1stOncology™: Cancer Intelligence Service – Page 6059 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Positive Interim ES104 Phase 2 Data Reported in Combination with Paclitaxel in Biliary Tract Cancers

On May 15, 2022 Elpiscience Biopharmaceuticals, Inc. ("Elpiscience"), a clinical-stage biopharmaceutical company focused on developing next-generation immunotherapies to benefit cancer patients worldwide, reported partner Compass Therapeutics reported positive interim ES104 (also known as CTX-009) Phase 2 data in combination with paclitaxel in patients with biliary tract cancers (BTC) (Press release, Elpiscience, MAY 5, 2022, View Source [SID1234613705]). ES104 is a bispecific antibody that simultaneously blocks Delta-like ligand 4/Notch (DLL4) and vascular endothelial growth factor A (VEGF-A) signaling pathways, which are critical to angiogenesis and tumor vascularization.

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!

In the study, ES104 demonstrated:

42% overall response rate (ORR) based on 10 patients with Partial Responses (PRs), including 9 PRs confirmed by RECIST 1.1 and 1 PR pending confirmation
Anti-tumor activity in previously treated patients with a clinical benefit rate (CBR) of 92% based on 22 patients with a PR or stable disease (SD) out of 24 enrolled patients
Well-tolerated and preliminary safety profile consistent with prior studies
The Phase 2 study in patients with BTC is currently being conducted at four leading medical centers in Korea and Compass Therapeutics plans to open additional sites in the United States. In China, Elpiscience is currently enrolling patients in a ES104 Phase 1/2 study for the treatment of unresectable locally advanced or metastatic colorectal cancer (CRC). ES104 is currently the only clinical-stage bispecific antibody targeting VEGF and DLL4 in China.

"We are encouraged by the impressive interim Phase 2 data in BTC patients from our partner," said Steve Chin, Chief Medical Officer of Elpiscience. "ES104 in combination with paclitaxel showed a high ORR including responses in all four BTC subtypes and good overall tolerability consistent with prior studies. We believe in the clinical strategy to simultaneously target VEGF and DLL4 and look forward to our study findings in advanced CRC patients."

For more information on the Phase 1/2 clinical study in patients with unresectable locally advanced or metastatic CRC, refer to Clinicaltrials.gov identifier NCT05167448.

About ES104

ES104 is a bispecific antibody that simultaneously blocks Delta-like ligand 4/Notch (DLL4) and vascular endothelial growth factor A (VEGF-A) signaling pathways, which are critical to angiogenesis and tumor vascularization. Pre-clinical and early clinical data of ES104 show that blocking both pathways provides robust anti-tumor activity across several solid tumors, including colorectal, gastric, cholangiocarcinoma, pancreatic, and non-small cell lung cancer. Partial responses to ES104 as monotherapy have been observed in heavily pre-treated cancer patients, who were resistant to currently approved anti-VEGF therapies. ES104 has completed a Phase 1 monotherapy dose-escalation and expansion study (NCT03292783). Phase 1b and Phase 2 clinical studies (NCT04492033) in combination with chemotherapy are ongoing. Elpiscience licensed ES104 greater China rights from Compass Therapeutics in January 2021 and is conducting Phase 1/2 study in China for treatment in patients with unresectable locally advanced or metastatic colorectal cancer.

SQZ Biotechnologies to Host Live & Virtual R&D Investor Event on May 19, 2022

On May 5, 2022 -SQZ Biotechnologies (NYSE: SQZ), focused on unlocking the full potential of cell therapies for multiple therapeutic areas, reported that the company will host a live R&D investor event with optional virtual participation on Thursday, May 19, 2022, from 4:05 – 5:30 p.m. ET (Press release, SQZ Biotech, MAY 5, 2022, View Source [SID1234613710]).

The event will feature presentations on the company’s point-of-care (POC) manufacturing system, currently in internal testing, and its potential impact on cell therapy development. The company will also discuss its first anticipated clinical use in the SQZ TAC clinical development program for celiac disease, which has an FDA investigational new drug application submission planned for the first half of 2023.

Company leadership will also discuss the collaboration with STEMCELL Technologies and the development of a research-use-only Cell Squeeze system.

The event will include a special fireside chat on the present and future state of cell engineering. Speakers include:

Robert S. Langer, Sc.D., Scientific Advisory Board Member and Founder of SQZ Biotechnologies, and David H. Koch Institute Professor at the Massachusetts Institute of Technology
Klavs F. Jensen, Ph.D., Board Member and Founder of SQZ Biotechnologies, and Warren K. Lewis Professor of Chemical Engineering at the Massachusetts Institute of Technology
Armon Sharei, Ph.D., Chief Executive Officer and Founder of SQZ Biotechnologies
Moderated by Mike Huckman, Global Practice Leader, Executive Communications at Real Chemistry, and former CNBC Pharmaceuticals Reporter
Event Details
The company will host a live R&D Investor event with optional virtual participation on Thursday, May 19, 2022, beginning at 4:05 p.m. ET. Onsite and virtual participants can register in advance by completing the registration form on the event website: View Source Following the event, a webcast replay will be made available on the company’s investor website: investors.sqzbiotech.com.

Median Technologies Is Moving Forward With the FDA Interactions for Its iBiopsy® Lung Cancer Screening CADe/CADx Software as Medical Device

On May 5, 2022 Median Technologies (ALMDT) reported that the company has received feedback from the United States Food and Drug Administration (FDA) regarding the 513(g) submission done on Feb. 17, 2022 for its iBiopsy Lung Cancer Screening (LCS) AI/ML technology-based end-to-end CADe/CADx1 Software as Medical Device (SaMD) (Press release, MEDIAN Technologies, MAY 5, 2022, View Source [SID1234613709]).

The aim of the 513(g) submission was to determine the relevant product classification and choose between the De Novo or the 510(k) regulatory pathways2 for iBiopsy LCS CADe/CADx SaMD. The FDA has stated that the Median’s iBiopsy LCS CADe/CADx falls within 21 CFR 892.2090 (Radiological Computer Assisted Detection And Diagnosis Software), a Class II type device, which requires the submission of a 510(k) in order to obtain the FDA clearance prior to marketing.

As next regulatory steps, Median Technologies is preparing several Q-submissions for Q2 and Q3, 2022. The first Q-sub has been submitted for FDA review on May 2, and focuses mostly on reviewing pivotal study protocols and possible predicate devices. A meeting will be scheduled with the FDA experts at their earliest convenience.

"After this first regulatory feedback of the FDA on the 513(g), we want to keep having frequent and fruitful interactions with the Agency in order to better tailor our device to the US market", Fredrik Brag, CEO and founder of Median Technologies said. "The design of the pivotal studies will be a key part of showing the unique performance of our iBiopsy CADe/CADx Software as Medical Device and how it could have an impact on saving patients’ lives by identifying lung cancer onsets at their earliest stage", Brag added.

About iBiopsy: iBiopsy is based on the most advanced technologies in Artificial Intelligence (AI) and Data Science (DS), benefiting from Median’s expertise in medical image processing. iBiopsy targets the development of innovative AI/ML-based Software as Medical Device, to be used in several indications for which there are unmet needs regarding early diagnosis, prognosis and treatment selection in the context of precision medicine. iBiopsy currently focuses on lung cancer, liver cancer (HCC) and liver fibrosis (NASH).

MaaT Pharma Reports Cash and Revenues for First Quarter 2022

On May 5, 2022 MaaT Pharma (EURONEXT: MAAT – the "Company"), a French clinical-stage biotech and a pioneer in the development of microbiome-based ecosystem therapies dedicated to improving survival outcomes for patients with cancer reported its cash position as of March 31, 2022, and its revenues for the first quarter of 2022 (Press release, MaaT Pharma, MAY 5, 2022, View Source [SID1234613708]).

Over the course of the first quarter 2022, the Company has continued its clinical development as previously announced in the context of its IPO in November 2021 such as:

– In January 2022, announcement of positive interim and preliminary data of its Phase 1b trial for MaaT033 in preventing complications of allogeneic hematopoietic stem cell transplantation
– In March 2022, inclusion of the first patient in a Phase 3 trial "ARES" for drug-candidate MaaT013 in the treatment of Graft-versus-Host Disease
– In April 2022, initiation of a Phase 2a trial, sponsored by AP-HP, evaluating MaaT013 in combination with immune checkpoint inhibitors for patients with melanoma

Moreover, the Company entered a partnership agreement in February 2022 with Skyepharma to build, to date, France’s largest cGMP manufacturing facility exclusively dedicated to the production of Microbiome Ecosystem Therapy (MET), thus increasing MaaT Pharma’s manufacturing capabilities ten-fold in line with supply needs required by 2030.

Cash position1

As of March 31, 2022, total cash and cash equivalents were EUR 41.1 million, as compared to EUR 43.3 million as of December 31, 2021. The Company believes it has sufficient cash to cover needs of the development programs presented during the IPO up until the end of the third quarter of 2023.

Revenues in Q1 20221

MaaT Pharma reported revenues of EUR 0.3 million for the quarter ended March 31, 2022, compared with 0.1 million for the same period of 2021. Revenues correspond to compensation invoiced in relation to the compassionate access program, as approved by the French National Drug Safety Agency (Agence Nationale de Sécurité du Médicament or ANSM). In 2022, the program was fully active whereas in 2021 the program began over the course of the first quarter, thus explaining the year-on-year increase.

Upcoming financial communication and investor conference participation

May 31, 2022 – Annual General Meeting
June 7, 2022 – Investor R&D Day
June 30, 2022 – 9th Portzamparc Annual Conference, Paris
July 28, 2022 – Revenues and Cash Position Quarter 2*
September 15 – 16, 2022 – KBCS Life Sciences Conference
September 29, 2022 – Half-year Results 2022*
*Indicative calendar that may be subject to change.

AbbVie Chooses Cerebras Systems to Accelerate AI Biopharmaceutical Research

On May 5, 2022 Cerebras Systems, the pioneer in high performance artificial intelligence (AI) computing, and AbbVie, a global biopharmaceutical company, reported a landmark achievement in AbbVie’s AI work (Press release, AbbVie, MAY 5, 2022, View Source [SID1234613707]). Using a Cerebras CS-2 on biomedical natural language processing (NLP) models, AbbVie achieved performance in excess of 128 times that of a graphics processing unit (GPU), while using 1/3 the energy. Not only did AbbVie train the models more quickly, and for less energy, due to the CS-2’s simple, standards-based programming workflow, the time usually allocated to model set up and tuning was also dramatically reduced.

"A common challenge we experience with programming and training BERT LARGE models is providing sufficient GPU cluster resources for sufficient periods of time," said Brian Martin, Head of AI at AbbVie. "The CS-2 system will provide wall-clock improvements that alleviate much of this challenge, while providing a simpler programming model that accelerates our delivery by enabling our teams to iterate more quickly and test more ideas."

With a focus on cutting edge R&D across immunology, neuroscience, oncology, and virology, it’s essential for AbbVie’s scientists to keep abreast of research findings from around the world. To that end, AbbVie employs large, sophisticated AI language models to build its machine translation service, Abbelfish. This service accurately translates and makes searchable vast libraries of biomedical literature across 180 languages using large, state-of-the-art Transformer models such as BERT, BERT LARGE, and BioBERT.

Ensuring Abbelfish is both accurate and always up to date requires training and re-training the NLP models from scratch with domain-specific biomedical data. However, the Abbelfish model is very large – 6 billion parameters. Such a model is impractical to train on even the largest GPU clusters. Cerebras Systems makes this type of large-scale AI training fast and easy.

Large language models like BERT LARGE have demonstrated state-of-the-art accuracy on many language processing and understanding tasks. Training these large language models using GPUs is challenging and time-consuming. Training from scratch on new datasets often takes weeks, even on large clusters of legacy equipment. As the size of the cluster grows, power, cost, and complexity grow exponentially. Programming clusters of graphics processing units requires rare skills, different machine learning frameworks and specialized tools that take weeks of engineering time to each iteration.

The CS-2 was built to directly address these challenges and radically reduce the time to insight. The CS-2 delivers the deep learning performance of 100s of GPUs, with the programming ease of a single node. As a result, less time is spent in set up and configuration, less time is spent training and more ideas are explored. The AbbVie team was able to set up and train their custom BERT LARGE model from scratch in less than two days with the Cerebras CS-2.

"At Cerebras Systems, our goal is to enable AI that accelerates our customer’s mission," said Andrew Feldman, CEO and co-founder of Cerebras Systems. "It’s not enough to provide customers with the fastest AI in the market — it also must be the most energy efficient and the easiest to deploy. It’s incredible to see AbbVie not only accelerating their massive language models, but doing so while consuming a fraction of the energy used by legacy solutions."

The Cerebras CS-2 is powered by the largest processor ever built – the Cerebras Wafer-Scale Engine 2 (WSE-2), which is 56 times larger than the nearest competitor. As a result, the CS-2 delivers more AI-optimized compute cores, more fast memory, and more fabric bandwidth than any other deep learning processor in existence. It was purpose built to accelerate deep learning workloads reducing the time to answer by orders of magnitude.

With customers and partners in North America, Asia, Europe and the Middle East, Cerebras is delivering industry leading AI solutions to a growing roster of customers in the enterprise, government, and high performance computing segments including GlaxoSmithKline, AstraZeneca, TotalEnergies, nference, Argonne National Laboratory, Lawrence Livermore National Laboratory, Pittsburgh Supercomputing Center, Edinburgh Parallel Computing Centre (EPCC), and Tokyo Electron Devices.