SPCEO1 wrote: The below press release from June 3rd, 2019 on their second partnership with Astra Zeneca is clearly not a partnership that indicates Star Pharma is operating from a position of strength. All of their activities that I have seen on a quick review of their news indicate they are a company that is not considered as a first or even second rate drug developer. They are something akin to CYDY. There almost certainly are some very serious shortcomings to the research they have done that explains the very slow movement in their drug candidates and JFM's inability to discover what it is their drug actually purports to do speaks loudly about those likely shortcomings. So, they are trying to derive revenues selling a very suspect product to help with covid in Inida and other low end markets and are marketing, without much success, a line of condoms covered with an anti-bacterial gel.
I think the CYDY analogy is likely pretty close to the mark.
Starpharma signs second oncology agreement with
AstraZeneca
Starpharma has signed a Development and Option Agreement with AstraZeneca to
progress the development of a Dendrimer Enhanced Product (DEP®) version of
one of AstraZeneca’s major marketed oncology medicines.
Following completion of agreed preclinical studies by Starpharma, AstraZeneca
has the option to licence the DEP® oncology drug candidate for an option exercise
fee of US$5M, plus industry standard development and commercialisation
milestones and escalating royalties on sales.
If AstraZeneca does not exercise the option to license the drug candidate,
Starpharma has the option to license the rights to develop and commercialise the
drug candidate itself or through a sub-licensee with milestones and royalties paid
to AstraZeneca upon commercialisation of the product.
This second oncology agreement follows an existing multiproduct licence for use
of Starpharma’s DEP® drug delivery platform in the development and
commercialisation of several AstraZeneca oncology drug candidates, including
AZD0466.
Melbourne, Australia; 3 June 2019: Starpharma (ASX: SPL, OTCQX: SPHRY) today
announced a Development and Option Agreement with AstraZeneca (LON: AZN) to
progress the development of a Dendrimer Enhanced Product (DEP®) version of an
undisclosed AstraZeneca major marketed oncology medicine. This is the second DEP®
commercial agreement Starpharma has signed with AstraZeneca, the first agreement being
a multiproduct licence which covers novel oncology drug candidates such as AZD0466 (a
Bcl2/xL inhibitor).
The agreement was signed during the 2019 ASCO (American Society of Clinical Oncology)
meeting in Chicago. ASCO attracts more than 40,000 cancer doctors, scientists, investors,
pharmaceutical and life science executives.
Under this agreement, Starpharma will conduct preclinical testing of the DEP® version of the
AstraZeneca oncology product. At any time from the signing of this agreement and for a
defined period after the completion of this testing, AstraZeneca may exercise its option and
licence the DEP® drug candidate for clinical and commercial development. If AstraZeneca
exercises the option, an option exercise fee of US$5 million is payable to Starpharma, as
well as industry standard development and commercialisation milestones and escalating
royalties on sales. Further details regarding the major oncology medicine involved, drug
candidates, and terms of the agreement remain confidential at this time for competitive
reasons.
In the event AstraZeneca does not exercise its option to licence the DEP® drug candidate
within the defined period, Starpharma has the option to license the rights to develop and
commercialise this DEP® drug either itself or through a sub-licensee with milestones and
royalties paid to AstraZeneca upon commercialisation of the resultant DEP® product.
Dr Jackie Fairley, Starpharma Chief Executive Officer, said: “We are delighted to sign a new
commercial DEP® agreement at ASCO with our long-standing partner, AstraZeneca. This
agreement follows a successful research program under which we identified a promising
DEP® candidate with a number of potential benefits. This agreement represents the
culmination of that work and this DEP® product has the potential to provide significantly
enhanced patient benefit. Unlike our first DEP® agreement with AstraZeneca, which applies
DEP® to novel oncology drug candidates, this agreement is for an existing major
AstraZeneca oncology medicine and provides further validation of the value of the DEP®
platform and its broad application to both new chemical entities and existing products.”
Susan Galbraith, Senior Vice President, R&D Early Oncology, AstraZeneca, said: "Building
on our long-standing and successful working relationship with Starpharma, this agreement
will enable us to further evaluate the potential of the DEP® technology with the aim of
improving treatment outcomes for patients.”
Starpharma’s DEP® platform remains available for further partnerships. Licences are
typically product specific and structured to allow for multiple partnered-DEP® programs to
run in parallel.
About Starpharma
Starpharma Holdings Limited (ASX: SPL, OTCQX:SPHRY), located in Melbourne Australia, is an ASX 300 company and is a world leader in the
development of dendrimer products for pharmaceutical, life science and other applications.
Starpharma’s underlying technology is built around dendrimers – a type of synthetic nanoscale polymer that is highly regular in size and structure
and well suited to pharmaceutical and medical uses. Starpharma has two core development programs: VivaGel® portfolio and DEP® drug delivery
with the Company developing several products internally and others via commercial partnerships.
VivaGel®: Starpharma’s women’s health product - VivaGel® BV is based on SPL7013, astodrimer sodium, a proprietary dendrimer. VivaGel® BV
is approved for marketing in the EU and available for sale in Australia for bacterial vaginosis (BV) and a new drug application has been submitted
to the US FDA. Starpharma has licensed the sales and marketing of VivaGel® BV to ITF Pharma for the US; Mundipharma for Europe, Russia,
CIS, Asia, the Middle East, Africa and Latin America; and to Aspen Pharmacare for Australia and New Zealand. Starpharma also has licence
agreements to market the VivaGel® condom (an antiviral condom which includes VivaGel® in the lubricant) in several regions, including Australia,
Europe, Canada, China and Japan (Okamoto). The VivaGel® condom has been launched in Australia and Canada under the Lifestyles® Dual
Protect™ brand.
DEP® - Dendrimer Enhanced Product®: Starpharma’s DEP® drug delivery platform has demonstrated reproducible preclinical benefits across
multiple internal and partnered DEP® programs, including improved efficacy, safety and survival. Starpharma has two internal DEP® products –
DEP® docetaxel and DEP® cabazitaxel - in clinical development in patients with solid tumours, with DEP® irinotecan due to commence clinical
trials shortly. Starpharma’s partnered DEP® programs include a multiproduct DEP® licence with AstraZeneca, which involves the development and
commercialisation of two novel oncology compounds, with potential to add more. In June 2019 Starpharma signed a Development and Option
agreement with AstraZeneca to progress a DEP® version of one of AstraZeneca’s major marketed oncology medicines.
SPCEO1 wrote: Maybe this headline gives us some insight into Star Pharma:
A Melbourne-based global biopharmaceutical company has been fined more than $93,000 for its alleged illegal advertising of a spray not approved for use in Australia that claims to stop SARS-Cov-2, the virus that causes Covid-19.
The Therapeutic Goods Administration issued seven infringement notices totalling $93,240 to Starpharma Holdings Limited.
The TGA alleges Starpharma promoted the use and supply of a nasal spray called Viraleze, which is not registered on the Australian Register of Therapeutic Goods, on two of the company’s websites and its YouTube channel.
SPCEO1 wrote: Please don't take my comments as a criticism of the great work you did. I just have experience as a global portfolio manager and know that small cap Australian companies are just a step above those trading on the Vancouver exchange. Perhaps I am biased because they do have the things you list but they also have barely progressed and have attracted no real analyst interest. And they have no NASH asset about to be partnered or two drugs already being marketed, yet their market cap exceeds that of TH. I am pretty skeptical but will find some time to look more closely soon.
jfm1330 wrote: Work with Google and many well chosen combinations of keywords. That being said, I don't understand why you say it's not a good comparison. I think you really need to look at it more closely and read about it and ask for explainations on the scientific side if you don't understand something. No comparison is perfect, but as I pointed out in my initial message, there are many similarities. Also, I don't understand why you call them sketchy, dubious or not a real company. They have money in the bank, many phase II trials, preclinical stuff, partnerships with at least two big pharmas and their technology is the base for a recent article in Nature by Astra Zeneca scientists.
I am not saying they will change the way cancer is treated... Also, as I said in my first message, their website is not good, and they seem to be much worst at communication and promotion of their assets than Thera. I hope it will console some here... But in a way they validate the docetaxel concentration approach, while at the same time showing that what they have may not be enough and that if TH1902 really works as designed in humans, it could relly be something special. Also, working with radioisotopes at the preclinical stage should show the way to Thera if they end up in a few months with a clear proof of concept. It also shows that weak efficacy won't do the trick. Thera needs more than stable diseases, and a few partial responses.
SPCEO1 wrote: I am not sure how you dug this up but "good on you" as they say down under.
Now, this is not a real company, at least in the sense that TH is a real company. They have almost no revenues and a stalled development program on a drug they really don't want to tell you too much about. It is worth remembering that Australia got its start, at least from a Western perspective, as a penal colony for the Brits. My experience is you need to be especially careful investing in small cap Australian stocks with stories like Star Pharma.
That being said, I have not had much time to look at it so I may be pre-judging it. There is only one analyst covering the stock from a no name small Australian brokerage firm (I think - Bell Potter is the name) and they have a "Speculative Buy" rating on it. They raised A$45 million in new equity via this firm last October so they are not going away anytime soon. Apparently Bell Potter started covering the stock in 2013 with a target price of $1.55 and recently upgraded their target price to A$2.20 - so not much progress over the years - in that it has a lot in common with TH's stock price!
Given what JFM and others been able to dig up so far, I don't think this is a very good comparison to TH. I see it as a rather dubious proposition of a company - just to much sketchiness and such minimal progress over a long time. That it is worth more than TH is just another piece of evidence that TH is ridiculously undervalued to my mind.
jfm1330 wrote: OK. Here is the company that I found yesterday and that shares many similarities with Thera. even though it's not a company working on PDCs. But other than that, there are many things that they do that Thera does, or will or should do. Here is the list of similarities
Both are from smaller countries, related to United Kingdom, Canada and Australia.
Market cap in USD, Thera (350 M$), Starpharma (370 M$)
Similar age: Thera founded in 1993, Starpharma founded in 1996
Both are working on infectious disease and oncology
In oncology, both claim to have a platform able to target cancer cells
In oncology, both claim to be able to concentrate chemotherapy drugs inside cancer cells
In oncology, both claim to be able to work with any chemotherapy drug
In oncology, both are in human trial with docetaxel, Thera in phase Ia, Starpharma in phase II
Maybe there are other similarities, but given that Starpharma is well ahead of Thera in cilinical trials in oncology and has poor market cap, I guess some here would say that Starpharma's management is also poor at communication and promotion....
I looked into Starpharma website, and it is worst than Thera's website, nonetheless, I found some informations there. In oncology it is hard to understand the details of their technology and how it really works. They call it dendrimer delivery system, and they claim it can target cancer cells, but I don't know how. They never talk about targeting a specific receptor, but at the same time they claim to acheive intracellular concentration of docetaxel, or other drugs, that is 45 to 70 times higher than docetaxel alone. They claim a modified phamacokinetic profile of docetaxel (lower C max of free docetaxel and higher AUC), which is what I expect for TH1902. They also say that they have very low neutropenia, all that in humans, out of a completed phase I. The phase I also yielded efficacy, some partial responses and many stable diseases. They also have preclinical data on mice similar to what Thera achieved.
So, with docetaxel, they already have or claim to have many of the things we hope TH1902 will be able to achieve in phase I and their market cap is similar to Thera. On the other hand, it provides some validation to the idea of increasing docetaxel concentration in cancer cells in advanced cancers. Can TH1902 beat that and show better efficacy? In phase II they also run a trial with their docetaxel-dendrimer + gemcitabine. So they are already at the combo trial stage. They are also working with their dendrimer on cabazitaxel (phase II) and SN38 (they call it Irinotecan, but in fact they work with the much more potent metabolite of irinotecan, called SN38). They are also in phase II with that.
https://www.starpharma.com/drug_delivery/dep_docetaxel
https://starpharma.com/news/339
https://www.starpharma.com/drug_delivery/dep_cabazitaxel
https://www.starpharma.com/drug_delivery/dep_irinotecan
https://www.starpharma.com/assets/uploads/2020-06/Starpharma%20AACR%20Poster%201716%20DEP%20docetaxel%20DEP%20cabazitaxel.pdf
https://www.starpharma.com/assets/uploads/2020-06/Starpharma%20AACR%20Poster%201715%20DEP%20irinotecan.pdf
So as you can see they are ahead of Thera by a good margin and they achieved some efficacy results. They are also doing what some here said Thera should not do, which is pushing combinations in human trials with many drugs, and even combo trial in phase II on top of that. Also they are already partnering their platform with big pharmas, like Astra Zeneca and Merck and other undiclosed companies. In one case they will attach their dendrimer + chemo drug to an ADC. That is complexing since why would you need an ADC if your dendrimer technology can target cancer cells by itself? Also, guess what? They are working with Lutetium 177 in preclinical with their dendrimer + a small molecule (nano body???) + Lu 177. This combo would target HER 2 recepror. They already have very good preclinical results on xenograft mice with that.
https://starpharma.com/assets/asxannouncements/210428%20Shareholder%20Newsletter.pdf
I concentrated my readings only on the oncology part of Starpharma, as I said, they also work on infectious diseases with anti-viral stuff. So as we can see, only with the the oncology part they are well ahead of Thera, and still, have a similar market cap. That is why I said in my initial message that this can be viewed as negative for Thera. I think Starpharma shows that "mild" efficacy results with TH1902 will not propel the stock price. We will need more than that. Starpharma is well ahead of Thera in their oncology program, with human trials on many drugs combinations, partnerships and working with ADC and radioisotopes in preclinical. This shows that a company of that size can run multiple things at the same time. That being said, there are reason to hope that SORT1+ will end up being a better approach than their dendrimer technology.
Thera got fast track at the preclinical stage, which Starpharma does not have in phase II. There is a reason for that and we can see it as validation that SORT1+ as a greater potential. Another thing that SORT1+ clearly has for itself is a clear target (sortilin) and a defined MOA., while in the case of Starpharma, the MOA is not explained in anything I found. Don't ask me how it targets cancer cells, I found nothing explaining it. There is also nothing about overcoming MDR resistance, or how they were able to determine that they can concentrate the drug 45 to 70 times more in cancer cells. They claim that without any explaination. Another thing that I found is that in phase I, they injected doses of their dendrimer-docetaxel entity at doses that are equivalent to 10 to 105 mg/m2 of docetaxel alone. So they were not able to really exceed the maximum tolerable dose of docetaxel alone, which is 100 mg/m2, while we think that Thera is now at twice the MTD of docetaxel alone (200 mg/m2 of docetaxel alone or 460 mg/m2 of TH1902). I don't understand why they did not go to a higher equivalent dose of docetaxel, since they claim to reduce neutropenia by a lot. Another thing is that Thera seems to be able to target more cancer types and they have the advantage of sortilin expression growth as the cancer advances to more aggressive stages.
The example of Starpharma is a very good one because even though they are not working on PDCs, thay have numerous similarities with Thera. Also, in my view, it allows to draw a line, or set a standard of what Thera will need to clearly beat if we are to see a much higher stock price in the relatively short term. It also shows that a company of that size can do many things at the same time, many things in human trials, combo trials, partnerships, and new preclinical stuff like working with ADC and Lu 177. I will continue to search and read about Starpharma, feel free to do the same and share any interesting fact.