Avid Bioservices Inc (CDMO)

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2-18-11 Interview wth Affitech CEO re: R84 (fully-human 2C3) development. Recall, the Peregrine/Affitech AntiVEGF-2C3 deal (incl. fully-human 2C3, aka R84=AT001), announced 7-22-09, called for $250k upfront ($100k/immed + $150k/6mos), $1,000,000 to Peregrine upon “delivery of a pre-clinical dev. package” to Affitech, up to $16.5mm in milestones, royalties on future sales, and addl. payments if Affitech sub-licenses “Ocular Field” indications. [See 7-31-09 10Q, pg.15: http://tinyurl.com/mfppjh & 7-22-09 PR: http://tinyurl.com/n67v57 ].
http://www.affitech.com
http://www.affitech.com/investors-news/press-releases-english

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“Promising Future for r84
• Affitech Tests Exciting New Anti-Cancer Drug Candidate”
By John Erik Stacy, 2-22-11 (orig. pub. 2-18-11)
http://blog.norway.com/2011/02/22/promising-future-for-r84

Affitech has an exciting anti-cancer drug candidate, now known simply as r84, shown to fight cancer growth in animal trials. Like Avastin (Genentech), Herceptin (Roche), Erbitux (Merck) and other new anticancer drugs, r84 is a monoclonal antibody. This type of drug continues to be an important part of recent advances in cancer treatment. Antibody-based drugs now represent a large fraction – pushing $50B – of the total pharmaceutical market.

PHOTO: Affitech co-founder and managing director Dr. Martin Welschof. Affitech laboratories are in the Oslo Research Park. (Photo courtesy of Affitech)


Dr. Martin Welschof, Managing director of Affitech A/S, answered questions about the company, r84 and other products in their pipeline:

What types of cancer might be treated using r84?
So far we have seen that r84 works on breast, lung, and pancreatic cancers transplanted into mice. Dr. Rolf Brekken and his team at the University of Texas performed these tests.

Is it correct to say that r84 slows cancer by blocking the formation of blood vessels in the tumor?
Yes, For a tumor to grow it needs to be able to form its own blood vessels. Affitech’s r84 is similar to the established anti-cancer antibody drug Avastin (Genentech) in that it interferes with a protein known to stimulate blood vessel formation (the name of this protein is Vascular Endothelial Growth Factor or VEGF for short).

As I understand it, r84 is more specific than Avastin. Why is that important?
We know that r84 interacts precisely with VEGF to block its interaction with another molecule (a receptor called VEGFR2). Avastin is less discriminating and blocks binding of the VEGF molecule to both of its receptors (VEGFR1 and 2). Therefore we believe that there is the potential for a better safety profile of r84. So far we have shown that r84 is at least as efficient as Avastin and does not induce toxicity in animal models.

There are some Russian names on the board of Affitech now, including Viktor Kharitonin. Affitech signed a E23 million ($ 31M) agreement with NauchTekhStroy Plus (NTS Plus) in April 2010. At the same time, Trans Nova Investment became a majority stockholder in Affitech (53%) by purchasing shares in the amount of E20 million ($ 27M). Trans Nova is an investment company operating on his behalf of Mr. Kharitonin, and he is also the Chairman of Pharmstandard (LON:PHST), Russia’s largest domestic pharmaceutical company, which owns 50% of the biotech company NTS Plus. Aleksandr Shuster is co-owner of Trans Nova and NTS Plus and is the Chairman of the Board for Affitech. Shuster has deep experience in pharmaceutical development and was involved in developing drugs that were later bought by Pharmstandard. He also founded the companies Masterpharm and Masterclone which primarily focus on new and biological drugs.

So, Pharmstandard acts as a natural bridge for Affitech into Russian markets?
Pharmstandard was “Company of the year” in 2010 and has 20% of the Russian market in relation to other Russian companies. It is clearly a powerful actor in the region and our best marketing partner for Russia and the CIS [Commonwealth of Independent States]. This represents a population of nearly 300 million people. We envision this market as a starting point, but plan to sell worldwide.

What sort of time frame for r84?
We are soon to file clinical trial applications in Russia. Moving a drug through clinical trials is a process that takes years, but Russia offers a favorable environment for clinical trials with the potential to Fast-track under the Russian Pharma 2020 initiative. Advantages of trials in Russia include high quality at reasonable cost and standards to assure data acceptance from the FDA and EMEA. That is, we plan to bring our drug through the approval process and to market in Russia in fewer years than it would take to accomplish in the US. And we expect to be able to use the work done in Russia to help achieve FDA & EMEA approval.

What other products are in the Affitech pipeline?
AT008 is a program which contains various antibodies being currently developed as a potential therapy for various cancers and autoimmune disorders. Those drug candidates target a cell-surface molecule called CCR4 (one of the many “G Protein Coupled Receptors”). AT008 is also being developed under the agreement with NTS Plus. We also have an ongoing relationship to develop products with Peregrine Pharmaceuticals (PPHM) as well as Roche.
*end*
DISCLAIMER: The author has a small holding in PPHM and once worked for Affitech.
This article was originally published in the Feb. 18, 2011 issue of the Norwegian American Weekly.

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ANTI-ANGIOGENESIS AGENT ’2C3’ [Fhu: R84=At001] ANTI-VEGF MAB:
9-30-10: PPHM & Affitech Amend 7-2009 R84 Licensing Agreement http://tinyurl.com/2cn77c2
…following Affitech/NTS+ Collab for dev. in Russia/Brazil. Also, Avid gets contract to mfg. R84 for clinical studies.
8-6-10/PLoS: PPHM-Brekken/UTSW/Affitech article on pre-clin. R84=AT001 (Fhu 2C3): http://tinyurl.com/2unp4j3
…”Extended r84 therapy controls tumor growth without induction of toxicity”
6-30-10: NTS-Plus to run 2C3/R84 clinical trial(s) in Russia: http://tinyurl.com/26hhln4
…”AT001/r84 differs from Avastin in a number of ways… more selective… may have a better side effect profile.”
4-21-10: Affitech sub-licenses Anti-VEGF mabs (incl. R84) to Russian partner NTS-Plus: http://tinyurl.com/29tzen9
11-3-09/PLoS: R.Brekken (PPHM SRB) on R84, increases “immune cell infiltration” in Breast Cancer: http://tinyurl.com/y8ooxah
7-22-09: Peregrine Licenses Anti-VEGF mabs (incl. R84) to Affitech: http://tinyurl.com/n67v57
6-30-09: R.Brekken article in Mol-Cancer-Ther on 2C3/R84+Avastin vs. Breast Cancer: http://tinyurl.com/mqv5ol
12-11-08: Dr. Brekken (PPHM SRB) presents F.H. 2C3 (R84/PGN311) at TX Breast-Cancer Conf. http://tinyurl.com/63utya
11-3-07: Dr. Brekken presents ‘R84’ (F.H. 2C3, aka PGN311) data at IBC-Conf: http://tinyurl.com/yp459d
4-16-07 AACR2007: Brekken [PPHM SRB] presents fully-human 2C3 (‘R3’) http://tinyurl.com/2udkgr
”The anti-tumor activity of 2C3, which only blocks VEGFR2 compared favorably to that of Avastin, which blocks both VEGFR1+2”
2-14-05: Humanized 2C3 Pre-Clin. data presented at "Anti-Angio. Symposium": http://tinyurl.com/85qy3
2-10-05: VEGF Pioneer Dr. Donald Senger joins PPHM’s SRB to assist with 2C3 pgm: http://tinyurl.com/yul72w
5-20-03: PPHM compares 2C3 vs. Genentech’s AVASTIN: http://tinyurl.com/37k2nl