Yes, it’s Merck Merck Merck on this board, but a case could be made for a number of other suitors. How about Bristol Myers? They’ve been out of the picture the past couple of years while they digested Celgene and advanced their pipeline, but they also have a checkpoint inhibitor (Opdivo) that could benefit from a combination with DCVax, and already have cell therapy products, with vast resources for them (including multiple cell therapy manufacturing facilities and a supply chain network). They know that immunotherapy and cell/gene therapy is the future, and have for a long time. And because they have experience with, and are more focused on cell therapies, (and patients) I think they’re probably a better partner for Northwest Bio . . . if it is a partnership. Just spend a few minutes poking around their website:
Our Mission Advancing cell therapy research for the benefit of patients across the globe. At the heart of Bristol Myers Squibb’s commitment to cell therapy is our continuous investment in advancing research for potentially life-changing cell therapies. We are studying cell therapy in patients with various cancers, striving to provide additional treatments to more patients. This commitment is deepened by our consideration of the patient journey as a whole. In collaboration with leading experts across the globe, we strive to fulfill the promise of cell therapy. Our vision of the future is clear: more life for more patients through the potential of cell therapy. (emphasis is not mine)
Today’s cell therapy insights shaping tomorrow JULY 20, 2022
While cancer remains one of the greatest global health challenges, there have been unprecedented breakthroughs and innovations in cancer research in recent years, and more people are living longer with cancer than ever before.
One innovation changing the way certain cancers can be treated and offering hope to patients and physicians around the world is cell therapy, a type of cancer immunotherapy where a patient’s own T cells are genetically engineered to recognize and bind to proteins found on the surface of certain cancer cells. Binding then leads to activation and expansion of the CAR T cells, resulting in the killing of cancer cells.
Over 25 years of industry-wide cell therapy research has resulted in once-inconceivable treatment options for patients with serious blood cancers who previously had few choices. Ten years after the first generation of autologous CAR T cell therapies, the fruits of that research are being seen, as patient stories renew hope.
However, the industry has only scratched the surface of cell therapy’s potential impact for patients with cancer. Globally, cancer ranks as a leading cause of death and an important barrier to increasing life expectancy — in 2020, there were an estimated 19.3 million new cases of cancer. The challenge of filling this unmet need is motivating and a reminder of what there still is to accomplish.
One thing is clear: riding this wave of excitement in the field will help unlock its potential for more patients.
As in the early days of any scientific field, scientists and other stakeholders in cell therapy still face an uphill climb. Cell therapy is a personalized medicine, and the process to get each treatment to patients is complex and intricate. Scaling operations remains a galvanizing challenge and a major focus of players across the industry.
Translating cell therapy science to treat solid tumors has also presented challenges, and researchers are actively exploring new approaches and targets that will extend the promise of cell therapy beyond blood cancers. There is potential for a long-term sustainable therapy in these diseases with the use of an auto-antigen as the external chimeric binder on the CAR T cell.
We are actively investigating how to bring cell therapy into the solid tumor space through our deep understanding of tumor biology, the immune system and by looking at a number of targets and approaches to optimize tumor trafficking and overcome the suppressive tumor microenvironment. Kristen Hege, MD, senior vice president, Hematology, Oncology and Cell Therapy Early Clinical Development, Bristol Myers Squibb
Bristol Myers Squibb is working to see around the bend and collaborate with industry peers and stakeholders to anticipate and tackle these hurdles.
Certain strategies can help make the cell therapy treatment experience easier for patients. Depending on a person’s health, some cell therapies can be administered in the outpatient setting, allowing the individual to recover at home while being closely monitored by his or her care team post-infusion. In addition, technology such as the TempTraq® wearable temperature-monitoring device offered to Bristol Myers Squibb CAR T patients can assist patients and caregivers with temperature monitoring outside the hospital setting during the post-infusion monitoring period.
It’s important to remember that innovation occurs not only in the lab, but in how we support the patients receiving our medicines. Lynelle Hoch, senior vice president, Global Cell Therapy Franchise Lead, Bristol Myers Squibb
While the industry looks ahead to next-generation cell therapies, it's imperative to continue working to optimize the current therapies available to patients. Beyond clinical trials, Bristol Myers Squibb development teams work closely with manufacturing teams to use technology and automation to continually improve the process, assessing which new approaches can be translated from the lab to the manufacturing floor.
What these insights mean to Bristol Myers Squibb Transforming patients’ lives through science remains the company’s focus. Playing a leadership role in the ongoing advancement of this field is one of the ways the company strives to help those living with cancer. The best is yet to come in cell therapy and Bristol Myers Squibb is committed to continue to learn, grow and invest in its progress.
Looking to the Future of Cell Therapy Advancing cell therapy research across a wide spectrum of blood cancers and solid tumors NOVEMBER 11, 2020
Piecing Together the Cell Therapy Puzzle Cell therapy has the potential to revolutionize the way scientists approach blood cancer treatment and is a core pillar of Bristol Myers Squibb’s cancer research efforts. Bristol Myers Squibb is the only company with two approved chimeric antigen receptor (CAR T) cell therapies in hematologic malignancies with two distinct targets addressing separate blood cancers. The company draws upon its transformative work and unparalleled experience in hematology and immuno-oncology as it advances a robust pipeline of cell therapies.
Recognizing that the industry is just beginning to understand how to potentially optimize the clinical benefits of cell therapy and with a great deal still to learn, Bristol Myers Squibb is taking a deliberately broad approach with its research and development. This allows us to identify and move quickly on the approaches that science shows may provide the greatest benefit.
“Our cell therapy program represents just one of many areas of cancer research at Bristol Myers Squibb – and in cell therapy alone, we’re relentlessly pursuing multiple early approaches in collaboration with several leading research partners,” said Kristen Hege, senior vice president, Early Clinical Development, Oncology/Hematology and Cell Therapy. “We think there is significant future opportunity, which is why we’re leaving no stone unturned.”
Rapidly Pursuing Cell Therapy Scientific Innovation for Patients Bristol Myers Squibb’s cell therapy research team is uniquely equipped to gain insight into next-generation strategies in cell therapy. With ~1,800 patients treated across six indications and 11 manufacturing process variations, Bristol Myers Squibb scientists have access to one of the largest CAR T product portfolios in the industry, including translational and clinical datasets.
“Cell therapy as a field can move quickly from first-in-human to registration studies, so it’s particularly crucial to be able to analyze data quickly and leverage impactful insights,” said Teri Foy, senior vice president, Research and Early Development Immuno-Oncology (I-O) and Cell Therapy. “Through machine learning and other sophisticated approaches, we’re using data to deliver critical insights that inform and optimize patient selection and process improvements, as well as engineering and combination approaches to address resistance mechanisms – and these insights are all the more valuable given that our datasets are derived from diverse patient populations and manufacturing processes.”
Scientists are also applying learnings from I-O resistance in solid tumors and overcoming hostile tumor microenvironments to better guide next-generation strategies in cell therapy.
With multiple cell-based therapeutic approaches under investigation in blood cancers and solid tumors, Bristol Myers Squibb’s researchers are focused on harnessing the immune system to reimagine the future of cell therapy and ultimately bring potentially life-changing cell therapies to more patients as quickly as possible.
Company celebrates cell therapy manufacturing facility progress in U.S. and Europe NOVEMBER 09, 2021
One project opens its doors, and another begins as Bristol Myers Squibb continues to expand its cell therapy manufacturing footprint and capabilities in the U.S. and Europe.
The company held a groundbreaking event at the Leiden, Netherlands, Bio Science Park on Oct. 28 to celebrate the start of construction of its first cell therapy facility in Europe. A week later on Nov. 3, a ribbon cutting ceremony marked the opening of a new cell therapy facility at the company’s Devens, MA, campus for its employees. “As our cell therapy franchise continues to grow, we are making continued investments to expand global manufacturing capacity to support the promise of cell therapy and bring treatments to patients faster,” said Lou Schmukler, president, Global Product Development & Supply, Bristol Myers Squibb. “It’s tremendously exciting to see these plans come to life as we celebrate significant back-to-back milestones.”
Manufacturing cell therapies is both operationally and technically complex because they are manufactured uniquely for each individual patient, using a patient’s own T cells as the starting material. Each batch of engineered T cells is developed and infused back to the original cancer patient, and it is critical for companies to develop reliable quality supply and rapid turnaround time. That makes the expansion of the company’s global manufacturing footprint critical to supplying these products to patients around the world. The sites at Devens and Leiden will join the company’s existing cell therapy manufacturing network of Bothell, WA, and Summit and Warren, NJ, in addition to major contract manufacturing partnerships globally.
Devens, Massachusetts
The 244,000 square-foot Devens facility integrates the latest cell therapy manufacturing equipment and most recent and impactful digital technology, including Automated Media Production, which reduces the time to prepare complex media formulations.
The facility will add an additional several hundred jobs to the Devens campus, with nearly 150 new employees already on board at the facility. This latest milestone opens the doors to local employees as they prepare the facility to begin manufacturing next year.
The cell therapy manufacturing facility represents the second significant expansion of the 89-acre Devens site. The site began operations in 2009 and focused on large-scale, bulk biologics manufacturing in its early years. A 200,000 square-foot expansion completed in 2016 added biologics process development and clinical manufacturing capabilities.
“The new facility at the existing Devens site is a critical component of expanding our cell therapy manufacturing footprint and capabilities,” said Devens Cell Therapy Facility Program Lead Mike Hausladen. “This will allow us to prepare for the approval and launch of new cell therapies to help more patients across the globe,” The Devens site is part of Bristol Myers Squibb’s growing presence in Massachusetts, which is home to a robust life sciences ecosystem. The company also operates two R&D facilities in Cambridge, MA, and will be bringing those two sites together into a new building at Cambridge Crossing in 2023.
Leiden, Netherlands
The 200,000 square-foot facility in Leiden will have the latest technology and production equipment, with capabilities for multi-product cell therapy manufacturing. Located in Leiden Bio Science Park, it will also leverage a growing life sciences region and is accessible to major transportation nodes. The location is conveniently located near Schiphol airport and to the cities of Amsterdam and Rotterdam.
Bristol Myers Squibb expects the facility at Leiden to be completed and operational at the end of 2024 and to attract talent from across Europe to fill several hundred new positions.
“The new production center is our first in Europe, which will enable us to bring the manufacturing of this innovative cell therapy closer to European patients,” said Senior Director and Program Head at BMS Leiden Arjen Schippers. “This may help to reduce the turnaround time, saving valuable time for patients in Europe with certain aggressive blood cancers.”
Cell therapy’s got talent – and is looking for more MARCH 05, 2021
As Vice President, Cell Therapy Pipeline & Product Lifecycle Strategy, Gargi Maheshwari leads teams responsible for advancing drug candidates from research to clinical studies to commercial supply. She joined Bristol Myers Squibb in 2020, leaving a senior executive role in bioprocess development at another company for the chance to “work with the best minds in cell therapy,” she said.
“I had been following the cell therapy field for the last several years. The cell therapy talent at Bristol Myers Squibb is well known in the industry as the best out there,” she said.
Maheshwari is one of more than 900 colleagues who joined the company’s Cell Therapy Development Operations (CTDO) organization in 2020. The number for 2021, encompassing both CTDO and enabling functions, is expected to be even higher as the company continues investing across the spectrum of cell therapy operations, from early development programs, to a budding commercial portfolio, to a global manufacturing infrastructure.
At Bristol Myers Squibb, chimeric antigen receptor (CAR) T cell therapy represents a new and personalized approach to treating certain blood cancers. Unlike traditional cancer therapies, CAR T cell therapies are administered as a treatment made from a patient’s own T cells, which are “reprogrammed” during a sophisticated manufacturing process to help the T cells recognize and fight cancer cells.
While the potential of cell therapy for patients and the need to grow is clear, finding talent in a field that’s so new and different from other modalities can be challenging. “We’re doing things that have never been done before,” said Andrew Rigoglioso, associate director, Talent Pipelining and Executive Recruiting, who leads the company’s cell therapy recruitment efforts. “The way we discover, develop and commercialize a cell therapy medicine is different than a small molecule or a biologic. That’s why recruiting is challenging, because we’re looking for people to do things that have never been done before.”
Andrew Rigoglioso, associate director, Talent Pipelining and Executive Recruiting, said recruiting in cell therapy can be challenging “because we’re looking for people to do things that have never been done before.”
Building a cell therapy team A limited candidate pool with direct cell therapy experience means thinking differently about talent. Beyond the baseline technical proficiencies, recruiters said evidence of an innovative mindset is a prerequisite.
“Even if they’ve never commercialized a cell therapy product, what processes have they innovated? What innovative technologies have they implemented? How do they stay at the forefront of technology? People who have a history of doing that will do well on our cell therapy teams,” Rigoglioso said. “People who need the blueprint may struggle, because there’s no blueprint for what we’re doing.”
The need for innovation also applies to the recruitment plan. The Cell Therapy Rotational Program is one of the novel ways the company is attracting talent. The two-year program, launched in 2020, hires a select cohort of new graduates who start their careers at Bristol Myers Squibb with four to six-month rotations through the cell therapy functional areas of Product & Analytical Development, Process Science & Technology, Manufacturing, Manufacturing Sciences & Technology, Pipeline & Product Lifecycle Strategy, Patient Operations/Experience, Strategy Business Operations, Supply Chain, and Quality.
Georges Motchoffo Simo joined Bristol Myers Squibb through the rotational program last August after graduating from the University of Washington with dual degrees in chemical engineering and biochemistry. He’s currently working in Process and Analytical Development in Seattle.
Simo said he was attracted by the company’s emphasis on patients and its values, and the chance to get broad experience in cell therapy through the rotational program. “I would love to be a well-rounded scientist with a breadth of knowledge in cell therapy. I will be able to develop a great network and meet a number of mentors who would push me in my career and help me find my position in the company,” said Simo. “I am hoping to find a group that I can call home and be able to use the knowledge and connections that I made from the other rotations.”
The concept of cell therapy – taking peoples’ cells from their bodies, engineering them and putting them back to fight disease – can still seem like science fiction. Simo describes cell therapy as “a beautiful technology” and said it astonished him when he was first exposed to it in college.
It’s a sense of wonder that Maheshwari still shares. “As an engineer, this is as close to the patient as one can get,” she said.
Business Development As a leading biopharma company, partnering is a key priority for us and plays a critical role in our strategy. We seek to combine external innovative science and technologies with our internal capabilities and expertise to transform patients’ lives through science. Partnerships and collaborations are essential to evolving our portfolio and driving our long-term sustainability.
Partnering to speed transformational medicines to patients Working together to transform patients' lives through science.
Working together We have a distinct and decisive approach to partnering that leverages the best of Bristol Myers Squibb and the best of our partners to speed transformational medicines to patients. We strive to be a partner of choice and establish a creative and customized approach for each agreement.
Why partner with us We take a distinct, decisive approach to partnering that leverages the best of Bristol Myers Squibb and the best of our partners
Our approach to partnering We have a distinct and decisive approach to partnering that leverages the best of Bristol Myers Squibb and the best of our partners to speed transformational medicines to patients. We strive to be a partner of choice and establish a creative and customized approach for each agreement.
Our business development approach Our partnering approach is transparent, direct and fully engaged with our leadership allowing us to execute agreements quickly and effectively. Our business development team brings deep science, development and business expertise to quickly align with our partners to foster successful relationships. Business development, R&D and commercial teams work closely together to source innovation that will combine leading science, technology and research with our development and commercial expertise.
Our alliance management approach Our approach centers on delivering a differentiated partnering experience to support long-term collaborations and relationships. We optimize the value of our alliances by being a premier biopharma partner of choice and maximizing the potential of our partners’ science to create powerful solutions for patients. Our dedicated, experienced alliance management teams ensure a focus on each partnership by: * driving joint steering committees to ensure successful discovery, development, commercialization, and manufacturing of partnered assets * enabling stakeholders to make key decisions that progress joint assets forward
Our focus on collaborative relationships Beginning with our search and evaluation team, through transactions, and finally to alliance management, we bring a collaborative mindset focused on alignment around opportunities, efficient process, and open, transparent communication. Our dedicated alliance management teams foster productive and transparent relationships with our partners, building and maintaining alignment across functions, ensuring constant progress against shared objectives, and enabling quick decisions to advance our asset. Working closely with our Leadership Team, we drive engagement across the Bristol Myers Squibb enterprise to ensure we are responsive and accessible at every step of our collaborative programs. https://www.bms.com/business-development/why-partner-with-us.html
Bristol Myers Squibb is a leading global biopharma company focused on discovering, developing and delivering innovative medicines that help patients prevail over serious diseases.
We are focused on our core therapeutic areas and are pursuing multiple drug platforms across these areas with a goal of transforming patients’ lives through science.
External innovation and partnering are critical drivers of our strategy and have brought significant commercial success and pipeline growth.
Therapeutic areas
Solid tumors
Over the past several decades our innovative medicines have improved how cancer is treated, making long-term survival a possibility for more patients. We strive to help more patients across a broad range of solid tumors and blood disorders with our medicines, scientific discovery and investigational research, and are working with partners to address all aspects of patient care, from diagnosis onward.
* Leverage our foundational expertise in tumor biology and application of translational approaches to benefit patients across all stages of disease * We are pursuing novel therapies that focus on disease biology of cancers with high unmet need * We seek opportunities in patient populations not currently addressable by checkpoint blockade * We will expand into oncogenic pathways for both tumor intrinsic and extrinsic factors, including the immune system
Areas of interest include, but are not limited to, the following:
* New modalities including, but not limited to, antibody-drug conjugates, immune cell engagers, and protein degraders * Tumor intrinsic biology with clear patient selection strategy * Historically intractable targets to develop disruptive therapeutic technologies * Novel innate and adaptive immune mechanisms * Novel therapies that transform response rates and durability for patients * Therapies that address tumor intrinsic vulnerabilities and primary or acquired mechanisms of resistance to standard of care
Immunology
Bristol Myers Squibb is pursuing pathbreaking science in immunology to deliver meaningful solutions that address unmet needs in rheumatology, gastroenterology, dermatology and neurology.
* Over two decades ago, our researchers pioneered the science of modulating the body’s immune response to treat disease. * Today, Bristol Myers Squibb’s immunology franchise encompasses two marketed products and a robust pipeline of more than 20 programs across nearly 20 diseases, including rheumatoid arthritis, systemic lupus erythematosus (SLE), inflammatory bowel disease (IBD), atopic dermatitis, psoriasis, multiple sclerosis and other immune-mediated diseases with high unmet needs. * Bristol Myers Squibb has an industry-leading pipeline, including discovery and clinical stage first-in-class agents spanning multiple pathways, mechanisms and approaches which are being developed internally and through partnerships and collaborations * Areas of interest include, but are not limited to, the following: * Agents that target selective immune suppression, eliminate pathogenic immune memory cells and/or promote immune homeostasis, including those that act on both immune and non-immune cell types (e.g., epithelial and stromal cells) * Novel therapeutic modalities that selectively leverage tissue restricted or genetically validated targets * Biomarkers of disease activity to inform patient stratification, measure pharmacodynamic responses and predict efficacy, with a particular interest in such biomarker-enabled programs
Cross-therapeutic areas of focus
Cell therapy
Bristol Myers Squibb is committed to building a leadership position in cell therapy by leveraging unparalleled disease expertise, CMC capabilities, manufacturing scale and portfolio of first/best-in-class assets.
* Our focus is to broaden the impact of cell therapy in oncology across hematologic malignancies and solid tumors by researching potential next-generation approaches that focus on new targets and utilize new technologies.
Areas of interest include, but are not limited to, the following:
* Allogeneic cell platforms – donor/iPSC, – NK cells, aß T cells, ?d T cells * Additional cell types – e.g., macrophages, NKT cells * Clinical products that have shown safety/efficacy and is in line with our strategy * Novel tumor targets for both – CAR and TCR, especially in AML and solid tumors * Next-generation engineering (e.g., CAR logic gates, gene editing, TME modulation) * Non-viral delivery for modifying cell gene expression * Enabling manufacturing platforms and technologies * Combination therapies that can increase or expand efficacy of our Cell Therapy products
Bristol Myers scraps $2B Nektar partnership after trial failures Published April 18, 2022
Bristol Myers paid $1.9 billion in 2018 to gain rights to Nektar’s drug, called bempegaldesleukin, at a time when interest was high in drugs designed to stimulate immune-signaling proteins called interleukins. There was particular interest from companies like Bristol Myers, which already sold immunotherapies like Opdivo and aimed to improve their effectiveness or expand their use into new types of cancer.
Hopes of success dimmed when the negative melanoma study results were announced in March. Now, the companies say the combination doesn’t work in renal cell carcinoma or urothelial cancer.
In renal cell carcinoma, the Opdivo-bempegaldesleukin combination didn’t lead to a better response rate than Cabometyx or other approved drugs, according to reviewers of a Phase 3 trial. At an interim checkpoint, the reviewers also saw no signs the Opdivo-bempegaldesleukin combination was helping patients to live longer. In urothelial cancer, meanwhile, the combination didn’t trigger a sufficient response rate in a Phase 2 trial to justify continued research, according to trial reviewers. These failures prompted the companies to also discontinue all other trials of the drug combination.
