Category Archives: Biotech Companies

Hemostatics, CUN and ICIQ receive €2.5M to validate a revolutionary therapy against disabling and lethal haemorrhage

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  • A public-private consortium formed by the biotech company Hemostatics, located in the Barcelona science Park, the Clínica Universidad de Navarra (CUN) and the Institute of Chemical Research of Catalonia (ICIQ) will accelerate the development of a next generation drug to tackle severe haemorrhagic processes, such as those associated with major surgery, trauma or intracranial haemorrhage, without effective treatment.
  • The aim of the consortium, which has obtained €2.5 M from the Spanish Research Agency, is to reach the clinical phase of the antifibrinolytic agent CM-352, a drug with a revolutionary therapeutic approach in this field. Until now, the total capital raised to develop the compound amounts to €3M, including €0,3 M from the CDTI’s Neotec programme received in 2022, plus other private funds.
  • According to SEMICYUC, haemorrhage accounts for 50% of deaths within 24 hours of traumatic injury, and of up to 80% of intra-operative trauma mortality. It is a very common complication in clinical situations, such as surgeries, and in cardiovascular patients and patients with certain rare genetic diseases. WHO also warns that postpartum haemorrhage (PPH) affects 14 million women each year and is the world’s leading cause of maternal death.

Barcelona, 20 March 2024. A public-private consortium formed by the biotech Hemostatics, based at the Barcelona Science Park, the Clínica Universidad de Navarra (CUN) and the Institute of Chemical Research of Catalonia (ICIQ), has received 2.5 million euros from the Spanish Research Agency (AEI), under the call for grants for Public-Private Collaboration Projects, to accelerate the development of an innovative treatment aimed at controlling disabling and lethal haemorrhage.

The aim of the project, led by Hemostatics – a spin-off from Cima Universidad de Navarra, attached to the CUN – is the preclinical and clinical development of the antifibrinolytic agent CM-352, a first-in-class drug that represents a pioneering therapeutic approach to control severe bleeding in unmet medical needs, such as those associated with major surgery, trauma or intracranial haemorrhage (ICH).

The CM-352 compound is the result of a long research process led by Dr. Josune Orbe (CSO of Hemostatics), head of the CIMA’s Atherothrombosis research group, and Dr. José Antonio Páramo (CMO) of the Hematology Service of the Clínica Universidad de Navarra and member of the Spanish Society of Thrombosis and Haemostasis (SETH). Strong preclinical studies have been obtained with this compound.

Based on a technology transfer and exclusive patent licensing agreement, Hemostatics was born in 2020, promoted by CIMA and a team of experts from the health and business sector, led by Dr. Orbe, Dr. Páramo and Nicolas Saglio, CEO of Hemostatics and managing partner at biomedical innovation consultancy HealthTech180, with more than 20 years’ experience in strategic consulting and innovation for technology and healthcare companies.

Until now, the total capital raised to develop the compound amounts to €3M, including €0,3 M from the CDTI’s Neotec programme received in 2022, plus other private funds. This grant will be complemented by several other fundings, both healthcare investors private funding and public grants.

A global health and economic issue

Haemorrhage accounts for up to 50% of trauma deaths occurring worldwide within 24 hours of traumatic injury, according to SEMICYUC-Spanish Society of Intensive and Critical Care Medicine and Coronary Units, and up to 80% of intraoperative trauma mortality. It is a very common complication in cardiovascular patients, or patients with certain rare genetic diseases, as well as in different clinical situations, such as surgeries, or postpartum haemorrhage, which is estimated to affect 14 million women each year and represents the world’s leading cause of maternal death, according to WHO, with some 70,000 deaths annually.

“The socio-economic cost of acute bleeding in trauma cases alone is enormous and causes more than 6 million deaths per year (more than all communicable diseases combined, including COVID-19, malaria, tuberculosis, HIV/AIDS, etc.), and is responsible for a total cost of over $670 billion in the United States alone. However, an antihaemorrhagic agent, that can address the unmet medical needs of severe haemorrhagic processes and minimise the risk of possible side effects in the face of less severe haemorrhagic episodes, has not yet been found,” reveals Nicolas Saglio. “Our compound, CM-352, in addition to reducing this major burden of morbidity and mortality, will significantly reduce the healthcare cost of annual expenditure on blood and transfusion-related activities”.

Public-private partnership to create a next generation antifibrinolytic

CM-352 is a drug with a completely innovative mechanism of action, as it targets cessation of bleeding by inhibiting matrix metalloproteinases (MMPs), a revolutionary pharmacological strategy that promises to be more effective and safer than the current standard antifibrinolytics (TXA and EACA) used in clinical practice to control acute bleeding.

The regulatory preclinical phase will be coordinated by Hemostatics Pharmaceuticals and will involve the integration of the efforts of the Atherothrombosis Research Group (CIMA), led by Dr. Josune Orbe.

“We already have experimental results indicating that CM-352 is highly effective in all major bleeding scenarios, with no signs of toxicity, thrombosis, or off-target adverse effects. We will now complete efficacy, toxicity, pharmacodynamic and pharmacokinetic studies in several preclinical models required by regulatory agencies. Obtaining these results will allow us to reach a key milestone of the project: approval from the health authorities to test CM-352 in a phase I clinical trial. Our initial focus will be on the US FDA. Subsequently, we will also go to the EMA in Europe, and everything will be done in close collaboration with the Spanish agency, the AEMPS,” Saglio explains.

Through the Innovation and Valorisation Laboratory and the High Throughput Experimentation (HTE Laboratory), the ICIQ will address the identification and optimisation of a CM-352 synthesis route that improves the efficiency and reduces the cost of the production process of the molecule. The team involved in the project will be led by Dr. Fernando Bravo, manager of the Knowledge and Technology Transfer Department (KTT) and Industrial Projects, and Dr. Xisco Caldentey, manager of HTE.

“The current synthesis route of CM-352 has enabled us to obtain sufficient compound quantities to progress through the preclinical phases, and ICIQ’s involvement will focus on developing a synthetic process with a new optimised synthesis route, which also allows for robust, reproducible scaling with safety guarantees. This objective will be addressed through a combination of intelligent catalyst design and high-performance parallelisation techniques for reaction optimisation. In this regard, techniques involving the screening of hundreds of reactions using automated analysis systems will be applied, such as the one available at ICIQ’s HTE Laboratory, a unique facility in Spain, with few similar models worldwide. The selection of the final synthetic route for obtaining CM-352 will be based on techno-economic criteria (cost/kg), including the relative cost of purification processes, efficiency, safety, and minimization of environmental impact, thereby facilitating its future industrialization and commercialization”, says Dr. Bravo.

Finally, the CM-352 phase I trial will involve the active participation of CUN, with technical support from CIMA and will focus on severe haemorrhage in traumatology, where there is no treatment with proven clinical efficacy. The study will be carried out by the Haemostasis and Thrombosis Unit of the Haematology Department and the Department of Orthopaedic Surgery, under the coordination of Dr. José Antonio Páramo.

“Our objective will be to evaluate the tolerance and safety of CM-352 in patients undergoing scheduled total knee replacement surgery (total knee arthroplasty) to prevent possible hemorrhagic complications, which constitute a serious associated adverse event. This represents a very important milestone in the compound’s development since, in existing literature, no clinical study has reported the use of MMP inhibitors to treat hemorrhages. The absence of toxicity and secondary effects after treatment with CM-352 will also represent the first time such results are obtained for an MMP inhibitor in humans, allowing us to move to a Phase II focused on severe hemorrhages in traumatology, where there is currently no treatment with proven clinical efficacy”, noted Dr. Páramo.

About Hemostatics Pharmaceuticals

Hemostatics Pharmaceuticals S.L.(https://hemostatics.com/) is a biotechnology company created in 2020 by a highly experienced team that set up a strategic partnership and exclusive licence for the technology with the Foundation for Applied Medical Research (FIMA), which manages CIMA, the Centre for Applied Medical Research of the Clínica Universidad de Navarra (CUN). Hemostatics is developing a new proprietary antifibrinolytic agent, CM-352, to reduce bleeding in disabling and life-threatening haemorrhagic conditions and address a number of important unmet medical needs in trauma, surgery, intracranial haemorrhage (ICH), postpartum haemorrhage (PPH) and gastrointestinal bleeding.

About Clínica Universidad de Navarra (CUN)

With more than 2,800 full-time professionals at its Pamplona and Madrid sites, Clínica Universidad de Navarra (https://www.cun.es/) is an academic hospital and a benchmark in personalised medicine in Spain. Recognised for its research and teaching work, the prestige of its professionals and its experience in the diagnosis and treatment of highly complex pathologies, Clínica Universidad de Navarra is a hospital that produces results through speedy diagnoses, thanks to its multidisciplinary work and acquisition of the latest technology, that allow it to offer care in 46 medical and surgical specialities. Clínica Universidad de Navarra is among the world’s 50 best hospitals, according to the World’s Best Hospitals ranking, and among the 35 best oncology hospitals worldwide according to the World’s Best Specialized Hospitals ranking. For the sixth consecutive year, it has been the private hospital with the best reputation in Spain (according to the MRS ranking).

About the Institute of Chemical Research of Catalonia (ICIQ)

The Institute of Chemical Research of Catalonia (https://www.iciq.org/) is a research centre dedicated to advancing scientific knowledge to address social and economic challenges such as climate change and the sustainable supply of raw materials and energy. It has two Severo Ochoa accreditations as a centre of excellence, which underline its recognition as an international benchmark in frontier chemical research. The ICIQ’s research is based on three pillars: sustainable catalysis, renewable energies and health. Also noteworthy are the lines of collaboration with industry, transferring knowledge and promoting the development of innovative applications, with a special focus on patents and spin-offs.

Project CPP2022-009643 funded by:

For further information:

Azucena Berea • Press Officer • Barcelona Science Park • +34 93 403 46 62 • aberea@pcb.ub.es

Miguel García San Emeterio • Media Director • Clínica Universidad de Navarra • +34 948 255 400 • mgsanemeterio@unav.es

Marina Vives • Corporate Communication • Institut Català d’Investigació Química (ICIQ) • +34 977 92 02 00 • comunicacio@iciq.es

KYinno – Boost your drug discovery with innovative products and services

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KYinno is a leading preclinical contract research organization (CRO) dedicated to providing tailored solutions in in vitro and in vivo pharmacology, cell line engineering, therapeutic target identification, and antibody discovery. Leveraging our proprietary assets, including over 3000 engineered cell lines, innovative bispecific and tri-specific antibody discovery mouse models, the comprehensive MPSA-AB5000 panel with screening capabilities for 5000 antibody specificities, and the cutting-edge KY-AITM antibody development artificial intelligence platform, we empower our clients to accelerate their research and development endeavors.

Located at F2 Building, Yizhuang Biomedical Park, No. 88, Kechuang Six Street, Beijing, P.R. China, 101111, and 204 Second Avenue, Waltham, MA 02451, USA, KYinno operates globally to serve the diverse needs of the biotechnology and pharmaceutical industries. Our team consists of highly skilled professionals committed to delivering exceptional results and exceeding expectations.

At KYinno, we are dedicated to advancing scientific discovery and therapeutic innovation. Learn more about how we can collaborate with you to achieve your research goals by visiting our website at www.kyinno.com.

KYinno – preclinical CRO – contract research organization – in vitro pharmacology – in vivo pharmacology – cell line engineering – therapeutic target identification – antibody discovery – engineered cell lines – bispecific antibodies – trispecific antibodies – antibody screening – antibody specificity screening – MPSA-AB5000 panel – KY-AITM antibody development platform – artificial intelligence platform

Ferronova – Nanoparticle Trial Begins in Patients With Gastric and Oesophageal Cancers

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ADELAIDE, Australia–(BUSINESS WIRE)–Australian biotech company Ferronova has announced the initiation of a clinical trial of the company’s FerroTrace® nanoparticle technology in patients with gastric and oesophageal cancers. It follows the completion of a first-in-human trial in 2020-2022 in oral cancer patients.

The MAGMAP trial will enrol 60 patients and commenced today with the first patient at the Royal Adelaide Hospital, to be followed by Flinders Medical Centre and Queen Elizabeth Hospital in South Australia, and then expanding to the Peter MacCallum Cancer Centre and Austin Hospital/Olivia Newton John Cancer Centre in Victoria. Trial imaging is supported by the South Australian Health and Medical Research Institute (SAHMRI) and the National Imaging Facility.

The MAGMAP trial (Clinicaltrials.gov ID: NCT05899985) is a multi-centre, partially blinded, side-by-side comparator study to assess the safety and tolerability, feasibility, and potential added diagnostic and clinical value of FerroTrace® for mapping high-risk lymph nodes in subjects.

Ferronova Chief Executive Officer Mr Stewart Bartlett said it is potentially an important study offering the promise of an innovative approach for identifying and assessing lymph nodes at high risk of containing cancer.

“Gastric, gastric-oesophageal junction, and oesophageal cancers have very poor outcomes, even where the tumour is localised to a primary location and surrounding lymph nodes where surgery is intended to be curative, and this trial is an important step to test whether our novel technology can improve outcomes in this group of patients.”

Studies show following surgery, the 5-year relative survival rates for localised gastric and oesophageal cancers are approximately 74.7% and 48.5% respectively. Where the cancer has also spread to lymph nodes, the 5-year relative survival is only 34.6% and 27.7% [1][2].

Ferronova’s FerroTrace® product is a super-paramagnetic iron oxide nanoparticle targeting CD206 receptors found in lymph nodes. It offers a unique targeting mechanism designed to enable a longer lymph node retention time allowing the use of MRI and a handheld surgical magnetic detector to identify and assess lymph nodes containing FerroTrace®.”

Principal Investigator, Dr Markus Trochsler said the trial will investigate the feasibility of mapping lymph nodes directly draining a primary tumour which theoretically have the highest risk of containing metastasis.

“Gastric and oesophageal cancers are difficult to treat due to unpredictable and extensive lymphatic drainage network in this area of the body, which means lymph nodes containing cancer could potentially be found anywhere from the neck down to the abdomen. At present, when these metastases are very small, they cannot be detected with current imaging technology” Dr Trochsler said.

“This pilot study may lead to providing us with another alternative, being a more informed treatment plan. We are testing whether nanoparticles can identify lymph nodes which are at high-risk of containing cancer cells.  It will support us to progress to larger randomised trials where we will investigate tailoring our treatment approach based on the identification and position of these nodes.”

Mr Bartlett said the study enrolment is predicted to take 12-15 months, and he hoped the results will lead to new methods of treating patients facing uncertain outcomes.

“The enrolment of the first patient is an important milestone for Ferronova,” Mr Bartlett said.

“We are incredibly thankful for the investigators and their support teams, led by Dr Trochsler, as well as Associate Professor Kanhere at the RAH, Professor Watson and Dr Bright at Flinders, Dr Liu at the Austin and Peter Mac, and Dr Dwyer at SAHMRI. They have all put in an incredible amount of work and planning to design and initiate this trial. We look forward to seeing the results when the trial is complete.”

About Ferronova

Ferronova is an Australian biotechnology company headquartered in Adelaide, South Australia. Shareholders include Renew Pharmaceuticals Limited, Uniseed, the University of South Australia, Artesian Venture Partners and the South Australian Venture Capital Fund (SAVCF), Powerhouse Ventures, the University of Wellington in New Zealand, the University of Sydney, PAN Ventures, Australian Unity, and ex-Macquarie Bank executive Allan Moss. Grant assistance has been provided by the SA Government since 2016 and the Federal Government’s BioMedTech Horizons Program, operated by MTPConnect. In 2023, Ferronova was awarded an Australian Government CRC-P grant to progress a nanoparticle formulation through to a Phase 1b brain cancer clinical trial. For more information go to: www.ferronova.com.au

1 Cancer of the oesophagus – cancer stat facts, National Cancer Institute SEER. Available at: https://seer.cancer.gov/statfacts/html/esoph.html (Accessed: 5 April 2024).

2 Cancer of the stomach – cancer stat facts, National Cancer Institute SEER. Available at: https://seer.cancer.gov/statfacts/html/stomach.html (Accessed: 5 April 2024).

Contacts

For more information:

Ferronova
Stewart Bartlett, CEO

Email: marketing@ferronova.com.au

S2 Genomics Announces Groundbreaking Single Cell FFPE Sample Prep Isolation Product

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LIVERMORE, Calif.–(BUSINESS WIRE)–S2 Genomics, a pioneer in tissue sample preparation systems, today announced the launch of its latest product, the Singulator™ 200+ System, an automated sample prep isolation system for single cell formalin-fixed, paraffin-embedded (FFPE) tissues. This cutting-edge solution addresses an unmet need in the market by automating sample preparation for the first time, offering a faster, more accurate, more efficient process for researchers and manufacturers.

The new FFPE sample prep isolation system is designed to isolate nuclei from FFPE tissue slices, enabling single-nucleus RNA sequencing (snRNA-Seq) for FFPE samples. This advancement is a game-changer for cancer-focused researchers who require precise and reliable sample preparation to drive forward their research and development efforts.

Jonathan Schimmel, President and CEO of S2 Genomics, expressed his enthusiasm for the new product: “The FFPE sample prep isolation system is a testament to our commitment to continuing innovation and excellence in the field of single cell genomics. By automating what was once a manual and time-consuming process, we are empowering researchers to conduct their work more effectively and efficiently than ever before.”

The introduction of the FFPE sample prep isolation product is expected to have a profound impact on the field of oncology research, where the quality and speed of sample preparation are crucial for the success of genomic assays.

Earlier this year, S2 Genomics announced that it had raised $16 million in Series A funding to accelerate commercial adoption of its benchtop Singulator platform, which uses single-use cartridges to enable reproducible, rapid, and automated tissue dissociations into single cell or nuclei suspensions.

For more information about the FFPE sample prep isolation system and other S2 Genomics products, please visit us at s2genomics.com or connect with us on LinkedIn or Twitter.

About S2 Genomics: S2 Genomics, Inc. is a leader in the field of tissue sample preparation for single-cell genomics assays. The company’s innovative Singulator platform uses single-use cartridges to enable reproducible, rapid, and automated tissue dissociations into single cell or nuclei suspensions, advancing research in neuroscience and oncology.

[For Research Use Only, Not for Diagnostic Procedures]

Contacts

Nicole Rapicavoli, Vice President of Marketing, nicole@s2genomics.com

Merck’s Corporate Venture M Ventures Arm Backs Nucleai to Advance Its First-in-class Spatial AI Biomarker in Active Clinical Enrollment

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The Extension Funds Nucleai to Advance Its First-in-Class Spatial AI Biomarker in Active Clinical Enrollment

Investment Expands Deployments of AI-Powered Spatial Biomarker Technology, Strengthening Companion Diagnostics for ADCs, Bi-specifics, and Immunotherapies

M Ventures is the corporate strategic venture arm of Merck KGaA, Darmstadt, Germany

CHICAGO–(BUSINESS WIRE)–Nucleai, a spatial AI biomarker company that deciphers cellular conversations and maps cellular interactions within tissue samples to predict therapeutic outcomes, has secured a $14 million investment led by M Ventures, the corporate venture capital arm of Merck KGaA, Darmstadt, Germany, and supported by existing investors, bringing the total funding to $60 million. The investment enables Nucleai to further deploy its AI algorithms for the prospective enrollment of patients in clinical trials – a first in the field and a significant advancement in personalized solutions tailored to the distinct needs of patients.

The funding exemplifies Nucleai’s growing momentum in the life sciences industry, evidenced by collaborations with over 60 percent of the top 20 biopharma companies, venture backing from renowned investors like Section 32 and Sanofi Ventures, and now with M Ventures. The funding will accelerate the deployment of Nucleai’s spatial analysis technology that transforms a static biopsy slide into a dynamic AI-guided action plan, empowering pathologists with the intelligence to anticipate and navigate complex diseases, like cancer, with unmatched precision.

By integrating AI algorithms for prospective patient enrollment in clinical trials, Nucleai is spearheading a first-in-field approach to personalized medicine. This process is crucial for enhancing the accuracy of treatment targeting and activation within the body, particularly for advanced therapeutics such as antibody-drug conjugates (ADCs) and bi-specifics. Nucleai’s platform tailors therapy strategies to the intricate cellular landscape of each patient, optimizing clinical trial participant selection. This personalized approach not only improves the likelihood of successful clinical outcomes but also significantly contributes to the speed and efficiency of bringing new therapies to market.

Leveraging AI and machine learning (ML), Nucleai analyzes pathology images and spatial data at the cellular and tissue levels. The proprietary technology extracts detailed patterns and features from medical images, offering profound insights into the tumor microenvironment, cellular morphology, and spatial relationships between different cell types. These capabilities advance drug development, refine biomarker discovery, and improve the precision of therapeutic targeting, ultimately leading to more effective and personalized treatment options for patients.

Avi Veidman, CEO and Co-Founder of Nucleai, said, “M Ventures’ investment boosts our ability to scale and deploy our spatial AI technology for patient enrollment in clinical trials and supports our work in the rapidly emerging areas of immunotherapies, antibody-drug conjugates, and bi-specifics. Our vision is that every next-generation therapeutic is accompanied with an AI-enabled companion diagnostic, ensuring that each patient’s treatment pathway is informed and efficacious. This funding positions us to scale spatial AI, not just to intercept but anticipate the complex behavior of diseases.”

Noga Yerushalmi, Investment Director at M Ventures, who is appointed to the board of Nucleai, stated, “Nucleai’s technology stands out by being the first spatial AI tool used by pathologists for clinical trial patient selection that is directly connected to a drug development program, setting them apart from other companies. Nucleai’s biology-driven mindset and their multimodal approach, which combines traditional pathology data with spatial biology data, allows for more accurate predictions of treatment responses, aligning perfectly with our commitment to optimise speed of new therapies to reach patients.”

By moving beyond traditional pathology’s analog analysis, Nucleai leverages AI to create dynamic, digital maps from biopsy samples, uncovering the complex interactions at play within tissue. This innovation marks a shift in disease diagnosis and treatment, offering an in-depth contextual view that underpins the development of novel therapeutics.

About Nucleai

Nucleai is the leading AI-powered spatial biomarker company, driving innovation at the intersection of technology and healthcare. Leveraging military intelligence-grade geospatial analytical methods, it intercepts, interprets, and analyzes complex cellular conversations and spatially oriented interactions within tissue samples, translating them into actionable insights. Nucleai’s platform empowers pathologists and researchers with an AI-powered data-rich action plan, paving the way for more informed decisions in the development of bi-specifics, antibody-drug conjugates (ADCs), and immunotherapy. Nucleai’s investors include Section 32, Sanofi, Vertex Ventures, M Ventures, and Debiopharm Innovation Fund. It is headquartered in Israel and Chicago. For more information, please visit www.nucleai.ai.

About M Ventures

M Ventures is the strategic, corporate venture capital arm of Merck KGaA, Darmstadt, Germany. From its headquarters in the Netherlands and offices in Germany, USA and Israel, M Ventures invests globally in transformational ideas driven by innovative entrepreneurs. Taking an active role in its portfolio companies, M Ventures teams up with management teams and co-investors to translate scientific discoveries into commercial success. M Ventures focuses on identifying and financing novel solutions to some of the most difficult challenges, through company creation and equity investments in fields that will impact the vitality and sustainability of Merck KGaA, Darmstadt, Germany’s current and future businesses.

http://www.m-ventures.com/

Contacts

Consort Partners for Nucleai

nucleai@consortpartners.com

Laverock Therapeutics announces appointment of Ali Elsley as Finance Director and expansion of team

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STEVENAGE, United Kingdom, March 26, 2024 (GLOBE NEWSWIRE) — Laverock Therapeutics, a gene-silencing company with a uniquely powerful technology for the development of programmable advanced therapies to tackle major diseases, today announces the appointment of Ali Elsley as Finance Director.

Ali has extensive experience in the biotechnology and pharma sector working with both private and public companies. She joins from Acacia Pharma Group plc, an early commercial-stage listed pharma company, where she was Group Financial Controller and Company Secretary and focused on equity fundraising, M&A activity and all aspects of financial operations. Prior to this, she spent 10 years as an auditor with PwC LLP in Cambridge, with a focus on early-stage biotech and pharma companies, together with advisory IPO work. She is a fellow of the Institute of Chartered Accountants in England and Wales and holds a degree in Archaeology and Anthropology from the University of Cambridge.

In addition to Ali’s appointment, Laverock has significantly grown its team to 24 people, representing growth of 50% over the past year, and expanded its R&D facilities in the Stevenage Bioscience Catalyst as it continues to build its capabilities following its £13.5m expanded seed round announced in September last year, the second highest seed investment by a UK company in 2023.

David Venables, CEO of Laverock, said: “Ali has an exceptional track record working with innovative biotechnology and pharma companies. I very much look forward to working closely with her and the rest of our fast-growing team as we continue to apply our uniquely powerful gene-silencing technology to the development of a new generation of programmable advanced therapies to tackle major diseases.”

Ali Elsley, FD of Laverock, said: “Laverock’s technology has the potential to create a step-change in advanced therapies and I have been hugely impressed with the pace of progress since joining the company. The management team and Board are exceptionally strong, and I believe we have a very solid foundation from which to deliver on the promise.”

For further information please contact:

Laverock Therapeutics:

E: contact@laverocktx.com

Media Enquiries :

Charles Consultants
Sue Charles – Sue@charles-consultants.com +44 (0)7968 726585
Chris Gardner – Chris@CGComms.onmicrosoft.com +44 (0)7956 031077

About Laverock Therapeutics

Laverock Therapeutics is a gene-silencing company with a uniquely powerful technology which harnesses the cell’s natural gene regulatory mechanisms to develop a new generation of programmable advanced therapies to tackle major diseases. Laverock’s truly innovative technology re-directs naturally-occurring micro RNAs (miRNAs) to conditionally silence genes in a way which is programmable, tunable, stable and specific. This opens a path to more effective, safer and accessible advanced therapies. Laverock is applying its technology through its own pipeline – targeting regenerative medicine and oncology – and through partnerships.

Laverock has a highly experienced leadership team with proven track records in biotechnology, pharma and academia, and an exceptionally strong Board. Laverock completed a £13.5m seed round in September 2023. Its high-calibre investors include Calculus Capital, Eli Lilly and Company, Mercia Ventures, Maven Capital Partners, Eos, UK Innovation & Science Seed Fund and Tekfen Ventures.

For more information, please visit www.laverocktx.com and follow us on LinkedIn.

Protembis Announces Completion of € 30 Million Series B Financing Round and the Addition of Keith D Dawkins MD to the Board of Directors

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AACHEN, Germany–(BUSINESS WIRE)–#CerebralProtection–Protembis GmbH (Protembis), a privately-held emerging cardiovascular medical device company, announced today the completion of a € 30 million Series B financing round to support the enrollment of the PROTEMBO Investigational Device Exemption (IDE) Pivotal Trial (NCT05873816). The funding round was structured in two separate capital increases which have both been completed. It was co-led by a European consortium of VC investors including Sweden-based Segulah Medical Acceleration, Italy-based XGEN Venture, and Germany-based TechVision Fund. Other investors include Coparion, several large family offices, angel investors and a multinational medical device strategic.

“We are delighted to announce the completion of the round and would like to thank our existing investors as well as the new investors for their trust and confidence,” said Karl von Mangoldt and Conrad Rasmus Co-CEOs of Protembis. “It reflects the fact that the field of cerebral embolic protection is buoyant, and that future growth will be driven by younger and lower risk patients who have zero tolerance for brain injury risk when selecting to undergo transcatheter aortic valve replacement.”

Additionally, Protembis is proud to announce the addition of Keith D. Dawkins, MD, to the Board of Directors. Dr Dawkins has more than 35 years’ experience in the cardiovascular environment. With over 20 years as a practicing interventional cardiologist in the UK he has held research roles as a Fulbright Scholar at Stanford University, served as President of the British Cardiovascular Intervention Society, and authored more than 750 academic publications and presentations. Dr Dawkins has been the Chief Medical Officer (CMO) of Shockwave (NASDAQ:SWAV) since 2019, and this was preceded by his role as Global CMO at Boston Scientific where he held senior positions since 2008. He also serves as a member of the boards of Ventric Health LLC and JenaValve Technology Inc., as well as Chairman of InnovHeart s.r.l. Dr Dawkins will contribute his significant expertise to the clinical strategies of Protembis and the pre-commercial programs as the IDE study reaches its conclusion.

“To have such a visionary leader as Dr Dawkins join our Board of Directors is an exciting indication of the opportunities that cerebral embolic protection holds for future transcatheter therapies. We look forward to close collaboration as the field develops and our superiority trial gains momentum,” said Azin Parhizgar, PhD, Chairwoman of the Board of Directors.

“As a long-term believer in the need to protect the brain from all new lesions during transcatheter aortic valve replacement, I am very pleased to join Protembis,” said Dr Dawkins. “The ProtEmbo System and the clinical trial design are both novel and I am confident that they will be highly disruptive to the field of cerebral embolic protection, removing or mitigating many of the current issues that concern the physician community.”

About ProtEmbo® and Protembis

The ProtEmbo® Cerebral Protection System is an intra-aortic filter device that protects the entire brain from embolic material liberated during transcatheter aortic valve replacement (TAVR). It is a low-profile non thrombogenic system that shields all cerebral vessels, delivered through the left radial artery for optimal placement and stability. This is an ideal access site enabling physicians to avoid interference with TAVR equipment typically delivered through the femoral artery.

Protembis is a privately held emerging medical device company that has developed the ProtEmbo® Cerebral Protection System. The company strives to provide a simple and reliable solution to protect patients from brain injury during left-sided heart procedures, improving patient quality of life and reducing overall healthcare costs associated with brain injury during such procedures. The ProtEmbo System is currently undergoing clinical investigations.

Contacts

Protembis GmbH

Conrad Rasmus & Karl von Mangoldt

+49(0)241 9903 3622

management@protembis.com
www.protembis.com

Biocytogen Enters Collaboration with ABL Bio to Develop New Bispecific Antibody-Drug Conjugates

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BEIJING–(BUSINESS WIRE)–#ADC–Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (“Biocytogen”, HKEX: 02315), a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies, and ABL Bio Inc. (“ABL”, KOSDAQ: 298380), a Korean clinical-stage biotechnology company developing novel therapeutics in oncology and CNS diseases, today announced a collaboration to develop new bispecific antibody-drug conjugates (bsADCs).

Biocytogen’s RenLite® mice platform can produce fully human antibodies with diverse epitopes and high affinity. This platform is notable for its ability to generate antibodies in a common light chain format, offering a distinctive combination of design flexibility, simplified manufacturing processes, and optimal developability for bsADC development. Based on this platform, both companies will be able to discuss expanding their collaboration for various types of ADC development.

Dr. Yuelei Shen, President and CEO of Biocytogen, said, “We are very pleased to collaborate with ABL, a company that possesses advanced platforms for cancer immunotherapy and treatments against CNS diseases. ABL’s consistent success in advancing its pipeline strongly showcases its expertise and capabilities in regulatory, clinical development, and business development activities. BsADC drugs derived from our RenLite® mice platform have shown preferable potency in various tumor models, while also exhibiting good safety profiles. We believe our fully human bsADC platform technology, which features increased tumor selectivity, target synergized internalization, and convenient CMC development, will complement ABL’s capabilities effectively. Together, we aim to expedite the development of innovative bsADC therapies.”

Sang Hoon Lee, CEO of ABL, said, “We are excited to establish this partnership with Biocytogen for bsADCs. This collaboration is one of the stepping stones for getting down to developing bsADCs. We look forward to a productive collaboration, and firmly believe that this partnership will contribute towards creating a distinctive pipeline, ultimately leading to novel therapies that improve the quality of life for patients.”

About Biocytogen

Biocytogen (HKEX: 02315) is a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies. Founded on gene editing technology, Biocytogen leverages genetically engineered proprietary RenMice® (RenMabTM/RenLite®/RenNano®/RenTCR-mimicTM) platforms for fully human monoclonal/bispecific/multispecific antibody discovery, bispecific antibody-drug conjugate discovery, nanobody discovery and TCR-mimic antibody discovery, and has established a sub-brand, RenBiologicsTM, to explore global partnerships for an off-the-shelf library of >400,000 fully human antibody sequences against approximately 1000 targets for worldwide collaboration. As of June 30, 2023, 50 therapeutic antibody and multiple clinical asset co-development/out-licensing/transfer agreements and 42 target-nominated RenMice® licensing projects have been established around the globe, including several partnerships with multinational pharmaceutical companies (MNCs). Biocytogen pioneered the generation of drug target knock-in humanized models for preclinical research, and currently provides a few thousand off-the-shelf animal and cell models under the company’s sub-brand, BioMiceTM, along with preclinical pharmacology and gene-editing services for clients worldwide. Headquartered in Beijing, Biocytogen has branches in China (Haimen Jiangsu, Shanghai), USA (Boston, San Francisco), and Germany (Heidelberg). For more information, please visit http://en.biocytogen.com.cn.

About ABL Bio

ABL Bio Inc. (KOSDAQ: 298380) is a clinical-stage biotechnology company developing antibody therapeutics for immune-oncology and neurodegenerative diseases. With internal R&D and global partnerships, ABL has developed multiple BsAb platforms, such as ‘Grabody-T,’ ‘Grabody-B’ and built an innovative pipeline of multiple clinical and pre-clinical stage drug candidates. In the oncology area, we have developed Grabody-T, a modular 4-1BB engaging platform that has demonstrated superior efficacy and safety. In the neurodegenerative disorder space, we have developed Grabody-B, which is designed to maximize blood-brain barrier (BBB) penetration. Grabody-B is applicable to various CNS targets across a plethora of neurological disorders, potentially providing a breakthrough to address the high unmet medical needs in neurodegeneration. For more information, please visit www.ablbio.com.

Contacts

Biocytogen Contacts
Antibody assets and platforms: BD-Licensing@biocytogen.com
Media: pr@bbctg.com.cn

AriBio Licenses Exclusive Marketing Rights for AR1001 for Alzheimer’s Disease in China for $770 Million USD

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SEONGNAM-SI, South Korea–(BUSINESS WIRE)–AriBio Co., Ltd. (AriBio), announces signing of exclusive marketing rights for AR1001, an investigational drug for early Alzheimer’s disease, in China for up to $770 million USD.

The term consists of a non-refundable upfront payment of 120 billion KRW (approximately 90 million USD), with the total deal summing up to 5.59 billion RMB (approximately 770 million USD) inclusive of milestone payments with additional royalties. The upfront payment will be paid starting from mid-2024.

In response to the increasing Alzheimer’s disease population in China, prominent pharmaceutical companies have sought to develop safe and effective oral treatments for Alzheimer’s disease. To date, AriBio has partnered for exclusive marketing rights in South Korea with Samjin Pharmaceutical for 100 billion KRW. And now, the partnership has expanded to China, cumulating to 1.12 trillion KRW (approximately 840 million USD). Considering the market competition for Alzheimer’s drugs in China and the sales strategy, the licensee requested not to be disclosed until an agreed upon time.

The global Phase 3 clinical trial for AR1001 in early Alzheimer’s disease patients (Polaris-AD) is on-going in the United States, United Kingdom, and South Korea. Furthermore, the clinical trial is awaiting regulatory approval in China and the European Union. This study will be conducted across 180 global sites. The first patient enrollment began in the United States in December 2022, and the rest of the regions are actively enrolling.

Matthew (Jai Jun) Choung, CEO and Chairman of AriBio, stated, “This deal demonstrates our unwavering commitment to developing meaningful treatments for Alzheimer’s disease, and our partners will help position AR1001 for success in the major Asian territories. We are building momentum in our AR1001 program, as we continue to discuss with other potential partners in Asian countries, the Middle East, South America, as well as Europe and the United States.”

About AR1001

AR1001 is a PDE5 inhibitor being developed as an investigational oral agent for the treatment of Alzheimer’s disease. Pre-clinical studies have confirmed neuroprotective effects of AR1001 via inhibiting neuron apoptosis and restoring synaptic plasticity. AR1001 has also demonstrated robust reduction of hyperphosphorylated tau proteins in pre-clinical models as well as in a Phase 2 trial.

About AR1001-ADP3-US01

AR1001-ADP3-US01 (NCT05531526) is a Phase 3 double-blind, randomized, placebo-controlled, multi-center trial to evaluate the efficacy and safety of AR1001 over 52 weeks in participants with early Alzheimer’s disease. The study aims to assess the efficacy and safety of AR1001 in slowing the progression of Alzheimer’s disease through various cognitive and functional assessments. The details of the clinical trial are available at ClinicalTrials.gov.

About AriBio

AriBio Co., Ltd. is a biopharmaceutical company based in South Korea with offices in both South Korea and the United States. The company focuses on the development of novel therapies for neurodegenerative diseases. The company continues to expand its partnerships to accelerate the development of meaningful treatment options for neurodegenerative diseases.

Contacts

Fred Kim

fredkim@aribiousa.com

Promising Intracranial Anti-Tumor Activity and Safety Data for Ivonescimab in NSCLC Patients with Brain Metastases Featured at ELCC 2024

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Ivonescimab alone or combined with chemotherapy led to intracranial responses among 34% of patients with brain metastases at baseline – 23% achieved a complete response

All patients who did not achieve an intracranial response demonstrated stable disease or non-progression by RANO criteria irrespective of cohort

Median intracranial PFS of 19.3 months observed across combined cohorts of ivonescimab administered as monotherapy or in combination with chemotherapy

No cases of intracranial bleeding were observed in these patients with brain metastases

Detailed safety and anti-tumor activity updates from Phase II trial for ivonescimab plus chemotherapy in multiple NSCLC settings, including 1L squamous NSCLC

MIAMI–(BUSINESS WIRE)–$SMMT–Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today announced promising data for its novel, potential first-in-class investigational bispecific antibody, ivonescimab, that is being presented today at the 2024 European Lung Cancer Congress (ELCC 2024) in Prague, Czech Republic. Two posters featuring updated ivonescimab data will be displayed from 12:00 to 12:45pm Central European Time. The posters will also be made available on our website after the presentation period.


The first poster, “Intracranial Activity of Ivonescimab Alone or in Combination with Platinum Doublet Chemotherapy in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) and Brain Metastases” includes data from patients with asymptomatic brain metastases at baseline. These patients were enrolled in either AK112-202 (NCT04900363), in which ivonescimab is delivered as monotherapy, or AK112-201 (NCT04736823), in which ivonescimab is delivered in combination with platinum doublet chemotherapy, both of which are Phase II clinical trials for patients with advanced or metastatic NSCLC. This analysis consisted of the 35 patients with advanced or metastatic NSCLC who had asymptomatic brain metastases at baseline; 28 patients were treated with ivonescimab plus chemotherapy in AK112-201, and seven patients were treated with monotherapy ivonescimab in AK112-202.

Notably, median intracranial progression-free survival was 19.3 months across all patients analyzed. Patients across both cohorts experienced an intracranial response rate of 34%, and eight patients (23%) experienced a complete response by RANO criteria. All patients who did not achieve a response demonstrated stable disease or non-progression; no patients experienced intracranial disease progression at the time of the initial follow-up scan. No cases of intracranial bleeding complications were observed in these patients.

“We are pleased to see ivonescimab’s favorable intracranial response rates and median intracranial progression-free survival as well as promising anti-tumor activity and safety profile in the subgroup of patients with brain metastases from NSCLC,” said Dr. H. Jack West, Vice President of Clinical Development at Summit. “We are grateful for the patients and clinical investigators supporting these trials, and our ongoing collaboration with our partners at Akeso.”

The second poster titled, “Phase 2 Results of Ivonescimab a Novel PD-1/VEGF Bispecific in Combination with Chemotherapy for First Line Treatment of Patients with Advanced / Metastatic Non-Small Cell Lung Cancer” includes updated data from the Phase II trial AK112-201 centered around the cohort of patients in which ivonescimab is combined with chemotherapy for first-line treatment of squamous and non-squamous advanced or metastatic NSCLC in patients without actionable genomic alterations (e.g., positive for endothelial growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK)). Summarized updates in NSCLC patients with EGFR mutations after a tyrosine kinase inhibitor (TKI) and NSCLC patients who have received prior PD-(L)1 plus doublet chemotherapy treatment are included as well.

Of significance, first-line advanced or metastatic squamous NSCLC patients experienced a median PFS of 11.1 months (95% CI: 9.5 – 16.3 months). In addition, first-line patients with advanced or metastatic non-squamous tumors experienced a median PFS of 13.3 months (95% CI: 8.3 – 16.4 months). Median overall survival was not reached in either subset of patients after a median follow-up time of 22.1 months. The frequency of treatment-emergent adverse events (TEAEs) leading to the discontinuation of ivonescimab was 11.1% and 2.8%, respectively, in patients with squamous and non-squamous tumors. The most frequent TEAEs were anemia and decreased neutrophil counts in squamous patients and anemia and constipation in non-squamous patients.

The posters will be presented by, amongst others, Dr. Li Zhang, Sun Yat-Sen University Cancer Center, and Dr. West, with data generated and analyzed by our collaboration and licensing partner, Akeso Inc. (HKEX Code: 9926.HK) with contribution by Summit staff.

Summit continues its clinical development of ivonescimab in order to establish its efficacy and safety in two NSCLC indications:

  • HARMONi Phase III trial: ivonescimab combined with chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a third-generation EGFR TKI (NCT05184712)
  • HARMONi-3 Phase III trial: ivonescimab combined with chemotherapy in first-line metastatic squamous NSCLC patients (NCT05899608)

About the ELCC 2024 Posters

Poster Title: Phase 2 Results of Ivonescimab a Novel PD-1/VEGF Bispecific in Combination with Chemotherapy for First Line Treatment of Patients with Advanced / Metastatic Squamous Non-Small Cell Lung Cancer

ELCC Presentation No.: 68P

Session Date & Time: Friday, March 22, 2024, 12:00 to 12:45pm CET

Poster Title: Intracranial Activity of Ivonescimab Alone or in Combination with Platinum Doublet Chemotherapy in Patients with Advanced Non-Small Cell Lung Cancer and Brain Metastases

ELCC Presentation No.: 174P

Session Date & Time: Friday, March 22, 2024, 12:00 to 12:45pm CET

About Ivonescimab

Ivonescimab, known as SMT112 in Summit’s license territories, the United States, Canada, Europe, and Japan, and as AK112 in China and Australia, is an investigational, novel, potential first-in-class bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays cooperative binding with each of its intended targets with higher affinity when in the presence of both PD-1 and VEGF.

This could differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. Ivonescimab’s tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the tumor microenvironment with over 18-fold increased binding affinity to PD-1 in the presence of VEGF in vitro, and over 4-times increased binding affinity to VEGF in the presence of PD-1 in vitro (Zhong, et al, SITC, 2023). This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of this design is to improve upon previously established efficacy thresholds, in addition to side effects and safety profiles associated with these targets.

Ivonescimab was discovered by Akeso Inc. (HKEX Code: 9926.HK) and is currently engaged in multiple Phase III clinical trials. Over 1,600 patients have been treated with ivonescimab in clinical studies globally. Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), commencing enrollment in 2023 in two Phase III clinical trials.

Ivonescimab is an investigational therapy that is not approved by any regulatory authority.

About Summit Therapeutics

Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of patient-, physician-, caregiver- and societal-friendly medicinal therapies intended to improve quality of life, increase potential duration of life, and resolve serious unmet medical needs.

Summit was founded in 2003 and our shares are listed on the Nasdaq Global Market (symbol ‘SMMT’). We are headquartered in Miami, Florida, and we have additional offices in Menlo Park, California, and Oxford, UK.

For more information, please visit https://www.smmttx.com and follow us on X @summitplc.

Summit Forward-looking Statements

Any statements in this press release about the Company’s future expectations, plans and prospects, including but not limited to, statements about the clinical and preclinical development of the Company’s product candidates, entry into and actions related to the Company’s partnership with Akeso Inc., the Company’s anticipated spending and cash runway, the therapeutic potential of the Company’s product candidates, the potential commercialization of the Company’s product candidates, the timing of initiation, completion and availability of data from clinical trials, the potential submission of applications for marketing approvals, potential acquisitions, and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” 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 the results of our evaluation of the underlying data in connection with the development and commercialization activities for ivonescimab, the outcome of discussions with regulatory authorities, including the Food and Drug Administration, the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials, the results of such trials, and their success, and global public health crises, that may affect timing and status of our clinical trials and operations, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials or preclinical studies will be indicative of the results of later clinical trials, whether business development opportunities to expand the Company’s pipeline of drug candidates, including without limitation, through potential acquisitions of, and/or collaborations with, other entities occur, expectations for regulatory approvals, laws and regulations affecting government contracts and funding awards, availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the “Risk Factors” section of filings that the Company makes with the Securities and Exchange Commission. Any change to our ongoing trials could cause delays, affect our future expenses, and add uncertainty to our commercialization efforts, as well as to affect the likelihood of the successful completion of clinical development of ivonescimab. Accordingly, readers should not place undue reliance on forward-looking statements or information. In addition, any forward-looking statements included in this press release represent the Company’s views only as of the date of this release and should not be relied upon as representing the Company’s views as of any subsequent date. The Company specifically disclaims any obligation to update any forward-looking statements included in this press release.

Appendix: Glossary of Critical Terms Contained Herein

Affinity – Affinity is the strength of binding of a molecule, such as a protein or antibody, to another molecule, such as a ligand.

Avidity – Avidity is the accumulated strength of multiple binding interactions.

Angiogenesis – Angiogenesis is the development, formation, and maintenance of blood vessel structures. Without sufficient blood flow, tissue may experience hypoxia (insufficient oxygen) or lack of nutrition, which may cause cell death.i

Baseline – The condition of a patient at the start of the clinical trial; a patient’s health status upon starting a clinical trial prior to receiving therapy.

Cooperative binding – Cooperative binding occurs when the number of binding sites on the molecule that can be occupied by a specific ligand (e.g., protein) is impacted by the ligand’s concentration. For example, this can be due to an affinity for the ligand that depends on the amount of ligand bound or the binding strength of the molecule to one ligand based on the concentration of another ligand, increasing the chance of another ligand binding to the compound.ii

Immunotherapy – Immunotherapy is a type of treatment, including cancer treatments, that help a person’s immune system fight cancer. Examples include anti-PD-1 therapies.iii

Intracranial – Within the cranium or skull.

PD-1 – Programmed cell Death protein 1 is a protein on the surface of T cells and other cells. PD-1 plays a key role in reducing the regulation of ineffective or harmful immune responses and maintaining immune tolerance. However, with respect to cancer tumor cells, PD-1 can act as a stopping mechanism (a brake or checkpoint) by binding to PD-L1 ligands that exist on tumor cells and preventing the T cells from targeting cancerous tumor cells.iv

PD-L1 – Programmed cell Death Ligand 1 is expressed by cancerous tumor cells as an adaptive immune mechanism to escape anti-tumor responses, thus believed to suppress the immune system’s response to the presence of cancer cells. v

PD-L1 TPS – PD-L1 Tumor Proportion Score represents the percentage of tumor cells that express PD-L1 proteins.

PFS – Progression-Free Survival.

RANO – Response Assessment in Neuro-Oncology, the standard for assessing the response of a brain or spinal cord tumor to therapy.

SQ-NSCLC – Non-small cell lung cancer tumors of squamous histology.

T Cells – T cells are a type of white blood cell that is a component of the immune system that, in general, fights against infection and harmful cells like tumor cells.vi

Tetravalent – A tetravalent molecule has four binding sites or regions.

Tumor Microenvironment – The tumor microenvironment is the ecosystem that surrounds a tumor inside the body. It includes immune cells, the extracellular matrix, blood vessels and other cells, like fibroblasts. A tumor and its microenvironment constantly interact and influence each other, either positively or negatively.vii

VEGF – Vascular Endothelial Growth Factor is a signaling protein that promotes angiogenesis.viii

i Shibuya M. Vascular Endothelial Growth Factor (VEGF) and Its Receptor (VEGFR) Signaling in Angiogenesis: A Crucial Target for Anti- and Pro-Angiogenic Therapies. Genes Cancer. 2011 Dec;2(12):1097-105.

ii Stefan MI, Le Novère N. Cooperative binding. PLoS Comput Biol. 2013;9(6)

iii US National Cancer Institute, a part of the National Institute of Health (NIH). https://www.cancer.gov/about-cancer/treatment/types/immunotherapy. Accessed March 2024.

iv Han Y, et al. PD-1/PD-L1 Pathway: Current Researches in Cancer. Am J Cancer Res. 2020 Mar 1;10(3):727-742.

v Han Y, et al. PD-1/PD-L1 Pathway: Current Researches in Cancer. Am J Cancer Res. 2020 Mar 1;10(3):727-742.

vi Cleveland Clinic. https://my.clevelandclinic.org/health/body/24630-t-cells. Accessed March 2024.

vii MD Anderson Cancer Center. https://www.mdanderson.org/cancerwise/what-is-the-tumor-microenvironment-3-things-to-know.h00-159460056.html. Accessed March 2024.

viii Shibuya M. Vascular Endothelial Growth Factor (VEGF) and Its Receptor (VEGFR) Signaling in Angiogenesis: A Crucial Target for Anti- and Pro-Angiogenic Therapies. Genes Cancer. 2011 Dec;2(12):1097-105.

Contacts

Contact Summit Investor Relations:
Dave Gancarz

Chief Business & Strategy Officer

Nathan LiaBraaten

Senior Director, Investor Relations

investors@smmttx.com