Accutar Biotechnology Receives NMPA Clearance of IND Application for AC0682 in ER-Positive Breast Cancer

On April 1, 2022 Accutar Biotechnology, Inc., a clinical stage biotechnology company focusing on artificial intelligence (AI)-empowered drug discovery, reported that the China National Medical Products Administration (NMPA) has cleared the company’s investigational new drug application (IND) for AC0682 for the treatment of patients with estrogen receptor (ER)-positive breast cancers (Press release, Accutar Biotechnology, APR 1, 2022, View Source [SID1234611360]). AC0682 is an orally bioavailable chimeric degrader molecule designed to target ERα protein with high potency and selectivity.

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"Breast cancer is the most common cancer among women in China. We are excited about the IND clearance of AC0682 in China, after its IND clearance and initiation of a Phase 1 study in the US late last year," said Jie Fan, Ph.D., Chief Executive Officer, Accutar Biotechnology, Inc. "We look forward to accelerating the development of AC0682 and furthering our commitment to bringing innovative medicines to patients worldwide."

The Phase 1 study in China will assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of AC0682 treatment in Chinese patients with ER-positive breast cancer. Accutar expects to begin enrollment of this study in the second half of this year.

About AC0682

AC0682 is an investigational orally bioavailable, chimeric degrader of ERα for the potential treatment of ER-positive breast cancers. ERα is a hormone-regulated transcription factor that plays a critical role in breast cancer initiation and proliferation, and nearly 80% of breast cancers express ERα. In preclinical studies, AC0682 demonstrated potent and selective ERα protein degradation with favorable pharmacological properties, as well as promising anti-tumor activity in ER-positive animal tumor models.

Dr. Reddy’s Laboratories and MediCane Health Announce the Launch of Medical Cannabis Products in Germany

On April 1, 2022 Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as "Dr. Reddy’s") and MediCane Health Inc. (along with its subsidiaries together referred to as "MediCane") reported the launch of its medical cannabis product in Germany (Press release, Dr Reddy’s, APR 1, 2022, View Source [SID1234611359]).

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As part of a collaboration between Dr. Reddy’s and MediCane that started in 2021, MediCane will supply the medical cannabis products to Dr. Reddy’s from its EU-GMP-certified facilities in Portugal along with providing logistical and regulatory support. As the exclusive distributor of the products in Germany, Dr. Reddy’s will provide access to MediCane’s medical cannabis products under its own brand supported by a specialized field force that can provide education on the use of the products and guidance on the health insurance reimbursement process to healthcare professionals.

The launch marks MediCane’s entry into the pharmaceutical sector of a major European market. For Dr. Reddy’s, the launch reinforces its presence in Germany’s growing medical cannabis market, building on its recent acquisition of Nimbus Health GmbH that specializes in the distribution, registration, sales and marketing of medical cannabis.

With over 83 million inhabitants benefitting from broad access to healthcare services, Germany already represents more than half of the current European Union medical cannabis market, thanks to developed regulations and reimbursement from sick-funds to medical cannabis under certain circumstances1. The demand for medical cannabis has increased over the past years, driven by the German Parliament’s (Bundestag) legalization of medical cannabis in 2017. The medical cannabis market in Germany is valued at ~122 Mio. € with growth of ~25% in 2021 compared to 2020 and a CAGR of ~55 % since 2017. Around 150,000 German patients benefit from medical cannabis for their otherwise unmet health needs2, according to the reports3 especially in the area of pain management, spasticity, anorexia, vomiting, depression.

Dr. Reddy’s and MediCane have also signed an agreement for the co-funding of a phase II clinical trial for a cannabis product aimed at symptom relief of Behavioral and Psychological Symptoms of Dementia (BPSD). Dr. Reddy’s will hold exclusive sales and marketing rights for such product in Europe (except Russia and CIS countries) upon completion of such trial. The parties expect to commence the clinical trial of the product during the second half of 2022. BPSD refers to the spectrum of commonly observed non-cognitive and non-neurological symptoms of dementia, such as agitation, aggression, psychosis, depression, and apathy.

Patrick Aghanian, Head of European Generics, Dr. Reddy’s, said: "This collaboration with MediCane Health demonstrates Dr. Reddy’s commitment to take a leadership position in Europe’s rapidly growing medical cannabis market. With MediCane, we join forces with a unique and differentiated research-based partner in the medical cannabis field. We are very pleased about the strategic, multi-dimensional collaboration with MediCane, which further complements our mission to accelerate access to medical cannabis to meet unmet patient needs and improve the quality of life of patients."

Yossi BenAmram, co-founder and Group CEO, MediCane, said: "This collaboration articulates MediCane’s strategy to develop evidence-based medical products and partnering with leading pharmaceutical companies to maximize the potential of these drugs for patients. This collaboration is a very important step for MediCane, for the short, medium and long term and we couldn’t be more excited to partner with a reputable and resourceful company like Dr. Reddy’s. With MediCane’s agrotechnical and biological cannabis-specific R&D resources and know-how, and Dr. Reddy’s proven sales, marketing and distribution capabilities, with wide geographic access in line with our strategy, as well as powerful regulatory and R&D capabilities for generic drug development, I believe this synergistic partnership can be at the forefront of the European medical cannabis market makers in the foreseeable future."

Novocure to Report First Quarter 2022 Financial Results

On April 1, 2022 Novocure (NASDAQ: NVCR) reported that it will report financial results for the first quarter 2022 on Thursday, April 28, 2022, before the U.S. financial markets open (Press release, NovoCure, APR 1, 2022, View Source [SID1234611358]). Novocure’s management will host a conference call and webcast to discuss its financial results for the three months ended March 31, 2022, at 8 a.m. EDT on Thursday, April 28, 2022. Analysts and investors can participate in the conference call by dialing 855-442-6895 for domestic callers and 509-960-9037 for international callers, using the conference ID 1476184.

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The webcast, earnings slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website, as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

Arrowhead Pharmaceuticals to Participate in Upcoming April 2022 Conferences

On April 1, 2022 Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) reported that it is scheduled to participate in the following upcoming events (Press release, Arrowhead Pharmaceuticals, APR 1, 2022, View Source [SID1234611357]):

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31st Conference of the Asian Pacific Association for the Study of the Liver (APASL 2022) – March 30-April 3, 2022

Title: Pharmacokinetics and Safety of JNJ-73763989, an RNA Interference Therapy for Hepatitis B Virus, in Moderately Hepatically Impaired Participants
Authors: Thomas N. Kakuda, et al.

Title: Pharmacokinetics, Safety, and Tolerability of the siRNA JNJ-73763989 in Healthy Chinese Adult Participants
Authors: Haiyan Li, et al.

Title: Short interfering RNA JNJ-3989 combination therapy in chronic hepatitis B shows potent reduction of all viral markers but no correlate was identified for HBsAg reduction and baseline factors
Authors: Edward Gane, et al.

American Association for Cancer Research Annual Meeting 2022 (AACR) (Free AACR Whitepaper) – April 8-13, 2022

Title: Targeting HIF2a with siRNA: From preclinical models to the clinic
Authors: Yuanqing Ma, et al.

DIA/FDA’s Oligonucleotide-based Therapeutics Conference (Oligo22) – April 25-27, 2022

Title: Short Interfering RNA JNJ-3989 Combination Therapy
Presenter: Michael Biermer, Senior Director, Clinical Development, Janssen Pharmaceuticals

Title: ARO-HIF2 Evaluated in Clear Cell Renal Cell Carcinoma Ph1b Clinical Trial
Presenter: James Hamilton, Senior Vice President, Discovery and Translational Medicine, Arrowhead Pharmaceuticals

A copy of the presentation materials may be accessed on the Events and Presentations page under the Investors section of the Arrowhead website.

Fortress Biotech Announces Virtual Two-Day R&D Summit Hosted by B. Riley Securities on Tuesday, April 5 and Wednesday, April 6, 2022

On April 1, 2022 Fortress Biotech, Inc. (NASDAQ: FBIO) ("Fortress"), an innovative biopharmaceutical company focused on efficiently acquiring, developing and commercializing or monetizing promising therapeutic products and product candidates, reported a two-day summit hosted by the B. Riley Securities’ Healthcare Equity Research team, that will feature multiple programs from Fortress’ diversified pipeline (Press release, Fortress Biotech, APR 1, 2022, View Source [SID1234611356]). The events will be held virtually on Tuesday, April 5, and Wednesday, April 6, 2022, beginning at 1:00 p.m. ET each day.

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Registration link and webcast information:

Please click here to register for the event.
Following each event, the webcast will be available on the News / Events page, located within the Investors section of Fortress’ website, View Source, for approximately 30 days.
Agenda:

Day One: Tuesday, April 5, 2022 (1:00 p.m. – 3:00 p.m. ET)

1:00 p.m. ET – Opening Remarks and Fortress Strategy

Lindsay Rosenwald, M.D., Chairman, President & Chief Executive Officer of Fortress Biotech; Mayank Mamtani, Head of HC Research, B. Riley Securities

1:30 p.m. ET – Panel #1 – Journey Medical Corporation (NASDAQ: DERM)

Claude Maraoui, Co-Founder, President & Chief Executive Officer; Ernie De Paolantonio, Chief Financial Officer; Ramsey Alloush, General Counsel

2:00 p.m. ET – Panel #2 – Cyprium Therapeutics

Charles Buchen, M.D., Chief Business Officer; Lung Yam, M.D., Ph.D., President & Chief Scientific Officer

2:30 p.m. ET – Panel #3 – UR-1 Therapeutics

Raymond Zheng, Ph.D., President & Chief Scientific Officer; Scott Baumgartner, M.D., Interim Chief Medical Officer

Day Two: Wednesday, April 6, 2022 (1:00 p.m. – 3:00 p.m. ET)

1:00 p.m. ET – Fortress Strategy – Execution and Value Generation

Lindsay Rosenwald, M.D., Chairman, President & Chief Executive Officer of Fortress Biotech

1:30 p.m. ET – Panel #1 – Mustang Bio (NASDAQ: MBIO)

Manuel Litchman, M.D., President & Chief Executive Officer; Knut Niss, Ph.D., Chief Technology Officer; Bruce Dezube, M.D., Senior Vice President, Head of Clinical Development; Eliot Lurier, C.P.A., Interim Chief Financial Officer

2:15 p.m. ET – Panel #2 – Checkpoint Therapeutics (NASDAQ: CKPT)

James F. Oliviero, President & Chief Executive Officer; Garrett Gray, Chief Financial Officer