CAR-T cell therapy is an individualized cell-based technique that involves removing some of your own white blood cells, including T cells. To make CAR-T cells, the collected T cells are genetically treated in the lab to produce special receptors called chimeric antigen receptors, or CARs. These CARs allow the T cells to recognize an antigen (or marker) at the surface of cancer cells and activate T cells' ability to kill these cancer cells. The CAR-T cells are infused back into your body to identify and destroy certain cancers. This immunotherapy is one of the most promising areas of cancer treatment.

The FDA-approved conditions for CAR-T cell therapy include:

People who have relapsed or refractory disease may be eligible for CAR-T cell therapy.

Most people have a reaction to CAR-T cells that requires them to stay in the hospital for days to weeks for monitoring and management. Typically, the reaction happens within hours to days after the infusion. Side effects may include:

Side effects are generally reversible. Your care team will talk with you about how to monitor for reactions. The long-term toxicity of CAR-T cell therapy is still being studied. Talk with your doctor about the potential risks of treatment.

Feb. 19, 2022

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About CAR-T cell therapy - Mayo Clinic

In an interview with Targeted Oncology, Peter A. McSweeney discussed the ways in which community oncology centers are implementing chimeric antigen receptor T-cell therapy into their practice and the challenges that come with it.

Community oncology practices come in all shapes and sizes with larger centers often having more resources to provide patients with. The same goes for chimeric antigen receptor (CAR) T-cell therapies and their availability in larger oncology centers vs the smaller ones.

There is anincreasing use of CAR T-cell therapies being seen as they make an entrance as a potential second-line therapy in different patient populations.

According to Peter A. McSweeney, MD, the larger community oncology centers typically can administer CAR T-cell therapy the same way or similarly to how it is done in academic centers. However, in smaller community practices, the resources for administering CAR T-cell therapy are not always available, and usually requires a referral to an academic center.

McSweeney also notes that administering CAR T cells in the community setting can be challenging as oncologists need the proper expertise and infrastructure to do so properly.

The biggest challenges for administering these CAR T cells in the community are developing a program that has the appropriate expertise and infrastructure for this type of work. It's a very multifaceted type of therapy that draws on inpatient and outpatient arrangements that meet the needs of the patients. Also, there is a need for subspecialty support in the hospital for patients who have complications with the therapy, stated McSweeney, hematologist/oncologist at the Colorado Blood Cancer Institute, in an interview with Targeted OncologyTM.

In the interview, McSweeney discussed the ways in which community oncology centers are implementing CAR T-cell therapy into their practice and the challenges that come with it.

Targeted Oncology: How are community practices handling the logistics of administering CAR T-cell therapies and the RMS requirements associated with CAR T use?

McSweeney: Community practices come in different types. There are some quite large community malignancy programs, which are clinically the equivalent of academic centers. They handle all this pretty much according to the same algorithms as the academic centers. The issue of smaller oncology practices in this area is not an issue right now. Theres been very little penetration of CAR T-cell therapy, and these types of cellular therapies to those practices, although they are subtly showing interest in trying to develop capability.

What are the biggest challenges with administering CAR T-cell therapy in community practices?

The biggest challenge for administering these CAR T cells in the community is developing a program that has the appropriate expertise and infrastructure for this type of work. It's a very multifaceted type of therapy, it draws on inpatient and outpatient arrangements that meet the needs of the patients, and there is a need for subspecialty support in the hospital for patients who have complications with the therapy.

Now that CAR T cells are entering the second-line for some cancers, how does this change how community practices may choose treatments for patients?

What I think is very important for second-line therapy is that the community practice is aware of these changes because patients are now moving into this as the therapy at first relapse, or at least incorporate this into the treatment strategy at first relapse, so one needs to know this. In some instances, the timing of therapy and the urgency of referral is a big issue. The physicians in the community who are not administering this therapy need to be aware and get the patient referred quickly to the appropriate places, particularly for diseases like diffuse large B-cell lymphoma in initial relapse or that is resistant to primary therapy.

What is your advice on when to give CAR T-cell therapy in a second-line setting?

The administration of CAR T-cell therapy in the second-line is disease dependent. It is indicated now for either initial resistance of diffuse large B-cell lymphoma or relapse diffuse large B-cell lymphoma in the first year after treatment. That is the aggressive B cell lymphomas. That's the main setting for second-line therapy. It can also be employed in B-cell acute lymphoblastic leukemia, mantle cell lymphoma, and select patients in the second-line.

How are community practices addressing and/or preventing toxicities seen with CAR T cells or bispecific antibodies?

The use of CAR T cells and bi-specific molecules can generate cytokine release syndrome and neurotoxicity, which are unique side effects that are not generally encountered in the general oncology setting. These are sort of specialized problems. There are some community hematologic malignancy programs that deal with these routinely. But in general, these are not going to be in the domain of the general oncologist.

When would you recommend referring a patient to an academic center for CAR T administration or to manage the toxicities for CAR T cells?

I think the academic centers play a big role in this. There are other very well-developed malignancy centers that provide equivalent sort of services. But if you're a general oncologist, you must be referring patients with the appropriate diseases to those centers. You are not going to try to take this on yourself. A lot of the toxicities that have to do with CAR T-cells and bispecifics are closely related to their administration, so they're not really falling under the jurisdiction of the general oncologist. There are late adverse events however, that remain for general oncologists as patients transition back to these doctors.

How comfortable are community practices when it comes to administering therapies like CAR T Cells and bispecific antibodies?

Community practices will only be comfortable administering these types of therapies if they have the appropriate infrastructure and have physicians who are experienced with managing them. For community oncologists or oncology networks, to think about managing these patients, they have to drill down on what they need to put in place. They're not going to be at all comfortable trying to manage these patients until I've tackled that issue.

Excerpt from:
Integrating CAR T-Cell Therapy Into Community Oncology Practices - Targeted Oncology

TOKYO--(BUSINESS WIRE)--Treatment of cancer using ones own immune cells, natural killer (NK) cells and T-cells, called autologous immune enhancement cell therapy (AIET) administered along with conventional chemotherapy, radiotherapy and surgery, practiced in Japan for long is now offered in Vinmec hospital, Hanoi, Vietnam, following technology transfer by GN Corporation. Cancer patients from neighboring countries are now visiting Vinmec hospital for this treatment. Autologous immune-cell therapy, regulated by the regenerative medicine law in Japan, uses lab-expanded autologous immune cells, without animal proteins or genetic manipulation.

Benefits of AIET & hyperthermia: While increase in survival rate in cancer patients is reported by adding immune-cell therapy to conventional treatment regimen, the Hyperthermia system developed in Japan further improves outcome of cancer treatment as it targets the cancer cells, vulnerable to damage at a higher temperature of 42 Deg Celsius. To propagate these add-on cancer treatments to overseas hospitals, GNC Japan is collaborating with Yamamoto Vinita, manufacturers of Thermotron, the first hyperthermia equipment to treat malignant tumors, approved in Japan, installed in more than 300 hospitals in six countries, till date. The latest Thermotron-RF8-EX version is a stand-alone system with Eight MHZ radiofrequency, uses electrodes of different sizes in combination to treat superficial and deep-seated solid tumors of the entire body except eye and brain.

Thermotron RF8-EX Salient features:

Hospitals in Japan offering these cancer therapies receive patients from abroad for treatment. Recently overseas cancer hospitals have started showing interest in adding these two therapies to their existing systems for cancer treatment in clinical oncology services.

Accomplishments of GN Corporation, in adding value to Japanese technologies by inter-disciplinary interaction, developing novel healthcare solutions and global propagation were featured by Govt of Japan in the official YouTube channel of the prime ministers office of Japan, JETRO Invest in Japan portal and a feature story sponsored by Govt of Japan in Bloomberg.

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Autologous immune-cell therapy, practiced in Japan, now helping Vinmec Hospital, treat cancer patients in Hanoi, Vietnam, after technology transfer by...

Pain.

It gnawsat you. It drains you. It becomes the focus of your life.

Experiencing a few pain-free moments can be euphoric; it makes you realize how long youve been living with aches and pain. You might wonder how you can find a solution to relieve the pain and regain your freedom from discomfort.

Regenerative Spine and Pain Institute on how to lesson your pain.

Dr. Ronak Patel at Regenerative Spine and Pain Institute wants you to know there are two new revolutionary answers to pain relief.

Both platelet-rich therapy otherwise known as PRP and stem cell therapy give patients new hope by using the bodys powerful healing power to accelerate the battle against pain. Dr. Patel has seen incredible success implementing these cutting-edge treatments on hundreds of patients suffering from pain-related issues.

So if you are suffering fromany of the ailments below, theres a lifeline.

Heres the best news: Neither PRP or stem cell therapy involves drug use with side effects or any surgical procedures.

Both PRP and stem cell treatments use the bodys own healing resources to repair diseased or damaged tissue and the results are quite remarkable.

PRP therapy involves injecting concentrated platelets and growth factors into damaged tissue to stimulate the faster growth of new healthy cells. Platelets are cells that prevent and stop bleeding. If a blood vessel is damaged, the body sends signals to our platelets to get on the job and start the healing. Some call platelets the bodys natural bandage.

So how does PRP therapy work? Its basically drawing a one small vial of blood from the patient and then using a centrifuge to turn it into a potent and concentrated form of platelets. It is then injected back into the patient. Think of it as a boost of your own blood only superpowered.

Recovery time for PRP therapy is far shorter than for surgery. Patients usually experience soreness for a week or so, but the gradual improvement soon begins. Unlike a steroid shot, which gives you immediate relief and quickly wears off, a PRP patient will see pain symptoms improve over a period of months, and up to 80 percent of patients will see relief for up to two years.

Stem cell therapy can be an even more powerful way to harness the bodys healing power. Stem cells are the building blocks for every cell in our body. These powerful cells can be harvested to produce powerful new cells to fight inflammation and disease.

For those suffering from osteoarthritis, stem cell therapy has proven very effective. Thats because the stem cells may help develop new cartilage cells and suppress inflammation. Stem cells can be harvested through a sample of body fat or bone marrow or be harvested from donated umbilical cord tissue.

And yes, you can even augment PRP therapy with stem cell therapy for an even bigger boost!

Stop wondering if youll have to live with your pain forever. Contact Regenerative Spine and Pain Institute today at 609-269-4451 or go to http://www.njpaindoc.com to book an appointment and learn more.

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Regenerative Spine and Pain Institute: Treating Pain with PRP and Stem Cell Therapy - Community News

Oncternal Therapeutics

SAN DIEGO, Oct. 03, 2022 (GLOBE NEWSWIRE) -- Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, today announced the receipt of a Study May Proceed letter from the U.S. Food and Drug Administration (FDA), 30 days after submitting its Investigational New Drug (IND) application for a Phase 1/2 dose escalation study of ONCT-808, an autologous chimeric antigen receptor (CAR) T therapy targeting ROR1, in patients with aggressive B cell non-Hodgkins lymphoma (B NHL), including those who have failed previous CD19 CAR T treatment.

We are very pleased with the clearance of our IND application for our lead autologous CAR T product candidate, ONCT-808, said James Breitmeyer, M.D., Ph.D., Oncternals President and CEO. This will be our second clinical program focusing on the important ROR1 cancer target, following the initiation of our phase 3 study for our ROR1 antibody zilovertamab, announced last week. ROR1 is an exciting and promising target that is highly expressed in a wide range of cancers and is an ideal candidate for cell therapy applications due to its highly specific tumor expression, and association with tumor survival mechanisms. Our initial dose finding study will enroll patients with aggressive B NHL, including those that have failed prior CD19 therapy, which represent a significant unmet need in the market today. We expect to initiate the study in the coming months and to present interim results at a scientific conference in 2023.

About Oncternal TherapeuticsOncternal Therapeuticsis a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies for the treatment of patients with cancers that have critical unmet medical need. Oncternal pursues drug development targeting promising, yet untapped biological pathways implicated in cancer generation or progression, focusing on hematological malignancies and prostate cancer. The lead clinical program iszilovertamab, an investigational monoclonal antibody designed to inhibit the function of Receptor Tyrosine Kinase-Like Orphan Receptor 1 (ROR1). ZILO-301, a global Phase 3 Study to evaluate zilovertamab in combination with ibrutinib for the treatment of patients with relapsed/refractory mantle cell lymphoma (MCL) has been initiated (NCT05431179). Zilovertamab continues to be evaluated in an ongoing Phase 1/2 study in combination with ibrutinib for the treatment of patients with MCL and chronic lymphocytic leukemia (CLL), and this trial was recently amended to include patients with marginal zone lymphoma (MZL). Zilovertamab is also being evaluated in two investigator-initiated studies, including a Phase 2 clinical trial of zilovertamab in combination with venetoclax, a Bcl-2 inhibitor, in patients with relapsed/refractory CLL, and in a Phase 1b study of zilovertamab in combination with docetaxel in patients with metastatic castration-resistant prostate cancer (mCRPC). Oncternal is also moving into the clinic with ONCT-808, an autologous chimeric antigen receptor T (CAR T) cell therapy that targets ROR1, with an active U.S. IND as of the end of September 2022 for the treatment of patients with relapsed or refractory aggressive B cell lymphoma, including patients who have failed previous CD19 CAR T treatment. The preclinical pipeline also includesONCT-534, a dual-action androgen receptor inhibitor (DAARI) that is undergoing final IND-enabling studies, as a potential treatment for castration resistant prostate cancer, including those with unmet medical need due to resistance to approved, standard of care androgen receptor inhibitors. More information is available athttps://oncternal.com/.

Forward Looking InformationOncternal cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as may, will, should, expect, plan, anticipate, could, intend, target, project, contemplates, believes, estimates, predicts, potential or continue or the negatives of these terms or other similar expressions. These statements are based on Oncternals current beliefs and expectations. Forward-looking statements include statements regarding the expected timing of initiation and interim updates for Oncternals planned study of ONCT-808. Forward-looking statements are subject to risks and uncertainties inherent in Oncternals business, including risks associated with the clinical development and process for obtaining regulatory approval of Oncternals product candidates, such as potential delays in the commencement, enrollment and completion of clinical trials; we have not conducted head-to-head studies of zilovertamab in combination with ibrutinib compared to ibrutinib monotherapy and data from separate studies may not be directly comparable due to the differences in study protocols, conditions and patient populations; the risk that interim results of a clinical trial do not predict final results and that one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, as follow-up on the outcome of any particular patient continues, and as more patient data become available; later developments with the FDA may be inconsistent with the minutes from the completed end of Phase 2 meeting, including that the proposed Study ZILO-301 that may not support registration of zilovertamab in combination with ibrutinib which is a review issue with the FDA upon submission of a BLA; and other risks described in Oncternals filings with theU.S. Securities and Exchange Commission. All forward-looking statements in this press release are current only as of the date hereof and, except as required by applicable law, Oncternal undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Contact Information:

InvestorsRichard Vincent 858-434-1113rvincent@oncternal.com

MediaCorey Davis, Ph.D. LifeSci Advisors 212-915-2577 cdavis@lifesciadvisors.com

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Oncternal Therapeutics Receives IND Clearance for ONCT-808, its autologous CAR T Product Candidate Targeting ROR1 for the Treatment of Aggressive B...

CONTACTLetisia Marquez(626) 476-7593lemarquez@coh.org

LOS ANGELES City of Hope, one of the largest cancer research and treatment organizations in the United States, announced today a $15 million gift from City of Hope patient and cancer survivor Ted Schwartz that will be used entirely to further accelerate immunotherapy research and treatment innovations, such as the chimeric antigen receptor (CAR) T cell therapy that saved his life. Schwartz, who is now cancer free, achieved complete remission at City of Hope in 2020 with the centers leading CAR T cell therapy after a 16-year battle with lymphoma, provided the gift to City of Hope to advance treatment options that offer better outcomes and quality of life for people living with cancer.

Schwartz made the gift in honor of the team at City of Hope and his trusted physician and friend Steven Rosen, M.D., City of Hopes provost and chief scientific officer, and Morgan & Helen Chu Directors Chair of the Beckman Research Institute, who will direct the research funds with a core committee. City of Hope, a global leader in CAR T cell therapy, has built one of the most comprehensive CAR T clinical research programs in the world. The Schwartz family gift will be used to establish two funds at City of Hope: the Accelerator Fund for Immunotherapeutics to provide immediate support for City of Hopes immunotherapy teams and the Immunotherapeutics Research Endowment Fund, a planned gift to provide steady support for research teams to explore new potential therapies for decades to come.

In an expression of gratitude for the Schwartz gift, City of Hope is naming a planned 1.65-acre park in honor of the Schwartz family. The Ted Schwartz Family Hope and Healing Park will open in 2024 on City of Hopes Los Angeles campus and offer a peaceful space for patients and visitors. This garden will provide comfort, hope and inspiration to people who are battling cancer, and their families, Schwartz said, "as I understand clearly what they are experiencing. Schwartz continues to mentor and coach other patients receiving CAR T and other advanced treatments in an effort to extend hope.

The CAR T treatment I received at City of Hope is what finally helped me conquer lymphoma after a long 16-year battle, including multiple rounds of chemotherapy and radiation. Im an early beneficiary of advances in this exciting immunotherapy, and I want the research to progress so more people can experience remission sooner, Schwartz added. My family and I provide this gift in honor of my friend and physician, Dr. Rosen. Dr. Rosen and his colleagues at City of Hope, who treat every patient with the utmost dignity and care, continue to lead the way in advancing world-class CAR T and other advanced treatments, and help others avoid some of the hardships and side effects associated with some current treatments and experience longer-lasting remission.

City of Hope, a leader in blood cancer research and treatment and a pioneer of CAR T cell therapy, applies proprietary CAR T-cell technology across clinical and preclinical programs to address some of the hardest-to-treat cancers. City of Hope is conducting over 70 CAR T and other immune effector cell trials and to-date, approximately 1,000 patients have participated in those trials or have been treated with Food & Drug Administration-approved CAR T cell therapies. Due to City of Hopes longstanding expertise delivering CAR T therapy, most CAR T treatments currently administered at City of Hope are provided in an outpatient setting.

A century of leading-edge research centered around patients has positioned City of Hope at the forefront of groundbreaking discovery in CAR T cell therapy. We now have one of the largest CAR T cell programs in the world. CAR T treatment holds remarkable promise for so many patients, like Ted, who are battling difficult to treat cancers, Rosen said. The Schwartz familys gift will allow us to continue advancing promising immunotherapy research in our City of Hope labs and produce meaningful options for patients in need of more targeted lifesaving treatments.

Immunotherapy harnesses the power of patients own immune systems to recognize and fight cancer, often producing lasting results with fewer side effects compared to surgery, chemotherapy or radiation. CAR T cell therapy is a powerful form of immunotherapy. CAR T cell therapy works by taking immune cells from a patients bloodstream, reprogramming the cells to recognize and attack a specific protein found in cancer cells, then reintroducing them into the patients system, where they can destroy targeted tumor cells.

We are so appreciative of Teds commitment to accelerating the immunotherapeutics research at City of Hope so that more patients like Ted will benefit from our innovative work, said Elizabeth Budde, M.D., Ph.D., executive medical director, City of Hopes Enterprise Immune Effector Cell Therapy.

City of Hope is at the forefront of developing personalized treatments that create hope where it was not possible before, and Ted knows firsthand that cancer patients cannot afford to wait. Philanthropic partnerships play a crucial role in accelerating the development of novel cancer therapies and cures, said Kristin Bertell, chief philanthropy officer at City of Hope. We are so grateful to Ted and his family for their courage, resilience and incredible generosity to ensure lifesaving therapies are brought more quickly to patients who need them.

# # #

City of Hope's mission is to deliver the cures of tomorrow to the people who need them today. Founded in 1913, City of Hope has grown into one of the largest cancer research and treatment organizations in the U.S. and one of the leading research centers for diabetes and other life-threatening illnesses. As an independent, National Cancer Institute-designated comprehensive cancer center, City of Hope brings a uniquely integrated model to patients, spanning cancer care, research and development, academics and training, and innovation initiatives. Research and technology developed at City of Hope has been the basis for numerous breakthrough cancer medicines, as well as human synthetic insulin and monoclonal antibodies. A leader in bone marrow transplantation and immunotherapy, such as CAR T cell therapy, City of Hopes personalized treatment protocols help advance cancer care throughout the world.

With a goal of expanding access to the latest discoveries and leading-edge care to more patients, families and communities, City of Hopes growing national system includes its main Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California and Cancer Treatment Centers of America. City of Hopes affiliated family of organizations includes Translational Genomics Research Institute and AccessHopeTM. For more information about City of Hope, follow us on Facebook, Twitter, YouTube, Instagram and LinkedIn.

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City of Hope To Accelerate Immunotherapy Research And Treatment Innovation with $15 Million Gift From Ted Schwartz Family - City of Hope

CARLSBAD, Calif.--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced today the opening of a new research and development (R&D) facility in Carlsbad, California, and the expansion of its Good Manufacturing Practice (GMP) manufacturing facility based in Jerusalem, Israel. Lineages new Carlsbad facility will broaden the Companys R&D capabilities in the U.S. and support the development of current and future allogeneic cell transplant programs. The expansion of Lineages Israel-based facility will increase the Companys infrastructure, including development and optimization of larger-scale clinical manufacturing processes, and continued execution under its ongoing collaboration with Roche and Genentech for RG6501 (OpRegen), a retinal pigment epithelium cell replacement therapy which has completed enrollment in a Phase 1/2a clinical trial for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

We have elected to increase our R&D footprint at our existing GMP manufacturing facility and establish a new R&D facility in Carlsbad, California, stated Brian M. Culley, Lineage CEO. These steps will permit us to expand our process development and analytical testing capabilities and conduct exploratory work on future programs, whether owned by us or our current or future partners. This move also is expected to reduce our reliance on certain vendors, which may reduce costs and risks of timeline uncertainty or supply chain disruption. The additional capacity also can help us become an even more capable partner in prospective alliances for new products and allow us to explore additional uses for our current cell transplant programs.

Mr. Culley added, Challenges in the biotech sector are unlikely to persist indefinitely. We believe it is important to take steps, even in this environment, to be positioned for a future recovery. The modest investments we are making today, partially offset by the termination of the lease for our research facility in Alameda, California in January of next year, will help centralize our operations and put us in a position of greater readiness for future success.

About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineages programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineages clinical programs are in markets with billion dollar opportunities and include five allogeneic (off-the-shelf) product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineages VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit http://www.lineagecell.com or follow the company on Twitter @LineageCell.

Forward-Looking Statements

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as believe, aim, may, will, estimate, continue, anticipate, design, intend, expect, could, can, plan, potential, predict, seek, should, would, contemplate, project, target, tend to, or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to: the potential benefits of the new and expanded facilities to the Company and its operations, including the broadening of the Companys R&D capabilities, increasing development and optimization of larger-scale clinical manufacturing processes, the expansion of the Companys process development and analytical testing capabilities and ability to conduct exploratory work on future programs, the increase in the Companys manufacturing facilities, the decreased reliance on certain vendors, the reduction in costs and risks of timeline uncertainty and supply chain disruption, and the improvement in the Companys position of greater readiness for future success. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineages actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the following risks: that potential benefits of the new and expanded facilities to the Company and its operations may not be realized as quickly as expected or at all; that we may need to allocate our cash to unexpected events and expenses causing us to use our cash more quickly than expected; that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; that competing alternative therapies may adversely impact the commercial potential of OpRegen; that Roche and Genentech may not successfully advance OpRegen or be successful in completing further clinical trials for OpRegen and/or obtaining regulatory approval for OpRegen in any particular jurisdiction; that we may not establish new partnerships or expand existing collaborations; that we do not successfully broaden awareness of our mission or accomplishments; that Lineage may not be able to manufacture sufficient clinical quantities of its product candidates in accordance with current good manufacturing practice; and those risks and uncertainties inherent in Lineages business and other risks discussed in Lineages filings with the Securities and Exchange Commission (SEC). Lineages forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading Risk Factors in Lineages periodic reports with the SEC, including Lineages most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC and its other reports, which are available from the SECs website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

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Lineage Establishes New R&D Facility in U.S. and Expands Current GMP Manufacturing Facility in Israel - Business Wire

Century Therapeutics, Inc.

PHILADELPHIA, Oct. 03, 2022 (GLOBE NEWSWIRE) -- Century Therapeutics (NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology, today announced the appointment of Daphne Quimi and Timothy Walbert to the Companys Board of Directors. Ms. Quimi is currently Chief Financial Officer of Amicus Therapeutics and brings experience in public accounting and financial reporting to Century. Mr. Walbert is currently Chairman, President, and Chief Executive Officer of Horizon Therapeutics, and brings expertise in product portfolio building and commercialization. In conjunction with these new appointments, Century also announced that Eli Casdin, Chief Investment Officer of Casdin Capital, has resigned from the Board of Directors, effective as of October 1, 2022.

I am thrilled to welcome both Daphne and Tim to our Board. They will each play critical roles as we accelerate our next-generation cell therapy platform, said Lalo Flores, Ph.D., Chief Executive Officer, Century Therapeutics. Daphnes strong financial background and experience at both biotechnology and large pharmaceutical companies will be a tremendous asset as we enter the next transformative years for Century. Tims background, which includes numerous product launches, will be instrumental to our continued evolution, particularly as we progress our pipeline candidates with the ultimate goal of delivering innovative cancer therapies. Additionally, on behalf of the management, Board and all of our employees, we would like to thank Eli for his contributions to Centurys rapid growth and his leadership in our early formative years, where he was a key strategic thought partner.

Before serving as Amicuss Chief Financial officer, Ms. Quimi was Amicuss Senior Vice President, Finance and Corporate Controller. Ms. Quimi is currently a member of the Board of Directors at Amylyx Pharmaceuticals. Prior to Amicus, Ms. Quimi served as Director of Consolidations and External Reporting at Bristol-Myers Squibb. She also held roles of increasing responsibility in the finance department at Johnson & Johnson. Earlier in her career she worked for KPMG. Ms. Quimi received a B.S. in Accountancy from Monmouth University and an M.B.A from the Stern School of Business of New York University.

In addition to his current role of President and Chief Executive Officer of Horizon Therapeutics, Mr. Walbert has served as Chairman of Horizons Board of Directors since 2010. Before joining Horizon, Mr. Walbert served as President, Chief Executive Officer and Director of IDM Pharma Inc., and also held prior senior roles at NeoPharm Inc., Abbott (AbbVie), G.D. Searle & Company, Merck & Co. Inc. and Wyeth. Mr. Walbert received a B.A. in Business from Muhlenberg College.

About Century Therapeutics

Century Therapeutics (NASDAQ: IPSC) is harnessing the power of adult stem cells to develop curative cell therapy products for cancer that we believe will allow us to overcome the limitations of first-generation cell therapies. Our genetically engineered, iPSC-derived iNK and iT cell product candidates are designed to specifically target hematologic and solid tumor cancers. We are leveraging our expertise in cellular reprogramming, genetic engineering, and manufacturing to develop therapies with the potential to overcome many of the challenges inherent to cell therapy and provide a significant advantage over existing cell therapy technologies. We believe our commitment to developing off-the-shelf cell therapies will expand patient access and provide an unparalleled opportunity to advance the course of cancer care. For more information on Century Therapeutics please visit http://www.centurytx.com.

Century Therapeutics Forward-Looking Statement

This press release contains forward-looking statements within the meaning of, and made pursuant to the safe harbor provisions of, The Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as may, might, will, should, expect, plan, aim, seek, anticipate, could, intend, target, project, contemplate, believe, estimate, predict, forecast, potential or continue or the negative of these terms or other similar expressions. These statements are not guarantees of future performance These risks and uncertainties are described more fully in the Risk Factors section of our most recent filings with the Securities and Exchange Commission and available at http://www.sec.gov. You should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

For More Information:

Company: Elizabeth Krutoholow investor.relations@centurytx.com

Investors: Melissa Forst/Maghan Meyers century@argotpartners.com

Media: Joshua R. Mansbach century@argotpartners.com

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Century Therapeutics Announces Appointment of Daphne Quimi and Timothy Walbert to its Board of Directors - Yahoo Finance