On December 18, 2019 Onconova Therapeutics, Inc. (NASDAQ: ONTX) ("Onconova"), a Phase 3-stage biopharmaceutical company discovering and developing novel products to treat cancer, with a focus on myelodysplastic syndromes (MDS), reported it has entered into a Distribution, License, and Supply Agreement whereby Specialised Therapeutics Asia ("STA") shall have the exclusive rights to commercialize rigosertib in Australia and New Zealand (Press release, Onconova, DEC 18, 2019, View Source [SID1234552466]). In addition, Onconova may be entitled to receive clinical, regulatory, and sales-based milestone payments up to US $30.4 million and tiered double-digit royalties on net sales.

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"We are pleased to partner with Specialised Therapeutics Asia, which has a strong track record of commercializing new products in oncology and hematology across Australia and New Zealand," said Dr. Steven Fruchtman, President and Chief Executive Officer of Onconova. "We look forward to working together and, pending a successful readout of the ongoing INSPIRE Trial, potentially providing rigosertib as a new therapeutic option for patients diagnosed with MDS."

STA Chief Executive Officer, Mr. Carlo Montagner, said that "patients with high-risk MDS have limited treatment options following currently available first-line treatment. There is no currently approved treatment following failure of standard chemotherapy with hypomethylating agents. Patients are left with the option of entering clinical trials, if available, or supportive care," he said. "If approved, rigosertib would address an unmet medical need and may be a valuable inclusion to the STA therapeutic portfolio. We are delighted to enter into this collaboration with Onconova and look forward to the results of the ongoing phase 3 INSPIRE Trial of intravenous (IV) rigosertib."

About Myelodysplastic Syndromes

MDS is a group of blood disorders that affect bone marrow function, whereby the bone marrow cells appear dysplastic and their capacity to produce cells is defective. As a result, patients with MDS have low blood cell counts and require frequent blood transfusions. In approximately one-third of patients, higher-risk MDS can progress to acute myelogenous leukemia (AML).

About Rigosertib

Rigosertib, Onconova’s lead candidate, is a proprietary Phase 3 small molecule. A key publication in a preclinical model described rigosertib’s ability to block cellular signaling by targeting RAS effector pathways (Divakar, S.K., et al., 2016: "A Small Molecule RAS-Mimetic Disrupts RAS Association with Effector Proteins to Block Signaling." Cell 165, 643). Onconova is currently in the clinical development stage with oral and IV rigosertib, including clinical trials studying single agent IV rigosertib in second-line higher-risk MDS patients (pivotal Phase 3 INSPIRE Trial) and oral rigosertib plus azacitidine in first-line and refractory higher-risk MDS patients (Phase 2). Patents covering oral and injectable rigosertib have been issued in the US and are expected to provide coverage until at least 2037.

About the INSPIRE Phase 3 Clinical Trial

The clinical trial INternational Study of Phase 3 IV RigosErtib, or INSPIRE, was finalized following guidance received from the U.S. Food and Drug Administration and European Medicines Agency. INSPIRE is a global, multi-center, randomized, controlled study to assess the efficacy and safety of IV rigosertib in higher-risk MDS (HR-MDS) patients who had progressed on, failed to respond to, or relapsed after previous treatment with a hypomethylating agent (HMA) within nine cycles over the course of one year after initiation of HMA treatment. This time-frame optimizes the opportunity to respond to treatment with an HMA prior to declaring treatment failure, as per NCCN Guidelines. Patients are randomized at a 2:1 ratio into two study arms: IV rigosertib plus Best Supportive Care versus Physician’s Choice plus Best Supportive Care. The primary endpoint of INSPIRE is overall survival. The trial continued beyond the pre-specified interim analysis and is nearing its conclusion. Full details of the INSPIRE trial, such as inclusion and exclusion criteria, as well as secondary endpoints, can be found on clinicaltrials.gov (NCT02562443).

On December 18, 2019 Geron Corporation (Nasdaq: GERN) reported that the Company has conducted an End of Phase 2 meeting with the U.S. Food and Drug Administration (FDA) to discuss the results of the IMbark Phase 2 clinical trial of imetelstat in patients with Intermediate-2 or High-risk myelofibrosis (MF) whose disease has relapsed after or is refractory to janus kinase (JAK) inhibitor treatment, or relapsed/refractory MF (Press release, Geron, DEC 18, 2019, View Source [SID1234552465]). Based on feedback from the meeting, over the coming months Geron plans to submit several Phase 3 trial design proposals in relapsed/refractory MF and to have further discussions with the FDA regarding potential regulatory approval pathways. The Phase 3 trial proposals will be designed to fully characterize the efficacy, safety, and benefit-risk profile of imetelstat treatment for these patients, as well as to confirm the clinical benefit and disease-modifying potential of imetelstat in this indication. Subsequent to these additional discussions with the FDA, and after considering the timing and resources required, as well as other clinical development opportunities for imetelstat, Geron will make a decision regarding potential late-stage development of imetelstat in relapsed/refractory MF.

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About Myelofibrosis

Myelofibrosis (MF), a type of myeloproliferative neoplasm, is a chronic blood cancer in which abnormal or malignant precursor cells in the bone marrow proliferate rapidly, causing scar tissue, or fibrosis, to form. As a result, normal blood production in the bone marrow is impaired and may shift to other organs, such as the spleen and liver, which can cause them to enlarge substantially. People with MF may have abnormally low or high numbers of circulating red blood cells, white blood cells or platelets, and abnormally high numbers of immature cells in the blood or bone marrow. MF patients can also suffer from debilitating constitutional symptoms, such as drenching night sweats, fatigue, severe itching, or pruritus, abdominal pain, fever and bone pain. The estimated prevalence of MF in the U.S. is approximately 13,000 patients, with an annual incidence of approximately 3,000 patients. Up to 20% of patients with MF develop acute myeloid leukemia.

Approximately 70% of MF patients are classified as having Intermediate 2 or High-risk disease, as defined by the Dynamic International Prognostic Scoring System Plus, or DIPSS Plus, described in a 2011 Journal of Clinical Oncology article. Today, there are two drugs approved in Intermediate-2 or High-risk MF, and both are JAK inhibitors. Currently, no drug therapy is specifically approved for those patients who fail or no longer respond to that treatment, and median survival for such MF patients is only approximately 14 to 16 months, representing a significant unmet medical need.

About Imetelstat

Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic myeloid malignancies. Early clinical data suggest imetelstat may have disease-modifying activity through the suppression of malignant progenitor cell clone proliferation, which allows potential recovery of normal hematopoiesis. Ongoing clinical studies of imetelstat consist of IMerge, a Phase 2/3 trial in lower risk myelodysplastic syndromes (MDS), and IMbark, a Phase 2 trial in Intermediate-2 or High-risk myelofibrosis (MF). Imetelstat has been granted Fast Track designation by the United States Food and Drug Administration for both the treatment of patients with non-del(5q) lower risk MDS who are refractory or resistant to an erythropoiesis-stimulating agent and for patients with Intermediate-2 or High-risk MF whose disease has relapsed after or is refractory to janus kinase (JAK) inhibitor treatment.

On December 18, 2019 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported that it has launched the antitumor agent bevacizumab BS for intravenous drip infusions 100 mg and 400 mg "Daiichi Sankyo" (generic name: bevacizumab (genetical recombination) [bevacizumab biosimilar 2], hereafter, "the product") today in Japan (Press release, Daiichi Sankyo, DEC 18, 2019, View Source [SID1234552464]).

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The product is a pharmaceutical agent developed by Amgen Inc. (Headquarters: Thousand Oaks, CA, U.S.A; hereafter, "Amgen") as a biosimilar product to the anti-VEGF humanized monoclonal antibody, bevacizumab. The product was approved on September 20, 2019, and indicated for unresectable advanced or recurrent colorectal cancer.

Based on the exclusive agreement on the commercialization of biosimilars concluded with Amgen in July 2016, Daiichi Sankyo is responsible for the distribution and commercialization of the product in Japan, while Amgen is responsible for its manufacture.

Daiichi Sankyo expects that the product will provide patients with various options for cancer treatment, thereby further contributing to medical treatment in japan.

Product name

Bevacizumab BS for intravenous drip infusions 100 mg and 400 mg "Daiichi Sankyo"

Generic name

Bevacizumab (Genetical Recombination)[ Bevacizumab Biosimilar 2]

Indications

Unresectable advanced or recurrent colorectal cancer.

Dosage and administration

In combination with other antineoplastic agents, adults are usually infused intravenously
at 5 mg / kg (body weight) or 10 mg / kg (body weight) once as bevacizumab (genetical recombination) bevacizumab biosimilar 2]. Dosing interval should be 2 weeks or more.

Date of approval for manufacturing and marketing

September 20, 2019

Date of listing in the
NHI reimbursement

November 27, 2019

Day of launch

December 19, 2019

Marketing authorization holder

On December 18, 2019 Bristol-Myers Squibb Company (NYSE: BMY) reported the submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for lisocabtagene maraleucel (liso-cel), its autologous anti-CD19 chimeric antigen receptor (CAR) T‑cell immunotherapy comprising individually formulated CD8+ and CD4+ CAR T cells for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) after at least two prior therapies (Press release, Bristol-Myers Squibb, DEC 18, 2019, View Source [SID1234552463]).

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The submission is based on the safety and efficacy results from the TRANSCEND NHL 001 trial, evaluating liso-cel in 269 patients with relapsed/refractory large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL). Bristol-Myers Squibb recently presented data from this pivotal study at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting.

Liso-cel has been granted Breakthrough Therapy (BT) and Regenerative Medicine Advanced Therapy (RMAT) designations by the FDA for relapsed/refractory aggressive large B-cell non-Hodgkin lymphoma (NHL), including DLBCL, not otherwise specified (de novo or transformed from indolent lymphoma), primary mediastinal B-cell lymphoma (PMBCL) or Grade 3B follicular lymphoma (FL) and Priority Medicines (PRIME) scheme by the European Medicines Agency for relapsed/refractory DLBCL.

Liso-cel is an investigational compound that is not approved for use in any country.

About Diffuse Large B-cell Lymphoma

Diffuse large B-cell lymphoma (DLBCL) is the most common and aggressive NHL, accounting for three out of every five cases. Approximately one-third of patients with DLBCL relapse after receiving first-line treatment, and about 10% have refractory disease. Historically, median life expectancy for patients who relapse or are refractory to current standard of care treatments is approximately six months.

Bristol-Myers Squibb: Advancing Cancer Research

At Bristol-Myers Squibb, patients are at the center of everything we do. The goal of our cancer research is to increase quality, long-term survival and make cure a possibility. We harness our deep scientific experience, cutting-edge technologies and discovery platforms to discover, develop and deliver novel treatments for patients.

Building upon our transformative work and legacy in hematology and Immuno-Oncology that has changed survival expectations for many cancers, our researchers are advancing a deep and diverse pipeline across multiple modalities. In the field of immune cell therapy, this includes registrational chimeric antigen receptor (CAR) T-cell agents for numerous diseases, and a growing early-stage pipeline that expands cell and gene therapy targets, and technologies. We are developing cancer treatments directed at key biological pathways using our protein homeostasis platform, a research capability that has been the basis of our approved therapies for multiple myeloma and several promising compounds in early to mid-stage development. Our scientists are targeting different immune system pathways to address interactions between tumors, the microenvironment and the immune system to further expand upon the progress we have made and help more patients respond to treatment. Combining these approaches is key to delivering new options for the treatment of cancer and addressing the growing issue of resistance to immunotherapy. We source innovation internally, and in collaboration with academia, government, advocacy groups and biotechnology companies, to help make the promise of transformational medicines a reality for patients.

About Lisocabtagene Maraleucel (liso-cel)

Liso-cel is an investigational chimeric antigen receptor (CAR) T-cell therapy designed to target CD19, which is a surface glycoprotein expressed during normal B-cell development and maintained following malignant transformation of B cells. Liso-cel aims to target CD19-expressing cells through a CAR construct that includes an anti-CD19 single-chain variable fragment (scFv) targeting domain for antigen specificity, a transmembrane domain, a 4-1BB costimulatory domain hypothesized to increase T-cell proliferation and persistence, and a CD3-zeta T-cell activation domain. The defined composition of CAR-positive viable T-cells (consisting of CD8 and CD4 components) in liso-cel may reduce product variability; however, the clinical significance of defined composition is unknown.

About TRANSCEND NHL 001

TRANSCEND NHL 001 is an open-label, multicenter, pivotal phase 1 study to determine the safety, pharmacokinetics, and antitumor activity of liso-cel in patients with relapsed/refractory B-cell NHL, including DLBCL, PMBCL, Grade 3B FL. Mantle cell lymphoma is investigated in a separate cohort. The primary outcome measures included treatment-related adverse events, dose-limiting toxicities and objective response rate. Secondary outcome measures included complete response rate, duration of response, and progression-free survival. The TRANSCEND program is a broad clinical program evaluating liso-cel in multiple disease states and treatment stages.

On December 18, 2019 BeyondSpring Inc. (the "Company" or "BeyondSpring") (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, reported an update on the Company’s operations and announced its financial results for the three months ended September 30, 2019 (Press release, BeyondSpring Pharmaceuticals, DEC 18, 2019, View Source [SID1234552462]).

"We are pleased with the progress we are seeing in our clinical programs surrounding our lead compound, Plinabulin, for the treatment of non-small cell lung cancer (NSCLC) and CIN," said Dr. Lan Huang, BeyondSpring’s Co-Founder, Chairman and Chief Executive Officer. "Our goal from day one has been to develop transforming treatments for cancer patients. Between the enrollment of the first patient in our global Phase 3 Study 106, the publication of Plinabulin’s immune mechanism as a potent Antigen Presenting Cell (APC) inducer in three peer-review journals and continual positive data being presented at medical meetings world-wide, we remain on track to address large unmet medical needs among these cancer patients."

"The combination of our clinical experience – over 900 patients enrolled globally – and the deep insight into Plinabulin’s immune mechanism – a potent APC inducer – lead us to believe Plinabulin has potential to be a ’pipeline in a drug’. Our life cycle plan for Plinabulin begins with the foundational indications in NSCLC and CIN. From here we expect to expand into a broader chemotherapy combination footprint, and eventually we expect to transform Plinabulin’s potential in combination with checkpoint inhibitors and radiation or chemotherapy. This triple therapy combination could be a powerful treatment in multiple cancer types with significant market opportunities," added Dr. Huang. "We anticipate filing NDAs for Plinabulin in the U.S. and China for both NSCLC and CIN over the next 18 months. The success of our recent round of financing ensures that we will have the necessary resources to achieve the clinical milestones moving forward."

Recent Operational Highlights

Novel Study Design of Plinabulin in NSCLC Phase 3

In October 2019, BeyondSpring announced that its abstract, titled, "DUBLIN-3, a Stage IIIb / IV NSCLC Phase 3 Trial Comparing the Plinabulin / Docetaxel Combination with Docetaxel Alone," was presented at this year’s European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress. The abstract highlighted the study’s unique design, which positively addressed the challenges associated with trial failure risk in NSCLC studies.

In November 2019, BeyondSpring presented a poster at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, titled, "Validation of a Single-Blinded (Patients Only) Study Design for the Prevention of Premature Patient Consent Withdrawal in the Immuno-Oncology Trial DUBLIN-3." This abstract explained that cancer patients generally prefer immunotherapy over chemotherapy, which can lead to premature withdrawal of their consent to participate in a clinical trial if they are allocated to the chemotherapy comparator arm, and can negatively impact the study’s outcome. Specifically, the DUBLIN-3 trial was a single-blinded study, while the Javelin trial was an open-label study, which led investigators to their conclusion.

1
Plinabulin’s Superior Profile in CIN Prevention

In September 2019, BeyondSpring announced that an abstract, titled, "The Effect of Increasing Doses of Pegfilgrastim on Thrombocytopenia in Breast Cancer Patients Receiving Taxotere, Doxorubicin, Cyclophsophamide and Plinabulin," was accepted for presentation at ESMO (Free ESMO Whitepaper). The abstract evaluated the effects of pegfilgrastim combined with Plinabulin on absolute neutrophil and platelet counts compared to pegfilgrastim alone. The data showed that the combination appears to have a superior product profile over pegfilgrastim in CIN control, platelet counts and bone pain.

In October 2019, BeyondSpring announced the enrollment of the first patient in its Study 106, a global Phase 3 trial with Plinabulin in combination with G-CSF to prevent CIN. The study is the key platform to confirm this finding and bring improved care to patients.

Most recently at the American Society of Hematology (ASH) (Free ASH Whitepaper)’s (ASH) (Free ASH Whitepaper) annual meeting, BeyondSpring presented two e-publications on Study 105 and a poster on Study 106, highlighting Plinabulin’s mechanism of action in preventing CIN.

The Study 105 e-publications titled, "Clinical Evidence of Granulocyte-Monocyte Progenitor (GMP) Stem Cell Involvement in Plinabulin’s Mechanism of Action (MoA) for the Prevention of Docetaxel (Doc) Chemotherapy (Chemo)-Induced Neutropenia (CIN)," and "Clinical Evidence Against the Continuum of Low-Primed Uncommitted Hematopoietic and Progenitor Cells (CLOUD-HSPC) Concept for Hematopoiesis," highlight Plinabulin’s ability to protect hematopoietic stem cells, which differentiates into neutrophils and other white blood cells.

The Study 106 poster titled, "A Randomized Phase 3 Clinical Trial of the Combination of Plinabulin (Plin) + Pegfilgrastim (Peg) versus (vs) Peg Alone for TAC (docetaxel, doxorubicin, cyclophosphamide) Induced Neutropenia (CIN)," provides rationale for the addition of Plinabulin to pegfilgrastim (Neulasta) due to their differing mechanisms of action (MoA) for the prevention against CIN.

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Plinabulin’s Anti-cancer Immune Mechanism and CIN Prevention Mechanism Published in Peer-Reviewed Journals

In October 2019, prestigious Cell publications, Chem and Cell Reports, published novel findings focusing on the mechanism of Plinabulin to mature dendritic cells, which leads to T-cell activation.

The Chem article, titled, "Structure, Thermodynamics and Kinetics of Plinabulin Binding to Two Tubulin Isotypes," outlined research utilizing X-ray crystallography and thermodynamic calculations to demonstrate Plinabulin as a new chemical entity with differentiated binding and kinetics compared to other tubulin binding agents, which gives rise to its differentiated superior efficacy and safety profile in the clinic.

In Cell Reports, titled, "GEF-H1 Signaling Upon Microtubule Destabilization Is Required for Dendritic Cell Activation and Specific Anti-tumor Responses," authors cited Plinabulin’s ability to destabilize microtubule and release the immune defense protein GEF-H1, which is a critical signaling protein for dendritic cell maturation. This leads to the priming of CD8 T-cells. GEF-H1 high immune signature showed better survival in cancer patients, which validated GEF-H1 as a first in class target.

In early December, Cancer Chemotherapy & Pharmacology published an article that examines the mechanism-of-action of Plinabulin and its anti-CIN benefits. The article, titled, "Plinabulin Ameliorates Neutropenia Induced by Multiple Chemotherapies Through a Mechanism Distinct from G‑CSF Therapies," reports the results of an animal study that support the clinical testing of Plinabulin as a non-G-CSF-based treatment for CIN associated with chemotherapies of different mechanisms. Results also support hematopoietic stem/progenitor cells as a focal point for future mechanism-of-action work aimed at understanding the ability of Plinabulin to reduce the serious side effect of cytotoxic therapy in cancer patients.

Strong Intellectual Property Protection through 2036 Globally

In October 2019, BeyondSpring announced that the U.S. Patent and Trademark Office granted the Company a new patent for methods of treating brain tumors by administering Plinabulin. This underscores the Company’s belief that Plinabulin is a first-in-class clinical pipeline asset. Currently, surgery and radiation are the only approved treatments for brain tumors. Chemotherapy has never been approved to treat metastatic brain tumors.

We now have 75 granted Plinabulin patents in 36 jurisdictions and 17 patents granted in the U.S., including the composition of matter patent, with protection to 2036.

Equity Financing

On October 25, 2019, BeyondSpring priced an underwritten public offering of its ordinary shares. The offering was led by Decheng Capital, with gross proceeds of $25.8 million including the overallotment options, before deducting underwriting discounts, commissions and other offering expenses. The Company expects to use the net proceeds to continue clinical and pre-clinical development in addition to general corporate purposes.

Financial Results for the Three Months Ended September 30, 2019

Research and development ("R&D") expenses were $7.2 million for the quarter ended September 30, 2019, compared to $14.1 million for the quarter ended September 30, 2018. The $6.9 million decrease was largely attributable to a $3.9 million decrease in expenses incurred by clinical research organizations and other service fees related to clinical trials, a $0.5 million decrease in preclinical trial expenses and a $0.5 million decrease in non-cash share-based compensation.

General and administrative ("G&A") expenses were $2.5 million for the quarter ended September 30, 2019, compared to $1.5 million for the quarter ended September 30, 2018. The $1.0 million increase was mainly due to the $0.7 million of market research expenses incurred during the quarter ended September 30, 2019.

Net loss attributable to the Company was $9.4 million for the quarter ended September 30, 2019, compared to $14.9 million for the quarter ended September 30, 2018.

As of September 30, 2019, the Company had a cash balance of $24.7 million. With the additional $25.8 million gross proceeds from the recent public offering described above, the Company believes it has sufficient cash to support its clinical trials and submit NDAs in the U.S. and China for Plinabulin for the treatment of NSCLC and CIN, as well as to advance its immuno-oncology pipeline and its ubiquitination protein degradation research platform.

Anticipated Milestones

The following outlines the Company’s anticipated upcoming milestones and projected timelines:

NDA submission to China’s National Medical Products Administration (NMPA) for Plinabulin for CIN – Q1 2020

Final data readout for Study 105 Phase 3 for CIN – H1 2020

Final data readout for Study 106 Phase 3 for CIN – H1 2020

Final data readout for Study 103 Phase 3 for NSCLC – H2 2020

NDA submission to China’s NMPA for Plinabulin for NSCLC – H2 2020

NDA submission to the U.S. Food and Drug Administration (FDA) for Plinabulin for CIN – H2 2020

NDA submission to the U.S. FDA for Plinabulin for NSCLC – H1 2021

Conference Call and Webcast Information

BeyondSpring’s management will host a conference call and webcast today at 8 a.m. Eastern Time to discuss the financial results and provide a corporate update. The dial-in numbers for the conference call are 1-877-451-6152 (U.S.) or 1-201-389-0879 (international). Please reference conference ID 13697474. A live webcast will be available on BeyondSpring’s website at www.beyondspringpharma.com under "Events & Presentations" in the Investors section. An archived replay of the webcast will be available for 30 days.