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FOR IMMEDIATE RELEASE

25th May 2016

 

Agalimmune to present novel immunotherapy targeting patient-specific tumour neoantigens at American Society of Clinical Oncology 

Presentation provides detail on how Agalimmune’s lead small molecule immunotherapeutic, AGI-134, displays potent anti-tumour activity as a stand-alone therapy and combines synergistically with an anti-PD1 checkpoint inhibitor


London, UK, May 25, 2016 – Agalimmune Ltd, an innovative anti-cancer immunotherapy biopharmaceutical company developing treatments for patients with solid tumours, announces today that Dr Sascha Kristian, Research Director, Agalimmune, will deliver a presentation on Agalimmune’s lead clinical candidate, AGI-134 and its potent anti-tumour activity. The presentation will be delivered at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting, June 3-7 2016 in Chicago, Illinois, US.

 

AGI-134 is in development for the treatment of solid tumours and is in preparation for a phase I/II clinical study.AGI-134 is a fully synthetic, alpha-Gal glycolipid-like small molecule with a unique mechanism of action that drives a patient-specific anti-tumour response in situ.

 

The presentation (abstract ID 3083) is entitled “AGI-134, a fully synthetic α-Gal-based cancer immunotherapy that shows synergy with an anti-PD-1 antibody and favourable pre-clinical pharmacokinetic and toxicity profiles”. It will provide the latest results demonstrating that AGI-134 displays potent anti-tumour activity. AGI-134 engages the cellular and humoral immune systems in situ against autologous tumour neoantigens, to attack the patient’s own tumour cells all around the body.

 

The presentation includes data generated in an in-vivo model of melanoma.  These data show that AGI-134 monotherapy induces an immune response that prevents the growth of distant untreated lesions. Importantly they also show that AGI-134 combines synergistically with an anti-PD1 checkpoint inhibitor. In addition, the results show that AGI-134 has an ideal profile as a clinical candidate with very good tolerability and favourable pharmacokinetics.

 

The presentation will be made in the poster session Developmental Therapeutics—Immunotherapy on Sunday 5 June between 8.00am and 11.30am.

 

“This presentation highlights the strong potential of AGI-134 as a novel immunotherapy for solid tumours. The unique mechanism of action of AGI-134 addresses directly two key issues in cancer therapy. The first is inter and intra-patient tumour neoantigen heterogeneity. This has recently been highlighted in a key paper in Science [1]. The second is the non-inflammatory, or cold, tumour microenvironment, that limits responsiveness to existing immunotherapies,” said Dr. Sascha Kristian, Research Director at Agalimmune. “Current immunotherapies alone lead to durable responses in less than half of patients and are associated with significant side effects. There is a huge need for therapies like AGI-134 that can increase the frequency and duration of responses. Furthermore, as a small molecule that can generate systemic T cell responses against the patient’s own neoantigens in situ and with a potentially benign safety profile, AGI-134 may be an ideal candidate to use in combination with the first wave of immunotherapies - the checkpoint inhibitors.”

 

References

[1] McGranahan, N. et al. Clonal neoantigens elicit T cell immunoreactivity and sensitivity to immune checkpoint blockade. Science (80-. ). (2016). doi:10.1126/science.aaf1490

 

ENDS

 

Notes to Editors.

For more information please contact:

 

Lorna Cuddon, Zyme Communications

This email address is being protected from spambots. You need JavaScript enabled to view it.

+44 (0)7811 996 942

 

About Agalimmune www.agalimmune.com

Agalimmune is a biopharmaceutical company with an innovative anti-cancer immunotherapy technology for generating a systemic, adaptive immune response to solid tumours. AGI-134, the company’s lead small molecule immunotherapeutic is in late-pre-clinical development. Agalimmune’s technology harnesses a universal & natural immune activation to drive an in-situ innate and adaptive, patient-specific anti-tumour response to the patient’s own neo-antigens. This will not only kill the tumour cells at the site of injection, but also bring about a durable anti-tumour immune response all around the body. Agalimmune's technology relies on an interaction between the alpha-Gal glycolipid Alphaject product and its interaction with anti-Gal antibodies, the most common natural antibody in humans. In each patient the anti-tumour immune response is unique to their cancer.

Agalimmune was established in 2013 and is headquartered in London, UK with laboratories in Sandwich, UK and Boston area, US.

 


 

FOR IMMEDIATE RELEASE

15th June 2015

 

Agalimmune Licenses KODE Biotech’s FSL Technology for Development of Cancer Immunotherapeutics

 

Deal worth up to $31M USD (£21 million GBP)

 

London, UK, 15 Jun 2015: Agalimmune Ltd, a biopharmaceutical company focused on the development of a pipeline of innovative immunotherapies for the personalised treatment of cancer, announced today it has licensed KODE Biotech’s Function-Spacer-Lipid (FSL) cell surface membrane modification technology (KODE™ Technology). The proprietary technology will be incorporated by Agalimmune into its novel cancer immunotherapy molecules.

 

Under the terms of the agreement, KODE may receive up to $31 million USD (£21 million GBP) in development and sales milestones, plus royalties on net sales. Agalimmune has exclusive rights to the use of the technology in the field of intratumoral injection for cancer treatment, and specifically relating to the clinical candidate molecule AGI-134.  KODE™ Technology has been extensively validated by Agalimmune prior to in-licensing, and has been shown to be effective for treatment of both primary and secondary tumours in animal models.

                                          

Agalimmune injects synthetic animal-antigen mimetics, which incorporate the FSL constructs, into primary tumours. As the immune system naturally rejects animal tissue, it attacks the modified tumour. In this process of destroying the tumour, the body’s immune system is educated to recognise the patient’s own (autologous) tumour antigens and so destroy unmodified primary and secondary tumours: http://www.agalimmune.com/index.php/movie. KODE™ constructs have been engineered to be easily dispersed in biocompatible media, spontaneously incorporate into cell membranes, and have low toxicity.

 

Graham Griffiths, Director of Agalimmune, commented: “We believe that this technology has great value in immunotherapy, and we are very pleased to be collaborating with a world-leader in the development of synthetic glycolipids. This licensing agreement also represents a significant step forward in Agalimmune’s progress towards the development of pioneering targeted cancer vaccines and immunotherapies for the benefit of patients.”

 

Stephen Henry, CEO of KODE Biotech, said: “We are delighted that Agalimmune has identified the potential of KODE™ Technology for this application, and we look forward to seeing the results of the next phase of development of the therapeutic.”

 

Giles Whalen, Professor of Surgery at University of Massachusetts where Agalimmune’s approaches were first developed, added: “This development builds on the mechanism of action research we have undertaken on this first-in-class therapeutic modality, opens the door to promising combination approaches of immune priming with checkpoint blockade and other immune-modulating therapies, and may bring new promise for the treatment of patients.”

 

 

ENDS

 

Notes to Editors.

For more information please contact:

 

Lorna Cuddon, Zyme Communications

This email address is being protected from spambots. You need JavaScript enabled to view it.

+44 (0)7811 996 942

 

About Agalimmune www.agalimmune.com

Agalimmune is a biopharmaceutical company developing innovative anti-cancer technologies for the treatment of patients with solid tumors. The Company’s vision is to harness the power of the cancer patient’s own immune system to specifically target the tumor; not only to kill the tumor cells but also to bring about a long-lasting protective anti-tumor immune response. In addition to its ongoing efforts to develop cancer treatments, Agalimmune also establishes partnerships and collaborations with leading institutions and companies to research and develop pioneering targeted cancer vaccines and cell-based immunotherapeutic products. These internal and external efforts will continue to position Agalimmune at the cutting edge of innovative anti-cancer technologies.


About KODE Biotech Limited http://www.kodebiotech.com/

KODE Biotech Ltd is a New Zealand biotech company that has developed a platform of synthetic constructs that can rapidly attach almost any compound onto any biological or non-biological surface (www.kodecyte.com). In addition to being a powerful R&D toolbox used by leading academic institutions, KODE™ Technology already exists in a range of diagnostics, and is now being licensed to create novel therapeutics. KODE Biotech is located on the campus of Auckland University of Technology, and its research is based within the Centre for KODE Technology Innovation, School of Engineering. Contact This email address is being protected from spambots. You need JavaScript enabled to view it.

 


 

FOR IMMEDIATE RELEASE

04 June 2014

 

Agalimmune Receives £1.2 million ($2 million) Milestone Payment

 

Agalimmune’s Alphaject technology, an injectable oncology therapy has completed a Phase I trial in melanoma. Data presented at AACR and ASCO.

London, UK, and Irvine, CA, USA, 04 June 2014: Agalimmune Ltd, a biopharmaceutical company focused on the development of innovative immunotherapeutics for the treatment of cancer, announced today that it has received a milestone payment from Loxbridge Research LLP (Loxbridge) and Animatrix Finance Ltd (Animatrix) following successful completion of two Phase I trials of its AlphajectTM technology in late stage cancer patients. The investment will be used to fund Agalimmune’s research into combination therapy with immune checkpoint inhibitors such as the CTLA-4, PD-1, and PD-L1 classes of compounds, as part of its supportive preclinical work packages.

The milestone payment represents continued investment into the Company, and is being made in response to the promising early clinical data from two separate Phase I trials involving twenty patients. The more recent trial, funded by the US National Institutes of Health, and performed at University of Wisconsin in Madison, WI, focused on late-stage melanoma patients. The results were reported in a poster presented at AACR, the American Association for Cancer Research conference, with a second poster presented this past week at ASCO, the American Society for Clinical Oncology conference.

Agalimmune is focused on the development of an anti-tumor injectable technology that harnesses pre-existing immunity present in all humans. Agalimmune’s Alphaject technology includes methods for treating solid tumors in such a way that the immune system actively rejects them, akin to a non-matched graft or transplant. Tumors are directly injected with the Alphaject compound, to which humans naturally have a high antibody titer. Alphaject coats the tumor cells in alpha-Gal, thereby presenting a foreign antigen to the immune system. This is thought to bring about a 'hyper-acute rejection' of the tumor, and breaks the immune tolerance shielding it from attack, allowing the immune system to both begin to destroy the tumor immediately and also over time, to confer a long-lasting protection in the form of enhanced immune surveillance. The effect is analogous to a personalized cancer vaccine, acting continuously to prevent both metastasis and recurrence. A short animation to show the mechanism of action of Alphaject can be viewed here: http://youtu.be/pIiWgQRa66o

Key findings presented in the AACR and ASCO posters were that in two of the nine patients, new melanoma-associated antigen specific T-Cells were found following treatment with Alphaject. Most significantly, also in two of nine patients, new necrosis of non-injected lesions was observed, suggesting effective systemic action of activated specific killer T-Cells, a key marker of likelihood of immune effect on survival. The posters can be viewed here: http://www.agalimmune.com/images/ZulegerCindy_AACR_2014.pdf, and http://www.agalimmune.com/images/ASCO_AlphaGal%20Poster%202014.pdf

Dr Charles Roberts, CEO of Loxbridge, commented: “We are delighted to see the Alphaject program advance. We believe that Alphaject has the potential to become an important addition to the oncologist’s arsenal in treating patients with potentially fatal solid tumors. The technology is perfectly suited to symbiotic activity with immune checkpoint blockade agents, and we are already seeing interest from a number of the developers of these drugs. I anticipate a combination trial in future with checkpoint blockade, and hope to see the synergies proven clinically.” 

Mike Westby, CEO of Agalimmune, added “We are encouraged by the results of the Wisconsin trial, in which repeated Alphaject injections were safe and induced promising immune responses in a subset of these advanced patients.  Immune priming is an important component of inducing a protective anti-tumor response. Alphaject is designed to induce a personalized immune priming against the patient’s own tumor; we believe therefore it can become an important component of effective immunotherapeutic combination regimens."

 

ENDS

 

Notes to Editors.

For more information please contact:

 

Lorna Cuddon, Zyme Communications

This email address is being protected from spambots. You need JavaScript enabled to view it.

+44 (0)7811 996 942

 

About Agalimmune www.agalimmune.com

Agalimmune is a biopharmaceutical company with an innovative anti-cancer technology for the treatment of patients with solid tumors. The Company’s vision is to harness the power of the cancer patient’s own immune system to specifically target the tumor; not only to kill the tumor cells but also to bring about a long-lasting protective anti-tumor immune response. In addition to its ongoing efforts to develop cancer treatments, Agalimmune also establishes partnerships and collaborations with leading institutions and companies to research and develop pioneering targeted cancer vaccines and cell-based immunotherapeutic products.  These internal and external efforts will continue to position Agalimmune at the cutting edge of innovative anti-cancer technologies.



About Loxbridge www.loxbridgeresearch.com

Loxbridge Research LLP is a UK-based investment and project-management company founded in 2008 to create innovative life sciences technologies companies addressing massive global unmet needs. It sources innovation from academic institutions, existing companies and independent scientists - as well as a significant element of internal invention via its own team and extensive network of innovation-partners / key opinion leaders. The company is headquartered in the Royal Institution of Great Britain in Mayfair, London with activities (portfolio investments, labs, and academic partnerships) elsewhere in the UK and US.


 

Alphaject™ Phase I data was presented at the recent ASCO Annual Meeting 2014 in Chicago:

Phase I study to evaluate toxicity and feasibility of intratumoral injection of alpha-gal glycolipids in patients with advanced melanoma.

PDF to download

 

Alphaject™ Phase I data was also presented at the recent AACR Annual Meeting 2014 in San Diego:

Immune responses to common melanoma-associated antigens following intratumoral injection of alpha-gal glycolipids in patients with advanced melanoma.

PDF to download

 


 

 

FOR IMMEDIATE RELEASE

26 November 2013

 

Agalimmune Ltd Founded to Develop Immunotherapeutics for Cancer

 

London, UK and Worcester, MA USA: Agalimmune Ltd, a biopharmaceutical company, has been created to develop innovative immunotherapeutics for the treatment of cancer, with a focus on solid tumours. The new company has been founded by an investment group comprising Loxbridge Research LLP and Animatrix Capital LLP. Agalimmune is based both in London (Agalimmune Ltd) and California (Agalimmune Inc.). The funding will be used to continue the translation of Agalimmune’s leading immunotherapeutic technology, AlphajectTM, licensed from the University of Massachusetts Medical School (UMMS), to the clinic.

Alphaject is based on over 20 years of biomedical research carried out by UMMS Professor of Surgery and Medicine Uri Galili, PhD, who discovered the anti-gal immune response and its role in ‘hyper-acute’ organ rejection. The Alphaject technology includes methods for treating solid tumours in such a way that the immune system actively rejects them, akin to a non-matched graft or transplant. Tumours are directly injected with the Alphaject compound, to which humans naturally have a high antibody titre. Alphaject coats the tumour cells in alphagal, thereby presenting a foreign antigen to the immune system. This is thought to bring about a 'hyper-acute rejection' of the tumour, and breaks the immune tolerance shielding the tumour from attack, allowing the immune system to both begin to destroy the tumour immediately and also to confer a long-lasting protection over time in the form of enhanced immune surveillance. The effect is analogous to a personalised cancer vaccine, acting continuously to prevent both metastasis and recurrence.

Mike Westby, CEO of Agalimmune, commented: “The development of immunomodulatory therapies is an exciting and rapidly emerging field, which hopefully will lead to improved anti-cancer treatments for patients. We welcome Loxbridge Research and Animatrix Capital as investors.”

Dr Charles Roberts, MD, CEO of Loxbridge Research, said: "Agalimmune is the first therapeutic investment we have made at a stage when the technology has already been in patients, and we are honoured to be working with proven innovators UMass Medical School and Dr Galili, in furthering this promising treatment toward the eventual benefit of people battling cancer. The investment we are making in the technology represents an upper mid-size in our portfolio, and whilst it will follow our investment model in general we are delighted to welcome in a dedicated and industry-experienced team from the outset, given the relatively late stage of the technology."

“Immunotherapy holds great promise as a potential cancer treatment because it allows the body’s own immune system to identify and eradicate cancer cells,” said Giles Whalen, MD, professor of surgical oncology at UMass Medical School and principal investigator on early clinical trials to develop the Alphaject technology. “One of the great benefits of this approach is that the immune system can seek out and attack even the smallest traces of tumour anywhere in the body. What makes Alphaject so remarkable is that it’s designed to alert the immune system and respond to a specific type of cancer cell. Unlike other immunomodulatory therapies, which may stimulate the immune system to attack cells indiscriminately, this helps ensure healthy cells don’t get mistakenly targeted and destroyed.”

ENDS

 

Notes to Editors.

For more information please contact:

 

Lorna Cuddon, Zyme Communications

This email address is being protected from spambots. You need JavaScript enabled to view it.

+44 (0)7811 996 942

 

Jim Fessenden, University of Massachusetts Medical School

(508) 856-2000

This email address is being protected from spambots. You need JavaScript enabled to view it.

 

About Agalimmune www.agalimmune.com

Agalimmune is a biopharmaceutical company with an innovative anti-cancer technology for the treatment of patients with solid tumors. The Company’s vision is to harness the power of the cancer patient’s own immune system to specifically target the tumor; not only to kill the tumor cells but also to bring about a long-lasting protective anti-tumor immune response. In addition to its ongoing efforts to develop cancer treatments, Agalimmune also establishes partnerships and collaborations with leading institutions and companies to research and develop pioneering targeted cancer vaccines and cell-based immunotherapeutic products.  These internal and external efforts will continue to position Agalimmune at the cutting edge of innovative anti-cancer technologies.

About Loxbridge www.loxbridgeresearch.com

Loxbridge Research LLP is a UK-based investment and project-management company founded in 2008 to create innovative life sciences technologies companies addressing massive global unmet needs. It sources innovation from academic institutions, existing companies and independent scientists - as well as a significant element of internal invention via its own team and extensive network of innovation-partners / key opinion leaders. The company is headquartered in the Royal Institution of Great Britain in Mayfair, London with activities (portfolio investments, labs, and academic partnerships) elsewhere in the UK and US.

About the University of Massachusetts Medical School

The University of Massachusetts Medical School (UMMS), one of five campuses of the University system, is comprised of the School of Medicine, the Graduate School of Biomedical Sciences, the Graduate School of Nursing, a thriving research enterprise and an innovative public service initiative, Commonwealth Medicine. Its mission is to advance the health of the people of the Commonwealth through pioneering education, research, public service and health care delivery with its clinical partner, UMass Memorial Health Care. In doing so, it has built a reputation as a world-class research institution and as a leader in primary care education. The Medical School attracts more than $240 million annually in research funding, placing it among the top 50 medical schools in the nation. In 2006, UMMS’s Craig C. Mello, PhD, Howard Hughes Medical Institute Investigator and the Blais University Chair in Molecular Medicine, was awarded the Nobel Prize in Physiology or Medicine, along with colleague Andrew Z. Fire, PhD, of Stanford University, for their discoveries related to RNA interference (RNAi). The 2013 opening of the Albert Sherman Center ushered in a new era of biomedical research and education on campus. Designed to maximize collaboration across fields, the Sherman Center is home to scientists pursuing novel research in emerging scientific fields with the goal of translating new discoveries into innovative therapies for human diseases.