On November 19, 2020 Epic Sciences, Inc. reported it has entered into an exclusive license and collaboration agreement with Dr. Peter Kuhn and the USC Michelson Center for Convergent Bioscience (Press release, Epic Sciences, NOV 19, 2020, View Source [SID1234571442]). Dr. Kuhn is a founding member of the USC Michelson Center and leads USC’s Convergent Science Institute in Cancer (CSI-Cancer). The collaboration will improve Epic’s platform and enable more precise characterization of rare circulating tumor cells (CTCs), which Epic is developing into liquid-biopsy diagnostics used for characterizing a patient’s cancer to guide treatment decisions.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Epic is a global leader in the identification and characterization of CTCs. Epic’s platform, originally licensed from Dr. Kuhn’s laboratory at The Scripps Research Institute, uses state-of-the-art Carl Zeiss optics coupled with AI-trained machine-vision algorithms to analyze blood treated with fluorescent antibodies. Epic’s platform provides unsurpassed sensitivity with the ability to detect one rare cell in ten million nucleated cells. Today Epic’s platform is used to make treatment decisions for patients with advanced prostate cancer marketed by Exact Sciences and is used in over 100 ongoing clinical trials of cancer therapeutics conducted by Epic’s corporate and academic research partners.

The Epic and USC Michelson partnership will give Epic exclusive access to the next generation, comprehensive liquid biopsy from Dr. Kuhn’s laboratory and expand Epic’s platform to provide in-depth characterization of both the cell-free fractions and CTCs in the liquid biopsy using genomic, proteomic and AI-based morphological tools, all from a single blood draw.

Rick Wenstrup, Chief Medical Officer of Epic Sciences, focused on the application of Epic’s enhanced platform in the monitoring of minimal residual disease (MRD) in cancer, "The ability to identify circulating neoplastic cells and cells from the tumor microenvironment, provides additional information critical to understanding the current state of a patient’s disease and offers the ability to monitor cancer status, and response to a specific therapy."

Epic plans to offer this next-generation CTC technology as part of its suite of Comprehensive Cancer Profiling technologies, that includes Epic’s ctDNA capabilities as a comprehensive solution designed to meet the growing needs of clinicians for precision medicine diagnostic tests and for pharmaceutical partners as they seek to develop life-changing therapies.

"We are excited about this collaboration with Epic Sciences intended to accelerate our goals towards improved cancer patient outcomes," said Dr. Kuhn, adding that "It also advances Epic Sciences further towards a data science company."

About Comprehensive Cancer Profiling

Epic Sciences’ Comprehensive Cancer Profiling provides a multi-technology approach to liquid biopsy from a single blood draw to complete several types of analyses. The Company leverages its exclusive license to technologies from The Scripps Research Institute and the University of Southern California to drive its high-throughput proprietary CTC capabilities. The enrichment-free approach reveals both genotypic and phenotypic insights and minimizes the risk of CTCs being missed. By combining CTC technology with ctDNA and immune cell analysis we enable a comprehensive analysis that is both minimally invasive and highly accurate.

On November 19, 2020 Lantern Pharma reported that it has reached a significant milestone by surpassing one billion curated data points on its RADR platform, a total it believes is the most amassed by any company in the biotech sector (Press release, Lantern Pharma, NOV 19, 2020, https://www.ddw-online.com/lantern-pharma-ai-platform-milestone-will-cut-cost-time-and-risk-in-developing-new-drug-therapies-8292-202011/#new_tab [SID1234571458]). The milestone, which was reached well ahead of schedule, enables new opportunities in Lantern’s work to identify and suggest combination cancer therapy programs, and the ability to compare and contrast biomarker signatures generated by a variety of machine learning algorithms.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The significance of one billion data points provides Lantern Pharma the opportunity to transform the pace, risk, and cost of oncology drug discovery and development. Current failure rates and prolonged processes have led to high developmental costs that are not sustainable for cancer patients. Utilising the RADRplatform, one billion data points brings real-world oncology data together with large-scale biomarker analytics to establish a sustainable route in oncology drug development.

The one billion data points are composed of genomic, transcriptomic and drug sensitivity data points that have been curated from both Lantern’s internal studies as well as relevant published studies and cancer datasets. These data points collected on the RADR platform allow Lantern to predict combinations of drugs that can be used together, such as Lantern’s pipeline of drug therapies, an existing drug already on the market, or an existing drug with a new type of compound that can improve efficacy in cancer patients.

"Since our IPO in June, our proprietary RADR platform has quadrupled its collection of curated data points and allowed us to meet our goal a year ahead of schedule," said Panna Sharma, CEO of Lantern Pharma. "Our growing AI platform will be pivotal in uncovering potential new therapeutic opportunities and developing insights into the creation of combination-therapy programs."

Achieving more than one billion data points in RADR enables Lantern to reduce the timeline in identifying new cancer therapies and in discovering how existing compounds can be aimed at the right subtypes of cancer. This is a process that can typically take years, but now, with large scale data and powerful new algorithms this process can be cut down to weeks. The growth in data points also positions Lantern for increased research activity in key cancer indications that the company is pursuing, including glioblastoma, lung cancer, prostate cancer, pancreatic cancer, and most recently, ovarian cancer. In fact, RADRis already beginning to predict how Lantern’s drugs will work with these types of cancer. The one billion, and counting, data points have saved months of time for Lantern’s team in understanding how their targeted therapies could be used with cancer patients.

The RADR platform has already provided Lantern with their three current drug compounds as well, where genomics and data-driven methods have been used to refine and accelerate the development process. These include: LP-100 in a Phase II trial for the treatment of metastatic, hormone-refractory prostate cancer (MHRPC) which is partnered with an European biotech; LP-300 which is preparing to enter into a Phase II trial for non-small cell lung cancer (NSCLC) as a combination therapy; and LP-184 which is in preclinical development for genomically-defined cancers, including prostate, pancreatic and glioblastoma multiforme (GBM).

On November 19, 2020 Nordic Nanovector ASA (OSE: NANO) reported that it enrolled the final two patients into the second safety cohort of its Phase 1 Archer-1 (LYMRIT 37-07) trial investigating safety and preliminary efficacy of Betalutin (177Lu lilotomab satetraxetan) in combination with rituximab in 2nd-line follicular lymphoma (2L FL) (Press release, Nordic Nanovector, NOV 19, 2020, View Source [SID1234571374]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The dosing regimen in this cohort is a single administration of 15 MBq/kg Betalutin preceded by 40mg lilotomab, followed by 375 mg/m2 rituximab once per week for four weeks.

Data from this cohort is expected in H1’2021 and will be analysed alongside the data generated from the first cohort of patients receiving 10 MBq/kg Betalutin/40mg lilotomab.

As announced in April 2020, Archer-1 is expected to be paused pending this analysis, which is expected to inform plans for the further development of Betalutin development in 2L FL. The Company’s primary focus for its resources is on the timely completion of the pivotal Phase 2b PARADIGME trial of Betalutin in 3rd-line FL (3L FL).

Christine Wilkinson Blanc, Chief Medical Officer of Nordic Nanovector, said: "We are pleased to complete patient enrolment into the second safety cohort of Archer-1. We look forward to the results from this cohort in H1’2021, which will add to our understanding of Betalutin use in FL patients. The data will also inform our thinking towards further development strategies for Betalutin in broader FL populations than that being investigated in our PARADIGME trial in 3L FL."

About Archer-1

Archer-1 is a Phase 1b open-label, single-arm, multi-centre dose-escalation trial designed to assess the safety and preliminary activity of combining the CD37-targeted radioimmunoconjugate Betalutin with the CD20-targeted immunotherapy rituximab in patients with relapsed/refractory (2L) FL who have received one or more prior therapies.

Rituximab was approved for the treatment of non-Hodgkin’s lymphoma (NHL), including FL, more than 20 years ago and is the current standard of care. It is administered to patients with newly diagnosed or relapsed FL as a single agent or in combination with chemotherapy. Over time, patients may develop resistance to rituximab, thus alternative targets and new treatments are important.

On November 19, 2020 Achilles Therapeutics ("Achilles"), a clinical-stage biopharmaceutical company developing personalised T cell therapies targeting clonal neoantigens, a novel class of tumour target, reported it has raised £52.7 million in an oversubscribed Series C financing (Press release, Achilles Therapeutics, NOV 19, 2020, View Source [SID1234571405]). OrbiMed, Boxer Capital of Tavistock Group, and other prominent US-based, healthcare-focused institutional investors join existing investors including RA Capital, Syncona, Forbion, Invus, Perceptive Advisors and Redmile Group.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Proceeds from this financing will be used to accelerate the Company’s R&D activities and further build the clinical network to support the Company’s ongoing Phase I/IIa trials, the THETIS trial in patients with recurrent or metastatic malignant melanoma and the CHIRON trial in patients with advanced non-small cell lung cancer. Both clinical trials use the Company’s innovative personalised T cell therapy approach targeting clonal neoantigens and are currently enrolling patients with interim data expected from both studies in the first half of 2021. In addition, the financing will enable the continued build out of Achilles’ manufacturing capabilities and broaden its growing pipeline of solid tumour pre-clinical product candidates.

"Achilles has made tremendous progress since its founding in 2016, and with this financing round we are further strengthening our outstanding syndicate with more leading US healthcare investors. I am delighted with this strong support for our innovative platform, team, and ambitious development strategy," said Dr. Iraj Ali, CEO of Achilles Therapeutics. "As we progress our two lead programmes in non-small cell lung cancer and melanoma through clinical trials, we believe that our personalised T cell therapy approach has the potential to transform how certain cancers are treated, bringing much needed novel cancer therapies to patients."

On November 19, 2020 Immunomic Therapeutics, Inc., ("ITI"), a privately-held clinical-stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, and CoImmune, Inc. ("CoImmune"), a privately held clinical-stage immuno-oncology company developing cell-based therapeutics to treat unmet medical needs in blood-borne and solid tumor indications, reported that the companies have entered into a license agreement for ITI to use CoImmune’s proprietary dendritic cell process for certain ITI cell therapy vaccine programs (Press release, Immunomic Therapeutics, NOV 19, 2020, View Source [SID1234571427]). The partnership highlights the oncology pipeline of ITI and CoImmune’s expertise and technology in the development and manufacture of cell-based therapeutics.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the terms of the license agreement that supports this partnership, ITI will employ CoImmune’s process for manufacturing and cGMP work for the advancement of ITI-1020, ITI’s autologous dendritic cell (DC) investigational vaccine loading with mRNA encoding LAMP: pp65 for the treatment of newly diagnosed glioblastoma (GBM). CoImmune is eligible to receive milestone payments from ITI upon the successful achievement of certain agreed-upon programmatic goals, including initiation of clinical studies and regulatory submissions. In addition, CoImmune will be eligible to receive royalty payments based upon net sales of ITI-1020, if the product were to be approved in the future.

"We are excited to work with CoImmune, an emerging leader in the development and manufacture of cell-based immunotherapies," said Dr. Tim Coleman, Senior Vice President of Operations at Immunomic Therapeutics. "This agreement supports our immediate and long-term goals for developing and commercializing cancer immunotherapies designed from our investigational UNITE nucleic acid platform. We look forward to collaborating with CoImmune and harnessing their expertise in cell therapies to bring our innovative products to patients in need."

"Our industry is experiencing an increase in the emergence of cell-based therapeutics based on encouraging clinical results to date. Our team at CoImmune has a great deal of expertise in developing and manufacturing these products to efficiently stimulate the immune system against cancer and we are excited to partner with ITI," said Charles Nicolette, CEO of CoImmune. "By combining our team’s know-how with the unique approach to immune system stimulation by UNITE, we believe ITI is well positioned to move into advanced clinical development, initially targeting GBM."

About UNITE

ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, works by fusing target antigens with the Lysosomal Associated Membrane Protein, an endogenous protein in humans, for immune processing. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach could put UNITE technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. UNITE is currently being employed in Phase II clinical trials as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of UNITE in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for UNITE therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.