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Talaris Therapeutics Presents Data Supporting Potential of FCR001 to Prevent Recurrence of Kidney-Related Autoimmune Disease in Kidney Transplant…

Posted: November 7, 2019 at 11:46 am

BOSTON & LOUISVILLE, Ky.--(BUSINESS WIRE)--

Talaris Therapeutics, Inc., a privately held biotechnology company developing transformative cell therapies that have the potential to eliminate the burden of chronic immunosuppression for organ transplant recipients, today presented data demonstrating the potential of its cell therapy to resolve certain auto-immune diseases of the kidney.

The data, presented in a late-breaking poster at the 2019 American Society of Nephrology (ASN) Kidney Week conference, reflect an analysis of living donor kidney transplant recipients with auto-immune diseases of the kidney who underwent kidney transplant and treatment with Talaris cell therapy, FCR001, in the companys Phase 2 trial.

Various auto-immune diseases including IgA nephropathy, focal segmental glomerulosclerosis (FSGS) and Alport syndrome degrade kidney function and can necessitate a kidney transplant. These conditions recur in a high percentage of cases post-transplant, potentially leading to an accelerated decline of the transplanted kidney. Therefore, repeated kidney transplants are often necessary for patients with these diseases.

Twelve subjects in Talaris Phase 2 trial experienced kidney failure as a result of an auto-immune disease. Within this cohort, seven patients were successfully tolerized with FCR001, including two with FSGS, which is a particularly aggressive kidney-related auto-immune condition. None of the seven successfully tolerized patients has to date had a detectable recurrence of their underlying auto-immune disease. Of the five other patients who displayed either transient or no immune chimerism, recurrence of the prior auto-immune disease was observed in two cases.

Were very excited by this demonstration of the potential of FCR001 to durably reset the immune system and halt auto-immune disease in patients in our Phase 2 trial. Many auto-immune diseases of the kidney are not resolved by a conventional kidney transplant, and therefore patients may require multiple transplants over the course of their lives. Were hopeful that our cell therapy could interrupt this cycle of repeat transplants, said Chief Executive Officer Scott Requadt. Talaris plans to build upon these promising findings in an upcoming Phase 2 trial, in which we will evaluate the potential of FCR001 to treat certain severe auto-immune or immune-mediated disorders.

About FCR001 FCR001 is an investigational, allogeneic cell therapy developed by Talaris Therapeutics to induce or restore patients immune tolerance. FCR001 builds on over 30 years of research by the companys founder, Dr. Suzanne Ildstad, into the means by which durable immune tolerance can be induced in a patient who receives a transplanted organ or can be restored in patients with certain immune-mediated or blood disorders. FCR001 has received both Orphan Drug Designation and Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration. A Phase 3 trial of FCR001 in living donor kidney transplant recipients is now enrolling patients. More information about the FREEDOM-1 trial can be found at: https://www.clinicaltrials.gov/ct2/show/NCT03995901

About Talaris Therapeutics Talaris Therapeutics, Inc. is a late-clinical stage biotechnology company that is developing transformative cell therapies with the potential to eliminate the burden of chronic immunosuppression for organ transplant recipients as well as induce durable remissions in patients with severe autoimmune and immune-mediated disorders. Talaris operates its own cell processing facility in Louisville, KY and maintains corporate offices in Boston, MA and Louisville, KY. Talaris is backed by leading life sciences investors Blackstone Life Sciences, Longitude Capital and Qiming Venture Partners USA. http://www.TalarisTx.com.

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Sorrento to Present New Data on Advanced Immunotherapies at Multiple Upcoming Scientific Conferences – GlobeNewswire

Posted: November 7, 2019 at 11:46 am

SAN DIEGO, Nov. 06, 2019 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (NASDAQ: SRNE, "Sorrento"), announced today that Dr. Henry Ji, Chairman and CEO, and members of Sorrentos research team will participate in upcoming industry conferences in the 4th quarter 2019.

Sorrento will provide new data on recent advances in allogeneic cellular therapy research, including but not limited to 3 clinical areas Sorrento has been focusing on:

Examples from the CD38 and BCMA programs will illustrate current progress in key development areas.

Several scientific posters will be presented at the upcoming Society of Immunotherapy of Cancer and American Society of Hematology conferences and will be available following the event.

Zhangjiang International Summit on Cell Therapy 2019

Date: November 14thTime: 11:15 AM China TimeLocation: ShanghaiNext-generation off-the-shelf CAR-T cell therapy Keynote Speaker, Dr. Henry Ji

American Society of Hematology (ASH Scientific Conference)

Date: December 7th through 10thLocation: Orange County Convention Center (OCCC), Orlando, Fl

ASH online (following scientific conference)

Longwood Annual Winter Meeting at Harvard Medical School 2019

Date: December 10thTime: 8:30 AM Eastern TimeLocation: Harvard Medical School, Joseph B. Martin Conference Center, Boston, MAIdentifying Novel Technologies and Therapeutic AreasExpert panel discussion with Dr. Henry Ji

About Sorrento Therapeutics, Inc.

Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to turn malignant cancers into manageable and possibly curable diseases. Sorrento's multimodal multipronged approach to fighting cancer is made possible by its extensive immuno-oncology platforms, including key assets such as fully human antibodies (G-MAB library), antibody-drug conjugates (ADC) as well CAR-T and oncolytic virus (Seprehvir).

Sorrento's commitment to life-enhancing therapies for cancer patients is also demonstrated by our effort to advance a first-in-class (TRPV1 agonist) RTX and ZTlido. RTX is completing a phase IB trial in terminal cancer patients. ZTlido was approved by US FDA on February 28, 2018.

For more information visit http://www.sorrentotherapeutics.com

Forward-Looking Statements

This press release and any statements made for and during any presentation or meeting contain forward-looking statements related to Sorrento Therapeutics, Inc. under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward looking statements include statements regarding the developments of and prospects for Sorrento's and its subsidiaries and affiliates products and technologies, expected research and development and clinical trials. Risks and uncertainties that could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: risks related to Sorrento's, its subsidiaries', affiliates and partners technologies and prospects; clinical development risks, including risks in the progress, timing, cost, and results of clinical trials and product development programs; risk of difficulties or delays in obtaining regulatory approvals; risks that clinical study results may not meet any or all endpoints of a clinical study and that any data generated from such studies may not support a regulatory submission or approval; risks related to seeking regulatory approvals and conducting clinical trials; risks of supplying drug product; risks related to leveraging the expertise of its employees, subsidiaries, affiliates and partners to assist the company in the execution of its strategies; risks related to Sorrentos debt obligations; and other matters that are described in Sorrento's Annual Report on Form 10-K for the year ended December 31, 2018, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release and we undertake no obligation to update any forward-looking statement in this press release except as required by law.

Media and Investor Relations

Alexis Nahama, DVM (SVP Corporate Development)

Telephone: 1.858.203.4120

Email: mediarelations@sorrentotherapeutics.com

ZTlido and G-MAB are trademarks owned by Scilex Pharmaceuticals Inc. and Sorrento, respectively.

Seprehvir, is a registered trademark of VirttuBiologics Limited, a wholly-owned subsidiary of TNK Therapeutics, Inc. and part of the group of companies owned by Sorrento Therapeutics, Inc.

All other trademarks are the property of their respective owners.

2019 Sorrento Therapeutics, Inc. All Rights Reserved.

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Canine Stem Cell Therapy Market Trends and Analysis to (2019-2025) – Pledge Times

Posted: November 7, 2019 at 11:46 am

Canine Stem Cell Therapy market report includes the estimation of market size for value and volume. Further, the report explains statistical forecasts, major trends, regional marketing analysis, and Canine Stem Cell Therapy industry based on Strengths, Weaknesses, industry internal and external environments. Those data are further broken down with manufacturing base distribution, Canine Stem Cell Therapy production area and product type. Major points like market situation and trends, concentration rate mergers, expansion which is basic Canine Stem Cell Therapy information to grow/establish a business is also provided.

Companies operating in the Canine Stem Cell Therapy Market are focusing on merger and acquisitions and new product launches to gain competitive advantage. The Canine Stem Cell Therapy report offers accurately prepared statistics that show the comparison of the aforementioned estimations for all years of the forecast period 2019-2025. numerous factors area unit accountable for the Canine Stem Cell Therapy markets growth, that area unit studied well during this analysis report.

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Triumvira Immunologics Announces Fast Track Designation for Its First TAC T-Cell Therapeutic Product Candidate: TAC01-CD19 – Yahoo Finance

Posted: November 7, 2019 at 11:46 am

AUSTIN, Texas & HAMILTON, Ontario--(BUSINESS WIRE)--

Designation Confirms Significant Unmet Need Remains in DLBCL

Triumvira Immunologics, Inc. (Triumvira), a private, clinical-stage biopharmaceutical company developing a novel platform for engineering T-cells to attack cancers, today announced that the U.S. Food & Drug Administration (FDA) has granted Fast Track designation for its novel T-cell therapy product TAC01-CD19 in patients with relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL) after at least 2 prior systemic therapies. A Phase 1/2 study (TACTIC-19) conducted in patients with CD19-positive B-cell malignancies, including DLBCL, is expected to be initiated by the end of 2019.

FDAs decision to grant Fast Track designation to TAC01-CD19 is an important recognition of both Triumviras differentiated cell therapy technology and the critical need to develop new therapies to address the unmet medical need in the treatment of B-cell lymphomas, commented Paul Lammers, MD, MSc., President and CEO of Triumvira. With our innovative TAC technology, we hope to significantly improve upon the limitations of existing cell therapies, including the risk of cytokine release syndrome (CRS) and neurotoxicity, which would allow us to expand the number of patients eligible to receive this type of treatment.

TAC01-CD19 will be tested at four leading lymphoma clinical study centers in the U.S. and Canada. Based on its preclinical profile, TAC01-CD19 has the potential to represent a significant advancement in T-cell therapy.

About TAC01-CD19

Despite transformational efficacy with existing approved Chimeric Antigen Receptor T-Cells (CAR-T), a significant unmet need remains due to substantial CAR-T toxicities and limited tumor types where CAR-T is effective. Triumvira is developing a proprietary T-Cell Antigen Coupler (TAC) receptor which is structurally and biologically distinct from CAR-T. The first of our pipeline product candidates, TAC01-CD19 is a novel T-cell therapy product targeting CD19, a validated target in lymphomas and leukemias. The product comprises patient-derived T-cells that have been genetically engineered to express the CD19 T-cell Antigen Coupler (TAC). Preclinical data suggest that TAC01-CD19 has the potential for being highly efficacious with minimal side effects in hematological malignancies.

About CD19 and Diffuse Large B-Cell Lymphoma (DLBCL)

CD19 is a B-cell marker and is expressed on the surface of B-cell malignancies such as Diffuse Large B-Cell Lymphoma (DLBCL). DLBCL is a subtype of Non-Hodgkin Lymphomas (NHLs). DLBCL impacted approximately 26,000 patients in the U.S. in 2018. While the objective response rates of 50 70% observed for treatment of large B-cell lymphomas with currently marketed patient-derived T-cell products are good, there still exists a significant percentage of patients who either do not benefit from treatment or who are not able to tolerate the serious toxicities associated with these products.

About U.S. FDAs Fast Track Designation Program

The FDAs Fast Track program was established to facilitate the development and expedite the review of drugs with the potential to treat serious conditions and address an unmet medical need. Companies that receive Fast Track designation are provided the opportunity for more frequent interactions with FDA during clinical development and are eligible for accelerated approval and/or priority review, if relevant criteria are met. Additionally, companies that receive Fast Track designation are allowed to submit completed sections of their New Drug Application (NDA) or Biologics License Application (BLA) for the drug on a rolling basis, resulting in the potential for an expedited FDA review process.

About Triumvira Immunologics

Triumvira Immunologics, Inc. (Triumvira) is a clinical stage immunotherapy company with the vision of developing novel T-cell therapies that are safer and more efficacious than current cell therapy cancer treatments, including chimeric antigen receptor (CAR) and engineered T-cell receptor (TCR) therapies. Our proprietary T-cell Antigen Coupler (TAC) technology recruits the entire natural T-cell receptor and functions independent of the Major Histocompatibility Complex (MHC), allowing for the development of better therapies for a broader range of patients with solid or liquid malignancies and with diseases other than cancer. With operations spanning North America, our corporate offices are in Austin, Texas, with our research facilities in Hamilton, Ontario. For more information, visit http://www.triumvira.com or send email inquiries to partners@triumvira.com.

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Autolus Therapeutics Reports Third Quarter 2019 Financial Results and Operational Progress – GlobeNewswire

Posted: November 7, 2019 at 11:46 am

LONDON, Nov. 07, 2019 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc(Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announced its operational and financial results for the third quarter ended September 30, 2019.

We are excited about the opportunity to share data updates at ASH on AUTO1 in ALL in three oral presentations, as well as an oral presentation on AUTO3 in DLBCL. We are also looking forward to presenting data on our other hematological clinical programs at ASH, and non-clinical data on our lead solid tumor program AUTO6NG at SITC, stated Dr. Christian Itin, chairman and chief executive officer of Autolus. This quarter we have made significant operational progress, delivering cell products from our new manufacturing operations at the Cell and Gene Therapy Catapult and further strengthening our management team. Supported by a strong balance sheet, our key focus is on moving AUTO1 into our first pivotal clinical program in adult patients with ALL.

Pipeline Updates:

Solid tumors (AUTO6NG) - AUTO6NG: Next generation GD2-targeting CAR T-cell therapy with improved persistence and insensitivity to TGFb and checkpoint inhibition for relapsed/refractory neuroblastoma (Saturday November 9, poster presentation)

Adult ALL (AUTO1) - AUTO1, a novel fast off CD19 CAR delivers durable remissions and prolonged CAR T cell persistence with low CRS or neurotoxicity in adult ALL (Saturday December 7, oral presentation)

Pediatric ALL (AUTO1) - Therapy of pediatric B-ALL with a lower affinity CD19 CAR leads to enhanced expansion and prolonged CAR T cell persistence in patients with low bone marrow tumor burden, and is associated with a favorable toxicity profile (Saturday December 7, oral presentation)

Integration Site Analysis (AUTO1) - Clonal dynamics of early responder and long-term persisting CAR-T cells in humans (Saturday December 7, oral presentation)

DLBCL (AUTO3) - Phase 1/2 study of AUTO3 the first bicistronic chimeric antigen receptor (CAR) targeting CD19 and CD22 followed by an anti-PD1 in patients with relapsed/refractory (r/r) Diffuse Large B Cell Lymphoma (DLBCL): Results of Cohort 1 and 2 of the ALEXANDER study (Saturday December 7, oral presentation)

Multiple Myeloma (AUTO2) - Phase 1 First-in-Human study of AUTO2, the first chimeric antigen receptor (CAR) T cell targeting APRIL for patients with relapsed/refractory Multiple Myeloma (RRMM) (Sunday December 8, poster presentation)

Pediatric ALL (AUTO3) - Phase 1 Study of AUTO3, a Bicistronic Chimeric Antigen Receptor (CAR) T-cell Therapy Targeting of CD19 and CD22, in Pediatric Patients with Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia (r/r B-ALL): AMELIA Study (Sunday December 8, poster presentation)

Operational and Corporate Highlights:

The Cell and Gene Therapy Catapult site is fully operational and is delivering clinical products for patients in both Europe and the US

In September, PPF Group announced that they had acquired, mainly from Woodford Investment Management, an approximate 19% holding of Autolus. Control of all the remaining shares of Autolus held by Woodford Investment Management are in the process of being transferred to Schroder UK Public Private Trust plc.

In September, Autolus announced that the journal Nature Medicine has published both pre-clinical results and clinical data from the ongoing Phase 1 CARPALL trial of AUTO1, demonstrating the potential of the companys novel CAR T therapy targeting CD19 in development for the treatment of pediatric acute lymphoblastic leukemia (ALL).

David Brochu has been named Senior Vice President, Head of Product Delivery to lead the transition of the companys manufacturing organization to deliver products for late-stage clinical studies and commercial sale. In addition, Vishal Mehta has been named Vice President, Head of Clinical Operations.

Key Upcoming Clinical Milestones:

Financial results for third quarter 2019

Cash and equivalents at September 30, 2019 totaled $229.4 million, compared with $247.1 million at September 30, 2018.

Net total operating expenses for the three months ended September 30, 2019 were $35.6 million, net of grant income of $0.3 million, as compared to net operating expenses of $17.1 million, net of grant income of $0.3 million, for the same period in 2018. The increase was due, in general, to the increase in development activity, increased headcount primarily in our development and manufacturing functions, and the cost of being a public company.

Research and development expenses increased to $27.3 million for the three months ended September 30, 2019 from $10.1 million for the three months ended September 30, 2018. Cash costs, which exclude depreciation as well as share-based compensation, increased to $21.6 million from $9.0 million. The increase in research and development cash costs of $12.6million consisted primarily of an increase of compensation-related costs of $5.2million primarily due to an increase in employee headcount to support the advancement of our product candidates in clinical development, an increase of $3.6 million in research and development program expenses related to the activities necessary to prepare, activate, and monitor clinical trial programs, including the manufacturing technical transfer activities required for AUTO1 to enable the commencement at the end of 2019 of a registration study in Adult Acute Lymphoblastic Leukemia, an increase of $2.6 million in facilities costs supporting the expansion of our research and translational science capability and investment in manufacturing facilities and equipment, an increase of $0.7 million in telecom and software costs, and an increase of $0.5 million in other costs.

General and administrative expenses increased to $8.6 million for the three months ended September30, 2019 from $7.3 million for the three months ended September30, 2018. Cash costs, which exclude depreciation expense as well as share-based expense compensation decreased to $5.6 million from $5.7 million. Compensation related expenses decreased by $0.6 million and IT, telecommunication, and general office expense costs decreased by $0.7 million which were offset by an increase in legal and professional fees of $0.9 million and an increase of $0.3 million in commercial costs.

Net loss attributable to ordinary shareholders was $27.2 million for the three months ended September 30, 2019, compared to $12.9 million for the same period in 2018.

The basic and diluted net loss per ordinary share for the three months ended September 30, 2019 totaled $(0.61) compared to a basic and diluted net loss per ordinary share of $(0.33) for the three months ended September 30, 2018.

Autolus anticipates that cash on hand provides a runway into the second half of 2021.

Conference Call and Presentation Information

Autolus management will host a conference call today, November 7, at 8:30 a.m. EST/ 1:30pm GMT, to discuss the companys financial results and operational update.

To listen to the webcast and view the accompanying slide presentation, please go to: https://www.autolus.com/investor-relations/news-events/events.

The call may also be accessed by dialing (866) 679-5407 for U.S. and Canada callers or (409) 217-8320 for international callers. Please reference conference ID 5075598. After the conference call, a replay will be available for one week. To access the replay, please dial (855) 859-2056 for U.S. and Canada callers or (404) 537-3406 for international callers. Please reference conference ID 5075598.

About Autolus Therapeutics plc

Autolus is a clinical-stage biopharmaceutical company developing next-generation, programmed T cell therapies for the treatment of cancer. Using a broad suite of proprietary and modular T cell programming technologies, the company is engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognize cancer cells, break down their defense mechanisms and eliminate these cells. Autolus has a pipeline of product candidates in development for the treatment of hematological malignancies and solid tumors. For more information please visit http://www.autolus.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, and in some cases can be identified by terms such as "may," "will," "could," "expects," "plans," "anticipates," and "believes." These statements include, but are not limited to, statements regarding Autolus financial condition and results of operations, as well as statements regarding the anticipated development of Autolus product candidates, including its intentions regarding the timing for providing further updates on the development of its product candidates, and the sufficiency of its cash resources. Any forward-looking statements are based on management's current views and assumptions and involve risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section titled "Risk Factors" in Autolus' Annual Report on Form 20-F filed on November 23, 2018 as well as discussions of potential risks, uncertainties, and other important factors in Autolus' future filings with the Securities and Exchange Commission from time to time. All information in this press release is as of the date of the release, and the company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required by law.

Investor and media contact: Silvia TaylorVice President, Corporate Affairs and Communications Autolus+1-240-801-3850s.taylor@autolus.com

UK:Julia Wilson+44 (0) 7818 430877j.wilson@autolus.com

Autolus Therapeutics PLCCondensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)(In thousands, except share and per share amounts)

Autolus Therapeutics PLCCondensed Consolidated Balance Sheets(In thousands, except share and per share amounts)

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SQZ Biotech and AskBio Announce Research Collaboration to Create Immune Tolerization Products for AAV Gene Therapies – GlobeNewswire

Posted: November 7, 2019 at 11:46 am

WATERTOWN, Mass. and RESEARCH TRIANGLE PARK, N.C., Nov. 07, 2019 (GLOBE NEWSWIRE) -- SQZ Biotechnologies (SQZ), and Asklepios BioPharmaceutical, Inc. (AskBio), announced a research collaboration to create tolerizing antigen carriers (TACs) containing AAV (adeno-associated virus) components to solve one of gene therapys biggest challenges the barrier to treatment posed by patients immune systems generating neutralizing antibodies toward therapeutic AAVs. SQZ and AskBio will combine their proprietary cell and gene therapy platform technologies to open the door to new treatment paradigms with potential impact across many genetic diseases.

Gene therapies utilizing AAV vectors can be transformative for patients with genetic diseases, but neutralizing antibodies can prevent large populations of patients from benefitting from AAV gene therapies. Patients immune systems develop neutralizing antibodies after receiving their first dose of AAV, or they can be pre-existing. This collaboration will strive to give these patients access to novel therapeutics and enable them to take multiple or repetitive doses to gain the full, durable benefit these treatments can provide. Expanding patient eligibility and allowing repeat treatment could change the future of how products are developed and significantly impact the long-term health of millions in need.

This is a tremendous opportunity to bring together the power of both cell and gene therapy for patients. AskBio has been an innovative leader in gene therapy and shares our patient-centric philosophy. By working together and leveraging the potential of both our platforms, we hope to bring more effective, more durable treatments to patients suffering from devastating rare genetic disorders, said Armon Sharei, PhD, founder and chief executive officer of SQZ Biotech.

The collaboration between SQZ and AskBio will evaluate the administration of SQZ TACs and AskBios gene therapies to potentially address AAV immunogenicity. SQZ is a pioneer in cell therapy, and the companys knowledge and expertise, as well as their advance capabilities in manufacturing, are critical to this collaborations approach to synergizing cell and gene therapies. Preclinical data from SQZ has demonstrated that SQZ TACs specifically inhibit undesired immune responses in multiple contexts, including AAV models. As a leader in the AAV field, AskBio brings expertise in AAV technology, capsid design, clinical processes and manufacturing that would allow for application of these novel methods to overcome immunogenicity. The two companies have a shared goal to increase world-wide access of transformative therapeutics.

R. Jude Samulski, PhD, chief scientific officer and co-founder of AskBio, noted, AskBio is firmly committed to improving the lives of underserved patients, such as those suffering from Pompe, Huntingtons and various neuromuscular and central nervous system diseases. Addressing AAV immunogenicity is essential to the future of gene therapy as it is one of the most significant limiting factors plaguing the gene therapy space today. SQZs pioneering approach to tolerance could offer a solution to this problem. Our collaboration with SQZ is exemplary of our goal to broadly explore potential redosing of AAV gene therapies, added Sheila Mikhail, chief executive officer and co-founder of AskBio. We are thrilled to be working with SQZ and are hopeful that this initial research collaboration utilizing two of the most promising therapeutic modalities currently available, cell and gene therapy, will ultimately provide options to improve patients immune response to gene therapy.

About AskBioFounded in 2001, Asklepios BioPharmaceutical, Inc. (AskBio) is a privately held, clinical-stage gene therapy platform company dedicated to improving the lives of children and adults with genetic disorders. AskBios gene therapy platform includes an industry-leading proprietary cell line manufacturing process known as Pro10 and an extensive AAV capsid library. Based in Research Triangle Park, N.C., the company has generated hundreds of proprietary third-generation gene vectors, several of which have entered clinical testing. An early innovator in the space, the company holds more than 500 patents in areas such as AAV production, chimeric vectors, and self-complementary DNA. AskBio maintains a portfolio of clinical programs across a range neurodegenerative and neuromuscular indications with a current pipeline that includes therapeutics for Pompe disease, Limb Girdle Muscular Dystrophy and congestive heart failure as well as out-license clinical indications for Hemophilia (Chatham Therapeutics acquired by Takeda) and Duchenne Muscular Dystrophy (Bamboo Therapeutics acquired by Pfizer). For more information, visit http://www.askbio.com.

About SQZ BiotechSQZ Biotech is a privately held, clinical-stage company creating innovative treatments by transforming cells into sophisticated therapeutics. Using its proprietary platform, SQZ has the unique ability to precision engineer virtually any cell type and deliver multiple materials, potentially resulting in powerful, multifunctional cell therapies for a range of diseases with an initial focus on cancer and autoimmune disease. The companys initial applications leverage SQZs ability to generate target-specific immune responses, both in activation for the treatment of solid tumors, and immune suppression for the treatment of immune reactions and diseases. For more information please visit http://www.sqzbiotech.com.

About SQZ TACsSQZ tolerizing antigen carriers (TACs) are being developed to induce tolerance to aberrant or unwanted immune activity. TACs are developed from red blood cells (RBCs) SQZd with target-specific antigens and piggyback on the natural process of RBC destruction in the body, also known as eryptosis. A process moderated by our liver and spleen, eryptosis causes macrophages to take up aged or senescent RBCs. When our bodies process RBCs for destruction, their components are presented in a tolerogenic manner, reminding our immune systems not to attack our own red blood cells. SQZ TACs drive targeted antigensthrough this powerful natural mechanism, specifically tolerizing the immune system, potentially stopping undesired immune responses.

AskBio Contacts: Mark Rosenbergmark@trueparallel.com919-412-7378

Roger Friedensen, APRroger@trueparallel.com919-349-3206

SQZ Contacts:Rebecca CohenSenior Manager, Corporate Relationsrebecca.cohen@sqzbiotech.com617-758-8672 ext. 728

Cait Williamson, PhDLifeSci Public Relations cait@lifescipublicrelations.com646-751-4366

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Bone Therapeutics Reports Financial Results for the First Nine Months of 2019 and Provides Third Quarter 2019 Business Update – OrthoSpineNews

Posted: November 7, 2019 at 11:46 am

Gosselies, Belgium, 6November 2019, 7am CET BONE THERAPEUTICS(Euronext Brussels and Paris: BOTHE), the leading biotech company focused on the development of innovative cell and biological therapies to address high unmet medical needs in orthopaedics and bone diseases, today reports its financial results for the first nine months of 2019 and provides a business update for the third quarter ended 30 September 2019.

Thomas Lienard, Chief Executive Officer of Bone Therapeutics commented: We are making strong progress across the entire business and we are now approaching key value inflection points. As we near the completion of the necessary regulatory and operational measures, including the successful production of clinical batches, we are fully prepared to start late-stage clinical development with our allogenic cell therapy product, ALLOB, in patients with difficult-to-heal fractures, and our enriched protein solution, JTA-004, in patients with knee osteoarthritis. With most preparations in place, we look forward to further executing on our strategy and to communicating the next milestones in the following months.

Operational highlights Q3 2019 to date

Financial highlights first nine months 2019(1)

Outlook for the remainder of 2019

(1)Unaudited numbers

About Bone Therapeutics

Bone Therapeutics is a leading biotech company focused on the development of innovative products to address high unmet needs in orthopaedics and bone diseases. Based in Gosselies, Belgium, the Company has a broad, diversified portfolio of bone cell therapy and an innovative biological product in later-stage clinical development across a number of disease areas, which target markets with large unmet medical needs and limited innovation.

Bone Therapeutics core technology is based on its allogeneic cell therapy platform (ALLOB) which uses a unique, proprietary approach to bone regeneration, which turns undifferentiated stem cells from healthy donors into bone-forming cells. These cells can be administered via a minimally invasive procedure, avoiding the need for invasive surgery, and are produced via a proprietary, cutting-edge manufacturing process.

The Companys ALLOB product pipeline includes a cell therapy product candidate that is expected to enter Phase IIb clinical development for the treatment of difficult-to-heal fractures and a Phase II asset in patients undergoing a spinal fusion procedure. In addition, the Company is also developing an off-the-shelf protein solution, JTA-004, which is expected to enter Phase III development for the treatment of pain in knee osteoarthritis.

Bone Therapeutics cell therapy products are manufactured to the highest GMP (Good Manufacturing Practices) standards and are protected by a broad IP (Intellectual Property) portfolio covering ten patent families as well as knowhow. Further information is available atwww.bonetherapeutics.com.

Contacts

Bone Therapeutics SAThomas Lienard, Chief Executive OfficerJean-Luc Vandebroek, Chief Financial OfficerTel: +32 (0) 71 12 10 00investorrelations@bonetherapeutics.com

International Media Enquiries:Consilium Strategic CommunicationsMarieke VermeerschTel: +44 (0) 20 3709 5701bonetherapeutics@consilium-comms.com

For French Media and Investor Enquiries:NewCap Investor Relations & Financial CommunicationsPierre Laurent, Louis-Victor Delouvrier and Arthur RouillTel: + 33 (0)1 44 71 94 94bone@newcap.eu

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors` current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person`s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

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Bone Therapeutics Reports Financial Results for the First Nine Months of 2019 and Provides Third Quarter 2019 Business Update - OrthoSpineNews

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Autolus Therapeutics to Present New Data on Its Advanced Programmed T Cell Therapies at the 61st ASH Annual Meeting – Yahoo Finance

Posted: November 7, 2019 at 11:45 am

Company to Present Four Oral Presentations and Two Posters

LONDON, Nov. 06, 2019 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc(AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies for the treatment of cancer, announced four oral and two poster presentations related to its AUTO1, AUTO2 and AUTO3 programs at the 61st American Society of Hematology (ASH) Annual Meeting and Exposition, to be held December 7-10, 2019 in Orlando, FL.

We are pleased that AUTO1 data will be presented in three oral presentations at ASH. The data form the basis for our decision to move AUTO1 into a pivotal clinical trial in adult ALL, our highest priority program, said Dr. Christian Itin, chairman and chief executive officer of Autolus. We are also looking forward to presenting data on our other hematological clinical programs at ASH. These presentations will further illustrate the significant progress we have made across our clinical portfolio this year.

The abstracts have been published today and are available on the ASH website at https://www.hematology.org/Annual-Meeting/Abstracts/.

The oral presentation details are as follows:

Title: AUTO1 A novel fast off CD19CAR delivers durable remissions and prolonged CAR T cell persistence with low CRS or neurotoxicity in adult ALLPresenter: Dr Claire RoddieSession Date and Time: Saturday, December 7, 2:45 PM Eastern Time

Title: AUTO1 Therapy of pediatric B-ALL with a lower affinity CD19 CAR leads to enhanced expansion and prolonged CAR T cell persistence in patients with low bone marrow tumor burden, and is associated with a favorable toxicity profilePresenter: Dr Sara GhorashianSession Date and Time: Saturday, December 7, 2:30 PM Eastern Time

Title: AUTO1 Clonal dynamics of early responder and long-term persisting CAR-T cells in humansPresenter: Dr Luca BiascoSession Date and Time: Saturday, December 7, 8:15 AM Eastern Time

Title: AUTO3 Ongoing Phase 1/2 ALEXANDER clinical trial in patients with relapsed/refractory diffuse large B cell lymphoma (DLBCL)Presenter: Dr Kirit ArdeshnaSession Date and Time: Saturday, December 7, 3:15 PM Eastern Time

The poster presentation details are as follows:

Title: AUTO2 Phase 1 First-in-Human study of AUTO2, the first chimeric antigen receptor (CAR) T cell targeting APRIL for patients with relapsed/refractory Multiple Myeloma (RRMM)Presenter: Dr Rakesh PopatSession Date and Time: Sunday, December 8, 6:00 PM 8:00 PM Eastern Time

Title: AUTO3 Phase 1/2 AMELIA clinical trial of AUTO3 in patients with relapsed/refractory pediatric acute lymphoblastic leukemia (pALL)Presenter: Professor Persis AmroliaSession Date and Time: Sunday, December 8, 6:00 PM 8:00 PM Eastern Time

About AUTO1

AUTO1 is a CD19 CAR T cell investigational therapy designed to overcome the limitations in safety - while maintaining similar levels of efficacy - compared to current CD19 CAR T cell therapies.Designed to have a fast target binding off-rate to minimize excessive activation of the programmed T cells, AUTO1 may reduce toxicity and be less prone to T cell exhaustion, which could enhance persistence and improve the T cells' abilities to engage in serial killing of target cancer cells. In 2018, Autolus signed a license agreement under which Autolus acquired global rights fromUCL Business plc(UCLB), the technology-transfer company of UCL, to develop and commercialize AUTO1 for the treatment of B cell malignancies. AUTO1 is currently being evaluated in two Phase 1 studies, one in pediatric ALL and one in adult ALL.

About AUTO3

AUTO3 is a programmed T cell therapy containing two independent chimeric antigen receptors targeting CD19 and CD22 that have each been independently optimized for single target activity. By simultaneously targeting two B cell antigens, AUTO3 is designed to minimize relapse due to single antigen loss in patients with B cell malignancies. AUTO3 is currently being tested in pediatric ALL in the AMELIA clinical trial and in diffuse large B cell lymphoma in the ALEXANDER clinical trial.

About AUTO2

AUTO2 is the first dual-targeting programmed T cell product candidate binding to two targets on multiple myeloma cells. AUTO2 uses a human ligand, known as APRIL, which binds to two antigens, B cell Maturation Antigen, or BCMA, and the transmembrane activator and CAML interactor, or TACI, both of which are expressed on the surface of multiple myeloma cancer cells. AUTO2 is designed to address a key escape route used by hematological cancers in response to T cell therapies.

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AboutAutolus Therapeutics plc

Autolus is a clinical-stage biopharmaceutical company developing next-generation, programmed T cell therapies for the treatment of cancer. Using a broad suite of proprietary and modular T cell programming technologies, the company is engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognize cancer cells, break down their defense mechanisms and eliminate these cells. Autolus has a pipeline of product candidates in development for the treatment of hematological malignancies and solid tumors. For more information please visit http://www.autolus.com.

Forward-Looking Statement

This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, and in some cases can be identified by terms such as "may," "will," "could," "expects," "plans," "anticipates," and "believes." These statements include, but are not limited to, statements regarding Autolus financial condition and results of operations, as well as statements regarding the anticipated development of Autolus product candidates, including its intentions regarding the timing for providing further updates on the development of its product candidates, and the sufficiency of its cash resources. Any forward-looking statements are based on management's current views and assumptions and involve risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section titled "Risk Factors" in Autolus' Annual Report on Form 20-F filed on November 23, 2018 as well as discussions of potential risks, uncertainties, and other important factors in Autolus' future filings with the Securities and Exchange Commission from time to time. All information in this press release is as of the date of the release, and the company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required by law.

Investor and media contact: Silvia TaylorVice President, Corporate Affairs and Communications Autolus+1-240-801-3850s.taylor@autolus.com

UK:Julia Wilson+44 (0) 7818 430877j.wilson@autolus.com

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Autolus Therapeutics to Present New Data on Its Advanced Programmed T Cell Therapies at the 61st ASH Annual Meeting - Yahoo Finance

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Woman Who Was Attacked By Cat Sues the Outrigger Canoe Club in Waikiki – Legal Reader

Posted: November 7, 2019 at 11:44 am

Leslie Mansfield, a California resident who enjoys running a Napa Valley winery and writing cookbooks filed a lawsuit against the Outrigger Canoe Club in Waikiki after her foot was allegedly attacked by a cat. Eventually, the bite marks caused a rare, incurable condition known as host versus graft disease, prompting Mansfield to file the suit.

The incident occurred in September 2015 when Leslie and her husband were visiting the Outrigger Canoe Club to celebrate the end of her leukemia treatments. In the middle of having lunch at the clubs Hau Terrace restaurant, a cat suddenly jumped from a nearby bush and attacked her foot. Mansfield said, all of a sudden I felt this unbelievable sharp, excruciating biteWithin a week it was worse and the bite marks were black and it was really frightening.

According to the lawsuit, the infection from the bite continued to worsen and eventually she began to develop lesions in her mouth, on her skin, and throughout her body. She said, the lesions in my mouth are so swollen around my tongue and cheeks I have deep crevasse-like cuts in the roof of my mouth.

How did a simple cat bite get so infected, though? Well, because Mansfield had recently undergone a stem cell transplant, the bite compromised her immune system. According to Mansfield, who had stem cells donated from her brother, doctors told her that when she got bit by the cat, those cells not only began attacking the pathogens introduced by the cat but they also started to attack her system.

As a result, Mansfield experiences regular painful flares that leave her exhausted and unable to do much of anything. Her quality of life has been diminished and she blames the Outrigger Canoe club that harbored the cat.

When commenting on the matter, attorney Jim Bickerton who is representing Mansfield said, the cat spent its entire existence on those premises. It wasnt a stray that lived somewhere else and came visiting. This was home for this cat. He added that under Hawaii law, the club is not only responsible for the cat bite but its also responsible for the subsequent damage to his clients immune system. He said, if someone has very brittle bones, for example, and they take a small fallYou or I might just fracture a bone or not even have a fracture but they have fractures in 20 places. The person who caused that fall owns all of the damage.

In response to the lawsuit, a spokesperson for the club said, The health, safety, and well-being of all of our members, guests and staff are of primary importance to the Outrigger.

The suit is expected to go to trial next August.

Lawsuit: Cat bite at Outrigger Canoe Club caused womans rare disease

GRAFT-VERSUS-HOST DISEASE

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Woman Who Was Attacked By Cat Sues the Outrigger Canoe Club in Waikiki - Legal Reader

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Spaceflight alters human heart cells, but they mostly return to normal: Study – Hampshire Chronicle

Posted: November 7, 2019 at 11:43 am

The thought of spaceflight may make the heart skip a beat, but actually travelling beyond Earth could alter the organs cells.

With extended stays aboard the International Space Station (ISS) commonplace, and the likelihood of humans spending longer periods in space increasing, there is a need to better understand the effects of micro-gravity on cardiac function.

New research suggests heart muscle cells derived from stem cells have a remarkable ability to adapt to their environment during and after spaceflight.

Scientists examined cell-level cardiac function and gene expression in human heart cells cultured aboard the International Space Station for five-and-a-half weeks.

They found that exposure to micro-gravity changed the expression of thousands of genes, but largely normal patterns reappeared within 10 days after returning to Earth.

Senior study author, Joseph Wu, of Stanford University School of Medicine, said: Our study is novel because it is the first to use human induced pluripotent stem cells to study the effects of spaceflight on human heart function.

Micro-gravity is an environment that is not very well understood, in terms of its overall effect on the human body, and studies like this could help shed light on how the cells of the body behave in space, especially as the world embarks on more and longer space missions such as going to the moon and Mars.

Until now, most studies on how the heart reacts to micro-gravity have been conducted in either non-human models or at tissue, organ or systemic level.

To address this, the beating cells were launched to the ISS aboard a SpaceX spacecraft as part of a commercial resupply service mission.

Simultaneously, they were also cultured on Earth for comparison purposes.

When they returned to the planet, the cells showed normal structure and morphology.

However, they did adapt by modifying their beating pattern and calcium recycling patterns.

Researchers sequenced the cells harvested at four-and-a-half weeks aboard the ISS, and 10 days after returning to Earth.

Results showed that 2,635 genes were differentially expressed among flight, post-flight, and ground control samples.

Most notably, gene pathways related to mitochondrial function were expressed more in the space-flown cells, according to the research published in the Stem Cells Reports journal.

A comparison of the samples revealed the space cells adopted a unique gene expression pattern during spaceflight, which reverted to one that is similar to ground-side controls upon return to normal gravity.

Dr Wu added: Were surprised about how quickly human heart muscle cells are able to adapt to the environment in which they are placed, including micro-gravity.

These studies may provide insight into cellular mechanisms that could benefit astronaut health during long-duration spaceflight, or potentially lay the foundation for new insights into improving heart health on Earth.

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Spaceflight alters human heart cells, but they mostly return to normal: Study - Hampshire Chronicle

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