Amendment: Nuvation Bio Inc. filed SEC Form 8-K: Other Events, Financial Statements and Exhibits
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Item 8.01. |
Other Events. |
• | The pursuit of validated targets FDA-approved drugs, and we then attempt to design or acquire novel or potential best-in-class |
• | Innovative medicinal chemistry expertise: |
• | Human capital management |
• | Safusidenib, a novel, oral, potent, brain penetrant, targeted inhibitor of mutant isocitrate dehydrogenase 1 (“mIDH1”), which we also acquired as part of the AnHeart acquisition. Safusidenib is being evaluated in a global Phase 2 study for the treatment of patients with diffuse mIDH1 glioma. |
• | NUV-868, a binding domain 2 (“BD2”)-selective, oral, small molecule bromodomain and extra-terminal (“BET”) inhibitor that inhibits bromodomain-containing protein 4 (“BRD4”). NUV-868 is being evaluated in a Phase 1b dose escalation study in combination with olaparib for the treatment of patients with ovarian cancer, pancreatic cancer, metastatic castration-resistant prostate cancer (“mCRPC”), triple negative breast cancer, and other solid tumors, and in combination with enzalutamide for the treatment of patients with mCRPC. |
• | NUV-1511, our first clinical-stage DDC fuses a targeting agent to a widely used chemotherapy agent that suppresses the growth of various advanced solid tumors. NUV-1511 is being evaluated in a Phase 1/2 study for the treatment of patients with advanced solid tumors who previously received and progressed on or after treatment with Enhertu® and/or Trodelvy® per approved U.S. FDA labeling, human epidermal growth factor receptor 2-negative (“HER2-”) metastatic breast cancer, mCRPC, advanced pancreatic cancer, and platinum-resistant ovarian cancer (“PROC”). |
• | Rapidly developing taletrectinib for the treatment of advanced ROS1-positive NSCLC and seeking global regulatory approvals. |
• | Advancing the ongoing clinical development of our other clinical-stage product candidates: safusidenib, NUV-868 and NUV-1511. |
• | Building a fully integrated biotechnology company that includes research, development, manufacturing, and commercial capabilities. |
• | Leveraging our deep insights in medicinal chemistry to pursue innovative clinical candidates and our business development expertise to identify and in-license or acquire additional promising drug candidates |
• | Identifying strategic opportunities to accelerate development timelines and maximize the value of our pipeline. |
• | 90.6% of patients’ tumors shrank following treatment with taletrectinib (cORR). |
• | Brain tumors shrank in 87.5% of taletrectinib-treated patients who had measurable central nervous system tumors (n=8; intracranial cORR). |
• | After median follow-up of 23.5 months, median duration of response and median progression-free survival have not yet been reached. |
• | At two years, 78.6% of patients who responded following treatment with taletrectinib were still responding, and 70.5% of patients were still progression-free. |
• | 51.5% of patients’ tumors shrank following treatment with taletrectinib (cORR). |
• | Brain tumors shrank in 73.3% of taletrectinib-treated patients who had measurable central nervous system tumors (n=15; intracranial cORR). |
• | Tumors shrank in 66.7% of taletrectinib-treated patients with G2032R mutations (n=12). |
• | After median follow-up of 9.7 months, median duration of response was 10.6 months and median progression-free survival was 7.6 months. Median duration of response and progression free survival data are still maturing and may change as results from future data cut-off dates are disclosed. |
• | At nine months, 69.8% of patients who responded following treatment with taletrectinib were still responding, and 47.4% were still progression-free. |
• | 92.0% of patients’ tumors shrank following treatment with taletrectinib (cORR). |
• | Brain tumors shrank in 80.0% of taletrectinib-treated patients who had measurable central nervous system tumors (n=5; intracranial cORR). |
• | After median follow-up of 8.1 months, median duration of response and median progression-free survival were not reached. |
• | At 12 months, 89.5% of patients who responded following treatment with taletrectinib were still responding, and 82.3% were still progression-free. |
• | 57.1% of patients’ tumors shrank following treatment with taletrectinib (cORR). |
• | Brain tumors shrank in 62.5% of taletrectinib-treated patients who had measurable central nervous system tumors (n=8; intracranial cORR). |
• | After median follow-up of 11.7 months, median duration of response was not reached and median progression-free survival was 11.7 months. Median progression free survival data are still maturing and may change as results from future data cut-off dates are disclosed. |
• | At 12 months, 81.5% of patients who responded following treatment with taletrectinib were still responding, and 42.6% were still progression-free. |
• | Tissue-selective targeting improves therapeutic index vs. untargeted warhead; |
• | Oral or IV delivery; |
• | Binds intracellular and cell membrane targets; |
• | Highly cell permeable; and |
• | Simpler and less expensive to manufacture than antibody-drug conjugates |
• | completion of extensive preclinical studies in accordance with applicable regulations, including studies conducted in accordance with Good Laboratory Practice (“GLP”); |
• | submission to the FDA of an IND, which must become effective before human clinical trials may begin; |
• | approval by an independent institutional review board (“IRB”) or ethics committee at each clinical trial site before each trial may be initiated; |
• | performance of adequate and well controlled human clinical trials in accordance with applicable IND regulations, current Good Clinical Practice (“GCP”) requirements and other clinical trial-related protocols and regulations to establish substantial evidence of the safety and efficacy of the investigational product for each proposed indication; |
• | submission to the FDA of an NDA after completion of all pivotal trials; |
• | determination by the FDA within 60 days of its receipt of an NDA to accept the filing for substantive review; |
• | satisfactory completion of an FDA pre-approval inspection of the manufacturing facility or facilities where the drug will be produced to assess compliance with current Good Manufacturing Practices (“cGMP”) requirements to assure that the facilities, methods and controls are adequate to preserve the drug’s identity, strength, quality and purity; |
• | potential FDA audit of the preclinical study and/or clinical trial sites that generated the data in support of the NDA filing to assess compliance with GCP; |
• | FDA review and approval of the NDA, including consideration of the views of any FDA advisory committee, prior to any commercial marketing or sale of the drug in the U.S.; and |
• | compliance with any post-approval requirements, including the potential requirement to implement a risk evaluation and mitigation strategy (“REMS”) and the potential requirement to conduct post-approval studies. |
• | Phase 1 clinical trials generally involve a small number of healthy volunteers or disease-affected patients who are initially exposed to a single dose and then multiple doses of the product candidate. The primary purpose of these clinical trials is to assess the metabolism, pharmacologic action, tolerability and safety of the drug. |
• | Phase 2 clinical trials involve studies in disease-affected patients to determine the dose and dosing schedule required to produce the desired benefits. At the same time, safety and further pharmacokinetic and pharmacodynamic information is collected, possible adverse effects and safety risks are identified, and a preliminary evaluation of efficacy is conducted. |
• | Phase 3 clinical trials generally involve a large number of patients at multiple sites and are designed to provide the data necessary to demonstrate the effectiveness of the product for its intended use, its safety in use and to establish the overall benefit/risk relationship of the product and provide an adequate basis for product approval. These trials may include comparisons with placebo and/or other comparator treatments. The duration of treatment is often extended to mimic the actual use of a product during marketing. |
• | restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market, or product recalls; |
• | fines, warning letters, or holds on post-approval clinical studies; |
• | refusal of the FDA to approve pending applications or supplements to approved applications; |
• | suspension or revocation of product approvals; |
• | product seizure or detention; |
• | refusal to permit the import or export of products; and |
• | injunctions or the imposition of civil or criminal penalties. |
• | The federal Anti-Kickback Statute, which makes it illegal for any person or entity, including a prescription drug manufacturer (or a party acting on its behalf), to knowingly and willfully solicit, receive, offer or pay any remuneration that is intended to induce or reward referrals, including the purchase, recommendation, order or prescription of a particular drug, for which payment may be made under a federal healthcare program, such as Medicare or Medicaid. Moreover, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, (collectively, the “Affordable Care Act”) provides that the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the civil False Claims Act. |
• | The federal false claims laws, including the civil False Claims Act that can be enforced by private citizens through civil whistleblower or qui tam |
• | The federal Health Insurance Portability and Accountability Act (“HIPAA”) prohibits, among other things, executing or attempting to execute a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters. |
• | HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (“HITECH”), and their implementing regulations also impose obligations on covered entities such as health insurance plans, healthcare clearinghouses, and certain healthcare providers and their respective business associates and their covered subcontractors, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information. |
• | The federal Physician Payments Sunshine Act requires applicable manufacturers of covered drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to annually report to the Centers for Medicare & Medicaid Services (“CMS”) information regarding certain payments and other transfers of value to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), other healthcare professionals (such as physician assistants and nurse practitioners), and teaching hospitals as well as information regarding ownership and investment interests held by physicians and their immediate family members. |
• | Analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws which may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers, state laws that require biotechnology companies to comply with the biotechnology industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government; state and local laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures and require the registration of their sales representatives, state laws that require biotechnology companies to report information on the pricing of certain drug products, and state and foreign laws that govern the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts. |
Item 9.01. |
Financial Statements and Exhibits. |
Nuvation Bio Inc. | ||||||
Date: June 20, 2024 | By: | /s/ David Hung, M.D. | ||||
Name: | David Hung, M.D. | |||||
Title: | Chief Executive Officer |