On February 27, 2019 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical stage biotechnology company focused on discovering and developing novel small molecule drugs for the treatment of cancer and other life-threatening diseases, reported that preclinical data highlighting the potential of CB-708, the company’s orally bioavailable CD73 inhibitor will be presented in a poster session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019, taking place March 29 to April 3, 2019 in Atlanta, Georgia (Press release, Calithera Biosciences, FEB 27, 2019, View Source [SID1234535228]).

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Details for the presentation are as follows:

Title: Reversal of adenosine-mediated immune suppression by CB-708, an orally bioavailable and potent small molecule inhibitor of CD73 Presenter:Clarissa Lee, Calithera Biosciences Session

Title: Novel Immunomodulatory Agents 2, Abstract #4134

Session Date and Time: Tuesday April 2, 20191:00 p.m. ET-5:00 p.m. ET

Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 25, Board 8

Additional meeting information can be found at the AACR (Free AACR Whitepaper) website www.aacr.org.

The poster presentation will be available at www.calithera.com in the Publications Section.

CD73 is an enzyme in the tumor microenvironment that produces adenosine, a powerful inhibitor of immune function in tumors. CD73 is expressed across a wide range of tumor types and tumor infiltrating leukocytes. Expression of CD73 often correlates with poor prognosis in patients with cancer. Blockade of adenosine production by CD73 inhibition is expected to reverse immunosuppression in the tumor microenvironment and enhance the immune system’s ability to fight the cancer. CB-708 is an orally bioavailable small molecule inhibitor of CD73.

On February 27, 2019 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported the Company’s VP of Business Development, Sari Fishman will participate in the Bio Asia International Conference in Tokyo, Japan on March 5th and 6th, 2019.

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The BIO Asia International Conference brings together the global biotechnology and pharmaceutical industry to explore licensing collaborations and investor engagement in the current Asia-Pacific business and policy environments.

Dr. Fishman is scheduled to conduct more than 20 one-on-one meetings with business development officers from leading pharmaceutical companies interested in learning more about Can-Fite’s advanced stage drug candidates.

Can-Fite’s current pharma partnerships in Asia include distribution and development agreements with Kwang Dong in Korea for Piclidenoson, Chong Kun Dang in Korea for Namodenoson, and CMS in China for Piclidenoson and Namodenoson. The Company sees substantial additional partnership opportunities in Asia.

On February 27, 2019 Orion Corporation and Bayer reported the completion of the rolling submission of a New Drug Application (NDA) for darolutamide to the U.S. Food and Drug Administration (FDA) (Press release, Bayer, FEB 27, 2019, View Source [SID1234533747]).

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The submission, which was initiated in December 2018, is based on data from the Phase III ARAMIS trial in men with non-metastatic castration-resistant prostate cancer (nmCRPC) showing a statistically significant improvement in metastasis-free survival (MFS) for darolutamide plus androgen deprivation therapy (ADT). Darolutamide plus ADT has shown a favorable safety profile compared to placebo plus ADT.1 These data were recently presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU) in San Francisco and published simultaneously in The New England Journal of Medicine.

"Darolutamide is highly effective in the patient population with non-metastatic castration-resistant prostate cancer, and it has a side-effect profile that parallels that of placebo. Patients who received Darolutamide had substantially longer MFS in the ARAMIS trial, and there was also a strong trend for improved overall survival. These results are truly exciting. We are looking forward to taking the next steps in bringing Darolutamide to men with nmCRPC and their treating physicians", said Christer Nordstedt, MD, PhD, Senior Vice President, Research and Development, Orion Corporation.

Bayer has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for darolutamide in men with nmCRPC. Bayer is also in discussions with other health authorities regarding a submission of darolutamide. The compound is being developed jointly by Orion Corporation and Bayer.

About ARAMIS

The ARAMIS trial is a randomized, Phase III, multi-center, double-blind, placebo-controlled trial evaluating the safety and efficacy of oral darolutamide in patients with nmCRPC who are currently being treated with ADT and are at high risk for developing metastatic disease. 1,509 patients were randomized in a 2:1 ratio to receive 600 mg of darolutamide twice a day or placebo along with ADT.

About darolutamide

Darolutamide is a non-steroidal androgen receptor antagonist with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells. In preclinical studies, darolutamide demonstrated lower blood-brain barrier penetration compared to other currently available AR antagonists. This may also explain the overall low incidence of central nervous system (CNS)-related adverse events seen in the ARAMIS Phase III study.

In addition to the Phase III trial ARAMIS in men with nmCRPC, darolutamide is also being investigated in a Phase III study in metastatic hormone-sensitive prostate cancer (ARASENS). Information about these trials can be found at www.clinicaltrials.gov.

Darolutamide is not approved by the U.S. FDA, the European Medicines Agency or any other health authority.

About castration-resistant prostate cancer (CRPC)

Prostate cancer is the second most commonly diagnosed malignancy in men worldwide.2 In 2018, an estimated 1.2 million men were diagnosed with prostate cancer, and about 358,000 died from the disease worldwide.2 Prostate cancer is the fifth leading cause of death from cancer in men.2 Prostate cancer results from the abnormal proliferation of cells within the prostate gland, which is part of a man’s reproductive system.3 It mainly affects men over the age of 50, and the risk increases with age.4 Treatment options range from surgery to radiation treatment to therapy using hormone-receptor antagonists, i.e., substances that stop the formation of testosterone or prevent its effect at the target location.5 However, in nearly all cases, the cancer eventually becomes resistant to conventional hormone therapy.6

CRPC is an advanced form of the disease where the cancer keeps progressing even when the amount of testosterone is reduced to very low levels in the body. The field of treatment options for castration-resistant patients is evolving rapidly, but until recently, there have been no effective treatment options for CRPC patients who have rising prostate-specific antigen (PSA) levels while on ADT and no detectable metastases. In men with progressive nmCRPC, a short PSA doubling time has been consistently associated with reduced time to first metastasis and death.7

On February 27, 2019 Aduro Biotech, Inc. (NASDAQ: ADRO) reported financial results for the fourth quarter and full year ended December 31, 2018 (Press release, Aduro Biotech, FEB 27, 2019, View Source;p=RssLanding&cat=news&id=2389321 [SID1234533779]).

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"2018 was an important year for Aduro as we prioritized our core technologies and determined a go-forward strategy that is committed to maintaining a leadership role in the STING and APRIL pathways and advancing our clinical programs in areas of high unmet medical need," said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. "With our strategic focus established and $277.9 million in cash taking us into 2022, we are eager to execute on our clinical development plans for 2019 and beyond."

Key Accomplishments in Fiscal Year 2018

STING

Presented first-in-human monotherapy clinical data for ADU-S100, a novel stimulator of interferon genes (STING) pathway activator, and preliminary observations of ADU-S100 in combination with spartalizumab during the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 33rd Annual Meeting
Entered into a research collaboration and exclusive license agreement with Eli Lilly and Company (Lilly) for the cGAS-STING pathway inhibitor program for autoimmune and inflammatory diseases
Presented preclinical data on the role of intratumoral STING activation by ADU-S100 in combination with checkpoint inhibitors in anti-tumor immunity at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2018 and the SITC (Free SITC Whitepaper) 33rd Annual Meeting
Published a paper titled, "Magnitude of Therapeutic STING Activation Determines CD8+ T-Cell Mediated Anti-Tumor Immunity," in the peer-reviewed journal, Cell Reports
APRIL

Presented preclinical data on BION-1301 for the treatment of IgA nephropathy at the American Society of Nephrology (ASN) Kidney Week 2018
Presented preclinical data on BION-1301 for the treatment of multiple myeloma at the AACR (Free AACR Whitepaper) Annual Meeting 2018 and 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition
Published a paper titled, "APRIL signaling via TACI mediates immunosuppression by T regulatory cells in multiple myeloma: therapeutic implications," in the peer-reviewed journal, Leukemia
Financial Results

Cash Position – Cash, cash equivalents and marketable securities totaled $277.9 million at December 31, 2018, compared to $349.7 million at December 31, 2017. In the fourth quarter of 2018, Aduro collected an $18.1 million cash tax refund from the Internal Revenue Service related to its carryback claim for 2017 losses.

Revenue – Revenues were $2.8 million for the fourth quarter of 2018 and $15.1 million for the full year 2018, compared to $3.8 million and $17.2 million, respectively, for the same periods in 2017. The decrease in revenue in both periods was primarily due to the adoption of the ASC 606 accounting standard on January 1, 2018, which resulted in a change in revenue recognition methodology under our Novartis collaboration agreement.

Expenses – Research and development expenses were $17.6 million for the fourth quarter of 2018 and $75.8 million for the full year 2018, compared to $22.9 million and $89.4 million, respectively, for the same periods in 2017. The decrease in research and development expenses for both periods was primarily due to lower expenses for our antibody and LADD programs.

General and administrative expenses were $9.0 million for the fourth quarter of 2018 and $36.0 million for the full year 2018, compared to $8.8 million and $33.8 million, respectively, for the same periods in 2017. The increase in general and administrative expenses for both periods was primarily due to higher professional services and consulting costs as well as stock-based compensation expense.

Loss on impairment of intangible assets was $4.0 million for the fourth quarter and full year 2018. This expense was recorded due to the discontinuation of one of our acquired early research programs.

Net Loss – Net loss for the fourth quarter and year ended December 31, 2018 was $26.3 million, or $0.33 per share, and $95.4 million, or $1.21 per share, respectively. This compared to net loss of $26.1 million, or $0.34 per share, and $91.9 million, or $1.26 per share, respectively, for the same periods in 2017. The increase in net loss for the year was primarily due to the income tax benefit recorded in 2017.

On February 26, 2019 Alkermes plc (Nasdaq: ALKS) reported the initiation of ARTISTRY-2, a new clinical study of ALKS 4230 administered subcutaneously as monotherapy and in combination with the PD-1 inhibitor KEYTRUDA (pembrolizumab) in patients with advanced solid tumors (Press release, Alkermes, FEB 26, 2019, View Source;p=irol-newsArticle&ID=2388952 [SID1234533688]). The study will explore the safety, tolerability and efficacy of ALKS 4230 administered subcutaneously and assess once-weekly and once-every-three-week dosing schedules. ALKS 4230 is a novel, engineered fusion protein designed to selectively activate tumor-killing immune cells while avoiding the expansion of immunosuppressive cells by preferentially binding to the intermediate-affinity interleukin-2 (IL-2) receptor complex. Pembrolizumab is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells.

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ARTISTRY-2, a phase 1/2 study, will be conducted in two stages: dose-escalation followed by dose-expansion. The dose-escalation stage is designed to evaluate the safety and tolerability of ascending doses of ALKS 4230 administered subcutaneously once-weekly and once-every-three-weeks as both lead-in monotherapy and in combination with pembrolizumab. Following identification of the optimal dose and recommended dosing schedule, the dose-expansion stage of the study will evaluate ALKS 4230 administered subcutaneously in combination with pembrolizumab in patients with advanced solid tumors. The dose-expansion stage will evaluate overall response rate, duration of response, non-progression rate at specific time points and overall survival.

"The initiation of our clinical subcutaneous dosing study represents an important milestone for the ALKS 4230 program as we explore new regimens that may offer patients a more convenient alternative to daily IV dosing that is complementary to checkpoint inhibitor regimens," said Craig Hopkinson, M.D., Chief Medical Officer and Senior Vice President of Medicines Development and Medical Affairs at Alkermes. "Based on the emerging profile of ALKS 4230, we’ve rapidly expanded our clinical development program in recent months to evaluate combination therapy, potential efficacy in new tumor types and dosing optionality. The expansion of this program reflects our belief in the significant potential of ALKS 4230 and our recognition of the urgent and persistent need that exists for patients with cancer."

Data presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 33rd Annual Meeting demonstrated that subcutaneous administration of ALKS 4230 in non-clinical models achieved similar total systemic exposure of ALKS 4230 compared to intravenous (IV) administration, yet with less frequent dosing and a lower Cmax, leading to similar expansion of total CD8+ T cell and natural killer (NK) cell populations. These data support further clinical evaluation of subcutaneous administration of ALKS 4230 as an alternative to IV dosing.

About ALKS 4230
ALKS 4230 is a novel, engineered fusion protein designed to selectively activate tumor-killing immune cells while avoiding the expansion of immunosuppressive cells by preferentially binding to the intermediate-affinity interleukin-2 (IL-2) receptor complex. The selectivity of ALKS 4230 is designed to leverage the proven anti-tumor effects of existing IL-2 therapy while mitigating certain limitations.

About the ARTISTRY Clinical Program
ARTISTRY is an Alkermes-sponsored clinical program evaluating ALKS 4230 in patients with advanced solid tumors. ARTISTRY-1 is an ongoing phase 1 study in which ALKS 4230 is administered as an intravenous infusion daily for five consecutive days. ARTISTRY-1 has three distinct stages: an ongoing monotherapy dose-escalation stage, a planned monotherapy dose-expansion stage and an ongoing combination therapy stage with pembrolizumab. ARTISTRY-2 is the second clinical study to initiate in the ARTISTRY clinical development program for ALKS 4230.