Upstate Foundation receives $25,000 grant from AstraZeneca for Upstate Cancer Center’s She Matters program

On December 9, 2021 SUNY Upstate reported that Selected as one of just 30 recipients from a field of 1400 applicants nationally, the Upstate Foundation was awarded a $25,000 grant from AstraZeneca’s inaugural ACT on Health Equity: Community Solutions Challenge for the Upstate Cancer Center’s She Matters program (Press release, SUNY Upstate, DEC 9, 2021, View Source [SID1234596679]).

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This award stems from AstraZeneca’s commitment to advance health equity through collaboration with non-profit organizations positively impacting the health of underserved populations through regional and local community-based programming.

She Matters is a peer-to-peer community outreach program of the Upstate Cancer Center to reduce breast cancer disparities in low income, primarily Black and Latinx women living in public housing in Syracuse. Working in partnership with the Syracuse Housing Authority, residents are recruited to serve as community health workers (CHWs). CHWs receive training and ongoing support from the Upstate Cancer Center while working as peer health advocates. CHWs provide breast health education, offer support from navigation to screening mammography, and improve access to necessary diagnostic and treatment services. The goal is to eliminate health care barriers, change behavior and make annual breast cancer screening a priority.

Since its establishment in 2014, She Matters has reached over 3,500 women of all ages and facilitated screening in over 650 women ages 40 and above, the majority of whom are low-income, women of color who experience lapses in routine health care services. At the same time, She Matters serves as a work readiness, skill development opportunity for women who serve as CHWs.

The grant will be used to expand She Matters into additional Syracuse Housing Authority residential communities to increase access to breast cancer education, screening and navigation services.

"We are so pleased that AstraZeneca recognizes the value of the She Matters program and the important work that the team does in the community to get underserved women screened for breast cancer," explained Linda Veit, assistant vice president of community relations and interim chief of staff at Upstate. "Due to this grant, we will be able to expand the program into other public housing communities in Central New York, educate more women on screening and find more breast cancers earlier, when treatment can be most effective."

"It’s exciting to receive this funding from AstraZeneca," said Eileen Pezzi, Upstate vice president for development. "To be selected from such a large field of applicants is a testament to the importance of the work Upstate carries out every day in our community."

According to the American Cancer Society, breast cancer is the most common cancer among American women and the second leading cause of cancer death. Black women are more likely than all other women to die from breast cancer. Their tumors are often found at a later, more advanced stage when there are fewer treatment options. In order to improve health and well-being in underserved communities, especially women of color, it is critical that outreach is provided to those most at risk of early death.

About AstraZeneca’s ACT on Health Equity: Community Solutions Challenge

Through its ACT on Health Equity: Community Solutions Challenge, AstraZeneca has awarded 30 nonprofit organizations across the country support for programs focused on community health and well-being and youth STEM education and career readiness. The organizations awarded represent a variety of innovative programs providing a wide range of services that support underserved communities to improve health outcomes. Click here for a complete list of programs awarded.

SQZ Biotechnologies Announces Lead Cell Therapy Candidate Induced Radiographic, Symptomatic and Immune Response as Monotherapy in Post-Checkpoint HPV+ Solid Tumor Patient

On December 9, 2021 SQZ Biotechnologies Company (NYSE: SQZ), a cell therapy company developing novel treatments for multiple therapeutic areas, reported that interim results from the highest-dose cohort of its ongoing Phase 1/2 clinical trial of lead Antigen Presenting Cell (APC) therapy candidate targeting Human Papillomavirus positive (HPV16+) solid tumors at the European Society for Medical Oncology Immuno-Oncology (ESMO-IO) Congress (Press release, SQZ Biotech, DEC 9, 2021, View Source [SID1234596677]). Of the five patients in this cohort evaluable for efficacy, one checkpoint refractory head-and-neck cancer patient showed a radiographic response and symptomatic improvement. The target lesion demonstrated a complete response at both radiographic assessments. At the most recent assessment, the major oropharyngeal lesion demonstrated continued improvement upon physical examination; however, a new dermal lesion was detected. The investigational therapy was well-tolerated, and no dose-limiting toxicities were observed as of October 8, 2021.

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"The combined radiographic response and symptomatic improvement observed in this patient and the strong correlation with histological data demonstrated the investigational therapy’s intended cellular vaccine mechanism at work," said study first author and presenter Jong Chul Park, MD, Medical Oncologist and Investigator, Massachusetts General Hospital Cancer Center. "This heavily treated patient with significant tumor burden in the neck had marked increases in CD8 T cell tumor infiltration which correlated with clinical improvement, including the ability to swallow more easily. SQZ-PBMC-HPV showed favorable safety data and was generally well tolerated in this patient and across all patients in the highest-dose cohort."

"While our clinical study is ongoing, we believe that this is a ‘Kitty-Hawk moment’ for the SQZ APC cell therapy platform," said Armon Sharei, Ph.D., Chief Executive Officer and Founder of SQZ Biotechnologies. "Our goal has been to develop a new generation of cell therapies – one that could potentially enable significant and broad patient impact by unlocking historically challenging biology while remaining practical and accessible. We believe this patient’s journey is consistent with the trial’s practical and rapid approach. We manufactured a cell therapy in under a day, administered it with mild treatment-related adverse events, and generated clinical benefit by marshalling the power of endogenous killer T cells. We are very excited for the advancement of this program into combination therapy and the broader future potential of SQZ cell therapy candidates."

Responder Patient Characteristics & Treatment Journey

The patient in the highest-dose cohort who achieved a complete response in the target lesion (patient 17) was a 52-year-old male diagnosed over three-and-a-half years prior to first dose with a locally advanced squamous cell carcinoma of the tonsil, a part of the oropharynx. He initially had chemo-radiation treatment but developed recurrence in the throat and the chest almost two years prior. At trial entry, patient 17 had received six prior lines of therapy, including two combination approaches with the checkpoint inhibitor pembrolizumab.

Patient 17 did not require pre-conditioning. Following a single leukapheresis session, his investigational therapy was manufactured in 18 hours and produced 7 doses.

Clinical Results

Patient 17 had marked improvement of the target lesion on physical examination and reported that his ability to swallow had substantially improved
Patient 17 experienced two low grade treatment related adverse events, i.e., grade 1 flushing and grade 1 fatigue
As of October 20, 2021, he received all seven doses of SQZ-PBMC-HPV and the investigational therapy was well tolerated
Radiographic Response

Patient 17’s main lesion was a large, diffuse, non-measurable oropharyngeal lesion
The target tumor lesion selected for response assessment was a mediastinal lymph node measuring 17.1mm in diameter, which decreased at second assessment below 10.0mm resulting in a complete response of the target lesion according to RECIST 1.1
At the second on treatment tumor assessment, despite continuing improvement of the target lesion and patient symptoms, a new dermal lesion was found in the previously irradiated region
Histologic Assays

At day 28 on treatment, patient 17’s matched tumor biopsy samples from the main oropharyngeal lesion showed an 8-fold increase in CD8 T cell tumor infiltration and a conversion of the tumor phenotype from desert to inflamed
PD-L1 expression, an additional maker of tumor inflammation, increased from 2 percent at baseline to 100 percent in the matched tumor biopsies
An RNA in situ hybridization (ISH) assay used for the detection of E6 and E7 expression demonstrated a dramatic reduction in the number of cells with high E6 and E7 antigen expression. E6 and E7 are the two antigens targeted by the SQZ APC cell therapy candidates
Highest Dose Monotherapy Cohort Interim Safety and Manufacturing Findings as of October 8, 2021

There were no observed treatment-related serious or severe (grade 3 or greater) adverse events in the highest-dose cohort
The investigational therapy was generally well-tolerated, and no dose-limiting toxicities were observed
All patient batches were produced in less than 24 hours and yielded multiple cryopreserved doses
Clinical Trial Progress

The combination stage of SQZ-PBMC-HPV-101 trial with checkpoint inhibitors (CPI) is now enrolling. The company believes the increase in PD-L1 expression observed in the patient 17 data suggests potential synergy with a CPI combinatory approach
The highest-dose monotherapy stage of the trial continues enrollment to further evaluate the investigational candidate in single agent settings
Today’s ESMO (Free ESMO Whitepaper)-IO presentation can be found on the Events & Presentations section of the company’s website.

Conference Call
The company will host a conference call and webcast today at 8:00 a.m. ET to discuss the ESMO (Free ESMO Whitepaper)-IO presentation. Participants can join via webcast link or by dialing 1-877-805-7920 (domestic) or 1-629-228-0702 (international) five minutes prior to the start of the call. An archived webcast will be accessible for 90 days after the event.

SQZ-PBMC-HPV-101 Trial Design
SQZ-PBMC-HPV is being evaluated in a Phase 1/2 clinical trial for the treatment of HPV16+ advanced or metastatic solid tumors. Patients must be positive for the human leukocyte antigen serotype HLA-A*02. The investigational candidate, which targets E6 and E7 oncoproteins, is being studied as a monotherapy and in combination with immuno-oncology agents. The study’s primary outcome measures in the monotherapy and combination phases of the trial include safety and tolerability. Antitumor activity is a secondary outcome measure in both the monotherapy and combination stages of the trial, and manufacturing feasibility is a secondary outcome measure in the monotherapy phase of the trial. The monotherapy phase of the study includes escalating dose cohorts with a dose-limiting toxicity (DLT) window of 28 days and is designed to identify a recommended phase 2 dose. The planned combination phase of the study will include SQZ-PBMC-HPV and checkpoint inhibitors. DLT will be measured over 42 days.

About Human Papillomavirus Positive Cancers
Human papillomavirus (HPV) is one of the most common viruses worldwide and certain strains persist for many years leading to cancer. According to the Centers for Disease Control (CDC), in the United States HPV+ tumors represent 3% of all cancers in women and 2% of all cancers in men, resulting in over 39,000 new cases of HPV+ tumors every year. HPV infection is larger outside of the U.S., and according to the International Journal of Cancer HPV+ tumors account for 4.5% of all cancers worldwide, resulting in approximately 630,000 new cases every year. According to the CDC, HPV infection plays a significant role in the formation of more than 90% of anal and cervical cancers, and most cases of vaginal (75%), oropharyngeal (70%), vulval (70%) and penile (60%) cancers.

ORIC Pharmaceuticals to Host ASH Conference Call with Key Opinion Leader to Discuss Potential of ORIC-533 in Multiple Myeloma

On December 9, 2021 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported that the company will host a conference call and webcast to discuss their CD73 inhibitor program in multiple myeloma (Press release, ORIC Pharmaceuticals, DEC 9, 2021, View Source [SID1234596666]). On the call, management will be joined by Kenneth C. Anderson, M.D., Kraft Family Professor of Medicine at Harvard Medical School and Director of the Lebow Institute for Myeloma Therapeutics and Jerome Lipper Multiple Myeloma Center at Dana-Farber Cancer Institute, who will share his perspectives on CD73 inhibition and its promise in overcoming immune suppression in multiple myeloma.

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Specifically, the call will focus on new ex vivo data from patients with multiple myeloma being presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, on the role of adenosine in immunosuppression, and on the ability of an ORIC CD73 inhibitor to restore antitumor immune activity as a single agent.

Details of the ASH (Free ASH Whitepaper) poster presentation are as follows:

Title: CD73 inhibition overcomes immunosuppression and triggers autologous T-cell mediated multiple myeloma cell lysis in the bone marrow milieu
Abstract #: 2675
Date & Time: Sunday, December 12, 2021, 6:00 – 8:00 pm ET
Session: 651. Multiple Myeloma and Plasma Cell Dyscrasias: Basic and Translational
KOL Webcast and Conference Call Details

ORIC will host a conference call and webcast, Monday, December 13, 2021, at 5:30 p.m. ET. To participate in the conference call, please dial (833) 651-0991 (domestic) or (918) 922-6080 (international) and refer to conference ID 7989199. A live webcast and audio archive of the conference call will be available through the investor section of the company’s website at www.oricpharma.com. The webcast will be available for replay for 90 days following the presentation.

LianBio Provides Corporate Update and Reports Third Quarter 2021 Financial Results

On December 9, 2021 LianBio (Nasdaq: LIAN), a biotechnology company dedicated to bringing innovative medicines to patients in China and other major Asian markets, reported financial results for the third quarter ended September 30, 2021 (Press release, LianBio, DEC 9, 2021, View Source [SID1234596662]).

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"Over the past several months, the LianBio team has achieved multiple meaningful milestones, including initiating our first clinical trial, completing dosing in our first PK study and successfully completing our initial public offering," said Yizhe Wang, Ph.D., Chief Executive Officer of LianBio. "In the year ahead, we intend to continue to advance our pipeline of innovative medicines and expect to initiate four pivotal studies to support regulatory approval in our territories. I’m confident we have the leadership and expertise at hand, as well as the capital resources necessary to deliver on our commitment to bring transformative medicines to patients across Asia."

Recent Business Highlights and Clinical Development Updates:

Initiated and completed enrollment and dosing in pharmacokinetic study of mavacamten

In November, LianBio initiated and completed enrollment and dosing in a pharmacokinetic (PK) study of mavacamten in healthy Chinese volunteers.
Initiated Phase 2a clinical trial of infigratinib in gastric cancer and other advanced solid tumors

In August, LianBio announced that the first patient was dosed in a Phase 2a clinical trial of infigratinib in locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with fibroblast growth factor receptor-2 (FGFR2) gene amplification and other advanced solid tumors with FGFR genomic alterations.
Appointed two independent directors to LianBio Board of Directors

In October, LianBio appointed Jesse Wu to the Company’s Board of Directors. Mr. Wu is the former Chairman of Johnson & Johnson China.

In October, LianBio appointed Susan Silbermann to the Company’s Board of Directors. Ms. Silbermann is the former Global President, Emerging Markets at Pfizer.
Strengthened LianBio leadership team with key China-based hires

In October, LianBio appointed Michael Humphries, MBBS as Chief Scientific Advisor to guide the Company’s research and development (R&D) strategy, advance the Company’s pipeline, and lead assessment of new in-licensing opportunities.

In August, LianBio appointed Pascal Qian as China General Manager to build out the Company’s operations and commercial infrastructure.
Completed Initial Public Offering

In November, LianBio completed an initial public offering (IPO) of its ordinary shares through the sale and issuance of 20,312,500 American Depositary Shares (ADSs) at a public offering price of $16.00 per ADS. Following the close of the IPO, pursuant to the partial exercise of their option to purchase additional ADSs, the underwriters purchased an additional 593,616 ADSs at the IPO price of $16.00 per ADS.

LianBio received gross proceeds of $334.5 million in connection with the IPO and subsequent exercise of the underwriters’ option and aggregate net proceeds of $311.1 million after deducting underwriting discounts and commissions.
2022 Key Anticipated Milestones

Mavacamten
Bristol Myers Squibb (BMS)-partnered cardiac myosin inhibitor in development for the treatment of hypertrophic cardiomyopathy and certain forms of heart failure

LianBio expects to initiate the Phase 3 EXPLORER-CN trial of mavacamten in Chinese patients with obstructive hypertrophic cardiomyopathy in the first quarter of 2022 to support regulatory approval in China.
LianBio’s partner BMS has announced a Prescription Drug User Fee Act (PDUFA) target action date of April 28, 2022 for the Company’s New Drug Application to the U.S. Food and Drug Administration (FDA) for mavacamten for the treatment of patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM).
TP-03
Tarsus Pharmaceuticals-partnered GABA-Cl channel blocker in development for the treatment of Demodex blepharitis (DB) and meibomian gland disease

LianBio expects to initiate a Phase 3 trial of TP-03 in Chinese patients with DB in the second half of 2022 to support regulatory approval in China.
LianBio’s partner Tarsus has announced that the Company expects to report topline data in the first quarter of 2022 from the ongoing Phase 3 Saturn-2 trial of TP-03 in DB patients.
NBTXR3
Nanobiotix-partnered radioenhancer in development for multiple solid tumor indications

LianBio expects to begin dosing Chinese patients in Nanobiotix’s planned global pivotal Phase 3 trial of NBTXR3 for the treatment of locally advanced head and neck squamous cell carcinoma in elderly patients ineligible for cisplatin in the second half of 2022.
LYR-210
Lyra Therapeutics-partnered anti-inflammatory implantable drug matrix in development for the treatment of surgically-naïve, medically refractory chronic rhinosinusitis

LianBio expects to begin dosing Chinese patients in Lyra’s planned global pivotal Phase 3 trial of LYR-210 for the treatment of surgically naïve chronic rhinosinusitis in the second half of 2022.
Third Quarter 2021 Financial Results:

Research & Development Expenses

R&D expenses were $4.7 million for the three months ended September 30, 2021, as compared to $116.9 million for the three months ended September 30, 2020. For the three months ended September 30, 2021, research and development cost was primarily attributable to $1.9 million in personnel-related expenses and $2.1 million in professional fees for development activities to support clinical trials.

General & Administrative Expenses

G&A expenses were $8.9 million for the three months ended September 30, 2021, as compared to $2.1 million for the three months ended September 30, 2020. The increase was primarily attributable to increases in payroll and personnel-related expenses (including share-based compensation expense) for increased employee headcount and increases in legal service costs, consulting costs and accounting services.

Net Loss

Net loss was $13.1 million for the three months ended September 30, 2021, or a net loss per share of $0.63, as compared to a net loss of $120.2 million for the three months ended September 30, 2020, or a net loss per share of $11.71.

Cash and Cash Equivalents

Cash and cash equivalents were $109.0 million as of September 30, 2021, which excludes the net proceeds of $311.1 million from the Company’s initial public offering, as compared to $254.4 million as of December 31, 2020. The Company expects its current cash and cash equivalents, inclusive of the IPO net proceeds subsequently received in November 2021, will be sufficient to fund its operating expenses and capital expenditure requirements through 2023.

CORRECTED: Greenwich LifeSciences Announces Presentation of 5 Year Data for GP2 Phase IIb Clinical Trial, Revealing Potential For New T Cell Platform Technology

On December 9, 2021 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported the publication of a poster for the GP2 Phase IIb clinical trial at the San Antonio Breast Cancer Symposium 2021 (SABCS) (Press release, Greenwich LifeSciences, DEC 9, 2021, View Source [SID1234596661]). The CEO of Greenwich LifeSciences, Snehal Patel, recorded an audio track providing an overview. The abstract can be viewed at the bottom of this press release. The full poster with figures, tables, and audio can be accessed or downloaded from the Company’s website here.

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Figure 1 is the new data published yesterday evening at SABCS, which shows that GP2 immune response at baseline could be a prognosticator of cancer recurrence. The Phase IIb clinical trial enrolled HER2 positive patients, who received a standard course of trastuzumab after surgery, and HER2 low patients, who did not receive trastuzumab after surgery. A Delayed-Type Hypersensitivity (DTH) reaction was used to assess baseline in vivo immune responses to GP2 in patients prior to exposure to GP2 treatment or placebo.

The poster data can be summarized as follows:

‒ It was observed that 22.8% or 33 patients of the 145 patients reacted to GP2 at baseline with a positive immune response, which is defined as an induration of 5 mm or greater in the baseline DTH test.

‒ Of the 33 patients who did have a positive baseline DTH immune response to GP2, 8 patients recurred, which is a recurrence rate of 24.2% over 5 years of follow up, with a median time to recurrence of 99 days (0.27 years).

‒ Of the 77.2% or 112 patients who did not have a positive DTH baseline immune response to GP2, 14 patients recurred, which is a recurrence rate of 12.5% over 5 years of follow up, with a median time to recurrence of 438 days (1.2 years).

Mr. Patel commented, "This new GP2 specific T cell data suggests that patients with a positive baseline immune response to GP2 recurred twice as fast and approximately 7 to 11 months sooner than those without a positive baseline immune response did. While this data is very promising, the number of recurrences are low, thus we need to further confirm these observations in the upcoming Phase III clinical trial to determine if they are statistically significant. To further diversify our pipeline, we plan to fully characterize GP2 specific T cells by sequencing the DNA of the T cells at baseline and after treatment with GP2 to assess how these T cells change over time and if they can be developed into CAR-T drug candidates. Expansion into GP2 specific CAR-T cells could potentially become another platform technology to complement GP2 peptide treatment in higher risk patients. We expect new T cell data from the Phase III trial to become available in 2022."

Today is the one year anniversary of the Company’s SABCS 2020 poster, which became the basis for Figure 2. This figure summarizes the efficacy, immune response, and safety Phase IIb data presented over the past year. The Kaplan Meier analysis for HER2 positive patients treated with GP2 immunotherapy shows 100% disease free survival (0% breast cancer recurrences, p = 0.0338) following surgery and Herceptin treatment over median 5 years of follow-up. These patients completed the Primary Immunization Series (PIS) which led to peak immunity at 6 months. No serious adverse events attributable to GLSI-100 were observed. Figure 1 and Figure 2 summarize all of the 5 year GP2 data published to date.

SABCS Abstract P2-13-29:

Title: Analysis of GP2 immune response and relationship to recurrence in a prospective, randomized, placebo-controlled, single-blinded, multicenter, phase IIb study evaluating the reduction of recurrences using HER2/neu peptide GP2 (GLSI-100) vs. GM-CSF alone after adjuvant trastuzumab in HER2 positive women with operable breast cancer

Snehal S Patel, David B McWilliams, Mira S Patel, Christine T Fischette, Jaye Thompson and F Joseph Daugherty.

Greenwich LifeSciences, Stafford, TX

Background: Delayed type hypersensitivity (DTH) skin tests in the randomized, active-controlled, single-blinded, multicenter Phase IIb trial investigating GLSI-100 (GP2+GM-CSF) administered in the adjuvant setting to node-positive and high-risk node-negative breast cancer patients with tumors expressing any degree of HER2 (immuno-histochemistry [IHC] 1-3+) (NCT00524277) have been analyzed. The trial enrolled HLA-A*02 patients randomized to receive GLSI-100 versus GM-CSF alone. The trial’s primary objective was to determine if treatment with GLSI-100, a HER2-derived peptide, reduces recurrence rates. Analyses for this trial showing GLSI-100 to be efficacious, safe and immunogenic have been previously reported by Patel et al. and Mittendorf et al.

Methods: Consented patients were randomized and scheduled to receive GLSI-100 (500 mcg GP2: 125 mcg GM-CSF) or control (GM-CSF only) via 6 intradermal injections every 3-4 weeks as part of the Primary Immunization Series (PIS) for the first 6 months and 4 booster intradermal injections every 6 months thereafter. Boosters were introduced during the trial, thus some patients did not receive all 4 boosters. DTH skin tests were assessed at baseline and after the 6th dose with the orthogonal mean of each skin reaction measured 48-72 hours after injection using the sensitive ballpoint-pen method.

Results: The study enrolled 180 patients across 16 clinical sites with both HER2 3+ positive and low HER2 expressors (1-2+). After 5 years of follow-up, the Kaplan-Meier estimated 5-year DFS rate in the 46 HER2 3+ patients treated with GLSI-100, if the patient completed the PIS, was 100% versus 89.4% (95% CI:76.2, 95.5%) in the 50 placebo patients treated with GM-CSF (p = 0.0338). GLSI-100 was shown to be well tolerated with no SAEs deemed related to study medication and elicited a potent immune response measured by local skin tests and immunological assays. Injection site reactions were common, occurring in almost 100% of patients treated with either GLSI-100 or GM-CSF alone. Previous publications have reported the increase in DTH response reported among patients after treatment with GLSI-100. However, it was of interest to understand the positive DTH responses to GP2 noted at baseline. 22.8% of patients reacted to GP2 at baseline with induration of 5mm or greater. In the subgroup of patients who later experienced a breast cancer recurrence, 36.4% (8/22) had such a baseline response. Analysis of the time to recurrence among those recurring found that the median time to recurrence was 0.6 years for those with a baseline response while those that did not have a positive baseline DTH response to GP2 took 1.2 years to recur.

Conclusions: This study demonstrated that GLSI-100 safely elicited a potent immune response as evidenced by increased DTH skin responses with treatment paired with improved disease-free survival. It is theorized that a positive baseline DTH skin test to GP2 may be evidence of an existing immune response to GP2 associated with residual disease, impending recurrence, or prior treatments. Further studies assessing if GP2 immune response is an important prognosticator of cancer disease state or recurrence are planned.

About SABCS

The 44th annual SABCS has grown to be the industry’s premier breast cancer conference for basic, translational, and clinical cancer research professionals. It is well-known for presenting the latest breast cancer data from all over the world. More than 7,500 health care professionals from more than 90 countries attend annually. Baylor College of Medicine became a joint sponsor of SABCS in 2005. The Cancer Therapy & Research Center at UT Health Science Center San Antonio and American Association for Cancer Research (AACR) (Free AACR Whitepaper) began collaborations with SABCS in 2007. For more information, please visit the conference website at: View Source

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.