On June 22, 2020 Calidi Biotherapeutics, Inc., a clinical-stage biotechnology company at the forefront of oncolytic virus-based immunotherapies for cancer, reported that data from clinical studies on their oncolytic agent, CAL1 vaccinia virus, and stem cell delivery system will be presented at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting II, which will be held in virtual format June 22 through June 24, 2020, due to COVID-19 concerns (Press release, Calidi Biotherapeutics, JUN 22, 2020, View Source [SID1234561345]).

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Calidi’s respective e-poster presentations will highlight findings from translational research on the potential use of the CAL1 vaccinia virus, a version of the ACAM2000 smallpox vaccine delivered via an allogeneic adipose-derived mesenchymal stem cell (MSC) system, as well as insights from clinical trials analyzing the potential use of Calidi’s autologous SVF delivery platform to modulate innate and adaptive immunity in patients with solid tumors and hematological malignancies.

CAL1 was evaluated for abilities to safely replicate and selectively kill cancer cells, to be genetically modified (generating next generation armed-oncolytic viruses) without affecting its natural tumor selectivity, and to determine if its anti-tumor effects can be enhanced and protected from inactivation by immune system response when delivered via Calidi’s off-the-shelf MSC platform. The modified vaccinia virus strain demonstrated efficacy as an oncolytic agent, exhibiting heightened therapeutic capacity when loaded into adipose-derived mesenchymal stem cells to create Calidi’s SuperNova (SNV) product.

Calidi’s study on the immunomodulatory potential of vaccinia virus delivered by autologous SVF-derived cells expanded on their recent first-in-human Phase I clinical trial, which confirmed the safety and feasibility of their approach for improving virus delivery and tumor targeting. This study establishes a timeline of treatment-related immunological changes, identifies potential immunological correlations with continued amplified oncolytic therapy, and provides insights into the role of interpatient immunological variability and future oncolytic virotherapy evaluation.

Both abstracts indicate significant advantages and fundamental rationale for the development of vehicles like Calidi’s cell-based delivery platform (View Source), designed to protect and potentiate oncolytic viruses by circumventing innate and adaptive immune barriers, resulting in enhanced oncolytic virotherapy.

AACR presentation details are as follows:

Abstract 6542: CAL1 vaccinia virus as oncolytic agent and potential use of cell-based platform to enhance its therapeutic effects
Date: June 22, 2020, from 9:00 AM to 6:00 PM

Abstract 4473: Evaluation of the potential of oncolytic vaccinia virus delivered by autologous SVF to modulate innate and adaptive immunity in patients with diverse solid and hematological malignancies
Date: June 22, 2020, from 9:00 AM to 6:00 PM

On June 22, 2020 Silverback Therapeutics ("Silverback"), a biopharmaceutical company advancing a pipeline of therapies that are systemically delivered but locally active, reported that preclinical data for its lead ImmunoTAC candidate, SBT6050, will be presented at AACR (Free AACR Whitepaper) Virtual Annual Meeting 2020 Session II at 9:00 a.m. ET on June 22, 2020 (Press release, Silverback Therapeutics, JUN 22, 2020, View Source [SID1234561344]).

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The presentation, titled "SBT6050, a HER2-Directed TLR8 ImmunoTAC Therapeutic, is a Potent Human Myeloid Cell Agonist that Provides Opportunity for Single Agent Clinical Activity," shows that TLR8 agonism potently and uniquely activates human myeloid cells, driving a broad spectrum of anti-tumor immune mechanisms, including those not dependent on T cells.

In preclinical studies, SBT6050 activates human myeloid cells in the presence of HER2 expressing tumor cells, resulting in proinflammatory cytokine and chemokine production, inflammasome activation, and the indirect activation of cytolytic activity associated with T and NK cells. SBT6050’s functional profile was not replicated with conjugates comprised of TLR7-specific or resiquimod-derived agonists.

Robust, durable single agent activity is observed with the SBT6050 mouse surrogate in multiple tumor models, including those with low tumor infiltrating lymphocytes. In a human xenograft model lacking T, B, and NK cells, the SBT6050 mouse surrogate is curative as a single agent, demonstrating the ability of myeloid cells to mediate strong anti-tumor activity.

"TLR8’s robust expression and functional profile in human myeloid cells uniquely positions SBT6050 to potentiate anti-tumor responses through the activation of these innate immune cells present in tumors," said Valerie Odegard, Ph.D., Silverback’s chief scientific officer. "Our preclinical data highlight SBT6050’s potential to maximize anti-tumor immune responses, even in tumors lacking T cells. We are excited to be developing a much-needed immunotherapy for patients with HER2-expressing disease and will enter the clinic later this year."

On June 22, 2002 Onco360, the nation’s largest independent Oncology Pharmacy, reported that it has been selected by Epizyme to be the specialty pharmacy partner for TAZVERIK (Tazemetostat), a new oral treatment for adult with relapsed/refractory follicular lymphoma whose tumors are positive for an EZH2-mutation as detected by an U.S. Food and Drug Administration (FDA)-approved test and who have received at least two prior systemic therapies or for adult patients with relapsed/refractory follicular lymphoma who have no satisfactory alternative treatment options (Press release, Onco360, JUN 22, 2020, View Source [SID1234561343]).

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"The approval of TAZVERIK as a treatment option for patients with relapsed/refractory follicular lymphoma is an important advancement in fighting this devastating disease," said Paul Jardina, President and CEO, Onco360. "As a specialty oncology pharmacy, we are committed to improving the lives of cancer patients suffering from follicular lymphoma."

Follicular lymphoma is the second-most common type of non-Hodgkin lymphoma and is considered to be indolent, yet incurable. According to the National Comprehensive Cancer Network Guidelines for B-Cell Lymphomas, approximately 12,600 patients are diagnosed with follicular lymphoma on an annual basis. When considering all stages of the disease, follicular lymphoma has a five-year overall survival of 89%. Approximately 30% of follicular lymphoma patients are found to have EZH2-mutations.

TAZVERIK is manufactured by Epizyme, a global, commercial-stage, research-based biotechnology company, and was previously approved by the FDA in January 2020 for the treatment of adult and pediatric patients (aged 16 years and older) with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. The FDA’s approval of TAZVERIK for relapsed/refractory follicular lymphoma is based on the results of two open-label, single-arm cohorts of the Phase I/II E7438-G000-101 clinical trial (NCT01897571) which demonstrated a 69% overall response rate in EZH2-mutant relapsed/refractory follicular lymphoma patients who received at least two prior lines of systemic therapy and a 34% overall response rate in EZH2-wild-type relapsed/refractory follicular lymphoma patients who received at least two prior lines of systemic therapy. For full prescribing information, visit TAZVERIK.com.

On June 22, 2020 EpimAb Biotherapeutics, an emerging Shanghai-based biopharmaceutical company specializing in bispecific antibodies, reported that preclinical data at the 2020 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II (Press release, EpimAb Biotherapeutics, JUN 22, 2020, View Source [SID1234561342]). The data presented in the poster titled, "EMB-01: An innovative bispecific antibody targeting EGFR and cMet on tumor cells mediates a novel mechanism to improve anti-tumor efficacy", characterizes EMB-01, EpimAb’s lead bispecific antibody candidate developed based on the company’s proprietary FIT-Ig platform to target EGFR and cMet on tumor cells simultaneously. EMB-01 is currently progressing through a Phase I/II clinical trial in patients with advanced metastatic solid tumors.

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"The characterization of EMB-01 shows that the FIT-Ig-based design enables it to bind simultaneously to EGFR and cMet, both found on the surface of various tumor cells, where it then induces co-degradation of these two receptors," said Dr. Chengbin Wu, CEO and founder of EpimAb. "The resulting highly potent and durable anti-tumor effect in animal models encouraged EpimAb to rapidly advance EMB-01 to the clinic where it is currently being investigated in oncology indications. The unique biology underlying EMB-01 encouraged our research teams to explore various options in human research, and the clinical validation of our FIT-Ig platform facilitated our efforts in advancing additional bispecific antibody programs, such as EMB-02 and EMB-06, for which we expect to file two new INDs in 2020."

"With the unique mechanism of action, EMB-01 could provide a new treatment option for non-small cell lung cancer patients previously treated with current drugs on the market but who later developed resistance, as well as for other solid tumors where disease progression is mediated by EGFR and/or cMet," said Dr. Bin Peng, Chief Medial Officer of EpimAb. "EpimAb is excited to learn more from our ongoing clinical trials."

The preclinical study shows that EMB-01 binds to EGFR and cMet simultaneously and induces co-degradation of both targets in various tumor cells, an effect unattainable by parental monoclonal antibodies (mAbs) alone or in combination. EMB-01 was also shown to exhibit more extensive inhibition of EGFR and cMet downstream signals, and a more potent and durable in vivo efficacy in various PDX tumor models compared to parental mAbs. This enhanced potency could likely be driven by EMB-01-mediated co-degradation of the EGFR and cMet in tumor cells.

EMB-01 is a novel bispecific antibody developed based on EpimAb’s proprietary FIT-Ig platform to simultaneously target EGFR and cMet on tumor cells. The anti-EGFR and anti-cMet Fab-domains in each EMB-01 arm are fused directly in-tandem in a unique crisscross orientation without any mutations or use of peptide linkers to form a final tetravalent binding complex with the corresponding receptors on the cell surface.

On June 22, 2020 ImmunSYS, Inc., a clinical-stage biopharmaceutical company focused on the development of innovative cancer immunotherapy products, reported results from a proof of concept (PoC) study evaluating its proprietary technology platform, YourVaccx for the treatment of patients with metastatic cancers (Press release, ImmunSYS, JUN 22, 2020, View Source [SID1234561341]).

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The retrospective, IRB approved case series was independently monitored by a contract research organization. A total of 27 patients were enrolled, including 21 with metastatic prostate cancer (mPCa), and 6 with metastatic cancers of varying types: 2 bladder, 1 pancreatic, 1 melanoma, 1 colon cancer and 1 unknown. A single treatment cycle consisted of in situ cryosurgical lysis of tumor tissue followed by a direct injection of a combination of anti CTLA-4 antibody, anti PD-1 antibody and GM-CSF into the target treatment zone, followed by 30 days of daily subcutaneous GM-CSF. The patients were assessed after the completion of therapy, which varied from between 1 and 3 cycles of treatment. All responses to therapy were assessed by RECIST v. 1.1 and metastatic prostate cancer patients were also assessed by serum PSA levels. 3 patients could not be evaluated due to a lack of follow-up imaging. For all evaluable patients, the PoC study data showed a 38% (9/24) complete response rate (CR) and a 4% (1/24) partial response rate (PR), for an objective response rate (ORR) of 42% (10/24). The combination therapy was generally well tolerated.

Key findings in mPCa patients:

Among the 18 evaluable mPCa patients, there was a 50% (9/18) CR
50% (9/18) ORR
62% (13/21) of patients had post-therapy PSA reductions of ≥ 50%
The majority of responses have been durable, with 5 of 9 CRs persisting from 12 months to over 51 months to date
6 Grade 3-4 adverse events occurred in 14.3% (3/21), with no treatment-related deaths
"We are pleased to present these encouraging findings at the AACR (Free AACR Whitepaper) virtual annual meeting II," said Eamonn Hobbs, Chairman and Chief Executive Officer of ImmunSYS. "These results demonstrate long-term, durable responses, ranging from 1 to 4.5 years, and a favorable tolerability profile in tough-to-treat patient populations. There is an unmet need for effective treatment options for patients with metastatic cancers and these data demonstrate the potential that YourVaccx has to significantly improve the lives of patients."

Our poster #6540 entitled, "Regression of metastatic cancer and abscopal effects following in situ vaccination by cryosurgical tumor cell lysis and intratumoral immunotherapy: A case series" and accompanying audio clip narrated by Gary Onik, M.D. is now available at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2020 Virtual Annual Meeting II.

For more information, a copy of the poster may be found on www.immunsys.com