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]).

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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.

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.

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"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.

On May 5, 2022 BiomX Inc. (NYSE American: PHGE) ("BiomX" or the "Company"), a clinical-stage microbiome company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, reported that the Company will host a conference call and a live audio webcast on Wednesday, May 11, 2022, at 8:00 a.m. EDT, to report first quarter 2022 financial results and provide business updates (Press release, BiomX, MAY 5, 2022, View Source [SID1234613706]). To participate in the conference call, please dial 1-877-407-0724 (U.S.) or 1-201-389-0898 (International). The live and archived webcast will be available in the Investors section of the Company’s website at www.biomx.com.

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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.

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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.

On May 5, 2022 Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, reported a late-breaking abstract presentation on 18F-rhPSMA-7.3 at the upcoming 2022 AUA Annual Meeting (AUA2022), to be held May 13 to 16 in New Orleans, La (Press release, Blue Earth Diagnostics, MAY 5, 2022, View Source [SID1234613704]). 18F-rhPSMA-7.3 is an investigational Prostate-Specific Membrane Antigen-targeted radiohybrid (rh) PET imaging agent. The SPOTLIGHT study (NCT04186845) is a Phase 3, multi-center, single-arm imaging study, conducted in the United States and Europe, to evaluate the safety and diagnostic performance of 18F-rhPSMA-7.3 PET imaging in men with suspected prostate cancer recurrence based on elevated PSA following prior therapy. Details of the presentation are listed below.

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Highlighted Oral Presentation

Friday, May 13, 2022 Morning Plenary Session

Presentation:

Impact of 18F-rhPSMA-7.3 PET on upstaging of patients with prostate cancer recurrence: results from the prospective, Phase 3, multicenter SPOTLIGHT study

Abstract Number:

Late-Breaking Abstract PLLBA-02

Presenter:

Mark T. Fleming, MD, Virginia Oncology Associates, U.S. Oncology Research, Norfolk, Va., on behalf of the SPOTLIGHT Study Group

Session Title & Times:

Plenary Session 7:30 AM – 11:30 AM CT

Oral Presentation:

11:13 – 11:21 AM CT

Location:

New Orleans Ernest N. Morial Convention Center, Great Hall A

Blue Earth Diagnostics invites participants at AUA2022 to attend the presentation above and to learn more about the Company at Booth 455. For full session details and scientific presentation listings, please see the AUA online program here.

About Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA)

rhPSMA compounds consist of a radiohybrid ("rh") Prostate-Specific Membrane Antigen-targeted receptor ligand which attaches to and is internalized by prostate cancer cells and they may be radiolabeled with 18F for PET imaging, or with isotopes such as 177Lu or 225Ac for therapeutic use – creating a true theranostic technology. They may play an important role in patient management in the future, and offer the potential for precision medicine for men with prostate cancer. Radiohybrid technology and rhPSMA originated from the Technical University of Munich, Germany. Blue Earth Diagnostics acquired exclusive, worldwide rights to rhPSMA diagnostic imaging technology from Scintomics GmbH in 2018, and therapeutic rights in 2020, and has sublicensed the therapeutic application to its sister company Blue Earth Therapeutics. Blue Earth Diagnostics has completed two Phase 3 clinical studies evaluating the safety and diagnostic performance of 18F-rhPSMA-7.3 PET imaging in prostate cancer: ("SPOTLIGHT," NCT04186845), in men with recurrent disease and ("LIGHTHOUSE," NCT04186819), in men with newly diagnosed prostate cancer. Currently, rhPSMA compounds are investigational and have not received regulatory approval.