On November 18, 2021 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported that new interim data published from the large multi-center observational registry study INSIGHT (Clinical Effectiveness Assessment of VeriStrat Testing and Validation of Immunotherapy Tests in NSCLC Subjects) (NCT03289780) utilizing its novel predictive and prognostic blood-based host immune classifier (the VeriStrat test) to stratify Immune checkpoint inhibition (ICI) treatment response in patients with advanced non-small cell lung cancer(NSCLC) (Press release, Biodesix, NOV 18, 2021, View Source [SID1234595802]). The study, titled "Real-world performance of blood-based proteomic profiling in first-line immunotherapy treatment in advanced stage non-small cell lung cancer," was published in the Journal of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (JITC) and can be viewed here.

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Results from the prespecified INSIGHT interim analysis of approximately 2,000 patients with at least one year of follow up showed that patients classified by VeriStrat as host immune classifier hot (HIC-Hot) had better outcomes, on average living 2-3 times longer when compared to patients classified by VeriStrat as HIC-Cold. A classification of HIC-H, also known as VeriStrat Good, implies that the normal tumor-directed immunity is active and patients are potentially responsive to therapies that boost immune response. HIC "cold" classification, also known as VeriStrat Poor, correlates to what experts refer to as an "immune desert," where tumor-directed immunity is compromised. Results additionally suggest that HIC-C (Veristrat Poor) patients should not be treated with single-agent ICI therapy regardless of their PD-L1 expressions.

"Inflammatory biomarker-driven treatment selection of immunotherapy in lung cancer may further improve upon the already astounding results noted with immunotherapy," said Wallace Akerley, M.D., of Huntsman Cancer Institute. "Further, observational studies, like INSIGHT, offer physicians valuable information gleaned from the broader population when determining optimal treatment approaches for their patients with NSCLC."

ICI either single agent or in combination with chemotherapy has helped advance the management and long-term survival of those living with advanced NSCLC. However, it’s not easy to know which patients will experience a favorable response to the various standard of care therapies. There are complex interactions between cancer and the patient’s immune system and this data suggests that using an HIC test alongside PD-L1 results and other clinical factors may help inform treatment response and improve outcomes.

"Biodesix is committed to supporting the lung cancer community by discovering, developing and commercializing proteomic tests while conducting supportive studies that aim to strategically inform patient treatment for better outcomes," said Scott Hutton, CEO of Biodesix. "This new INSIGHT Study data demonstrate how our host immune classifier test, VeriStrat, provides valuable information that can help healthcare professionals make informed decisions when evaluating immunotherapy against the increasingly complex treatment landscape for their patients with NSCLC."

On November 18, 2021 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GLSI-100, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported that an exclusive interview with CEO Snehal Patel will air on the upcoming The RedChip Money Report on Bloomberg TV, this Saturday November 20th at 7 pm ET. Bloomberg TV airs in an estimated 73 million homes across the United States (Press release, Greenwich LifeSciences, NOV 18, 2021, View Source [SID1234595801]).

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In the interview Mr. Patel discusses the Phase IIb clinical trial results in HER2 positive patients, where no metastatic breast cancer recurrences were observed over 5 years of follow-up, an overview of the next steps in the upcoming FLAMINGO-01 Phase III clinical trial, potential Phase IIb and Phase III clinical data publications in 2022, the impact of joining the Russell 2000, and examples of recent comparable strategic transactions in breast cancer and immunotherapy.

To view a preview of the interview, please click here.

About The RedChip Money Report

The RedChip Money Report delivers insightful commentary on small-cap investing, interviews with Wall Street analysts, and financial book reviews, as well as featured interviews with executives of public companies.

About FLAMINGO-01 and GLSI-100

The Phase III clinical trial will be called FLAMINGO-01 and the combination of GP2 + GM-CSF will be called GLSI-100. The Phase III trial is comprised of 2 blinded, randomized, placebo-controlled arms for approximately 500 HLA-A*02 patients and 1 open label arm of up to 100 patients for all other HLA types. An interim analysis has been designed to detect a hazard ratio of 0.3 in IDFS, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater. The trial is currently being registered on clinicaltrials.gov and the link and trial identifier will be published shortly. For future updates about FLAMINGO-01 please visit the Company’s clinical trial tab at View Source

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 282,000 new breast cancer patients and 3.8 million breast cancer survivors in 2021. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

On November 18, 2021 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported that it will participate at the following investor conferences (Press release, Halozyme, NOV 18, 2021, View Source [SID1234595800]):

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33rd Annual Piper Sandler Virtual Healthcare Conference , Elaine Sun, senior vice president and chief financial officer, will represent the company in an on-demand, pre-recorded fireside chat that will be made available on the conference website starting on Monday, November 22, 2021, at 10:00 a.m. ET.
Evercore ISI 4th Annual HealthCONx Conference on Wednesday December 1, 2021, at 3:55 p.m. Eastern Time / 12:55 p.m. Pacific Time. Dr. Helen Torley, president and chief executive officer will represent the company in a virtual fireside chat.
A direct link to the presentations can be accessed through the "Investors" section of www.halozyme.com, and a recording will be made available for 6 months following the events. To access the link, please visit Halozyme’s website approximately 10 minutes prior to the presentation to register and download any necessary audio software.

On November 18, 2021 Molecular Templates, Inc. (Nasdaq: MTEM, "Molecular Templates," or "MTEM"), a clinical-stage biopharmaceutical company focused on the discovery and development of proprietary targeted biologic therapeutics, engineered toxin bodies (ETBs), reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for MT-6402 for the treatment of patients with advanced non-small cell lung cancer (NSCLC) expressing PD-L1 (Press release, Molecular Templates, NOV 18, 2021, View Source [SID1234595799]).

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"Fast Track Designation is an acknowledgement from the FDA of the potential of MT-6402 to address a significant unmet need in NSCLC," said Roger Waltzman, Molecular Templates’ Chief Medical Officer. "This designation will allow for continued contact with the FDA regarding the ongoing clinical program as well as future studies."

The Fast Track program is designed to accelerate the development and review of products such as MT-6402, which are intended to treat serious diseases and for which there is an unmet medical need. Fast Track designation enables more frequent communication with the FDA and may allow for further benefit from FDA accelerated programs such as priority review and/or rolling review.

MT-6402 is the first of MTEM’s third generation ETBs to enter the clinic. It was designed to induce potent anti-tumor effects via PD-L1 targeting through multiple mechanisms that may overcome the limitations of the PD-L1 antibodies. MT-6402 is currently being evaluated in a multi-center, open-label, dose escalation and dose expansion Phase I trial in patients with solid tumors in the United States. Patient enrollment is currently ongoing. Following determination of the maximum tolerated dose (MTD) or recommended Phase 2 dose, expansion cohorts are planned to evaluate MT-6402 as a monotherapy in tumor-specific and basket cohorts.

On November 18, 2021 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported data from two scientific posters for its Phase 2 clinical studies of VAL-083, the Company’s lead compound for the treatment of glioblastoma multiforme (GBM) (Press release, Kintara Therapeutics, NOV 18, 2021, View Source [SID1234595798]). The data are being presented at the 26th Annual Scientific Meeting of the Society for Neuro-Oncology (SNO) being held in Boston on November 18-21, 2021.

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Kintara is presenting posters on two Phase 2 clinical studies evaluating VAL-083 in patients with MGMT-unmethylated GBM as follows:

Poster CTNI-21: "Phase 2 clinical trial of dianhydrogalactitol (VAL-083) in patients with newly diagnosed MGMT-unmethylated GBM"

The first poster outlined the open-label, Phase 2 study of VAL-083 as a first-line treatment in newly-diagnosed, unmethylated GBM patients conducted at Sun Yat-sen University Cancer Center in China.

For the 25 efficacy evaluable patients enrolled with a starting dose of 30 mg/m2/day x 3 days every 21 days, progression free survival (PFS) was 8.7 months (95% confidence interval: CI 6.4-12.5) and median overall survival (mOS) was 19.1 months (CI 12.0-22.3). While not a head-to-head study, this compares favorably to historical temozolomide (TMZ) control ranging from 5.0-6.9 months PFS and 12.7-16.0 months mOS*.

The poster also highlights a case report from the study for a patient who remains progression free for more than 37 months after diagnosis. All patients have completed treatment. Adverse events have been consistent with prior studies with myelosuppression being the most common adverse event.

Poster CTNI-26: "Phase 2 study of dianhydrogalactitol (VAL-083) in patients with MGMT unmethylated, bevacizumab naïve glioblastoma in the adjuvant or recurrent setting"

The second poster outlined the two groups of patients receiving VAL-083 in the open-label, Phase 2 study in recurrent and adjuvant unmethylated GBM being conducted at the MD Anderson Cancer Center in Houston.

In the recurrent group, for the 48 efficacy evaluable patients enrolled with a starting dose of 30 mg/m2/day x 3 days every 21 days, mOS was 8.0 months (CI 6.6-10.3). While not a head-to-head study, this compares favorably to historical lomustine control mOS of 7.2 months**.

In the adjuvant group, for the 36 efficacy evaluable patients enrolled with a starting dose of 30 mg/m2/day x 3 days every 21 days, PFS was 9.5 months (CI 8.2-10.8) and mOS was 16.5 months (CI 13.6-19.3). While not a head-to-head study, this compares favorably to historical TMZ control ranging from 5.0-6.9 months PFS and 12.7-16.0 months mOS*.

All patients have completed treatment. Consistent with prior studies, myelosuppression was the most common adverse event in both recurrent GBM and in the adjuvant setting.

*Hegi et al N Eng J Med (2005); Tanguturi et al. NeuroOncol (2017); Alnahhas et al. Neurooncol Adv (2020)

** Wick et al N.Eng.J.Med (2017)