On May 15, 2024 OmniAb, Inc. (Nasdaq: OABI) reported its participation in the 20th Annual PEGS Boston – The Essential Protein & Antibody Engineering Summit underway at the Omni Hotel (Press release, OmniAb, MAY 15, 2024, View Source [SID1234643364]). Earlier today the Company presented an overview of xPloration, a high-throughput single B-cell screening platform that leverages machine learning and Artificial Intelligence (AI), in a presentation titled "Deep Screening in Harmony with Artificial Intelligence for Bispecific Antibody Discovery."

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"xPloration enables large-scale data collection of massive, diverse antibody repertoires generated utilizing the Biological Intelligence built into our proprietary engineered animals, and facilitates efficient evaluation of AI selections from these repertoires," said Bob Chen, Ph.D., Senior Director, Discovery Systems. "The synergy between xPloration, OmniFlic, OmniClic, and OmniDeep enables new bispecific antibody discovery workflows for our partners. We are delighted that our innovative technology stack continues to make important impacts on partner R&D pipelines, and assists in delivering novel, highly effective therapeutic solutions to patients."

Today’s presentation included a case study demonstrating the ability to rapidly discover antibody panels from the Company’s OmniFlic and OmniClic platforms against a promising target called NKp46. These antibodies may be used by partners in a natural killer cell engager bispecific antibody. With xPloration, OmniAb’s scientific team screened tens of millions of cells and recovered thousands of unique antibody sequences. The team applied OmniDeep to help understand natural immune repertoires and to guide antibody selection and characterization, resulting in a large panel of high-affinity, potentially developable antibodies.

Dr. Chen’s presentation is available on the Scientific Publications section of OmniAb’s website.

For more information about OmniAb’s proprietary technologies, please visit www.omniab.com or contact our business development team at [email protected].

On May 15, 2024 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported its financial results for the first quarter ended March 31, 2024 and provided an update on recent corporate developments (Press release, Bio-Path Holdings, MAY 15, 2024, View Source [SID1234643316]).

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"The multiple milestones achieved throughout the first quarter and in recent weeks are creating momentum to help advance our goal to deliver a better path for cancer patients," said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. "We made meaningful progress across all areas of the business, which include important clinical milestones, expanding our global patent portfolio and strengthening the balance sheet. These achievements leave us well positioned for continued progress throughout the balance of the year."

Recent Corporate Highlights
Expanded Global Patent Portfolio. In April, Bio-Path announced the receipt of newly issued patents in Mexico, Australia and Japan, and updated investors on the extent of its global intellectual property portfolio. Bio-Path expanded its intellectual property portfolio by filing patent applications applicable to its technology and business strategy. Bio-Path’s patent portfolio currently includes five issued patents in the U.S. and 54 issued patents in foreign jurisdictions, providing protection in 21 countries.

Successfully Completed Higher Dose Second Cohort in Phase 1/1b Clinical Trial of BP1002 in Refractory/Relapsed Acute Myeloid Leukemia (AML) Patients. In April, the Company announced completion of the second dose cohort of the dose escalation portion of its Phase 1/1b clinical trial of BP1002 evaluating the ability of BP1002 to treat refractory/relapsed acute myeloid leukemia (AML) patients, including venetoclaxresistant patients. The dose escalation portion calls for a total of six evaluable patients to be treated with BP1002 monotherapy over two dose levels in a standard 3+3 design, with a starting dose of 20 mg/m2 and the second dose of 40 mg/m2. The testing of these two dose levels is now complete and the clinical trial will pause for a brief data review by the FDA, and then Bio-Path expects dose testing will continue at the next planned higher dose of 60 mg/m2. The approved treatment cycle is two doses per week over four weeks, resulting in eight doses administered over twenty-eight days. The Phase 1b portion of the study is expected to commence after completion of BP1002 monotherapy cohorts and will assess the safety and efficacy of BP1002 in combination with decitabine in refractory/relapsed AML patients.

Completed $1.2 Million Registered Direct Offering and $2.3 Million Through At-TheMarket (ATM) Financing. In April, Bio-Path entered into a definitive agreement with certain institutional investors for the sale and issuance of 375,000 shares of its common stock at a purchase price per share of $3.225 in a registered direct offering priced at-the-market under Nasdaq rules. The gross proceeds to Bio-Path from the offering were approximately $1.2 million, before deducting the placement agent’s fees and other offering expenses payable by Bio-Path. Bio-Path intends to use the net proceeds from the offering for working capital and general corporate purposes. In addition, Bio-Path sold $2.3 million shares of common stock under its At-The-Market Offering Agreement, bringing funds raised to $3.5 million.

Completed First Dose Cohort in Phase 1 Clinical Trial Evaluating BP1002 to Treat Refractory/Relapsed Lymphoma and Refractory/Relapsed Chronic Lymphocytic Leukemia Patients. In January, Bio-Path announced completion of the first dose cohort of the dose escalation portion of its Phase 1 clinical trial of BP1002 evaluating the ability of BP1002 for the treatment of refractory/relapsed lymphoma and refractory/relapsed chronic lymphocytic leukemia (CLL) patients.

On May 15, 2024 Oncolytics Biotech, a leading clinical-stage company specializing in immunotherapy for oncology, reported that it has entered into a preliminary collaboration with the Global Coalition for Adaptive Research (GCAR) (Press release, Oncolytics Biotech, MAY 15, 2024, View Source [SID1234643333]). The purpose of the preliminary collaboration is to commence planning activities for the evaluation of pelareorep in the treatment of first-line metastatic pancreatic ductal adenocarcinoma (PDAC) as part of GCAR’s anticipated master protocol for metastatic pancreatic cancer. Activities are currently underway to finalize the seamless Phase 2/3 master protocol design that will evaluate multiple investigational therapies for the treatment of pancreatic cancer. An intent of the study is to produce registration-enabling data.

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"We are thrilled to collaborate with GCAR and are honored that pelareorep has been selected as the first therapeutic for evaluation in GCAR’s planned adaptive trial in pancreatic cancer patients. We believe this opportunity presents a strategic and efficient pathway forward for the development of pelareorep to address an urgent need for pancreatic cancer patients," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics. "GCAR’s anticipated trial design seeks to cut registrational study time and reduce trial costs, speeding up the journey to potentially deliver effective cancer treatment sooner. Through our interactions with GCAR, we have seen the strength of their capabilities and strong engagement with disease experts in pancreatic cancer. These attributes give us great enthusiasm to begin working together right away."

Meredith Buxton, PhD, MPH, Chief Executive Officer and President of GCAR, commented, "Our unwavering mission at GCAR is to accelerate the development of treatments for patients with deadly diseases such as pancreatic cancer. We believe that adaptive platform trials have the potential to achieve that mission and to be game-changing for patients. We are enthusiastic about collaborating with Oncolytics on our planned pancreatic cancer initiative, which was announced earlier this year, and we look forward to working with Oncolytics to advance our program."

Thomas Heineman, MD, PhD, Chief Medical Officer of Oncolytics shared, "The combination of pelareorep’s impressive results to date and GCAR’s innovative trial design creates a powerful path forward. This strategy, which includes leveraging GCAR’s extensive investigator network, enhances our ability to quickly and effectively advance the development of this pelareorep-based combination therapy for PDAC. Updated data from cohort 1 of the GOBLET study, presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023, showed that patients treated with pelareorep combined with a checkpoint inhibitor, gemcitabine, and nab-paclitaxel experienced a 62% objective response rate, nearly triple what has been seen in historical control trials.1-4 We hope to build on these results in GCAR’s forthcoming study that will employ GCAR’s broad and established network of clinical leaders in pancreatic cancer. I am very optimistic about our program and our collaboration with GCAR and look forward to advancing the evaluation of pelareorep as soon as possible."

On May 15, 2024 MediGene, an immuno-oncology platform company focusing on the discovery and development of T cell immunotherapies for solid tumors, reported the company’s proprietary T cell receptor (TCR) discovery process to obtain optimal affinity 3S (sensitive, specific and safe) TCRs at the 21th Association for Cancer Immunotherapy (CIMT) (Free CIMT Whitepaper) Annual Meeting in Mainz from May 15 – 17, 2024 (Press release, MediGene, MAY 15, 2024, View Source [SID1234643365]). Data presented also shows the clear benefit of adding the PD1-41BB costimulatory switch protein (CSP) to further armor and enhance these 3S TCR-T cells, which enables them to overcome the immunosuppressive tumor microenvironment.

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The poster with the title "Selection of superior KRAS G12V mutation-specific T cell receptors with unique characteristics for 3rd generation armored and enhanced T cell therapy" will be available on Wednesday, May 15, 2024, following the presentation on Medigene’s website: View Source

"The discovery process of unique TCR sequences is the first key step to generate TCR-T cells with optimal safety, efficacy and durability," said Dr. Selwyn Ho, Chief Executive Officer at Medigene. "Employing a high-throughput process as part of our End-To-End (E2E) Platform enabled us to discover unique TCR sequences with distinct features with respect to specificity, sensitivity and safety (3S). These potential best-in-class 3S TCRs hold promise for utilization across diverse modalities, here focusing on T cell receptor engineered T cell (TCR-T) therapies, but also for use in T cell engagers and TCR natural killer cell therapies. "

He continued: "Our TCRs can undergo further enhancement through integration of various technologies within our E2E Platform such as with our exclusive PD1-41BB CSP, which significantly enhances TCR-T cell functionality, persistence and proliferation and offers the promise of highly effective and durable TCR-T therapies in patients."

The presented data highlighted the specificity and sensitivity of TCR-T cells co-expressing the PD1-41BB CSP alongside one of three distinct 3S TCRs targeting the mKRAS G12V neoantigen. These TCR-T cells displayed markedly increased secretion of interferon gamma (IFNγ) observed upon TCR-T cell stimulation with mKRAS G12V-positive tumor cells, contrasting with the absence of IFN γ secretion upon stimulation with any tumor or healthy cell expressing naturally occurring wild-type KRAS protein.

All three 3S TCRs also demonstrated high sensitivity to the mKRAS G12V neoantigen, as demonstrated by their activation in response to extremely low levels of mKRAS-G12V peptide. Concurrent expression of the PD1-41BB CSP significantly augmented TCR-T cell functionality, enabling sustained cytotoxicity targeting 3D tumor spheroids across multiple rounds of tumor exposure. This underscores the potent anti-cancer efficacy of the TCR-T cells.

From a safety perspective, all three 3S TCRs combined with the PD1-41BB CSP demonstrated favorable safety profiles, with no IFNγ secretion or cytotoxicity when exposed to healthy cells from major tissues or organs, affirming their selective cytotoxicity towards cancer cells while sparing healthy tissue from toxicity.

On May 15, 2024 Merck, a leading science and technology company, reported a good start to fiscal 2024 (Press release, Merck KGaA, MAY 15, 2024, View Source [SID1234644741]). The Healthcare business sector performed strongly. Electronics also delivered solid organic sales growth, mainly driven by Semiconductor Solutions. Life Science recorded sales and earnings declines compared with the particularly high base of the year-earlier quarter.

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