Scientific Advisory Board Member Resigns Due to Conflict with Responsibilities with Important Public Sector Entity

Scientific Advisory Board Member Resigns Due to Conflict with Responsibilities with Important Public Sector Entity




Scientific Advisory Board Member Resigns Due to Conflict with Responsibilities with Important Public Sector Entity

LOS ANGELES, Oct. 15, 2021 (GLOBE NEWSWIRE) — (NASDAQ: ENOB) Enochian BioSciences, a company focused on gene modified cellular and immune therapies for infectious diseases and cancer, announced that Dr. Peter Piot has resigned as Chairperson of the Respiratory Diseases Scientific Advisory Board due to important responsibilities advising a major governmental organization on COVID-19 that creates a conflict.

“I remain very impressed by, and enthusiastic about, the innovative science and potential of Enochian BioSciences’ entire pipeline,” said Dr. Piot. “However, my responsibilities advising a governmental organization do not allow me to continue as a scientific advisor.”

About Enochian BioSciences, Inc.
Enochian BioSciences, Inc. is a biopharmaceutical company focused on developing innovative platforms for gene-modified cellular and immune therapies to potentially cure and treat deadly diseases. The company’s gene-modified cell and immune therapy platforms can potentially be applied to multiple indications, including HIV/AIDS, Hepatitis B, all Corona and Influenza viruses, and Oncology. For more information, please visit Enochianbio.com

Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties, including but not limited to the success or efficacy of our pipeline. All statements other than historical facts are forward-looking statements, which can be identified by the use of forward-looking terminology such as “believes,” “plans,” “expects,” “aims,” “intends,” “potential,” or similar expressions. Actual events or results may differ materially from those projected in any of such statements due to various uncertainties, including as set forth in Enochian BioSciences’ most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, and Enochian BioSciences undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.

CONTACT: Contact: ir@enochianbio.com

XORTX Therapeutics Announces Closing of US$12 Million Public Offering

XORTX Therapeutics Announces Closing of US$12 Million Public Offering




XORTX Therapeutics Announces Closing of US$12 Million Public Offering

CALGARY, Alberta, Oct. 15, 2021 (GLOBE NEWSWIRE) — XORTX Therapeutics Inc. (“XORTX” or the “Company”) (CSE: XRX | NASDAQ: XRTX), a pharmaceutical therapeutics company focused on developing innovative therapies to treat progressive kidney disease, today announced the closing of an underwritten public offering of 2,906,000 units (“Units”), with each Unit consisting of one common share, no par value, and one warrant (“Warrant”) to purchase one common share at a public offering price of US$4.13 per Unit, for aggregate gross proceeds of approximately US$12 million, prior to deducting underwriting discounts and other offering expenses (the “Offering”). The common shares and warrants contained in the Units are immediately separable upon issuance. The warrants have an initial exercise price of US$4.77 per share, are immediately exercisable, and have a term of approximately five years. In addition, the Company granted the underwriters a 45-day option to purchase up to an additional 435,900 common shares and/or warrants to purchase up to an additional 435,900 common shares at the Offering price less the underwriting discounts. On October 15, 2021, A.G.P. exercised its option to purchase additional warrants to purchase up to an additional 435,900 common shares.

A.G.P. / Alliance Global Partners acted as sole book-running manager for the Offering.

Dr. Allen Davidoff, President and CEO stated, “We wish to thank the team at Alliance Global Partners for this successful offering and to welcome our new shareholders.  This financing, along with recent warrant exercises that have brought in over $1 million (Canadian dollars), places XORTX in a strong cash position to continue to advance our clinical trial programs and regulatory filings in support of our proprietary formulations – XRx-008 and XRx-101.”

The offering was made pursuant to an effective registration statement on Form F-1 (Registration No. 333-258741) previously filed with the U.S. Securities and Exchange Commission (the “SEC”). A final prospectus relating to this offering was filed with the SEC. Copies of the final prospectus relating to the offering may be obtained by contacting A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by email at prospectus@allianceg.com. Investors may also obtain these documents at no cost by visiting the SEC’s website at www.sec.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About XORTX Therapeutics Inc.

XORTX Therapeutics Inc. is a pharmaceutical company with two clinically advanced products in development – XRx-008 for Autosomal Dominant Polycystic Kidney Disease (ADPKD), XRx-101 for Coronavirus / COVID-19 infection and XRx-225 is a pre-clinical stage program for Type 2 Diabetic Nephropathy (T2DN). XORTX is working to advance its clinical development stage products that target aberrant purine metabolism and xanthine oxidase to decrease or inhibit production of uric acid. At XORTX Therapeutics, we are dedicated to developing medications to improve the quality of life and future health of patients. Additional information on XORTX Therapeutics is available at www.xortx.com.

For further information, please contact:  
   
Allen Davidoff, CEO   Nick Rigopulos, Director of Communications
adavidoff@xortx.com or +1 403 455 7727  nick@alpineequityadv.com or +1 617 901 0785
   
Dr. David Sans, Head of Corporate Development in New York City  
dsans123@xortx.com or +1 347 573 0541  

The CSE and Nasdaq have neither approved nor disapproved the contents of this news release. No stock exchange, securities commission or other regulatory authority has approved or disapproved the information contained herein.

Important Information

No announcements or information regarding the Offering may be disseminated to the public in jurisdictions where a prior registration or approval is required for such purpose. No steps have been, or will be taken for the Offering of securities in any jurisdiction where such steps would be required. The issue or sale of securities, and the subscription for or purchase of shares or securities are subject to special legal or statutory restrictions in certain jurisdictions. XORTX is not liable if these restrictions are not complied with by any other person.

Forward Looking Statements

This press release contains express or implied forward-looking statements pursuant to U.S. Federal securities laws. These forward-looking statements and their implications are based on the current expectations of the management of XORTX only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as otherwise required by law, XORTX undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. More detailed information about the risks and uncertainties affecting XORTX is contained under the heading “Risk Factors” in XORTX’s Registration Statement on Form F-1 filed with the SEC, which is available on the SEC’s website, www.sec.gov.

Avadel Pharmaceuticals Announces Ongoing FDA Review of NDA for FT218 for Patients with Narcolepsy

Avadel Pharmaceuticals Announces Ongoing FDA Review of NDA for FT218 for Patients with Narcolepsy




Avadel Pharmaceuticals Announces Ongoing FDA Review of NDA for FT218 for Patients with Narcolepsy

DUBLIN, Ireland, Oct. 15, 2021 (GLOBE NEWSWIRE) — Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on transforming medicines to transform lives, announced today that the U.S. Food and Drug Administration (FDA) notified the company that the review of the New Drug Application (NDA) for FT218 is still ongoing, and action will likely not be taken in October. The FDA informed the company that there are no information requests at this time and a new target action date will be provided as soon as possible.

“We have addressed all questions received to date and remain confident that the package we have submitted satisfies all of the FDA’s requests. We have not been informed of any deficiencies in our application and remain fully committed to work closely with the FDA for the duration of its review of our NDA for FT218,” said Greg Divis, Chief Executive Officer of Avadel. “Once-at-bedtime FT218 has the potential to truly impact the way people with narcolepsy are able to live their lives and we are dedicated to making this important therapy available to patients as quickly as possible.”

In February 2021, the FDA accepted Avadel’s NDA for FT218 and assigned a target action date of October 15, 2021. The NDA submission is supported by positive data from the pivotal Phase 3 REST-ON study, which was completed under a Special Protocol Assessment (SPA) agreement with the FDA.

About FT218
FT218 is an investigational formulation of sodium oxybate leveraging Avadel’s proprietary drug delivery technology and designed to be taken once at bedtime for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy.

In March 2020, Avadel completed the REST-ON study, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial, to assess the efficacy and safety of FT218 in patients with narcolepsy. Among the three co-primary endpoints, FT218 demonstrated statistically significant and clinically meaningful results in EDS, the clinician’s overall assessment of the patient’s functioning, and reduction in cataplexy attacks, for all three evaluated doses when compared to placebo.

In January 2018, the FDA granted FT218 Orphan Drug Designation for the treatment of narcolepsy based on the plausible hypothesis that FT218 may be clinically superior to the twice-nightly formulation of sodium oxybate already approved by the FDA for those with narcolepsy due to the consequences of middle-of-the-night dosing of the approved product. FT218 is currently under review by the FDA.

About Avadel Pharmaceuticals plc
Avadel Pharmaceuticals plc (Nasdaq: AVDL) is a biopharmaceutical company focused on transforming medicines to transform lives. Our approach includes applying innovative solutions to the development of medications that address the challenges patients face with current treatment options. Our current lead drug candidate, FT218, is an investigational formulation of sodium oxybate leveraging our proprietary drug delivery technology and designed to be taken once at bedtime for the treatment of excessive daytime sleepiness or cataplexy in adults with narcolepsy. For more information, please visit www.avadel.com.

Cautionary Disclosure Regarding Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements relate to the Company’s future expectations, beliefs, plans, strategies, objectives, results, conditions, financial performance, prospects, or other events. Such forward-looking statements include, but are not limited to, expectations regarding the timing of the FDA’s review of the NDA for FT218 and the sufficiency of data supporting the NDA for FT218. In some cases, forward-looking statements can be identified by the use of words such as “will,” “may,” “could,” “believe,” “expect,” “look forward,” “on track,” “guidance,” “anticipate,” “estimate,” “project,” “next steps” and similar expressions, and the negatives thereof (if applicable).

The Company’s forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. However, the Company’s business and operations are subject to significant risks, and, as a result, there can be no assurance that actual results and the results of the Company’s business and operations will not differ materially from the results contemplated in such forward-looking statements. Factors that could cause actual results to differ from expectations in the Company’s forward-looking statements include the risks and uncertainties described in the “Risk Factors” section of Part I, Item 1A of the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 and subsequent SEC filings.

Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. The Company does not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law.

Investor Contact:
Courtney Turiano
Stern Investor Relations, Inc.
Courtney.Turiano@sternir.com
(212) 698-8687

Media Contact:
Nicole Raisch Goelz
Real Chemistry
ngoelz@realchemistry.com
(408) 568-4292

Cabaletta Bio Announces Presentation of Preclinical Data Supporting PLA2R-CAART as a Potential Precision Therapy for Antigen-Specific B Cell Depletion in PLA2R Membranous Nephropathy at ASN Kidney Week 2021

Cabaletta Bio Announces Presentation of Preclinical Data Supporting PLA2R-CAART as a Potential Precision Therapy for Antigen-Specific B Cell Depletion in PLA2R Membranous Nephropathy at ASN Kidney Week 2021




Cabaletta Bio Announces Presentation of Preclinical Data Supporting PLA2R-CAART as a Potential Precision Therapy for Antigen-Specific B Cell Depletion in PLA2R Membranous Nephropathy at ASN Kidney Week 2021

– Chimeric AutoAntibody Receptor (CAAR) T cells specifically recognized and eliminated anti-PLA2R antibody-expressing B cells in vitro –

– Membrane proteome arrays screened with PLA2R CAAR candidates did not identify off-target interactions –

– Pre-IND interaction with the Food and Drug Administration (FDA) is planned for later this year for PLA2R-CAART preclinical candidate –

PHILADELPHIA, Oct. 15, 2021 (GLOBE NEWSWIRE) — Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies for patients with B cell-mediated autoimmune diseases, today announced that data from in vitro studies supporting the early preclinical validation of PLA2R-Chimeric AutoAntibody Receptor T (CAART) cell candidates will be presented at ASN Kidney Week 2021. The data will be presented as an oral abstract by Aimee Payne, M.D., Ph.D., Professor of Dermatology at the University of Pennsylvania’s Perelman School of Medicine and co-chair of the Scientific Advisory Board and co-founder at Cabaletta Bio at the American Society of Nephrology (ASN) Kidney Week 2021 being held virtually from November 4-7, 2021.

“Current therapeutic strategies for PLA2R membranous nephropathy patients include generalized immune suppression, including B cell depletion with rituximab, which often requires repeat treatments and may cause serious infections in certain patients. Building on the platform for CAART product candidates that are more advanced in development, including DSG3-CAART and MuSK-CAART, we aim to develop a highly specific therapy that provides safety, efficacy, and durability for patients suffering from this autoimmune disease,” said Dr. Payne “This initial preclinical data is promising, as it demonstrates the in vitro function of PLA2R-CAART cells against autoantibody-binding epitopes relevant to pathogenic B cells from patients with primary membranous nephropathy, with no evidence of off-target interactions.”

For this study, the Payne Laboratory generated multiple CAARs comprised of the PLA2R epitopes targeted by autoantibodies in PLA2R membranous nephropathy patients, as an extracellular decoy on the surface of T cells. These CAARs were observed to direct specific cytolysis of B cells expressing each of the anti-PLA2R autoantibodies tested. The data suggest that PLA2R-CAAR T cell therapy has the potential to target pathogenic B cells expressing autoantibodies against PLA2R while sparing healthy B cells, which could provide a novel precision therapeutic approach for patients with PLA2R membranous nephropathy. Membrane proteome arrays screened against leading PLA2R CAAR candidates did not identify any off-target interactions.

“These discovery and early preclinical studies conducted by our co-founder Dr. Aimee Payne and colleagues at the University of Pennsylvania are a meaningful step for Cabaletta Bio, as they further support the breadth of the CABA™ platform for patients with B cell-mediated autoimmune diseases and high unmet clinical need,” said Gwendolyn Binder, Ph.D., EVP Science and Technology at Cabaletta Bio. “These data provide the scientific rationale to commit our lead PLA2R-CAART candidate to preclinical development for patients with PLA2R membranous nephropathy.”

Oral Abstract Presentation Details
Title Chimeric autoantibody receptor (CAAR) T cells as a precision therapy for antigen-specific B cell depletion in PLA2R membranous nephropathy
Abstract Number FR-OR32
Session Glomerular Diseases: Antibodies, Complement, and Inflammatory Mediators
Session Date/Time Fri, Nov 5, 4:30 PM – 6:00 PM PDT
Format Pre-recorded, virtual with live Q&A after presentation

PLA2R-CAART is one of seven CAAR T programs that have emerged from the Cabaletta Approach to selective B cell Ablation (CABA™) platform. Cabaletta’s lead product candidate, DSG3-CAART, is currently being evaluated in the DesCAARTes™ Phase 1 clinical trial as a potential treatment for patients with mucosal pemphigus vulgaris (mPV). The lead preclinical product candidate, MuSK-CAART, is designed as a potential treatment for patients with MuSK-associated myasthenia gravis, with an IND submission planned by the end of 2021. Cabaletta has four additional discovery programs derived from the CABA™ platform.

About Membranous Nephropathy
Primary membranous nephropathy (MN) is a B cell-mediated autoimmune disease that affects the kidneys. Approximately 70-80% of the 15,000 primary MN patients in the U.S. have autoantibodies directed to the phospholipase A2 receptor (PLA2R) on kidney podocytes. Since the discovery of these anti-PLA2R autoantibodies in 2009, evidence has shown that these autoantibodies accumulate as immune deposits in the glomeruli of the kidney and damage the filtration barrier, leading to nephrotic syndrome as characterized by proteinuria as well as risk for progression to kidney failure and dialysis and potential need for transplant. Immunosuppressive therapies are commonly used, but high unmet need remains as a significant fraction of patients either relapse or fail to respond or experience risk of serious infection following treatment with immunosuppressive agents.

About CAAR T Cell Therapy
Chimeric AutoAntibody Receptor (CAAR) T cells are designed to selectively bind and eliminate only disease-causing B cells, while sparing the normal B cells that are essential for human health. CAAR T cells are based on the chimeric antigen receptor (CAR) T cell technology. While CAR T cells typically contain a CD19-targeting molecule, CAAR T cells express an autoantibody-targeted antigen on their surface. The co-stimulatory domain and the signaling domain of both a CAR T cell and a CAAR T cell carry out the same activation and cytotoxic functions. Thus, Cabaletta’s CAARs are designed to direct the patient’s T cells to kill only the pathogenic cells that express disease-causing autoantibodies on their surface, potentially leading to complete and durable remission of disease while sparing all other B cell populations that provide beneficial immunity from infection.

About Cabaletta Bio
Cabaletta Bio is a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies, and exploring their potential to provide a deep and durable, perhaps curative, treatment, for patients with B cell-mediated autoimmune diseases. The Cabaletta Approach to selective B cell Ablation (CABA™) platform, in combination with Cabaletta’s proprietary technology, utilizes CAAR T cells that are designed to selectively bind and eliminate only specific autoantibody-producing B cells while sparing normal antibody-producing B cells, which are essential for human health. The Company’s lead product candidate, DSG3-CAART, is being evaluated in the DesCAARTes™ phase 1 clinical trial as a potential treatment for patients with mucosal pemphigus vulgaris, a prototypical B cell-mediated autoimmune disease. The FDA granted Fast Track Designation for DSG3-CAART in May 2020. For more information about the DesCAARTes™ Phase 1 clinical trial, please visit our website (DesCAARTes™ Phase 1 Trial). The Company’s lead preclinical product candidate, MuSK-CAART, is in IND-enabling studies and is designed as a potential treatment for patients with MuSK-associated myasthenia gravis. For more information, visit www.cabalettabio.com.

University of Pennsylvania Financial Disclosure
Dr. Payne is a Penn faculty member, scientific collaborator, key advisor, and co-founder of Cabaletta Bio. As such, she holds an equity stake in the Company, her laboratory at Penn receives sponsored research funding from Cabaletta Bio, and as an inventor of the licensed technology she may receive additional future financial benefits under licenses granted by Penn to Cabaletta Bio. The University of Pennsylvania may also receive future financial benefit under licenses it has granted to Cabaletta Bio.

Forward-Looking Statements
This press release contains “forward-looking statements” of Cabaletta Bio within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including without limitation, express or implied statements regarding expectations regarding the progress and results of its DesCAARTes™ Phase 1 trial, including Cabaletta Bio’s ability to enroll the requisite number of patients; the expectations regarding the preliminary results from in vitro data in anti-PLA2R antibody-expressing B cells; the timing of Cabaletta’s planned initiation of investigational new drug (IND) enabling studies for MuSK-CAART; the effectiveness and timing of additional product candidates and discovery programs that Cabaletta may develop from the CABA™ platform, including in collaboration with academic partners; the safety, efficacy and tolerability of DSG3-CAART for the treatment of mPV, MuSK-CAART for the treatment of MuSK-associated myasthenia gravis, and PLA2R-CAART for the treatment of PLA2R membranous nephropathy; the impact of preclinical data on the future development of CAAR T therapies in Cabaletta’s pipeline portfolio; expectations of the potential impact of COVID-19 on strategy, future operations, and the timing of Cabaletta’s clinical trials, including the potential impacts on its DesCAARTes™ Phase 1 trial; and statements regarding regulatory filings regarding its development programs.

Any forward-looking statements in this press release are based on management’s current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: Cabaletta Bio’s ability to demonstrate sufficient evidence of safety, efficacy and tolerability in its preclinical and clinical trials of DSG3-CAART, MuSK-CAART and PLA2R-CAART; risks related to clinical trial site activation or enrollment rates that are lower than expected; risks related to unexpected safety or efficacy data observed during clinical studies; risks related to our planned regulatory submissions and developments; risks related to the impact of public health epidemics affecting countries or regions in which we have operations or do business, such as COVID-19; risks related to Cabaletta’s ability to protect and maintain its intellectual property position; uncertainties related to the initiation and conduct of studies and other development requirements for its product candidates; and the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Cabaletta’s actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in Cabaletta’s most recent annual report on Form 10-K as well as discussions of potential risks, uncertainties, and other important factors in Cabaletta’s other filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Cabaletta undertakes no duty to update this information unless required by law.

Contacts:

Anup Marda
Chief Financial Officer
investors@cabalettabio.com

Sarah McCabe
Stern Investor Relations, Inc.
sarah.mccabe@sternir.com

Chinook Therapeutics Announces Upcoming Data Presentations and Investor Conference Call During the American Society of Nephrology (ASN) Kidney Week 2021

Chinook Therapeutics Announces Upcoming Data Presentations and Investor Conference Call During the American Society of Nephrology (ASN) Kidney Week 2021




Chinook Therapeutics Announces Upcoming Data Presentations and Investor Conference Call During the American Society of Nephrology (ASN) Kidney Week 2021

  • Additional data to be presented from the ongoing phase 1/2 study of BION-1301 in patients with IgA nephropathy, including biomarker and proteinuria reductions
  • Several presentations on the atrasentan clinical program, including translational research demonstrating ETA activation is associated with clinical progression in IgA nephropathy
  • Chinook to host investor conference call and webcast on November 4, 2021 to review abstracts and provide updates on the company’s pipeline

SEATTLE, Oct. 15, 2021 (GLOBE NEWSWIRE) — Chinook Therapeutics, Inc. (NASDAQ: KDNY), a biopharmaceutical company focused on the discovery, development and commercialization of precision medicines for kidney diseases, today announced upcoming presentations at ASN Kidney Week 2021 from November 4-7, 2021. The six abstracts covering the BION-1301 and atrasentan clinical programs will be delivered as ePoster presentations.

Chinook will host a live conference call and webcast on Thursday, November 4, 2021 at 4:30 pm EDT to review the abstracts and provide updates on the company’s pipeline. Members of the Chinook executive team will be joined by Dr. Jonathan Barratt, the Mayer Professor of Renal Medicine at University of Leicester in Leicester, UK.

ePoster Presentations:

Abstract PO1632 Pharmacodynamic and Clinical Responses to BION-1301 in Patients with IgA Nephropathy: Initial Results of a Ph1/2 Trial
Presenting Author Jonathan Barratt, MChB, PhD, University of Leicester, Leicester, UK
Session PO1203-3 Glomerular Diseases: Treatment and Outcomes
   
Abstract PO1633 Atrasentan Exhibits a Consistent, Predictable Pharmacokinetic Profile Among Healthy Asian Adults
Presenting Author Anjay Rastogi, MD, PhD, University of California Los Angeles David Geffen School of Medicine, Los Angeles, CA
Session PO1203-3 Glomerular Diseases: Treatment and Outcomes
   
Abstract PO1593 Precision Medicine Approach Identifies Patients with IgA nephropathy at Risk for Progression Using Endothelin Activation Signatures
Presenting Author Viji Nair & Matthias Kretzler, MD, University of Michigan, Ann Arbor, MI
Session PO1203-2 Glomerular Diseases: Clinicopathological Features and Outcomes in IgAN, Lupus Nephritis, and Vasculitis
   
Abstract INFO32 A Phase 1/2, Multicenter Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BION-1301 in Healthy Volunteers and Adults With IgA Nephropathy
Session Informational Posters: Glomerular Diseases
   
Abstract INFO35 Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Atrasentan in Patients with IgA Nephropathy (The ALIGN Study)
Session Informational Posters: Glomerular Diseases
   
Abstract INFO36 Atrasentan in Patients with Proteinuric Glomerular Diseases (The AFFINITY Study)
Session Informational Posters: Glomerular Diseases
   

For more information on these and other abstracts, please visit the ASN Kidney Week 2021 website and Abstract Supplement.

Investor Conference Call Details
To access the call, please dial (844) 309-0604 (domestic) or (574) 990-9932 (international) and provide the Conference ID 1381696 to the operator.

To access the live webcast and subsequent archived recording of this and other company presentations, please visit the Investors section of Chinook’s website. The archived webcast will remain available for replay on Chinook’s website for 90 days.

About Chinook Therapeutics, Inc.
Chinook Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing precision medicines for kidney diseases. Chinook’s product candidates are being investigated in rare, severe chronic kidney disorders with opportunities for well-defined clinical pathways. Chinook’s lead program is atrasentan, a phase 3 endothelin receptor antagonist for the treatment of IgA nephropathy and other proteinuric glomerular diseases. BION-1301, an anti-APRIL monoclonal antibody is being evaluated in a phase 1b trial for IgA nephropathy. In addition, Chinook is advancing CHK-336, an oral small molecule LDHA inhibitor for the treatment of primary hyperoxaluria, as well as research programs for other rare, severe chronic kidney diseases. Chinook is building its pipeline by leveraging insights in kidney single cell RNA sequencing, human-derived organoids and new translational models, to discover and develop therapeutics with differentiating mechanisms of action against key kidney disease pathways. To learn more, visit www.chinooktx.com.

Cautionary Note on Forward-Looking Statements
Certain of the statements made in this press release are forward looking, including those relating to Chinook’s business, future operations, advancement of its product candidates and product pipeline, clinical development of its product candidates, including expectations regarding cash forecasts and timing of initiation and results of clinical trials. In some cases, you can identify these statements by forward-looking words such as “may,” “will,” “continue,” “anticipate,” “intend,” “could,” “project,” “expect” or the negative or plural of these words or similar expressions. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, our ability to develop and commercialize our product candidates, including initiation of clinical trials of our existing product candidates or those developed as part of the Evotec collaboration, whether results of early clinical trials or preclinical studies will be indicative of the results of future trials, our ability to obtain and maintain regulatory approval of our product candidates, our ability to operate in a competitive industry and compete successfully against competitors that may be more advanced or have greater resources than we do, our ability to obtain and adequately protect intellectual property rights for our product candidates and the effects of COVID-19 on our clinical programs and business operations. Many of these risks are described in greater detail in our filings with the SEC. Any forward-looking statements in this press release speak only as of the date of this press release. Chinook assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

CONTACT: Contact:
Noopur Liffick
Vice President, Investor Relations & Corporate Communications
investors@chinooktx.com
media@chinooktx.com

Nabriva Therapeutics to Present Data at CHEST Annual Meeting 2021

Nabriva Therapeutics to Present Data at CHEST Annual Meeting 2021




Nabriva Therapeutics to Present Data at CHEST Annual Meeting 2021

DUBLIN, Ireland and FORT WASHINGTON, Pa., Oct. 15, 2021 (GLOBE NEWSWIRE) — Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, today, announced data presentation at CHEST 2021, the annual meeting of the American College of CHEST Physicians, which will be held virtually October 17-20.

On behalf of Nabriva, Dr. Thomas M. File, MD, MS, FCCP will participate in a live oral session on Lefamulin Efficacy and Safety in Adults with Community-Acquired Bacterial Pneumonia: Pooled Analysis of the Lefamulin Evaluation Against Pneumonia (LEAP) 1 and LEAP 2 Trials in Patients with Multilobar or Unilobar Pneumonia. XENLETA® (lefamulin) is a first-in-class pleuromutilin antibiotic for the treatment of community-acquired bacterial pneumonia (CABP).

PRESENTATION:

Presenter: Dr. Thomas M. File, MD, MS, FCCP
Session Date/Time: October 17, 2021, 11:45AM – 12:50 PM ET
Session Title: New Insights and Approaches to Management of Severe Pneumonia and Its Complications
Presentation: “Lefamulin Efficacy and Safety in Adults with Community-Acquired Bacterial Pneumonia: Pooled Analysis of the Lefamulin Evaluation Against Pneumonia (LEAP) 1 and LEAP 2 Trials in Patients with Multilobar or Unilobar Pneumonia”

About Nabriva Therapeutics plc

Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections. Nabriva Therapeutics received U.S. Food and Drug Administration approval for XENLETA® (lefamulin injection, lefamulin tablets), the first systemic pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP). Nabriva Therapeutics is also developing CONTEPO™ (fosfomycin) for injection, a potential first-in-class epoxide antibiotic for complicated urinary tract infections (cUTI), including acute pyelonephritis. Nabriva entered into an exclusive agreement with subsidiaries of Merck & Co. Inc., Kenilworth, N.J., USA to market, sell and distribute SIVEXTRO® (tedizolid phosphate) in the United States and certain of its territories.

Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for Nabriva Therapeutics, including but not limited to statements about the ability of Nabriva Therapeutics to raise awareness of XENLETA and SIVEXTRO, drive prescription demand growth and drive top-line sales growth, the potential benefits to patients of SIVEXTRO and XENLETA, the market opportunity for SIVEXTRO and XENLETA, the availability of SIVEXTRO through major U.S. specialty wholesalers, the impact on Nabriva Therapeutics’ reported revenue from anticipated sales of SIVEXTRO, the sufficiency of its cash resources and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “likely,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: Nabriva Therapeutic’s ability to comply with its obligations under its loan agreement with Hercules, Nabriva Therapeutic’s ability to maintain the conditions under the distribution agreement to exclusively distribute and promote SIVEXTRO, including its ability to maintain a commercial infrastructure sufficient to promote and distribute SIVEXTRO, the extent of business interruptions resulting from the infection causing the COVID-19 outbreak or similar public health crises, the ability to retain and hire key personnel, the availability of adequate additional financing on acceptable terms or at all and such other important factors as are set forth in Nabriva Therapeutics’ annual and quarterly reports and other filings on file with the SEC. In addition, the forward-looking statements included in this press release represent Nabriva Therapeutics’ views as of the date of this press release. Nabriva Therapeutics anticipates that subsequent events and developments may cause its views to change. However, while Nabriva Therapeutics may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Nabriva Therapeutics’ views as of any date subsequent to the date of this press release.

CONTACTS:

For Investors

Kim Anderson
Nabriva Therapeutics plc
ir@nabriva.com

For Media

Andrea Greif
Ogilvy
andrea.greif@ogilvy.com
914-772-3027

T2 Biosystems Reports Granting of Inducement Award

T2 Biosystems Reports Granting of Inducement Award




T2 Biosystems Reports Granting of Inducement Award

LEXINGTON, Mass., Oct. 15, 2021 (GLOBE NEWSWIRE) — T2 Biosystems, Inc. (NASDAQ:TTOO) a leader in the rapid detection of sepsis-causing pathogens, announced today that it issued inducement awards to twenty new employees.

The awards were made on October 1, 2021 under T2 Biosystems’ Inducement Award Plan (the “Inducement Plan”), which was adopted on March 1, 2018 and amended and restated on January 8, 2020 and provides for the granting of equity awards to new employees of T2 Biosystems. The inducement awards consist of options to purchase 621,500 shares of T2 Biosystems common stock and have a ten-year term. The exercise price of the options was $0.938 which was the per-share closing price of T2 Biosystems common stock on the Nasdaq Capital Market on October 1, 2021. The options vest over a four-year period, with 25% vesting on the first anniversary of the employee’s date of hire and the remainder vesting in equal monthly installments over the three years thereafter. The award was approved by the independent compensation committee of T2 Biosystems’ board of directors and was granted as an inducement material to the new employee entering into employment with T2 Biosystems in accordance with Nasdaq Marketplace Rule 5635(c)(4).

About T2 Biosystems:

T2 Biosystems, a leader in the rapid detection of sepsis-causing pathogens, is dedicated to improving patient care and reducing the cost of care by helping clinicians effectively treat patients faster than ever before. T2 Biosystems’ products include the T2Dx® Instrument, T2Candida® Panel, the T2Bacteria® Panel, the T2Resistance® Panel, and the T2SARS-CoV-2™ Panel and are powered by the proprietary T2 Magnetic Resonance (T2MR®) technology. T2 Biosystems has an active pipeline of future products, including the T2Cauris™ Panel, and T2Lyme™ Panel, as well as additional products for the detection of bacterial and fungal pathogens and associated antimicrobial resistance markers, and biothreat pathogens.

Media Contact:
Meagan Dominick, Vault Communications
mdominick@vaultcommunications.com
773-369-4255

Investor Contact:
Philip Trip Taylor, Gilmartin Group
philip@gilmartinIR.com
415-937-5406

Genmab Announces that Janssen has Received Positive CHMP Opinion for RYBREVANT® (amivantamab) for Patients with Advanced Non-small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations, After Failure of Platinum-based Therapy

Genmab Announces that Janssen has Received Positive CHMP Opinion for RYBREVANT® (amivantamab) for Patients with Advanced Non-small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations, After Failure of Platinum-based Therapy




Genmab Announces that Janssen has Received Positive CHMP Opinion for RYBREVANT® (amivantamab) for Patients with Advanced Non-small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations, After Failure of Platinum-based Therapy

Media Release

Copenhagen, Denmark, October 15, 2021

  • Janssen-Cilag International NV (Janssen) received a positive CHMP opinion recommending conditional marketing authorization of amivantamab in Europe for the treatment of adult patients with advanced non-small cell lung cancer with activating epidermal growth factor receptor exon 20 insertion mutations, after failure of platinum-based therapy
  • Represents First CHMP opinion for a DuoBody® product candidate

Genmab A/S (Nasdaq: GMAB) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended the granting of a conditional marketing authorization in Europe for Janssen’s amivantamab, a fully human bispecific antibody, for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) exon 20 insertion mutations, after failure of platinum-based therapy. In July 2012, Genmab entered into a collaboration with Janssen Biotech, Inc. to create and develop bispecific antibodies using Genmab’s DuoBody technology platform. This is the first CHMP opinion for a product that was created using Genmab’s proprietary DuoBody technology platform.

“Following the U.S. FDA approval of RYBREVANT® earlier this year, we are extremely pleased that the CHMP has granted Janssen a positive opinion for amivantamab, the first such opinion for a product created using Genmab’s DuoBody technology platform. We are hopeful that this opinion will lead to an approval and to the first treatment option for European patients with advanced NSCLC with activating EGFR exon 20 insertion mutations,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

For more information related to Janssen’s CHMP opinion for amivantamab, click here.

About Genmab
Genmab is an international biotechnology company with a core purpose to improve the lives of people with cancer. For more than 20 years, Genmab’s vision to transform cancer treatment has driven its passionate, innovative and collaborative teams to invent next-generation antibody technology platforms and leverage translational research and data sciences, fueling multiple differentiated cancer treatments that make an impact on people’s lives. To develop and deliver novel therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. Genmab’s proprietary pipeline includes bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates.

Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan. For more information, please visit Genmab.com and follow us on Twitter.com/Genmab.

Contact:        
Marisol Peron, Senior Vice President, Global Investor Relations & Communications
T: +1 609 524 0065; E: mmp@genmab.com

For Investor Relations:
Andrew Carlsen, Vice President, Head of Investor Relations
T: +45 3377 9558; E: acn@genmab.com

This Media Release contains forward looking statements. The words “believe”, “expect”, “anticipate”, “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Media Release nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.

Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; DuoBody in combination with the DuoBody logo®; HexaBody®; HexaBody in combination with the HexaBody logo®; DuoHexaBody®; HexElect®; and UniBody®. RYBREVANT® is a trademark of Johnson & Johnson.

 

 

Media Release no. 12
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122

Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V
Denmark

Attachment

Disclosure of received notification of The Capital Group Companies and NN Group NV

Disclosure of received notification of The Capital Group Companies and NN Group NV




Disclosure of received notification of The Capital Group Companies and NN Group NV

Regulated information
Nazareth (Belgium)/Rotterdam (The Netherlands), 15 October 2021

Disclosure of received notification of The Capital Group Companies and NN Group NV

Pursuant to the Belgian law of 2 May 2007 regarding the disclosure of major shareholdings in listed companies, Fagron received notifications of The Capital Group Companies, Inc. (“CGC”) and NN Group NV

Notification of The Capital Group Companies, Inc.

  • On 14 October 2021, Fagron received a notification that the shareholding of CGC had fallen below the disclosure threshold of 5% on 13 October 2021, as the result of the disposal of voting securities or voting rights.
  • The notification is made by a ‘parent undertaking or a controlling person’.
  • On 13 October 2021, CGC held a total of 2,788,420 voting rights. 1,484,803 voting rights are held by Capital Research and Management Company (“CRMC”) and 1,303,617 voting rights are held by Capital International, Inc.
  • Based on the denominator of 72,960,154 (total number of voting rights), CGC held 3.82% of the total number of voting rights on 13 October 2021.
  • CGC is the parent company of CRMC and Capital Bank & Trust Company (“CB&T”). CRMC is a U.S.-based investment management company that serves as investment manager to the American Funds family of mutual funds, other pooled investment vehicles, as well as individual and institutional clients. CRMC and its investment manager affiliates manage equity assets for various investment companies through three divisions, Capital Research Global Investors, Capital International Investors and Capital World Investors. CRMC is the parent company of Capital Group International, Inc. (“CGII”), which in turn is the parent company of four investment management companies (“CGII management companies”): Capital International, Inc., Capital International Limited, Capital International Sàrl and Capital International K.K. CGII management companies and CB&T primarily serve as investment managers to institutional and high net worth clients. CB&T is a U.S.-based investment management company that is a registered investment adviser and an affiliated federally chartered bank.
  • Neither CGC nor any of its affiliates, own Fagron NV shares for its own account. Rather, the shares reported on this notification are owned by accounts under the discretionary investment management of one or more of the investment management companies described above.
  • The notification of CGC can be viewed on investors.fagron.com via this link.

Notification of NN Group NV

  • On 15 October 2021, Fagron received a notification that the shareholding of NN Group NV had crossed the disclosure threshold of 15% on 13 October 2021 as the result of the acquisition of voting securities or voting rights.
  • The notification is made by a parent undertaking or a controlling person.
  • On 13 October 2021, NN Group NV (indirectly) held a total 11,101,452 voting rights. 8,950,000 voting rights are held by Nationale-Nederlanden Levensverzekering Maatschappij NV, 796,117 voting rights are held by NN Investment Partners BV, 735,335 voting rights are held by NN Investment Partners Belgium SA, 510,000 voting rights are held by Nationale-Nederlanden Schadeverzekering Maatschappij NV and 110,000 voting rights are held by NN Re (Netherlands) NV.
  • Based on the denominator of 72,960,154 (total number of voting rights), NN Group NV (indirectly) held 15.22% of the total number of voting rights on 13 October 2021.
  • The notification of NN Group NV can be viewed on investors.fagron.com via this link.

In the event of differences between the English translation and the Dutch original of this press release, the latter prevails.

For more information
Karen Berg
Global Investor Relations Manager
Tel. +31 6 53 44 91 99
karen.berg@fagron.com

Please open the link below for the press release: 
Disclosure of received notification of The Capital Group Companies and NN Group NV

US FDA approves Roche’s Tecentriq as adjuvant treatment for certain people with early non-small cell lung cancer

US FDA approves Roche’s Tecentriq as adjuvant treatment for certain people with early non-small cell lung cancer




US FDA approves Roche’s Tecentriq as adjuvant treatment for certain people with early non-small cell lung cancer

  • Tecentriq is the first and only cancer immunotherapy approved for NSCLC in the adjuvant setting
  • Approval is based on the Phase III IMpower010 study showing adjuvant Tecentriq improved disease-free survival by more than one-third in PD-L1-positive Stage II-IIIA lung cancer, compared with best supportive care

Basel, 15 October 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) as adjuvant treatment, following surgery and platinum-based chemotherapy, for adults with Stage II-IIIA non-small cell lung cancer (NSCLC) whose tumours express PD-L1≥1%, as determined by an FDA-approved test.

“Tecentriq is now the first and only cancer immunotherapy available for adjuvant treatment of NSCLC, introducing a new era where people diagnosed with early lung cancer may have the opportunity to receive immunotherapy to increase their chances for cure,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Today’s landmark approval gives physicians and patients a new way to treat early lung cancer that has the potential to significantly reduce risk of cancer recurrence, after more than a decade with limited treatment advances in this setting.”

“Too many patients with early-stage lung cancer experience disease recurrence following surgery. Now, the availability of immunotherapy following surgery and chemotherapy offers many patients new hope and a powerful new tool to reduce their risk of cancer relapse,” said Bonnie Addario, Co-founder and Chair, GO2 Foundation for Lung Cancer. “With this approval, it is more important than ever to screen for lung cancer early and test for PD-L1 at diagnosis to help bring this advance to the people who can benefit.”

The approval is based on results from an interim analysis of the Phase III IMpower010 study. The results showed treatment with Tecentriq, following surgery and platinum-based chemotherapy, reduced the risk of disease recurrence or death by 34% (hazard ratio [HR]=0.66, 95% CI: 0.50-0.88) in people with Stage II-IIIA NSCLC (UICC/AJCC 7th edition) whose tumours express PD-L1≥1%, compared with best supportive care (BSC). Safety data for Tecentriq were consistent with its known safety profile and no new safety signals were identified. Fatal and serious adverse reactions occurred in 1.8% and 18%, respectively, of patients receiving Tecentriq. The most frequent serious adverse reactions (>1%) were pneumonia (1.8%), pneumonitis (1.6%), and pyrexia (1.2%).

The review of this application was conducted under the FDA’s Project Orbis initiative, which provides a framework for concurrent submission and review of oncology medicines among international partners. According to the FDA, collaboration among international regulators may allow people with cancer to receive earlier access to products in other countries where there may be significant delays in regulatory submissions. Simultaneous applications were submitted to regulators in Switzerland, the UK, Canada, Brazil and Australia under Project Orbis. Additionally, the FDA reviewed and approved the application under its Real-Time Oncology Review pilot programme, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. The IMpower010 data have also been submitted as the basis of marketing applications to the European Medicines Agency (EMA) and other global health authorities.

Tecentriq has previously shown clinically meaningful benefit in various types of lung cancer, with six currently approved indications in the US. In addition to becoming the first approved cancer immunotherapy for adjuvant NSCLC, Tecentriq was also the first approved cancer immunotherapy for front-line treatment of adults with extensive-stage small cell lung cancer (SCLC) in combination with carboplatin and etoposide (chemotherapy). Tecentriq also has four approved indications in advanced NSCLC as either a single agent or in combination with targeted therapies and/or chemotherapies. Tecentriq is available in three dosing options, providing the flexibility to choose administration every two, three or four weeks.

Roche has an extensive development programme for Tecentriq, including multiple ongoing and planned Phase III studies across different settings in lung, genitourinary, skin, breast, gastrointestinal, gynaecological, and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines, as well as studies in metastatic, adjuvant and neoadjuvant settings across various tumour types.

About the IMpower010 study
IMpower010 is a Phase III, global, multicentre, open-label, randomised study evaluating the efficacy and safety of Tecentriq compared with BSC, in participants with Stage IB-IIIA NSCLC (UICC/AJCC 7th edition), following surgical resection and up to 4 cycles of adjuvant cisplatin-based chemotherapy. The study randomised 1,005 people with a ratio of 1:1 to receive either Tecentriq (up to 16 cycles) or BSC. The primary endpoint is investigator-determined DFS in the PD-L1-positive Stage II-IIIA, all randomised Stage II-IIIA and intention-to-treat (ITT) Stage IB-IIIA populations. Key secondary endpoints include overall survival (OS) in the overall study population, ITT Stage IB-IIIA NSCLC.

About lung cancer
Lung cancer is one of the leading causes of cancer death globally.1 Each year 1.8 million people die as a result of the disease; this translates into more than 4,900 deaths worldwide every day.1 Lung cancer can be broadly divided into two major types: NSCLC and SCLC. NSCLC is the most prevalent type, accounting for around 85% of all cases.2 Approximately 50% of patients with NSCLC are diagnosed with early-stage (Stages I and II) or locally advanced (Stage III) disease.3 Today, about half of all people with early lung cancer still experience a cancer recurrence following surgery.4 Treating lung cancer early, before it has spread, may help prevent the disease from returning and provide people with the best opportunity for a cure.

About Tecentriq
Tecentriq is a monoclonal antibody designed to bind with a protein called Programmed Death Ligand-1 (PD-L1), which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T-cells. Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers. The development of Tecentriq and its clinical programme is based on our greater understanding of how the immune system interacts with tumours and how harnessing a person’s immune system combats cancer more effectively.

Tecentriq has shown clinically meaningful benefit in advanced NSCLC and SCLC, with five currently approved indications in the EU. Tecentriq is approved in the US, EU and countries around the world, either alone or in combination with targeted therapies and/or chemotherapies in various forms of NSCLC, SCLC, certain types of metastatic urothelial cancer, in PD-L1-positive metastatic triple-negative breast cancer and for hepatocellular carcinoma. In the US, Tecentriq is also approved in combination with Cotellic® (cobimetinib) and Zelboraf® (vemurafenib) for the treatment of people with BRAF V600 mutation-positive advanced melanoma.

About Roche in cancer immunotherapy
Roche’s rigorous pursuit of groundbreaking science has contributed to major therapeutic and diagnostic advances in oncology over the last 50 years, and today, realising the full potential of cancer immunotherapy is a major area of focus. With over 20 molecules in development, Roche is investigating the potential benefits of immunotherapy alone, and in combination with chemotherapy, targeted therapies or other immunotherapies with the goal of providing each person with a treatment tailored to harness their own unique immune system to attack their cancer. Our scientific expertise, coupled with innovative pipeline and extensive partnerships, gives us the confidence to continue pursuing the vision of finding a cure for cancer by ensuring the right treatment for the right patient at the right time.

In addition to Roche’s approved PD-L1 checkpoint inhibitor, Tecentriq® (atezolizumab), Roche’s broad cancer immunotherapy pipeline includes other checkpoint inhibitors, such as tiragolumab, a novel cancer immunotherapy designed to bind to TIGIT, individualised neoantigen therapies and T-cell bispecific antibodies.

To learn more about Roche’s scientific-led approach to cancer immunotherapy, please follow this link:
http://www.roche.com/research_and_development/what_we_are_working_on/oncology/cancer-immunotherapy.htm

About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics, as well as growing capabilities in the area of data-driven medical insights help Roche deliver truly personalised healthcare. Roche is working with partners across the healthcare sector to provide the best care for each person.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. In recent years, Roche has invested in genomic profiling and real-world data partnerships and has become an industry-leading partner for medical insights.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
[1] World Health Organization: GLOBOCAN 2020 – Lung Cancer: Estimated cancer incidence, mortality and prevalence worldwide. [Internet; cited September 2021] Available from: https://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf
[2] American Cancer Society: What Is Lung Cancer? [Internet; cited September 2021] Available from: https://www.cancer.org/cancer/lung-cancer/about/what-is.html
[3] EpiCast report: NSCLC Epidemiology Forecast to 2025. GlobalData. 2016. [Internet; cited September 2021] Available from: https://store.globaldata.com/report/gdhcer132-16–epicast-report-non-small-cell-lung-cancer-nsclc-epidemiology-forecast-to-2025/
[4] Yano T, et al. Therapeutic strategy for postoperative recurrence in patients with non-small cell lung cancer. World J Clin Oncol. 2014;5(5):1048-54.

Roche Group Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Dr. Nicolas Dunant
Phone: +41 61 687 05 17
Patrick Barth
Phone: +41 61 688 44 86

 

Dr. Barbara von Schnurbein
Phone: +41 61 687 89 67
Karsten Kleine
Phone: +41 61 682 28 31

 

Nina Mählitz
Phone: +41 79 327 54 74

Sileia Urech
Phone: +41 79 935 81 48

Nathalie Meetz
Phone: +41 61 687 43 05

 

 

 

 

 

Roche Investor Relations  
Dr. Karl Mahler
Phone: +41 61 68-78503
e-mail: karl.mahler@roche.com
Jon Kaspar Bayard
Phone: +41 61 68-83894
e-mail: jon_kaspar.bayard@roche.com

 

Dr. Sabine Borngräber
Phone: +41 61 68-88027
e-mail: sabine.borngraeber@roche.com
Dr. Bruno Eschli
Phone: +41 61 68-75284
e-mail: bruno.eschli@roche.com

 

Dr. Birgit Masjost
Phone: +41 61 68-84814
e-mail: birgit.masjost@roche.com
Dr. Gerard Tobin
Phone: +41 61 68-72942
e-mail: gerard.tobin@roche.com
   
Investor Relations North America  
Loren Kalm
Phone: +1 650 225 3217
e-mail: kalm.loren@gene.com
 

 

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