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Incyte Announces Positive Phase 3 REACH3 Study Data Published in NEJM for Ruxolitinib (Jakafi®) in Chronic Graft-Versus-Host Disease

On July 14, 2021 Incyte (Nasdaq:INCY) reported that positive data from the Phase 3 REACH3 study have been published in The New England Journal of Medicine (NEJM) demonstrating that treatment with ruxolitinib (Jakafi) resulted in significantly improved outcomes in patients with steroid-refractory or steroid-dependent chronic graft-versus-host disease (GVHD) compared to best available therapy (BAT)1 (Press release, Incyte, JUL 14, 2021, View Source [SID1234584854]). The study’s main findings, previously presented at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, were published along with new subgroup analyses showing favorable overall response rate (ORR) at Week 24 for ruxolitinib across all major subgroups, including baseline individual organ involvement1. REACH3 is jointly sponsored by Incyte and Novartis.

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"Results from the REACH3 study published in NEJM are extremely compelling and underscore the potential benefits ruxolitinib can offer appropriate patients facing the serious complications associated with chronic GVHD," said Peter Langmuir, M.D., Group Vice President, Oncology Targeted Therapies, Incyte. "At Incyte, we remain committed to advancing our research and understanding of this complex disease, and will continue to work closely with the FDA to bring this innovative treatment to chronic GVHD patients, who currently have limited treatment options."

The study found that treatment with ruxolitinib led to significant improvements in ORR at Week 24 (49.7% vs. 25.6%; odds ratio [OR], 2.99; P<0.001i), the primary endpoint of the study1. Also, best overall response (BOR) rate at any time up to Week 24 was achieved in 76.4% of patients in the ruxolitinib arm compared to 60.4% of patients in the BAT arm (OR, 2.17; 95% CI, 1.34-3.52)1. Ruxolitinib also demonstrated statistically significant and clinically meaningful improvements in key secondary endpoints1:

Patients on ruxolitinib achieved longer failure-free survival (FFS) than patients receiving BAT (median FFS not yet reached vs. 5.7 months; hazard ratio, 0.37; 95% CI, 0.27 to 0.51; P<0.0001).
Patients treated with ruxolitinib also had greater improvements in self-reported symptoms compared to BAT1 (modified Lee Symptom Scale [mLSS] responder rate: 24.2% vs. 11.0%; OR, 2.62; P=0.001)ii.
In addition, a new subgroup analysis included in the publication found that patients on ruxolitinib had better outcomes regardless of the individual organs affected at baseline1.

No new safety signals were observed in REACH3, and adverse events (AEs) attributable to treatment were consistent with the known safety profile of ruxolitinib1. The most common AEs of grade 3 or higher in the ruxolitinib vs. BAT arms were thrombocytopenia (15.2% vs. 10.1%), anemia (12.7% vs. 7.6%), neutropenia (8.5% vs. 3.8%) and pneumonia (8.5% vs. 9.5%). While 37.6% and 16.5% of patients required ruxolitinib and BAT dose modifications due to AEs, respectively, the percentage of patients who discontinued treatment due to AEs was 16.4% in the ruxolitinib arm vs. 7% in the BAT arm1. Mortality rates were similar across treatment arms (18.8% in the ruxolitinib arm vs. 16.5% in the BAT arm)1. Deaths reported as primarily due to chronic GVHD complications and/or its treatment were higher in the ruxolitinib vs. BAT arms (13.3% vs. 7.9%, respectively)1.

"Patients with chronic GVHD can experience severe and life-threatening symptoms in different organs around the body, which makes the disease more difficult to treat and increases the risk of poor outcomes," said Dr. Robert Zeiser, University Hospital Freiburg, Department of Haematology, Oncology and Stem Cell Transplantation, Freiburg, Germany. "With these new results from REACH3, we can see more clearly the potential benefits of ruxolitinib for patients with chronic GVHD who have not adequately responded to first-line steroids."

The REACH3 data serve as the basis for the Company’s supplemental New Drug Application (sNDA) for ruxolitinib for the treatment of steroid-refractory chronic GVHD in adult and pediatric patients 12 years and older, which was accepted for review by the U.S. Food and Drug Administration (FDA) and has a Prescription Drug User Fee Act (PDUFA) target action date of September 22, 2021.

GVHD is a condition that can occur after an allogeneic stem cell transplant (the transfer of stem cells from a donor) where the donated cells initiate an immune response and attack the transplant recipient’s organs, leading to significant morbidity and mortality. There are two major forms of GVHD: acute, which generally occurs within 100 days of transplant, and chronic, which generally occurs more than 100 days after transplant2. GVHD can affect multiple organ systems including the skin, gastrointestinal (digestive) tract and liver.

In 2019, Jakafi (ruxolitinib) was approved by the FDA for the treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older, based on the positive results of the Phase 2 REACH1 trial4. Jakafi is marketed by Incyte in the U.S.; ruxolitinib (Jakavi) is licensed to Novartis ex-U.S. Outside of the U.S., Novartis regulatory submissions for acute and chronic GVHD are underway.

The NEJM publication of the REACH3 results is available online.

About REACH3

REACH3 (NCT03112603), a randomized, open-label, multicenter Phase 3 study sponsored by Novartis and conducted in collaboration with and co-funded by Incyte, is evaluating the safety and efficacy of ruxolitinib compared with best available therapy in patients with steroid-refractory chronic GVHD.

The primary endpoint is overall response rate (ORR) at Day 1 of the Cycle 7 (Day 168) visit, defined as the percentage of participants demonstrating a complete or partial response. Secondary endpoints include change in the modified Lee chronic GVHD symptom scale score at Day 1 of Cycle 7, rate of failure-free survival (FFS) up to 36 months, best overall response (BOR), duration of response (DoR), overall survival (OS), among others. For more information about the study, please visit View Source

About REACH

The REACH clinical trial program evaluating ruxolitinib in patients with steroid-refractory GVHD includes the randomized pivotal Phase 3 REACH2 and REACH3 trials, conducted in collaboration with Novartis. Positive data from the Phase 3 REACH2 study evaluating the safety and efficacy of ruxolitinib compared with best available therapy in patients with steroid-refractory acute GVHD were previously published in The New England Journal of Medicine.

The REACH program was initiated with the Incyte-sponsored REACH1 trial, a prospective, open-label, single-cohort, multicenter, pivotal Phase 2 trial (NCT02953678) evaluating ruxolitinib in combination with corticosteroids in patients with steroid-refractory grade II-IV acute GVHD. For more information about the study, including trial results, please visit View Source

About Jakafi (ruxolitinib)

Jakafi is a first-in-class JAK1/JAK2 inhibitor approved by the U.S. FDA for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea, in adults with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF and for treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older.

Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi (ruxolitinib) outside the United States. Jakafi is a registered trademark of Incyte Corporation. Jakavi is a registered trademark of Novartis AG in countries outside the United States.

Important Safety Information
Jakafi can cause serious side effects, including:

Low blood counts: Jakafi (ruxolitinib) may cause your platelet, red blood cell, or white blood cell counts to be lowered. If you develop bleeding, stop taking Jakafi and call your healthcare provider. Your healthcare provider will perform blood tests to check your blood counts before you start Jakafi and regularly during your treatment. Your healthcare provider may change your dose of Jakafi or stop your treatment based on the results of your blood tests. Tell your healthcare provider right away if you develop or have worsening symptoms such as unusual bleeding, bruising, tiredness, shortness of breath, or a fever.

Infection: You may be at risk for developing a serious infection during treatment with Jakafi. Tell your healthcare provider if you develop any of the following symptoms of infection: chills, nausea, vomiting, aches, weakness, fever, painful skin rash or blisters.

Skin cancers: Some people who take Jakafi have developed certain types of non-melanoma skin cancers. Tell your healthcare provider if you develop any new or changing skin lesions.

Increases in cholesterol: You may have changes in your blood cholesterol levels. Your healthcare provider will do blood tests to check your cholesterol levels during your treatment with Jakafi.

The most common side effects of Jakafi include: for certain types of MF and PV – low platelet or low red blood cell counts, bruising, dizziness, headache, and diarrhea; and for acute GVHD – low platelet, red or white blood cell counts, infections, and fluid retention.

These are not all the possible side effects of Jakafi. Ask your pharmacist or healthcare provider for more information. Tell your healthcare provider about any side effect that bothers you or that does not go away.

Before taking Jakafi, tell your healthcare provider about: all the medications, vitamins, and herbal supplements you are taking and all your medical conditions, including if you have an infection, have or had tuberculosis (TB), or have been in close contact with someone who has TB, have or had hepatitis B, have or had liver or kidney problems, are on dialysis, have a high level of fat in your blood (high blood cholesterol or triglycerides), had skin cancer or have any other medical condition. Take Jakafi exactly as your healthcare provider tells you. Do not change or stop taking Jakafi without first talking to your healthcare provider.

Women should not take Jakafi while pregnant or planning to become pregnant. Do not breast-feed during treatment with Jakafi and for 2 weeks after the final dose.

Full Prescribing Information, which includes a more complete discussion of the risks associated with Jakafi, is available at www.jakafi.com.

Arrowhead Pharmaceuticals to Webcast Fiscal 2021 Third Quarter Results

On July 14, 2021 Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) reported that it will host a webcast and conference call on August 5, 2021, at 4:30 p.m. ET to discuss its financial results for the fiscal third quarter ended June 30, 2021 (Press release, Arrowhead Pharmaceuticals, JUL 14, 2021, View Source [SID1234584853]).

Conference Call and Webcast Details

Investors may access a live audio webcast on the Company’s website at View Source For analysts that wish to participate in the conference call, please dial 855-215-6159 or 315-625-6887 and provide Conference ID 7398304.

A replay of the webcast will be available on the Company’s website approximately two hours after the conclusion of the call and will remain available for 90 days. An audio replay will also be available approximately two hours after the conclusion of the call and will be available for 3 days. To access the audio replay, dial 855-859-2056 or 404-537-3406 and provide Conference ID 7398304.

Celldex Therapeutics Announces Pricing of Upsized $250 Million Public Offering of Common Stock

On July 14, 2021 Celldex Therapeutics, Inc. ("Celldex" or the "Company") (Nasdaq: CLDX) reported the pricing of an underwritten public offering of 5,952,381 shares of its common stock at a public offering price of $42.00 per share (Press release, Celldex Therapeutics, JUL 14, 2021, View Source [SID1234584852]). In connection with the offering, Celldex has granted the underwriters a 30-day option to purchase up to an additional 892,857 shares of common stock at the public offering price, less underwriting discounts and commissions.

Jefferies, SVB Leerink, Guggenheim Securities and Cantor are acting as the joint book-running managers for the offering. LifeSci Capital LLC and H.C. Wainwright & Co. are acting as co-lead managers for the offering.

The Company expects to receive gross proceeds from the offering, excluding the exercise of the underwriters’ option, if any, of approximately $250 million, excluding underwriting discounts and commissions and other offering-related expenses.

Celldex intends to use the net proceeds from the offering to continue clinical and preclinical development of its product candidates, including current and future development of CDX-0159, growing its bispecific antibody platform and clinical candidates, funding ongoing efforts to develop additional clinical pipeline products and for general corporate purposes.

The offering is expected to close on July 16, 2021, subject to customary closing conditions.

The securities described above are being offered pursuant to a prospectus supplement and an accompanying base prospectus forming part of a shelf registration statement on Form S-3 (File No. 333-249917), which was previously filed with the Securities and Exchange Commission ("SEC") and deemed effective on November 6, 2020. A final prospectus supplement relating to the offering will be filed with the SEC and will be available on the SEC’s website located at View Source When available, copies of the final prospectus supplement and the accompanying base prospectus may be obtained for free by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388 or by e-mail at [email protected]; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6105, or by e-mail at [email protected]; or Guggenheim Securities, LLC Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017 or by telephone at (212) 518-9544, or by email at [email protected]; or Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Avenue, 4th Floor, New York, New York 10022 or by email at [email protected].

The offering will be made only by means of a prospectus. This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

City of Hope and Osel Announce Exclusive License for Intellectual Property on the Use of Live Biotherapeutic Product CBM588 for Oncology Therapeutic Applications

On July 14, 2021 City of Hope, a world-renowned independent research and treatment center for cancer, diabetes and other life-threatening diseases, and Osel, Inc., a company developing live biotherapeutic products (LBPs) for diseases linked to the disruption of the human microbiome, reported that City of Hope has granted an exclusive worldwide license to Osel for intellectual property on the novel use of a LBP CBM588 to enhance efficacy of checkpoint inhibitors to treat cancer, including metastatic renal cell carcinoma (Press release, City of Hope, JUL 14, 2021, View Source [SID1234584851]). The experimental treatment was evaluated in a City of Hope investigator-initiated Phase 1b trial.

Data from the study demonstrated that an LBP – Clostridium butyricum MIYAIRI 588 strain (CBM588) – plus nivolumab/ipilimumab improved overall response rate (ORR) and progression-free survival (PFS) compared to nivolumab/ipilimumab alone in patients with metastatic renal cell carcinoma (RCC).

Data from the Phase 1b study were presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting by City of Hope’s Luis Meza, a postdoctoral fellow, and Sumanta K. Pal, M.D., clinical professor, Department of Medical Oncology & Therapeutics Research. Abstract no. 4513 titled "First results of a randomized phase IB study comparing nivolumab/ipilimumab with or without CBM588 in patients with metastatic renal cell carcinoma" is available here.

"The results from this trial demonstrate that CBM588 has the potential to enhance immune checkpoint inhibitor efficacy and suggests that disruption of the human microbiome (dysbiosis) plays an integral role in cancer treatment response," said Thomas Parks, Ph.D., head of development at Osel. "We look forward to working with City of Hope to further investigate how CBM588 can improve the lives of cancer patients."

CBM588 is a spore forming anaerobe that produces short chain fatty acids, mainly butyric acid, which is a well-known energy source of intestinal epithelium. The bacterial strain exerts several beneficial effects through multiple modes of action, including inhibition of pathogenic microorganisms, immunomodulatory activities and restorative effects on intestinal dysbiosis. City of Hope is expected to initiate a study of CBM588 plus recently-approved nivolumab/cabozantinib combination therapy in advanced RCC in July, and expansion to the treatment of other tumor types is planned. In addition, CBM588 is being evaluated in a clinical trial for the prevention of graft-vs-host disease (GVHD) in recipients of allogeneic hematopoietic stem cell transplantation.

"To my knowledge, this is the first data in a randomized study demonstrating clinical benefit with the addition of a live bacterial product to immunotherapy," Pal said. "The signal here, with a dramatic improvement in progression-free survival and response rate, is very compelling and warrants rapid evaluation in a larger study."

CBM588 is manufactured under GMP and marketed in Japan by Miyarisan Pharmaceutical as a prescription product known as Clostridium butyricum MIYAIRI 588 strain for the treatment of gastrointestinal (GI) indications. It has an excellent safety profile in all age groups and immunocompromised patients, as confirmed by post-marketing surveillance.

Leading Gene Writing Company Tessera Therapeutics Announces Pivotal Expansion of Leadership Team

On July 14, 2021 Tessera Therapeutics, a biotechnology company pioneering a new approach in genetic medicine known as Gene Writing, reported the appointment of Howard Liang, Ph.D., as President and Chief Financial Officer (Press release, Tessera Therapeutics, JUL 14, 2021, View Source [SID1234584849]). The company also expanded its executive bench with newly promoted talent and hires: Madhusudan Peshwa, Ph.D., as Chief Technology Officer for Cell Therapy; Bill Querbes, Ph.D., as Senior Vice President, Therapeutic Discovery & Translational Sciences; Cecilia Cotta-Ramusino, Ph.D. as Senior Vice President, Platform Development; Vikram Ranade, Ph.D., as Senior Vice President, Corporate Development; David Pollard, Ph.D., as Head of Bioprocess, and Steve Garbacz as Head of Finance.

These additions represent the latest leadership expansion for the company, following the appointments of Elliott Sigal, M.D., Ph.D., and Mary Rozenman, Ph.D., to the Board of Directors in June, and the appointments of David Davidson, M.D., as Chief Medical and Development Officer, Hari Pujar, Ph.D., as Chief Operating Officer, and Lin Guey, Ph.D., as Senior Vice President of Rare Diseases Program Strategy and Operations in March. Tessera also announced the successful completion of $230 million Series B financing in January.

"Outstanding people are the lifeblood of great companies and I’m thrilled to welcome these accomplished individuals to the Tessera leadership team," said Dr. Geoffrey von Maltzahn, CEO and Co-Founder of Tessera and General Partner, Flagship Pioneering. "Howard’s track record in both strategy and finance at BeiGene and in the capital markets will play a key role in guiding Tessera to new territory in Gene Writing. I am excited to be working with him, and our other new senior leaders, each of whom will be instrumental in expanding the limits of how we discover life-changing medicines."

Howard Liang, Ph.D., President and Chief Financial Officer
Howard Liang joined Tessera in 2021 as President and Chief Financial Officer. Dr. Liang brings nearly three decades of combined experience in management, financing, strategy, and research in the biotechnology and pharmaceutical industries and investment research on Wall Street. Prior to joining Tessera, he was Chief Financial Officer and Chief Strategy Officer at BeiGene for six years, where he was a member of the senior team that led the company’s growth from a research organization with fewer than 200 employees to a fully integrated global biotechnology company with more than 6,000 employees on five continents. At BeiGene, he led the company’s IPOs on NASDAQ and the Hong Kong Stock Exchange and its ongoing effort to list on the Shanghai Stock Exchange, raising more than $8 billion to date through equity and alternative financings, and overseeing the growth of the company’s market capitalization from less than $300 million to more than $30 billion during his tenure. Prior to BeiGene, Dr. Liang spent 10 years at Leerink Partners, where he was Managing Director and Head of Biotechnology Equity Research. His prior investment research experience included positions at A.G. Edwards, JMP Securities, and Prudential Securities, covering biotechnology, and major and specialty pharmaceutical sectors. He started his career in R&D at Abbott Laboratories, where he was a Senior Scientist and member of an industry-leading structure-based drug discovery team. Dr. Liang is a member of the Hong Kong Stock Exchange Biotech Advisory Panel. He was named a member of the All-America Research Team by Institutional Investor magazine and "Best of the Street" by The Wall Street Journal. As a scientist, he authored 14 papers, including 6 in Nature, Science, and Proceedings of the National Academy of Sciences, and a review in the Journal of Molecular Biology. He received his Ph.D. in Biochemistry and Molecular Biology and M.B.A. from the University of Chicago and his B.S. in Chemistry from Peking University.

"Tessera is developing a first-of-its-kind technology with the potential to cure diseases across multiple categories by writing in the code of life itself," said Dr. Howard Liang. "I look forward to helping the company realize the full breadth of Gene Writing’s potential."

Madhusudan Peshwa, Ph.D., Chief Technology Officer for Cell Therapy
Dr. Peshwa joined Tessera in May 2021 and is responsible for developing the strategy and executing the operating plan encompassing the design, development, and manufacture of Tessera’s proprietary mobile gene element engineered cell therapy product portfolio. Recently, in March 2020, Dr. Peshwa was inducted into the College of Fellows at the American Institute for Medical and Biological Engineering (AIMBE), in recognition of Lifetime contributions in Regenerative Medicine to the advancements in the field of cell & gene therapies.

Prior to joining Tessera, Dr. Peshwa was CTO at Mana Therapeutics, an immunotherapy company focused on the development of allogeneic, multi-tumor-antigen-targeted, non-engineered, T-cell immunotherapies with additional oversight of Quality Assurance and Quality Control functions. Previously, Dr. Peshwa was CTO and Global Head of R&D for the Cell and Gene Therapies business at GE Healthcare (GEHC), with responsibilities that include GEHC’s CGT product and service portfolio to enable and accelerate the development of robust, scalable, industrialized manufacturing and delivery of cell and gene therapies. Prior to these roles, Dr. Peshwa held various executive positions at MaxCyte, Inc., NewNeural LLC, and Dendreon Corporation. At MaxCyte, as CSO and EVP, Cellular Therapies, Dr. Peshwa was responsible for leading the development and commercialization of ex vivo cell loading platform technology. Additionally, he also established MaxCyte’s proprietary therapeutic product portfolio with lead program being a non-viral mRNA engineered CAR Immunotherapy (CARMA) with one-day manufacturing process under company sponsored IND for treatment of solid cancers; and additional collaborative programs under CRADA Agreement with Investigators at NIAID and NHLBI, for ex vivo gene correction in autologous hematopoietic stem cells, as cell therapy for potential treatment of monogenic diseases. As Vice President of Process Sciences and Manufacturing, at Dendreon Corporation, Dr. Peshwa was responsible for leading the CMC and GMP manufacturing for Provenge (Sipuleucel-T), an autologous cellular immunotherapy product for treatment of prostate cancer, the first ever active cellular immunotherapy product approved by the US FDA.

In addition to his broad industry experience, Dr. Peshwa has served as Principal Investigator / Co-Investigator on multiple grant-funded research studies, is an inventor of six issued US patents in the field of cell therapy, and has served in various consultative, advisory, and board capacities to industry, government, not-for-profit, and financial organizations. Dr. Peshwa earned his Ph.D. in Chemical Engineering from the University of Minnesota and his B.Tech. in Chemical Engineering from the Indian Institute of Technology in Kanpur, India.

"Tessera’s Gene Writing platform represents an opportunity to drive a fundamental change in our ability to treat disease," said Dr. Madhusudan Peshwa. "I look forward to joining the executive team to help move Tessera’s bold mission forward."

Bill Querbes, Ph.D., Senior Vice President, Therapeutic Discovery & Translational Sciences
Bill Querbes joined Tessera in April of 2021 as Senior Vice President of Therapeutic Discovery and Translational Sciences. He brings a strong background in genetic medicine and a passion for rare disease drug development with over 15 years of experience leading cross-functional teams from early discovery through clinical trials.

Before joining Tessera, Dr. Querbes held the position of Vice President and Fabry Program Lead at AVROBIO. Prior to this role, as Senior Director at Synlogic, he led clinical program teams in PKU and urea cycle disorders. Earlier in his career he spent 12 years at Alnylam Pharmaceuticals where he made important contributions to the maturation of both the siRNA delivery platforms and therapeutic pipeline. Dr. Querbes led the discovery and early clinical development of GIVLAARI (givosiran) for the treatment of acute hepatic porphyria, which was the first FDA approved RNAi therapeutic utilizing GalNAc conjugate technology.

He holds a B.S. in Biology from SUNY Geneseo and a Ph.D. from Brown University.

Cecilia Cotta-Ramusino, Ph.D., Senior Vice President, Platform Development
Cecilia Cotta-Ramusino joined Tessera in 2019 as the Head of Platform Development. She drives the discovery and optimization of novel Gene Writers, enabling their translation into gene therapy tools. Dr. Cotta-Ramusino has spent more than 20 years in academia and biotech, working in the areas of gene editing, cell engineering, and DNA damage. Dr. Cotta-Ramusino was the first employee at insitro where she was the Head of Functional Genomics. Prior to insitro, she was one of the first scientists hired at Editas, the first CRISPR-based therapeutic company, where she helped to define and shape the vision of the Editas platform. She spearheaded numerous academic collaborations devoted to platform optimization and led the development of a T cell gene therapy treatment aiming to treat an immunodeficiency disease. She conducted her postdoc in Steve Elledge’s lab at Harvard Medical School where she performed whole genome high-throughput screens in mammalian cells using siRNA/shRNA to identify novel components of the DNA damage response. Dr. Cotta-Ramusino obtained her Ph.D. in genetics at University of Milan, Italy and has been principal author and co-author on several publications in high impact factor journals, such as Science, Nature, Nature Communications and Molecular Cell. She has invented several foundational patents in all of the early-stage companies in which she has worked.

Vikram Ranade, Ph.D., Senior Vice President, Corporate Development
Dr. Ranade joined Tessera in 2020 as the Head of Corporate Development. In this role, he drives corporate strategy, business development, and investor relations for Tessera.

Dr. Ranade was previously at McKinsey & Company, where he was an Associate Partner in the healthcare practice. At McKinsey, he worked with large biopharma and early-stage biotech companies on strategy, M&A, and R&D topics. He led diligence efforts for more than $15B in completed deals and advised on clinical strategy for more than 20 programs. Dr, Ranade also co-led McKinsey’s Center for Asset Optimization, which focuses on clinical-stage asset development strategy. He holds a Ph.D. in Genetics and Development from Columbia University, where he studied transcriptional regulation of developmentally important genes at the molecular level. He has a B.S. in biochemistry from Brandeis University, where he was awarded highest honors for his research on DNA damage repair pathways.

David Pollard, Ph.D., Head of Bioprocess
David Pollard has over 25 years of bioprocess development for a range therapeutics including novel mAbs, peptides, anti infectives, biocatalysts and more recently cell and gene therapies. During his career at Merck & Co. Inc, Dr. Pollard led early and late stage CMC teams, providing contributions to multiple IND’s & BLA’s for Biologics & Vaccines. Dr. Pollard also led an innovation team that co-developed the state-of-the-art ambr250 high throughput bioreactor system and also pioneered ‘lights out’ automated continuous mAb production. More recently Dr. Pollard pursued processing for personalized neoantigen T cell therapies and helped create corporate research for the technology provider Sartorius. Dr. Pollard will help Tessera drive digital workflows and high throughput automation to accelerate sustainable gene therapy process development.

Steve Garbacz, Head of Finance
Steve Garbacz joined Tessera in 2021 as the Head of Finance and is responsible for financial reporting, planning, taxes, and treasury. Garbacz has more than 25 years of experience in financial management for a range of companies, including Biogen, Epizyme, Spero, and Anika. He has a passion for building scalable financial organizations leveraging new technology, and drove successful IPOs at Epizyme and Spero. At Anika, Garbacz was a key leader in acquiring and integrating two private companies. Garbacz has a B.S. in Economics from George Mason University and an MBA in Finance from the Leonard Stern School of Business at New York University.