On December 9, 2021 Helix BioPharma Corp. (TSX: "HBP"), ("Helix" or the "Company"), a clinical-stage biopharmaceutical company developing unique therapies in the field of immuno-oncology based on its proprietary technological platform DOS47, reported financial results for the 2021 fiscal year ended July 31, 2021 (Press release, Helix BioPharma, DEC 9, 2021, View Source [SID1234597359]).

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The Company reported a net loss and total comprehensive loss of $8,038,000 or $0.06 loss per common share for fiscal 2021 (2020-$8,985,000 or $0.07 loss per common share). Clinical development  Phase I combination therapy study in lung cancer (LDOS001):  Final clinical study report expected to be completed in December 2021;  Phase II combination therapy trial in lung cancer (LDOS003):  Final clinical study report expected to be completed in March 2022 provided the Company settles a contractual disagreement with the clinical research organization engaged to oversee the study.  The Company ceased patient enrolment into the trial in 2020 and proceeded to data analysis.  As previously announced, the Company will not be advancing the randomized portion of the study without third-party partner funding. To date, no third-party partner has been identified.  Phase Ib/II combination trial in pancreatic cancer (LDSOS006):

 Two dose limiting toxicity events (each, a "DLT") have been reported in the first cohort ("Cohort 1") of the trial. As a result of an amended protocol, an additional three

(3) patients are required for this trial, bringing the total number of patients required to complete Cohort 1 to nine (9) patients. The Company currently continues to enroll patients in Cohort 1;  If another DLT is observed in Cohort 1, the Company will not be able to complete the currently planned dose escalation plan, but instead will be required to design a protocol revision;  On November 15, 2021, the Company applied for a revision to the clinical protocol to the U.S. Food and Drug Administration ("FDA").  L-DOS47 immunotherapy chemo combination study in lung cancer:  The Company engaged key opinion leaders on the feasibility and design of a possible immunotherapy chemo combination clinical study and had targeted a possible submission to the FDA by December 2021.

The Company is not currently in a position to make a submission to the FDA regarding the potential clinical study.  Clinical drug product strategic review:  The Company hired a biotechnology consulting firm to assess the Company’s drug product candidate with a focus on identifying value propositions and positioning strategies that would enable clinical adoption of L-DOS47. This engagement includes input from key opinion leaders on the positioning 1 of possible combination therapies and the prioritization of current and/or any additional clinical indications. The Company expects the consulting firm’s report to be finalized by December 2021. Corporate development

 On September 3, 2020, Helix Immuno-Oncology S.A., the Company’s former wholly-owned subsidiary ("HIO"), completed a direct financing with an arm’s length party, CAIAC Fund Management AG ("CAIAC"), as designated trustee of an alternative investment fund to be established, resulting in a further dilution of the Company’s holding in HIO from approximately 42.51% to 29.89% and a loss of the Company’s control in HIO. On December 22, 2020, the Company disposed of its remaining interest in HIO to CAIAC for gross proceeds of CDN$2,308,000 ($2,020,000 net of transaction costs).  Effective October 21, 2020, the financial advisory services agreement dated July 2, 2018 between the Company and ACM Consulting Management AG and the investor relations and advisory services agreement dated July 2, 2018 between the Company and ACM Consulting Management Est. ("ACMest") were terminated by mutual agreement of the parties.

 On December 4 and 30, 2020, the Company completed two private placements resulting in the issuance of 8,200,000 units ("Units") at a price of $0.50 per Unit for aggregate gross proceeds of $4,100,000. See Liquidity and Capital Resources below.  In February 2021, BDO Canada LLP resigned as the Company’s auditors. The Company appointed Marcum LLP as its new auditors on June 24, 2021.

 On May 11, 2021, the Company entered into a definitive convertible security funding agreement (the "Lind Agreement") with Lind Global Macro Fund, LP, a New York based institutional investment fund managed by The Lind Partners, LLC (collectively "Lind"). The Company closed the first tranche under the Lind Agreement on May 13, 2021 for gross proceeds of $3,500,000 (the "First Tranche"). See Liquidity and Capital Resources section below.

 In the fourth quarter of fiscal 2021, the Company decided to defer its application to the Nasdaq Stock Market (the "NASDAQ") as a result of no longer being able to qualify for an accelerated cross border qualifying financing under the Multijurisdictional Disclosure System ("MJDS").

 On August 19, 2021, the Company announced that Dr. Krzysztof Saczek had been appointed as a member of the board of directors of the Company (the "Board") effective immediately in connection with the resignation of Mr. Heman Chao as CEO, CSO and as a member of the Board. Mr. Chao’s resignation became effective on September 1, 2021 and Mr. Chaor assumed the position of Chair of the Company’s Scientific Advisory Board on the same date.  On September 20, 2021, the Company announced the appointment of the company’s Chairman, Dr. Slawomir Majewski, as Interim Chief Executive Officer to hold office while the Board worked to identify and evaluate potential candidates as permanent CEO. Research and development Research and development expenses for fiscal 2021 totalled $5,880,000 (2020-$5,868,000)Research and development expenditures in fiscal 2021, when compared to fiscal 2020, were higher by $12,000. Higher collaborative research activity totaling $1,023,000 and salaries of $79,000 were offset by lower clinical study expenditures of $476,000, lower intellectual property patent expenses of $303,000, lower manufacturing and stability assay expenses of $136,000 and a reduction in stock-based compensation expense of $116,000.

The increase in collaborative research spend in fiscal 2021 compared to fiscal 2020 is related to the Company’s sublicensing agreement with HIO, whereby the Company was responsible to fund pre-clinical activity in exchange for future royalties and milestones. As part of the sub-licensing agreement, HIO is responsible for certain intellectual property expenditures.

In addition, the Company also incurred collaborative research spend in fiscal 2021 related to research activities with Moffitt Cancer Centre. Lower clinical operations spend in fiscal 2021 compared to fiscal 2020 are related to the Company’s LDOS003 Phase II clinical study in Poland and Ukraine as a result of enrollment being halted in the previous fiscal year, causing no further expenditures incurred in the current fiscal year. The Company intends to finalize reporting by March 2022 provided the Company’s disagreement over billings by the clinical research organization overseeing the program are resolved. The Company also incurred lower expenditures associated with its LDOS001 clinical study in the current fiscal year and is now finalizing the clinical study report which is expected to be completed by December 2021.

The Company’s LDOS006 Phase Ib/II pancreatic clinical study in the U.S. commenced enrollment in December 2019 during the early days of the coronavirus pandemic (COVID-19) which delayed the clinical trial patient enrollment. In early 2021, the Company added two additional new sites in an effort to increase the rate of patient enrollment and advance the study. The study is currently still in the first cohort. The decrease in intellectual property spend in fiscal 2021 compared to fiscal 2020 includes an amount totaling $135,000 which the Company invoiced to HIO as passthrough costs for reimbursement associated with the sublicensing agreement. This amount is included in receivables at July 31, 2021.

The decrease in manufacturing and stability assay spend in fiscal 2021 compared to fiscal 2020 of $136,000 mainly reflects the timing of manufacturing expenses related to the repolishing of older drug substance and the resulting lyophilization of new drug product where the expenses overlapped both fiscal years. Operating, general and administration Operating, general and administration expenses for fiscal 2021 totalled $3,251,000 (2020-$2,748,000).The increase in operating, general and administration expenses of $503,000 in fiscal 2021 compared to fiscal 2020 reflects higher stock-based compensation expense, and higher expenses associated with various third-party advisory services such as legal, accounting, business development and investment banking services in an attempt to raise additional capital as part of a qualifying transaction to list the common shares in the capital of the Company ("Common Shares") on the NASDAQ or other United States stock exchange.

Several factors materialized that resulted in the Company eventually abandoning its plans to up-list on a U.S. stock exchange. These include but are not limited to the increase in the percentage ownership of the Common Shares by new insiders, a decline in the price of the Common Shares making it extremely challenging for the Company to leverage the MJDS, and the resignation of the Company’s previous auditors. Stock based compensation expense for fiscal 2021 totaled $663,000 (2020-$353,000).

The increase represents the expense associated with the vesting of stock options granted to directors, over their vesting period. 3 The reduction in investor relations expense for fiscal 2021 compared to fiscal 2020 mainly reflects the termination of the investor relations and advisory services agreement with ACMest. LIQUIDITY AND CAPITAL RESOURCES As at July 31, 2021 the Company had working capital of $144,000 (2020-$2,735,000), shareholders’ deficiency of $1,393,000 (2020 – shareholders’ equity of 2,981,000) and a deficit of $188,554,000 (2020-$180,516,000). On December 22, 2020, the Company disposed of its remaining interest in HIO for net proceeds of $2,020,000. See Corporate developments above. On December 4 and 30, 2020, the Company completed two private placements resulting in the issuance of 8,200,000 Units at a price of $0.50 per Unit for aggregate gross proceeds of $4,100,000 ($3,561,000 net of transaction costs).

The sale of the Units resulted in the issuance of an aggregate of 8,200,000 Common Shares and 8,2000,000 Common Share purchase warrants ("Warrants"). Each Warrant entitles the holder thereof to purchase one Common Share at an exercise price of $0.70 for a period of five years from the date of issuance. On May 11, 2021, the Company entered into the Lind Agreement and on May 13, 2021, closed the First Tranche for gross proceeds of $3,500,000. In connection with the closing of the First Tranche, the Company issued a convertible security (a "Convertible Security") with a two-year term and a face value of $4,112,500 and issued an aggregate of 1,957,056 warrants exercisable into Common Shares for a period of 48 months at an exercise price of $1.0283 per Common Share.

The Convertible Security issued under the First Tranche accrues a simple interest rate obligation of 8.75% per annum on the amount funded, being $3,500,000, which interest is prepaid and attributed to the face value of the Convertible Security. The Lind Agreement also contemplates the issuance of a second Convertible Security upon the mutual agreement of the Company and Lind for gross proceeds to the Company of up to $6,500,000. Lind is entitled to convert the Convertible Securities issued under the terms of the Lind Agreement into Common Shares over their term, subject to certain limitations, at a conversion price equal to 85% of the five-day volume-weighted average trading price ("VWAP") of the Common Shares prior to the date a notice of conversion is provided to the Company by Lind. The Lind Agreement includes certain restrictions on the maximum face value of each of the Convertible Securities that may be converted in any particular month.

In addition, the Company has the option to buyback 66.7% of the Convertible Securities in cash at any time with no penalty, subject to the option of Lind to convert up to 1/3 of the face value of the Convertible Security into Common Shares at the time of such buy-back. The Lind Agreement is subject to covenant requirements. In the event of default Lind may declare, by notice to the Company, effective immediately, all outstanding obligations by the Company under the Funding Agreement to be immediately due and payable in immediately available funds and terminate the agreement. No such declaration has been made at time of filing of these annual consolidated financial statements. In order for the Company to advance the currently planned preclinical and clinical research and development activities, its collaborative scientific research programs and pay for its overhead costs, the Company will need to raise approximately $15,000,000 through to the end of fiscal 2023.

The Company projects an average monthly fixed overhead spend of approximately $275,000. This amount does not include the costs related to any of the Company’s third-party activities such as clinical studies, collaborative research activities and contract manufacturing. The Company currently has one clinical study enrolling patients in LDOS006. Due to slow enrollment, the Company stopped LDOS001 enrollment and continues to work on finalizing the clinical study report. The Company is forecasting a cost of approximately $4,826,000 through to October 2023 to complete both the Phase Ib and Phase II portion of the study. Certain conditions need to be achieved in order for the Company to be able to progress through to the Phase II portion of the study. Of the forecasted $4,826,000, the portion attributable to Phase II is approximately $2,603,000 and is forecasted to begin sometime in May 2023. The Company is forecasting approximately $256,00 and $456,000, respectively to fully complete and report on both the LDOS001 and LDOS003 studies which are forecasted for December 2021 and March 2022, respectively. The Company is forecasting manufacturing expenditures of approximately $1,243,000 through to the end of fiscal 2023 in support of the Company’s clinical program. The Company previous forecasted a manufacturing technology transfer to a new manufacturer with a scaled-up production in anticipation of having sufficient supply for a contemplated pivotal trial and a new clinical study of L-DOS47 in combination with an immune-oncology drug.

The Company has since produced a new batch of drug product from previous drug substance providing additionally sufficient supply for the Company’s current clinical program, provided stability assays continue to meet protocol standards. 4 The Company is currently not forecasting any collaborative research enditures. The Company’s cash reserves of $3,565,000 as at July 31, 2021 are insufficient to meet anticipated cash needs for working capital and capital expenditures through the next twelve months, nor are they sufficient to see planned research and development initiatives through to completion. Though the funds raised during this fiscal year have assisted the Company in dealing with its immediate working capital requirements, additional funds are required to advance the Company’s clinical and preclinical programs and deal with future working capital requirements. To the extent that the Company does not believe it has sufficient liquidity to meet its current obligations, management considers securing additional funds, preferably through the issuance of equity securities of the Company, to be critical for its development needs.

The Company’s consolidated financial statements, management’s discussion and analysis and annual information form will be filed under the Company’s profile on SEDAR at www.sedar.com, as well as on the Company’s website at www.helixbiopharma.com.

On December 9, 2021 Totus Medicines, a drug discovery company using breakthrough chemical biology to make the entire human genome druggable, reported its revolutionary drug program targeting PI3Kα, the most commonly mutated cancer oncogene (Press release, Totus Medicines, DEC 9, 2021, View Source [SID1234596658]). The company also announced a $40 million Series A funding round led by investors DCVC Bio and Northpond Ventures and supported by Camford Capital with original seed funding from Social Impact Capital. The Series A financing will be used to expand and scale Totus Medicines’ proprietary drug discovery platform and advance the company’s lead program into the clinic.

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Totus Medicines’ TOS-358 drug program targets the PI3Kα mutation, which impacts more than 500,000 people in the U.S. every year and drives a significant percentage of breast, colon, lung, bladder, stomach, and other cancers. The pharmaceutical industry has spent decades and billions of dollars attempting to target PI3Kα, and current inhibitors only achieve moderate success in <10% of patients with PI3Kα-mutant cancers.

In just 18 months, Totus has used its proprietary drug discovery platform to develop TOS-358, which shows strong preclinical efficacy across PI3Kα-mutant tumor types where current PI3Kα inhibitors show weak to no efficacy. In patient-derived mouse xenograft models, TOS-358 induces tumor regressions across breast, colon, lung, stomach, and other models, while current inhibitors show mild effects. Totus Medicines will begin clinical trials for the TOS-358 drug program in the second half of 2022.

"Our drug discovery platform is capable of creating treatments for previously untreatable diseases," said Neil Dhawan, Ph.D., co-founder and CEO of Totus Medicines. "We are drugging undruggable targets at scale, moving us closer to a world where every physician and every patient can look forward to effective treatments for the most devastating illnesses. The TOS-358 drug program is a crowning achievement in that mission, and we look forward to advancing the program—and many others—into the clinic."

Totus Medicines’ platform uses proprietary molecular tags that track drug binding in individual cells to screen billions of drug molecules across thousands of genes in parallel. By combining this approach with breakthrough machine learning techniques, the company has developed the next generation of cellular analysis. Continuously learning and adapting, the Totus platform is more effective, less costly, and thousands of times faster than legacy drug discovery methods, enabling the rapid translation of therapies to patients. Totus aims to screen two billion compounds across the human genome within the next two years to unlock precise, effective drugs across hundreds of high-value drug targets.

"The Series A financing will allow us to refine and grow the Totus platform to find new treatments for previously untreatable diseases—faster and more successfully than has ever been possible," said Jason Pontin, a Partner at DCVC, and a board member and co-founder of Totus Medicines. "The promise of Totus Medicines is that doctors can offer life-changing medicines to patients who would otherwise have little hope."

On December 9, 2021 Sapience Therapeutics, Inc., a biotechnology company focused on the discovery and development of peptide therapeutics to address difficult-to-treat cancers, reported that it will present multiple posters on its lead program, ST101, at the 2021 San Antonio Breast Cancer Symposium, being held in San Antonio, Texas in a hybrid format (in-person and virtual), December 7-10, 2021 (Press release, Sapience Therapeutics, DEC 9, 2021, View Source [SID1234596689]).

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Presentation details for the posters are as follows:

Presentation Title: Phase 1 study of ST101, a first-in-class peptide antagonist of CCAAT/-binding protein β (C/EBPβ), in patients with advanced solid tumors, with a phase 2 expansion in patients with hormone receptor positive breast cancer (HR+ BC)
Date/Time: Thursday, December 9, 2021 5:00 PM-6:30 PM CT

Presentation Title: C/EBPβ antagonist peptide, ST101, as a novel therapeutic for breast cancer
Date/Time: Friday, December 10, 2021 7:00 AM-8:30 AM CT

About ST101
ST101, a peptide antagonist of C/EBPβ, is currently being evaluated in an ongoing Phase 1-2 clinical study in patients with advanced unresectable and metastatic solid tumors (NCT04478279). In the ongoing study, ST101 has demonstrated clinical proof-of-concept with a RECIST 1.1-confirmed partial response (PR) in a patient with cutaneous melanoma and evidence of long-lasting stable disease in several additional patients. Following conclusion of the final dose-escalation cohort, Sapience plans to initiate four Phase 2 expansion cohorts in refractory, locally advanced and metastatic cutaneous melanoma, hormone-receptor-positive breast cancer, castrate-resistant prostate cancer, and glioblastoma starting in the second half of 2021. ST101 has been granted orphan drug product designation from the U.S. Food and Drug Administration and orphan medicinal product designation for the treatment of glioma by the European Commission.

On December 9, 2021 Eucure Biopharma, a wholly owned subsidiary of Biocytogen, reported the first patient dosing for a phase I clinical trial of YH004 (anti-4-1BB monoclonal antibody, mAb) (No. YH004002) in Australia (Press release, Biocytogen, DEC 9, 2021, View Source [SID1234596714]).

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The study is an open-label, multi-center, classical dose-escalation phase I study of YH004 monotherapy or YH004 in combination with anti-PD-1 mAb. Subjects are patients with advanced solid tumors or relapsed/refractory non-Hodgkin’s lymphoma (R/R NHL). The objective of the study is to evaluate the safety, tolerability and efficacy of YH004 alone or in combination with anti-PD-1 mAb in patients with advanced solid tumors or R/R NHL. Pharmacokinetics and immunogenicity of YH004 will also be evaluated.

Dr. Yuelei Shen, Chairman and CEO of Biocytogen and Eucure Biopharma, said that Eucure Biopharma plans to continue making rapid progress in clinical studies of YH004, so that patients around the world may be able to access the therapy as soon as possible.

About YH004
YH004 is a humanized IgG1 agonistic monoclonal antibody (mAb) targeting 4-1BB with high affinity and specificity. YH004 can enhance the immune response against tumors through multiple mechanisms. Antibody-mediated activation of 4-1BB can enhance the co-activation of T cells, enhance NK cell cytotoxicity, promote the maturation of antigen presenting cells (APCs) and inhibit regulatory T cells (Tregs). Both in vitro and in vivo data indicates that YH004, whether alone or in combination with anti-PD-1 antibody, exhibits significant anti-tumor activities with good safety and tolerability.

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.