Month: May 2022

Houston, Texas and Tuebingen, Germany, May 18, 2022 – Immatics N.V. (NASDAQ: IMTX, “Immatics”), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, today announced that the first patient has been dosed in the IMA203 and nivolumab combination Phase 1b dose expansion cohort. This cohort will evaluate Immatics’ TCR-engineered cell therapy (TCR-T) approach ACTengine® IMA203 targeting an HLA-A*02-presented peptide derived from PRAME, in combination with Bristol Myers Squibb’s PD-1 checkpoint inhibitor nivolumab, in patients with advanced solid tumors. The objectives of the study will be to evaluate the safety, biological activity, and initial anti-tumor activity of the IMA203 and nivolumab combination.

“Initiating the second of three dose expansion cohorts is an important milestone in our comprehensive approach to target PRAME. It builds on the successful completion of the dose escalation part of the Phase 1 trial and the early positive clinical data we observed with IMA203,” said Cedrik Britten, Chief Medical Officer at Immatics. “We are excited to elucidate how the combination with an immune checkpoint inhibitor could enhance the potency of our engineered IMA203 T cells. We also look forward to initiating the third Phase 1b cohort with IMA203CD8, our next generation approach that additionally harnesses the power of CD4 T cells.”

The IMA203 and nivolumab combination Phase 1b dose expansion cohort is expected to enroll up to 18 patients with different types of solid tumors across 10 clinical trial sites in Germany and the U.S. Bristol Myers Squibb will provide Immatics, the study sponsor of the combination trial, with nivolumab as part of a clinical supply agreement. Nivolumab has become the standard of care treatment for many solid cancer indications and we believe it fits well into the IMA203 treatment and observation schedule. According to the clinical trial protocol for ACTengine® IMA203, nivolumab will be administered at regular intervals following IMA203 treatment. The primary endpoint of this cohort is to assess the safety of the combination. Anti-tumor activity resulting from the drug combination is a secondary endpoint, which will be assessed through imaging and measured according to the standard Response Evaluation Criteria In Solid Tumors (RECIST).

The combination treatment of IMA203 and nivolumab is part of Immatics’ strategy to realize the full clinical potential of IMA203 TCR-T targeting PRAME. Based on this strategy, the company has expanded the IMA203 trial to a total of three Phase 1b dose expansion cohorts – each designed to assess observed objective response rates, demonstrate durability of response, and form the basis for enrollment in pivotal studies. In addition to the IMA203 and nivolumab combination (first patient treated, initial data read-out planned for YE 2022), Immatics will also investigate IMA203 as monotherapy (patient enrollment ongoing, next data read-out planned in 2H 2022) and IMA203CD8, a next-generation cell therapy where IMA203-engineered T cells are co-transduced with a CD8αβ co-receptor (initiation planned for 2Q 2022, initial data read-out planned for YE 2022).

About IMA203 and target PRAME
ACTengine® IMA203 T cells are directed against an HLA-A*02-presented peptide derived from preferentially expressed antigen in melanoma (PRAME), a protein frequently expressed in a large variety of solid cancers thereby supporting the programs’ potential to address a broad cancer patient population. Immatics’ PRAME peptide is present at a high copy number per tumor cell and is homogenously and specifically expressed in tumor tissue. The peptide has been identified and characterized by Immatics’ proprietary mass spectrometry-based target discovery platform XPRESIDENT®. Through its proprietary TCR discovery and engineering platform XCEPTOR®, Immatics has generated a highly specific T cell receptor (TCR) against this target for its TCR-based cell therapy approach, ACTengine® IMA203.

About ACTengine®
ACTengine® is a personalized approach for patients with advanced solid tumors. The patient’s own T cells are genetically engineered to express a novel, proprietary TCR directed against a defined cancer target. The modified T cells are then reinfused into the patient to attack the tumor. The approach is also known as TCR-engineered cell therapy (TCR-T). All Immatics’ ACTengine® product candidates can be rapidly manufactured utilizing a proprietary manufacturing process designed to enhance T cell engraftment and persistence in vivo.

The ACTengine® T cell products are manufactured at the Evelyn H. Griffin Stem Cell Therapeutics Research Laboratory in collaboration with UTHealth. The ACTengine® Programs are co-funded by the Cancer Prevention and Research Institute of Texas (CPRIT).

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About Immatics
Immatics combines the discovery of true targets for cancer immunotherapies with the development of the right T cell receptors with the goal of enabling a robust and specific T cell response against these targets. This deep know-how is the foundation for our pipeline of Adoptive Cell Therapies and TCR Bispecifics as well as our partnerships with global leaders in the pharmaceutical industry. We are committed to delivering the power of T cells and to unlocking new avenues for patients in their fight against cancer.

For regular updates about Immatics, visit www.immatics.com. You can also follow us on Instagram, Twitter and LinkedIn.

Forward-Looking Statements:
Certain statements in this press release may be considered forward-looking statements. Forward-looking statements generally relate to future events or Immatics’ future financial or operating performance. For example, statements concerning the timing of product candidates and Immatics’ focus on partnerships to advance its strategy are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “expect”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “potential” or “continue”, or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Immatics and its management, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Factors that may cause actual results to differ materially from current expectations include, but are not limited to, various factors beyond management’s control including general economic conditions and other risks, uncertainties and factors set forth in filings with the SEC. Nothing in this presentation should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Immatics undertakes no duty to update these forward-looking statements. All the scientific and clinical data presented within this press release are – by definition prior to completion of the clinical trial and a clinical study report – preliminary in nature and subject to further quality checks including customary source data verification.

For more information, please contact:

Tuebingen, Germany and Houston, Texas, May 10, 2022 – Immatics N.V. (NASDAQ: IMTX, “Immatics”), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, today announced the initiation of a Phase 1 clinical trial with its T cell engaging receptor (TCER®) IMA401 for patients with recurrent and/or refractory solid tumors. IMA401 is the most advanced product candidate from Immatics’ TCR Bispecific pipeline targeting an HLA-A*02-presented peptide derived from both MAGEA4 and MAGEA8. TCER® IMA401 will be developed in collaboration with Bristol Myers Squibb. Immatics is responsible for conducting the Phase 1 clinical trial.

The primary objectives of the clinical trial (NCT#05359445) are to determine the maximum tolerated dose (MTD) and/or the recommended phase 2 dose (RP2D) for IMA401 in biomarker-positive (HLA-A*02:01 and MAGEA4/8) patients with recurrent and/or refractory solid tumors. Secondary objectives are to characterize safety and tolerability, evaluate initial anti-tumor activity and assess pharmacokinetics of IMA401. The Phase 1 trial consists of a dose-escalation (Phase 1a) portion that will be followed by a dose-expansion (Phase 1b) portion to treat patients at the recommended dose level. The trial is planned to be conducted at up to 15 centers in Germany, with the first site already being initiated. The Phase 1 trial is designed to enroll approximately 50 patients.

“IMA401 is the first TCER® candidate from our TCR Bispecifics pipeline entering clinical development, and expands our clinical portfolio with an exciting new TCR-based immunotherapy approach that can be supplied off-the-shelf compared to autologous cell therapies,” said Cedrik Britten, Chief Medical Officer at Immatics. “Our innovative TCER® format leads to an extended-half-life and incorporates novel binding-moieties that are designed to maximize efficacy while minimizing toxicities in patients. Our TCER® IMA401 could treat a range of solid tumors and therefore meet currently unmet needs of a broad patient population. This is best achieved with a strong pharma partner which we have found in Bristol Myers Squibb.”

Immatics entered into a global exclusive license agreement with Bristol Myers Squibb in December 2021 for the IMA401 program under which both companies will collaborate to advance the program through clinical development.

Immatics’ TCR Bispecific pipeline includes a second TCER® product candidate, IMA402, which targets PRAME. Manufacturing of the clinical IMA402 batch is planned for the second half of 2022 and initiation of the Phase 1 trial is planned in 2023. Immatics’ TCER® pipeline is further strengthened by additional innovative TCER® program(s), IMA40X, in preclinical development.

About IMA401
IMA401 is Immatics’ most advanced TCER® molecule that targets an HLA-A*02-presented (human leukocyte antigen) peptide derived from two different cancer-associated proteins, melanoma-associated antigen 4 and/or 8 (“MAGEA4/8”). The MAGEA4/8 peptide has been identified and validated by Immatics’ proprietary mass spectrometry-based target discovery platform XPRESIDENT® and is presented at a 5-fold higher copy number per tumor cell than a MAGEA4 peptide targeted in other clinical trials. Following preclinical proof-of-concept data, including complete remissions of transplanted human-derived tumors in xenograft mouse models, the Phase 1 trial investigates IMA401 in patients with tumors of high MAGEA4/8 prevalence, such as squamous non-small cell lung carcinoma (sqNSCLC), small cell lung cancer (SCLC), head and neck squamous cell carcinoma (HNSCC), bladder, uterine, esophageal and ovarian carcinomas, as well as melanoma, sarcoma subtypes and other solid cancer types.

About TCER®
Immatics’ half-life extended TCER® molecules are antibody-like “off-the-shelf” biologics that leverage the body’s immune system by redirecting and activating T cells towards cancer cells expressing a specific tumor target. The design of the TCER® molecules enables the activation of any T cell in the body to attack the tumor, regardless of the T cells’ intrinsic specificity. Immatics proprietary biologics are engineered with two binding regions: a TCR domain and a T cell recruiter domain. The TCER® format is designed to maximize efficacy while minimizing toxicities in patients. It contains a high-affinity TCR domain that is designed to bind specifically to the cancer target peptide on the cell surface presented by an HLA molecule. The antibody-derived, low-affinity T cell recruiter domain is directed against the TCR/CD3 complex and recruits a patient’s T cells to the tumor to attack the cancer cells. With a low-affinity recruiter aiming for optimized biodistribution and enrichment of the molecule at the tumor site instead of the periphery, TCER® are engineered to reduce the occurrence of immune-related adverse events, such as cytokine release syndrome. In addition, the TCER® format consists of an Fc-part conferring half-life extension, stability, and manufacturability. TCER® are “off-the-shelf” biologics and thus immediately available for patient treatment. They can be distributed through standard pharmaceutical supply chains and provide the opportunity to reach a large patient population without the need of specialized medical centers.

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About Immatics
Immatics combines the discovery of true targets for cancer immunotherapies with the development of the right T cell receptors with the goal of enabling a robust and specific T cell response against these targets. This deep know-how is the foundation for our pipeline of Adoptive Cell Therapies and TCR Bispecifics as well as our partnerships with global leaders in the pharmaceutical industry. We are committed to delivering the power of T cells and to unlocking new avenues for patients in their fight against cancer.

For regular updates about Immatics, visit www.immatics.com. You can also follow us on Twitter, Instagram and LinkedIn.

Forward-Looking Statements:
Certain statements in this press release may be considered forward-looking statements. Forward-looking statements generally relate to future events or Immatics’ future financial or operating performance. For example, statements concerning the timing of product candidates and Immatics’ focus on partnerships to advance its strategy are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “expect”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “potential” or “continue”, or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Immatics and its management, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Factors that may cause actual results to differ materially from current expectations include, but are not limited to, various factors beyond management’s control including general economic conditions and other risks, uncertainties and factors set forth in filings with the SEC. Nothing in this presentation should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Immatics undertakes no duty to update these forward-looking statements. All the scientific and clinical data presented within this press release are – by definition prior to completion of the clinical trial and a clinical study report – preliminary in nature and subject to further quality checks including customary source data verification.

For more information, please contact:

GRENOBLE, France, May 11, 2022 (GLOBE NEWSWIRE) —  UroMems, developer and manufacturer of UroActive™, the first active medical implantable device for treating stress urinary incontinence, today announced the elevation of Steffen Hovard, currently on UroMems’ Board, to Chairman of the Company’s Board of Directors. Mr. Hovard is a medical device industry leader in the U.S, with a successful track record in urology. As chairman, he will be focused on increasing UroMems’ financial, clinical development and commercial footprint in the U.S.

“I joined UroMem’s Board in 2020 because I believed that the UroActive™ device is truly innovative and potentially transformational treatment for the millions of men and women worldwide who suffer from stress urinary incontinence or SUI,” said Mr. Hovard. “Now as we approach the initiation of clinical trials in the U.S., I was offered the opportunity to increase my involvement with UroMems by taking on the responsibility as Chairman of the Board. I hope to further assist the Company in reaching its goals of increasing U.S. investors’ interest, launching clinical trials and anticipating the commercial launch in the U.S. and other geographies.”

For more than 20 years, Mr. Hovard has been a prominent leader in the medical device industry especially in urology. He has held multiple leadership roles at subsidiaries of Coloplast, a publicly traded global medical device company. Most recently, from 2011 to 2019, he served as the President of the global Interventional Urology business, a global $300M fast growing business with a broad portfolio of both single use and implantable devices. Mr. Hovard currently serves on a number of medical device company Boards. Having worked internationally throughout his career, and now living in the U.S., Mr. Hovard brings a geographical and business perspective to UroMems, giving a solid foundation for the company’s transformation to the next stage, as it prepares for clinical trial and eventually commercialization.

“The U.S. is an important geography for UroMems because a large percentage of urological procedures occur there,” said Hamid Lamraoui, Chief Executive Officer and co-founder of UroMems. “This is also the opportunity for the company to bring on board of U.S.-based investors involved in emerging innovative medical device companies. In addition, Steffen has been a key contributor to the Company’s development since he joined our Board in 2020. We are grateful that he has accepted the additional responsibility as Chairman of our Board of Directors. His strong reputation within the medical device industry will be of great assistance as we transition from being a French emerging medical device company into a global, clinical stage medical device company.”

About UroActive™
UroActive™ is an active implantable electronic artificial urinary sphincter that compensates for sphincter insufficiency in patients, both men and women, with SUI. It is based on a unique mechatronic platform using embedded smart, AI-based, digital & robotic systems which, based on data collected from a patient, creates a treatment algorithm that is specific for each patient’s needs. The UroMem’s technology platform is protected by more than 100 patents and is designed to overcome the limitations of current solutions by optimizing safety and performance, patient experience and surgeon convenience.

About UroMems
Founded in 2011 by Pr Pierre Mozer, Hamid Lamraoui and Stéphane Lavallée, UroMems aims to restore the quality of life, dignity and self-esteem of millions of men and women worldwide suffering from untreated chronic conditions by the commitment to change the perception that these disorders are inevitable as one grows older and is simply something to endure with no real solution. The first challenge for the company will be applying robotic methods and smart systems for treating urinary incontinence: designed by urologists and collaborating scientists and engineers, UroActive™ will present a new standard of care combining safety, efficacy, durability and ergonomics fitting any individual’s lifestyle and anatomy.

Since the inception of the company, significant investments have been made for the development of UroMems’ first product. This includes 2 financing rounds totaling $30 million, led by Wellington Partners, Bpifrance, Supernova Invest, Cita Investissement, btov Partners, Hil-Invent and Financière Arbevel. The company has been awarded by several renowned innovation prizes including the Prix Galien Award Medstart’up, and the Worldwide Innovation Challenge initiated by the French government. For more information, please visit www.uromems.com

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Media: Robert Flamm
Burns McClellan

BERLIN, BOSTON, REYKJAVIK, 05 May 2022 – International digital therapeutics leader Sidekick Health (www.sidekickhealth.com) today announces that it has raised $55 million in Series B funding. The round was led by London-based venture capital firm Novator Ventures, with additional participation from Wellington Partners, Asabys Partners, and Frumtak Ventures, as well as a US-based strategic investor that will be revealed at a later stage.
Sidekick is on a mission to develop and deliver effective, personalized digital therapeutics that prevent suffering and add millions of quality life years to people around the world. Digital therapeutics are the next generation of therapeutics designed to prevent, treat and help people manage a wide range of medical disorders or diseases.

“By harnessing the power of technology we have a unique opportunity to deliver personalized treatments via smartphones and other mobile devices, empowering people to take control of their own health,” Sidekick’s chief executive officer and co-founder Dr. Tryggvi Thorgeirsson said.

“The major challenge facing the world’s healthcare systems is how to support and treat people who are dealing with with two or more chronic conditions. The cornerstone of Sidekick’s approach is our multi-chronic digital therapeutics platform, and this funding will allow us to scale even faster the production of a new generation of clinical treatments across all major chronic diseases,” Thorgeirsson added.

Novator Ventures general partner and founder Birgir Mar Ragnarsson joins Sidekick’s board of directors in conjunction with the closing of the Series B financing.
“It has been impressive to follow the rapid growth of the company from the close of its A round 18 months ago. The company may have begun in the Nordics, but I am proud to say that Sidekick is now a globally-recognized digital therapeutics player,” Ragnarsson said. “Novator Ventures recognizes the immense opportunities presented by third generation therapeutics and Sidekick’s ability to scale and operate at the global level. We look forward to working closely with the Sidekick team to transform how healthcare is delivered.”

Sidekick operates its platform in partnership with some of the biggest names in healthcare, including leading US-based health company Anthem Inc. to offer a digital-first care programs, as well as global pharmaceutical majors such as Pfizer and Bayer, to develop integrated combination therapeutics consisting of a molecular drug and a digital therapeutic.

In 2019, Sidekick entered into a strategic partnership with Bayer to provide a digital therapeutic to patients with Peripheral Artery Disease (PAD). In 2020, Sidekick then secured a deal with Pfizer addressing five inflammatory diseases across Europe and beyond.

Following this, during the height of the pandemic, Sidekick assisted the Government of Iceland by providing the remote triaging, remote monitoring and management of people infected with COVID-19. Shortly after, the company raised a $20 million Series A led by Wellington Partners and Asabys Partners. Over the past year Sidekick has further
increased its commercial footprint in the US, including a collaboration with Anthem to support members dealing with COVID-19, Crohn’s disease, and other chronic conditions.
Amidst this backdrop of this rapid growth, the company is now looking to further diversify its portfolio by expanding its chronic disease treatments across even more therapeutic areas, bolstering existing partnerships and forging new alliances with key stakeholders across the healthcare ecosystem.

About Sidekick Health

Sidekick is a digital therapeutics innovator, founded by two passionate medical doctors on a mission to improve the health of humanity. Sidekick is driven by a vision to bring healthcare into people’s everyday lives, empowering them to take control of their own health. Sidekick’s therapeutics are developed and delivered with digital technology, addressing the same endpoints as traditional treatments – such as small molecule drugs and biologics, but with the added benefit of giving people the opportunity to be actively involved in their own treatment. When combined with traditional treatments, the overall efficacy can be strongly increased. That is why Sidekick partners with the world’s most innovative companies across the healthcare spectrum. Sidekick has offices in Berlin, Boston, Reykjavik and Stockholm.
www.sidekickhealth.com

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Sidekick
Gulli Arnason, CMCO

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Sam Hearne

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