On April 14, 2020 MEI Pharma, Inc. (NASDAQ: MEIP) and Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151) reported that the companies have entered into a global license, development and commercialization agreement to further develop and commercialize MEI’s ME-401, an oral, once-daily, investigational drug-candidate, selective for phosphatidylinositol 3-kinase delta (PI3Kδ), in clinical development for the treatment of B-cell malignancies (Press release, MEI Pharma, APR 14, 2020, View Source [SID1234556292]). MEI and Kyowa Kirin will co-develop and co-promote ME-401 in the U.S., with MEI booking all revenue from U.S. sales. Kyowa Kirin has exclusive commercialization rights outside of the U.S.

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ME-401 is being studied in the ongoing Phase 2 TIDAL clinical trial evaluating patients with relapsed or refractory follicular lymphoma which, subject to results, may support an accelerated approval of a marketing application with the U.S. Food and Drug Administration (FDA). An ongoing Phase 1b study is evaluating ME-401 as a monotherapy and in combination with rituximab (Rituxan) or zanubrutinib (Brukinsa) in patients with B-cell malignancies. Also, a Phase 1 study was initiated in 2019 evaluating ME-401 as a monotherapy in patients with indolent B-cell malignancy in Japan.

"This global partnership with Kyowa Kirin is a key step to achieving our goal of broadly developing and commercializing ME-401, optimizing the opportunity to benefit patients across multiple B-cell malignancies inside and outside the U.S., and also building value for our shareholders," said David M. Urso, J.D., chief operating officer & general counsel of MEI Pharma. "The decision to expand our alliance with Kyowa Kirin is based on the successful relationship we’ve built working together to date under our 2018 Japan license agreement, and the respect we have for Kyowa Kirin and their ability to jointly execute our shared vision of ME-401 in the U.S. and around the world."

"I am delighted to expand our agreement with MEI Pharma for the development and commercialization of ME-401 all over the world," said Tomohiro Sudo, Executive Officer, Director of Strategic Product Planning Department for Kyowa Kirin. "We believe that ME-401 may be an important new treatment option for patients and further enhances our global oncology pipeline."

About the Global License, Development and Commercialization Agreement

Under the terms of the agreement, which substantially retains and consolidates the terms of the 2018 license agreement between MEI and Kyowa Kirin to develop and commercialize ME-401 in Japan, MEI will receive a $100 million upfront payment from Kyowa Kirin. MEI is also eligible to receive up to $582.5 million in additional payments from Kyowa Kirin depending on the achievement of certain U.S. and ex-U.S. development, regulatory and commercial milestones.

If approved by FDA in the U.S., MEI and Kyowa Kirin will co-promote ME-401, with MEI booking all revenue from sales. MEI and Kyowa Kirin will share U.S. profits and costs (including development costs) on a 50-50 basis.

Outside the U.S., Kyowa Kirin will have exclusive commercialization rights, lead commercialization and book all revenues from sales of ME-401. Kyowa Kirin will pay MEI escalating tiered royalties on ex-U.S. sales starting in the teens. Kyowa Kirin will be responsible for all incremental ex-U.S. clinical development costs and all ex-U.S. regulatory, CMC and commercial costs.

The companies have agreed to a development plan designed to broadly evaluate ME-401 in patients with various B-cell malignancies, including in combination with other agents.

Conference Call & Webcast Information (Conducted by MEI)
When: April 14, 2020, 8:00 a.m. ET
Dial-in: 1-877-879-1183 (International Toll: 1-412-902-6703)
Conference ID: 0809665

Please join the conference call at least 10 minutes early to register. You can access the live webcast under the investor relations section of MEI’s website at: www.meipharma.com. A replay of the conference call will be archived under events and webcasts for at least 30 days after the call.

About ME-401

MEI-401 is an investigational treatment and not approved by the U.S. Food and Drug Administration (FDA) or other Health Authorities. Clinical development of ME-401 as an oral, once-daily, selective PI3Kδ inhibitor for the treatment of B-cell malignancies is ongoing. The U.S. FDA recently granted ME-401 Fast Track designation.

MEI is currently conducting two ongoing studies evaluating ME-401. The first is a Phase 2 clinical trial evaluating ME-401 as a monotherapy for the treatment of adults with relapsed or refractory follicular lymphoma after failure of at least two prior systemic therapies including chemotherapy and an anti-CD20 antibody. Subject to the results, upon completion of the Phase 2 clinical trial, ME-401 is planned to be submitted with the FDA to support an accelerated approval of a marketing application under 21 CFR Part 314.500, Subpart H. The second study is a multi-arm, open-label, Phase 1b dose escalation and expansion trial evaluating ME-401 as a monotherapy and in combination with other therapies or investigational agents in patients with relapsed or refractory B-cell malignancies. Additionally, a Phase 1 study was initiated by Kyowa Kirin in 2019 evaluating ME-401 as a monotherapy in patients with indolent B-cell malignancy in Japan.

On April 14, 2020 Coherus BioSciences, Inc. ("Coherus" or the "Company", Nasdaq: CHRS), reported its intention to offer, subject to market and other conditions, $200,000,000 aggregate principal amount of convertible senior subordinated notes due 2026 (the "notes") in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act") (Press release, Coherus Biosciences, APR 14, 2020, View Source [SID1234556290]). Coherus also expects to grant the initial purchasers of the notes an option to purchase, for settlement within a period of 13 days from, and including, the date notes are first issued, up to an additional 30,000,000 principal amount of notes.

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The notes will be general unsecured obligations of Coherus, and will be subordinated to the Coherus’ designated senior indebtedness. The notes will accrue interest payable semi-annually in arrears and will mature on April 15, 2026, unless earlier repurchased or converted. At any time before the close of business on the second scheduled trading day immediately before the maturity date, noteholders may convert their notes at their option into shares of Coherus’ common stock, together, if applicable, with cash in lieu of any fractional share, at the then-applicable conversion rate. The notes will not be redeemable at Coherus’ election before maturity. The interest rate, initial conversion rate and other terms of the notes will be determined at the pricing of the offering.

Coherus intends to use a portion of the net proceeds from the offering to fund the cost of entering into the capped call transactions described below. Coherus intends to use the remainder of the net proceeds from the offering for opportunistic pipeline acquisitions or licenses, working capital, and other general corporate purposes, which may include other debt repayment in the future. Coherus has not entered into any agreements or commitments with respect to any material acquisitions or licenses at this time. If the initial purchasers exercise their option to purchase additional notes, then Coherus intends to use a portion of the additional net proceeds to fund the cost of entering into additional capped call transactions as described below.

In connection with the offering of the notes, Coherus expects to enter into privately negotiated capped call transactions with one or more of the initial purchasers or their respective affiliates and/or other financial institutions (the "option counterparties"). If the initial purchasers exercise their option to purchase additional notes, Coherus expects to enter into additional capped call transactions with the option counterparties.

In connection with establishing their initial hedges of the capped call transactions, the option counterparties or their respective affiliates expect to enter into various derivative transactions with respect to Coherus’ common stock and/or purchase shares of Coherus’ common stock concurrently with or shortly after the pricing of the notes. This activity could increase (or reduce the size of any decrease in) the market price of Coherus’ common stock or the notes at that time.

In addition, the option counterparties or their respective affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to Coherus’ common stock and/or purchasing or selling Coherus’ common stock or other securities of Coherus in secondary market transactions following the pricing of the notes and prior to the maturity of the notes. This activity could also cause or avoid an increase or decrease in the market price of Coherus’ common stock or the notes, which could affect the value of Coherus’ common stock that noteholders will receive upon conversion of the notes.

The offer and sale of the notes and the shares of common stock issuable upon conversion of the notes have not been, and will not be, registered under the Securities Act or any other securities laws, and the notes and such shares cannot be offered or sold except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and any other applicable securities laws.

This press release does not constitute an offer to sell, or the solicitation of an offer to buy, the notes or the shares of common stock issuable upon conversion of the notes, nor will there be any sale of the notes or such shares, in any state or other jurisdiction in which such offer, sale or solicitation would be unlawful.

On April 13, 2020 BroadenBio reported that in March 2020, the company has completed the Angel+ round financing from Beijing Kaiyuan Hongdao Venture Capital Center (L.P.) (Kaiyuan Hongdao Fund) (Press release, BroadenBio, APR 13, 2020, View Source [SID1234640196]).

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Kaiyuan Hongdao Fund is an industry-finance linkage investment fund established by Beijing Zhongguancun Venture Capital Development Co., Ltd., and its investment fields involve medical devices, biomedicine, and security payments.

On April 13, 2020 Antengene reported that it has dosed the first patient in Taiwan, China in its phase 1 open-label clinical trial of ATG-019 (KPT-9274), a dual inhibitor of both PAK4 and NAMPT (Press release, Antengene, APR 13, 2020, View Source [SID1234556300]). This trial is being conducted to evaluate the safety and tolerability of ATG-019 monotherapy or ATG-019 combined with niacin ER (vitamin B3/nicotinic acid), for the treatment of advanced solid tumors or non-Hodgkin’s lymphoma.

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ATG-019 is a first-in-class, also the only orally bioavailable dual-target inhibitor targeting both p21-activated kinase 4 (PAK4) and nicotinamide phosphoribosyl transferase (NAMPT). PAK4 regulates numerous fundamental cellular processes, including intracellular transport, cellular division, cell shape and motility, immune defense and the development of cancer. PAK4 interacts with many key signaling molecules involved in cancer development such as beta-catenin, CDC42, Raf-1, BAD and myosin light chain. The overexpression and overactivation of PAK4 lead to tumor proliferation and metastasis and show a negative correlation with the infiltration of immune cells, leading to tumor proliferation and metastasis. NAMPT is the rate-limiting enzyme in the metabolic scavenging pathway that utilizes nicotinamide to replenish nicotinamide adenine dinucleotide (NAD), an essential metabolic cofactor and second messenger. Inhibition of NAMPT can effectively inhibit the energy metabolism and growth of tumor cells.

In May 2018, Antengene entered into a broad strategic collaboration with Karyopharm Therapeutics Inc. (Nasdaq: KPTI) and obtained exclusive rights for development and commercialization of four clinical stage, novel, oral drug candidates, including KPT-9274 (ATG-019), in various Asian countries and regions. As an oral small molecule inhibitor with the novel mechanism with novel targets, ATG-019 inhibits the occurrence, development, invasion and migration of tumors through the precise targeting and inhibiting both PAK4 and NAMPT. Preclinical studies has demonstrated the significant inhibitory effect of ATG-019 on multiple tumors types including lung cancer, multiple myeloma, leukemia, and lymphoma, etc.

"We are pleased that the first patient of ATG-019 was successfully enrolled and dosed. This is our first step in developing PAK4/NAMPT dual-target inhibitor," said Dr. Jay Mei, founder, chairman and CEO of Antengene," In addition to conducting the clinical trial for the treatment of advanced solid tumors and non-Hodgkin’s lymphoma, Antengene is also exploring the potential for ATG-019 in the treatment of different indications and in combination with existing regimens based on the anti-proliferative activity of ATG-019 on cancer cells. We hope to explore its potential from multiple dimensions in the near future. "

On April 13, 2020 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported that the Phase 3 trial evaluating its anti-PD-1 antibody tislelizumab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of patients with non-squamous non-small cell lung cancer (NSCLC) met its primary endpoint, demonstrating a statistically significant improvement in progression-free survival (PFS) compared to pemetrexed and platinum chemotherapy alone at the planned interim analysis, as assessed by independent review committee (IRC) (Press release, BeiGene, APR 13, 2020, View Source [SID1234556298]). The safety profile of tislelizumab in combination with pemetrexed and platinum chemotherapy was consistent with the known risks of each study treatment, and no new safety signals were identified.

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"We are excited to announce the positive outcome in the interim analysis of this Phase 3 study of tislelizumab in first-line non-squamous NSCLC, following the positive interim analysis in first-line squamous NSCLC earlier this year," said Yong (Ben) Ben, M.D., Chief Medical Officer, Immuno-Oncology at BeiGene. "These results add to our growing body of evidence demonstrating the efficacy and safety of tislelizumab for the treatment of advanced cancers. We look forward to continuing to evaluate tislelizumab in more than 25 studies, including 15 potentially registration-enabling trials."

BeiGene plans to discuss its plans for filing a supplemental new drug application (sNDA) for tislelizumab as a first-line treatment for non-squamous NSCLC with the Center for Drug Evaluation (CDE) at the National Medical Products Administration (NMPA) in China and present detailed data at upcoming medical conferences.

This trial (NCT03663205, known as BGB-A317-304) is a Phase 3, open-label, multi-center, randomized trial investigating tislelizumab (200mg every three weeks) combined with pemetrexed and investigator’s choice of platinum (either carboplatin or cisplatin) versus pemetrexed and platinum alone in patients with previously untreated stage IIIB or stage IV non-squamous NSCLC and with no EGFR mutations or ALK translocations. The primary endpoint is PFS as assessed by IRC. Key secondary endpoints included overall survival and safety. The study began enrollment in July 2018, and 334 patients were randomized 2:1 to receive tislelizumab in combination with chemotherapy or chemotherapy alone.

"NSCLC is a debilitating disease that comprises approximately 85 percent of lung cancer cases globally. It is estimated that approximately 60 percent of lung cancer diagnoses are made when the disease is in advanced stages and patients need more treatment options. The positive outcome at interim analysis for tislelizumab in this study and in other clinical trials, including for first-line squamous NSCLC, demonstrate that it is a promising option for people living with this advanced cancer," said Shun Lu, M.D., Professor at Shanghai Chest Hospital, Jiao Tong University and lead investigator for the trial.

About Non-Small Cell Lung Cancer

In contrast to most Western countries where lung cancer death rates are decreasing, the lung cancer incidence rate is still increasing in China.1,2 In 2018, there were approximately 770,000 new cases of lung cancer in China and it is the leading cause of cancer-related death in both men and women, with approximately 690,500 deaths.3 Non-small cell lung cancer (NSCLC) comprises the most common form of lung cancer in China.4

About Tislelizumab

Tislelizumab (BGB-A317) is a humanized IgG4 anti–PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is the first drug from BeiGene’s immuno-oncology biologics program and is being developed as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.

Tislelizumab is approved by the China National Medical Products Administration (NMPA) as a treatment for patients with classical Hodgkin’s lymphoma who received at least two prior therapies and for patients with locally advanced or metastatic urothelial carcinoma (UC) with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Currently, 15 potentially registration-enabling clinical trials are being conducted in China and globally, including 11 Phase 3 trials and four pivotal Phase 2 trials.

Tislelizumab is not approved for use outside of China and is not approved to treat non-small cell lung cancer.