Quantum Leap Healthcare Collaborative

Findings presented by Agendia collaborators at the European Breast Cancer Conference indicate that the Research Use Only ImPrint test can predict response and non-response to common immunotherapy regimens IRVINE, Calif. & AMSTERDAM--(BUSINESS WIRE)-- Agendia®, Inc. today announced new data from the I-SPY 2 trial showcasing its ImPrint signature for patients with triple negative (TN) breast cancer, shared by I-SPY 2 researchers in an oral presentation at the 14th European Breast Cancer Conference in Milan, Italy. Agendia has been in partnership with Quantum Leap Healthcare Collaborative, the sponsors of the neoadjuvant biomarker-rich I-SPY 2 trial, since 2010. I-SPY 2 established a new benchmark for the efficacy of Phase 2 clinical trials and is widely regarded as the pioneer of the platform trial. The presentation, titled Immune subtyping in the Response Predictive Subtypes (RPS) identifies a subset of triple negative (TN) early-stage breast cancer patients with a very low likelihood of response to neoadjuvant immunotherapy (IO): results from 5 IO arms of the I-SPY 2 TRIAL (van ’t Veer, L, J., et al.), investigates the utility of a refined version of ImPrint, called ImPrintTN, designed to provide more accurate predictions to response to common immunotherapy (IO) regimens for TN patients. The study, examining the responses of patients who received a variety of IO regimens in the I-SPY 2 trial, showed that ImPrintTN predicts both response and non-response, suggesting that the test may help inform prioritization of IO versus other treatments for TN patients to best balance likely benefit versus the risk of the serious adverse effects that often accompany IO. “Many immunotherapy treatments can have difficult, severe adverse side effects on patients that can outweigh the benefit of the treatment. It is imperative to understand what a patient’s response will be to these therapies prior to using them,” said Laura van ‘t Veer, Professor of Laboratory Medicine, Co-leader of the Breast Oncology Program and Director of Applied Genomics at the Helen Diller Family Comprehensive Cancer Center, University of California, and Co-Founder of Agendia, Inc. “The data we are presenting at the European Breast Cancer Conference demonstrates ImPrintTN’s predictive ability to help patients with triple negative breast cancer avoid immunotherapy if they are not likely to benefit – these insights are critical and can be used to inform alternative treatment strategies and customize our approach to meet the needs of each patient’s cancer diagnosis.” ImPrint was developed to be used in the clinic to predict the likelihood of patients responding to immunotherapies by looking at the biology of the patient’s tumor. Agendia currently holds an FDA Investigational Device Exempt status for the ImPrint signature, allowing for its use in the I-SPY 2 trial and for other ongoing research with collaborators. About the I-SPY TRIALs The I-SPY TRIAL (Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular analysis 2) (I-SPY 2 TRIAL) was designed to rapidly screen promising experimental treatments and identify those most effective in specific patient subgroups based on molecular characteristics (biomarker signatures). The trial is a unique collaborative effort by a consortium that includes the Food and Drug Administration (FDA), industry, patient advocates, philanthropic sponsors, and clinicians from over 40 major U.S. cancer research centers. Under the terms of the collaboration agreement, Quantum Leap Healthcare Collaborative is the trial sponsor and manages all study operations. For more information, visit . About Quantum Leap Healthcare Collaborative™ The I-SPY 2 TRIAL ( ), is sponsored by Quantum Leap Healthcare Collaborative™, a 501c (3) charitable organization. Quantum Leap is dedicated to integrating high-impact clinical research with patient care to improve and save lives. By bridging the gap between research and clinical care, Quantum Leap works in collaboration with patients, medical researchers at the University of California, other academic centers nationwide, healthcare innovators, and stakeholders--to accelerate learning in medicine, improve the delivery of healthcare, create better outcomes, and increase the quality of life. Our goal is to improve and save lives. About Agendia Agendia is a leading provider of innovative solutions in the field of precision oncology. With a focus on early-stage breast cancer, Agendia offers reliable biological insights that inform personalized treatment decisions for patients and their care teams. Their advanced genomic assays, MammaPrint® + BluePrint®, enable clinicians to quickly identify the most effective treatment plan, minimizing the risk of both under- and over-treatment. Founded in 2003 in Amsterdam, Agendia is headquartered in Irvine, California with a state-of-the-art laboratory facility. Led by world-renowned scientists and oncologists, Agendia is committed to advancing genomic insights through ongoing research. This includes the notable FLEX Study– the world's largest whole transcriptome Real-World Evidence-based Breast Cancer database which aims to revolutionize precision in breast cancer management. With cutting-edge technology, research and innovation, Agendia strives to shape the future of precision oncology and make a significant impact in the fight against breast cancer. View source version on businesswire.com: Contacts Media Terri Clevenger ICR Westwicke Healthcare PR Tel: 203.856.4326 Terri.Clevenger@Westwicke.com Source: Agendia, Inc. 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40-site U.S. trial enrolling more than 300 patients could significantly change the way DCIS is treated and reduce possibly unnecessary surgery SAN FRANCISCO, Oct. 30, 2023 /PRNewswire/ -- Quantum Leap Healthcare Collaborative (QLHC) announces the enrollment launch for the Re-Evaluating Conditions for Active Surveillance Suitability as Treatment: Ductal Carcinoma In Situ (RECAST DCIS), a Phase 2 platform study aimed at preventing the progression of DCIS to breast cancer. The study is evaluating three investigational endocrine therapy arms: (Z)-endoxifen, a selective estrogen receptor modulator (SERM) in development by Atossa Therapeutics (Nasdaq: ATOS); HAVAH T+Ai™, a proprietary combination of testosterone (T) and anastrozole (Ai) that targets the androgen and estrogen receptor pathways in development by Havah Therapeutics; and ORSERDU® (elacestrant), the only FDA approved oral selective estrogen receptor degrader (oSERD) in development by Stemline Therapeutics Inc. (Stemline), a wholly-owned subsidiary of the Menarini Group. "DCIS indicates the very earliest, noninvasive stage of the disease, that's why it is important for us to seek out alternative therapies for DCIS patients and find ways to reduce toxicity and unnecessary surgeries. We are excited to partner with three innovative companies to explore new treatments for this large and often over-treated patient population," said Laura Esserman, MD, a lead investigator for the study and founder of QLHC. Surgery is the current standard treatment for DCIS even though many patients never progress to breast cancer, which means that patients are often over-treated with invasive procedures. This new trial, sponsored and operated by QLHC, offers DCIS patients up to six months of endocrine therapy with the intent to forego surgery and instead be monitored via long-term active surveillance, if appropriate. A key element in reducing overtreatment of DCIS is identifying biomarkers that reflect the risk of progression so that those with low-risk lesions are spared surgery. RECAST DCIS features the assessment of imaging and molecular-based biomarkers in addition to evaluating new investigational agents in this setting. The study is open to enrollment with each investigational agent arm expected to enroll up to 110 patients. The three collaborators for this trial, Atossa Therapeutics, Havah Therapeutics, and Stemline, all aim to find alternative solutions for DCIS patients and are providing different agents for assessment. Atossa's (Z)-endoxifen has the potential to mitigate breast cancer risk (by reducing the density of breast tissue); to reduce cancer cell activity before surgery; and to reduce the risk of recurrent or new breast cancer after the initial treatment. According to published studies, (Z)-endoxifen is a competitive inhibitor of ERα and represses ERα transcriptional activity (Z)-endoxifen is 100-fold more potent in anti-estrogen activity compared to other SERMs. (Z)-endoxifen also binds to and disrupts protein kinase C beta one function (PKCb1, a known oncogenic protein). The National Cancer Institute (NCI) and others have studied (Z)-endoxifen and have demonstrated promising results in the treatment of breast cancer as well as for the treatment of other solid tumors. Treatment with (Z)-endoxifen may avoid off target effects of tamoxifen and remaining metabolites potentially increasing adherence by improving the safety profile. Havah Therapeutics' HAVAH T+Ai™ combines T, the natural ligand for the androgen receptior and Ai, an inhibitor of T conversion to estradiol, to modulate the growth of abnormal breast tissues. HAVAH T+Ai™ is a proprietary combination subcutaneously delivered system to overcome hormonal symptoms by balancing hormonal irregularities in the breast, developed from more than 10 years of clinical research into hormonal regulation in women. Havah has extensive clinical experience using HAVAH T+Ai™ to address pre- and postmenopausal prevention of breast disease, and the company generated data from more than 1,000 Australian women with breast disease through an ongoing open label cohort study (more than 6,200 implants), with critical safety pharmacokinetic and early efficacy data already demonstrated. Stemline's Elacestrant (ORSERDU), was approved by the U.S. Food & Drug Administration in January 2023 for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, HER2-negative, ESR-1 mutated advanced or metastatic breast cancer, following at least one line of endocrine therapy. For more information including full prescribing information and important safety information, please visit . About Quantum Leap Healthcare Collaborative Quantum Leap Healthcare Collaborative is a 501c(3) charitable organization established in 2005 as a collaboration between medical researchers at University of California, San Francisco and Silicon Valley entrepreneurs. Our mission is to integrate high-impact research with clinical processes and systems technology, resulting in improved data management and information systems, greater access to clinical trial matching and sponsorship, and greater benefit to providers, patients and researchers. Our goal is to improve and save lives. For more information, visit . About Atossa Atossa Therapeutics is a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology. Atossa's current focus is on breast cancer. More information is available at atossatherapeutics.com. About Havah Therapeutics Havah Therapeutics is a biopharmaceutical company developing innovative, proprietary hormonal therapies that aim to improve quality of life for women. Havah brings together a world-class team passionate about helping women live lives free from the suffering caused by breast pain, debilitating menopausal symptoms and breast cancer. More information is available at . About The Menarini Group The Menarini Group is a leading international pharmaceutical and diagnostics company, with a turnover of over $4.4 billion and over 17,000 employees. Menarini is focused on therapeutic areas with high unmet needs with products for cardiology, oncology, pneumology, gastroenterology, infectious diseases, diabetology, inflammation, and analgesia. With 18 production sites and 9 Research and Development centers, Menarini's products are available in 140 countries worldwide. For further information, please visit . About Stemline Therapeutics Inc. Stemline Therapeutics, Inc. ("Stemline") a wholly-owned subsidiary of the Menarini Group, is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics. Stemline commercializes ORSERDU® (elacestrant) in the United States, an oral endocrine therapy indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. Stemline also commercializes ELZONRIS® (tagraxofusp-erzs), a novel targeted treatment directed to CD123 for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), an aggressive hematologic cancer, in the United States and Europe, which is the only approved treatment for BPDCN in the US and EU to date. Stemline also commercializes NEXPOVIO® in Europe, an XPO1 inhibitor for multiple myeloma. Stemline also has an extensive clinical pipeline of small molecules and biologics in various stages of development for a host of solid and hematologic cancers. SOURCE Quantum Leap Healthcare Collaborative

SOUTH SAN FRANCISCO, Calif., May 11, 2023 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., (“ALX Oncology”) (Nasdaq: ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today reported financial results for the first quarter ended March 31, 2023 and provided clinical development and operational highlights. “In the first quarter of 2023, we continued to make significant progress in advancing our lead program, evorpacept, through new collaborations and clinical trial starts,” said Dr. Jaume Pons, Founder, President and Chief Executive Officer of ALX Oncology. “This included our recently announced clinical trial collaboration with Sanofi to evaluate evorpacept in combination with SARCLISA® in patients with multiple myeloma, and the initiation of three new clinical studies. These studies encompass our initiation of a Phase 1 trial in urothelial cancer in combination with PADCEV®, the initiation of a Phase 1 I-SPY-PI TRIAL for the treatment of patients with unresectable or metastatic HER-positive and HER2-low breast cancer in combination with ENHERTU® in partnership with Quantum Leap Healthcare Collaborative (“Quantum Leap”), and the recently announced initiation of a Phase 2 investigator-sponsored trial of evorpacept, in combination with liposomal doxorubicin and KEYTRUDA® in patients with recurrent platinum-resistant ovarian cancer.” Dr. Pons added, “We look forward to important readouts in the second half of 2023 from ASPEN-06, a randomized Phase 2 trial of evorpacept in combination with trastuzumab, paclitaxel and CYRAMZA® (ramucirumab) for the treatment of patients with HER2-positive gastric/gastroesophageal junction cancer, and from ASPEN-02, a Phase 1b clinical trial of evorpacept in combination with azacitidine in patients with myelodysplastic syndromes. Additionally, in collaboration with Tallac Therapeutics, we remain on track to file an Investigational New Drug application in the first half of this year for ALTA-002, a SIRPa Toll-like receptor agonist antibody conjugate, that will broaden our immuno-oncology pipeline beyond evorpacept.” Recent Clinical Developments for Evorpacept First patient dosed in Phase 2 investigator-sponsored trial of evorpacept in combination with KEYTRUDA in patients with ovarian cancer. In May 2023, we announced the initiation of a Phase 2 investigator-sponsored trial of evorpacept in combination with liposomal doxorubicin and KEYTRUDA (pembrolizumab) in patients with recurrent platinum-resistant ovarian cancer at the UPMC Hillman Cancer Center. This is an open-label, single-arm Phase 2 clinical trial. The study is being led by Haider Mahdi, M.D., M.P.H., Assistant Professor, Department of Obstetrics, Gynecology and Reproductive Sciences, The University of Pittsburgh and UPMC Magee-Womens Research Institute. Announced clinical trial collaboration with Sanofi to evaluate evorpacept in combination with SARCLISA in patients with multiple myeloma. In April 2023, we entered into a clinical trial collaboration and supply agreement with Sanofi to evaluate evorpacept and SARCLISA (isatuximab-irfc), Sanofi’s monoclonal antibody that targets a specific epitope on the CD38 receptor on multiple myeloma cells, for the treatment of patients with relapsed or refractory multiple myeloma (“RRMM”). Under the terms of the agreement, Sanofi will conduct a Phase 1/2 study to evaluate the safety, efficacy, pharmacokinetics and biomarker data of evorpacept in combination with SARCLISA and dexamethasone in patients with RRMM. First patient dosed in I-SPY-PI TRIAL evaluating evorpacept in combination with ENHERTU, a HER2 directed antibody-drug conjugate (“ADC”), in breast cancer. In March 2023, we announced the dosing of the first patient in the I-SPY-PI TRIAL for the treatment of patients with breast cancer. Sponsored by Quantum Leap, this Phase 1 (open label), multi-center study arm is investigating evorpacept in combination with ENHERTU (fam-trastuzumab deruxtecan-nxki) to determine the safety, tolerability and efficacy of this drug combination in patients with unresectable or metastatic HER2-positive and HER2-low breast cancer. First patient dosed in ASPEN-07 study evaluating evorpacept in combination with PADCEV, an ADC, in patients with urothelial cancer (“UC”). In February 2023, we announced the first patient was dosed in the Phase 1 ASPEN-07 study evaluating evorpacept in combination with PADCEV (enfortumab vedotin-ejfv), an ADC, in patients with UC. ASPEN-07 is a Phase 1, open-label, multi-center study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of evorpacept in combination with PADCEV in subjects with unresectable locally advanced or metastatic UC. First Quarter 2023 Financial Results: Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments as of March 31, 2023 were $256.2 million. ALX Oncology believes its cash, cash equivalents, investments along with the ability to draw down an additional $40 million of its term loan are sufficient to fund planned operations through mid-2025.Research and Development (“R&D”) Expenses: R&D expenses consist primarily of pre-clinical, clinical and manufacturing expenses related to the development of the Company’s current lead product candidate, evorpacept, and R&D employee-related expenses. These expenses for the three months ended March 31, 2023 were $24.8 million, compared to $17.1 million for the prior-year period. The increase was primarily due to an increase of $5.3 million in clinical costs from an increase in the number of active trials and patient enrollment as well as manufacturing of clinical trial materials to support a higher number of active clinical trials and future expected patient enrollment related to the advancement of evorpacept, an increase of $1.5 million in personnel and related costs primarily driven by headcount growth, and an increase of $1.1 million in stock-based compensation expense due to additional awards granted since March 31, 2022 offset by a decrease of $0.6 million related to the Tallac Collaboration for costs related to the IND filing planned for 2023 in which the primary work was completed in 2022.General and Administrative (“G&A”) Expenses: G&A expenses consist primarily of administrative employee-related expenses, legal and other professional fees, patent filing and maintenance fees, and insurance. These expenses for the three months ended March 31, 2023 were $7.4 million, compared to $7.7 million for the prior-year period. The small decrease year over year was primarily attributable to reduced stock-based compensation expense primarily due to forfeited stock options during the quarter and a decrease in other general and administrative costs due primarily to corporate legal and patent costs.Net loss: GAAP net loss was $30.2 million for the first quarter ended March 31, 2023, or $0.74 per basic and diluted share, as compared to GAAP net loss of $24.5 million for the first quarter ended March 31, 2022, or $0.60 per basic and diluted share. Non-GAAP net loss was $23.8 million for the first quarter ended March 31, 2023, as compared to a non-GAAP net loss of $19.0 million for the first quarter ended March 31, 2022. A reconciliation of GAAP to non-GAAP financial results can be found at the end of this press release. About ALX Oncology ALX Oncology is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system. ALX Oncology’s lead product candidate, evorpacept, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. Evorpacept has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. ALX Oncology intends to continue clinical development of evorpacept for the treatment of multiple solid tumor indications and hematologic malignancies. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include statements regarding future results of operations and financial position, business strategy, product candidates, planned preclinical studies and clinical trials, results of clinical trials, research and development costs, regulatory approvals, timing and likelihood of success, plans and objects of management for future operations, as well as statements regarding industry trends. Such forward-looking statements are based on ALX Oncology’s beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology’s actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These and other risks are described more fully in ALX Oncology’s filings with the Securities and Exchange Commission (“SEC”), including ALX Oncology’s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents ALX Oncology files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. ALX ONCOLOGY HOLDINGS INC.Condensed Consolidated Statements of Operations(unaudited)(in thousands, except share and per share amounts) Three Months Ended March 31, 2023 2022 Operating expenses: Research and development $24,763 $17,073 General and administrative 7,440 7,674 Total operating expenses 32,203 24,747 Loss from operations (32,203) (24,747)Interest income 2,311 225 Interest expense (387) (3)Other income (expense), net 95 (8)Net loss $(30,184) $(24,533)Net loss per share, basic and diluted $(0.74) $(0.60)Weighted-average shares of common stock used to compute net loss per shares, basic and diluted 40,862,513 40,616,302 Condensed Consolidated Balance Sheet Data(unaudited)(in thousands) March 31, December 31, 2023 2022 Cash, cash equivalents and investments $256,164 $282,906 Total assets $278,138 $306,489 Total liabilities $37,750 $43,025 Accumulated deficit $(355,651) $(325,467)Total stockholders’ equity $240,388 $263,464 GAAP to Non-GAAP Reconciliation(unaudited)(in thousands) Three Months Ended March 31, 2023 2022 GAAP net loss, as reported $(30,184) $(24,533)Adjustments: Stock-based compensation expense 6,351 5,501 Accretion of term loan discount and issuance costs 61 — Total adjustments 6,412 5,501 Non-GAAP net loss $(23,772) $(19,032) Use of Non-GAAP Financial Measures We supplement our consolidated financial statements presented on a GAAP basis by providing additional measures which may be considered “non-GAAP” financial measures under applicable SEC rules. We believe that the disclosure of these non-GAAP financial measures provides our investors with additional information that reflects the amounts and financial basis upon which our management assesses and operates our business. These non-GAAP financial measures are not in accordance with generally accepted accounting principles and should not be viewed in isolation or as a substitute for reported, or GAAP, net loss, and are not a substitute for, or superior to, measures of financial performance performed in conformity with GAAP. “Non-GAAP net loss” is not based on any standardized methodology prescribed by GAAP and represent GAAP net loss adjusted to exclude stock-based compensation expense and accretion of term loan discount and issuance costs. Non-GAAP financial measures used by ALX Oncology may be calculated differently from, and therefore may not be comparable to, non-GAAP measures used by other companies.