On August 23, 2018 Rakuten Aspyrian, a biotechnology company developing precision-targeted cancer therapies based on its proprietary Photoimmunotherapy platform, reported that it has raised $150 million in a Series C financing (Press release, Aspyrian Therapeutics, AUG 23, 2018, View Source [SID1234529073]). This round, as with previous rounds, was led by Hiroshi Mikitani, CEO of Rakuten Inc., a leading global innovation company in e-commerce, communications and fintech, and chairman of Rakuten Aspyrian. The Series C brings the company’s total fundraising to approximately $238 million in equity.

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"Developing treatments for cancer patients is a mission I began to pursue years ago and is the motivation behind my investment in Rakuten Aspyrian," said Mr. Mikitani, chairman of Rakuten Aspyrian. "Rakuten Aspyrian’s approach of combining a biologic with laser-activation to target tumors holds the potential to offer an alternative treatment option to help cancer patients fight their disease. Our company has advanced rapidly in developing this technology and is now poised to start Phase 3 studies. My vision is to develop and commercialize a strong pipeline of treatments based on Photoimmunotherapy to create a new platform for cancer treatments."

"With this financing we will advance our lead compound ASP-1929, a treatment that received Fast Track designation by the FDA, into a global, pivotal Phase 3 trial to evaluate the efficacy and safety to treat recurrent head and neck squamous cell carcinomas," said Miguel Garcia-Guzman, Ph.D., president and CEO of Rakuten Aspyrian. "I congratulate the Rakuten Aspyrian team for their excellence and commitment to rapidly advancing ASP-1929 into a Phase 3 study by the end of this year."

The financing will also support manufacturing scale-up for the commercialization of ASP-1929 and corporate growth including the initial buildup of commercial operations to support the launch of ASP-1929 in the United States, Japan and Europe.

In addition, this funding will support the expansion of R&D efforts to evaluate the safety and efficacy of ASP-1929 and other therapies in a range of cancer types, including the initiation of two additional Phase 2 proof of concept studies of ASP-1929 in other cancer types before the end of 2018.

"We are honored to be working with Hiroshi Mikitani, a visionary leader who supports our long-term corporate mission of conquering cancer," said Dr. Garcia-Guzman. "With this influx of capital, we are well positioned to advance our company to the next phase towards developing a fully integrated R&D and commercial biopharmaceutical corporation advancing first-in-class precision tumor-targeted therapies."

About ASP-1929

ASP-1929, a conjugate of cetuximab and IRDye 700DX, targets epidermal growth factor receptor (EGFR), a cancer antigen expressed in multiple types of solid tumors, including head and neck squamous cell carcinomas, esophagus, lung, colon, pancreas and other cancers. This first-in-class therapy targets cancer cells, after which it is locally activated with red light using a proprietary investigational laser and fiber optics. The local activation of the tumor-selective conjugate targets the tumor but not surrounding normal tissues and structures.

Interim results of the Phase 1/2 trial in patients with head and neck squamous cell carcinoma showed a clinically meaningful improvement in the overall response rate, and potential improvements in progression free survival and overall survival when compared to historical data for the standard of care treatments currently available to this patient population. Top line results of the Phase 1/2 trial are expected later this year.

ASP-1929 is an investigational compound that is not approved for any use in any country.

On August 22, 2018 Pfizer Inc. (NYSE:PFE) and Astellas Pharma Inc. (TSE:4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") reported amendments to the protocols for two registrational Phase 3 trials, ARCHES and EMBARK, designed to evaluate the safety and efficacy of XTANDI (enzalutamide) in men with hormone-sensitive prostate cancer (HSPC) (Press release, Pfizer, AUG 22, 2018, https://www.pfizer.com/news/press-release/press-release-detail/pfizer_and_astellas_amend_clinical_research_protocols_for_two_phase_3_trials_of_enzalutamide_in_patients_with_hormone_sensitive_prostate_cancer [SID1234529035]). These amendments accelerate timelines for the anticipated primary completion dates of both trials.

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ARCHES is a randomized Phase 3 study evaluating the efficacy and safety of enzalutamide plus androgen deprivation therapy (ADT) versus ADT alone in metastatic HSPC patients. The primary endpoint of the trial is radiographic progression-free survival (rPFS). Changes to the protocol include revision of the planned analyses of the primary and secondary endpoints. Enrollment was completed earlier this year. The companies now anticipate the primary completion date for the ARCHES clinical trial to be in late 2018. The previously expected primary completion date was April 2020.

Revisions were also made to the protocol for EMBARK, a randomized Phase 3 study of enzalutamide plus leuprolide, enzalutamide monotherapy, and leuprolide alone in men with high-risk non-metastatic HSPC. The primary endpoint of the trial is metastasis-free survival (MFS). The main purpose of the amendment is to revise the planned analyses of the primary and several secondary endpoints, which reduced the target sample size. Enrollment was completed earlier this year. With these changes, the estimated primary completion date for the EMBARK clinical trial is mid-2020. Previously, the expected primary completion date for EMBARK was March 2021.

"We continually strive to design and implement clinical trials that bring innovations to people with the greatest need," said Steven Benner, M.D., senior vice president and global therapeutic area head, Oncology Development, Astellas. "With the amendments to ARCHES and EMBARK, we will be able to evaluate the potential of XTANDI for men with hormone-sensitive prostate cancer sooner, including for those with non-metastatic disease in which there are no currently approved oral treatment options."

"With a large body of evidence demonstrating the activity of XTANDI in men with castrate-resistant prostate cancer, ARCHES and EMBARK are designed to extend the evaluation of XTANDI to men with hormone-sensitive prostate cancer," said Mace Rothenberg, M.D., chief development officer, Oncology, Pfizer Global Product Development. "Our goal is to build upon the body of clinical evidence for enzalutamide in an effort to help address the unmet needs of an even broader spectrum of prostate cancer patients."

XTANDI is approved by the U.S. Food and Drug Administration for the treatment of castration-resistant prostate cancer.

Details regarding ARCHES (NCT02677896) and EMBARK (NCT02319837) are available on ClinicalTrials.gov.

About XTANDI (enzalutamide) capsules XTANDI (enzalutamide) is an androgen receptor inhibitor indicated for the treatment of patients with castration-resistant prostate cancer.

Important Safety Information for XTANDI

Warnings and Precautions
Seizure occurred in 0.4% of patients receiving XTANDI in clinical studies. In a study of patients with predisposing factors for seizure, 2.2% of XTANDI-treated patients experienced a seizure. Patients in the study had one or more of the following pre-disposing factors: use of medications that may lower the seizure threshold; history of traumatic brain or head injury, cerebrovascular accident or transient ischemic attack, Alzheimer’s disease, meningioma, or leptomeningeal disease from prostate cancer, unexplained loss of consciousness within the last 12 months, history of seizure, presence of a space occupying lesion of the brain, history of arteriovenous malformation, or history of brain infection. It is unknown whether anti-epileptic medications will prevent seizures with XTANDI. Advise patients of the risk of developing a seizure while taking XTANDI and of engaging in any activity where sudden loss of consciousness could cause serious harm to themselves or others. Permanently discontinue XTANDI in patients who develop a seizure during treatment.

Posterior Reversible Encephalopathy Syndrome (PRES) In post approval use, there have been reports of PRES in patients receiving XTANDI. PRES is a neurological disorder which can present with rapidly evolving symptoms including seizure, headache, lethargy, confusion, blindness, and other visual and neurological disturbances, with or without associated hypertension. A diagnosis of PRES requires confirmation by brain imaging, preferably MRI. Discontinue XTANDI in patients who develop PRES.

Hypersensitivity reactions, including edema of the face (0.5%), tongue (0.1%), or lip (0.1%) have been observed with XTANDI in clinical trials. Pharyngeal edema has been reported in post-marketing cases. Advise patients who experience any symptoms of hypersensitivity to temporarily discontinue XTANDI and promptly seek medical care. Permanently discontinue XTANDI for serious hypersensitivity reactions.

Ischemic Heart Disease In the placebo-controlled clinical studies, ischemic heart disease occurred more commonly in patients on the XTANDI arm compared to patients on the placebo arm (2.7% vs 1.2%). Grade 3-4 ischemic events occurred in 1.2% of patients on XTANDI versus 0.5% on placebo. Ischemic events led to death in 0.4% of patients on XTANDI compared to 0.1% on placebo. Monitor for signs and symptoms of ischemic heart disease. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue XTANDI for Grade 3-4 ischemic heart disease.

Falls and Fractures In the placebo-controlled clinical studies, falls occurred in 10% of patients treated with XTANDI compared to 4% of patients treated with placebo. Fractures occurred in 8% of patients treated with XTANDI and in 3% of patients treated with placebo. Evaluate patients for fracture and fall risk. Monitor and manage patients at risk for fractures according to established treatment guidelines and consider use of bone-targeted agents.

Embryo-Fetal Toxicity Safety and efficacy of XTANDI have not been established in females. XTANDI can cause fetal harm and loss of pregnancy when administered to a pregnant female. Advise males with female partners of reproductive potential to use effective contraception during treatment with XTANDI and for 3 months after the last dose of XTANDI. XTANDI should not be handled by females who are or may become pregnant.

Adverse Reactions
The most common adverse reactions (≥ 10%) that occurred more frequently (≥ 2% over placebo) in the XTANDI patients from the randomized placebo-controlled trials were asthenia/fatigue, decreased appetite, hot flush, arthralgia, dizziness/vertigo, hypertension, headache and weight decreased. In the bicalutamide-controlled study, the most common adverse reactions (≥ 10%) reported in XTANDI patients were asthenia/fatigue, back pain, musculoskeletal pain, hot flush, hypertension, nausea, constipation, diarrhea, upper respiratory tract infection, and weight loss.

In the placebo-controlled study of metastatic CRPC (mCRPC) patients taking XTANDI who previously received docetaxel, Grade 3 and higher adverse reactions were reported among 47% of XTANDI patients and 53% of placebo patients. Discontinuations due to adverse events were reported for 16% of XTANDI patients and 18% of placebo patients. In the placebo-controlled study of chemotherapy-naïve mCRPC patients, Grade 3-4 adverse reactions were reported in 44% of XTANDI patients and 37% of placebo patients. Discontinuations due to adverse events were reported for 6% of both study groups. In the placebo-controlled study of non-metastatic CRPC (nmCRPC) patients, Grade 3 or higher adverse reactions were reported in 31% of XTANDI patients and 23% of placebo patients. Discontinuations with an adverse event as the primary reason were reported for 9% of XTANDI patients and 6% of placebo patients. In the bicalutamide-controlled study of chemotherapy-naïve mCRPC patients, Grade 3-4 adverse reactions were reported in 39% of XTANDI patients and 38% of bicalutamide patients. Discontinuations with an AE as the primary reason were reported for 8% of XTANDI patients and 6% of bicalutamide patients.

Lab Abnormalities: In the two placebo-controlled trials in patients with mCRPC, Grade 1-4 neutropenia occurred in 15% of XTANDI patients (1% Grade 3-4) and 6% of placebo patients (0.5% Grade 3-4). In the placebo-controlled trial in patients with nmCRPC, Grade 1-4 neutropenia occurred in 8% of patients receiving XTANDI (0.5% Grade 3-4) and in 5% of patients receiving placebo (0.2% Grade 3-4).

Hypertension: In the two placebo-controlled trials in patients with mCRPC, hypertension was reported in 11% of XTANDI patients and 4% of placebo patients. Hypertension led to study discontinuation in <1% of patients in each arm. In the placebo-controlled trial in patients with nmCRPC, hypertension was reported in 12% of patients receiving XTANDI and 5% of patients receiving placebo.

Drug Interactions
Effect of Other Drugs on XTANDI Avoid strong CYP2C8 inhibitors, as they can increase the plasma exposure to XTANDI. If co-administration is necessary, reduce the dose of XTANDI.

Avoid strong CYP3A4 inducers as they can decrease the plasma exposure to XTANDI. If co-administration is necessary, increase the dose of XTANDI.

Effect of XTANDI on Other Drugs Avoid CYP3A4, CYP2C9, and CYP2C19 substrates with a narrow therapeutic index, as XTANDI may decrease the plasma exposures of these drugs. If XTANDI is co-administered with warfarin (CYP2C9 substrate), conduct additional INR monitoring.

On August 22, 2018 Nordic Nanovector ASA (OSE: NANO) reported its second quarter and first half 2018 results (Press release, Nordic Nanovector, AUG 22, 2018, View Source [SID1234553495]). A presentation by the company’s senior management team will take place today in Oslo at 08:30 CEST, see details below.

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Eduardo Bravo, CEO, commented: "I am pleased to report a quarter marked by important progress in the development of lead candidate Betalutin in follicular lymphoma (FL). The first patients in the PARADIGME trial have now been dosed. Betalutin was also granted Fast Track designation in June for relapsed or refractory 3L FL, adding to the Orphan drug designation for treating FL it received in 2014. These designations, granted based on the potential of Betalutin to address an unmet patient need in FL, could support a quicker and smoother regulatory process and path to market, if PARADIGME is successful. We are also pleased that Archer-1 has been approved in Norway and we expect the first patient to be dosed before the end of 2018.

"Betalutin is an exciting therapeutic candidate for non-Hodgkin’s lymphoma (NHL) and Nordic Nanovector is well positioned to drive its development through clinical trials. I’m excited to join the Company at this important time and look forward to working with the excellent board and management team to realise the significant potential of Betalutin and to provide a new treatment option to NHL patients who are in need of effective therapies."

Operational Highlights

• Eduardo Bravo appointed as Chief Executive Officer
o Brings more than 25 years’ experience from the biopharmaceutical industry

• First patient dosed in pivotal Phase 2b PARADIGME trial investigating Betalutin as a potential new treatment for patients with third-line relapsed antiCD20 refractory follicular lymphoma (3L R/R FL)
o Site activations continuing – as of August 21st, 41 (of 80-85) sites in 13 (of 20) countries are open for enrolment
o First data read-out targeted for 1H 2020

• Betalutin granted Fast Track designation in the US for FL
o Based on promising safety and preliminary efficacy data from the LYMRIT 37-01 study

• Phase 1b Archer-1 trial of Betalutin in combination with rituximab in second-line (2L) FL patients approved in Norway
o First patient expected to be dosed in 2H 2018

• Phase 1 study with Betalutin in DLBCL advances to next dosing level
o First dosing levels found to be safe and well-tolerated

• Further appointments to strengthen the Management Team and Board of Directors
o Maureen Deehan, PhD, appointed as Head of Corporate Development and Strategy
o Rainer Boehm, MD, elected as a member of the Board of Directors

Financial Highlights Q2 and 1H 2018

(Figures in brackets = same period 2017 unless otherwise stated)

• Revenues for the second quarter amounted to NOK 0 (NOK 0.1 million). Revenues for the first half of 2018 were NOK 0 (NOK 0.1 million).

• Total operating expenses for the second quarter were NOK 84.5 million (NOK 76.3 million). Total operating expenses for the first half of 2018 amounted to NOK 166.8 million (NOK 142.1 million)
o Research and development (preclinical, clinical, medical affairs, regulatory and CMC activities) expenses accounted for 72.2 % of total operating expenses (71 %) for the first half of 2018.

• Comprehensive loss for the second quarter amounted to NOK 82.9 million (loss of NOK 66.3 million). Comprehensive loss for the first half was NOK 173.6 million (loss of NOK 122.1 million)

• Cash and cash equivalents amounted to NOK 570.1 million at the end of June 2018 (NOK 641.5 million at 31 March 2018 and NOK 756.6 million at 31 December 2017)

Outlook

Nordic Nanovector aspires to become a leader in the field of targeted therapies for haematological cancers by developing, manufacturing and commercialising innovative therapies to address major unmet medical needs and advance cancer care.

Betalutin, the company’s most advanced product candidate, has a highly differentiated, competitive, clinical profile for R/R FL, based on the promising results from the LYMRIT 37-01 Phase 1/2a clinical study. The company’s pivotal Phase 2b PARADIGME trial with Betalutin in 3L R/R FL is underway with initial clinical data read-outs targeted for 1H 2020 and subsequent filing in 2020 for marketing approval.

Betalutin has been granted Fast Track designation in the US for the treatment of patients with R/R FL.

Nordic Nanovector intends to maximize the value of Betalutin across other stages of FL, NHL and other haematological cancer indications.

The company is confident that Betalutin could become an attractive and convenient therapeutic option, which, based on detailed market research, has the potential to be commercially successful.

Current cash resources are expected to be sufficient to reach data read-out from PARADIGME in 1H 2020.

Second Quarter and First Half 2018 Results Presentation and Webcast

A presentation by Nordic Nanovector’s senior management team in English will take place today at 8:30 am CEST at:

Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo

Meeting Room: AKER

The presentation will be recorded as a webcast and will be available at www.nordicnanovector.com in the section: Investors & Media

The results report and the presentation are available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentations/Interim Reports/2018.

Results presentation in Norwegian

A separate presentation of the results in Norwegian, to be hosted by Nordic Nanovector’s CFO, and its VP IR & Corporate Communications, will take place on Thursday, 23 August 2018 at 8:30 am CEST at:

Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo

Meeting Room: VIPPETANGEN

To attend the meeting please email – [email protected]

The presentation will NOT be recorded as a webcast

On August 22, 2018 Sierra Oncology, Inc. (Nasdaq: SRRA), a clinical stage drug development company focused on advancing targeted therapeutics for the treatment of patients with significant unmet needs in hematology and oncology, reported it has acquired the drug candidate momelotinib from Gilead Sciences (Press release, Sierra Oncology, AUG 22, 2018, View Source [SID1234529036]). Momelotinib has been investigated in two completed Phase 3 trials for the treatment of myelofibrosis and has demonstrated a potentially differentiated therapeutic profile encompassing anemia-related benefits, as well as achieving substantive spleen and constitutional symptom control.

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"The majority of myelofibrosis patients have anemia at diagnosis or develop it during treatment with other therapies, including ruxolitinib. Anemia is the most significant negative prognostic indicator in myelofibrosis patients and, as a result, one of the most important disease consequences to address," said Dr. Srdan Verstovsek, Medical Oncologist and Professor in the Department of Leukemia at The University of Texas MD Anderson Cancer Center, Houston, Texas. "The therapeutic focus in myelofibrosis has traditionally been on treating the enlarged spleen and constitutional symptoms common to the disease. However, optimal drug therapy would also address disease-related cytopenias, including anemia and transfusion dependency, while also improving splenomegaly and symptoms. The Phase 3 clinical data for momelotinib demonstrate clinical benefits in all of these categories and I believe the drug candidate warrants further development. Given its anemia benefit, momelotinib could potentially become an important option for the treatment of myelofibrosis."

"Opportunistically adding this compelling Phase 3 asset to our existing pipeline of next generation oncology drug candidates, SRA737 and SRA141, helps establish Sierra as a diversified late-stage drug development company with a commercial orientation," said Dr. Nick Glover, President and CEO of Sierra Oncology. "The company is uniquely positioned to advance momelotinib towards potential registration with several members of the Sierra senior management team having played key roles in the development of momelotinib from its discovery through to Phase 3 clinical trials. The body of clinical data generated from more than 1,200 patients dosed to date will guide and support our momelotinib development strategy. We believe an additional clinical study likely will be required to consolidate these clinical data, and over the coming months we plan to engage with key opinion leaders and regulators to further define an expeditious regulatory path for momelotinib."

"Unlike other JAK inhibitors, momelotinib addresses myelofibrosis-related anemia. The Phase 2 and Phase 3 data to date demonstrate that momelotinib consistently improves the anemia that frequently occurs in advanced myelofibrosis, postulated via ACVR1 inhibition. ACVR1 is a member of the TGFβ superfamily of receptors that regulate the iron metabolism pathway. ACVR1 activates the transcription of hepcidin, which leads to decreased erythropoiesis. Demonstrable splenic responses and constitutional symptom control have also been achieved with momelotinib, suggesting that the compound is able to address a spectrum of unmet medical needs in myelofibrosis," noted Dr. Barbara Klencke, Chief Development Officer for Sierra Oncology. "Momelotinib also has a well-defined, predictable safety profile, with more than 180 patients still remaining on active long-term therapy, some benefitting from treatment for more than seven years, reinforcing its potential durable efficacy and favorable long-term tolerability."

Deal terms

Sierra will pay Gilead a $3 million upfront fee for momelotinib and potential aggregate milestone payments of up to $195 million, which are largely associated with commercial sales of the drug. Sierra will also pay Gilead royalties on any sales of momelotinib, which will be tiered based on commercial success and range from mid-teens to high-twenties. Sierra will assume all currently ongoing clinical studies with momelotinib following a transition period.

Fenwick & West LLP served as legal counsel to Sierra in connection with the transaction. Mizuho Securities USA LLC served as exclusive financial advisor to Gilead. Skadden, Arps, Slate, Meagher & Flom LLP served as legal counsel to Gilead.

Analyst & Investor Call Thursday, August 23st at 4:00 p.m. Eastern Time (1:00 p.m. Pacific Time)
Sierra will host an Analyst and Investor conference call on Thursday, August 23st at 4:00 p.m. ET where the company will introduce momelotinib and respond to questions. Members of the professional investment community may participate by phone by calling (866) 548-4713 (Toll-free in North America) or (323) 794-2093 (International Dial-in) and enter the Conference ID number: 6356543. The call will be webcast live and will be accessible through the company’s website at www.sierraoncology.com. An archived replay of the webcast will also be available.

About momelotinib
Momelotinib is a potent, selective and orally-bioavailable JAK1, JAK2 & ACVR1 inhibitor with a differentiated therapeutic profile in myelofibrosis encompassing a range of meaningful anemia benefits, including eliminating or reducing the need for frequent blood transfusions, as well as achieving substantive spleen and constitutional symptom control. More than 1,200 subjects have received momelotinib since clinical studies began in 2009. Momelotinib is covered by patents anticipated to provide exclusivity to 2035 in the U.S. and 2033 in the EU.

Momelotinib was discovered and initially developed at Cytopia Ltd., an Australian biotechnology company whose CSO, Dr. Andrew Wilks, discovered the JAK1 and JAK2 kinases while at the Ludwig Institute for Cancer Research. Cytopia was acquired in 2011 by YM BioSciences Inc. (YM), a drug development company. Dr. Nick Glover, President & CEO of Sierra Oncology, previously led YM where he and his team advanced momelotinib through Phase 1/2 studies that first identified momelotinib’s unique anemia benefit. YM was acquired by Gilead in 2013. Current members of Sierra’s management team have prior experience developing momelotinib while at Cytopia, YM and Gilead.

On August 22, 2018 Aduro Biotech, Inc. (NASDAQ: ADRO) reported that the United States Patent and Trademark Office has issued a new composition of matter patent related to altered APRIL-binding antibodies, further enhancing the company’s B-select intellectual property portfolio (Press release, Aduro Biotech, AUG 22, 2018, View Source;p=RssLanding&cat=news&id=2364506 [SID1234529060]). Specifically, the granted claims cover BION-1301, Aduro’s first-in-class anti-APRIL antibody being evaluated in a Phase 1/2 dose escalation trial for the treatment of multiple myeloma.

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"Blocking APRIL represents a unique approach to treating patients with multiple myeloma and we believe BION-1301 has potential to treat a myriad of oncology indications as well as other autoimmune and inflammatory diseases," commented Stephen Isaacs, chairman and chief executive officer of Aduro Biotech. "Ensuring a robust intellectual property position around BION-1301 is inherent to advancing the program and the claims granted in this particular patent exemplify the novel science behind this exciting program."

U.S. patent 9,969,808 adds to previously issued U.S. and international counterpart patents and patent applications that form Aduro’s APRIL patent portfolio. Claims were granted on the basis that BION-1301 enables full blockade of APRIL binding to both its receptors BCMA and TACI. Preclinical studies have demonstrated that blocking APRIL with BION-1301 not only inhibited proliferation and survival of multiple myeloma cells but also alleviated drug resistance and immune suppression, leading to enhanced myeloma cell killing.1 Further preclinical research by Aduro and its collaborators indicate that blocking APRIL further enhances anti-BMCA cytotoxic cell killing and that prevention of APRIL binding to TACI may also be a potentially important mechanism for BION-1301 to inhibit the function of regulatory T cells.2

About APRIL
APRIL (A PRoliferation-Inducing Ligand) is a member of the tumor necrosis factor (TNF) superfamily and is primarily secreted by bone marrow and/or myeloid cells. APRIL is overproduced in patients with multiple myeloma and binds to BCMA (B cell maturation antigen) and TACI (Transmembrane Activator and CAML Interactor) to stimulate a wide variety of responses that promote multiple myeloma growth and survival and suppress the immune system so that the tumor cells are protected and sustained in the bone marrow.

About BION-1301
Aduro is currently evaluating BION-1301, its most advanced proprietary B-select monoclonal antibody, as a novel therapy for multiple myeloma. Despite new treatments recently approved in multiple myeloma, this disease remains incurable as patients relapse, or become resistant to, currently-available therapies. In preclinical studies, Aduro has established that A PRoliferation-Inducing Ligand (APRIL) plays a crucial part in the protective bone marrow tumor microenvironment. In these studies, APRIL, through the B cell maturation antigen (BCMA), was shown to be critically involved in the survival, proliferation and chemoresistance of multiple myeloma, and upregulates mechanisms of immunoresistance, including PD-L1 upregulation. BION-1301, a humanized antibody that blocks APRIL from binding to its receptors, has been shown in preclinical studies to halt tumor growth and overcome drug resistance. In addition, BION-1301 also demonstrated the ability to inhibit immune suppressive effects of regulatory T cells via TACI but not BCMA in multiple myeloma blood and bone marrow. BION-1301 is currently being evaluated in a Phase 1/2 clinical study.