On January 11, 2021 Resolution Bioscience, Inc. reported a companion diagnostic agreement with Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical stage targeted oncology company (Press release, Mirati, JAN 11, 2021, View Source [SID1234573845]). As part of the agreement, Resolution’s ctDx liquid biopsy technology will be used to help identify non-small cell lung cancer (NSCLC) patients who may benefit from Mirati’s investigational KRAS G12C inhibitor therapy. The fast and non-invasive assay was designed to detect actionable NSCLC mutations, such as KRAS G12C.

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Cancers stemming from RAS mutations account for nearly a quarter of all human cancers and contribute to 1 million deaths per year worldwide. Among the RAS family of oncogenes, KRAS gene mutations are the most common, making up to 85% of all RAS mutations. Mirati’s investigational drug candidate adagrasib (MRTX849) is an orally available small molecule that potently and selectively inhibits the G12C substitution mutation. The Resolution assay will be used to identify patients whose cancers are driven by this KRAS variant.

"We are excited to join forces with Mirati to address this large unmet medical need and to further drive adoption of our innovative liquid biopsy diagnostic tests," said Mark Li, CEO of Resolution Bioscience. "Our mission is to provide critical, actionable information to improve care and clinical outcomes for cancer patients worldwide."

About Resolution Bioscience’s Liquid Biopsy Technology

The Resolution liquid biopsy assays are powered by the company’s patented cell-free DNA (cfDNA) analysis platform, which includes proprietary targeted capture next-generation sequencing (NGS) biochemistry and tightly coupled, cloud-based bioinformatics. The liquid biopsy assays are designed to provide rapid and accurate tumor genotyping, all without an invasive tissue procedure. Now covered by Medicare and private payors, Resolution’s technology has been recognized as novel by the FDA and cited in several important scientific publications and presentations. For example:

97% clinical response was seen for NSCLC patients who received plasma-directed therapy selection from Resolution’s assay as reported in a publication with Memorial Sloan Kettering Cancer Center and the Northern Cancer Institute of Sydney. With more than 1,000 patients enrolled, the ongoing study is the largest prospective study of stage II, III, or IV NSCLC aimed at demonstrating clinical response and outcomes based upon plasma-directed therapy selection.
A recent study by the Dana-Farber Cancer Institute found that the Resolution ctDx Lung assay identified more actionable gene fusion mutations than Guardant Health’s Guardant360 test.
Resolution was the first to demonstrate the detection of all four major types of mutations in a blinded clinical study led by scientists at Dana-Farber Cancer Institute. The team determined the assay has the potential to be implemented broadly for patient care and translational research.
Resolution was also the first company to demonstrate gene deletion detection in cfDNA in a study led by scientists at Vanderbilt University in small cell lung cancer. The team determined that cfDNA sequencing allows for improved monitoring of disease burden, depth of response to treatment, and timely warning of disease relapse in patients.
The Resolution HRD assay was granted Breakthrough Device Designation by the US Food and Drug Administration.
In a recent AstraZeneca publication, Resolution had the highest positive predictive value and the lowest false positive rate among four leading NGS liquid biopsy companies in a blinded comparison study.

On January 11, 2021 Sosei Group Corporation ("the Company";) (TSE: 4565), reported its Chief Financial Officer, Chris Cargill, will present at the 39th Annual J.P. Morgan Healthcare Conference, which will take place virtually, on Thursday, 14 January 2021 (Press release, Sosei Heptares, JAN 11, 2021, View Source [SID1234573861]).

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The presentation will begin at 10:00 a.m. Eastern Standard Time, and will be video broadcasted live in English to registered conference attendees via the Digital Conference Book. For non-attendees, an audio link to the Company’s virtual session presentation can be accessed here. Presentation slides will be made available through the investor section of the Company’s Home Page, www.soseiheptares.com. View Source

On January 11, 2021 iCo Therapeutics Inc. (TSXV: ICO) (OTCQB: ICOTF) ("iCo" or the "Company"), reported that they are submitting an application to the TSX Venture Exchange to amend the exercise price of 66,200,000 previously granted common share purchase warrants (the "Warrants") issued pursuant to a private placement of 25,000,000 units that was completed over several tranches from January 31, 2019 to March 4, 2019 (the "Spring 2019 Private Placement") and pursuant to a private placement of 41,200,000 units that closed on August 16, 2019 (the "Summer 2019 Private Placement") (Press release, iCo Therapeutics, JAN 11, 2021, View Source [SID1234576167]).

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Subject to the TSX Venture Exchange approval, the Company is amending the exercise price of the Warrants from $0.075 to $0.065 per Warrant. The Warrants issued under the Spring 2019 Private Placement are exercisable until dates ranging from January 31, 2022 to March 4, 2022. The Warrants issued under the Summer 2019 Private Placement are exercisable until August 16, 2022. To date, 3,190,000 of the Warrants have been exercised.

"iCo has been pursuing a number of strategic initiatives throughout 2020. It is our hope that one or more of these will come to fruition in early 2021. By reducing the strike price of the warrants we believe more warrants might be exercised and thereby allow the Company to capitalize on these opportunities," noted William Jarosz, the Chief Executive Officer of iCo.

On January 11, 2021 Forma Therapeutics Holdings, Inc. (Nasdaq: FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancer reported a review of corporate highlights from 2020 and outlined anticipated key clinical program milestones for 2021 (Press release, Forma Therapeutics, JAN 11, 2021, View Source [SID1234573778]).

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"While 2020 was marked by tremendous challenges due to the COVID-19 pandemic, Forma made important strides due to the courage of patients and the dedication of our employees. We reported promising results our from our clinical programs including FT-4202 in sickle cell disease, olutasidenib in both AML and glioma, and FT-7051 in prostate cancer, and also raised approximately $695 million in public equity offerings," said Frank Lee, president and chief executive officer of Forma. "In this coming year, we anticipate continued progress, and look forward to advancing drug candidates that we believe have the potential to significantly impact patients living with rare hematologic diseases and cancers."

Clinical Program Highlights and Milestones

PKR Program in Sickle Cell Disease (SCD):

FT-4202 is a novel investigational selective red blood cell pyruvate kinase R (PKR) activator Forma is actively evaluating in a multi-center, placebo-controlled Phase 1 trial in individuals with sickle cell disease ages 12 years and older.

In June 2020, encouraging ­single dose cohort data were reported at the 25th European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress. Initial findings from Forma’s Phase 1 trial of FT-4202 in patients with SCD demonstrated a favorable tolerability profile and biologic effects, with evidence of pharmacodynamic activity.
In December 2020, clinical proof-of-concept data were presented at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition. Forma presented data from a multi-dose cohort of its Phase 1 trial of FT-4202 in patients with SCD, showing that 86% of patients dosed with 300 mg of FT-4202 for 14 days achieved a hemoglobin increase of greater than 1 g/dL from baseline. The observed reduction in hemolysis in conjunction with the biomarker analysis showing improved deformability and hydration of RBCs supports the hypothesis that pyruvate kinase activation may have an impact on vaso-occlusive crises (VOCs).
Additional clinical data anticipated from the ongoing Phase 1 randomized placebo-controlled trial in SCD patients. Data from the MAD2 600 mg cohort of the Phase 1 trial is expected to be reported in the first quarter of 2021, followed by results from the 12-week open-label extension in the second quarter of 2021.
Expanding FT-4202 development program. Forma has initiated a global pivotal Phase 2/3 trial of FT-4202 in SCD patients, with plans to initiate a Phase 2 trial in thalassemia in the second half of 2021, and a pediatric SCD trial in the first half of 2022.
IDH1 Program in AML and Glioma:

Olutasidenib (FT-2102) is a selective inhibitor for cancers with IDH1 mutations Forma is evaluating for the treatment of acute myeloid leukemia (AML) and glioma. Olutasidenib is currently being studied in a registrational Phase 2 trial for relapsed/refractory (R/R) AML and an exploratory Phase 1 trial for glioma.

In May 2020, positive data for olutasidenib in glioma was announced at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper). Forma announced positive preliminary Phase 1 data for olutasidenib in refractory, enhancing glioma at ASCO (Free ASCO Whitepaper) 2020, suggesting the potential for response and prolonged disease control in relapsed/refractory IDH1-mutated glioma patients.
In October 2020, positive data for olutasidenib in a registrational trial for R/R AML was announced. Forma announced positive results from the planned interim analysis of the Phase 2 registration trial of olutasidenib in R/R AML patients with IDH1 gene mutations. Olutasidenib as a monotherapy demonstrated a favorable tolerability profile and achieved a composite complete remission (CR/CRh) rate of 33.3% (30% CR and 3% CRh), the primary efficacy endpoint. While a median duration of CR/CRh has not yet been reached, a sensitivity analysis indicated the median duration of CR/CRh to be 13.8 months. Further data analysis indicates an estimated 87% survival rate at 18 months in patients who respond to treatment with olutasidenib. Olutasidenib’s potential transformative treatment profile is based upon three key indicators: durability of response and increased survival for responders, favorable tolerability suggesting ability to combine with other therapies, and properties to support indication expansion to other IDH1 mutated cancers.
Forma has begun preparing for a new drug application for olutasidenib in R/R AML.
CPB/p300 Program in Prostate Cancer:

FT-7051 is a potent and selective CBP/p300 inhibitor Forma is evaluating for the treatment of metastatic prostate cancer resistant to androgen receptor (AR) signaling inhibitor therapy.

In April 2020, preclinical data on FT-6876 (a research compound related to FT-7051) in breast cancer was presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper). Forma presented preclinical data that demonstrated antitumor activity of FT-6876 in AR-dependent breast cancer cell lines, suggesting that FT-6876 could serve as a treatment for patients with other AR-dependent tumors, such as prostate cancer.
Phase 1 underway in 2021. In December 2020, Forma initiated recruitment in a Phase 1 trial of FT-7051 in men with metastatic castration-resistant prostate cancer including those with AR-v7 splice variants. Dosing in this trial is anticipated to begin in early in the first quarter of 2021. Forma plans to disclose initial safety, tolerability and preliminary response data in the second half of 2021.

On January 11, 2021 Magenta Therapeutics (NASDAQ: MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of immune and blood systems reset via stem cell transplant to more patients, reported progress across its stem cell mobilization and collection and targeted conditioning programs, and set expectations for 2021 (Press release, Magenta Therapeutics, JAN 11, 2021, View Source [SID1234573795]). These updates will be discussed during a webcast presentation at the 39th Annual J.P. Morgan Healthcare Conference on Thursday, January 14 at 7:50 a.m. PST / 10:50 a.m. EST.

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"I’m exceptionally proud of the entire Magenta team who continued to adapt and execute across our portfolio, despite the disruptions that characterized 2020. This past year, we continued to drive our vision to bring immune and blood systems reset to more patients. We announced four pipeline-expanding partnerships, presented clinical and pre-clinical data across our pipeline and secured the capital that we expect can fund our operations into 2023. We continue to advance four ongoing and planned clinical trials that we believe can advance our portfolio in 2021 and, for MGTA-145 specifically, can provide proof-of-concept for stem cell mobilization across multiple diseases and the first clinical data for MGTA-117 targeted conditioning," said Jason Gardner, D. Phil., President and Chief Executive Officer, Magenta. "I am also delighted to welcome Alison Lawton’s return to Magenta’s Board of Directors. Alison brings extensive experience and leadership in both regulatory and business arenas, essential as the Magenta portfolio advances. We look forward to building on the momentum generated in 2020 as we relentlessly focus on execution."

Stem Cell Mobilization and Collection

MGTA-145: Three Phase 2 Clinical Trials Ongoing or Planned

Autologous Stem Cell Transplant of Multiple Myeloma Patients. Previously announced ongoing enrollment continues for the Phase 2 investigator-initiated clinical trial of MGTA-145, used in combination with plerixafor, to mobilize and collect stem cells for autologous stem cell transplantation in multiple myeloma patients at Stanford University. Magenta expects that this trial will provide data on stem cell mobilization and collection, durability of engraftment in transplanted patients and disease outcomes, including progression-free survival. Initial data from the study are expected in mid-2021.

Allogeneic Donor Stem Cell Mobilization and Collection for Stem Cell Transplant in AML, ALL and MDS Patients. Through a collaboration with the National Marrow Donor Program/Be The Match, Magenta plans to initiate, within the next several weeks, a Phase 2 clinical trial using MGTA-145 to mobilize and collect stem cells from allogeneic donors for transplant in patients with AML, ALL and MDS. This clinical trial will evaluate stem cell mobilization, collection, cell quality, engraftment and disease outcomes, including Graft-versus-Host Disease (GvHD), which is of particular importance in the allogeneic transplant setting. Initial data from this clinical trial are expected in the second half of 2021.

Sickle Cell Disease – Stem Cell Mobilization and Collection; Cell Characterization; Pre-Clinical Gene Modification Model. In collaboration with bluebird bio, Magenta plans to initiate a Phase 2 clinical trial in the second half of 2021 to evaluate MGTA-145, in combination with plerixafor, for the mobilization and collection of stem cells in adults and adolescents with sickle cell disease (SCD). Each party will characterize the cells and Magenta plans to gene-correct the cells and transplant them into established pre-clinical disease models to evaluate engraftment. Data from this clinical trial could provide proof-of-concept for MGTA-145, in combination with plerixafor, as the preferred mobilization regimen for patients with SCD and, more broadly, across all gene therapy applications where safe, reliable and rapid mobilization of quality stem cells for gene-modification and transplant are necessary components.

About MGTA-145

Magenta is developing MGTA-145 in combination with plerixafor to harness complementary mechanisms to mobilize hematopoietic stem cells (HSCs) for collection and transplantation. This combination has the potential to be the preferred mobilization regimen for safe, rapid and reliable mobilization and collection of HSCs and could improve outcomes in autologous and allogeneic stem cell transplantation.

Targeted Conditioning

MGTA-117: Plans to Initiate Phase 1 Clinical Trial in mid-2021; Initial Safety and Pharmacokinetics (PK) data to be assessed in the fourth quarter of 2021

AML and MDS. Magenta is completing its IND-enabling GLP toxicology studies and GMP manufacturing process for MGTA-117, the first antibody-drug conjugate (ADC) candidate from the company’s research platform for targeted conditioning of patients prior to receiving a stem cell transplant for blood cancers or gene therapy drug products. Later this month, Magenta expects to complete its initial discussions with the U.S. Food and Drug Administration regarding the design of the first-in-human clinical trial. Magenta expects to file an Investigational New Drug (IND) application and, upon approval, plans to initiate a Phase 1 clinical trial in mid-2021 to assess the safety and PK in the first cohort of patients in the fourth quarter of 2021.

About MGTA-117

MGTA-117, Magenta’s most advanced conditioning program, is a CD117-targeted antibody engineered for the transplant setting and conjugated to amanitin, a payload in-licensed from Heidelberg Pharma. MGTA-117 is designed to precisely deplete only hematopoietic stem and progenitor cells to clear space in the bone marrow prior to transplant, which supports long-term engraftment and disease outcomes in patients. MGTA-117 has shown high selectivity, potent efficacy, wide safety margins and broad tolerability in non-human primate models.

Cash Guidance

With focused allocation of resources on the Company’s clinical trials and advancement of its research platform, the Company now believes its cash position will fund its operations into the first quarter of 2023.

Alison Lawton Background

Ms. Lawton is an executive leader with more than 30 years of experience in biopharma. She served as President and Chief Executive Officer of Kaleido Biosciences, Inc. (Nasdaq: KLDO) from August 2018 to June 2020, and served as President and Chief Operating Officer from December 2017 to August 2018. Prior to joining Kaleido Biosciences, Inc., Ms. Lawton served as Chief Operating Officer at Aura Biosciences, Inc., an oncology therapeutics company, from January 2015 until December 2017, and, prior to joining Aura, served as a consultant to Aura from March 2014 to December 2014. From January 2013 to January 2014, Ms. Lawton served as Chief Operating Officer at OvaScience Inc., a life sciences company. From 2014 to 2017, Ms. Lawton served as a biotech consultant for various companies, including as Chief Operating Officer consultant at X4 Pharmaceuticals. Prior to that, Ms. Lawton spent more than 20 years in various positions of increasing responsibility including Senior VP and General Manager of Biosurgery and prior, Senior VP of Market Access at Genzyme Corporation, a global biopharmaceutical company, and subsequently at Sanofi S.A., also a global biopharmaceutical company, following the acquisition of Genzyme by Sanofi in 2011. Additionally, Ms. Lawton previously served two terms as the industry representative on the U.S. Food & Drug Administration’s Cell & Gene Therapy Advisory Committee and as Chairman of the Board of the Regulatory Affairs Professional Society. Ms. Lawton currently serves on the boards of directors of ProQR Therapeutics N.V., X4 Pharmaceuticals Inc. and Aeglea Biotherapeutics Inc. Ms. Lawton previously served on the boards of directors of Magenta Therapeutics, Kaleido Biosciences Inc., Verastem, Inc., CoLucid Pharmaceuticals, Inc. prior to its acquisition by Eli Lilly and Cubist Pharmaceuticals, Inc. prior to its acquisition by Merck & Co. Ms. Lawton holds a B.Sc. in pharmacology from Kings College, University of London.

Upcoming Presentations at the 2021 Transplantation and Cellular Therapy (TCT) Annual Meeting

Title: MGTA-145 / Plerixafor-Mediated HSC Mobilization and Intravenous HDAd5/35++ Vector Injection into Mice Allows for Efficient In Vivo HSC Transduction and Stable Gene Marking in Peripheral Blood Cells (Oral Abstract, #16)
Presenting Author: Chang Li, Ph.D., Division of Medical Genetics, Department of Medicine, University of Washington
Date and Time of Oral Presentation: Monday, February 8, 2021, 2:30 PM CST

Title: MGTA-145, In Combination with Plerixafor in a Phase 1 Clinical Study, Mobilizes Large Numbers of Hematopoietic Stem Cells and a Graft with Potent Immunosuppressive Properties for Autologous and Allogeneic Transplant (Oral Abstract, #35)
Presenting Author: Kevin Goncalves, Ph.D., Magenta Therapeutics
Date and Time of Oral Presentation: Tuesday, February 9, 2021, 3:00 PM CST

Title: MGTA-456, A CD34 Expanded Cord Blood Product, Permits Selection of Better HLA Matched Units and Results in Rapid Hematopoietic Recovery, Uniform Engraftment and Reduced Graft-Versus-Host Disease in Adults with High-Risk Hematologic Malignancies (Oral Abstract, #31)
Presenting Author: Heather Stefanski, M.D., Ph.D., Assistant Professor, Department of Pediatrics, University of Minnesota
Date and Time of Oral Presentation: Tuesday, February 9, 2021, 3:00 PM CST

Title: A Single Dose of a Novel Anti-Human CD117-Amanitin Antibody Drug Conjugate (ADC) Engineered for a Short Half-life Provides Dual Conditioning and Anti-Leukemia Activity and Extends Survival Compared to Standard of Care in Multiple Pre-clinical Models of Acute Myeloid Leukemia (AML) (Oral Abstract, #53)
Presenting Author: Leanne Lanieri, M.S., Magenta Therapeutics
Date and Time of Oral Presentation: Wednesday, February 10, 2021, 3:00 PM CST

Title: Targeted CD45 Antibody Drug Conjugate Enables Full Mismatch Allogeneic Hematopoietic Stem Cell Transplantation in a Murine HSCT Model as a Single Agent (AML) (Poster #242)
Lead Author: Sharon Hyzy, M.S., Magenta Therapeutics