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the United States during the first quarter of 2022, with dosing of our first patient in March 2022.
Our Strategy
Our objective is to develop and commercialize innovative drugs that address the ser... |
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based on the positive results from AMPECT, our pivotal Phase 2 study in this patient population, which met its primary endpoint. The FDA accepted the NDA in July 2021 and we were granted approval fo... |
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part of the Expanded Access Program. Based on exploratory data in patients with
TSC1
or
TSC2
alterations from the completed
AMPECT and the Expanded Access Program, in the first quarter of 2022,... |
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a monotherapy as well as in combination with other targeted therapies, particularly in mTOR adjacent signaling pathways. These additional indications may be important drivers of commercial value and... |
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FYARRO in KRAS
G12C
mutant non-small cell lung cancer ("NSCLC") and other solid tumors. Under the terms of the agreement, Mirati is responsible for sponsoring and operating the Phase 1/2 study an... |
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are supported by our board of directors and specialized scientific advisors, who contribute their deep understanding of drug discovery and development, as well as expertise in building public compan... |
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between anabolic and catabolic cellular processes and facilitates the progression of cell-cycle from G1 to S phase. Due to its key role in anabolic processes needed for cell division, the majority o... |
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C1 activity. Decreased phosphorylation of S6K leads to decreased activity, while decreased phosphorylation of 4EBP1 leads to increased activity. Sirolimus (also known as rapamycin) is an allosteric i... |
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and a reduction from the labelled dose can result in a decrease in efficacy. Preclinical study comparisons with FYARRO showed significantly higher tumor uptake, greater downstream mTOR target suppre... |
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ai, our founder and Executive Chairman, and former colleagues while at Abraxis Bioscience. This technology takes advantage of the protein albumin, a natural carrier of water insoluble molecules (e.g.... |
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States and worldwide for the treatment of breast cancer, non-small cell lung cancer and pancreatic cancer. Abraxane has generated >$1.0 billion of sales in the United States every year since 2018.
... |
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proliferating tumor cells via endocytosis and macropinocytosis, then catabolized by lysosomal degradation to support de novo protein synthesis, energy, and tumor growth. Ultimately, nab technology a... |
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when injected into human glioblastoma patients 24-48 hours before surgery resulted in excellent visualization of the tumors during surgery under fluorescent light and allowed the complete resection ... |
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’s impression of these nanoparticles is shown below.
Figure 3 –
Nanoparticle artist impression
The orally available mTOR inhibitors have poor and variable absorption, often require therapeutic dru... |
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in animals bearing bladder cancer tumors or liver cancer tumors. Data from these tumor-bearing animal models showed many-fold higher tumor drug levels for FYARRO at equal dose to the other mTOR inhi... |
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accumulation, and ability to effectively inhibit important targets in the mTOR pathway make it a well-positioned drug to address resistance and suboptimal efficacy of existing mTOR inhibitors.
We a... |
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studies in planning are summarized in the figure below.
Figure 5
– Pipeline
Our EAP was opened to bridge access to FYARRO until market authorization and has since been closed in the United States... |
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Comas show a wide anatomical distribution, but most often arise in the retroperitoneum, abdominopelvic region, uterus and gastrointestinal tract, and have a 4:1 female predominance. Malignant PEComas... |
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in part due to loss-of-function mutations in or deletions of the
TSC1
or
TSC2
genes. In a retrospective analysis, patients with malignant PEComa treated with available mTOR inhibitors (mTORi, si... |
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from our Phase 2 registration-directed study, Advanced Malignant PEComa Trial, (“AMPECT”), in advanced malignant PEComa for which there were, prior to FYARRO, no approved therapies in the United Sta... |
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$15.2 million for the year ended December 31, 2022.
FYARRO - Clinical Development
Preclinical profile FYARRO
We demonstrated the antitumor activity of FYARRO in a series of nonclinical pharmacolo... |
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and prolonged sirolimus distribution to different organs and in tumors. As a single agent monotherapy and in combination with other therapies, FYARRO was well tolerated with limited body weight loss... |
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survival compared with equal weekly dose of oral sirolimus and everolimus.
Table of Contents
Figure 6
We also determined the antitumor activity of FYARRO in comparison to oral Rapamune against TS... |
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a Trial (AMPECT)
PEComa.
AMPECT was the first prospective clinical trial in advanced malignant PEComa. Patients with metastatic or inoperable locally advanced disease were treated with FYARRO at 10... |
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This registrational trial met its primary endpoint demonstrating the efficacy of
nab-
sirolimus in this rare disease for which there was no FDA approved treatment, with an independently assessed OR... |
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% CI: 1.3 to 2.8 months). At the time of the primary analysis (predefined as when all patients had an opportunity to be treated for 6 months), the median for the key secondary endpoint of DOR was not... |
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).
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Figure 6 shows the target tumor responses (waterfall plot). One patient with a primary renal PEComa metastatic to the lungs and lymph nodes had a PR for 10 months that conv... |
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(Wagner et al., JCO 2021)
A patient with unconfirmed PR is considered having SD as best response (trial required confirmation of responses per RECIST v1.1). Additionally, a patient with a complete ... |
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details are provided in Table 1 below. There were no grade 4 or 5 TRAEs. Noninfectious pneumonitis occurred in 6/34 (18%) patients and all were low grade (G1/G2). Patient discontinuation due to adve... |
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3, No. (%)
Patients with any TRAEs
34
(100)
Hematologic TRAEs
Anemiaa
16
(47)
(12)
Thrombocytopeniaa
11
(32)
(3)
Nonhematologic TRAEs
Mucositisa
27
(79)
(18)
Rasha
19
(56)
Fatigu... |
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a
11
(32)
Decreased appetite
11
(32)
Dermatitisa
10
(29)
Dysgeusia
10
(29)
Headache
10
(29)
Peripheral edema
(26)
“a” Indicates groupings of preferred terms defined by standardized q... |
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PEComa. In October 2018, the FDA granted Fast Track designation for FYARRO for the treatment of patients with advanced (metastatic or locally advanced) malignant PEComa. In December 2018, the FDA gr... |
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Coma indication, the FDA may not approve any other application to market the same drug for the same indication for a period of seven years from NDA approval of FYARRO (November 22, 2028), except in l... |
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was 64% (9/14) (Figure 8). In particular,
TSC2
mutations were significantly associated with response (89% of patients) to FYARRO.
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Table of Contents
Figure 9 –
Spider plot demonstrating chan... |
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in 2021 showing the early results in tumors bearing
TSC1
or
TSC2
inactivating alterations in patients with histologies other than advanced malignant PEComa. Of the 8 patients treated with FYARRO... |
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continue on treatment. A waterfall plot of tumor response is provided below Figure 9. Figure 10 shows the prior therapy and duration of treatment for each patient. Patients with inactivating alterat... |
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) and acute kidney injury (patient #7) possibly also related to administration of contrast. Dose reductions occurred in 3/8 patients (38%) from 100 mg/m2 to 75 mg/m2.
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A recent... |
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treatment: 25% achieved a response (duration of response range: 1.3+–25.2+ months, 3 ongoing), and 50% had stable disease as best response as best response. Of patients with
TSC1 or TSC2
inactivat... |
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(CTOS) Annual Meeting in 2020) and the Expanded Access Program (presented at the ASCO Annual Meeting in 2021). We have completed a Type B meeting with the FDA in which we discussed the trial design ... |
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or
TSC2
genes can result in activation of mTORC1.
TSC1
or
TSC2
alterations have been reported across a broad range of cancer types. Based on the SEER cancer statistics database and an analysis ... |
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responses to mTOR inhibition in patients with these alterations.
Figure 12
FYARRO in combination with KRAS
G12C
inhibitors for KRAS
G12C
mutated cancer xenografts
In 2022, we conducted precli... |
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patients. The mTOR pathway is often activated in patients with the KRAS mutation and contributes to adaptive resistance to KRAS inhibitors. We conducted these studies to determine the utility of a c... |
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as both single-agent or in combination with other drugs. We believe there is a significant opportunity to utilize FYARRO in other indications as a monotherapy, e.g., in other mTOR pathway mutations,... |
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and maintaining patent protection intended to cover formulations of FYARRO, its methods of use, related technologies, and other inventions that are important to our business. In addition to patent p... |
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positions for biotechnology and pharmaceutical companies like us are generally uncertain and can involve complex legal, scientific, and factual issues. We cannot predict whether the patent applicati... |
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Our Intellectual Property”.
We own or exclusively license twelve (12)
issued patents in the United States as well as issued patents in other countries. With respect to our licensed patents, we hav... |
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America, South America, and Asia that are expected to expire between 2023 and 2037. We also licensed many pending U.S. applications and related pending applications in Europe, Australia, North Ameri... |
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compensation for the loss of patent term during FDA regulatory review process. The period of extension may be up to five years but cannot extend the remaining term of a patent beyond a total of 14 y... |
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FDA, will agree with our assessment of whether such extensions should be granted, and even if granted, the length of such extensions.
In addition to patent protection, we also rely on trade secret ... |
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be able to obtain adequate remedies for such breaches. In addition, third parties may independently develop the same or similar proprietary information or may otherwise gain access to our proprietar... |
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PEComa. Our sales team is supported by marketing, commercial operations, and market access functions. We have assembled a network of specialty distributors and a specialty pharmacy to distribute FYA... |
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markets outside the United States, or selectively establish partnerships. Accordingly, we will consider entering into relationships with strategic partners that enable the expansion of the ongoing c... |
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develop and commercialize will compete with existing drugs and new drugs that may become available in the future. We compete in the segments of the pharmaceutical, biotechnology, and other related m... |
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even more resources being concentrated among a smaller number of our competitors. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative ar... |
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which could result in our competitors establishing a strong market position before we or our collaborators are able to enter the market. The key competitive factors affecting the success of FYARRO a... |
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Coma. FYARRO may face competition from available mTOR inhibitors including sirolimus, everolimus, and temsirolimus or other drug candidates in clinical trials. As of today, we are not aware of any ot... |
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such as dual mTORC1/2 inhibitors or other next-generation mTOR inhibitors.
Manufacturing
We do not own or operate, and have no plans to establish, any manufacturing facilities. We currently rely o... |
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date, we have obtained drug substance and drug product from third-party manufacturers to support pre-clinical and clinical testing of FYARRO. On January 13, 2022, we entered into a Negotiated Purcha... |
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may be agreed between the parties in writing), we may purchase FYARRO for either clinical or commercial purposes for use in the United States and Canada. We have a fully validated commercial manufac... |
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additional payment from us to Fresenius Kabi.
We have supply agreements in place for key raw materials used in the manufacture of FYARRO such as the drug substance sirolimus and for human albumin, ... |
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among other things, the manufacturing, research and clinical development, marketing, labeling and packaging, storage, distribution, post-approval monitoring and reporting, advertising and promotion,... |
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promotion, advertising, distribution, post-approval monitoring and reporting, marketing, and export and import of products such as those we are developing.
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Table of Contents
Generally, before ... |
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, or after approval, may subject an applicant to administrative or judicial sanctions. These sanctions could include, among other actions, the regulatory authority’s refusal to approve pending applic... |
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and local statutes and regulations. Drugs must be approved by the FDA through the NDA process before they may be legally marketed in the U.S. The process required by the FDA before a drug may be mar... |
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good clinical practices (“GCPs”), to establish the safety and efficacy of the proposed drug for its proposed indication(s);
submission to the FDA of an NDA for a new drug;
a determination by the F... |
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.S.
Prior to beginning a clinical trial with a product candidate in the United States, companies must submit an IND to the FDA. An IND is a request for authorization from the FDA to administer an in... |
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within the 30-day time period, raises safety concerns or questions about the proposed clinical trial. In such a case, the IND may be placed on clinical hold and the IND sponsor and the FDA must reso... |
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or a separate submission to the existing IND must be made for each successive clinical trial conducted during product development and for any subsequent protocol amendments. Furthermore, an independ... |
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monitoring board, which may review data and endpoints at designated check points, make recommendations and/or halt the clinical trial if it determines that there is an unacceptable safety risk for s... |
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for severe or life-threatening diseases, especially when the product may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in patien... |
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overall risk/benefit ratio of the investigational product and to provide an adequate basis for product approval.
A pivotal study is a clinical study that adequately meets regulatory agency requirem... |
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Phase 4 clinical trials.
Progress reports detailing the results of the clinical trials must be submitted at least annually to the FDA and written IND safety reports must be submitted to the FDA and... |
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, and Phase 3 trials may not be completed successfully within any specified period, if at all. The FDA, the IRB, or the clinical trial sponsor may suspend or terminate a clinical trial at any time on... |
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as well as finalize a process for manufacturing the drug in commercial quantities in accordance with cGMP requirements. The manufacturing process must be capable of consistently producing quality ba... |
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the first initiation of a Phase 2 or Phase 3 trial of the
20
Table of Contents
investigational drug or, as applicable, 15 days after the drug receives a designation as a breakthrough therapy, fas... |
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product inspections during COVID-19 public health emergency; and remote interactive evaluations of drug manufacturing and bioresearch monitoring facilities during the COVID-19 public health emergenc... |
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of preclinical
studies and clinical trials are then submitted to the FDA as part of a NDA, along with proposed labeling for the drug and information about the manufacturing process and facilities t... |
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safety and efficacy of the investigational drug product for a particular indication or indications to the satisfaction of the FDA. FDA approval of an NDA must be obtained before a drug may be offere... |
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Fee Act (PDUFA) guidelines that are currently in effect, the FDA has a goal of ten months from the date of “filing” of a standard NDA for a new molecular entity to review and act on the submission. ... |
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or clarification. In such event, the NDA must be resubmitted with the additional information. The resubmitted application is also subject to review before the FDA accepts it for filing.
After the N... |
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conditions. The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions. In the course of its review, the FDA may re-a... |
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requirements and adequate to assure consistent production of the drug within required specifications. In addition, before approving an NDA, the FDA may also audit data from clinical trials to ensure... |
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an additional pivotal clinical trial(s), and/or other significant, expensive and time-consuming requirements related to clinical trials, preclinical studies, or manufacturing. If a Complete Response... |
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. If a drug receives marketing approval, the approval may be significantly limited to specific diseases, dosages, or patient subgroups, or the indications for use may otherwise be limited, which coul... |
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FDA may approve the NDA with a Risk Evaluation and Mitigation Strategy (“REMS”) to ensure the benefits of the product outweigh its risks. A REMS is a safety strategy to manage a known or potential s... |
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’s safety and effectiveness after commercialization and may limit further marketing of the product based on the results of these post-marketing studies. In addition, new government requirements, incl... |
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from our Phase 2 registrational study, AMPECT, in patients with advanced malignant PEComa, for whom there were no approved therapies in the U.S.
FDA Expedited Development and Review Programs
The F... |
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Specifically, new drugs are eligible for fast track designation if they are intended to treat a serious or life-threatening disease or condition and demonstrate the potential to address unmet medica... |
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development and review, such as priority review and accelerated approval. A product is eligible for priority review if it has the potential to provide safe and effective therapy where no
22
Table ... |
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diseases or conditions may be eligible for accelerated approval upon a determination that the product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or ... |
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product. In addition, the drug may be subject to accelerated withdrawal procedures. On December 29, 2022, the Consolidated Appropriations Act, 2023, including the Food and Drug Omnibus Reform Act (... |
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may seek FDA designation of a product candidate as a “breakthrough therapy” if the product is intended, alone or in combination with one or more other products, to treat a serious or life-threatenin... |
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FDA may review new drug applications under the Oncology Center of Excellence Real-Time Oncology Review (“RTOR”), which, according to the FDA, aims to explore a more efficient review process to ensur... |
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potential review issues and allows the FDA to provide early feedback regarding the most effective way to analyze data to properly address key regulatory questions.
Fast track designation, priority ... |
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, monitoring and recordkeeping activities, reporting to the applicable regulatory authorities of adverse experiences with the drug, providing the regulatory authorities with updated safety and effica... |
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FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses. Failure to comply with these requirements can result in, among other things, adverse pub... |
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alleged improper promotion of off-label use and has enjoined companies from engaging in off-label promotion. The FDA and other regulatory agencies have also required that companies enter into consen... |
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drug promotional materials must be submitted to the FDA in conjunction with their first use. Any distribution of prescription drugs and pharmaceutical samples must comply with the U.S. Prescription ... |
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manufacturers and their collaborators are also required to place a unique product identifier on prescription drug packages. This identifier consists of the National Drug Code, serial number, lot num... |
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of records and documentation and the obligation to investigate and correct any deviations from cGMP. Drug manufacturers and other entities involved in the manufacture and distribution of approved dr... |
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