STAND UP TO CANCER FUNDED RESEARCH TO BE PRESENTED DURING THE AACR VIRTUAL MEETING 1 – APRIL 27-28, 2020

On April 27, 2020 Stand Up To Cancer (SU2C) reported that will be presented during the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual (AACR) (Free AACR Whitepaper) Virtual Meeting 10 from April 27th to 28th (Press release, Stand Up To Cancer, APR 27, 2020, View Source [SID1234556629]).

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Work presented by SU2C-funded investigators highlights continued support for developing effective immunotherapy approaches to pediatric and young adult ALL and lung cancer as well as progress in the emerging field of Cancer Interception. Cancer Interception seeks approaches to intervene and stop the formation or progression of early or pre-cancerous conditions.

"Stand Up To Cancer has invested significantly and has made notable contributions in advancing the field of immunotherapy and has pioneered new approaches to cancer diagnostics and treatment, notably through Cancer Interception," stated SU2C CEO Sung Poblete, PhD, RN. "Not only are we excited about the continuing impact SU2C is making in new immunotherapy approaches to treat refractory ALL in children and young adults and to treat non-small cell lung cancer, but we are making measurable strides in moving cancer interception forward toward clinical practice so we can treat patients at earlier stages to optimize patient outcomes.."

Tuesday, April 28, VMS.PR01.01. Translational Prevention Studies

10:50-11:00 a.m. (1098) – Mediators of early immune response in bronchial premalignant lesions

Members of the SU2C-LUNGevity Foundation-American Lung Association Lung Cancer Interception Dream Team used gene expression profiling to identify genes that may be responsible for immune suppression or activation in Bronchial premalignant lesions (PMLs) which are precursors to lung squamous cell carcinoma. Of 15 candidate genes identified, the GSTP1 gene was found to be upregulated in progressing lesions and negatively correlated with several immune activation pathways. Ultimately, GSTP1 represents a promising new target for immunotherapy of squamous cell lung cancer and may allow for novel early intervention treatments.
Tuesday, April 28, VCTPL05. Adoptive Cell Transfer Therapy

11:05-11:15 a.m. (CT051): Safety and efficacy of CD19/CD22 CAR T cells in children and young adults with relapsed/refractory ALL

Haneen Shalabi, DO, investigator on the St. Baldrick’s Foundation – Stand Up To Cancer Pediatric Cancer Dream Team reports that the team, which has been pioneering dual antigen targeting strategies for CAR T cell therapy, tested a novel humanized bispecific CD19/CD22 CAR T cell construct in patients with relapsed/refractory B ALL seeking to prevent antigen negative escape. In this phase 1 study, CD19/22 CAR was well tolerated and effective in CAR naïve patients, with four of six patients achieving minimal residual disease, negative complete remission. Future plans include exploring an additional dose level, intensifying lymphodepletion for prior CAR patients, and evaluating CAR T-cell product characteristics with outcomes.
1:00-1:10 p.m. (CT056): Durable complete responses to adoptive cell transfer using tumor infiltrating lymphocytes (TIL) in non-small cell lung cancer (NSCLC): a phase I trial.

Ben Creelan, MD, clinical lead on the SU2C Catalyst Lung Cancer Immunotherapy Research Team, led by Scott J. Antonia, MD, PhD, H. Lee Moffitt Cancer Center & Research Institute, will be presenting data on durable complete responses in metastatic non-small cell lung cancer (NSCLC) with manageable toxicity, potentially extending the benefits of adoptive cell transfer seen in melanoma to NSCLC.
Tuesday, April 28, VCTPL02. Early Detection and ctDNA

2:30-2:40 p.m. (CT023): Phylogenetic tracking and minimal residual disease detection using ctDNA in early-stage NSCLC: A lung TRACERx study

Christopher Abbosh, MB, young investigator on the SU2C-LUNGeivity-American Lung Association Lung Cancer Interception Dream Team reports that circulating tumor DNA is an adjuvant biomarker capable of both detecting minimal residual disease following surgery and defining the clonality of relapsing disease. These data pave the way for clinical trials predicated on escalation of adjuvant standard of care in patients who exhibit minimal residual disease following surgery.
Tuesday, April 28, VMS.CL11.01 – Predictive Biomarkers for Immunotherapeutics

3:55-4:05 p.m. (5666) – A noninvasive approach for early prediction of therapeutic benefit from immune checkpoint inhibition for lung cancer.

Maximilian Diehn, MD, PhD, co-leader and Ash Alizadeh, MD, investigator on the SU2C-LUNGevity Foundation-American Lung Association Lung Cancer Interception Research Team, and other team members report on the use of circulating tumor DNA to predict which non-small cell lung cancer (NSCLC) patients will achieve durable clinical benefit after treatment with immune checkpoint inhibitors. Currently, conventional imaging is often not able to identify which patients will achieve durable clinical benefit. The team was able to demonstrate that pre-treatment circulating tumor DNA and circulating immune profiles can provide accurate, noninvasive, and early forecasting of ultimate outcomes for NSCLC patients receiving immune checkpoint inhibitor therapy.

Erasca Raises $200 Million Series B Financing

On April 27, 2020 Erasca, a company whose mission is to erase cancer, reported the completion of a $200 million Series B financing round co-led by ARCH Venture Partners and Cormorant Asset Management (Press release, Erasca, APR 27, 2020, View Source [SID1234556627]). New investors participating in this financing include global Singapore-based investor EDBI, Invus, Terra Magnum Capital Partners and other private and strategic investors. Existing investors City Hill Ventures, Colt Ventures and LifeSci Venture Partners also participated meaningfully in the round.

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This financing brings the total capital raised by the company to more than $260 million. Erasca will use the proceeds to support the clinical development of multiple promising oncology programs and further advance the company’s in-house drug discovery pipeline.

"We are honored by the magnitude of support from such an impressive syndicate of investors, especially during these turbulent times," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO and co-founder. "Unfortunately, millions of people still suffer from cancer daily. At Erasca, we are doing everything we can to help these patients live longer and healthier lives by taking an aggressive long-term approach to tackling this disease with leading-edge science and world-class talent. We are immensely grateful to have new and existing shareholders who embrace our mission to erase cancer."

Erasca has assembled a robust pipeline of targeted therapies directed at undisclosed targets through in-house drug discovery as well as active pipeline expansion through collaborations with world-class academic and biopharmaceutical organizations.

"We are pleased to continue backing Erasca’s terrific team and bold mission," said Kristina Burow, managing director at ARCH Venture Partners. "Cancer is a formidable disease. Therefore, Erasca’s team has built an impressive portfolio of potentially first-in-class and best-in-class assets, including successful in-licensing of several key programs to address significant unmet needs. The company has the talent, assets and perseverance to substantially change the trajectory of cancer treatment and improve patient outcomes in a meaningful way."

Bihua Chen, portfolio manager of Cormorant Asset Management, added, "Erasca continues to strengthen and build upon its exciting foundation. I have been impressed by how much progress the Erasca team has made since commencing operations just 18 months ago. I am confident that this team, now armed with an expanded portfolio and a bolstered balance sheet, will continue to execute on the pipeline and develop novel and impactful therapies for patients."

eFFECTOR’s Zotatifin (eFT226) Inhibited Tumor Growth and Caused Tumor Regression Across Diverse Receptor Tyrosine Kinase-Driven Tumor Types in Preclinical Models of Disease

On April 27, 2020 eFFECTOR Therapeutics, Inc., a leader in the development of selective translation regulator inhibitors (STRIs) for the treatment of cancer, reported that data presented today in a virtual session at the AACR (Free AACR Whitepaper) Annual Meeting, showed the anti-tumor activity of the company’s product candidate, zotatifin, in preclinical models of FGFR1, FGFR2 and HER2 driven cancers, demonstrating the potential of zotatifin in receptor tyrosine kinase (RTK)-driven cancers (Press release, eFFECTOR Therapeutics, APR 27, 2020, View Source [SID1234556626]).

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Peggy A. Thompson, Ph.D., executive director, translational medicine at eFFECTOR, gave a presentation entitled, "Preclinical evaluation of eFT226, a potent and selective eIF4A inhibitor with anti-tumor activity in FGFR1, FGFR2 and HER2 driven cancers" which showed that zotatifin significantly inhibited tumor growth and caused tumor regression across diverse RTK-driven tumor types. Zotatifin has been shown to downregulate RTK protein levels and associated AKT and MAPK signaling, resulting in anti-tumor activity in FGFR1, FGFR2 and HER2 driven models. In a HER2+ breast cancer model, tumor regression was sustained long after cessation of therapy. Further evaluation of predictive markers of sensitivity or resistance showed that RTK tumor models with mTOR mediated activation of eIF4A are most sensitive to zotatifin.

"These promising preclinical studies demonstrated that the association of zotatifin activity in RTK tumor models with mTOR pathway activation provides an opportunity to further enrich for sensitive patient subsets during clinical development," said Steve Worland, Ph.D., president and chief executive officer of eFFECTOR. "This selection strategy will complement our selection of KRAS-mutant tumors based on zotatifin’s down-regulation of KRAS protein in preclinical studies."

A Phase 1/2 clinical trial of zotatifin in patients with KRAS- or RTK-mutant solid tumors is ongoing [NCT04092673]. The trial is enrolling patients with activating mutations, amplifications or fusions in HER2, ERBB3, FGFR1, or FGFR2 receptor tyrosine kinases, or any KRAS mutation subtype. The primary objectives of the trial include safety and tolerability of zotatifin as monotherapy. Secondary objectives include antitumor activity and survival, as well as pharmacokinetics of the drug. Exploratory objectives include pharmacodynamics of zotatifin.

About Zotatifin
Zotatifin is a potent and sequence selective inhibitor of eukaryotic translation initiation factor 4A (eIF4A) mediated translation. Zotatifin is designed to inhibit the translation of mRNAs encoding several important oncogenes and survival factors, including several RTKS, KRAS, Cyclin D, CDK4/6, MYC, MCL1 and BCL-2 resulting in potent in vivo tumor regression in multiple tumor models dependent on these factors, including colorectal cancer, non-small cell lung cancer, breast cancer, hepatocellular carcinoma and B cell lymphomas. Since zotatifin inhibits the translation of mRNA encoding KRAS and RTK, it is not limited to any mutation subtypes. The product candidate is currently being evaluated in a Phase 1/2 clinical trial in patients with solid tumors.

About eIF4A
eIF4A is an RNA helicase that catalyzes the ATP-dependent translation of highly structured mRNA. eIF4A helicase activity is tightly controlled by the PI3K and RAS signaling pathways. Activation of eIF4A results in the selective upregulation of oncogenes with highly structured 5’-UTRs (untranslated regions) that are involved in cell proliferation, survival and metastasis. Inhibition of eIF4A selectively regulates the translation of a set of target mRNAs distinct from those regulated by MNK1/2 and eIF4E. Targeting these selective translational regulators may expand the potential patient population that benefits from translation regulation therapy.

Corcept Therapeutics to Announce First Quarter Financial Results, Provide Corporate Update and Host Conference Call

On April 27, 2020 Corcept Therapeutics Incorporated (NASDAQ: CORT) reported it will report first quarter financial results and provide a corporate update on May 4, 2020 (Press release, Corcept Therapeutics, APR 27, 2020, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announce-first-quarter-financial-results-5 [SID1234556625]). The company will also host a conference call that day at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time).

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Conference Call Information
To participate, dial 1-800-458-4121 from the United States or 1-323-794-2093 internationally approximately ten minutes before the start of the call. The passcode will be 2827359.

A replay will be available through May 18, 2020 at 1-888-203-1112 from the United States and 1-719-457-0820 internationally. The passcode will be 2827359.

Bio-Path Holdings Presents at 2020 American Association for Cancer Research Annual Meeting

On April 27 , 2020 Bio-Path Holdings, Inc., (NASDAQ: BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported the presentation of a poster highlighting the clinical trial design of its Phase 1 study of BP1002 at the 2020 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting being held virtually from April 27-28, 2020 (Press release, Bio-Path Holdings, APR 27, 2020, View Source [SID1234556624]).

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The poster, titled, "A Phase I Clinical Trial to Study the Safety, Pharmacokinetics, and Efficacy of BP1002 (L-Bcl-2) Antisense Oligonucleotide in Patients with Advanced Lymphoid Malignancies," was presented virtually by Dr. Ana Tari Ashizawa, Senior Vice President of Research, Development and Clinical Design at Bio-Path Holdings.

"We are particularly pleased to have our Phase 1 clinical development program for BP1002 as a potential therapy for lymphoma and chronic lymphocytic leukemia patients highlighted in a poster at this important scientific meeting," stated Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. "We believe this poster will enhance visibility for our Bcl-2 program among an audience of world-leading oncologists and cancer researchers."

The Phase 1 clinical trial is expected to be conducted at several leading cancer centers, including The University of Texas MD Anderson Cancer Center, the Georgia Cancer Center and the Sarah Canon Research Institute. Initially, a total of six evaluable patients will be treated with BP1002 monotherapy in a standard 3+3 design, with a starting dose of 20 mg/m2. The approved treatment cycle is two doses per week over four weeks, resulting in eight doses administered over 28 days. The primary objective of the study is to evaluate the safety and tolerability of escalating doses of BP1002.

BP1002 targets the protein Bcl-2, which is responsible for driving cell survival in up to 60% of all cancers. High expression of Bcl-2 has been correlated with adverse prognosis for patients diagnosed with relapsed, aggressive non-Hodgkin’s lymphoma. Preclinical studies have shown BP1002 to be a potent inhibitor against the Bcl-2 target, and Bio-Path believes that its benign safety profile should enable BP1002 combination therapy with approved agents.