The Big Red Biotech Blog

Roche's T-DM1 Crosses Finish Line as Kadcyla

The second ADC in the past year has crossed the finish line to be approved by the FDA.  This time it is Roche's (Genentech) Kadcyla to be used in the treatment of HER2 positive breast cancers.  The drug has performed in clinicals -- despite missing out on accelerated approval -- as it was widely expeced to be approved this time around.

"Kadcyla is an antibody-drug conjugate representing a completely new way to treat HER2-positive metastatic breast cancer, and it helped people in the EMILIA study live nearly six months longer," said Hal Barron, Roche's chief medical officer and head of global product development

Unfortunately, it is priced at $9800 per month per patient and is expected to cost about $94,000 for a single course of treatment -- about double its predeccessor (non-ADC) Herceptin alone.  While I am excited to see ADCs make it to market --- and to be successful clinically.  I do worry about pricing models that have most new biological drugs -- particularly in oncology areas --- costing a minimum of 6 figures per patient course. 

It is the type of thing that does not seem sustainable in the current world fiscal and economic crisis.  See reports from Fierce Biotech and Xconomy for more on the medicine and FDA approval.

On a happier economic note, Genetech (no doubt boosted by successes like Kadcyla) announced that it will be adding 600 new staff in the US.  Just to put that into perspective, 600 staffers would easily handle the work of more than 30 average biotechs in pursuit of their first drug approval.  Genentech says it prefers to promote from within, making a number of these new hires replacements for upward bound employees. And they pay well, with many of these positions tied to starting salaries that range from $70,000 to $80,000 a year.  At least this company is hiring for more success as it experiences new successes. Huzzah!  See Fierce Biotech.

Posted by Bruce Lehr Feb 23rd 2013

 

PS - There is no truth to the rumor that Kadcyla battled Xalkori to a draw over Tokyo for control of that fine metropolis.    

Synthon Unveils Another ADC Facility

ADCs are a hot topic in drug development even though only two have been approved so far and one of those withdrawn.  Regardless, Roche's (Genentech) T-DM1 is widely expected to gain approval in 2013 an dmany many more ADCs are in development in a large number of companies.

Synthon Unveils ADC Facility as Data Show Promise for First Candidate.

With that as backdrop, Synthon has just opened a new ADC facility in Nijmegan, Netherlands.  The facility is geared to bring Synthon's internal pipeline of HER2-ADCs to market (same target as T-DM1).  HER2 is overexpressed in breast cancers and non-small cell lung cancers. Synthon refers to its therapy as second generation ADCs. Synthon also has other ADCs in development (at least two other targets) and has not closed the door on partnering with other companies to manufacture these products.

Posted by Bruce Lehr Jan 27th 2013.

ADCs Prominent in Celgene-Sutro Deal

Sutro Biopharma and Celgene struck a deal that could be worth as much as $500 M plus royalties to Sutro if milestones are met.  Celgene will gain access to Sutro technology that enables it to make biologicals by  a cell free protein synthesis approach.  Sutro will make drugs from Celgenes pipeline including both bi-specific Abs and ADCs to two undisclosed targets. Sutro will get a "substantial [undisclosed]" cash upfront and Celgene will make an equity investment and provide R&D funding. 

The Sutro ADC technology is considered to be next generation compared to that of leaders Seattle Genetics and ImmunoGen.  Mainly, the Sutro technology can incorporate non-natural amino acids in specific sites to allow it to make single species ADCs by conjugation of linker and payload at the site. Sutro can also identify the optimal sites in antibodies to make these site specific insertions. This leads to more controlled molecules and shorter timelines in development.

Sutro has been on a bit of a roll with other development deals with the likes of Pfizer.  They also have from venture investments from Lilly and Amgen venture groups among others. I like to see ADCs becoming more successful in the market and look forward to more exploitation of this technology. See Xconomy and Fierce Biotech.

Posted by Bruce Lehr Dec 18th 2012.

T-DM1: Four More Months! Four More Months!

Roche reported today that the FDA has granted it (and partner ImmunoGen) a priority review for its breast cancer drug T-DM1.  The decision is due by Feb 26th.  When approved, T-DM1 will be the second approved ADC on the market. The EMA also accepted Roche's marketing application for the key European market.  Phase III results for T-DM1 have been strong and the drug is considered to be a potential blockbuster by many analysts.  Peak sales volumes of $5B or greater have been projected upon its approval. See Fierce Biotech.

We only have 4 months (maximum) to wait.

Posted by Bruce Lehr Nov 7th 2012.

ADCs Clear Another Hurdle as Adcetris Gains EU Approval

Backers of ADCs have more good news coming from Europe today as the EU approves Adcetris for use in the treatment of relapsesed Hodgkin's and ALCL.  Millennium (Takeda) licensed rights to sell the product outside the US from its inventor Seattle Genetics and will now pay the latter a $25 M milestone.  SeaGen will also receive tiered double digit royalties on the sales of the product.

Thus ADCs continue their role as one of the hottest new technologies in the treatment of cancers. SeaGen has already generated nearly $150 M in sales in the US since the drug's approval earlier this year.  Many companies now have ADC programs in their pipelines and there are 10's of drugs in clinical trials. This is only expected to expand with Adcetris' success so far and the expected approval soon of Roche's T-DM1 for breast cancer. See Xconomy.

Menarini Partners on Cancer ADCs for $1 Billion

Show some success in medicine and others will follow. Genentech's soon to be licensed T-DM1 for the treatment of breast cancer has spawned many other entrants pouring into the ADC field. The latest to play is Menarini.

Menarini today announced a partnering effort with Oxford BioTherapeutics on 5 new programs aimed at the development of ADC cancer therapeutics. Oxford will supply the antibody, linking technology and cancer targets.  Menarini will do the manufacturing and development work.  Both will pursue clinicals and commercialization in different parts of the world.  Oxford gets North America and Japan, while Menarini takes Europe, Asia and Latin America.

The arrangment is expected to speed Oxford's participation in clinical trials and helps bolster Menarini's pipeline.  Both should benefit if the therapies succeed. See Fierce Biotech.

Posted by Bruce Lehr Oct 29th 2012.

 

 

SeaGen Leverages ADC Success into Big Deal with Abbott

Cha-ching! Cha-ching!

Seattle Genetics announced today that it has completed a deal with Abbott for use of its antibody drug conjugate (ADC) technology for a series of cancer applications. SeaGen will receive $25 M upfront and have the possibility of earning $220 M in milestones plus mid- to high single digit royalties for each new Abbott cancer drug.

Thus, Seattle Genetics has successfully parlayed its licensed Hodgkin's therapy, Adcetris, into another long-term money generating technology deal.  Previously, Abbott hahad only committed $8 M to SeaGen in a single 1 molecule deal in 2011. Oh, what a little clinical success can bring.  Also, Genentech's success with T-DM1 in its partnership with ImmunoGen has hurt either. 

ADCs are coming.  There are more than 15 other ADC candidates in clinical trials.  Backers of this technology include: Astellas Pharmaceuticals, Bayer, Celldex Therapeutics, Daiichi Sankyo, Genentech, GSK, Millenium/Takeda, Pfizer, and Progenics.

"We are leading the field in ADC development, and this expanded collaboration with Abbott further validates our technology and approach in targeting and treating cancer," said Natasha Hernday, SeaGen VP of corporate development. See Xconomy and Fierce Biotech.

Posted by Bruce Lehr Oct 23rd 2012.

ADCs Poised to Go Beyond Cancer Treatment

I meant to comment on the news last week that Merck will pay $15 M upfront with plenty (possible $288 M) in back end incentives to partner with Ambrx on its ADC technology. I'm big on the potential of ADC particularly with the success we're seeing this year with Seattle Genetics' Adcetris and with Genentech's T-DM1 soon to join the party.

Up till now, ADC programs have been geared to the treatment of various cancers. But with Ambrx's unique binding methods for linking antibodies to toxins that allow it to better control the ratio of bound toxins to antibodies, the Merck-Ambrx partnership will look to go after other diseases outside the cancer arena.  This could include autoimmune conditions and diseases like diabetes. I think it is exciting to see the technology extend to these other chronic disease areas. See Xconomy here and here.

Posted by Bruce Lehr Jun 22, 2012

Reports on ASCO Consolidated

Today you can read summaries of the going's on at ASCO as reported in Pharmalot, Fierce Biotech and Xconomy.  Clearly the cancer treatment world is heating up and there were a number of exciting clinical trials reported on at this year's meetings.  The concensus seems to be the companies following made the biggest splashes (with patients, analysts and investors) with their clinical results.

Who Got The Most Buzz At The Noisy ASCO Fair? // Pharmalot.

In the order mentioned in the Pharmalot post:

• J&J reported on Zytiga for treatment of prostate cancer for patients who have not received chemo
• Roche reported results on its latest stage antibody-drug conjugate, T-DM1, for the treatment of breast cancer. Roche says it has 8 ADCs in the clinic and 25 in its pipeline targeted at cancers
• BMS reported on its drug, BMS-936558, which targets PD-1 in a variety of cancer cells. BMS hopes to establish this as a blockbuster for a number of cancers. PD-1 encourages the patient's immune system to fight the cancer
• Bayer reported on regorafenib for the treatment of stomach cancer. It is also being directed toward colorectal cancers and gastrointestinal stromal tumors

Other notable results were reported by Dendreon (prostate), Ariad Pharmaceuticals (CML), Onyx Pharmaceuticals (colorectal cancer), Aveo (kidney cancer), and GSK (melanoma). 

These drugs have the potential to change the standard of care and the "empowered antibodies" being pushed by Roche utilizing technologies from Seattle Genetics or Immunogen look to usher in the world of ADCs with so-called "smart bombs".  All and all an exciting conference with exciting results.

Posted by Bruce Lehr June 6th 2012.

 

 

Antibody-Drug Conjugates Continue to Gain Momentum

Antibody-drug conjugates (ADCs) are continuing to garner greater attention in the treatment of cancers and are being prominently discussed at the American Society of Clinical Oncology (ASCO) this year. Both Genentech's (and partner Immunogen) T-DM1 -- a souped of version of herceptin -- and Seattle Genetics' Adcetris will be prominently featured for the treatment of breast cancer and lymphoma respectively. Success of these companies is further paving the way for other therapies using the antibody linked to chemotoxin strategy. See Fierce Biotech.

Venture groups, like Celtic Therapeutics, have invested more than $50 M in the development of future ADCs. Says Celtics managing partner, Stephen Evans-Freke, "I don't think there is a mjor pharma or a midsized pharma with interest in cancer that doesn't have a program or isn't scrambling to put one together."

Xconomy's, Luke Timmerman, wrote another good story on ADCs coming of age this week -- and profiled a dozen or more companies actively pursuing programs.  This included not only the 3 companies mentioned above but companies like BMS, Sutro Biopharma, Ambrx, CytomX Therapeutics, Allozyne, Igencia, Spirogen, Centrose, Mersana Therapeutics, PolyTherics and more. See Xconomy.

For those with further interest in this area, the 3rd Annual ADC Meeting is being held in San Francisco from October 23-26th. Look here to see a draft agenda, Download ADC Agenda.

Posted by Bruce Lehr June 1st 2012.

 

Sigma-Aldrich differentiates to HPAPIs for future

The market for production of small molecule APIs is becoming much more competitive - especially as these become more genericized and manufacturing moves to lower cost (for now) Asian suppliers.

Sigma-Aldrich looks to HPAPIs as generic sector heats up.

As a result, SAFC is moving its focus away from these more generic APIs and is focusing its efforts on the product of high potency APIs (HPAPIs).  SAFC has several new facilities that are geared toward this type of higher value more difficult manufacturing -- which separates its right away from some of the lower cost, less specialized manufacturers.  This capability allows SAFC to cater to drug developers working in cancer therapeutics with both HPAPIs and antibody drug conjugates.

Sigma-Aldrich CEO Rakesh Sachdev commented on this approach at the recent JP Morgan Healthcae Conference, "A greater percentage of [custom pharma] will become highly specialized offerings."  Sigma's focus will be "on very unique products" and this is driving our expansion in the high potency area to give ourselves a competitive advantage.

Posted by Bruce Lehr Jan 18th 2012.

 

ImmunoGen and Lilly Cut ADC Deal

From Fierce Biotech, ImmunoGen and Eli Lilly announced a deal for the latter to gain an exclusive license to a defined number of treatments utilizing the formers antibody drug conjugate technology.  ImmunoGen will receive $20 M in upfront payments, can earn up to $200 M in milestones and also can earn royalties when the drugs reach commercialization.

Lilly plans to exploit the ADC technology with its pipeline of oncology drugs to "develop agents with clear clinical benefit in specific patients populations."

Posted by Bruce Lehr Dec 20th 2011.

ADCs are Hot and Offer CROs/CMOs Opportunities

As covered in the BioProcessBlog, BPTC's first bioPULSE survey found that the market was bullish on the prospects of antibody drug conjugates (ADCs) to become a major therapeutic area going forward.

Increasing interest in ADCs.

Key findings in the web-based survey included:

• 83% of respondents expect to see a signifcant increase in the number of ADCs entering the pipeline in the next 5 years
• 24% indicated that they were not currently working on ADCs but expected to be doing so soon
• 24% indicated that they were already working on ADCs
• 95% of respondents said ADCs would be as big as mAbs or very important but not quite as big as mAbs (only 5% felt it was a niche application)

Conjugation technology and linker chemistry was seen to be the biggest challenge. Survey participants cited this as an opportunity for CROs/CMOs who could provide help with conjugation and linkers and provide manufacturing.  See Big Red Biotech posts here and here.

Posted by Bruce Lehr Dec 16th 2011.

ADC Biotechnolgy Wins Grant for new ADC Production Technology

ADC Bio received a new development grant from the Welsh government for its new antibody drug conjugate manufacturing technology that it hopes will make drug production cheaper.  The new "lock and release" method will minimize production steps and cut costs.

ADC Bio wins development grant for new ADC production tech.

The new technology is performed on a solid support versus current methods done in solution at high dilution. Binding the antibody to a solid support prior to the conjugation step provides some of the following advantages according to ADC Bio:

•  column binding of the antibody followed by conjugation to the cytoxic drug allows all superfluous reactants to be washed away from the immobilized antibody
• structural integrity of the antibody binding activity is maintained
• the antibody is protected throughout the process and can't be lost by leakage providing signficant risk management for pricey material
• reportedly production yields are increased in the new process by minimizing antibody aggregation

ADC Bio expects to begin testing commercial scale production in the next year and a half.  It plans to license the technology to CMOs and drug companies. The prospect of ADC's making a much bigger splash in cancer therapeutics over the next decade bodes well for demand for ADC manufacturing services and technologies.

Posted by Bruce Lehr Dec 13th 2011.

 

T-DM1 Generates More Positive Breast Cancer Data

Roche reported more positive data on T-DM1 in its latest breast cancer trial with 137 women. In this study, T-DM1 (aka trastuzumab emtansine) showed a 41% decrease in the progression of disease versus the standard of care -- Herceptin plus Taxotere.  T-DM1 kept patients' tumors from spreading an average of 5 months longer than the standard control. T-DM1 also had only about half the reported side effects and only 25% as many patients dropped out of treatment as the standard due to adverse events. Thus T-DM1 was better tolerated by patients.

This is more good news for Roche and its partner Immunogen in their quest to gain FDA approval for T-DM1, the latest antibody drug conjugate ("empowered antibody") to seek approval.  Thus the empowered T-DM1 appears to work better than its parent Herceptin plus standard chemotherapy.  Immunogen -- responsible for linking emtansine to Herceptin -- stands to gain as well from milestones and royalties when T-DM1 is finally approved.  Phase III results still await but the trend is positive. See Fierce Biotech and Xconomy.

 

Posted by Bruce Lehr Sep 26th 2011.

Seattle Genetics and Oxford BioTherapeutics Team Up on Cancer

Seattle Genetics and Oxford BioTherapeutics (OBT) have formed a collaboration to discovery novel antibody-drug conjugates against cancer. OBT will create panels of mAbs against tumor-specific antigens identified using its Oxford Genome Anatomy Project (OGAP®) database. These will be screened using Seattle’s ADC technology.

The OGAP database is built on disease protein information generated by OBT in-house coupled with genetic and clinical data from 50 different human tissues, including 5,000 cancer membrane proteins. OBT claims the database integrates all clinical and experimental  expression data from about 1 million human protein peptide sequences, 15000  validated genes,  50 tissues/organs, 58 diseases, and about 8 million SNPs and haplotypes.

Under the deal's terms, the firms will have an equal number of alternating options to select programs from preclinical ADCs for exclusive, worldwide development and commercialization. Each firm will receive progress-dependent milestone payments and royalties on net sales of any resulting ADCs developed by its partner.

Seattle Genetics is focused on the development of antibody-based therapeutics against cancer.  Its ADC drug Adcetris was recently FDA approved for two indications:  Hodgkin lymphoma and systemic anaplastic large cell lymphoma (ALCL).  Seattle Genetics has three additional ADC candidates undergoing Phase I testing: SGN-75 is in development against renal cell carcinoma and non-Hodgkin lymphoma, ASG-5ME is being evaluated for the treatment of pancreatic cancer and prostate cancer, and ASG-22ME is in development against solid tumors. See GEN.

 

 

 

 

Posted by Bruce Lehr Sep 18th 2011.

FDA Clears Seattle Genetics' Adcetris for Sale in US

Cue the Trumpets!  Seattle Genetics gained FDA approval to market its antibody drug conjugate (ADC) brentuximab vedotin for the treatment of Hodgkin's lymphoma and anaplastic large cell lymphoma (ALCL).  Yeah!

This is the first ADC to gain approval on the US market and it will be sold under the name Adcetris.  The approval came about two weeks ahead of the official review date of August 30th.  This is great news for Seattle Genetics as it is the Company's first approved drug after being in business for 14 years and spending nearly $546 M in R&D to reach this point.

The industry has been watching the progress of so-called "empowered antibodies" -- antibodies linked to powerful toxins to target specific cancers -- and a big success here for Seattle Genetics will only embolden other companies in the field. Seattle Genetics also has several more candidates of its own in various stages of the clinical pipeline. 

The company didn’t discuss one of the key facts investors will want to know immediately about the new product—its price. Most analysts expect that the drug will end up costing more than $100,000 per patient, as it is given to patients in a series of intravenous infusions once every three weeks. Seattle Genetics said it plans to discuss more of its commercial plans on a conference call with investors at 8:30 am ET/5:30 am PT on Aug. 22.  See Xconomy. 

 

Posted by Bruce Lehr Aug 19th 2011.

What have you done for me lately Seattle Genetics?

Yesterday, FDA advisory panels recommended that Seattle Genetics new "empowered antibody" drug called Adcentris (brentuximab vedotin) receive accelerated approval from the agency in late August for the treatment of Hodgkin's patients (non-responsive to chemo) and patients with anaplastic large cell lymphoma (ALCL) who've relapsed.  Pretty good stuff, huh?

Today, investors thus far have rewarded the company by driving down its stock price 5.7% from $20.33 to $19.17 in premarket trading.  Wow. What have you done for me lately? See Forbes.

 

Posted by Bruce Lehr July 15th 2011.

And Then There Were Two - Adcetris Gets OK for ALCL

Seattle Genetics' Adcetris (brentuximab vedotin) recieved its second thumbs up from a second FDA advisory panel today -- this time for the treatment of anaplastic large cell lymphoma (ALCL).  Once again, the panel voted 10-0 to recommend the drug's approval. 

About 2,000 new cases of anaplastic large cell lymphoma are diagnosed each year, half get effectively treated with chemo, but once it recurs, patients are only expected to live a little more than three months. The data for the Seattle Genetics drug in this group of patients was striking. The drug completely or partially shrank tumors in 86 percent of the patients studied in a mid-stage trial (50 of 58). Most of the patients (57 percent) went into complete remissions.

The FDA has a deadline of August 30 to complete its review of the Seattle Genetics application to start marketing the drug for patients with Hodgkin’s and anaplastic large cell lymphoma. If approved, the new drug will be Seattle Genetics’ first marketed product after 14 years in business, and it would the first commercially successful version of an “empowered antibody” -- a completely new type of molecule in the fight against cancer. See Xconomy.

 

Posted by Bruce Lehr July 14th 2011.

 

 

Seattle Genetics' Adcetris Gains FDA Panel Endorsement

Seattle Genetics, as expected, got the endorsement of an FDA advisory panel to approve Adcetris (brentuximab vedotin) for the treatment of Hodgkin's lymphoma.  If the drug is now approved by the FDA for sale (decision Aug 30th), it will be the first approved antibody drug conjugate (ADC) on the market.  Another FDA expert panel will be discussing this afternoon whether or not Adcetris should also be recommended for the treatment of anaplastic large cell lymphoma (ALCL). 

"Brentuximab works and it works well. People with Hodgkin's lymphoma will have another option for treating a terrible disease," said Michael Sekeres, an oncologist at the Cleveland Clinic. See Xconomy. 

Seattle Genetics will not only be gaining its first approved drug but as an ADC the first one of that class.  This is the second drug this year from the Seattle biotech pool, besides Dendreon's Provenge, that represents a novel treatment type for a cancer.  Fierce Biotech notes in an article today that Dendreon and Seattle Genetics would both appear to be high on Big Pharma's short list of acquisitions.  Cancer therapies are expected to grow twice as fast as the rest of the pharmaceutical market (according to IMS Health) and many novel oncology drugs have been approved so far in 2011 (see next post on Yervoy).  Indeed, look for more acquisitions in the oncology space to happen.

 

Posted by Bruce Lehr July 14th 2011.

 

 

Seattle Genetics 'Empowered Antibody' on Track

Seattle Genetics antibody drug conjugate, brentuximab vedotin or Adcetris, remains on track for its hearing at FDA on Thursday.  A briefing from the FDA staff report on the drug revealed no big surprises or negatives.  Adcetris is applying for approval to treat patients with Hodgkin's lymphoma and anaplastic large cell lymphoma (ALCL). 

The FDA did note that both Seattle Genetics trials were single arm rather than double blind.  We'll need to see if that sways FDA opinion as to whether to recommend accelerated approval or not.  All signs up till now would point toward the drug receiving the go ahead. If approved, the will be Seattle Genetics first ever drug and will also be the first ADC approved. See Xconomy.

 

Posted by Bruce Lehr July 12th 2011.

 

Innovation as the Antidote to Biosimilar Market Erosion?

Here is an interesting report created by RBC Capital Markets, entitled Biosimilars - A Wall Street Perspective that discusses the evolution of biosimilars and offers an opinion as to how the market will evolve.  One of the more interesting aspects is a discussion of modifications that can be made to innovator biologics to fend off challenges from biosimilars - including such technologies:

• Pegylation - reduce injections
• Ultra potent antibodies and ligand traps - less injections, subQ dosing, safety
• Bispecific antibodies and antibody fragments - potency, dual activity
• Antibody/drug conjugates (ADCs) - potency
• Glycoengineering - potency
• Fc engineering - potency, half-life modifications, novel functions

I post frequently here about some of the ADCs advancing through the clinic - the two most advanced being brentuximab vedotin (Seattle Genetics) and T-DM1 (Genetech/Immunogen).  Both drugs are in late stages phase III and are expecting approval.  There are at least another 34 programs identified publicly -- 22 of which are in phase I or II. We can expect to see a continuing cavalcade when the first two are approved and shown to be successful.

Here's a copy of the report: Download Wall Street report on biosimilars

Posted by Bruce Lehr June 29th 2011.  

 

Cha-Ching! Seattle Genetics Gets $5M Milestone from Takeda for ADC

Seattle Genetics has begun to cash in on its antibody drug conjugate (ADC), brentuximab vedotin, for reaching a key milestone by filing an MAA with the European Medicines Agency (EMA).  The milestone triggers a $5 M payment from its licensing partner The Takeda Oncology Company.

Seattle Genetics retains marketing rights to brentuximab vedotin in the US and Canada while Takeda has the rights in the rest of the world. The partners are splitting development costs 50:50. The drug will be targeted to the treatment of Hodgkin's lymphoma and anaplastic large cell lymphoma (ALCL). Seattle Genetics application with the US FDA is pending for both applications as well.

The review date with the FDA is scheduled on Bastille Day (July 14th) and the action date is August 30, 2011. See PBR story.

 

Posted by Bruce Lehr June 28th 2011.

FDA Sets Review Date on SGN-35 ADC

Seattle Genetics has its review date with the FDA set for July 14th to get an Advisory Committee decision on its antibody drug conjugate (ADC) brentuximab vedotin (SGN-35).  BLA's for the drug's use in the treatment of Hodgkin's and anaplastic large cell lymphoma will both be reviewed in back to back sessions.

SGN-35 remains on pace to be the first ADC approved.  And if the committe recommendation is positive as widely expected, Seattle Genetics will be really have something to celebrate (besides Bastille Day) as it moves to storm the market.

 

Posted by Bruce Lehr June 16th 2011.

Seattle Genetics and Agensys Expand ADC Deal

Seattle Genetics and Agensys (now owned by Astellas) will work on their second ADC together under the terms of their existing 2007 agreement.  The new project will develop ASG-22ME directed to the Neclin-4 antigen found on bladder, breast, lung and pancreatic tumors.

With this deal, Seattle Genetics says it now has 15 ADC projects underway between its own pipeline and through external collaborations.  Agensys says the deal confirms its commitment to ADCs and building its cancer portfolio.  Seattle Genetics expects its first ADC, brentuximab vedotin (SGN-35), to be approved sometime this year by the FDA.  See PBR.

Posted by Bruce Lehr June 9th 2011.