Amgen’s high-profile cancer med Lumakras set for rollout in England thanks to NHS access deal

On September 10, 2021 Amgen reported that is first-in-class KRAS G12C inhibitor Lumykras (sotorasib) has been received a conditional marketing authorisation in the UK (Press release, Amgen, SEP 10, 2021, View Source [SID1234587519]).

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The UK Medicines and Healthcare products Regulatory Agency (MHRA) has conditionally approved Lumykras under Project Orbis – an international collaborative programme between the US Food and Drug Administration and regulatory agencies across the world.

KRAS G12C is one of the most common identified or known drivers in non-small cell lung cancer (NSCLC).

Amgen’s med binds with a mutated KRAS G12C protein in a bid to ‘switch off’ the signals it sends to trigger cell division and cancer cell growth.

The MHRA review of Lumykras considered data from the Phase II CodeBreaK 100 clinical study, which evaluated the drug in 126 patients with KRAS G12c-mutated advanced NSCLC.

Results from this trial demonstrated a confirmed objective response rate (ORR) of 37.1% and a disease control rate (DCR) of 80.6% for Lumykras-treated patients.

Recently published data also showed a median overall survival (OS) of 12.5 months among 124 evaluable patients, with the median duration of response (DoR) – evaluated in 46 patients – shown to be 11.1 months.

"Today’s conditional marketing authorisation by the MHRA marks an important moment in treating lung cancer patients, with a new targeted therapy, who have failed first-line treatment and face extremely poor outcomes with limited further treatment options," said Tony Patrikios, executive medical director, Amgen UK and Ireland.

"This reflects the clinical investigation programme, demonstrating the use of sotorasib in adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC who have progressed on, or are intolerant to, platinum-based chemotherapy and/or anti PD-1/PD-L1 immunotherapy," he added.

Elicio Therapeutics Presents Preclinical Data on AMP TCR-T Combination Therapy in Solid Tumors at the CAR-TCR Annual Summit 2021

On September 10, 2021 Elicio Therapeutics, a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer and other diseases, reported that it presented preclinical data on its Amphiphile (AMP) platform in combination with TCR-T therapy in solid tumors at the 6th Annual CAR-TCR summit, that was held virtually from August 30 – September 2, 2021 (Press release, Elicio Therapeutics, SEP 10, 2021, https://elicio.com/2021/09/elicio-therapeutics-presents-preclinical-data-on-amp-tcr-t-combination-therapy-in-solid-tumors-at-the-car-tcr-annual-summit-2021/ [SID1234587518]). The data was presented in a session co-chaired by industry leaders Adrian Bot, MD, PhD, Vice President of Translational Medicine at Kite, and member of Elicio’s Scientific Advisory Board, and Christopher Heery, MD, Chief Medical Officer of Arcellx Inc., as part of the "Understanding and Managing Toxicity to Enhance Patient Outcomes" workshop.

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"The preclinical data showed that AMP-boosting transformed an ineffective TCR-T cell monotherapy regimen into a combination which induced long-term non-progression in a fraction animals. It also showed that the AMP combination therapy not only enhanced the expansion and functionality of transferred TCR-T cells but also induced a T-cell response to additional tumor antigens from the original therapy, called antigen spreading, to more broadly attack the tumor." said Peter DeMuth, Ph.D., Elicio Vice President of Research. "We are encouraged by these results because they demonstrate the AMP platform’s ability to enhance multiple axes of immune activation, both systemically as well as in the tumor microenvironment, which may help overcome known challenges to T cell therapy for solid tumors in the clinic."

Adrian Bot, MD, PhD, co-chair of that session, added, "Elicio’s AMP technology is showing promising results in terms of enhancing T cell therapy, through effectively restimulating in vivo the T cells, via deployment of professional antigen presenting cells and co-delivery of biological response modifiers."

This effort expands on the previous work reported in Science from studies conducted at MIT and exclusively licensed to Elicio combining AMP and CAR-T. As observed in the TCR-T combination setting, AMP-boosting of CAR-T cells can promote CAR-T expansion and solid tumor infiltration, contributing to durable responses and resistance to relapse due to loss of CAR-target loss in recurring tumors. Elicio is currently applying this strategy in collaboration with Moffitt Cancer Center to improve CAR-T cell therapies for patients with hematological cancers. This effort is focused on evaluating the combination of CD19 CAR-T AMPlifier, referred to as ELI-011, together with CD19-targeted CAR-T therapy, in mouse models of B cell lymphoma. Positive results in these preclinical assessments may support the advancement of the program into clinical trials.

Presentation will be available on the Elicio Therapeutics website following the Summit via link.

About the Amphiphile Platform

Our proprietary Amphiphile, or AMP, platform delivers investigational immunotherapeutics directly to the "brain center" of the immune system – the lymph nodes. We believe this site-specific delivery of disease-specific antigens, adjuvants, and other immunomodulators may efficiently educate, activate, and amplify critical immune cells, potentially resulting in induction and persistence of potent adaptive immunity required to treat many diseases. In preclinical models, we have observed lymph-node specific engagement driving therapeutic immune responses of increased magnitude, function, and durability. We believe our AMP lymph node targeted approach will produce superior clinical benefits compared to immunotherapies that do not engage the lymph nodes.

Our AMP platform, originally developed at the Massachusetts Institute of Technology, or MIT, has broad potential across cancers, infectious diseases and other disease indications to advance a number of development initiatives through internal activities, in-licensing arrangements or development collaborations and partnerships.

Amphiphile platform is thought to deliver immunotherapeutics to target the lymph node directly to the lymph nodes by latching on to the protein albumin, found in the bloodstream, as it travels to lymphatic tissue. In preclinical models, we have observed lymph-node specific engagement driving therapeutic immune responses of increased magnitude, function, and durability.

Deciphera Pharmaceuticals to Host Virtual Investor Event Featuring Key Opinion Leaders to Discuss Rebastinib and Vimseltinib Data Presented at ESMO Congress 2021

On September 10, 2021 Deciphera Pharmaceuticals, Inc. reported that the Company will host a virtual investor event to review the rebastinib and vimseltinib clinical data to be presented at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021 on Friday, September 17, 2021, from 10:00 AM to 12:30 PM ET (Press release, Deciphera Pharmaceuticals, SEP 10, 2021, View Source [SID1234587517]).

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Deciphera’s senior executive team will be joined by the following key opinion leaders at the event:

Dr. Robert L. Coleman, M.D., FACOG, FACS, Gynecologic Oncologist and Chief Scientific Officer at US Oncology Research
William D. Tap, M.D., Chief of the Sarcoma Medical Oncology Service at Memorial Sloan Kettering Cancer Center

Coherus Management to Present at the H.C. Wainwright 23rd Annual Global Investment Conference

On September 10, 2021 Coherus BioSciences, Inc., reported that senior management will present at the 23rd Annual H.C. Wainwright Global Investment Conference (Press release, Coherus Biosciences, SEP 10, 2021, View Source [SID1234587516]). The presentation will be made available at 7 a.m. ET on Tuesday, September 14, 2021, during the virtual conference.

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Aurinia Pharmaceuticals to Participate in H.C. Wainwright 23rd Annual Global Investment Conference

On September 10, 2021 Aurinia Pharmaceuticals Inc. reported that members of the senior management team will participate in the H.C. Wainwright & Co. 23rd Annual Global Investment Conference, September 13-15, 2021 (Press release, Aurinia Pharmaceuticals, SEP 10, 2021, https://ir.auriniapharma.com/news/detail/235/aurinia-pharmaceuticals-to-participate-in-h-c-wainwright-23rd-annual-global-investment-conference [SID1234587514]). The Aurinia presentation will be available on-demand beginning September 13, 2021 at 3 pm ET.

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The audio webcast is available here. Interested parties can also register and access the presentation under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available on Aurinia’s website.