On December 19, 2017 Onconova Therapeutics, Inc. (Nasdaq:ONTX), a Phase 3-stage biopharmaceutical company focused on discovering and developing small molecule drug candidates to treat cancer, with a focus on Myelodysplastic Syndromes (MDS), reported the signing of a license and collaboration agreement with HanX Biopharmaceuticals, Inc., a company focused on development of novel oncology products, for the further development, registration and commercialization of ON 123300 in China (Press release, Onconova, DEC 19, 2017, View Source [SID1234522713]). ON 123300 is a first-in-class dual inhibitor of CDK4/6 + ARK5, which is currently in advanced pre-clinical development. This compound has the potential to overcome the limitations of current generation CDK 4/6 inhibitors.

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Under the terms of the agreement, Onconova will receive an upfront payment, regulatory and commercial milestone payments, as well as royalties on Chinese sales. The key feature of the collaboration is that HanX will provide all funding required for Chinese IND enabling studies performed for Chinese Food and Drug Administration IND approval. The Companies also intend for these studies to comply with US Food and Drug Administration (FDA) standards. Accordingly, such studies may be used by Onconova for an IND filing with the FDA. Both Companies will oversee the IND enabling studies. Onconova will maintain global rights outside of China.

"This collaboration provides an innovative way forward for our promising pipeline molecule. We are excited to advance ON 123300 towards a US IND as we seek to create a new standard of care with the potential to overcome the limitations of current generation compounds that require a combination treatment for therapeutic use. We believe that ON 123300 also has the potential to act as a single agent, due to the unique targeting of ARK 5, as well as CDK 4 and 6, making it potentially suitable for indications that may not be responsive to the current generation of CDK4/6 inhibitors, such as Palbociclib," commented Ramesh Kumar, President and CEO of Onconova. "CDK inhibitors have emerged as one of the most promising and targeted large market cancer therapies. We remain focused on our later stage rigosertib clinical development programs in MDS with near term milestones, and look forward to a close collaboration with HanX as we leverage their strong expertise in drug development and commercialization."

Faming Zhang, Ph.D., founder and Chief Executive Officer of HanX, commented, "HanX is a specialty pharmaceutical company focused on oncology, with an emerging pipeline of targeted agents including a proprietary PD-1 checkpoint antibody soon entering Phase 1 trials. We are pleased to be working with Onconova, which shares our commitment to developing innovative therapeutics in oncology. We look forward to working together to accelerate the development of ON 123300 for patients suffering from many types of cancer, including breast cancer, in both China and globally. As we launch our internally developed programs, such as a novel PD-1 program and other kinase inhibitors, we are excited by the potential synergies between our pipeline of checkpoint product candidates and CDK inhibitors."

Onconova recently presented promising pre-clinical data on in vitro metabolism and bioavailability for ON 123300 at the American Association of Pharmaceutical Scientists Annual Meeting and Exposition. The data showed improved understanding of the metabolism of ON 123300 and the identification of metabolites, as well as a two to three-fold increase in bioavailability as a result of the Company’s formulation development efforts.

On December 19, 2017 Atreca, Inc., a biotechnology company focused on developing novel therapeutics based on a deep understanding of the human immune response, reported publication of noteworthy results in preclinical cancer research enabled by Atreca’s Immune Repertoire Capture (IRC) technology (Press release, Atreca, DEC 19, 2017, View Source [SID1234522717]). As reported in Clinical Immunology (DOI: 10.1016/j.clim.2017.10.002), Atreca scientists, collaborating with researchers at Stanford University and California Pacific Medical Center, demonstrated that patients with non-­progressing, metastatic cancer generate antibodies directed against public tumor antigens (epitopes present in tumors of more than one patient) in a manner having the hallmarks of a typical antigen-­driven humoral immune response. In preclinical in vivo models, certain of these antibodies also induce tumor regression and durable anti-­tumor immunity. The research involved the sequencing and analysis of native antibodies accessed from single B cells in the active, ongoing anti-­tumor immune responses of non-­progressing patients with metastatic melanoma, lung adenocarcinoma, or renal cell carcinoma.

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"This published research further confirms our ability to use IRC technology to validate B cell responses as a vital window for understanding effective patient immune responses in cancer, including the discovery of patient antibodies serving as the foundation for therapeutic discovery," commented William H. Robinson, M.D., Ph.D., Atreca board member, Co-­Founder, and Associate Professor of Medicine in the Division of Immunology and Rheumatology of the Department of Medicine at Stanford University, as well as co-­author on the published research. "By measuring key features of the immune response from non-­progressing patients, including patient antibodies’ targeting of antigens expressed across multiple cancer types, we now have important new evidence of the role of B cells in mounting effective immune responses to cancer."

"We are proud of this seminal work, having discovered key features of patient immune responses to cancer. By examining single patient B cells, Atreca has a unique opportunity to understand productive anti-­tumor responses and develop effective, next-­generation cancer immunotherapies," said Tito A. Serafini, Ph.D., Atreca’s President, Chief Executive Officer, and Co-­Founder. "Based on these and other compelling research findings, Atreca is executing on its goals of both identifying the widest range of antibodies targeting public tumor antigens and advancing a robust therapeutic pipeline using that information."

On December 19, 2017 Bristol-Myers Squibb Company (NYSE:BMY) reported that it will announce results for the fourth quarter of 2017 on Monday, February 5, 2018 (Press release, Bristol-Myers Squibb, DEC 19, 2017, View Source [SID1234522695]). During a conference call at 8:00 a.m. ET on February 5th company executives will review financial information and will address inquiries from investors and analysts.

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Investors and the general public are invited to listen to a live webcast of the call at View Source or by dialing in the U.S. toll free 866-548-4713 or international 323-794-2093, confirmation code: 4392051. Materials related to the call will be available at the same website prior to the conference call. A replay of the call will be available beginning at 11:00 a.m. ET on February 5, 2018 through 11:00 a.m. ET on February 19, 2018. The replay will also be available through View Source or by dialing in the U.S. toll free 888-203-1112 or international 719-457-0820 confirmation code: 4392051.

On December 18, 2017 Aduro Biotech, Inc. (Nasdaq:ADRO), a biopharmaceutical company with three distinct immunotherapy technologies, reported that the first patient in its Phase 1/2 dose escalation and dose expansion clinical trial (see www.clinicaltrials.gov, identifier NCT03340883) has been dosed at Virginia Cancer Specialists in Fairfax, Virginia, the first site in this multi-center trial (Press release, Aduro Biotech, DEC 18, 2017, View Source;p=RssLanding&cat=news&id=2323132 [SID1234522686]). The study is designed to evaluate the safety and activity of BION-1301, a humanized anti-APRIL (A PRoliferation-Inducing Ligand) antibody, for adults with relapsed or refractory multiple myeloma.

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"Neutralizing APRIL is a differentiated approach in the treatment of multiple myeloma, and it has been shown to inhibit tumor growth and overcome drug resistance in preclinical studies," said Natalie Sacks, M.D., chief medical officer of Aduro Biotech. "BION-1301 is our wholly-owned novel antibody that has been shown in non-clinical studies to fully block the APRIL-induced signaling cascade at a critical juncture, and we are eager to further characterize its potential activity in the clinic. Until there is a cure for multiple myeloma which remains a debilitating disease, alternative treatments are needed."

Recently, two datasets on anti-APRIL were presented at the 59TH American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in Atlanta, Georgia. Data presented by Yu-Tzu Tai, Ph.D., of the Dana Farber Cancer Institute in an oral session at ASH (Free ASH Whitepaper) demonstrate that BION-1301 and its parental antibody blocked APRIL binding to both its receptors BCMA and TACI. Blocking APRIL with BION-1301 (or its parental antibody) not only inhibited proliferation and survival of multiple myeloma cells but it also alleviated drug resistance and immune suppression in preclinical models and cell culture, leading to enhanced anti-BCMA and daratumumab-mediated myeloma cell killing. Additionally, Dr. Tai and her colleagues demonstrated that regulatory T cells in the blood and bone marrow expressed TACI, and that APRIL blockade inhibited their function. Also, John Dulos, Ph.D., director and project team leader at Aduro Biotech, and his team conducted preclinical pharmacokinetic and pharmacodynamic studies indicating BION-1301 was well tolerated and binding of APRIL in preclinical models resulted in decreased IgA, IgG and IgM production in a dose-dependent fashion.

"We know that APRIL sets off a cascade of events that hinders the immune response to multiple myeloma cells, helping the disease escape immune attack. The data presented at ASH (Free ASH Whitepaper) indicate that blocking APRIL by targeting BCMA alone may not be sufficient for the treatment of multiple myeloma, as APRIL critically modulates regulatory T cell function via TACI, not BCMA," said Dr. Tai. "Importantly, BION-1301, as a fully-blocking monoclonal antibody, may have unique efficacy by inhibiting APRIL-induced proliferation of immune system components linked to multiple myeloma progression."

About Phase 1/2 Trial
The Phase 1/2 multi-center, open-label study is designed to evaluate the safety and activity of BION-1301 in patients with relapsed or refractory multiple myeloma whose disease has progressed after at least 3 prior systemic therapies, including immunomodulatory drugs (IMiDs), proteasome inhibitors, chemotherapies, or monoclonal antibodies. The Phase 1 part of the study will evaluate the safety, pharmacokinetics and pharmacodynamics of escalating doses of BION-1301 administered once every two weeks in a 28-day cycle. Once the recommended Phase 2 dose is determined, the Phase 2 part of the study will begin. It will assess safety and preliminary activity of BION-1301 at the selected dose, with a primary activity endpoint of objective response rate.

About APRIL and BION-1301
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 suppress the immune system so that the tumor cells are allowed to proliferate. BION-1301 is a humanized anti-APRIL antibody that has been shown in preclinical studies to effectively neutralize APRIL, eliminate malignant cells and reduce resistance to therapy in models of multiple myeloma. In addition to multiple myeloma, APRIL’s role in other cancers and in B cell dependent autoimmune and inflammatory diseases indicate that BION-1301 may also be useful in treating chronic lymphocytic leukemia, colorectal cancer and Berger’s disease (caused by IgA antibody deposits in the kidneys).

About Multiple Myeloma
Lymphocytes (B cells and T cells) are the primary cell types within the immune system that work together to fight infection and disease. As B cells respond to normal infection in the body, they mature and change into plasma cells, which in turn make antibodies that help the body attack infection. While lymphocytes circulate throughout the body, plasma cells remain primarily in the bone marrow. Multiple myeloma is a blood cancer that occurs when malignant plasma cells proliferate uncontrollably. Approximately 50,000 new cases of multiple myeloma are expected to be diagnosed in the United States and Europe each year. While many new therapies have become available in recent years, multiple myeloma remains incurable and significant unmet needs exist among patients who relapse following, are resistant to, or cannot tolerate currently available agents.

On December 18, 2017 Innovation Pharmaceuticals, (IPIX) ("the Company"), a clinical stage biopharmaceutical company, reported an update on the developmental plan for Brilacidin, its first-in-class defensin-mimetic drug candidate, for the prevention and treatment of Oral Mucositis (OM) (Press release, Innovation Pharmaceuticals, DEC 18, 2017, View Source [SID1234522691]). On December 11, 2017, the Company released topline data from a Phase 2 trial. The study met its primary endpoint of reducing the incidence of severe OM experienced by patients receiving chemoradiation for treatment of Head and Neck Cancer (HNC).

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Oral Mucositis is a disease which is largely unfamiliar to the general public, many of whom haven’t witnessed the harsh side effects of OM first hand— namely extreme difficulty swallowing and painful sores in the mouth that can be so intense that cancer treatment must be stopped and a feeding tube inserted. There are currently no approved drugs for the prevention of severe OM in patients receiving chemoradiation treatment of HNC. Moreover, OM is a consequence of therapy for an array of cancers, not just HNC, where the incidence rate is particularly high.

Significant value inflection point for shareholders

Innovation Pharmaceuticals’ Brilacidin is now anchored in OM, representing a value inflection point for shareholders, as further supported by its lead positioning in an untapped $1 Billion market. "Anchored" is an industry term indicating a drug has delivered a meaningful response in a clinical setting for a specific disease along with good apparent safety and toleration. As such, Brilacidin-OM now represents a significant asset to the company. The next steps will be aimed at defining the most appropriate development plan to complete its evaluation prior to submission for marketing approval. This will involve consultation with the FDA and other health authorities worldwide, once full efficacy and safety endpoint data are available from the recent clinical trial.

Towards commercial planning, the Company has begun exploring potential unit dose drug product packaging in the form of a sachet. Sachets, which people are very familiar with and use on an almost daily basis (e.g., sugar packets, artificial sweeteners) increasingly are being developed as a novel means of patient-friendly, drug delivery. Manufacturing plans for drug substance appropriate for late phase testing and eventual market introduction are also underway.

As there are currently no approved drugs for prevention of severe OM in patients receiving chemoradiation treatment of HNC, management opinion is that Brilacidin-OM has the potential to rapidly assume a lead position after market introduction. This perspective is shared by multiple Pharma companies, potential partners the Company currently is in active discussions with, equally interested in the continued development and eventual market introduction of Brilacidin-OM worldwide.

"I am extremely proud that our team has achieved this very important milestone in cancer care and I feel very optimistic for the future. There is an urgent need for a drug such as Brilacidin to help cancer patients facing the threat of OM. We will be pursuing every option available to us toward providing these patients with a new therapeutic option," commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. "I have spoken with family members of patients dealing with OM and to hear the pain and suffering is simply heart-wrenching. I envision a day where doctors will have a viable option for preventing and treating severe OM and if Brilacidin-OM could be that drug, it would be a considerable accomplishment for the Company, our shareholders and the entire oncology industry."

About Brilacidin

Brilacidin is Innovation Pharmaceuticals’ lead drug candidate in its defensin mimetic franchise. Modeled after Host Defense Proteins (HDPs), the "front-line" of defense in the immune system, it is a small, non-peptidic, synthetic molecule that kills pathogens swiftly and thoroughly. Just as importantly, Brilacidin also functions in a robust immunomodulatory capacity, lessening inflammation and promoting healing. Due to its unique properties, the Company is studying Brilacidin’s effect on Oral Mucositis (under Fast Track designation) and on Ulcerative Proctitis / Proctosigmoiditis (UP/UPS) in Phase 2 trials. Additional trials of Brilacidin are planned in other conditions, including: Atopic Dermatitis, Hidradenitis Suppurativa and Acne. Brilacidin is also being developed under FDA’s Qualified Infectious Disease Product (QIDP) designation as an antibacterial product for Acute Bacterial Skin and Skin Structure Infection (ABSSSI)—qualifying it for Fast Track and possible Priority FDA Review and an extra 5 years of United States market exclusivity upon drug approval.

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About Brilacidin-OM

Innovation Pharmaceutical’s first-in-class immunomodulatory drug candidate, Brilacidin, targets the prevention of severe Oral Mucositis (OM)—a common and debilitating side-effect of receiving chemoradiation therapy—in Head and Neck Cancer. Each year, OM affects hundreds of thousands of patients worldwide. Only a limited number of OM treatments are available, most of which are palliative in nature. A Phase 2 randomized, placebo-controlled clinical trial of Brilacidin-OM (see NCT02324335) has been recently completed in which topline results demonstrate a reduced rate of severe OM (WHO Grade >3) in patients treated with Brilacidin-OM compared to those on placebo.

About Oral Mucositis

Oral Mucositis (OM) is a frequent, painful and debilitating complication of chemoradiation. Head and Neck Cancer (HNC) patients—comprising an estimated 65,000 newly diagnosed cases in the U.S. alone in 2017, and an estimated 700,000 worldwide (source:GLOBOCAN)—are at the greatest risk of developing OM (a 90 to 100 percent rate of occurrence). By 2030, the global incidence of HNC cases is expected to exceed 1 million per year. Moreover, between 25 and 60 percent of cancer patients, regardless of cancer type, also will experience OM. Characterized by inflammation and ulceration, patients suffering from OM are often unable to speak and eat (requiring the insertion of a feeding tube) and are more susceptible to infections, with severe cases leading to hospitalization at increased treatment costs of up to $25,000. There currently are no approved medications for the prevention of OM in the HNC population, with only limited palliative care options available. Worldwide, the potential marketfor OM is expected to exceed $1 billion in the next few years.