Patupilone

The number of projects in Novartis’ pipeline fell from 150 to 134. Novartis has undertaken an old-fashioned decimation of its pipeline. The Swiss drugmaker has decided to dump or out-license 10% of its R&D projects to narrow its sights on five core therapeutic areas and focus investment on its most promising programs within those spaces.  In recent quarters, Novartis has decided to make five therapeutic areas—cardiovascular, hematology, solid tumors, immunology and neuroscience—and a small clutch of technology platforms the focus of its R&D activities. More recently, disclosures about partnered programs that Novartis is dumping gave hints that an overhaul was underway. Now, Novartis has shared a full look at its slimmed-down pipeline. “We reduced our pipeline size by about 10%. And that's primarily as we prune assets that are outside of those five core therapeutic areas, or in the sixth area we call TAX which incubate certain therapeutic areas we're interested in,” Novartis CEO Vas Narasimhan, M.D., said on an early morning call with the media. “So we've taken the principal decision that if it doesn't fit within that framework, we are either going to stop the programs or divest them.”  Expanding on the decision in a later call with analysts, Narasimhan explained that part of the pipeline “cleanup” had been the result of benchmarking Novartis’ R&D against its fellow Big Pharmas. “We had more projects than our peers, which led us to have less investment per project versus the peer set,” the CEO explained. “We think that's important because in having strong investment in the early stage pre-clinically or in early clinical can also help us go faster, go broader into more lines of therapy, more indications.” As a result of the changes, the number of projects in Novartis’ pipeline has fallen from 150 to 134. Solid tumors, an ongoing area of focus, took the biggest hit, with the number of active projects falling from 42 to 32 between the two updates.  Addressing the significant reduction in early-stage cancer assets, Narasimhan told analysts that Novartis had removed candidates with targets that “are no longer priority tumors for the company.” Below, we provide an overview of the programs that Novartis dropped from its pipeline in its quarterly pipeline update. But before getting to that, there is one candidate clinging on that is nonetheless worth discussing. In the fourth quarter, Novartis listed six studies involving spartalizumab, an anti-PD-1 checkpoint inhibitor that failed a phase 3 melanoma trial in 2020. Today, only one study remains.  Phase 2 ADPT06: A cognitive impairment candidate that Novartis tested in a phase 2 platform clinical trial of various anti-inflammatory agents. The mechanism of action is unknown. Novartis tested canakinumab, sold in other indications as Ilaris, in the same trial of patients with mild cognitive impairment due to Alzheimer's disease. HSY244: An atrial fibrillation candidate that Novartis took into phase 2 in 2020. Novartis “prematurely ended” the study, per the European database, but ClinicalTrials.gov still lists it as recruiting patients. Ensovibep: The COVID-19 antiviral that Novartis bought at the start of last year for 150 million Swiss francs ($168 million). Within months, Novartis’ plan to bring the molecule to market unraveled as the FDA requested phase 3 data. Novartis licensed the asset from Molecular Partners. LKA651: A MorphoSys-partnered EPO inhibitor that Novartis studied in diabetic macular edema. Novartis completed a phase 2 clinical trial of the drug candidate last summer. Phase 1 FIA586: The final domino to fall in Novartis’ exit from nonalcoholic steatohepatitis (NASH). The Swiss drugmaker wrapped up an early-phase trial of the candidate in mild and moderate hepatic impairment last summer. MHS552: An autoimmune disease candidate that Novartis was studying in a phase 1 lupus trial when it decided to pull the plug. The company filed to test the molecule in type 1 diabetes but withdrew the study before enrolling any patients.  ADPT03: A BCL11A program targeting sickle cell disease. Intellia disclosed that Novartis had stopped work on an ex vivo, CRISPR-edited cell therapy designed to reduce the activity of BCL11A earlier this year. JEZ567: A anti-CD123 CAR-T cell therapy that Novartis was developing in acute myeloid leukemia. MAK683: An inhibitor of embryonic ectoderm development protein that Novartis has studied in people with diffuse large B-cell lymphoma since 2016. WVT078: A BCMAxCD3 bispecific antibody that Novartis studied in multiple myeloma. The presence of many other BCMA candidates at other companies makes WVT078 a poor fit for Novartis’ focus on “high value medicines with transformative potential for patients.”

LA JOLLA, Calif., Sept. 14, 2022 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that it has received an Issue Notification from the U.S. Patent and Trademark Office for a new patent which covers MN-166 (ibudilast) for the treatment of glioblastoma. This new patent is expected to expire no earlier than February 2039. The allowed claims cover a method of treating a patient diagnosed with glioblastoma or recurrent glioblastoma, wherein the patient expresses unmethylated MGMT, using MN-166 (ibudilast) in combination with one or more other therapeutic agents including temozolomide (TMZ), carmustine, bevacizumab, procarbazine, hydroxyurea, irinotecan, lomustine, nimotuzumab, sirolimus, mipsagargin, cabozantinib, onartuzumab, patupilone (epothilone B), and recombinant oncolytic poliovirus (PVS-RIPO). The allowed claims cover a wide range of doses of MN-166 (ibudilast) as well as the other therapeutic agents. The allowed claims also cover different types of glioblastoma including classical glioblastoma, proneural glioblastoma, mesenchymal glioblastoma, and neural glioblastoma. Kazuko Matsuda, MD, PhD, MPH, Chief Medical Officer of MediciNova, Inc. commented, “We are very pleased to receive the issue notification for this new patent as it offers additional coverage compared to our other two patents covering glioblastoma. We have an ongoing clinical trial of MN-166 in combination with temozolomide for the treatment of recurrent glioblastoma at the Dana-Farber Cancer Institute, Harvard Medical School. Results of our glioblastoma animal model study showed that median survival was longer in the group that received combination treatment with MN-166 plus temozolomide compared to the group that received the standard treatment of temozolomide alone, and this data was presented at the American Society of Clinical Oncology (ASCO) annual meeting. Encouragingly, the FDA granted orphan-drug designation to MN-166 as adjunctive therapy to temozolomide for the treatment of glioblastoma based on this data.” About Glioblastoma According to the American Association of Neurological Surgeons, glioblastoma is an aggressive brain cancer that often results in death during the first 15 months after diagnosis. Glioblastoma develops from glial cells (astrocytes and oligodendrocytes), grows rapidly, and commonly spreads into nearby brain tissue. Glioblastoma is classified as Grade IV, the highest grade, in the World Health Organization (WHO) brain tumor grading system. The American Brain Tumor Association reports that glioblastoma represents about 15% of all primary brain tumors and approximately 10,000 cases of glioblastoma are diagnosed each year in the U.S. Despite decades of advancements in neuroimaging, neurosurgery, chemotherapy and radiation therapy, only modest improvements have been achieved and the prognosis has not improved for individuals diagnosed with glioblastoma. Median survival is about 11-15 months for adults with more aggressive glioblastoma (IDH-wildtype) who receive standard treatment of surgery, temozolomide, and radiation therapy. About MN-166 (ibudilast) MN-166 (ibudilast) is a small molecule compound that inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines, including macrophage migration inhibitory factor (MIF). It is in late-stage clinical development for the treatment of neurodegenerative diseases such as ALS (amyotrophic lateral sclerosis), progressive MS (multiple sclerosis), and DCM (degenerative cervical myelopathy); and is also in development for glioblastoma, CIPN (chemotherapy-induced peripheral neuropathy), and substance use disorder. In addition, MN-166 (ibudilast) was evaluated in patients that are at risk for developing acute respiratory distress syndrome (ARDS). About MediciNova MediciNova, Inc. is a clinical-stage biopharmaceutical company developing a broad late-stage pipeline of novel small molecule therapies for inflammatory, fibrotic, and neurodegenerative diseases. Based on two compounds, MN-166 (ibudilast) and MN-001 (tipelukast), with multiple mechanisms of action and strong safety profiles, MediciNova has 11 programs in clinical development. MediciNova’s lead asset, MN-166 (ibudilast), is currently in Phase 3 for amyotrophic lateral sclerosis (ALS) and degenerative cervical myelopathy (DCM) and is Phase 3-ready for progressive multiple sclerosis (MS). MN-166 (ibudilast) is also being evaluated in Phase 2 trials in glioblastoma and substance dependence. MN-001 (tipelukast) was evaluated in a Phase 2 trial in idiopathic pulmonary fibrosis (IPF) and a second Phase 2 trial in non-alcoholic fatty liver disease (NAFLD) is ongoing. MediciNova has a strong track record of securing investigator-sponsored clinical trials funded through government grants. Statements in this press release that are not historical in nature constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding the future development and efficacy of MN-166, MN-001, MN-221, and MN-029. These forward-looking statements may be preceded by, followed by or otherwise include the words "believes," "expects," "anticipates," "intends," "estimates," "projects," "can," "could," "may," "will," "would," “considering,” “planning” or similar expressions. These forward-looking statements involve a number of risks and uncertainties that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied by these forward-looking statements include, but are not limited to, risks of obtaining future partner or grant funding for development of MN-166, MN-001, MN-221, and MN-029 and risks of raising sufficient capital when needed to fund MediciNova's operations and contribution to clinical development, risks and uncertainties inherent in clinical trials, including the potential cost, expected timing and risks associated with clinical trials designed to meet FDA guidance and the viability of further development considering these factors, product development and commercialization risks, the uncertainty of whether the results of clinical trials will be predictive of results in later stages of product development, the risk of delays or failure to obtain or maintain regulatory approval, risks associated with the reliance on third parties to sponsor and fund clinical trials, risks regarding intellectual property rights in product candidates and the ability to defend and enforce such intellectual property rights, the risk of failure of the third parties upon whom MediciNova relies to conduct its clinical trials and manufacture its product candidates to perform as expected, the risk of increased cost and delays due to delays in the commencement, enrollment, completion or analysis of clinical trials or significant issues regarding the adequacy of clinical trial designs or the execution of clinical trials, and the timing of expected filings with the regulatory authorities, MediciNova's collaborations with third parties, the availability of funds to complete product development plans and MediciNova's ability to obtain third party funding for programs and raise sufficient capital when needed, and the other risks and uncertainties described in MediciNova's filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2021 and its subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof. MediciNova disclaims any intent or obligation to revise or update these forward-looking statements. INVESTOR CONTACT:Geoff O'BrienVice PresidentMediciNova, Inc.info@medicinova.com