On January 10, 2020 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq:SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported a strategic outlook for 2020 outlining key priorities for its broad pipeline (Press release, Syndax, JAN 10, 2020, View Source [SID1234552980]).

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"We expect 2020 to be an exciting and transformative year for the Company, with significant data read outs anticipated for all three of our innovative pipeline programs, each addressing an unmet need for some of today’s most underserved patient populations," said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. "Notably, this includes the final overall survival readout for E2112, our Phase 3 registration trial of entinostat plus exemestane in HR+, HER2- breast cancer, which we expect in the second quarter of 2020. Based on compelling survival data from the Phase 2b ENCORE 301 trial, we believe that the combination of entinostat and exemestane has strong potential to serve as an effective therapeutic option for the substantial number of patients who have progressed on first line hormone treatment. We are on track to file for regulatory approval in 2020 and to become a fully-integrated oncology company with the launch of entinostat in HR+ breast cancer expected in 2021."

Dr. Morrison added, "In 2020, we also expect meaningful data readouts from the Phase 1/2 AUGMENT-101 trial of SNDX-5613, our potent, highly selective, oral Menin inhibitor, in adults with relapsed/refractory acute leukemias and the Phase 1 dose escalation trial of SNDX-6352, our anti-CSF-1R monoclonal antibody, in patients with cGVHD."

Anticipated Key Milestones for 2020

Entinostat

The Company continues to anticipate that the E2112 trial will reach 410 death events in the second quarter of 2020, triggering the final overall survival (OS) analysis. E2112 is Syndax’s NCI-sponsored, ECOG-ACRIN-led Phase 3 registration trial of entinostat, a Class I selective HDAC inhibitor, plus exemestane in advanced hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+, HER2-) breast cancer.

A positive OS assessment would enable the Company to file for full regulatory approval in the U.S. The E2112 trial design was informed by the Phase 2b ENCORE 301 trial, the results of which led to entinostat’s Breakthrough Therapy designation in HR+ breast cancer, in which patients receiving the entinostat/exemestane combination demonstrated a clinically meaningful OS benefit over treatment with exemestane alone. The Company continues to actively engage in expanding its commercial and medical affairs activities, to support the planned launch of entinostat in the U.S.

SNDX-5613

Syndax anticipates presenting initial clinical data from its Phase 1/2 open-label AUGMENT-101 trial of SNDX-5613, the Company’s potent, highly selective oral Menin inhibitor, at a medical conference in the fourth quarter of 2020. Given that the AUGMENT-101 trial is open-label, meaningful interim data including pharmacokinetic, pharmacodynamic and efficacy data may be available earlier in the year.

The Phase 1 dose escalation portion of AUGMENT-101 is enrolling adults with relapsed/refractory acute leukemias, including patients with MLL-rearrangements and NPM1c mutations, to establish a recommended Phase 2 dose. The Phase 2 portion will evaluate efficacy, as defined by Complete Response rate (per International Working Group response criteria), across three expansion cohorts: MLL-rearranged (MLL-r) acute lymphoblastic leukemia, MLL-r acute myeloid leukemia (AML), and NPM1 mutant AML.

SNDX-6352

The Company has also initiated a Phase 2 expansion cohort for SNDX-6352, its anti-CSF-1R monoclonal antibody, for the treatment of chronic graft versus host disease (cGVHD). The decision to move to the Phase 2 expansion was driven by recently announced encouraging proof of concept results from the ongoing Phase 1 dose escalation trial in which the Company observed responses in all evaluable patients as of the data cutoff date, with no dose limiting toxicities reported.

The Phase 2 expansion cohort is expected to enroll up to 22 patients to further characterize the safety and efficacy at an initial dosing schedule of 1.0 mg/kg of SNDX-6352 administered every two weeks. The Company expects to present results from the Phase 1 trial, for which dose escalation remains ongoing, in the second half of 2020.

On January 10, 2020 Kronos Bio, Inc., dedicated to the development of first-in-class therapies that modulate historically undruggable targets, reported that Norbert Bischofberger, Ph.D., President and Chief Executive Officer, will present at the 38th Annual J.P. Morgan Healthcare Conference on Monday, January 13, 2020 at 10:30 a.m. Pacific Time (Press release, Kronos Bio, JAN 10, 2020, View Source [SID1234552996]). The event will be held in San Francisco at the Westin St. Francis.

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Launched in May 2018, the company announced a $105 million Series A financing in July 2019 to support the advancement of its Small Molecule Microarray platform (SMM). SMM is ideally suited for the rapid discovery of novel modulators or degraders of historically undruggable targets, such as transcription factors. Kronos has demonstrated SMM’s potential to identify compounds that bind to target proteins directly or interfere at nanomolar potency with protein activity. SMM enables discovery of hits that act through a variety of mechanisms, including disruption of protein-protein or protein-DNA interactions, or indirect modulation of target protein activity by binding to co-factors or other protein complex members.

On January 10, 2020 PACT Pharma, in pursuit of its vision to eradicate solid tumors using transformational, first-in-class fully personalized NeoTCR-T cell therapies, reported that it has closed an oversubscribed $75 million Series C financing (Press release, PACT Pharma, JAN 10, 2020, View Source [SID1234552981]). This round, led by Vida Ventures, a next generation life science venture firm with industry-leading experience in the cell and gene therapy, also included current investors of PACT.

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Combined with proceeds from previous financings, PACT will use the Series C proceeds to expand the scope of its clinical plan to investigate NeoTCR-T cell products targeting multiple neoantigens for a spectrum of solid tumor types. In addition to clinical expansion, PACT will open in 2020 a next-gen GMP manufacturing facility in South San Francisco to support the end-to-end production and supply chain for the engineering of personalized neoantigen-targeted autologous T cells. Under the direction of industry veteran Tim Moore, President and Chief Technology Officer, PACT will leverage the new in-house manufacturing facility to automate manufacturing and analytic processes to reduce cycle time and manufacturing costs.

"PACT has grown from company launch to opening its first-in-kind clinical trial in two years. Our progress has been exhilarating and the support from our existing investors has made that progress possible," said Alex Franzusoff, PhD, Chief Executive Officer of PACT Pharma. "As we look to the next stage of our development and expansion of our clinical programs, we are excited to have interest from a new group of prominent investors who both understand the potential of NeoTCR-T cell therapy and have direct experience in the space. Vida Ventures stood out as a partner of choice, given their depth of operational experience in research, clinical development and manufacturing in cell therapy as well as their proven ability to guide companies like Kite and Allogene across key stages of development.

As part of the Series C financing, Helen S. Kim, Managing Director at Vida Ventures, will join the Company’s Board of Directors. Ms. Kim brings over 25 years of biotechnology leadership experience and serves on the boards of Assembly Biosciences, Applied Molecular Transport, A2 Biotherapeutics and Exicure, Inc.

"Our investment in PACT Pharma represents our goal to fund scientific advances by embracing cutting edge innovation with the potential to make a meaningful difference in the lives of patients," said Kim. "PACT has developed a pioneering platform of personalized designer T cells with the potential to target some of the most elusive solid cancers facing society today."

On January 10, 2020 ReadCoor, Inc., a company reinventing omics and pathology with its 3-dimensional (3D) multi-omic spatial sequencing platform, reported a $27 million Series B financing to accelerate the commercialization of its proprietary FISSEQ technology for use in research, drug discovery, and diagnostics (Press release, ReadCoor, JAN 10, 2020, View Source [SID1234552997]). The Series B financing includes new investor Pavilion Capital and other investors, as well as existing investors Decheng Capital and Hansjörg Wyss.

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"ReadCoor has made rapid progress in bringing multi-omic spatial sequencing from development to the market," said Victor E. Tong, Jr., Partner at Decheng Capital and Chairman of the ReadCoor board of directors. "The platform that ReadCoor has developed features a leading-edge technology to sequence and characterize tissue in 3D that offers the potential for new insights in clinical research and drug discovery."

Proceeds from the Series B financing will be used to accelerate commercialization of ReadCoor’s platform, powered by its proprietary FISSEQ (fluorescent in situ sequencing) technology, which simultaneously reads the sequences of thousands of molecules and visualizes high resolution 3D spatial information within whole cells and tissues. With first-of-a-kind capabilities to sequence and characterize data in three dimensions, ReadCoor’s platform gives researchers access to previously undiscovered data to guide evaluation and validation of new drug targets, pathogen identification, disease diagnosis, and the advancement of regenerative medicine. The platform is comprised of an instrument, kits, and data analysis and visualization cloudware, so that it can be incorporated into the workflow of researchers in research and drug discovery.

ReadCoor’s platform and product portfolio have been validated across a range of applications over the past year, including non-small cell lung cancer, breast cancer, and a brain atlas. The company’s initial product suite includes research and discovery applications in oncology, infectious disease, and neuroscience. The Select Release Program and platform will be unveiled at the 20th Advances in Genome Biology and Technology (AGBT) in February 2020.

"The development true spatial sequencing is currently burdened by technical challenges, including the need for specialized imaging hardware, laborious protocols, and unsupported analysis software. To overcome these challenges and integrate these methods, we created an all-in-one solution with unparalleled capacity for true multi-omic spatial sequencing with high-resolution 3D imaging, robust data collection and analysis," said Richard Terry, Founder, President, and Chief Executive Officer of ReadCoor. "It is gratifying that our investors support our technology and approach as we move rapidly towards commercialization, and we are excited to expand the availability of our platform to customers."

Leading up to this Series B financing, ReadCoor’s progress has been marked by collaborative agreements and research grants with leading research institutions, including the Chan Zuckerberg Initiative, Bill & Melinda Gates Foundation, Oregon Health State University, and Harvard University.

About Fluorescent in situ Sequencing (FISSEQ)
ReadCoor’s platform is powered by proprietary Fluorescent in situ Sequencing (FISSEQ) technology, which offers researchers the ability to sequence across multiple omic formats (genomics, transcriptomics, proteomics, and metabolomics) without disruption to cell structure or loss of spatial data. This platform delivers the precise locations of molecular targets and a corresponding 3D image plotting the coordinates within the sequenced sample. Currently, available sequencing technologies can only provide sequencing information, not true spatial information. FISSEQ provides both, representing the first true merging of imaging and sequencing. This 3D molecular atlas can enable meaningful scientific insights into therapeutic areas, including cancer, immuno-oncology, gene therapy, and neurodegenerative diseases, enabling researchers to gain more robust diagnostic insights to deliver precise therapeutics to patients. FISSEQ was developed in the Church Lab at Harvard University and the Wyss Institute for Biologically Inspired Engineering, and first published in Science in 2014 (Highly multiplexed three-dimensional subcellular transcriptome sequencing in situ). The platform has broad applications in the areas of drug development, diagnostics, and machine learning.

On January 10, 2020 iCo Therapeutics (TSXV: ICO) (OTCQB: ICOTF) ("iCo" or the "Company"), reported that granted 2,000,000 stock options to directors, officers and an advisor (Press release, iCo Therapeutics, JAN 10, 2020, View Source [SID1234553650]).

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The stock options are exercisable at the price of $0.08 and will expire on January 10, 2025. The stock options shall vest as follows: 1/5 on today’s date (the "Effective Date") and then 1/5 every six months until all options are vested. The closing price of the Company’s shares on the TSX Venture Exchange on January 10, 2020 was $0.08. After giving effect to this option grant, a total of 2,975,000 options will be issued and outstanding with 710,357 remaining for future issuance under the Company’s stock option plan.