further evidence and support for the potential of INT230-6 to treat several different and highly prevalent cancer types from before surgery to late stage disease. We look forward to reporting the full data set from the INVINCIBLE study and further development of our pioneering new medicine."

Spotlight Poster Discussion Presentation
Submission ID: 1310100
Poster ID: PD11-02
Poster Title: A Phase II Randomized Window of Opportunity Trial Evaluating Cytotoxic and Immunomodulatory effects of Intratumoral INT230-6 in Early Stage Breast Cancer: the INVINCIBLE Trial
Session Date: Thursday, December 8, 2022
Time: 7:00 AM – 8:15 AM CST
First Author: Angel Arnaout M.D., FACS

Each Spotlight Poster Discussion Session will consist of two to three sub-topic groups of posters, with an independent clinical oncology expert as a discussant for each group, to speak about the posters, followed by questions addressed to the discussant and the poster presenter, Dr. Arnaout.

The presentation will be accessible on the "Publications, Papers and Posters" page of Intensity’s website at: View Source

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 (SHAO) 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.

On December 8, 2022 Dragonfly Therapeutics, Inc. ("Dragonfly" or the Company), a clinical stage biotechnology company developing novel immunotherapies, reported the first patient dosed in a Phase 1/2 study of the Company’s proprietary EGFR-targeting TriNKET (Press release, Dragonfly Therapeutics, DEC 8, 2022, View Source [SID1234624972]).

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DF9001is the sixth Dragonfly-developed drug to enter into clinical trials. The Company’s first TriNKET, DF1001, entered Phase 2 trials this month after being well-tolerated in Phase 1 with encouraging clinical responses, including showing tumor burden reductions across several tumor types, including in HER2-low and heavily pre-treated patients.

"Given our positive experience over the last two years with Dragonfly’s DF1001 HER2-targeting TriNKET, we are excited to begin offering patients with an even broader set of solid tumor cancers this new EGFR-targeting therapeutic," said Howard P. Safran, MD, Chief of Hematology/Oncology at the Lifespan Cancer Institute and Medical Director for the Brown University Oncology Group. "We see an opportunity for Dragonfly’s next generation of NK cell-engaging immune-oncology therapies to attack solid tumor cancers directly, recruit T cells to cold tumor environments, and offer a broadened therapeutic index – helping patients that presently have very few other therapeutic options."

"Initiating clinical trials with the sixth drug candidate developed by Dragonfly demonstrates how comprehensively we and our Pharma partners are bringing critically-needed new treatment options to patients with cancer," said Jean-Marie Cuillerot, Dragonfly’s Chief Medical Officer.

Dragonfly Therapeutics’ DF9001 Phase 1/2 clinical trial is a first-in-human, multi-part, open-label, non-randomized, multiple-ascending dose study to investigate the safety, tolerability, pharmacokinetics, biological, and clinical activity of DF9001 alone and in combination with a PD-1 checkpoint inhibitor in patients with locally advanced or metastatic solid tumors, followed by expansion in selected indications including Head and Neck Squamous Cell Carcinoma (HNSCC), Colorectal cancer (CRC), and Non-small Cell Lung Cancer (NSCLC).

Additional information about the trial, including eligibility criteria, can be found at: View Source (ClinicalTrials.gov Identifier: NCT05597839).