On November 4, 2019 Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, reported it has initiated its compassionate use program for Namodenoson in the treatment of hepatocellular cancer (HCC), the most common form of liver cancer (Press release, Can-Fite BioPharma, NOV 4, 2019, View Source [SID1234550208]). Can-Fite’s compassionate use program has enrolled and started treating patients. The compassionate use program, which enables liver cancer patients not enrolled in Can-Fite’s clinical study to be treated with Namodenoson, is being administered by Dr. Salomon Stemmer, the Principal Investigator of the Company’s prior Phase II liver cancer study, and Professor at the Institute of Oncology, Rabin Medical Center, Israel.

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Compassionate use allows doctors and their patients the option of early access to investigational new drugs, under closely controlled and monitored circumstances, when a patient who is facing serious illness has exhausted all available treatment options.

Can-Fite’s completed Phase II liver cancer study found that Namodenoson increased overall survival in HCC patients with Child Pugh B7 (CPB7), the largest subpopulation of the study, as compared to placebo, even though the trial did not meet its primary endpoint. The Company recently completed a successful End-of-Phase II meeting with the U.S. Food and Drug Administration (FDA), in which the FDA agreed with Can-Fite’s proposed pivotal Phase III trial design to support a New Drug Application (NDA) submission and approval of Namodenoson in the treatment of HCC.

We are grateful to Dr. Stemmer for leading this compassionate use program, making Namodenoson available to patients who have exhausted all other treatment options. Based on the encouraging results of our recent Phase II trial, in which Namodenoson demonstrated clinical benefits in patients with underlying CPB7 cirrhosis, Can-Fite is committed to providing Namodenoson to fulfill the unmet medical need in this population," stated Can-Fite CEO Dr. Pnina Fishman.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is being evaluated as a second line treatment for hepatocellular carcinoma, with a recently completed Phase II trial and planned Phase III trial in this indication. The drug is currently in an ongoing Phase II trial as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

On November 4, 2019 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology (I-O) company with a pipeline of immune checkpoint antibodies, adoptive cell therapies1, and cancer vaccines provided a corporate update and reported financial results for the third quarter of 2019 (Press release, Agenus, NOV 4, 2019, View Source [SID1234550207]).

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"We have made solid progress this year," said Garo H. Armen, Ph.D., Chairman and CEO of Agenus. "We expect clinical readouts from six separate antibody programs in 2020 as our robust pace continues. We expect to commence combo trials of our NexGen CTLA-4 with our own PD-1 this month. 2020 is expected to be an important year of data generation, substantial milestone payments and prudent collaborations for Agenus. We look forward to discussing these developments in more detail during our call and at our R&D day on November 15th."

Achievements
Delivered on partnership programs; received additional cash milestones
Received $22.5 million from Gilead as milestone payment for IND acceptances of AGEN1423 (now GS-1423), AGEN1223, & AGEN2373
CTLA-4 & PD-1 trials advance
2L cervical cancer trial designed to support BLA via accelerated pathway
Combination trial completes accrual and interim analysis
Monotherapy trial is on track to complete accrual and interim analysis by year-end
AGEN1181 (NexGen CTLA-4) trial advancing; combos with AGEN2034 (PD-1) to start
QS-21 Updates
Sales of Shingrix exceed $1Bn; eliminating HCR debt obligation and nearing milestone triggers of up to $40M
AgenTus Cell Therapy Business:
IND for AgenTus allogeneic cell therapy on track by year end; combos with Agenus check point antibodies planned in 2020
Partnership and private financing discussions are underway
Dr. Walter Flamenbaum appointed CEO of AgenTus
Third Quarter 2019 Financial Results

We ended the third quarter of 2019 with a cash balance of $93 million as compared to $53 million at December 31, 2018.

Cash used in operations for the quarter ended September 2019 was $28 million compared to $25 million for the same period in 2018. Cash provided by operations for the nine months ended September 2019 was $13 million as compared to cash used in operations of $95 million for the same period in 2018.

For the third quarter ended September 30, 2019, we reported net loss of $46 million or $0.33 per share compared to a net loss for same period in 2018 of $34 million, or $0.29 per share. For the nine months ended September 30, 2019, we reported a net loss of $81 million or $0.58 per share compared to a net loss for the same period in 2018 of $113 million or $1.04 per share.

During the nine months ended September 2019 we recognized revenue of $116 million which includes revenue from our transaction with Gilead and non-cash royalties earned. This compares to revenue of $30 for the nine months ended September 2018. Through the third quarter of 2019 we also recorded $30 million of non-cash interest expense due to our transaction with HCR related to the sale of future royalties.

Conference Call, Webcast and Prepared Statement Information

Date: Monday, November 4, 2019
Time: 8:30 a.m. ET
Domestic Dial-in Number: (844) 492-3727
International Dial-in Number: (412) 317-5118
Conference ID: Agenus

Live Webcast: accessible from the Company’s website at View Source or with this link View Source

A replay will be available on the Company’s website approximately two hours after the call and will remain available for 90 days.

On November 4, 2019 Vivoryon Therapeutics AG (Euronext Amsterdam: VVY), reported that the company is scheduled to attend and present at upcoming conferences in November (Press release, Vivoryon Therapeutics, NOV 4, 2019, View Source [SID1234550200]).

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(1) BIO Europe

November 11-13, 2019; Hamburg Messe, Hamburg, Germany

Dr. Ulrich Dauer, CEO, and Dr. Michael Schaeffer, CBO, to host meetings
Dr. Dauer to present on Monday, November 11, 2019; at 3:30pm CET, in Hall B1, Room 6 on Level 1

(2) Deutsches Eigenkapitalforum

November 25-27, 2019; Sheraton Frankfurt Airport Hotel & Conference Center, Frankfurt, Germany

Dr. Ulrich Dauer, CEO, to host meetings and present on Monday November 25, 2019; at 3:00pm CET in Room Oslo

On November 2, 2019 Veracyte, Inc. (Nasdaq: VCYT) reported new data that advance understanding of the frequency, positive predictive value and co-occurrence of genomic alterations that are targeted by newly available and investigational precision medicine therapies for thyroid cancer (Press release, Veracyte, NOV 2, 2019, View Source [SID1234550197]). The findings were enabled by Afirma Xpression Atlas analyses, which uses RNA sequencing, of Veracyte’s extensive biorepository of thyroid nodule fine needle aspiration (FNA) samples from patients undergoing evaluation for thyroid cancer. The data were presented this week during the 89th Annual Meeting of the American Thyroid Association (ATA).

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In one study, researchers assessed the frequency of ALK, BRAF, NTRK and RET fusions in nearly 48,000 consecutive patients whose thyroid nodule FNA samples were deemed indeterminate, suspicious for malignancy or malignant (Bethesda III/IV, V and VI categories, respectively) by cytopathology. The researchers found that 425 (0.89 percent) of the FNA samples harbored one of the alterations, with NTRK fusions the most common at 0.38 percent, followed by RET (0.32 percent), BRAF (0.13 percent) and ALK (0.06 percent). Additionally, RNA whole transcriptome sequencing demonstrated differences in the prevalence of these four fusions across Bethesda categories, with Bethesda V being the highest.

"NTRK fusion inhibitors have received pan-cancer FDA approval and clinical trials have included selective inhibitors of ALK, BRAF, NTRK and RET, which makes their detection in patients with thyroid cancer of interest to physicians," said Mimi I. Hu, M.D., professor at The University of Texas MD Anderson Cancer Center, who presented the findings in a poster. "As our understanding of the role of genomics in thyroid cancer advances, this information offers the potential to optimize initial treatment, predict response to treatment and prioritize selective targeted therapy should systemic treatment be needed."

In another study, researchers evaluated the positive predictive value of the NTRK, RET, BRAF and ALK fusions in 58 patients with indeterminate thyroid nodules (Bethesda III/IV categories) from Veracyte’s biorepository for whom surgical pathology diagnoses were available. They found that NTRK and RET fusions were associated with malignancy in 28 of 30 nodules, while risk of malignancy was lower among nodules with ALK (67 percent) or BRAF (75 percent). In a third study, researchers found that when using RNA sequencing data on a large sample of nearly 48,000 thyroid nodule FNA samples (Bethesda categories III-VI), they identified 263 co-occurrences of gene fusions and variants that were previously considered "mutually exclusive."

"The findings from these three studies underscore the power of our extensive biorepository of thyroid nodule FNA samples and our optimized RNA sequencing platform to advance understanding of the genomic underpinnings of thyroid cancer and to better capture the biology of thyroid lesions," said Richard T. Kloos, M.D., senior medical director, endocrinology, at Veracyte. "As precision medicine therapies that target specific gene alterations emerge, understanding individual patients’ genomic profiles becomes increasingly important to physicians. Our Afirma Xpression Atlas provides this information at the same time as initial diagnosis with the Afirma Genomic Sequencing Classifier, or GSC, to help inform treatment decisions."

Also during the ATA meeting, Veracyte unveiled its new Afirma patient report, which in addition to identifying patients with benign or suspicious-for-cancer nodules among those deemed indeterminate by cytopathology, based on Afirma GSC results, now provides individualized and actionable variant and fusion information on each patient. This information includes: risk of malignancy, associated neoplasm type, relative risk of lymph node metastasis and extrathyroidal extension; availability of FDA-approved therapy; and genetic counseling and germline testing considerations. This information is also provided for patients with cytopathology results that are suspicious for malignancy or malignant (Bethesda V and VI).

About Afirma

The Afirma Genomic Sequencing Classifier (GSC) and Xpression Atlas provide physicians with a comprehensive solution for a complex landscape in thyroid nodule diagnosis. The Afirma GSC was developed with RNA whole-transcriptome sequencing and machine learning and helps identify patients with benign thyroid nodules among those with indeterminate cytopathology results in order to help patients avoid unnecessary diagnostic thyroid surgery. The Afirma Xpression Atlas provides physicians with genomic alteration content from the same fine needle aspiration samples that are used in Afirma GSC testing and may help physicians decide with greater confidence on the surgical or therapeutic pathway for their patients. The Afirma Xpression Atlas includes 761 DNA variants and 130 RNA fusion partners in over 500 genes that are associated with thyroid cancer.

On November 2, 2019 Vaccibody AS, a clinical stage company focused on developing personalized neoepitope cancer vaccines to target solid tumors, reported that it will host its capital markets day on November 12 and is pleased to invite investors, analysts and press to presentations by the members of the company’s executive management team and by Ulrich Granzer, PhD, founder of Granzer Regulatory Consulting & Services (Press release, Vaccibody, NOV 2, 2019, View Source [SID1234550196]). Granzer has a wide range of experience in all aspects of drug development and regulatory affairs, with particular focus on bringing novel therapies to market.

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Venue: Forskningsparken, Gaustadalléen 21, 0349 Oslo. Meeting room Faros.

Date: Tuesday, 12th November 2019

Agenda:

14.00-14.10 Introduction Michael Engsig
14.10-15.00 Update on the VB N-01 study including the clinical data Agnete Fredriksen
15.00-15.45 Status of the cancer vaccine field and development of novel immunotherapies Ulrich Granzer
15.45-16.05 Company update Michael Engsig
16.05-16.30 Questions & Answers All
16.30-17.30 Mingling, snacks and drinks All