On October 13, 2020 Cedilla Therapeutics, a private biotechnology company developing targeted small molecules for the treatment of cancer and other diseases caused by protein dysregulation, reported the closing of a $57.6 million Series B financing (Press release, Cedilla Therapeutics, OCT 13, 2020, View Source [SID1234568423]). The financing was co-led by Casdin Capital and Boxer Capital of Tavistock Group and included new investors Eli Lilly and Company and Schroder Adveq, as well as other undisclosed institutional investors, along with existing investor Third Rock Ventures. In connection with the financing, Eli Casdin, Chief Investment Officer and Founder of Casdin Capital, and Dominik Naczynski, Senior Vice President at Boxer Capital, will join the Company’s Board of Directors.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Cedilla was founded on the understanding that therapeutic targets exist in multiple proteoforms, or protein states, which can be evaluated for functional relevance and exploited to create novel opportunities for intervention, even where conventional approaches have failed," said Alexandra Glucksmann, Ph.D., Cedilla’s president and chief executive officer. "Over the past two years, we have honed our integrated approach and we are now prepared to advance target-specific efforts toward the clinic. We appreciate the support of our new and existing investors, which will enable us to name our first two development candidates, expand our discovery-stage research and work toward our goal of delivering novel small molecules that can redirect the course of disease and deliver profound benefit to patients."

Cedilla identifies previously unexploited proteoforms of high-value targets. While prior attempts to drug these targets have focused only on their canonical states, Cedilla has discovered the means to affect function or stability by engaging pivotal, post-translationally modified states. Cedilla’s product candidates are designed with mechanisms best fit to modulate these functionally-relevant proteoforms, which may include protein inhibition or degradation. Proceeds from this financing will support ongoing efforts to build a broad portfolio of small molecule medicines, including the identification and preclinical development of Cedilla’s first two product candidates.

"Cedilla is establishing an entirely new approach to drug development, based on a deep understanding of proteomics and a unique ability to identify and modulate functionally-relevant proteoforms of high-value targets," said Eli Casdin, Chief Investment Officer and Founder of Casdin Capital. "It is a big idea with powerful potential and we are excited to partner with the management team to accelerate the next stage of the company’s growth."

On October 13, 2020 Tyme Technologies, Inc. (NASDAQ: TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs), reported that its leadership will present at the Jefferies Virtual Global Healthcare Conference on November 17-19 (Press release, TYME, OCT 13, 2020, View Source [SID1234568421]). In one-on-one sessions, the Company will present its corporate overview for fiscal year 2021 with a special focus on multiple growth opportunities driven by advances in the science of cancer cell metabolism, SM-88 (racemetyrosine) late-stage trials in pancreatic cancer, SM-88 HopES trial in ultra-rare metastatic sarcoma, proof-of-concept RESPOnD trial evaluating TYME-19 in COVID-19, and expanding clinical plans for its cancer-metabolism pipeline candidate SM-88 in prostate, breast and hematological cancers.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Event: Jefferies Virtual Global Healthcare Conference
Place: Waldorf Hilton, London
Presentation Date: November 17-19, 2020
Format: One-on-one sessions

The presentation will be accessible on the events page under the investor relations section of Tyme Technologies’ website at www.tymeinc.com.

About SM-88

SM-88 is an oral investigational modified proprietary tyrosine derivative that is believed to interrupt the metabolic processes of cancer cells by breaking down the cells’ key defenses and leading to cell death through oxidative stress and exposure to the body’s natural immune system. Clinical trial data have shown that SM-88 has demonstrated encouraging tumor responses across 15 different cancers, including pancreatic, lung, breast, prostate and sarcoma cancers with minimal serious grade 3 or higher adverse events. Learn more.

About TYME-18

TYME-18 is composed of a proprietary surfactant delivery agent with a specific sulfonic acid component. It is designed for intra-tumoral administration of difficult to treat tumors and leverages the acidic tumor microenvironment and signaling pathways to kill cancer cells. TYME-18 is distinct in composition, but like SM-88, aims to leverage susceptibilities of a cancer that are related to its altered metabolism. Initial preclinical data for TYME-18 in animal tumor models demonstrate rapid and complete tumor regression, with no reported local or systemic toxicities. TYME-18 continues to be studied as a potential therapy for difficult to treat tumors that may not be eligible for surgical or other interventions. Learn more.

About TYME-19

TYME-19 is a potent, well characterized synthetic antiviral bile acid that is being evaluated as a potential oral therapy for COVID-19. In preclinical testing, TYME-19 repeatedly prevented COVID-19 viral replication without attributable cytotoxicity in treated cells. COVID-19 hijacks a cell’s ability to make proteins and lipids and divert these processes to make viral proteins and lipids in order to reproduce. COVID-19 accomplishes this by inducing stress in the endoplasmic reticulum (ER), where cells process proteins, which enables the virus to remodel protein and lipid synthesis. In preclinical testing, TYME-19 has been shown to counteract these effects, preventing viral replication, by reducing ER stress. TYME-19 is believed to physically degrade viruses by solubilizing the protective lipid layer and other structural components, which prevent a virus from binding to and infecting a cell.

About TYME-88-Panc Pivotal Trial

The TYME-88-Panc pivotal trial applies the latest advances in the field of cancer metabolism by evaluating the efficacy and safety of an oral investigational compound that targets the metabolic mechanisms of the disease at its source. A prospective, open label pivotal trial in metastatic pancreatic cancer for patients who have failed two lines of any prior systemic therapy. The trial is designed to evaluate the safety and efficacy of SM-88 used with MPS (methoxsalen, phenytoin and sirolimus) in advanced pancreatic cancer and will measure multiple endpoints, including overall survival, progression free survival, relevant biomarkers, quality of life, safety, and overall response rate. Learn more.

On October 13, 2020 CytRx Corporation (OTCQB:CYTR) ("CytRx" or the "Company"), a specialized biopharmaceutical company focused on research and development for the oncology and neurodegenerative disease categories, highlighted that ImmunityBio, Inc. and NantKwest, Inc. (collectively, the "Companies") reported the addition of a third cohort to their ongoing Phase 2 study of a novel combination immunotherapy – which includes CytRx’s licensed drug aldoxorubicin – for locally advanced or metastatic pancreatic cancer (QUILT-88) (Press release, CytRx, OCT 13, 2020, View Source [SID1234568419]). According to the Companies, the third cohort will enable pancreatic cancer patients who have failed all approved standards of care to participate in the study.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

As previously noted in CytRx’s October 7, 2020 press release regarding the reportedly promising treatment delivered to former Senator Harry Reid for his stage IV pancreatic cancer, this randomized, open-label study is evaluating the safety and efficacy of a combination immunotherapy that includes aldoxorubicin, ImmunityBio’s IL-15 superagonist Anktiva (N-803), NantKwest’s PD-L1 t-haNK, and standard of care. The study results will be compared to standard of care chemotherapy for first- and second-line treatment. However, the third-line cohort is a single arm with no comparator. Each cohort will be evaluated independently to provide more precise comparative data for each disease stage.

Trial Sites and Enrollment

There are presently three trial sites activated: Hoag Memorial Hospital Presbyterian in Orange County, Calif., The Chan Soon-Shiong Institute for Medicine in Los Angeles County, Calif., and Avera McKennan Hospital and University Health Center in Sioux Falls, South Dakota. The latter site will serve patients in the tri-state area (Iowa, Nebraska and South Dakota). Forty patients are currently enrolled in or being evaluated for the trial.

The Companies’ combination immunotherapy is designed to harness the body’s immune system to target, kill, and "remember" cancer cells. The agents being assessed in the study are designed to find pancreatic cancer cells and initiate a large immune response against them, which may allow the body to develop its own antibodies to fight the cancer.

Study Details

Each treatment setting, as well as each first- and second-line or later maintenance treatment, will be evaluated independently as Cohort A, Cohort B, and Cohort C, respectively, with Cohorts A and B having independent experimental and control arms. The study will initially enroll 298 subjects across all three cohorts. The primary objective of Cohorts A and B is progression-free survival (PFS) and the objective of Cohort C is overall survival (OS) per RECIST V1.1. Secondary objectives include initial safety and additional efficacy measures, including overall response rate (ORR), complete response (CR) rate, durability of response (DoR), disease control rate (DCR), and overall survival (OS).

"Pancreatic cancer is the fourth leading cause of cancer-related deaths in the United States and requires significant advancements in treatment to improve outcomes for patients," said Steven A. Kriegsman, CytRx’s Chairman and Chief Executive Officer. "We commend the Companies for adding a third cohort and expanding this Phase 2 study of their combination immunotherapy that includes aldoxorubicin. We are encouraged that aldoxorubicin continues to play a role in their mission to recruit and amplify the power of the human body’s own immune system to target and destroy even the most difficult cancer cells."

CytRx out-licensed global development, manufacturing and commercialization rights for aldoxorubicin to ImmunityBio in 2017. The Company has an agreement with ImmunityBio that can yield up to $343 million in potential milestone payments as well as prospective royalties on sales of aldoxorubicin.

On October 13, 2020 Eureka Therapeutics, Inc., a clinical stage biotechnology company developing novel T cell therapies to treat solid tumors, reported that it will participate virtually in two upcoming conferences in October (Press release, Eureka Therapeutics, OCT 13, 2020, View Source [SID1234568418]):

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

TCR-based Therapies Summit
Title: ARTEMIS Antibody TCR T Cell Therapies for Solid Tumors
Speaker: Cheng Liu, Ph.D., President and CEO
Date: Tuesday, October 27, 2020
Time: 9:00 a.m. EST
Cell & Gene Therapy Bioprocessing & Commercialization
Title: Optimizing Viral Vector Production
Speaker: Nicole Nunez, Ph.D., Process Development Scientist
Date: Thursday, October 22, 2020
Time: 8:00 a.m. EST

On October 13, 2020 BryoLogyx, Inc., reported that it has completed the synthesis of bryostatin-1 molecule, pursuant to FDA’s Good Manufacturing Practice (GMP) regulations (Press release, BryoLogyx, OCT 13, 2020, View Source [SID1234568416]). Bryostatin-1 is the company’s lead compound being developed to improve patient outcomes by amplifying the response and increasing the durability of targeted cancer immunotherapies. The GMP synthesis, accomplished in partnership with Albany Molecular Research Inc. (AMRI), a global contract research, development and manufacturing organization (CDMO), paves the way for BryoLogyx’s planned clinical program with bryostatin-1 in immuno-oncology, additional research on the compound’s potential in other therapeutic areas, and the development of next generation synthetic analogs.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The GMP-manufactured compound is based on the landmark patented synthesis process for bryostatin-1 reported in Science (2017) and developed by Paul Wender, PhD, and colleagues at Stanford University and licensed to BryoLogyx. Bryostatin-1 is an extremely complex molecule, originally isolated from a marine organism more than 50 years ago that has generated extensive research interest based on its protein kinase C (PKC) – modulating activity that affects many cellular processes. Much of the world’s supply to date was produced years ago by the National Cancer Institute (NCI), through a costly extraction from its marine source organism which is impractical for commercial development; that supply is largely depleted.

"The Wender synthesis process, which has been compared to the conquest of Mt. Everest, is a foundational pillar of BryoLogyx," said Thomas Loarie, CEO of BryoLogyx. "The Wender method’s translation into a scalable and economical process to sustainably supply clinical grade bryostatin-1 is a key step towards defining the molecule’s potential in immuno-oncology through clinical trials and exploring additional therapeutic opportunities." He noted that synthetic bryostatin-1 will be integrated into the company’s clinical program, which is expected to begin early next year.

"There exists an extensive body of clinical and preclinical research from the NCI and other laboratories that suggests that bryostatin-1 has a broad range of potential therapeutic applications. Its development as a therapeutic has been limited until today by supply. The availability of bryostatin-1 provides an important avenue for continued exploration of this molecule in cancer, auto-immune diseases, anti-inflammatory diseases, and infectious diseases," said Dr. Wender, Bergstrom Professor of Chemistry at Stanford University; and cofounder and Board of Directors member at BryoLogyx.

BryoLogyx recently announced that the Company had entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) to conduct its first clinical trial with bryostatin-1 in patients with relapsing or refractory CD22 expressing acute lymphoblastic leukemia (ALL) and lymphoma. The study will evaluate bryostatin-1’s safety and tolerability, its ability to upregulate the CD22 antigen, an essential target of CD 22-directed antibody drug conjugates (ADCs) and CAR T cell therapies. Subsequent studies will evaluate bryostatin-1’s ability to upregulate target antigens in a variety of other B cell hematologic malignancies.

Underscoring the broad impact of this synthesis, earlier this year BryoLogyx announced an agreement with Neurotrope, to supply that company with synthetic bryostatin-1 for use in developing a treatment for Alzheimer’s disease and other neurological disorders.

Christopher Conway, President, AMRI, noted, "The GMP synthesis of this extraordinarily complex molecule took more than two years of work at our facilities in Hyderabad, India; Albany, NY, and Grafton, WI. The close collaboration on the project among our drug development team, BryoLogyx, and Dr. Wender, underscores how AMRI works with partners to produce complex pharmaceuticals and become integral to our partners’ supply chains."