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Coherus BioSciences to Report Third Quarter 2018 Financial Results on November 8th

On October 22, 2018 Coherus BioSciences, Inc. (Nasdaq: CHRS) reported that its third quarter 2018 financial results will be released after market close on Thursday, November 8, 2018 (Press release, Coherus Biosciences, OCT 22, 2018, View Source/news-releases/news-release-details/coherus-biosciences-report-third-quarter-2018-financial-results" target="_blank" title="View Source/news-releases/news-release-details/coherus-biosciences-report-third-quarter-2018-financial-results" rel="nofollow">View Source [SID1234531696]). Starting at 4:30 p.m. ET, Coherus’ management will host a conference call to discuss the financial results and provide a general business update.

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After releasing third quarter 2018 financial results, we will post them on the Coherus website at View Source." target="_blank" title="View Source." rel="nofollow">View Source

Conference Call Information
When: Thursday, November 8, 2018 at 4:30 p.m. ET
Dial-in: (844) 452-6826 (toll free) or (765) 507-2587 (International)
Conference ID: 7181479
Webcast: View Source
Please join the conference call at least 10 minutes early to register. The webcast will be archived on the Coherus website.

Forbius Announces First Patient Dosed in Phase 2 Trial of anti-EGFR ADC AVID100 in EGFR-Overexpressing Squamous NSCLC

On October 22, 2018 Forbius, a clinical stage company developing biotherapeutics targeting EGFR and TGF-β pathways, reported that the first patient has been dosed in a Phase 2a trial evaluating the efficacy and safety of AVID100 in patients with squamous non-small cell lung cancer (sqNSCLC) whose tumors over express epidermal growth factor receptor (EGFR) (Press release, Forbius, OCT 22, 2018, View Source [SID1234531670]).

Approximately 25% of patients with sqNSCLC have tumors that highly overexpress EGFR. Currently, no therapy is approved for the treatment of EGFR-overexpressing sqNSCLC.

An initial safety Phase 1 study for AVID100 was completed mid 2018, having enrolled 24 patients, and established a recommended Phase 2 dose (RP2D) of AVID100 of 240 mg/m2 (~6 mg/kg). This is one of the highest RP2Ds reported for maytansinoid payload ADCs (Deslandes, MAbs. 2014 Jul 1; 6(4):859–870) and is expected to be in the therapeutically active range based on preclinical efficacy studies. The majority of treatment related adverse events at RP2D were well-tolerated and grade 1 and 2 in severity. Of note, skin-related side-effects, that have been observed previously for therapeutic anti-EGFR antibodies, remained low grade and well tolerated.

"The sqNSCLC trial, along with additional soon-to-be launched Phase 2a trials, will provide us with important information about the efficacy of AVID100 in patients with confirmed EGFR overexpression. No therapy is approved for the treatment of EGFR-overexpressing malignancies, and AVID100 could be the first agent to address this significant unmet medical need," commented Paul Nadler, M.D., Chief Medical Officer of Forbius.

The primary goal of the Phase 2a trial is to evaluate efficacy, safety, and tolerability of AVID100 when administered to sqNSCLC patients with confirmed EGFR-overexpression. The study is being conducted at multiple sites across North America and will initially enroll approximately 15 sqNSCLC patients who failed all prior lines of treatment. The number of patients will be increased pending preliminary signs of AVID100 efficacy. This Phase 2a study is being supported by the previously announced $18.8M peer-reviewed grant from the Cancer Prevention Institute of Texas(CPRIT).

About AVID100
AVID100 is a highly potent EGFR-targeting antibody-drug conjugate (ADC) that was engineered to achieve enhanced anti-tumor efficacy without a corresponding increase in toxicity against skin and other EGFR-expressing normal tissues. In preclinical studies, AVID100 demonstrated significant anti-cancer activity, including in EGFR overexpressing tumor models that are resistant to marketed EGFR inhibitors. AVID100 is the only broadly active anti-EGFR ADC in clinical development

Oncolytics Biotech® Announces Positive Clinical Trial Results for Pelareorep in Patients with KRAS Mutant Metastatic Colorectal Cancer for Presentation at ESMO 2018

On October 22, 2018 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus turning cold tumors hot, reported positive clinical trial results for pelareorep in the treatment of patients with KRAS mutant metastatic colorectal cancer. Patients receiving treatment with the recommended phase 2 dose (RPTD) of pelareorep ("Reo") in combination with FOLFIRI/B (irinotecan, fluorouracil, leucovorin, plus bevacizumab) had progression free survival (PFS) of 65.6 weeks and an overall survival (OS) of 107.5 weeks, which exceeded expectations when compared to historical data (Press release, Oncolytics Biotech, OCT 22, 2018, View Source [SID1234530638]). Engagement of the adaptive immune system was also noted, suggesting that pelareorep promotes an inflamed tumor phenotype. This clinical data was presented at the annual European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress, taking place October 19-23 in Munich.

"The results from the six patients in this study receiving the recommended phase two dose demonstrate a more than doubling of overall survival based on previous phase three studies using FOLRIRI with anti-VEGF therapy," said lead author, Dr. Sanjay Goel, M.D., Department of Medical Oncology, Montefiore Medical Center. "These favorable results lend support to pelareorep as a potential treatment option in this patient population with metastatic disease, that has shown disease progression on current standard-of-care chemotherapy."

Poster Presentation at ESMO (Free ESMO Whitepaper) 2018
The poster titled "Dose finding and safety study of Reovirus (Reo) with irinotecan/fluorouracil/leucovorin/bevacizumab (FOLFIRI/B) in patients with KRAS mutant metastatic colorectal cancer (mCRC): Final Results", was presented yesterday at ESMO (Free ESMO Whitepaper). This phase 1 dose escalation study enrolled 36 patients with oxaliplatin refractory KRAS mutant metastatic colorectal cancer. The trial was designed to determine the maximum tolerated dose and a RPTD.

Highlights from the Poster:
•
Of the six patients receiving the RPTD, three had a partial response (50%) and the median PFS and OS were 65.6 weeks and 107.5 weeks, respectively, exceeding expectations when compared to historical data
•
Reovirus administration is marked by activation of cytotoxic T-cells and rapid maturation of dendritic cells
•
Reovirus is safe and well tolerated in combination with FOLFIRI and Bevacizumab

"This impressive survival data coupled with the engagement of the adaptive immune system reinforce both the data from our metastatic breast cancer program and the increasing interest in studies combining pelareorep with immune checkpoint inhibitors," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech. "The results presented at ESMO (Free ESMO Whitepaper) suggest the clinical utility of pelareorep may expand into multiple indications, including breast, colon and other cancers, and support our clinical development program."

Additional details can be found on the company website: View Source

References:
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Journal of Oncology, Vol. 30, Number 28, October 1, 2012
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The Lancet, Vol. 16, May 2015
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The Lancet, Vol. 14, January 2013

About Pelareorep
Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

Moffitt Cancer Center and Anixa Biosciences Announce Completion of Pre-IND Meeting with FDA for CAR-T Therapy

On October 22, 2018 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on using the body’s immune system to fight cancer, reported that it, along with its partner Moffitt Cancer Center (MCC), completed a pre-IND (Investigational New Drug) meeting with the US FDA on October 16, 2018 (Press release, Anixa Biosciences, OCT 22, 2018, View Source [SID1234530498]).

The meeting was focused on discussing the development of a novel CAR-T therapy that takes advantage of specific hormone–hormone receptor biology to address ovarian cancer. Approved CAR-T therapies and others in clinical trials have demonstrated dramatic results for certain hematological cancers (also known as liquid tumors), but to date there has not been any meaningful demonstration of CAR-T efficacy against solid tumors in humans. Anixa and MCC hope their therapy will demonstrate success with ovarian cancer patients due to their unique hormone–hormone receptor approach. If successful in ovarian cancer, this approach may create a new pathway for CAR-T development against many other solid tumors.

Dr. Amit Kumar, President and CEO of Anixa Biosciences said, "It is very consequential that we have begun a dialogue with the FDA. The pre-IND meeting answered a number of questions we presented to the FDA and clarified some matters, providing us with a good understanding of the design for the clinical trial in our IND application. Further, we identified the final experiments needed to complete our IND filing. We are in the process of completing these experiments, after which we will file our IND application. The IND, after review and approval by the FDA, will enable us to test our therapy in ovarian cancer patients. Assuming the FDA approves our IND, we anticipate beginning the trial as early as the summer of 2019."

Dr. Jose Conejo-Garcia, chair of the Department of Immunology at Moffitt Cancer Center, the inventor of the technology, and the Principal Investigator of the team developing the therapy added, "Our CAR-T is the first in human therapy of its kind and the feedback we received from the FDA was quite helpful. We are excited to be so close to bringing our investigational therapy to ovarian cancer patients."

Corvus Pharmaceuticals Announces New Data on Adenosine Gene Signature Biomarker Associated with Patient Response to CPI-444 at European Society for Medical Oncology (ESMO) 2018 Congress

On October 22, 2018 Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of precisely targeted oncology therapies, reported new data on a biomarker associated with patient response to therapy with CPI-444, an adenosine receptor antagonist. This "adenosine gene signature" has the potential to be used as a predictive biomarker for patient selection in future clinical studies of CPI-444 and other therapies targeting the adenosine pathway, including CPI-006 (Press release, Corvus Pharmaceuticals, OCT 22, 2018, View Source [SID1234530341]). The biomarker data was presented today in a poster discussion session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress in Munich, Germany, by Stephen Willingham Ph.D., a senior scientist at Corvus.

CPI-444, Corvus’ lead product candidate, is a selective and potent inhibitor of the adenosine A2A receptor. It is currently being evaluated in clinical trials in patients with various solid tumors as a single agent and in combination with Genentech’s atezolizumab, an anti-PD-L1 antibody. CPI-006 is a humanized monoclonal antibody directed against CD73. It is currently being evaluated in an early-stage, three-arm clinical trial in patients with a variety of solid tumors as a single agent, in combination with CPI-444, and in combination with pembrolizumab, an anti-PD-1 antibody.

"The gene expression profiles associated with the adenosine pathway have been shown to lead to the secretion of various inflammatory cytokines and chemokines that recruit suppressive myeloid cells and dampen T-cell function. The biomarker data presented at ESMO (Free ESMO Whitepaper) demonstrates that in vitro and in vivo treatment of human immune cells with CPI-444 blocks the expression of this adenosine gene signature, confirming its mechanism of action," said Dr. Willingham. "The expression of the adenosine gene signature has been shown to correlate with tumor regression in our ongoing Phase 1/1b trial of CPI-444 for the treatment of patients with renal cell carcinoma (RCC). In the trial, patients with high expression of the adenosine gene signature were more likely to have tumor regression than those patients with low expression (p<0.008). Our data, together with other recently published data, indicate that tumors with an adenosine-rich environment are resistant to therapy with anti-PD-(L)1 antibodies, and provide support for the addition of CPI-444 to these therapies to enhance efficacy."

"Our discovery of the adenosine gene signature biomarker represents a major step forward for therapies based on blockade of the adenosine pathway," said Richard A, Miller M.D., an oncologist; co-founder, president and chief executive officer of Corvus. "This biomarker could potentially be used in the future to select patients most likely to benefit from adenosine blockade with either CPI-444 or antibodies that inhibit adenosine production, such as CPI-006. These data, as well as our ongoing trials with CPI-444 and CPI-006, continue to advance the field and confirm the mechanism of action of CPI-444 and adenosine antagonism. Additional data on these programs will be presented at the Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting in November."

About CPI-444
CPI-444 is a small molecule, oral, checkpoint inhibitor designed to disable a tumor’s ability to subvert attack by the immune system by blocking the binding of adenosine in the tumor microenvironment to the A2A receptor. Adenosine, a metabolite of ATP (adenosine tri-phosphate), is produced within the tumor microenvironment where it may bind to the adenosine A2A receptor present on immune cells and block their activity. CD39 and CD73 are enzymes on the surface of tumor cells and immune cells. These enzymes work in concert to convert ATP to adenosine. In vitro and preclinical studies have shown that dual blockade of CD73 and the A2A receptor may be synergistic.

About CPI-006
CPI-006 is a potent humanized monoclonal antibody that reacts with the active site of CD73, blocking the conversion of AMP to adenosine. In vitro studies of CPI-006 have shown it is capable of substantially inhibiting the production of adenosine by blocking the CD73 enzyme.