On May 30, 2017 Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a leader in the discovery and development of engineered cell therapies, reported the issuance of United States Patent No. 9,663,763 relating to Celyad’s method of treating cancer by administering allogeneic primary human T cells that are engineered to be T-Cell Receptor (TCR)-deficient and to express a chimeric antigen receptor (CAR) (Press release, Celyad, MAY 30, 2017, View Source [SID1234519314]).

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US Patent 9,663,763 was examined under the Cancer Immunotherapy Pilot Program, also known as the "Patents 4 Patients" initiative, and is the third patent in Celyad’s allogeneic intellectual property portfolio awarded by the United States Patent and Trademark Office (USPTO). This new patent claims specifically methods of treating cancer patients with allogeneic TCR-deficient CAR-T immunotherapies. Earlier patents were related to the allogeneic TCR-deficient CAR-T cells per se, and to methods of producing them. The combination of these granted patents strengthens Celyad’s position and further confirms its leadership in engineered cell therapy, and in the allogeneic CAR-T space.

Allogeneic technology has the potential to broaden the therapeutic applications of CAR T-Cell immunotherapies as it does not depend on cells derived from the patient. TCR-deficient CAR-T cells are aimed at avoiding or greatly reducing adverse immune reactions (such as a graft- versus-hostdisease (GVHD) response) which would greatly benefit patients.

Dr. Christian Homsy, CEO of Celyad: "We are pleased to have obtained this new patent. The combination of this patent with the earlier granted US Patents consolidates our strong IP position in the CAR-T field and strengthens our IP portfolio covering key elements in the allogeneic TCR-deficient CAR-T cells production value chain."

Dr. Georges Rawadi, VP Business Development & IP at Celyad: "Allogeneic CAR-T cells are of increasing interest to many Pharma and BioPharma companies involved in cell-based cancer immunotherapies. We are looking to maximize the significant value of our allogeneic CAR-T assets through strategic collaborations and partnerships such as the ones we have established with ONO Pharma and Novartis."

On May 30, 2017 Sierra Oncology, Inc. (NASDAQ: SRRA), a clinical stage drug development company focused on advancing next generation DNA Damage Response (DDR) therapeutics for the treatment of patients with cancer, reported it has been issued a selection patent for its Chk1 inhibitor, SRA737, from the U.S. Patent and Trademark Office (Press release, Sierra Oncology, MAY 30, 2017, View Source [SID1234519311]). The patent explicitly covers SRA737 and extends its protection out to 2033 in the U.S., before any patent term extensions.

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The company also reported that a similar European Patent (No. 2855448) was previously issued for SRA737 on February 8, 2017. SRA737 is currently being evaluated in two Phase 1 clinical trials.

"These issuances further build on our intellectual property position for SRA737 and establish a solid foundation for the potential future commercialization of this promising drug candidate," said Dr. Nick Glover, President and CEO of Sierra Oncology. "We anticipate generating additional intellectual property claims as we advance our DDR-focused research activities and our innovative genetics-driven clinical programs."

U.S. Patent No. 9,663,503 pertains to SRA737, pharmaceutical compositions comprising such compounds, and the use of such compounds and compositions, both in vitro and in vivo, to inhibit Chk1 kinase function, and in the treatment of diseases and conditions that are mediated by Chk1, including proliferative conditions such as cancer. The patent also covers the use of SRA737 in combination with other agents.

SRA737-01, a Monotherapy trial prospectively enrolling patients with tumors identified to have genetic aberrations hypothesized to confer sensitivity to Chk1 inhibition via synthetic lethality into five indication-specific cohorts: colorectal, ovarian, non-small cell lung, prostate, and head and neck cancers. In cancer cells, replication stress induced by oncogenes (e.g., MYC or RAS) or genetic mutations in DNA repair machinery (e.g., BRCA1 or FA) combined with loss of function in tumor suppressors (e.g., TP53 or ATM) results in persistent DNA damage and genomic instability leading to an increased dependency on Chk1 for survival. Targeted inhibition by SRA737 may therefore be synthetically lethal to these cancer cells and have utility as a monotherapy in a range of tumor indications.

SRA737-02, a Chemotherapy Combination trial evaluating SRA737 in combination with low-dose gemcitabine in indication-specific cohorts of prospectively-selected, genetically-defined subjects with bladder or pancreatic cancer. Profound mechanistic potentiation has been reported when Chk1 inhibition is combined with DNA damaging cytotoxic agents or radiation. The widely-used chemotherapy gemcitabine is a strong exogenous inducer of replication stress and preclinical modeling demonstrates robust synergistic anti-tumor activity for SRA737 potentiated by gemcitabine.

Sierra Oncology is also advancing SRA141, a potent, selective, orally bioavailable small molecule inhibitor of Cell division cycle 7 kinase (Cdc7) undergoing preclinical development. Cdc7 is a key regulator of DNA replication and is involved in the DDR network, making it a compelling emerging target for the potential treatment of a broad range of tumor types. For more information, please visit www.sierraoncology.com.

On May 30, 2017 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, reported that the United States Food and Drug Administration cleared the Investigational New Drug (IND) application for LOXO-195, Loxo Oncology’s next-generation TRK inhibitor (Press release, Loxo Oncology, MAY 30, 2017, View Source [SID1234519310]). LOXO-195 was developed to treat patients with TRK fusion cancers who become resistant while receiving another TRK inhibitor, such as larotrectinib.

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"We hope that LOXO-195 can extend the period of durable disease control for patients with TRK fusion cancers," said Josh Bilenker, M.D., chief executive officer of Loxo Oncology. "Today, there are patients receiving larotrectinib in ongoing clinical trials who have ongoing clinical responses. We have an obligation to these patients, and all patients with TRK fusion cancers, to be ready when they need a new treatment option."

Informed by internal research and the medical literature, LOXO-195 was designed to address anticipated mechanisms of acquired resistance in cancers exposed to a prior TRK inhibitor, including "solvent front" mutations (e.g. NTRK1 G595R, NTRK3 G623R), which are not well-addressed by existing investigational agents. LOXO-195 will be developed as a sequential treatment, to follow larotrectinib or another TRK inhibitor, to extend the total time of benefit from TRK inhibition.

LOXO-195 will initially be studied in a multi-center Phase 1/2 trial. The primary objective of the trial is to determine the maximum tolerated dose or recommended dose for further study. Key secondary objectives include measures of safety, pharmacokinetics, and anti-tumor activity (i.e. Objective Response Rate and Duration of Response, as determined by RECIST v1.1). The trial will include a dose escalation phase and dose expansion phase.

About LOXO-195
LOXO-195 is a potent, oral and selective investigational new drug in clinical development for the treatment of patients with cancers that have acquired resistance to initial TRK therapy such as larotrectinib. Growing research suggests that the NTRK genes, which encode for TRKs, can become abnormally fused to other genes, resulting in growth signals that can lead to cancer in many sites of the body. Though drugs such as larotrectinib can induce durable responses in these patients, the cancer may eventually begin to grow again. This phenomenon is called "acquired resistance," in that the cancer has acquired features conferring resistance to the initial therapy that was once effective. Emerging data in the field of TRK inhibition suggest that acquired resistance may emerge due to TRK kinase point mutations, such as those in the solvent front domain, xDFG domain, or gatekeeper region. LOXO-195 was designed to address these new point mutations and induce a new response in the patient’s cancer. Interested patients and physicians can contact the Loxo Oncology Physician and Patient Clinical Trial Hotline at 1-855-NTRK-123 or email [email protected].

On May 30, 2017 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that the Company and an affiliate of Sanofi have amended their license agreements covering all compounds in development by Sanofi using ImmunoGen’s technology (Press release, ImmunoGen, MAY 30, 2017, View Source [SID1234519309]).

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Under the terms of the amended 2003 collaboration and license agreement, ImmunoGen has granted Sanofi a fully-paid, exclusive license to develop, manufacture, and commercialize the following experimental compounds in development: isatuximab (SAR650984), an unconjugated anti-CD38 antibody in Phase 3 development for relapsed and refractory multiple myeloma; SAR566658, an ADC targeting CA6 in Phase 2 development for triple negative breast cancer (TNBC); SAR408701, an anti-CEACAM5 ADC being studied for the treatment of solid tumors; and an additional ADC directed to an undisclosed target. ImmunoGen and Sanofi have also amended a separate 2013 exclusive license to grant Sanofi a fully-paid, exclusive license to develop, manufacture, and commercialize the experimental compound SAR428926, an anti-LAMP1 ADC being studied for the treatment of solid tumors.

As consideration for these amendments, ImmunoGen will receive a $30 million payment and has agreed to forego a limited co-promotion option in the U.S. with respect to the compounds covered by the 2003 agreement, as well as future milestones or royalties under both license agreements.

"Amending these agreements allows us to continue to focus on the development of our lead program, mirvetuximab soravtansine, while advancing our earlier-stage portfolio and further strengthening ImmunoGen’s cash position," stated Mark Enyedy, president and chief executive officer of ImmunoGen. "We believe Sanofi possesses the right resources to complete the development of these innovative candidates and potentially bring them to patients around the globe."

On May 30, 2017 Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported financial results for the three months ended March 31, 2017 and provided clinical and corporate updates (Press release, Can-Fite BioPharma, MAY 30, 2017, View Source [SID1234519308]).

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Clinical Development Program and Corporate Highlights Include:

● Piclidenoson (CF101) – Phase III Trials in Rheumatoid Arthritis & Psoriasis
Rheumatoid Arthritis: Can-Fite is ready to commence its pivotal Phase III ACRobat trial of Piclidenoson by the third quarter of 2017. Shortly following the end of the first quarter, Can-Fite’s ACRobat trial received Institutional Review Board (IRB) approval to commence patient enrollment at Barzilai Medical Center in Israel, one of several planned sites in Israel, Europe and Canada. Also in May, Can-Fite announced it filed a Clinical Trial Application with Health Canada to recruit patients in Canada. Piclidenoson is being developed as a first line therapy and replacement for the current standard of care, Methotrexate (MTX), the most widely used drug for rheumatoid arthritis. ACRobat will enroll approximately 500 patients. The estimated cost of the entire Phase III study is approximately $5 million. This includes the cost of global clinical research organizations that have been engaged to help conduct ACRobat. The required supply of Piclidenoson has already been manufactured and paid. Can-Fite expects that this pivotal Phase III study will serve as the first of two pivotal studies required for European Medicines Agency (EMA) drug approval.

Rheumatoid arthritis is a treatment market forecast to reach $34.6 billion by 2020.

Psoriasis: Can-Fite’s Phase III trial for Piclidenoson in the treatment of psoriasis will investigate the efficacy and safety of Piclidenoson compared to placebo as its primary endpoint and as compared to apremilast (Otezla) as its secondary endpoint in approximately 400 patients with moderate-to-severe plaque psoriasis. The EMA agreed with Can-Fite’s final trial design. Can-Fite expects to submit its clinical protocol to Institutional Review Boards (IRBs) in the fourth quarter of 2017. Can-Fite expects that this pivotal Phase III study will serve as the first of two pivotal studies required for EMA drug approval.

The psoriasis market is forecast to be $8.9 billion in 2018 and Otezla sales are estimated to be $2.35 billion by 2020.

● Namodenoson (CF102) – Phase II NAFLD/NASH Trial to Commence; Phase II Liver Cancer Trial Nearing Completion
Liver Cancer: Can-Fite continues to enroll and dose patients in its global Phase II study of Namodenoson in the treatment of hepatocellular carcinoma, the most common form of liver cancer. A total of approximately 78 patients are expected to be enrolled in the U.S., Europe, and Israel. Completion of patient enrollment is expected in the second quarter of 2017.

Liver cancer drugs are expected to generate $1.4 billion in sales in 2019.

NAFLD/NASH: During the first quarter of 2017, leading IRBs in Israel including Hadassah Medical Center and Rabin Medical Center cleared Can-Fite to commence patient enrollment in its Phase II clinical trial of Namodenoson in the treatment of non-alcoholic fatty liver disease (NAFLD), the precursor to non-alcoholic steatohepatitis (NASH). The estimated cost of the Phase II trial is under $1 million. Namodenoson supplies are ready to be administered and the costs of supply have been paid. Patient enrollment is expected to begin by the third quarter of 2017.

New preclinical data on Namodenoson was announced by Can-Fite during the first quarter. Data show that Namodenoson prevented liver (hepatic) fibrosis progression in preclinical studies, demonstrating the drug’s potential efficacy in combating NAFLD/NASH.

By 2025, the addressable pharmaceutical market for NASH is estimated to reach $35-40 billion.

● Raised $5 Million in Registered Direct Offering

During the first quarter of 2017, Can-Fite received gross proceeds of $5 million through a registered direct offering. The Company issued 2,500,000 registered American Depository Shares (ADSs) at a purchase price of $2.00 per ADS. For each ADS purchased by investors, the investors received an unregistered warrant to purchase 50% of an ADS. The warrants have an exercise price of $2.25 per ADS and are exercisable six months following the issuance date and will expire five and one-half years from the issuance date.

"We look forward to commencing patient enrolment in two important trials that we believe may have a positive impact on our company. This is especially so given the modest cost of these significant trials. Our Phase III trial of Piclidenoson will evaluate our lead drug candidate as a first line therapy for rheumatoid arthritis and replacement for the current standard of care, Methotrexate (MTX). Our estimated cost for this trial is $5 million. The Phase II trial of Namodenoson in the treatment of NAFLD/NASH, an indication for which there is currently no FDA approved drug, will cost less than $1 million according to our estimates," stated Can-Fite CEO Dr. Pnina Fishman.

Revenues for the three months ended March 31, 2017 were NIS 0.27 million (U.S. $0.07 million) compared to revenues of NIS 0.21 million (U.S. $0.06 million) during the three months ended March 31, 2016. The increase in revenues for the first quarter of 2017 was mainly due to the recognition of a portion of the NIS 1.9 million (U.S. $0.5 million) advance payment received in December 2016 under the distribution agreement with CKD.

Research and development expenses for the three months ended March 31, 2017 were NIS 4.49 million (U.S. $1.24) compared with NIS 4.08 million (U.S. $1.12 million) for the parallel period in 2016. Research and developments expenses for the first quarter of 2017 comprised primarily of expenses associated with the Phase II study for Namodenoson as well as expenses for ongoing studies of Piclidenoson. The increase is primarily due to costs associated with preparations of the Piclidenoson Phase III studies in the treatment of rheumatoid arthritis and psoriasis and Namodenoson for treatment in liver cancer. We expect that the research and development expenses during 2017 will not increase, as compared to 2016 levels.

General and administrative expenses were NIS 2.82 million (U.S. $0.78 million) for the three months ended March 31, 2017 compared to NIS 2.36 million (U.S. $0.65 million) for the same period in 2016. The increase is primarily due to bonuses paid to employees. We expect that the annual general and administrative expenses will remain at the same level as 2016.

Financial income, net for the three months ended March 31, 2017 aggregated NIS 2.49 million (U.S. $0.69 million) compared to financial income, net of NIS 0.44 million (U.S. $0.12 million) for the same period in 2016. The increase in financial income, net in the first quarter of 2017 was mainly due to a decrease in the fair value of warrants that are accounted as financial liability as compared to the same period in 2016.

Can-Fite’s net loss for the three months ended March 31, 2017 was NIS 4.55 million (U.S. $1.25 million) compared with a net loss of NIS 5.79 million (U.S. $1.59 million) for the same period in 2016. The decrease in net loss for the first quarter of 2017 was primarily attributable to an increase in financial income.

As of March 31, 2017, Can-Fite had cash and cash equivalents of NIS 35.43 million (U.S. $9.75 million) as compared to NIS 31.2 million (U.S. $8.59 million) at December 31, 2016. The increase in cash during the three months ended March 31, 2017 is due to NIS 16.64 million (U.S. $4.58 million) received from the issuance of shares and warrants, net of issuance expenses.

For the convenience of the reader, the reported NIS amounts have been translated into U.S. dollars, at the representative rate of exchange on March 31, 2017 (U.S. $ 1 = NIS 3.632).

The Company’s consolidated financial results for the three months ended March 31, 2017 are presented in accordance with International Financial Reporting Standards.