UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`BLUEBIRD BIO, INC.,
`Petitioner,
`
`v.
`
`SLOAN KETTERING INSTITUTE FOR CANCER RESEARCH,
`Patent Owner.
`____________
`Case No. IPR2023-00074
`Patent No. 8,058,061
`____________
`
`
`DECLARATION OF CHAD MAY
`IN SUPPORT OF PATENT OWNER’S PRELIMINARY RESPONSE
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`I, Chad May, declare as follows:
`1.
`I am over the age of 21 years and am fully competent to make this
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`Declaration. I make the following statements based on personal knowledge and, if
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`called to testify to them, could and would do so.
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`2.
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`I am the named inventor of several United States patents, including U.S.
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`Patent No. 7,541,179 (“the ‘179 Patent”) and U.S. Patent No. 8,058,061 (“the ‘061
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`Patent”). The ‘179 Patent, entitled “Vector Encoding Human Globin Gene and Use
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`Thereof in Treatment of Hemoglobinopathies,” was filed July 1, 2002, and is based
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`on two provisional applications—Application Nos. 60/301,861 and 60/302,852—
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`filed June 29, 2001 and July 2, 2001, respectively. I understand these patents are
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`being challenged in inter partes reviews in front of the Patent Trial and Appeal
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`Board of the United States Patent and Trademark Office.
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`3.
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`I make this declaration in support of Patent Owner’s Preliminary
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`Response to the Petitions challenging the ‘179 and ‘061 Patents.
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`Employment
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`4.
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`I am currently the Chief Scientific Officer at Serotiny. I have worked at
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`Serotiny since May 2022.
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`5.
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`Prior to that, from January 2017 to April 2022, I was a Senior Vice
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`President of Research and Development at Maverick Therapeutics, which was
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`acquired by Takeda in August 2021. From January 2010 to January 2017, I was
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`Senior Director of Targeted Immunotherapy at Pfizer Pharmaceuticals. From
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`September 2001 to January 2010 I was a Senior Scientist at ImClone Systems, which
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`was acquired by Eli Lilly in 2008.
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`Education
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`6.
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`I received a B.S. in Genetics and Cell Biology from the University of
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`Minnesota in 1993.
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`7.
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`In the Fall of 1995, I began graduate school at Cornell University
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`Graduate School of Medical Sciences (now the Weill Cornell Graduate School of
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`Medical Sciences) in the Department of Immunology.
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`8. My Ph.D. program was part of a joint program with the Sloan Kettering
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`Institute (SKI). Specifically, in or around the winter of 1995/96, I spent a few months
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`in a lab rotation with Dr. Malcom Moore at SKI to learn how to culture and work
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`with murine hematopoietic stem cells. In or around the summer of 1996, I joined
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`Dr. Michel Sadelain’s lab at SKI to pursue my doctoral thesis work.
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`9.
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`I received a Ph.D. in Immunology from the Weill Medical College of
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`Cornell University in 2001. After receiving my doctorate, I stayed in Dr. Sadelain’s
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`lab at SKI to pursue my post-doctoral fellowship.
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`10. A copy of my current CV is attached as Appendix A.
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`Conception and Reduction to Practice of the Inventions Disclosed in the ‘179
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`and ‘061 Patents
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`11. During my doctoral and post-doctoral work at SKI, my lab was
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`pursuing the idea of doing gene therapy, or gene transfer into hematopoietic stem
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`cells, to treat hemoglobinopathies, including beta-thalassemia. There were several
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`individuals who worked on developing vectors for the cure of beta-thalassemia at
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`SKI. This included at least Michel Sadelain, Stefano Rivella, and Joseph Bertino, all
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`of whom are also named inventors on the ‘179 and ‘061 Patents. It is my
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`understanding that Dr. Joseph Bertino passed away in Octoboer 2021 at around the
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`age of 90 years old.
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`12. From 1996-1997, I worked with Dr. Stefano Rivella to design and
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`create viral vectors that included larger nucleotide sequences from the locus control
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`region (LCR) than those that were previously reported, for use in gene therapy
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`approaches to treat hemoglobinopathies. The LCR is known to regulate expression
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`of globin genes, including gamma- and beta-globin. Our goal was to increase globin
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`expression to therapeutic levels, and to improve the efficiency of stable gene transfer
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`of these larger viral genomes into hematopoietic stem cells. At this time, there were
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`several labs working on these same issues but everyone in the field was using
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`different nucleotide sequences, i.e., they were actively working to identify different
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`nucleotide sequences encompassing one or more of the hypersensitive (HS) core
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`elements, which are part of the larger LCR nucleotide sequence. The thinking at the
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`time was that there is something in or around these HS sites that was important to
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`sufficiently regulate the globin genes, but no one knew exactly which part(s) were
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`important and necessary to include in a viral vector to achieve therapeutic levels of
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`globin expression.
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`13. When I first joined Dr. Sadelain’s lab, we initially incorporated these
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`larger LCR nucleotide sequences into the more commonly used retroviral vectors
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`based on the Moloney Murine Leukemia Virus (MMLV) but were unable to stably
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`transfer the retroviral genomes due to RNA splicing that resulted from the addition
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`of the larger LCR nucleotide sequences.
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`14. Based on my education and experience in virology, I understood that
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`lentiviral vectors, like MMLV based vectors, are RNA viruses. However, I also
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`understood that unlike MMLV, lentiviruses are inherently able to regulate the
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`packaging of unspliced viral genomes. Lentiviruses express a protein called Rev and
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`include a sequence in their viral genome called the Rev Response element (RRE).
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`At the time, Rev protein complexes were reported to directly interact with the RRE
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`sequence on the viral genomes and stabilize them prior to being packaged into a viral
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`particle. I was aware that expression of the Rev protein and the incorporation of the
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`RRE were retained. With this knowledge, I predicted the use of this lentiviral vector
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`may overcome the challenges we observed using MMLV based retroviral vectors
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`and prevent splicing of the larger LCR sequences we were trying to incorporate into
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`our designs, thereby allowing their efficient gene transfer into hematopoietic stem
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`cells and the potential to significantly increase globin expression.
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`15.
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`In or around the winter of 1997/98 to the winter of 1998/1999, I worked
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`with Dr. Rivella on designing and cloning the varying sized hypersensitive sites
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`(HS2, HS3 and HS4) into the lentiviral vectors and testing them in vitro for stable
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`gene transfer of the full-length viral genome and measured human beta-globin
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`expression levels in relevant cell lines after transduction with the designs. Through
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`this process, we were able to create a vector, which we coined the TNS9 vector, that
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`we believed was capable of being successfully transferred into hematopoietic stem
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`cells to achieve therapeutic expression levels of the beta-globin gene. While we
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`focused on trying to express the beta-globin gene, we continued to discuss the use
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`of our vector design with other globin genes, which included discussions of fetal or
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`gamma-globin as well as alpha- and beta-globins. I remember talking to
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`Drs. Sadelain and Rivella about the potential of using our vector design with other
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`globin genes.
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`16.
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`In 1999, we initiated in vivo studies in mice. During these studies, I
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`learned how to quickly measure globin protein expression levels using a gel-based
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`assay. This was the first time we had a sense that the use of the TNS9 vector was
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`resulting in therapeutic levels of human beta-globin protein expression, especially in
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`vivo. After the completion of the first in vivo study, we conducted a second follow-
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`up study to ascertain that our lentiviral vectors had truly integrated into
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`hematopoietic stem cells. To confirm this, we transplanted the bone marrow from
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`our initial mouse subjects into a second set of mice, and after allowing sufficient
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`time for the bone marrow to engraft, we measured the continued integration of our
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`lentiviral vector designs.
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`17. Based on preliminary results from our experiments, I submitted an
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`abstract on our work, which I understand bluebird bio, Inc. (hereafter, “Petitioner”)
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`has referred to as the May Abstract.
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`18. On July 6, 2000, a letter that I, along with several colleagues, had
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`submitted to Nature, published. This letter describes our work and initial findings to
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`date, and is referred to “the Nature Article.” The letter discloses the same work that
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`forms the basis of the disclosures made in the ‘179 and ‘061 Patents.
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`Inventorship
`19.
`I am an inventor of the subject matter disclosed and claimed in the ‘179
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`and ‘061 Patents. I am familiar with the specification and the claims of the ‘179 and
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`‘061 Patents.
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`20.
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`I understand thatPetitioner has challenged the validity of the claims of
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`the ‘179 and ‘061 Patents by asserting multiple references as either anticipating the
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`claims or rendering them obvious. First, I understand Petitioner has asserted May, et
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`al., “Lentiviral-Mediated Transfer of the Human β-Globin Gene and Large Locus
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`Control Region Elements Permit Sustained Production of Therapeutic Levels of β-
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`Globin in Long-Term Bone Marrow Chimeras,” Mol. Therapy, 1(5):S248-49 (2000)
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`(“the May Abstract”) against the ‘179 and ‘061 Patents. The May Abstract represents
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`the work of the inventors of the ‘179 and ‘061 Patents. In addition to the inventors
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`of the ‘179 and ‘061 Patents, the May Abstract lists John Callegari and Dr. Karen
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`Gaensler as authors. While these individuals are named as co-authors of the May
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`Abstract, they are so-named in recognition of non-inventive roles and contributions.
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`Specifically, Callegari was a lab technician and Dr. Gaensler provided some of the
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`mice used in the studies.
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`21. Second, I understand that Petitioner has asserted May et al.,
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`“Therapeutic Haemoglobin Synthesis
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`in β-Thalassaemic Mice Expressing
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`Lentivirus-Encoded Human β-globin,” Nature, 406:82-86 (2000) (“the Nature
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`Article”) against the ‘179 and ‘061 Patents. The Nature Article represents the work
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`of the inventors of the ‘179 and ‘061 Patents. In addition to the inventors of the ‘179
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`and ‘061 Patents, the Nature Article lists John Callegari, Dr. Glen Heller, Dr. Karen
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`M. L. Gaensler, and Dr. Lucio Luzzatto as authors. While these individuals are
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`named as co-authors of the Nature Article, they are so-named in recognition of non-
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`inventive roles and contributions to the paper. As described above, Callegari as a lab
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`technician and Dr. Gaensler provided mice. In addition, Dr. Heller was a
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`biostatistician and Dr. Luzzatto provided expert consultation.
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`22. None of these individuals (Heller, Callegari, Gaensler, and Luzzatto)
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`are inventors of the invention claimed in the ‘179 or ‘061 Patents.
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`23. Third, I understand Petitioner has asserted May, “Therapeutic
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`Hemoglobin Synthesis in Beta-Thalassemic Mic Expressing Lentivirus-Encoded
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`Human Beta-Globin,” Cornell University (2001) (“the May Thesis”). The May
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`Thesis was authored solely by me and represents the work of myself and the other
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`inventors of the ‘179 and ‘061 Patents, which was work conducted prior to June 1,
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`2000.
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`24. The May Abstract, the Nature Article, and the May Thesis all reference
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`the testing of the TNS9 vector. This is the same vector that our lab worked to create
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`throughout the 1990s and which was being tested in the late 1990s and early 2000s.
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`If we created a vector having different genetic material, e.g., different nucleotide
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`fragments, than the TNS9 vector, we would have used a different vector name. For
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`example, Dr. Sadelain had previously created a vector using just the HS-spanning
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`core fragments, which he coined the RNS1 vector.
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`25. To create the LCR fragments in the TNS9 vector, we initially used
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`restriction enzymes to cut the DNA. Several different companies sold restriction
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`enzymes, each having their own catalog enzymes. We bought restriction enzymes
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`from multiple companies for different projects. However, other approaches could be
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`used to create the LCR fragments. For example, the LCR fragments could have also
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`been constructed using polymerase chain reactions (or PCR).
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`26. We did not include any disclosure about whether the LCR fragments
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`were made through PCR or by cutting the DNA using restriction enzymes in either
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`the May Abstract or Nature Article. We also did not provide details about which
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`positions on the LCR the fragments spanned. Even though we did not provide these
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`details in the May abstract or the Nature Article, regarding the three restriction
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`enzyme fragments of the LCR (a BstXI and SnaBI HS2-spanning nucleotide
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`fragment, a BamHI and HindIII HS3-spanning nucleotide fragment, and a BamHI
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`and BanII HS4-spanning nucleotide fragment) which are claimed in the ’179 and
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`‘061 Patents, it is clear of course that we, as in the inventors, had knowledge and
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`possession of these fragments since we had created the TNS9 vector and were testing
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`it in vivo by 1999.
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`27. As discussed above, the May Abstract and Nature Article published in
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`2000. Well before this publication, we (the inventors) had unquestionably conceived
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`of the TNS9 vector design, which I understand is an embodiment of the vector
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`claimed in the ’179 and ‘061 Patents, as well as reduced it to practice. Both the
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`Nature Article and the May Abstract disclose our “TNS9” vector and provides
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`preliminary results from our testing. While neither the May Abstract nor the Nature
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`Article identifies the claimed restriction enzyme fragments of the LCR, the very fact
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`that these references show we possessed this vector demonstrates that I, along with
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`my co-inventors, clearly recognized and knew of these claimed fragments.
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`28.
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`I have also reviewed notes from our work on the TNS9 vector from the
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`1990s. I understand these notes are being filed as Exhibits 2033-2034.
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` I declare under penalty of perjury that the foregoing is true and correct.
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`Executed on January 23, 2023.
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`____________________________
`Dr. Chad May
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`Chad May, Ph.D.
`San Carlos, CA
`Phone: 917-929-6459
`Email: may.chad@gmail.com
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`PROFESSIONAL EXPERIENCE
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`Over twenty years of immuno-oncology research experience in the biotechnology and
`pharmaceutical industries, including bispecific T-cell engager and cell therapy platform
`development. Core expertise in preclinical research with novel therapeutic formats within
`oncology; from target validation and lead candidate selection, through to IND submission and
`initiation of Phase 1 clinical trials. Experience managing cross-functional teams on several
`biotherapeutic programs, and a successful track record of leading collaborative programs with
`academic and industry partners.
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`EDUCATION
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`Cornell University, Weill Graduate School of Medical Sciences (jointly with The Sloan Kettering
`Institute)
`New York, NY
`1/2001
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`Ph.D. Immunology
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`
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`University of Minnesota
`Minneapolis, MN
`6/1993
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`B.S. Genetics and Cell Biology
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`WORK HISTORY
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`Serotiny
`South San Francisco, CA
`5/2022 – Present
`Chief Scientific Officer
`• Member of the Executive Leadership Team
`• Oversee the advancement of a novel gene and cell therapy platform at
`an early-stage biotechnology company
`• Lead internal pipeline strategy
`• Work in tandem with the CEO and CTO on fundraising efforts and
`business development opportunities
`• Co-chair the Serotiny/Janssen Joint Steering Committee
`• Member of the Serotiny/Tessera Joint Steering Committee
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`APPENDIX A
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`Maverick Therapeutics/Takeda (acquired by Takeda in April 2021)
`Brisbane, CA
`Senior Vice President, Research and Development
`1/2019 – 4/2022
`1/2017 – 12/2018 Vice President, Research and Development
`• Oversaw R&D team advancing novel T cell engagers from preclinical
`characterization through to initiation of Phase 1 clinical trials
`• Member of the Executive Leadership Team reporting to the CEO
`• Reported quarterly to the Board of Directors
`• Co-chaired the Maverick/Takeda Joint Steering Committee
`• Coordinated and managed the Scientific Advisory Board
`• Member of the Clinical Strategy Team
`• Communicated with the research and investment communities
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`
`Pfizer
`Pearl River, NY
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`3/2016 – 1/2017
`1/2010 – 3/2016
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`
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`Oncology Research Unit, Targeted Immunotherapy
`Senior Director
`Director
`• Led a team of scientists in the development of novel tumor targeting T-
`cell engagers and antibody drug conjugates
`• Managed programs from target validation to Phase I clinical trials
`• Led Pfizer’s first bispecific program to a Phase 1 clinical trial
`• Advanced numerous preclinical oncology pipeline programs
`• Managed cross-functional teams that include colleagues in drug safety,
`translational, clinical, legal and manufacturing
`• Contributed to IND applications and other regulatory filings
`• Participated in the review and due diligence of in-licensing
`opportunities, including therapeutic targets and technologies
`• Initiated and managed several academic and industry collaborations
`
`Department of Cell Biology
`Senior Scientist
`Scientist
`Post-doctoral Fellow
`• Led a team of research scientists in the development of novel tumor
`targeting monoclonal antibodies and radioimmunoconjugates
`• Guided therapeutic programs from target validation to lead candidate
`selection
`• Initiated and managed several academic and industry collaborations
`• Participated in the review and due diligence of therapeutic target in-
`licensing opportunities
`
`
`ImClone Systems/Eli Lilly (acquired by Eli Lilly in October 2008)
`New York, NY
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`
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`3/2006 – 1/2010
`4/2003 – 3/2006
`9/2001 – 4/2003
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`Memorial Sloan-Kettering Cancer Center
`New York, NY
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`Department of Human Genetics
`Postdoctoral Fellow
`Graduate Student
`Laboratory of Dr. Michel Sadelain
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`1/2001 - 9/2001
`9/1995 - 1/2001
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`7/1993 - 8/1995
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`University of Minnesota
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`Minneapolis, MN
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`Institute of Human Genetics
`Senior Laboratory Technician
`Laboratory of Dr. R. Scott McIvor
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`PUBLICATIONS
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`1. Dettling DE, Kwok E, Quach L, Datt A, Degenhardt JD, Panchal A, Seto P, Krakow JL, Wall R,
`Hillier BJ, Zhu Y, Vinogradova M, DuBridge RB, May C (2022) Regression of EGFR positive
`established solid tumors in mice with the conditionally active T cell engager TAK-186. J
`Immunother Cancer, 10:e004336
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`2. Culp PA, Degenhardt JD, Dettling DE, and May C (2022), Chapter Nine - T-cell engaging
`bispecific antibody therapy, in Mansoor Amiji M & Milane L eds., Cancer Immunology and
`Immunotherapy, Academic Press 1:267-319
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`3. Panchal A, Seto P, Wall R, Hillier BJ, Zhu Y, Krakow J, Datt A, Pongo E, Bagheri A, Chen TT,
`Degenhardt JD, Culp PA, Dettling DE, Vinogradova MV, May C, DuBridge RB (2020) COBRA:
`A highly potent conditionally active T cell engager engineered for the treatment of solid
`tumors. mAbs 12:1
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`4. Gupta V, Root A, Fisher T, Norberg R, David J, Clark T, Cohen J, May C, Giddabasappa A
`(2020) Molecular imaging reveals biodistribution of P-cadherin LP-DART bispecific and
`trafficking of adoptively transferred T cells in mouse xenograft model. Oncotarget 11:
`1344–1357
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`5. Zhong W, Myers JS, Wang F, Wang K, Lucas J, Rosfjord E, Lucas J, Hooper A, Yang S, Lemon
`L, Guffroy M, May C, Bienkowska JR, Rejto PA. (2020) Comparison of the molecular and
`cellular phenotypes of common mouse syngeneic models with human tumors. BMC
`Genomics 21, 2
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`6. Fisher TS, Hooper AT, Lucas J, Clark TH, Rohner AK, Peano B, Elliott MW, Tsaparikos
`K, Wang H, Golas J, Gavriil M, Haddish-Berhane N, Tchistiakova L, Gerber HP, Root AR,
`May C. (2018) A CD3-bispecific molecule targeting P-cadherin demonstrates T cell-
`mediated regression of established solid tumors in mice. Cancer Immunol Immunother.
`67:247-259
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`7. Root A, Cao W, Li B, Lapan P, Meade C, Sanford J, Jin M, O'Sullivan C, Cummins E, Lambert
`M, Sheehan A, Ma W, Gatto S, Kerns K, Lam K, D'Antona A, Zhu L, Brady W, Benard B, King
`A, He T, Racie L, Arai M, Barrett D, Stochaj W, Lavallie E, Apgar JR, Svenson K, Mosyak L,
`Yang Y, Chichili GR, Liu L, Li H, Burke S, Johnson S, Alderson R, Finlay WJ, Lin L, Olland S,
`Somers W, Bonvini E, Gerber HP, May C, Moore PA, Tchistiakova L, Bloom L. (2016)
`Development of PF-06671008, a highly potent anti-P-cadherin/anti-CD3 bispecific DART
`molecule with extended half-life for the treatment of cancer. Antibodies 5:6
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`8. Gerber HP, Sapra P, Loganzo F, May C. (2016) Combining Antibody-Drug Conjugates and
`Immune-mediated Cancer Therapy: What to Expect? Biochemical Pharmacology 102:1-6
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`9. May C, Sapra P, Gerber HP. (2012) Advances in Bispecific Biotherapeutics for the
`Treatment of Cancer. Biochemical Pharmacology 84:1105-12.
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`10. Hooper A, Loganzo F, May C, Gerber HP (2012) Identification and development of vascular
`disrupting agents: Natural products that interfere with tumor growth. Natural Products
`and Cancer Therapy, edited by Frank Koehn, Springer Books, NY. pp17-39
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`11. Ruggiero A, Villa CH, Holland JP, Sprinkle SR, May C, Lewis JS, Scheinberg DA and McDevitt
`MR. (2010) Imaging and treating tumor vasculature with targeted radiolabeled carbon
`nanotubes. International Journal of Nanomedicine 5:783 – 802.
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`12. Penack O, Henke E, Suh D, King CG, Smith OM, Na I, Holland AM, Ghosh A, Lu SX, Jenq RR,
`Lu S, Jenq R, Lu C, Murphy GF, Lu T, May C, Scheinberg DA, Gao DC, Mittal V, Heller G,
`Benezra R, van den Brink MRM (2010) Inhibition of Neovascularization Simultaneously
`Ameliorates Graft-versus-host Disease and Decreases Tumor Growth. Journal of the
`National Cancer Institute 102:894-908.
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`13. Butler JM, Nolan DJ, Vertes EL, Varnum-Finney B, Kobayashi H, Hooper AT, Seandel M,
`Shido K, White IA, Kobayashi M, Witte L, May C, Shawber C, Kimura Y, Kitajewski J,
`Rosenwaks Z, Bernstein ID, Rafii S. (2010) Endothelial Cells Are Essential for the Self-
`Renewal and Repopulation of Notch-Dependent Hematopoietic Stem Cells. Cell Stem Cell.
`6:251-264.
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`14. Jaggi JS, Henke E, Seshan SV, Kappel BJ, Chattopadhyay D, May C, McDevitt MR, Benezra R
`and Scheinberg DA. (2006) Selective alpha-particle mediated depletion of tumor
`vasculature with vascular normalization. PLoS ONE 2:e267.
`
`15. Sadelain M, Lisowski L, Samakoglu S, Rivella S, May C, and Riviere I. (2005) Progress
`Toward the Genetic Treatment of the b-Thalassemias. Annals of the NY Academy of
`Sciences 1054:78-91.
`
`16. Vincent L, Kermani P, Young LM, Cheng J, Zhang F, Shido K, Lam G, Bompais-Vincent H, Zhu
`Z, Hicklin DJ, Bohlen P, Chaplin DJ, May C and Rafii S. (2005) Combretastatin A4 phosphate
`induces rapid regression of tumor neovessels and growth through interference with
`vascular endothelial-cadherin signaling. Journal of Clinical Investigation 115:2992-3006.
`
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`17. Belur L, James RI, May C, Diers MD, Swanson D, Gunther R, McIvor RS. (2005)
`Methotrexate preconditioning allows sufficient engraftment to confer drug resistance in
`mice transplanted with marrow expressing drug-resistant dihydrofolate reductase activity.
`Journal of Pharmacology and Experimental Therapeutics 314:668-674.
`18. Lamszus K, Brockmann MA, Eckerich C, Bohlen P, May C, Mangold U, Fillbrandt R,
`Westphal M. (2005) Inhibition of glioblastoma angiogenesis and invasion by combined
`treatments directed against VEGFR-2, EGFR and VE-cadherin. Clinical Cancer Research
`11:4934-4940.
`19. May C, Doody JF, Abdullah R, Balderes B, Xu S, Chen CC, Zhu Z, Shapiro L, Kussie P, Hicklin
`DJ, Liao F, Bohlen P. (2005) Identification of a transiently exposed VE-cadherin epitope that
`allows for specific targeting of an antibody to the tumor neovasculature. Blood 105:4337-
`4344.
`20. Rivella S, May C, Chadburn A, Riviere I, Heller G, Sadelain M. (2003) A novel murine model
`of Cooley’s anemia and its rescue by lentiviral mediated human b-globin gene transfer.
`Blood 2003 101:2932-2939.
`21. Koehne G, Doubrovin M, Doubrovina E, Zanzonico P, Gallardo HF, Ivanova A, Balatoni J,
`Teruya-Feldstein J, Heller G, May C, Ponomarev V, Ruan S, Finn R, Blasberg RG, Bornmann
`W, Riviere I, Sadelain M, O'Reilly RJ, Larson SM, Tjuvajev JG. (2003) Serial in vivo imaging of
`the targeted migration of human HSV-TK-transduced antigen-specific lymphocytes. Nature
`Biotechnology 21:405-413.
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`22. MacKenzie K, Franco S, Naiyer AJ, May C, Sadelain M, Rafii S, Moore MAS. (2002) Multiple
`stages of malignant transformation of human endothelial cells modeled by co-expression
`of telomerase reverse transcriptase, SV40 large T antigen and oncogenic N-ras. Oncogene
`21:4200-4211.
`23. May C, Rivella S, Chadburn A, Sadelain M. (2002) Successful treatment of b-thalassemia
`intermedia by transfer of the human b-globin gene. Blood 99:1902-1908.
`24. Boklan J, Nanjangud G, MacKenzie K, May C, Sadelain M, Chaganti RSK, Moore MAS.
`(2002) Limited proliferation and telomerase dysfunction following telomerase inhibition in
`immortal murine fibroblasts. Cancer Research 62:2104-114.
`25. May C, Sadelain M. (2001) A Promising Genetic Approach to the Treatment of b-
`Thalassemia. Trends in Cardiovascular Medicine 11:276-280.
`26. May C, Rivella S, Callegari JA, Heller G, Gaensler KML, Luzzatto L, Sadelain M. (2000)
`Therapeutic haemoglobin synthesis in b-thalassemic mice expressing lentivirus–encoded
`human b-globin. Nature 406:82-86.
`27. MacKenzie KL, Franco S, May C, Sadelain M, Moore MAS. (2000) Mass cultured human
`fibroblasts over-expressing hTERT encounter a growth crisis following an extended period
`of proliferation. Experimental Cell Research 259:336-350.
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`28. Rivella S, Callegari JA, May C, Tan C, Sadelain M. (2000) The cHS4 insulator increases the
`probability of retroviral expression at random chromosomal integration sites. Journal of
`Virology 74:4679-4687.
`29. Sadelain M, May C, Rivella S, Bender JG. (1999) Basic principles of gene transfer in
`hematopoietic stem cells. Progress in Experimental Tumor Research. JR Bertino, Editor. S
`Karger AG, Basel CH 36:1-19
`30. James RI, May C, Vagt MD, Wagner JE, McIvor RS. (1999) Methotrexate resistance
`conferred by transplantation of drug-resistant transgenic marrow cells fractionated by
`counterflow elutriation. Bone Marrow Transplantation 24:815-821.
`31. James RI, May C, Vagt MD, Studebaker R, McIvor RS. (1997) Transgenic mice expressing
`the Tyr22 variant of murine DHFR: Protection of transgenic marrow transplant recipients
`from lethal doses of methotrexate. Experimental Hematology 25:1286-1295.
`32. Orchard PJ, Katsanis E, Boyer M, May C, McIvor RS, Blazar BR. (1996) Interleukin-2
`secretion by transduced and unselected BDL-2 lymphoma results in increased survival in
`mice with previously established disseminated disease. Cancer Biotherapy and
`Radiopharmaceuticals 11:155-164.
`33. May C, James RI, Gunther R, McIvor RS. (1996) Methotrexate dose-escalation studies in
`transgenic mice and marrow transplant recipients expressing drug-resistant dihydrofolate
`reductase activity. Journal of Pharmacology and Experimental Therapeutics 278:1444-
`1451.
`34. Morris JA, May C, Kim HS, Ismail R, Wagner JE, Gunther R, McIvor RS. (1996) Comparative
`methotrexate resistance of transgenic mice expressing two distinct dihydrofolate
`reductase variants. Transgenics 2:53.
`35. May C, Gunther R, McIvor RS (1995). Protection of mice from lethal doses of methotrexate
`by transplantation with transgenic marrow expressing drug-resistant dihydrofolate
`reductase activity. Blood 86:2439-2448.
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`PATENTS
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`WO2022040128A2 Constrained Conditionally Activated Binding Proteins
`WO2019051102
`Constrained Conditionally Activated Binding Proteins
`WO2018073680
`Anti-EDB Antibodies and Antibody-Drug Conjugates
`WO2016001810
`Bispecific heterodimeric diabodies and uses thereof
`WO2003002155
`Vector encoding human globin gene and use thereof in treatment of
`hemoglobinopathies
`Method for selective engraftment of drug-resistant hematopoietic stem
`cells
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`US6485722
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`SKI Exhibit 2007
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`AFFILIATIONS
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`Member - American Association of Cancer Research (AACR)
`Member - The New York Academy of Sciences (NYAS)
`Member - Society for Immunotherapy of Cancer (SITC)
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`SKI Exhibit 2007
`Page 18 of 18
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