On January 9, 2023 Caris Life Sciences(Caris), the leading molecular science, artificial intelligence (AI) and machine learning technology company actively developing and delivering innovative solutions to revolutionize healthcare, and ConcertAI, the leading oncology real-world evidence data and AI technology company, reported a unique partnership to align the two companies’ oncology capabilities (Press release, Caris Life Sciences, JAN 9, 2023, View Source [SID1234626130]). The collaboration creates one of the largest translational and clinical development research platforms aimed at supporting and accelerating biopharmaceutical drug development and novel therapeutic research.

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Unprecedented Molecular and Clinical, Multi-modal Data at Population Scale

As the pioneer in precision medicine and molecular profiling, Caris has created a molecular-rich, real-world database of hundreds of thousands of cases that include genomic, transcriptomic and proteomic data. Caris was the first in the industry to provide Whole Exome Sequencing DNA coverage and Whole Transcriptome Sequencing RNA coverage (WES / WTS) for every patient, which includes mutations, copy number variations, insertions and deletions, fusions and variant transcripts, as well as genomic signatures for gLOH, MSI, HRD, TMB, Caris FOLFIRSTai, and Caris GPSai.

ConcertAI has the largest collection of research-grade clinical data in oncology, hematology and urological cancers, representing the treatment and outcomes of almost seven million patients, partnering with healthcare providers and medical societies around the world. The company’s Patient360 specification has emerged as the reference standard for leading biopharma and other research groups. In addition, the company’s AI SaaS solutions for clinical trial design and clinical development studies have emerged as the leading solution for next generation precision oncology trials.

Two Companies, One Unified Approach

David Spetzler, MS, PhD, MBA, Caris’ President and Chief Scientific Officer, said: "As precision oncology continues to evolve, Caris’ cutting-edge work on tumor biology and molecular biomarkers combined with ConcertAI’s definitive clinical data at scale will have broad implications in the discovery and development of novel signatures and therapeutic options for patients across a range of tumor types."

Jeff Elton, PhD, MBA, ConcertAI’s Chief Executive Officer, added: "By leveraging Caris’ expansive real-world clinico-genomic database and ConcertAI’s large clinical data of multiple types (EMR, Imaging, Medical Claims), our biopharma partners are able to uncover new insights into the underpinnings of cancer biology, translate these insights with confidence into the clinic, and define clear clinical development strategies for enhancing patient clinical outcomes."

While detailed partnership terms have not been disclosed, as part of the partnership, the two organizations will also align their scientific talent and AI SaaS technologies to the research objectives of their academic and biopharma

On January 9, 2023 Aethon Therapeutics reported New therapies targeting oncogenic mutations in proteins such as RAS and EGFR hold great promise for people fighting cancer (Press release, Aethon Therapeutics, JAN 9, 2023, View Source [SID1234626126]). However, their efficacy is limited by tumor cells’ ability to develop resistance to these drugs, which can lead to disease recurrence.

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Today, Aethon Therapeutics launches to create novel antibodies designed to eliminate drug resistance by enabling the immune system to find and kill persistent cancer cells. Apple Tree Partners (ATP), a leader in life sciences venture capital, co-founded Aethon with researchers from NYU Langone Health’s Perlmutter Cancer Center – Shohei Koide, Ph.D. and Benjamin G. Neel, M.D., Ph.D. – inventors of the HapImmune immunotherapy platform that is Aethon’s drug discovery engine. Aethon is funded with $30 million in Series A financing, $25 million of which comes from ATP. NYU Langone Health also participated in this funding round and holds equity in Aethon.

Raj Chopra, FRCP, FRCPath, FRSB, Ph.D., Head of Oncology for ATP, and a Venture Partner at the firm, is acting Chief Executive Officer for Aethon, and Paul Da Silva Jardine, Ph.D., an ATP Venture Partner, is acting Chief Scientific Officer for the new company, which is based in New York City. Seth Harrison, M.D., ATP founder and managing partner, chairs Aethon’s Board of Directors. Drs. Koide and Neel are scientific advisors to Aethon.

"ATP worked with Drs. Koide and Neel to establish Aethon because we were struck by the novelty of their original observation: That when covalent inhibitors bind to their target proteins inside cancer cells, they produce a peptide conjugate ‘beacon’ that is delivered only to the surface of cancer cells, not to healthy cells. Aethon has discovered customized antibodies that home in on that beacon, making the cancer cells vulnerable to attack," Dr. Chopra said. "Aethon is moving quickly to advance programs focused on combinations with KRAS and EGFR inhibitors, and over the mid to long term we plan to develop other bespoke drug-antibody combinations."

Aethon’s proprietary HapImmune platform is a mechanism to increase the antigenicity of any cancer-specific protein that can be targeted with any covalent drug and presented by the major histocompatibility complex (MHC), an essential component of the adaptive immune system. The antibodies produced via the HapImmune platform are designed to activate T cells that will specifically kill tumor cells. HapImmune uses NYU Langone Health’s proprietary repertoire of 100 billion synthetic antibody sequences to find antibodies that recognize drug-peptide complexes (haptens) presented by MHC molecules while avoiding binding to wild-type (e.g., drug-free) peptides on the same MHCs or to the free drug.

The chosen antibodies are then reformatted into custom bi-specific T cell engagers, with one recognition arm directed toward the drug-peptide:MHC and the other toward T cell surface proteins, to recruit T cells to attack the tumor cells. In vitro studies have shown that such engineered antibodies can selectively kill drug-treated resistant tumor cells. The HapImmune platform is described in an article published online recently in Cancer Discovery, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper).[1]

"Immuno-oncology therapy can be curative, but it is not applicable to most tumors or intracellular proteins because many cancers lack neo-antigens recognizable by the immune system," said Dr. Koide. "We are excited to be part of new efforts in the field to improve and extend the effects of targeted therapy and prevent resistance and relapse. By uniting immunotherapy and targeted therapy in this way, we hope to amplify the power of both."

"This is an amazing opportunity, and we are grateful to everyone who has been a part of this research over the years," Dr. Neel said. "’We are excited to deploy the HapImmune platform to advance new therapeutic approaches that we believe will ultimately help many people to not only fight cancer—but to fight cancer and win."

NYU Langone Health and its Technology Opportunities & Ventures arm has exclusively licensed to Aethon pending patent applications and expertise covering the HapImmune platform. NYU Langone Health is the owner of the technology exclusively licensed to Aethon and has equity and other financial interests in Aethon. Drs. Koide and Neel also have equity in Aethon, and Aethon is also sponsoring research conducted by Dr. Koide and Dr. Neel at NYU Langone Health. These interests are being disclosed and managed in accordance with NYU Langone Health policies.

[1] T. Hattori T, Maso L, Araki K, Koide A, Hayman J, Akkapedi P, Bang I, Neel B, Koide S. Creating MHC-Restricted Neoantigens with Covalent Inhibitors That Can Be Targeted by Immune Therapy. Cancer Discovery, January 2023 print edition, first published October 2022. View Source Accessed on January 7, 2023.

on January 9, 2023 Avenge Bio, Inc. ("Avenge"), an oncology-focused biotechnology company developing the LOCOcyte Immunotherapy platform for the precision administration of potent immune effector molecules to treat solid tumors, reported its dosing of the first patient in a First-in-Human Phase 1/2 clinical trial evaluating AVB-001 in relapsed refractory ovarian cancer (Press release, Avenge Bio, JAN 9, 2023, View Source [SID1234626129]).

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AVB-001, developed in the LOCOcyte platform, consists of proprietary engineered allogeneic human cells. The cells are encapsulated in a pro-inflammatory biomaterial that are delivered to the local tumor environment and generate high, sustained concentrations of native IL-2. The product initiates a robust and durable, local and systemic immune response while avoiding toxicities associated with systemic immunotherapies.

This first-in-human, single-arm, open-label, dose-escalation and expansion study (NCT05538624) is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of AVB-001 delivered intraperitoneally (IP) to patients with high grade serous adenocarcinoma of the ovary, primary peritoneum, or fallopian tube.

"The initiation of our first clinical trial of AVB-001 is a significant milestone for Avenge and the first candidate leveraging our LOCOcyte immunotherapy platform to enter the clinic. We are excited to advance AVB-001 as a potential treatment for patients with relapsed refractory ovarian cancer which has limited treatment options," said Michael Heffernan, Chief Executive Officer of Avenge.

"Ovarian cancer is one of the most difficult cancers to treat. It is typically not detected until later stages, and about 70 percent of patients will have recurrence after an initial treatment, which is often fatal. Immune checkpoint inhibitors have limited activity in this disease and there is a critical need for novel and effective therapies. Patients with ovarian cancer and other peritoneal malignancies are uniquely positioned to benefit from this novel cellular therapy," added Dr. Claudio Dansky Ullmann, Avenge’s Chief Medical Officer.

About LOCOcyte Platform
Our LOCOcyte allogeneic cell-based immunotherapy platform enables potent localized modulation of the immune system which also precipitates a systemic immune response, allowing us to treat previously intractable cancers. The technology leverage three unique advantages:

(1) Potent immune effector molecules are generated by synthetically engineering allogeneic cells creating a ready-to-use therapy,

(2) Therapy is localized in proximity to the primary tumor site and generates innate and adaptive immune response, and

(3) The immunomodulator trains the patient’s immune system generating a robust immune response that seeks and eradicates distal metastasis without systemic toxicity.

On January 9, 2023 Illumina Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, and Nashville Biosciences LLC, a wholly owned subsidiary of Vanderbilt University Medical Center (VUMC), reported an agreement with Amgen, a global biopharmaceutical company, to whole-genome sequence approximately 35,000 DNA samples (Press release, Illumina, JAN 9, 2023, View Source [SID1234626128]). The sample cohort is primarily made up of DNA from African Americans, who are currently underrepresented in research for the clinical applications of genomics, including drug target discovery. This cohort will be the largest data set of genomes of its kind to date.

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Illumina and Nashville Biosciences reported an agreement with Amgen to whole-genome sequence approximately 35,000 DNA samples. The sample cohort is primarily made up of DNA from African Americans, who are currently underrepresented in research for the clinical applications of genomics, including drug target discovery. Whole-genome sequencing will be performed by deCODE genetics, a wholly owned subsidiary of Amgen. Image courtesy of deCODE genetics.
Illumina and Nashville Biosciences reported an agreement with Amgen to whole-genome sequence approximately 35,000 DNA samples. The sample cohort is primarily made up of DNA from African Americans, who are currently underrepresented in research for the clinical applications of genomics, including drug target discovery. Whole-genome sequencing will be performed by deCODE genetics, a wholly owned subsidiary of Amgen. Image courtesy of deCODE genetics.
It’s widely recognized that most genomic data sets are drawn from people of European ancestry. This lack of diversity in genomic data has created a gap in the scientific understanding of the underlying genetic causes of disease and inhibits equitable access to precision health therapies.

Sequencing this set of samples is the first in Illumina and Nashville Biosciences’ Alliance for Genomic Discovery (AGD), a multiyear agreement to accelerate therapeutic development through large-scale genomics and establish a preeminent clinico-genomic data set.

Launched in 2022, the AGD aims to whole-genome sequence at least 250,000 de-identified human DNA samples from VUMC’s BioVU biobank over two and a half years in collaboration with multiple biopharmaceutical companies. The BioVU samples were extracted from blood collected during routine clinical testing. The patients who provided them consented to research use, and the samples are linked to extensive de-identified clinical data derived from VUMC’s electronic medical records.

"The whole-genome sequencing of these 35,000 samples will work toward greater diversity of genomic data to ultimately enable improved access to precision therapies for all people," said Joydeep Goswami, chief strategy and corporate development officer and interim chief financial officer of Illumina.

"The initial cohort will be among the largest sequencing efforts involving African Americans to date," said Leeland Ekstrom, chief executive officer of Nashville Biosciences. "Once complete, this data set will provide a wealth of new information about the human genome and accelerate the study of disease in—and discovery of new therapeutics for—populations less well represented in prior large-scale sequencing efforts. The opportunity to sequence this diverse set of samples will help broaden our understanding for individuals who have been underrepresented in genetic research and continue to experience health disparities."

As part of the agreement announced today, deCODE genetics, a wholly owned subsidiary of Amgen, will perform whole-genome sequencing on the 35,000 samples using Illumina sequencing technologies and will upload the data to the Illumina Connected Analytics platform.

"deCODE’s sophisticated human data capabilities are well positioned to sequence these samples and analyze the resulting data to provide a better scientific understanding of disease through the context of human diversity," said Kári Stefánsson, founder of deCODE genetics. "Insights from human data, including both genetics and clinical records, can help inform how medicines may affect different patient populations."

Pharma and biotech collaborators that plan to participate in the AGD and in further sequencing may soon be announced. Researchers will analyze the data for drug discovery and therapy development. The data will also be returned to BioVU to be made available for academic research within the Vanderbilt community.

On January 9, 2023 Secura Bio, Inc. (Secura Bio) – (www.securabio.com), an integrated pharmaceutical company dedicated to the worldwide development and commercialization of impactful oncology therapies, reported that the European Commission (EC) issued an Orphan Drug Designation for duvelisib for the treatment of patients with peripheral T-cell lymphoma (PTCL) (Press release, Secura Bio, JAN 9, 2023, View Source [SID1234626127]). Duvelisib was previously granted orphan drug designation by the United States Food and Drug Administration.

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Orphan Drug Designation in the EU is granted by the EC based on a positive opinion issued by the European Medicines Agency Committee for Orphan Medicinal Products. It is intended to encourage the development of drugs that may provide significant benefit to patients suffering from rare, life-threatening diseases. If approved for marketing, this designation will provide ten years of marketing exclusivity and other special incentives for sponsors, including eligibility for protocol assistance and possible exemptions or reductions in certain regulatory fees.

Duvelisib is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first US-approved dual inhibitor of PI3K-delta and gamma pathways, which are involved in the proliferation and sustenance of malignant cells. Duvelisib was fully approved by the US Food and Drug Administration in September 2018 for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma after at least two prior therapies.

"This Orphan Drug Designation recognizes the significant unmet need in patients with PTCL, especially those with relapsed/refractory disease. This patient group has very limited therapeutic options and duvelisib may offer a new choice of therapy." Said Dr. David Sidransky, Clinical Advisor to Secura Bio.

"Secura Bio is dedicated to developing duvelisib for the treatment of patients with difficult-to-treat cancers, which includes relapsed/refractory PTCL. We are investing significant corporate resources in this endeavor and hope to see new treatment options brought to the market which may benefit patients, such as those with relapse/refractory PTCL." Said Joseph M. Limber, President and CEO of Secura Bio.