On April 6, 2021 Bioniz Therapeutics, Inc., ("Bioniz"), a clinical-stage biopharmaceutical company advancing a pipeline of first-in-class peptide-based multi-cytokine inhibitors for the treatment of cancer and autoimmune diseases, reported the European Commission (EC) has granted orphan designation to BNZ-1 for the treatment of cutaneous T-cell lymphoma (CTCL), a rare skin cancer (Press release, Bioniz Therapeutics, APR 6, 2021, View Source [SID1234577646]). BNZ-1 has previously been granted orphan drug designation by the U.S. Food and Drug Administration (FDA). Bioniz recently completed a phase 2 study of BNZ-1 in CTCL in the United States and intends to initiate a phase 3 clinical trial of BNZ-1 for the treatment of patients with relapsed or refractory CTCL (rCTCL). Bioniz expects the phase 3 to begin enrolling the second half of 2021.

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"The currently approved therapies to treat CTCL are not ideal given the limited efficacy and safety concerns and are typically tolerated by patients only for a limited time due to many side effects that are associated with these treatments," said Nazli Azimi, Pharm.D., Ph.D., Founder, President, and CEO of Bioniz Therapeutics. "With our lead product candidate, BNZ-1, we have completed several significant milestones, including positive efficacy data from our phase 2 study, guidance from the FDA on our phase 3 trial design, and now orphan designation in the U.S. and EU. BNZ-1 has the potential to be a significant treatment for CTCL."

Orphan designation from the EC provides incentives for companies to develop medicines intended for the treatment, prevention, or diagnosis of a disease that is life-threatening or chronically debilitating and where no satisfactory treatment is currently authorized. The prevalence of the condition must not exceed more than five in 10,000 people in the European Union (EU). In addition to being eligible for a 10-year period of marketing exclusivity in the EU upon product approval, orphan designation provides fee waivers, protocol assistance, and eligibility for marketing authorization under the centralized procedure granting approval in all EU countries.

About Refractory Cutaneous T-cell Lymphoma (rCTCL)
Cutaneous T-cell lymphomas (CTCLs) are a rare, aggressive, heterogeneous group of non-Hodgkin’s lymphomas that manifest primarily in the skin. Although a wide array of therapeutic options are available for early-stage CTCL, not all patients respond, resulting in refractory CTCL (rCTCL) with limited treatment options and a poor prognosis.

About BNZ-1
The company’s lead product candidate, BNZ-1, is a selective inhibitor of cytokines IL-2, IL-9, and IL-15, which are potent T-cell growth factors and key disease drivers in CTCL and autoimmune diseases. Bioniz is also planning a phase 2 study of BNZ-1 for the treatment of alopecia areata, which is also driven by unregulated T-cell biology.

On April 5, 2021 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas" ) and TOA EIYO Ltd. (President: Atsuo Takahashi, Ph.D., "TOA EIYO") reported that the both companies have agreed to terminate the distribution agreement on March 31, 2022 (Press release, Astellas, APR 5, 2021, View Source [SID1234577557]). In accordance with this agreement, after April 1, 2022, TOA EIYO will independently sell and provide information on all 18 products such as Bisono tape, a transdermal patch of β1 blocker, for treatment of hypertension and atrial fibrillation and Frandol tablets and tape for treatment of ischemic heart disease, which TOA EIYO obtained Marketing Authorization in Japan, that are currently sold on consignment by Astellas.

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Astellas and TOA EIYO has collaborated for sales and marketing for a long time. Astellas currently sells most of the products which TOA EIYO obtained Marketing Authorization in Japan, and TOA EIYO provides their product information to medical institutions. The both companies have discussed and agreed to terminate the distribution agreement on March 31, 2022.

Astellas is continuously working on optimizing the allocation of management resouces in order to maximize the value of each product, and the termination of the distribution agreement is part of this effort. As a specialty pharmaceutical company in the field of cardiovascular medicine, TOA EIYO has decided that it is necessary to establish its own sales structure of products in order to meet the diverse needs of cardiovasculartreatment.

Astellas and TOA EIYO will work closely during the sales transfer process to ensure stable supply of the relevant products and a smooth continuation of activities, including the provision/collection of product information and the promotion of their proper use.

On April 5, 2021 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported two upcoming presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021, which will be held virtually from April 10-15, 2021 and May 17-21, 2021 (Press release, Arvinas, APR 5, 2021, View Source [SID1234577576]). These presentations will describe the discovery of Arvinas’ two clinical-stage PROTAC degraders, ARV-110 and ARV-471, including the first disclosures of their structures.

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Details for the presentations are as follows:

Title: Discovery of ARV-110, a first in class androgen receptor degrading PROTAC for the treatment of men with metastatic castration resistant prostate cancer
Date and Time: April 11, 2021 from 2:05 PM – 2:15 PM ET
Presenter: Lawrence B. Snyder, Ph.D., Executive Director of Medicinal Chemistry at Arvinas
Session Title: New Therapeutics Targeting Molecular Drivers in Cancer

Title: The discovery of ARV-471, an orally bioavailable estrogen receptor degrading PROTAC for the treatment of patients with breast cancer
Date and Time: April 11, 2021 from 2:20 PM – 2:30 PM ET
Presenter: Lawrence B. Snyder, Ph.D., Executive Director of Medicinal Chemistry at Arvinas
Session Title: New Therapeutics Targeting Molecular Drivers in Cancer

Abstracts will be available for registered attendees on the AACR (Free AACR Whitepaper) website beginning on April 9, 2021.

On April 5, 2021 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory and liver diseases, reported it has completed pre-clinical studies demonstrating that a CBD rich T3/C15 cannabis fraction induces inhibition of liver cancer cell growth (Press release, Can-Fite BioPharma, APR 5, 2021, View Source [SID1234577559]). Can-Fite has expertise in developing drugs to treat liver diseases including advanced liver cancer with its drug candidate Namodenoson which is expected to enter a pivotal Phase III study in Q4 2021.

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As a global leader in discovering and developing drugs which target the A3 adenosine receptor (A3AR), Can-Fite showed that a CBD rich T3/C15 cannabis fraction inhibited the growth of liver HEP-3b hepatocellular carcinoma cells via the A3AR by inhibiting Wnt- and NF-kappa B-related regulatory pathways. The Wnt signaling pathway is known to be highly active in controlling the growth of liver cancer cells. An A3AR antagonist, MRS1523 reversed this effect demonstrating that the inhibitory effect is mediated via Can-Fite’s target, A3AR.

"These findings present a novel therapeutic opportunity for cannabis derived compounds in liver cancer and further enhance Can-Fite’s assets. Liver cancer is very difficult to treat and patients are in need of more options. Cannabinoid-based compounds may offer an effective and safe alternative for this unmet need," stated Can-Fite CEO Dr. Pnina Fishman.

The Company has filed patent applications protecting its discovery of cannabinoid-based therapies where the A3AR target is overexpressed including liver cancer.

According to Adroit Market Research, the medical cannabis market is projected to grow at a CAGR of 29% to $56.7 billion by 2026. Liver cancer is one of the leading causes of cancer deaths globally, with an estimated 854,000 new cases and 810,000 deaths annually. DelveInsight estimates the HCC drug market will reach $3.8 billion in 2027 in the G8 countries.

On April 5, 2021 Illumina, Inc. (NASDAQ: ILMN) reported preliminary revenue for the first quarter of fiscal year 2021 and updated its fiscal year 2021 revenue guidance (Press release, Illumina, APR 5, 2021, View Source [SID1234577577]). Subject to quarter-end closing adjustments, Illumina expects to report first quarter 2021 revenue of approximately $1,085 million, compared to $859 million in the first quarter of 2020 . This represents year-over-year revenue growth of approximately 26% for the quarter. For fiscal year 2021, Illumina now expects year-over-year revenue growth in the range of 25%-28% compared to fiscal year 2020.

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The company’s record preliminary revenue in the first quarter of 2021 was driven by:

Record orders of approximately $1.4 billion in the quarter and sequencing revenue growth of approximately 28% compared to the prior year period
Sequencing consumables growth of approximately 25% compared to the prior year period demonstrating the solid recovery from the COVID-19 pandemic and the strength of our core business. Most customers are now at or above pre-COVID activity levels. COVID-19 surveillance revenues for sequencing consumables were approximately $20 million in the quarter
Sequencing instrument growth of approximately 120% compared to the prior year period, reflecting strong performance across all instrument categories. The mid-throughput category achieved another record quarter in placements. Some customers built additional capacity for COVID-19 surveillance work and accelerated instrument purchases, which resulted in approximately $35 million of incremental instrument revenue in the quarter
"Our core business is exceptionally strong and growing ahead of our expectations. This is reflected in our outstanding preliminary first quarter revenue and, as a result, we are raising our 2021 revenue guidance," said Francis deSouza, President and CEO. "We are seeing broad-based acceleration across our core clinical and research applications as more patients, physicians and researchers than ever access the benefits of next generation sequencing. In addition, we are experiencing increased demand for COVID surveillance globally due to the critical role that Illumina’s next generation sequencing technology plays in the fight against this pandemic."

The company expects to report its full first quarter 2021 results on its upcoming quarterly conference call following the close of market on Tuesday, April 27, 2021.

Conference call information

The conference call will begin at 2:00 pm Pacific Time (5:00 pm Eastern Time) on Tuesday, April 27, 2021. Interested parties may access the live teleconference through the Investor Info section of Illumina’s website under the "Company" tab at www.illumina.com. Alternatively, individuals can access the call by dialing 1-866- 211-4597 or 1-647-689-6853 outside North America, both using conference ID 4359912.

A replay of the conference call will be posted on Illumina’s website after the event and will be available for at least 30 days following.