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

On June 22, 2020 VBI Vaccines Inc. (Nasdaq: VBIV) ("VBI") a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, reported that updated Part B data from its ongoing Phase 1/2a study of VBI-1901, the company’s cancer vaccine immunotherapeutic candidate, in recurrent glioblastoma (GBM) patients is being presented in an e-poster at the 2020 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II, June 22-24, 2020 (Press release, VBI Vaccines, JUN 22, 2020, View Source [SID1234561340]).

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Emerging data from the ongoing Phase 1/2a study suggest that patients with a normal baseline CD4+/CD8+ T cell ratio may be more likely to experience delayed progression or tumor reduction, reflected as a tumor response. Five out of the six tumor responses seen to-date, including a recently confirmed partial response (PR), defined as a tumor reduction of more than 50% per the Response Assessment in Neuro-Oncology (RANO) criteria, suggest that the biomarker may predict patients most likely to respond to, and derive clinical benefit from, treatment with VBI-1901. Based on the data seen to-date, VBI is exploring a randomized, controlled, registrational clinical study for the next phase of development, which, subject to approval from regulatory bodies, could begin in 2021. In parallel, enrollment in the Phase 1/2a Part B study arm of VBI-1901 in combination with GSK’s AS01B adjuvant systems continues, with immunologic and tumor data expected in Q4 2020.

"The identification of the CD4+/CD8+ T cell ratio as a potentially-predictive biomarker and a recently confirmed partial response are more promising developments in what has, to-date, been an encouraging Phase 1/2a clinical study of VBI-1901," said David E. Anderson, Ph.D., VBI’s Chief Scientific Officer. "The CD4+/CD8+ ratio may reflect the immunologic fitness of CD4+ T cells in recurrent GBM patients and may be used in the next phase of clinical development to help identify patients most likely to respond to VBI-1901. Importantly, testing of the CD4+/CD8+ T cell ratio in this biomarker strategy would use a common assay that could be widely implemented throughout treatment settings. We are working diligently to advance an effective and accessible treatment for GBM patients, who currently have few options available."

A webcast of Dr. Anderson discussing this data with Allen Waziri, M.D., CEO and Co-Founder, iCE Neurosystems, Former Director of the Brain Tumor Program at Inova Neuroscience Institute, and member of VBI’s GBM/Immuno-Oncology Scientific and Clinical Advisory Board, can be found here: View Source

The e-poster is available on the "Events/Presentations" page in the "Investors" section of the VBI Vaccines website.

Highlights from the ongoing Phase 1/2a study of VBI-1901 in recurrent GBM patients:

Safety:
VBI-1901 continues to be well-tolerated with no vaccine-related safety signals observed at any dose
Immunogenicity:
In Part A, 12-month overall survival (OS) rate of 83% in vaccine responders (n=6) vs. 33% in non-responders (n=9)
Vaccine responders saw a 6.25-month improvement in median OS (14.0 months) vs. non-responders (7.75 months)
In both Part A and B of the study, tumor responses have been observed in 6 patients: 5 stable disease (SD) and 1 recently confirmed PR, which was previously reported as SD in November 2019
CD4+/CD8+ ratio biomarker:
A normal CD4+/CD8+ T cell ratio present at baseline has been identified as a potentially predictive biomarker correlated with tumor response
CD4+ effector memory cells (Tem), a component of this baseline biomarker, are the dominant subset of T cells that are known to depart from the blood and traffic to the tumor microenvironment
Patients with tumor responses have shown dynamic loss and boosting of these T cells, which may indicate that the T cells are trafficking to the tumor tissue
About the Phase 1/2a Study Design

VBI’s two-part Phase 1/2a study is a multi-center, open-label, dose-escalation study of VBI-1901 in up to 38 patients with recurrent GBM:

Phase 1 (Part A)
Dose-escalation phase that defined the safety, tolerability, and optimal dose level of VBI-1901 adjuvanted with granulocyte-macrophage colony-stimulating factor (GM-CSF) in recurrent GBM patients with any number of prior recurrences.
This phase enrolled 18 recurrent GBM patients across three dose cohorts of VBI-1901: 0.4 µg, 2.0 µg, and 10.0 µg.
Enrollment completed in December 2018.
Phase 2a (Part B)
Subsequent extension of the optimal dose level, 10.0 µg, as defined in the Part A dose escalation phase.
This phase is a two-arm study, enrolling 10 first-recurrent GBM patients in each arm, assessing 10.0 µg of VBI-1901 in combination with either GM-CSF or GSK’s proprietary AS01Badjuvant system as immunomodulatory adjuvants.
Enrollment of the 10 patients in the GM-CSF arm is complete. Enrollment of the 10 patients in the AS01B arm is ongoing.
VBI-1901 is administered intradermally when adjuvanted with GM-CSF and intramuscularly when adjuvanted with the AS01B adjuvant system. Patients in both phases of the study receive the vaccine immunotherapeutic every four weeks until tumor progression.

Per the Response Assessment in Neuro-Oncology (RANO) criteria – an international working group that was created to benchmark brain tumor response – a partial response (PR) is defined as a greater than 50% reduction in the sum of products of perpendicular diameters of all measurable enhancing lesions compared with the baseline, sustained for at least four weeks, with no new lesions or clinical progression of disease.

About VBI-1901 and GBM

VBI-1901 is a novel cancer vaccine immunotherapeutic candidate developed using VBI’s enveloped virus-like particle (eVLP) technology to target two highly immunogenic cytomegalovirus (CMV) antigens, gB and pp65. Scientific literature suggests CMV infection is prevalent in multiple solid tumors, including glioblastoma (GBM). GBM is among the most common and aggressive malignant primary brain tumors in humans. In the U.S. alone, 12,000 new cases are diagnosed each year. The current standard of care for treating GBM is surgical resection, followed by radiation and chemotherapy. Even with aggressive treatment, GBM progresses rapidly and is exceptionally lethal.