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Biotech Company Pascal Biosciences and SōRSE Technology Announce Partnership for Cannabinoid Drug Development and Cancer Clinical Trials

On September 15, 2020 Pascal Biosciences Inc. (TSX.V:PAS) ("Pascal") and SōRSE Technology Corporation ("SōRSE") reported that they have entered into a Collaborative Research Agreement to advance Pascal’s PAS-393 into clinical testing (Press release, Pascal Biosciences, SEP 15, 2020, View Source [SID1234565179]). Pascal and SōRSE will share their respective technologies to test the cannabinoid PAS-393 in human volunteers, enabling testing of cancer patients treated with checkpoint inhibitors.

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As initially announced last March, this partnership leverages SōRSE’s industry-leading formulation technology with Pascal’s proprietary cannabinoid programs for clinical trials. This will be the first pharmaceutical use of the novel formulation technology developed by SōRSE. The agreement will include Pascal’s intellectual property, which covers the use of cannabinoids in cancer patients treated with checkpoint inhibitors.

SōRSE currently sells and licenses a proprietary water-soluble cannabinoid emulsion technology (patent-pending) that enables increased bioavailability, accurate dosing, and more than 12 months’ shelf stability. Pascal and SōRSE scientists will optimize a cannabinoid formulation for human subjects and will then test the formulated PAS-393 in volunteers. SōRSE will provide $750,000 in research funding to Pascal throughout the 15-month collaboration and will pay for related research expenditures.

Following characterization of safety and pharmacology in a Phase 1a clinical trial, Pascal and SōRSE may elect to continue clinical development as equal partners in a Phase 1b cancer trial in combination with a checkpoint inhibitor. Dr. Gray will present scientific data this September 15th at the 3rd Annual International Cannabinoid-Derived Pharmaceutical Conference occurring in Boston, MA; the topic of his presentation is "Identifying and Validating Mechanism of Action In vivo/vitro."

"At SōRSE, we’re driven by our mission to help people better their lives through superior cannabinoid ingredients and delivery methods," said SōRSE CEO Howard Lee. "We were thrilled when Pascal Biosciences reached out to us in the summer of 2019 asking to use our emulsion in their research study on immune recognition markers on cancer cells. Today, we are excited to continue to support pharmaceutical studies of cannabinoids with Pascal and other world-class researchers."

SōRSE intends to collaborate with other researchers and product developers to study cannabinoids in other medical applications. Pascal will continue to pursue other non-cancer indications for PAS-393.

"This is an impressive step forward for both Pascal and SōRSE, and hopefully our product will be a significant help to patients," commented Dr. Patrick Gray, CEO of Pascal Biosciences. "This will be the first clinical trial for each company, and we look forward to a long, fruitful relationship."

EpimAb Biotherapeutics Announces FDA Clearance of its IND Application for EMB-02, a Bispecific Dual Checkpoint Inhibitor

On September 15, 2020 EpimAb Biotherapeutics, a clinical stage biotech company specializing in bispecific antibodies, reported that it has received "STUDY MAY PROCEED" letter from the U.S. Food and Drug Administration (FDA) on an Investigational New Drug (IND) application for the Company’s second therapeutic development candidate, EMB-02 (Press release, EpimAb Biotherapeutics, SEP 15, 2020, View Source [SID1234565178]). The application was submitted to the FDA to investigate the treatment of solid tumors with EpimAb’s novel bispecific antibody.

"The advancement of our second bispecific antibody into the clinic expands our clinical portfolio and also shows that our FIT-Ig technology can generate a variety of clinical candidates," commented Dr. Chengbin Wu, founder and CEO of EpimAb Biotherapeutics. "We expect to file additional applications in the near future for novel bispecific antibody programs being developed to treat patients suffering from serious cancer types. In 2021, we expect to have a total of three programs under investigation in clinical trials."

EMB-02 is a bispecific antibody based on EpimAb’s proprietary FIT-Ig (Fabs-In-Tandem Immunoglobulin) technology to generate bispecific molecules with superior properties. EMB-02 simultaneously targets two checkpoint proteins, PD-1 and LAG-3, and has shown strong anti-tumor activities in preclinical models resistant to standard anti-PD-1 monotherapies.

While EMB-02 is progressing towards the clinic, EpimAb continues to investigate EMB-01, its lead candidate, in a Phase I/II clinical study in both China and the U.S., and is generating several additional biologics, creating a proprietary pipeline based on its FIT-Ig platform. These earlier-stage assets are focused on immuno-oncology approaches in areas of high unmet medical need in cancer.

Gilead’s Magrolimab, an Investigational Anti-CD47 Monoclonal Antibody, Receives FDA Breakthrough Therapy Designation for Treatment of Myelodysplastic Syndrome

On September 15, 2020 Gilead Sciences, Inc. (Nasdaq: GILD) reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for magrolimab, a first-in-class, investigational anti-CD47 monoclonal antibody for the treatment of newly diagnosed myelodysplastic syndrome (MDS) (Press release, Gilead Sciences, SEP 15, 2020, View Source [SID1234565177]).

MDS is a type of cancer caused by poorly formed or dysfunctional blood cells in the bone marrow. Approximately 15,000 people are diagnosed with MDS in the U.S. each year, and no new treatments have been approved in 14 years. The average survival rate for those with lower-risk MDS is six years and approximately 18 months for those with higher-risk MDS.

Breakthrough Therapy designation is designed to expedite the development and regulatory review of investigational treatments for serious or life-threatening conditions that, based on preliminary clinical evidence, have the potential to substantially improve clinical outcomes compared with available therapy.

The FDA granted Breakthrough Therapy designation for magrolimab based on positive results of an ongoing Phase 1b study, which evaluated magrolimab in combination with azacitidine in previously untreated intermediate, high and very high-risk MDS. In data presented at the 2020 European Hematology Society Congress, 91 percent of evaluable patients (n=33) treated with magrolimab plus azacitidine achieved an objective response, with 42 percent achieving a complete remission (CR). The combination of magrolimab plus azacitidine was generally well-tolerated. No maximum tolerated dose was reached and no MDS patients discontinued treatment due to a treatment-related adverse event.

"The Breakthrough Therapy designation recognizes the potential for magrolimab to help address a significant unmet medical need for people with MDS and underscores the transformative potential of Gilead’s immuno-oncology therapies in development," said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences.

Magrolimab is currently being studied in the double-blind, placebo-controlled, randomized Phase 3 ENHANCE trial in previously untreated higher risk MDS. The trial will evaluate the safety and efficacy of magrolimab, in combination with azacitidine, as measured by CR and duration of CR.

Magrolimab is an investigational agent and has not been approved anywhere globally. Its safety and efficacy have not been established.

About Magrolimab

Magrolimab is a first-in-class investigational monoclonal antibody against CD47 and macrophage checkpoint inhibitor that is designed to interfere with recognition of CD47 by the SIRPα receptor on macrophages, thus blocking the "don’t eat me" signal used by cancer cells to avoid being ingested by macrophages. Magrolimab is being developed in several hematologic and solid tumor malignancies, including MDS. Magrolimab has been granted Fast Track Designation by the FDA for the treatment of MDS, acute myeloid leukemia (AML), diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma. Magrolimab has also been granted Orphan Drug Designation by the FDA for MDS and AML and by the European Medicines Agency for AML.

Exelixis and Iconic Therapeutics Announce Promising Preclinical Data That Support Best-in-Class Potential for ICON-2 in Treatment of Solid Tumors

On September 15, 2020 Exelixis, Inc. (Nasdaq: EXEL) and Iconic Therapeutics reported new preclinical data that support the continued development of ICON-2, an ADC comprised of an anti-Tissue Factor (TF) antibody and Zymeworks’ proprietary linker-payload, for the treatment of diverse solid tumors (Press release, Exelixis, SEP 15, 2020, View Source [SID1234565175]). Exelixis has an exclusive option and license agreement for ICON-2 in oncology indications under its May 2019 agreement with Iconic Therapeutics, which discovered and is developing this novel ADC. The new data, which demonstrate the superior tolerability and exposure of ICON-2 compared with an MMAE anti-TF ADC, are being presented this week in a poster at the World ADC Digital Conference, which is being held online September 15-18.

"These data provide additional preclinical validation both of our platform of proprietary anti-TF molecules designed to efficiently but safely bind TF, which is overexpressed in a variety of solid tumors, and specifically for Iconic Therapeutics’ strategy to advance its next generation ADC targeting TF," said William L. Greene, M.D., Chief Executive Officer of Iconic Therapeutics. "Other anti-TF ADCs that use MMAE as a linker-payload have been associated with side effects that can reduce tolerability, including bleeding, neutropenia and skin toxicities. The data presented today demonstrate ICON-2 effectively kills solid tumor cells in a variety of preclinical studies with an improved tolerability profile, and support continued development of ICON-2 as a treatment for solid tumors. We are currently conducting additional preclinical and nonclinical studies in support of initiating human clinical trials of this potentially best-in-class anti-TF ADC."

TF plays a critical role in the coagulation cascade and its expression is generally restricted in normal tissue. However, solid tumors, including gastrointestinal, head and neck, cervical, ovarian and bladder tumors, frequently express TF at high levels, which is associated with poor prognosis. Although TF is an attractive target for ADC therapy, previous approaches have demonstrated the potential to interfere with the coagulation cascade and may have additional toxicities that could negatively impact their risk-benefit profile.

The data presented today include results from several preclinical studies of ICON-2. Key findings from these studies are:

ICON-2 binds to TF on human and non-human primate (NHP) cells with high affinity but does not affect coagulation as measured by FXa conversion and thrombin generation assays.
ICON-2 does not induce neutropenia in NHPs.
ICON-2 is more potent than an ADC containing MMAE conjugated to the same anti-TF antibody in mouse xenograft model of human pancreatic tumor cells.
ICON-2 is highly active in patient-derived xenograft models derived from multiple tumor types.
ICON-2 exhibits superior tolerability and exposure when compared directly with an MMAE ADC using the same anti-TF antibody in a NHP study.
"We entered into our exclusive option and license agreement with Iconic Therapeutics because its expertise in TF biology and access to proprietary ADC technology provide a robust foundation for developing potentially best-in-class therapies for solid tumor indications with significant unmet clinical need," said Peter Lamb, Ph.D., Executive Vice President, Scientific Strategy and Chief Scientific Officer of Exelixis. "The data presented today continue to support that potential and differentiate ICON-2 from other anti-TF ADCs. These promising results also underscore Exelixis’ ability to identify promising licensing opportunities as part of our ongoing pipeline expansion strategy, which includes both internally developed and in-licensed programs."

Under the terms of the May 2019 agreement, Exelixis has an exclusive option to license ICON-2 in exchange for an upfront option payment to Iconic of $7.5 million and a commitment of preclinical development funding. Exelixis can exercise its option at any time up to a potential IND application, and upon doing so would make an option exercise payment to Iconic and assume responsibilities for all subsequent clinical development and commercialization activities. Should Exelixis elect to exercise its option, Iconic will become eligible for future development, regulatory and commercialization milestone payments, as well as royalties on potential sales.

IDERA PHARMACEUTICALS TO PRESENT TILSOTOLIMOD DATA AT ESMO VIRTUAL CONGRESS 2020

On September 15, 2020 Idera Pharmaceuticals, Inc. ("Idera") (Nasdaq: IDRA) reported that final data from the ILLUMINATE-204 trial investigating intratumoral tilsotolimod, Idera’s investigational Toll-like receptor 9 (TLR9) agonist, will be presented in a Mini Oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020, to be held September 19-21, 2020 (Press release, Idera Pharmaceuticals, SEP 15, 2020, View Source [SID1234565174]). In addition, final results from ILLUMINATE-101 will be shared in a poster presentation.

ILLUMINATE-204 is a multi-center, two-arm phase 1/2 trial in patients with anti-PD-1 refractory advanced melanoma. The phase 1 portion of the trial tested the safety and efficacy of increasing doses of tilsotolimod in combination with either Yervoy* (ipilimumab) or Keytruda† (pembrolizumab). The phase 2 expansion of the trial enrolled additional patients at the recommended phase 2 dose (RP2D) of 8 mg of tilsotolimod in combination with Yervoy, which is the treatment regimen being evaluated for the same indication in the Company’s registrational trial, ILLUMINATE-301. Adi Diab, M.D., of The University of Texas MD Anderson Cancer Center, will be delivering the Mini-Oral presentation as part of the Mini Oral Session on Melanoma and Other Skin Tumors.

ILLUMINATE-101 is a phase 1b trial evaluating intratumoral tilsotolimod monotherapy in patients with refractory solid tumors, which was completed in December 2019. Final results for ILLUMINATE-101 will be presented by Hani M. Babiker, M.D., of the University of Arizona Cancer Center.

In addition to presentations on these Idera-sponsored trials, AbbVie will be presenting a trial-in-progress poster on their phase 1b study to determine the safety, tolerability, pharmacokinetics, and preliminary efficacy of combinations of ABBV-368 plus tilsotolimod in subjects with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). This trial is being conducted as part of an immuno-oncology clinical research collaboration between Idera and AbbVie.

The presentation titles are as follows:

1083MO: Final Results from ILLUMINATE-204, a Phase 1/2 Trial of Intratumoral Tilsotolimod in Combination with Ipilimumab in PD-1 Inhibitor Refractory Advanced Melanoma
1031P: Tilsotolimod Engages the TLR9 Pathway to Promote Antigen Presentation and Type I IFN Signaling in Solid Tumors
975TiP: Phase 1b Trial of ABBV-368 + Tilsotolimod in Combination With Nab-Paclitaxel and/or Budigalimab (ABBV-181) in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
The on-demand poster and oral presentations will be available beginning on Thursday, September 17 and Friday, September 18, respectively.

"We are very pleased that Dr. Diab will present final data from our phase 2 trial exploring tilsotolimod plus ipilimumab in advanced melanoma patients," stated Elizabeth Tarka, M.D., Idera’s Chief Medical Officer. "We are looking forward to completing our registrational trial for this indication, ILLUMINATE-301, where a comparator arm is included, and moving this potential therapy one step closer to those patients in need."

Idera also announced that the company will present at the H.C. Wainwright 22nd Annual Global Investment Conference on Tuesday, September 15, 2020 at 1:30 pm EDT. A live audio webcast of Idera’s presentation will be accessible in the Investor Relations section of Idera’s website at www.iderapharma.com.

About Tilsotolimod (IMO-2125)

Tilsotolimod is an investigational, synthetic Toll-like receptor 9 agonist. Intratumoral injection of tilsotolimod has been shown to promote both innate and adaptive immune activation. Tumors with an active immune response appear to respond better to CPIs than those that exclude or inhibit anti-tumor immune cells. Tilsotolimod in combination with CPIs may cause regression of locally injected and distant tumor lesions and increase the number of patients who benefit from immunotherapy.

Tilsotolimod has received both Fast Track designation and Orphan Drug designation from the FDA and is being evaluated in multiple tumor types and in combination with multiple checkpoint and costimulation therapies. For more information on tilsotolimod trials, please visit ClinicalTrials.gov.