On May 15, 2024 Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through the development of potentially best-in-class IL-2 therapeutics, reported a new collaboration and supply agreement with Ares Trading S.A., a Swiss subsidiary of Merck KGaA, Darmstadt, Germany, for use of Bavencio (avelumab) in a clinical study of its lead human monoclonal antibody candidate, AU-007 (Press release, , MAY 15, 2024, View Source [SID1234643315]). Under the terms of the agreement, Merck KGaA, Darmstadt, Germany will provide Aulos with a free supply of Bavencio to evaluate in combination with AU-007 and low-dose, subcutaneous aldesleukin in an additional Phase 2 cohort of Aulos’ Phase 1/2 clinical trial of AU-007 in solid tumor cancers. Bavencio is a human anti-programmed death ligand-1 (PD-L1) antibody approved for use in multiple clinical indications.

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"We are excited to embark on this clinical trial collaboration with Merck KGaA, Darmstadt, Germany, which will enable our team to further investigate AU-007 in tandem with an anti-PD-L1 antibody, based on positive preclinical results," said Aron Knickerbocker, Aulos Bioscience’s chief executive officer. "We believe Bavencio may offer distinct mechanistic synergy with AU-007 when compared to other immune checkpoint inhibitors because it is the only approved anti-PD-L1 antibody that has effector function and engages natural killer cells to kill tumor cells by a process known as ADCC, while also interrupting the PD-L1/PD-1 checkpoint that inhibits effector T cells. This unique profile of Bavencio, along with the ability of AU-007 and aldesleukin to accelerate the activation and expansion of effector T cells and natural killer cells, holds promise for creating a powerful combination therapeutic regimen that may eradicate tumor cells in multiple cancer types."

AU-007 is the first human IgG1 monoclonal antibody designed using artificial intelligence to enter a human clinical trial. In preclinical studies, strong anti-cancer activity, including complete tumor eradications, was observed when AU-007 was dosed in combination with a single loading dose of human interleukin-2 (hIL-2) and an anti-PD-L1 surrogate of avelumab.

A Phase 1/2 study is currently evaluating AU-007 and is enrolling patients with unresectable locally advanced or metastatic cancer at multiple clinical trial site locations in the United States and Australia. Interim data from the Phase 1 portion of the study indicate that AU-007 is the only IL-2 therapy ever to demonstrate an overall trend in decreasing regulatory T cells (Tregs) and eosinophils, with encouraging early signs of anti-tumor activity.

Aulos plans to present additional Phase 1 data and preliminary Phase 2 data, with a focus on melanoma and renal cell carcinoma, at an upcoming medical conference. The company anticipates commencing patient enrollment in the Phase 2 cohort studying Bavencio with AU-007 and aldesleukin in the second half of 2024.

About AU-007
AU-007 is a computationally designed, human IgG1 monoclonal antibody that is highly selective to the CD25-binding portion of IL-2. With a mechanism of action unlike any other IL-2 therapeutic in development, AU-007 leverages IL-2 to reinforce anti-tumor immune effects. This is achieved by preventing IL-2, either exogenous or secreted by effector T cells, from binding to trimeric receptors on regulatory T cells while still allowing IL-2 to bind and expand effector T cells and NK cells. This prevents the negative feedback loop caused by other IL-2-based treatments and biases the immune system toward activation over suppression. AU-007 also prevents IL-2 from binding to CD25-containing receptors on eosinophils, as well as vasculature and pulmonary endothelium, which may significantly reduce the vascular leak syndrome and pulmonary edema associated with high-dose IL-2 therapy.

To learn more about the AU-007 Phase 1/2 clinical trial program, including study locations in the United States and Australia, please visit ClinicalTrials.gov (identifier: NCT05267626), www.solidtumorstudy.com (U.S.) and www.solidtumourstudy.com (Australia).

On May 15, 2024 Oncocyte Corporation (Nasdaq: OCX), a precision diagnostics company, reported financial results for the quarter ended March 31, 2024 (Press release, Oncocyte, MAY 15, 2024, View Source [SID1234643332]).

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Recent Highlights

● Announced global commercialization partnership with Bio-Rad Laboratories, Inc.
● On track to ship research use only (RUO) GraftAssureTM transplant monitoring test kits to initial customers in Asia, the U.S., and the EU in 2Q 2024. IVD kits are under development for FDA submission.
● Raised $15.8 million in gross proceeds from equity private placement; as part of the financing, Bio-Rad purchased 8.99% of Oncocyte; new and existing investors invested as well.
● Reduced cash burn to $3.9 million, reflecting capital-efficient business model.

"In the first quarter of 2024, Oncocyte made significant progress toward commercializing its innovative blood-based diagnostic tests. That progress was bolstered by a $15.8 million equity private placement and a global strategic partnership with Bio-Rad Laboratories," said Josh Riggs, Oncocyte’s CEO. "We believe that the collaboration with Bio-Rad is pivotal for the upcoming launch of our GraftAssure RUO transplant rejection diagnostic test kit and central to our mission of developing and providing accessible point of care diagnostics and continuous innovation in transplant rejection monitoring."

"The Bio-Rad partnership validates the efficacy and market opportunity of our proprietary assays and enables us to rapidly enter the growing transplant monitoring market at key academic centers with GraftAssure RUO. It also lays the groundwork for broader commercial expansion. Together with Bio-Rad, we are developing regulated products including VitaGraft TM Kidney IVD, and preparing for clinical adoption. Additionally, our technology has been selected to support multiple Phase 2 clinical studies by pharmaceutical companies that are developing therapeutics to treat and manage anti-body mediated rejection. These therapeutic studies may unlock valuable new commercial applications."

"Building on the momentum of these achievements, we are preparing to ship to several initial commercial customers in the U.S., the EU, and Asia in Q2. We are encouraged by prospective customers’ positive response to GraftAssure’s superior affordability, turn-around-time, and ease of use. We are well-positioned to achieve numerous critical commercial and regulatory milestones throughout 2024 and into 2025. We also are continuing to advance the development of our oncology diagnostics pipeline products, DetermaIO and DetermaCNI. Lastly, in Q1 2024, our cash burn stayed low at $3.9 million , reflecting our cost-control measures and financial discipline. We continue to meet our goal of maintaining a low average quarterly burn rate below $5 million."

2024 First Quarter Financial Results

Net revenue for the three months ended March 31, 2024 was $176,000, a decrease of 41% compared to the same period in 2023, due to decreased revenue from our Pharma Services business.

Total cost of revenues for the three months ended March 31, 2024 was $274,000, a decrease of 5% compared to the same period in 2023. Total cost of revenues included $252,000 from the cost of diagnostic tests and testing services we performed for Pharma Services customers, with the remaining cost from noncash amortization expense.

Research and development expense for the three months ended March 31, 2024 was $2.2 million, an increase of 2% compared to the same period in 2023. The increase was driven by continued focused investment in developing kitted versions of assays including DetermaIOTM, VitaGraft and DetermaCNITM.

Sales and marketing expense for the three months ended March 31, 2024 was $846,000, an increase of 22% compared to the same period in 2023. The increase was primarily driven by a continued ramp in sales, marketing and commercialization activities related to the commercial launch of GraftAssure.

General and administrative expense for the three months ended March 31, 2024 was $2.7 million, a decrease of 22% compared to the same period in 2023. The decrease was primarily due to decreased stock-based compensation, personnel expenses, professional fees, and facilities and insurance expenses.

Loss from operations for the three months ended March 31, 2024 was $9.3 million, compared to income from operations of $5.9 million during the same period in 2023. The increased loss from operations was primarily due to the unrealized noncash change in fair value of contingent consideration. The 2024 loss from operations included a loss of $3.3 million from the change in fair value of contingent consideration, compared to a gain of $18.3 million in 2023. Excluding the change in fair value of contingent consideration, the 2024 loss from operations decreased 52% compared to 2023.

For Oncocyte’s complete financial results for the first quarter ended March 31, 2024, see the Company’s quarterly Form 10-Q to be filed with the Securities and Exchange Commission on May 15, 2024.

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."