Rafael Holdings from IDT
Summary
(01 Apr 2018) This spinoff could allow the investor to get in on the ground floor in a company that may one day cure cancer. The opportunity is supported by a Real Estate business that will help generate cash as the company's drugs go through clinical trials. The CEO is experienced in creating valuable spinoffs from his original company IDT. Although it lacks cash flow, this unique play on the pharmaceutical investment company shows the CEO knows how to limit risk in a business in which he may lack experience.
Parent Ticker: IDT
Announced Record Date: 13 Mar 2018
Announced Distribution Date: 26 Mar 2018
Anticipated Ticker: RFL
Business
Rafael will own certain commercial real estate assets and interests in clinical and early stage pharmaceutical companies. The assets will be operated as separate lines of business. The commercial real estate holdings consist of IDT’s headquarters building and its associated public garage in Newark, New Jersey, an office/data center building in Piscataway, New Jersey and a portion of a building in Israel that hosts offices for IDT and its affiliates. The pharmaceutical holdings include debt interests and warrants in Rafael Pharmaceuticals, Inc. (“Rafael Pharmaceuticals”), which is a clinical stage, oncology-focused pharmaceutical company committed to the development and commercialization of therapies that exploit the metabolic differences between normal cells and cancer cells, and a majority equity interest in Lipomedix Pharmaceuticals Ltd., an early stage pharmaceutical development company based in Israel. All of these assets were non-core assets - outside of IDT’s telecom and payment services businesses.
Parent Child comparison
The parent company, IDT, provides telephone communications services to its customers. RFL will run the real estate and clinical/early stage oncology business that IDT held prior to the spin. These companies do not not have similar products. IDT pays a dividend, RFL will not.
Spin Ratio
1 share RFL for every 2 shares of IDT
Cash Flow
RFL will not have positive cash flow from operations when it is spun off. The 10-12(g) seems to indicate that the reason for the spinoff is to use the cash flows from its real estate holdings to support the Pharmaceutical business while it goes through clinical trials.
Cash Position
As of January 31, 2018, RFL had cash and cash equivalents of under $12.0 million. They anticipate their total operating costs will be between $2.0 to $2.3 million year as a result of being a public reporting company.
Revenue Projections
RFL will likely have between $750,000 and $1 million in revenue from its real estate operations, the only profitable portion of the business.
Break even
The company will not reach break even unless one of its drugs in pre-clinical trials becomes profitable. Therefore, a brief discussion on the pharmaceutical business is needed. The company's pharmaceutical business is focused on curing cancer by attacking the process that provides energy for the cancer cells. They have multiple drugs in clinical and pre-clinical phases of testing. They expect to get their drug (CPI-613) that is focused on myeloid leukemia to market no sooner than 2021.
Management Actions
Upon completing the spinoff, Howard Jonas will own approximately 20% of RFI's class B common stock. However, he also retains 70% of the voting power in the company through class A common stock. Clearly, Mr. Jonas does not want to relinquish control of the company's decision making. This is how Mr. Jonas has made millions in the past. He sits on the boards of several previous IDT spinoffs. Apparently his method of investing is to commit significant time to pet projects until they are profitable and then get them working on their own. He founded IDT in 1990 and served as its CEO from 2009-2013. He was also CEO of Genie Energy International Corporation from 2014-2017. He sits on other boards like Zedge, Inc. and IDW Media Holdings, Inc. both of which are IDT spinoffs. Although he will be joining RFL as Chairman and CEO, one might question his motivation or even need to make sure that this company survives with such a packed schedule and portfolio.
Of note, IDT retains a warrant to purchase over 50% of the company as part of this spinoff. As the controlling shareholder at IDT, Mr. Jonas again has tight control over Raphael. The warrant does present an opportunity for Mr. Jonas to gain a significant return on his investment. This warrant is strange because Mr. Jonas already has voting control through his class A shares, it would simply improve the cash return from this investment.
Activist Investor Activity
Activist investor activity does not seem to be present. However, the CEO, Mr Jonas might be similar to an activist in his activity given his past spinoff activity. Jonas makes multiple millions of dollars a year and has approximately $10 million in this investment at this time. This seems like a no-brainer to put money into curing cancer at this price for him. If the pharmaceutical business is successful, it will bring significant return to him with less than his annual compensation from IDT last year-think philanthropy for a small price that could reward him handsomely if successful.
Peer Comparison
Raphael is the first to bring CPI-613 to FDA approved Pivotal Studies. Pharmaceutical Investment Companies are beholden to the news surrounding their drug pipeline. Raphael has multiple drugs in their pipeline however, this seems to be the only one that doesn't have competition yet. The use of real estate holdings to fund this company seems to buy it more time and lessens the associated risk as it works through its clinical processes to get this drug to market.
Opinion
All Pharmaceutical Investment Companies carry a high level of risk. Personally, I think this is a great business but my current lack of experience in this field makes me wary of committing funds. If CPI-613 were to make it past clinical studies, it would command a significant market capitalization. My gut feeling due to my limited experience is to wait until it passes the next clinical trial. The problem with this is that I would expect its price to skyrocket as it gets closer to market.
SEC Reports
Research Notes
Rafael Pharmaceuticals
Rafael Pharmaceuticals is a clinical stage, oncology-focused pharmaceutical company committed to the development and commercialization of therapies that exploit the metabolic differences between normal cells and cancer cells.
We will own our interests/rights in Rafael Pharmaceutical through a 90%-owned non-operating subsidiary, IDT-Rafael Holdings, LLC. IDT-Rafael Holdings holds a warrant to purchase a significant stake in Rafael Pharmaceuticals, as well as other equity and governance rights in Rafael Pharmaceuticals, and owns 50% of CS Pharma, a non-operating entity which holds convertible debt and other rights to purchase equity interests in Rafael Pharmaceuticals.
Those interests/rights include:
1. $10,000,000 of Series D Convertible Notes of Rafael Pharmaceuticals held by CS Pharma.
2. A warrant to purchase up to 56% of the capital stock of Rafael Pharmaceuticals – the right to exercise the first $10,000,000 worth of the warrant is held by CS Pharma; and the remainder is held directly by IDT-Rafael Holdings.
We also have certain governance rights, including appointment of directors.
On September 19, 2017, IDT approved a compensatory arrangement with Howard S. Jonas related to the right held by IDT-Rafael Holdings to receive additional Rafael Pharmaceutical shares (“Bonus Shares”) upon the achievement of certain milestones. Under that arrangement, IDT and the Company transferred to Howard Jonas the contractual right to receive “Bonus Shares” for an additional 10% of the outstanding capital stock of Rafael Pharmaceuticals that was previously held by IDT-Rafael Holdings, which is contingent upon achieving certain milestones. This right was previously held by IDT-Rafael Holdings, subject to its right to transfer to recipients that IDT-Rafael Holdings, in its sole discretion, felt merit because of special efforts by such persons in assisting Rafael Pharmaceuticals and its products. IDT-Rafael Holdings distributed the rights to its members and we transferred the portion we received to Howard Jonas. If any of the milestones are met, the Bonus Shares are to be issued without any additional payment. Howard Jonas has the right to transfer the Bonus Shares, in his discretion, to others, including those who are instrumental to the future success of Rafael Pharmaceuticals.
On March 2, 2017, Howard Jonas, our Chairman of the Board, and Chairman of the Board of Rafael Pharmaceuticals purchased 10% of IDT-Rafael Holdings, LLC, in which the Company’s direct and indirect interest and rights in Rafael Pharmaceuticals were held, for a purchase price of $1 million, which represented 10% of the Company’s cost basis in IDT-Rafael Holdings. We hold our interest in CS Pharma through our 90%-owned non-operating subsidiary, IDT-Rafael Holdings, LLC, which holds a 50% interest in CS Pharma. Accordingly, we will hold an effective 45% indirect interest in the assets held by CS Pharma, including its cash. Separately, Howard Jonas and Deborah Jonas jointly own $525,000 of Series C Convertible Notes of Rafael Pharmaceuticals, and The Howard S. and Deborah Jonas Foundation owns $525,000 of Series C Notes of Rafael Pharmaceuticals.
The Rafael Pharmaceuticals Series D Note earns interest at 3.5% per annum, with principal and accrued interest due and payable on September 16, 2018. The Series D Note is convertible at the holder’s option into shares of Rafael Pharmaceuticals’ Series D Preferred Stock. The Series D Note also includes a mandatory conversion into Rafael Pharmaceuticals common stock upon a qualified initial public offering, and conversion at the holder’s option upon an unqualified financing event. In all cases, the Series D Note conversion price is based on the applicable financing purchase price. We and CS Pharma were issued warrants to purchase shares of capital stock of Rafael Pharmaceuticals representing up to 56% of the then issued and outstanding capital stock of Rafael Pharmaceuticals, on an as-converted and fully diluted basis. The right to exercise warrants as to the first $10 million thereof is owned by CS Pharma and the remainder is owned by IDT. The warrant expires on December 31, 2020. Currently, if IDT desires to raise additional financing from unaffiliated parties in connection with IDT’s exercise of its warrant or other current rights to invest in Rafael Pharmaceuticals (but not including the Rafael Pharmaceuticals rights held by CS Pharma), it first must give the other CS Pharma holders the opportunity to provide such financing on a pro rata basis. The exercise price of the warrant is the lower of 70% of the price sold in an equity financing, or $1.25 per share, subject to certain adjustments. The minimum initial and subsequent exercises of the warrant shall be for such number of shares that will result in at least $5 million of gross proceeds to Rafael Pharmaceuticals, or such lesser amount as represents 5% of the outstanding capital stock of Rafael Pharmaceuticals, or such lesser amount as may then remain unexercised. The warrant will expire upon the earlier of December 31, 2020 or a qualified initial public offering or liquidation event of Rafael Pharmaceuticals.
As of the date hereof and based on the current shares issued and outstanding of Rafael Pharmaceuticals, we, and our affiliates that hold interests in Rafael Pharmaceuticals would need to pay in the aggregate approximately $71 million to exercise the Warrant in full and approximately $56 million to purchase a 51% controlling stake in Rafael Pharmaceuticals. On an as-converted fully diluted basis (for all convertible securities of Rafael Pharmaceuticals outstanding), we and our affiliates that hold interests in Rafael Pharmaceuticals would need approximately $122 million to exercise the Warrant in full and approximately $98 million to purchase a 51% controlling stake in Rafael Pharmaceuticals. Following that exercise, a portion of our interest in Rafael Pharmaceuticals would continue to be held for the benefit of the other equity holders in IDT-Rafael Holdings and CS Pharma. Given the Company’s anticipated available cash upon the spin-off, we would not be able to exercise the warrant in its entirety and we may never be able to exercise the warrant in full.
The Company serves as the managing member of IDT-Rafael Holdings and IDT-Rafael Holdings serves as the managing member of CS Pharma, with broad authority to make all key decisions regarding their respective holdings. Any distributions that are made to CS Pharma from Rafael Pharmaceuticals that are in turn distributed by CS Pharma, will need to be made pro rata to all members, which would entitle IDT-Rafael Holdings to 50% (based on current ownership) of such distributions. Similarly, if IDT-Rafael Holdings were to distribute proceeds it receives from CS Pharma, it would do so on a pro rata basis, entitled the Company to 90% (based on current ownership) of such distributions.
Rafael Pharmaceuticals is a variable interest entity; however, we have determined that we are not the primary beneficiary as we do not have the power to direct the activities of Rafael Pharmaceuticals that most significantly impact Rafael Pharmaceuticals’ economic performance. At January 31, 2018, July 31, 2017 and July 31, 2016, the Company’s investment in Rafael Pharmaceuticals was $11.7 million, $12.1 million and $2.0 million, respectively. In addition to interests issued to IDT, CS Pharma has issued member interests to third parties in exchange for cash investment in CS Pharma of $10.0 million. At January 31, 2018, July 31, 2017 and July 31, 2016, CS Pharma had received $10.0 million, $10.0 million and $8.8 million, respectively, of such investment.
As of March 26, 2018, IDT had provided Rafael Pharmaceuticals with $1.2 million in working capital financing that remains outstanding. The related receivable from Rafael Pharmaceutical is being transferred by IDT to us prior to the spin-off.
Science & Pre-Clinical:
The lead product of Rafael Pharmaceuticals is CPI-613 (as small molecule). CPI-613 is suitable for intravenous (IV) administration.
In the 1920’s, Nobel Prize Winner Dr. Otto Warburg observed that cancer cells metabolize glucose differently than normal cells. This effect has more recently come to be recognized as a component of a broadly pervasive repurposing and reregulation of metabolism in cancer, including mitochondrial components. This broad, deep reconfiguration of metabolism is now understood to represent one of the defining hallmarks of most or all cancers.
All living cells require a continual input of fuel to survive and reproduce. Adenosine 5-triphosphate (ATP) is the universal energy-carrying molecule generated by consumption of fuels in biological systems. Glucose is the primary source of raw material fuel needed for the generation of ATP in most normal cells. Mutations known to cause cancer engender changes in the processing of fuels as well as the nature of the fuel needed by cancer cells to support their growth and survival. Some of the changes are largely unique to cancer and not typically found among healthy cells in the body. While these changes are not identical in every tumor cell type there is sufficient overlap to suggest that targeting the process of fuel conversion to anabolic intermediates and energy is likely to produce a more durable response than less selective effects of earlier chemotherapeutics. By attacking a process that is unique to cancer and not found in healthy cells an improvement in both potency and safety and quality of life is expected to be achievable (Heiden, M. G. V., & DeBerardinis, R. J. (2017). Understanding the Intersections between Metabolism and Cancer Biology. Cell, 168, 657-669. doi:10.1016/j.cell.2016.12.039 and Warburg, O. (1956). Origin of Cancer Cells. Science, 123, 309-314. doi:10.1126/science.123.3191.309).
In addition to exploiting the metabolic regulatory differences between normal and cancerous cells, Altered Energy Metabolism Directed (AEMD) compounds are selectively taken up by cancer cells as opposed to normal cells at cancer cell killing concentrations in cell culture. It is hypothesized that this feature of our AEMD compounds is associated with their structural resemblance to fatty acids, another bioenergetic fuel source and critical cellular component whose uptake is widely upregulated in tumor cells.
In preclinical testing, CPI-613 exhibited 100% growth inhibition against all tested cells derived from human patient tumor biopsies and 100% cell kill against the vast majority of cell lines tested in cell culture from the National Cancer Institute and American Type Tissue Culture Collection library. Several of these tested cell lines are known to be resistant to the more frequently prescribed current chemotherapeutic agents. CPI 613 was tested at levels having no material impact on normal cells. Additional preclinical AEMD/CPI-613 studies demonstrated potent tumor growth inhibition in human tumor animal models in vivo (Zachar, et al., 2011, Journal of Molecular Medicine 89, 1137).
There are many potential advantages to the AEMD platform. Among them, AEMD molecules selectively target altered energy metabolism in cancer cells (more specifically chokepoints in the tricarboxylic cycle) which reregulated in cancer cells resulting in inhibition mitochondrial flux of fuels (glucose, glutamine). This in turn triggers apoptosis or excessive hydrogen peroxide and other radical production leading to cancer cell specific necrosis. High toxicity of many cancer drugs is because of unintended killing healthy cells. It is anticipated that AEMD molecules will have minimal toxic effect on healthy cells and thus, potentially exhibit high safety and tolerability profile. Further, high selectivity of AEMD compounds has potential to treat cancers in multiple clinical settings (metastatic, neoadjuvant and adjuvant) and because of their low toxicity, AEMD molecules may be used in combination with current standard of care.
Preliminary data from pre-clinical trials suggests that Rafael Pharmaceuticals’ strategy of targeting metabolic changes specific to tumor cells has yielded the potential for a very potent and highly selective therapeutic option for patients with difficult to treat malignancies. Such data suggests that the potency results in excellent and unprecedented response rates in several refractory patient populations. The high degree of selectivity for tumor vs. non-tumor cells results in a favorable safety and tolerability profile, such that the drugs may provide low intensity single agent treatment options for patients as Rafael Pharmaceuticals may have the ability to improve the efficacy of standard of care therapies with little or no incremental toxicity.
We believe the probability of improvements in safety is high, by selectively attacking metabolic processes unique to cancer and required for tumor cell survival. Further, by simultaneously attacking multiple processes that are common to the majority of cancer cell types and essential for their survival, the probability of developing local relapse or metastatic progression due to evolved resistance to CPI-613 therapy is believed to be reduced.
In addition, Rafael Pharmaceuticals has demonstrated in laboratory studies and clinical trials:
- Wide therapeutic potential across multiple tumor types and even late-stage disease: In preclinical studies and Phase I safety clinical trials to date, Rafael Pharmaceuticals’ drugs have demonstrated activity in a spectrum of cancers, including hematological cancers and solid tumors, even in late-stage cancer patients who have failed multiple rounds of chemotherapy, radiation and stem cell transplantation. Assays to predict and characterize responses at the cellular level are being developed.
- A favorable safety profile.
- Multiple formulations are being developed in addition to IV infusion including oral delivery, and long-acting sustained release.
- Low-cost, efficient, and scalable manufacturing.
Clinical Results
Pancreatic Cancer: CPI-613 in Combination with Modified FOLFIRINOX in First-Line Metastatic Pancreatic Cancer.
Twenty patients were enrolled in this study. The maximum tolerated dose of CPI-613 was 500 mg/m². The median number of treatment cycles given at the maximum tolerated dose was 11. Two patients enrolled at a higher dose of 1000 mg/m2, and both had a dose-limiting toxicity. No deaths due to adverse events were reported. For the 20 patients given the maximum tolerated dose, the most common grade 3–4 non-hematological adverse events were hyperglycaemia, hypokalaemia, peripheral sensory neuropathy, diarrhea, and abdominal pain. The most common grade 3–4 hematological adverse events were neutropenia, lymphopenia, anaemia, and thrombocytopenia. Sensory neuropathy (all grade 1–3) was recorded in 17 out of the 18 patients and was managed with dose de-escalation or discontinuation of oxaliplatin per standard of care. Of the 18 patients given the maximum tolerated dose, 11 (61%) achieved an objective (complete or partial) response. Given that the Phase II clinical trial evaluating the FOLFIRINOX regimen reported an Overall Response Rate (ORR) of 31% and Complete Remission (CR) of <1%, the further evaluation of CPI-613 in pancreatic cancer is warranted.
Acute Myeloid Leukemia: CPI-613 in Combination with High Dose Cytarabine and Mitoxantrone in Elderly Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML).
2 trials were conducted to investigate the safety and efficacy of CPI-613 in combination with high dose cytarabine and mitoxantrone (HAM) in patients with relapsed or refractory Acute Myeloid Leukemia (AML). Overall, the treatment was well tolerated. Total 67 patients dosed in this phase I study and 62 were evaluable for efficacy. The median overall survival (OS) of elderly patients (≥60 years or older, N =32) was 6.9 months, which is substantially higher than historical control of patient treated with HAMA alone. This result is consistent in phase II study (CCCWFU 22215) with median OS of 10 months (N = 21, study is ongoing). CR was also substantially higher in elderly patients (60 years or older) treated with CPI-613 + HAM compared to patients treated with HAM alone (38% in phase I study and 33% in phase II study compared to only 26% in historical cohort).
Peripheral T-cell Lymphoma: Phase I Dose-Escalation Study of CPI-613, in Combination with Bendamustine, in Patients with Relapsed or Refractory T-cell Lymphoma
To date, 10 patients have received at least one dose of CPI-613 in combination with bendamustine. 9 patients are evaluable for safety and 7 patients for efficacy. Overall, the patients exhibited a good safety profile. The most common grade 3 or higher toxicities were lymphopenia and leukopenia, neutropenia, anemia and thrombocytopenia. CPI-613 in combination with bendamustine also exhibited excellent efficacy profile with an ORR of 86% (CR: 43%, PR: 43%). All 3 patients with CR were diagnosed with peripheral T cell lymphoma, not otherwise specified. Although the numbers are small, continued investigation is warranted as these response rates in a poor risk population of patients with relapsed/refractory T Cell Lymphoma is very exciting.
Lipomedix
Lipomedix Pharmaceuticals Ltd. (“Lipomedix”) is a development-stage, privately held, Israeli company focused on the development of an innovative, safe and effective cancer therapy based on liposome delivery.
We own ordinary shares of Lipomedix representing approximately 50.6% of the issued and outstanding ordinary shares, which were purchased in Fiscal 2016-2018 for $2.4 million.
Science and Pre Clinical:
Lipomedix was established in order to advance the pharmaceutical and clinical development of a patented prodrug of mitomycin-C and its efficient delivery in liposomes to cancer-affected target organs. Lipomedix believes that this formulation, known as Promitil® – Pegylated Liposomal Mitomycin-C Prodrug (PL-MLP) – overcomes the problems associated with the mitomycin-C toxicity of certain current treatments and turns it into passively targeted, anti-cancer drug that could potentially become the therapy of choice in a variety of cancers. The inventor and scientific founder, of Lipomedix is Prof. Alberto Gabizon of the Hebrew University – Shaare Zedek Medical Center, Israel who is also the co-inventor and co-developer of Doxil® (doxorubicin hydrochloride liposome injection). Prof. Gabizon is one of the few scientists intimately familiar with the successful development and commercialization process of liposomal drugs.
Promitil is an innovative nanomedicine designed for controlled delivery of a chemotherapeutic agent in a proprietary prodrug form. Lipomedix believes it may have advantages over conventional anticancer agents that have serious adverse side effects, and limited efficacy with resistance to treatment. Promitil is based on an innovative and breakthrough technology that could potentially help cancer patients receive safer therapy with a more potent anti-tumor effect.
In pre-clinical trials, Promitil inhibited a range of cancer types in animal models (pancreatic, colorectal, stomach, breast, ovarian, melanoma) and potentiated the activity of a co-administered cancer drug. The API (MLP), a prodrug of mitomycin C, is carried by a pegylated liposomal delivery system that confers an extended circulation time in vivo and improved delivery to tumors. In pre-clinical trials, Promitil significantly reduced mitomycin-C’s systemic toxicity and mitigated its side-effects. Promitil is a highly stable formulation with prolonged storage shelf life of over 3 years.
Clinical:
A total of 88 patients have been treated with Promitil as a single agent or in combination with other anticancer drugs under the framework of a clinical study. Promitil was well tolerated and safe for use at the tested doses. The majority of the adverse events reported were mild to moderate and unrelated to the study drug.
A Phase IA dose escalation open trial has, Lipomedix believes, demonstrated that Promitil is a conceptually attractive formulation system (by analogy with the success of Doxil) which has successfully and substantially modified the pharmacokinetic characteristics of mitomycin C delivery, resulting in the ability to clinically administer much larger amounts of active drug (approximately 3 times greater mitomycin C-equivalent dose than the maximal tolerated dose of mitomycin C), with an acceptable toxicity profile, and with long circulation time to ensure adequate drug delivery.
A Phase IB continuation trial in advanced colon cancer patients receiving Promitil as 3rd line therapy has confirmed the safety and pharmacokinetic features of Promitil in this patient population, as well as the feasibility of combining Promitil with Bevacizumab and/or Capecitabine. This stage of colon cancer has an ominous prognosis with median survival of approximately 5 months for untreated patients, and 6-7 months using any of the two approved therapies (Regorafenib, TAS-102), and a rate of partial responses (tumor shrinkage) nearly zero.
In an ongoing 1B study, clinical efficacy appears so far to be limited to stabilization of disease based on interim data. Lipomedix believes the survival data, yet immature, of the Promitil-Bevacizumab combination is encouraging, but the lack of a head-to-head comparator for survival and the lack of meaningful tumor shrinkage in treated patients leaves uncertainty as to whether colorectal carcinoma is the optimal indication for Promitil. To clarify this point, and dependent on available funding, Lipomedix believes that the next development step should be to conduct an active comparator Phase 2B trial using as end-points PFS and OS, which will provide information to resolve this issue in colorectal cancer. Lipomedix believes that a 100-patient strong study should suffice to see if it has a significant signal. Given the large number of patients with this condition, Lipomedix anticipates this study can be completed relatively quickly (approximately 18 months) with centers in 3 or 4 countries only.
Additional complementary plans with the Lipomedix flagship product, Promitil, include:
- Conduct exploratory trials of Promitil in combination with radiotherapy. This is a separate avenue of clinical development sprouting from preclinical observations (see Dr. Andrew Wang et al. paper in the Red Journal on Promitil and Radiotherapy, 2016). Lipomedix plans on asking for FDA advice on the best way to maximize clinical information from these exploratory studies for regulatory purposes.
- Explore other indications and combinations of Promitil with other chemotherapeutic or immunotherapeutic agents in small investigator-initiated or company-sponsored clinical studies.
Promitil-based products:
In addition to Promitil, Lipomedix has developed a pipeline of Promitil-based products with potentially important applications:
- Folate-targeted Promitil (Promi-Fol), aimed at local treatment (intravesical) of superficial bladder cancer. Decorating Promitil with folate ligands exploits the frequent overexpression of folate receptors in urothelial cancers for selective and enhanced delivery of Promitil to cancer cells. Promi-Fol could be a safe and effective therapeutic alternative for local treatment of the growing patient population with superficial bladder cancer.
- Promi-Dox, a highly potent dual drug liposome with MLP and doxorubicin (“the “SuperDoxil”) for a basket of tumors. If a strong clinical signal can be detected there are several possible cancer settings with substantial patient numbers and significant unmet need where PromiDox could be utilized.
- Promitil-Alendronate (Promi-Ald), a formulation of Promitil loaded with the bisphosphonate Alendronate, which may serve as an optional, companion PET-imaging product of the distribution of Promitil liposomes in the patient body to detect patients in whom cancer targeting of liposomes is most effective. A micro-dose of Promi-Ald can be labeled with the PET-radioemitter Zirconium89 for PET-CT imaging. Because it is used in micro-dosing form, it requires minimal product development.
Non-Promitil based product: PLAD (dual drug liposome with doxorubicin and alendronate), which Lipomedix hopes will soon be licensed by Yissum-Shaare Zedek Scientific to Lipomedix, is a unique chemo-immunotherapeutic tool developed by Dr. Gabizon’s team that provides two therapeutic modalities in one single formulation, that may be effective in breast cancer, ovarian cancer, and Kaposi sarcoma.