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MESSAGE FROM THE CHAIR MESSAGE FROM THE CEO
SOCIETY FOR IMMUNOTHERAPY OF CANCER (SITC) 2017 ANNUAL MEETING & BIO EUROPE 2017 BOARD OF DIRECTORS AND CLINICAL ADVISORY BOARD
Message from the Chair
As your new Company Chairman, I would like to take this opportunity to welcome you to the first edition of our Investor Update (Vol. 22) as Immutep Limited.
It is a privilege to be taking over as Chairman at this exciting time in the Company s journey. I believe my extensive biotechnology industry and capital markets experience,
both in Australia and the U.S., will be valuable as I look forward to leading the Company in advancing its innovative portfolio of oncology and autoimmune product candidates.
As a longstanding contributor to the biotechnol-ogy industry, there is no greater thrill than bringing novel and innovative treatments to
market that prolong and improve patients quality of life. There is a growing acknowledgment that im-munotherapies will play a key role in the future treatment of cancer. The industry is investing heavily
in this space, with combination treatments that may have synergistic mechanisms of action garnering the most attention. There are currently over 1,100 active oncology combination trials. As the global leader in
Immutep has an enormous opportunity to capitalise on this movement.
I am very confident that we have the right product candidates, industry collaborations and team of professionals to build a highly successful global biotechnology company. I am
extremely focused on ensuring we are able to advance our unique combination trials, build on our clinical partnerships, deliver sensible commercial pathways, and enhance shareholder value.
As our focus is now on LAG-3, which already has a close association with the name Immutep, the name change will assist in providing greater
visibility for our Company both in the industry and global investment markets. Our CEO, Marc Voigt, and the team have worked tirelessly to build our Company s reputation and pipeline. I would like to thank all of the Immutep employees for their
Lastly, I would also like to acknowledge the excellent job former board members Lucy Turnbull and Albert Wong have done in guiding the Company
over the past few years. Immutep is well positioned to take advantage of the multiple growth avenues ahead and I look forward to reporting on our continued progress.
Message from the CEO
I would like to take this opportunity to congratulate
Russell Howard and Pete Meyers on their
appointments as Chair and Deputy Chair of the board of directors, respectively. Both Russell and Pete have broad industry and commercial experience and a collective desire to bring innovation to the health care sector.
I would also like to thank Lucy and Albert for their guidance and counsel over the years, through what has been an important and successful transformation. I wish them both well in
their future endeavours.
I am also very excited to deliver my first CEO message under the new Immutep name and logo. The Company has undergone significant change
and this represents our successful transformation to a globally recognised leader in LAG-3.
As you may have noticed, we are
now referring to our lead LAG-3 product candidate as Eftilagimod Alpha, or Efti for short. This is the International Non-proprietary Name (INN) for LAG-3Ig or IMP321, which is regulated by the World Health Organisation. We will be referring to IMP321 as Efti in future communications.
We recently engaged with the U.S. FDA to discuss an Investigational New Drug Application (IND) for a regulatory pathway for the development of Efti in the United States. We intend
to file an IND in the first half of calendar year 2018, which would provide the Company the opportu-nity to commence clinical studies and regulatory interactions in the U.S. in the future. This is an important component of our global
commercialisation strategy for Efti.
Intellectual Property
work with our pharma partners on their respective programs and in broadening our patent portfolio and global interest in LAG-3.
In November, we announced a new patent from the European Patent Office. Filed as a divisional
application, it follows the grant of the European parent patent, which was issued in 2013.
The claims of this new patent are geared toward the use of Immutep s lead candidate Efti in combination with a chemotherapeutic agent for the treatment of cancer.
According to the claims, Efti elicits a monocyte-mediated immune response and is administered before, with, or subsequent to administration of the chemotherapeutic agent.
Importantly, these granted claims support the application of Efti in Immutep s AIPAC clinical trial in metastatic breast cancer in Europe.
Operationally, our Australian Phase I clinical trial in metastatic melanoma, TACTI-mel, is progressing well and we presented new data in a poster presentation at
the Society for Immunotherapy of Cancer (SITC) 2017 Annual Meeting in the U.S. on November 10, 2017. The findings demonstrated anti-tumour activity when Efti is administered in combination with pembrolizumab.
The SITC poster presentation included data showing tumor reductions in 58% of advanced metastatic melanoma patients in the study, which is extremely encouraging for future clinical
indications of Efti as well as combinatory trials.
The third cohort of TACTI-mel is now fully recruited and we expect results from all three cohorts in the first
half of 2018. Similarly, recruitment for the randomised phase of our Phase IIb AIPAC trial in metastatic breast cancer is ongoing. In total, 29 out of 34 clinical sites have been activated with the outstanding site activations expected to occur in
early calendar 2018.
Message from the CEO
[Continued from p. 3]
Based on our current assumptions, the 226 patient trial should be fully
enrolled by mid calendar 2018. The primary Progression Free Survival (PFS) data readout of this portion of the study could be available as early as the first half of calendar 2019.
The investigator-led INSIGHT clinical trial, which is looking at Efti given as intra-tumoural or intraperitoneal injections, continues to
make positive progress. Three patients have already been recruited in this clinical trial and we expect single case data throughout calendar 2018.
keep you updated on relevant industry developments, including pertinent updates from our industry partners. Further to this, I would like to highlight that our partner Novartis again recently increased the number of patients in the Phase I/II trial
of LAG525 (Single Agent and in Combination with PDR001in Patients With Advanced Malignancies) by 99 patients to a total of 515 patients. In addition, Novartis are planning a completely new Phase II clinical trial aiming to recruit 160 patients. I
believe that this is an encouraging sign for LAG525 (which we refer to as IMP701).
Meanwhile our partner EOC Pharma, an oncology focused affiliate of Eddingpharm
that holds the Chinese rights for Efti, continues to leverage the improved clinical and regulatory environment in China and successfully raised US$32 million in capital from Chinese investors in November 2017. EOC plans to use these funds to
commercialize its oncology portfolio, including Efti. This is part of a broader effort to increase access to novel therapies for patients.
We are very encouraged
by increasing investment into development of products targeting LAG-3, the immune checkpoint discovered by our CSO, particularly from our licensing partners and look forward to updating you on further
We believe that based on the current levels of investment by the industry (as illustrated in the chart below),
LAG-3 is emerging as a very significant immune checkpoint. Six new clinical trials were started, or planned to start, in 2017 by other companies. This includes companies such as Boehringer Ingelheim, Tesaro,
and MacroGenics entering the clinic for the first time with their LAG-3 product candidates, while BMS and Novartis commenced new clinical trials for their respective product candidates.
3,000 2,780 14 -10 2,000 1,539 3ClinicalTrials
TotalEstimatedPatientsinLAG 1,000
0 1 0 2013 2014 2015 2016 2017*
TotalEstimatedPatientsinTrials NumberofClinicalTrials
Sources:GlobalData,companywebsites,clinicaltrials.gov,andsec.gov [Continued on p. 5]
* AsofDecember11,2017
Message from the CEO
[Continued from p. 4]
Notably, the CEO of BMS, Dr. Giovanni Caforio, stated during their
last earnings call that he is really looking forward to the initiation of registrational studies for their LAG-3 product candidate. Furthermore, Sanofi highlighted REGN3767, the product candidate they are
developing with Regeneron, in their recent R&D presentation (December 13, 2017).
Even with the continued investment into LAG-3-related programs by other companies, Immutep remains the global leader in terms of the development of LAG-3 modulating therapeutics, as depicted in the LAG-3 Therapeutic Landscape Overview table below.
On behalf of Immutep Limited, I would like to wish all of our shareholders a
happy and prosperous festive season and I look forward to updating you further on our progress in 2018.
LANDSCAPE OVERVIEW TABLE
Program Company Preclinical Phase I Phase I/ II Phase II Phase IIb Total Estimated
Eftilagimo Alpha Immute (1),(2) 244 LAG525 Novarti ) 4) 675 Relatlimab BMS(4) 3,319
REGN3767 Regeneron/Sanofi 283 TSR-033 Tesaro 260 MK4280 Merck&Co.Inc. 240 MGD013 Macrogenics 131 BI754111 B.I. 75 GSK2831781 GSK ) 67 IMP761 Immutep N/A N/A Agenus/Incyte N/A N/A PeregrinePharma. N/A N/A
RXi Pharmaceuticals N/A N/A F-starBio/Merck N/A
Sources: GlobalData,
company websites, clinical trials.gov, and sec.gov (2) Total estimated patients does not include INSIGHT clinical trial As of December 11, 2017 (3) Immutep partnered program (4) As of December 11 2017, one clinical trial was
still planned and not open for enrollment Indicates product candidate that was developed by Immutep research & development
SOCIETY FOR IMMUNOTHERAPY OF CANCER (SITC) 2017 ANNUAL MEETING & BIO EUROPE 2017
In November we attended two important conferences, presented new data from TACTI-mel and engaged in substantive interaction with several key industry players.
While SITC is a key conference in the field of immuno oncology, BioEurope is one of the largest international partnering & business development conferences.
Pushing the accelerator and releasing the break: testing the soluble LAG-3 protein (IMP321), an antigen presenting cell activator, together
with pembrolizumab in unresectable or metastatic mel-anoma.
Authors: Victoria Atkinson, An-drew Haydon, Melissa Eastgate, Amitesh Roy, Adnan Khattak, Christian Mueller, Tina Dunkel-mann, Chrystelle
Brignone, Fred-eric Triebel
Click here to see detailed Poster:
Members of the Immutep Board of Directors are listed below.
Non-Executive Chairman
Dr. Russell Howard joined
the Board in 2013 and is a highly regarded Australian scientist, executive and entrepreneur with nine patents and over 150 scientific publications to his name. He is currently Chairman of cleantech company Oakbio, Inc., Executive Chairman of
NeuClone Pty Ltd and Head of Commercial Strategy, Genomics at Genome.One.
Non-Executive Director & Deputy Chairman
Meyers joined the Board in early 2014. He has had an extensive career in healthcare both in senior industry roles and as an investment banker. He is currently the Chief Financial Officer of Nasdaq-listed Eagle Pharmaceuticals, Inc. and Chairman and
President of The Thomas M. Brennan Memorial Foundation.
Director & Chief Executive Officer
Marc Voigt joined the Company as Chief Financial Officer and Chief Business Officer in 2012 and was appointed CEO and