On August 1, 2024 BostonGene, a leading provider of artificial intelligence (AI)-driven molecular and immune profiling solutions, reported that it will collaborate with Takeda on immuno-oncology focused research studies (Press release, BostonGene, AUG 1, 2024, View Source [SID1234645284]). This partnership aims to identify key molecular drivers and predictive markers for treatment efficacy and adverse effects with the primary goal of advancing clinical solutions and improving patient outcomes.

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Takeda will leverage BostonGene’s AI-powered multiomics platform in select early-stage clinical trials to enhance trial design, improve indication selection and identify biomarker signatures for response and toxicity. BostonGene will perform sophisticated multiomic analytics using proprietary computational platforms on clinical and laboratory data provided by Takeda. Additionally, BostonGene will conduct extensive bioinformatics analysis on flow cytometry, RNA-seq and proteomics data.

"We are pleased to enter this partnership with BostonGene, which will enable us to leverage cutting-edge technology to advance our oncology research and development," said PK Morrow, MD, Head, Oncology Therapeutic Area Unit at Takeda. "Through this collaboration we look forward to utilizing data and AI to gain more insights into the biology and mechanisms of investigational therapies at the earliest stages. These data will help us to better understand their potential in certain patient populations and ultimately help advance oncology medicines for patients who need them."

"BostonGene is excited to collaborate with Takeda," said Nathan Fowler, MD, Chief Medical Officer at BostonGene. "Our advanced multiomic analytics will significantly improve patient selection processes and pinpoint critical mechanistic signatures associated with response, driving forward the development of innovative treatments."

On August 1, 2024 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported members of its executive team are scheduled to participate in the upcoming conference, detailed below (Press release, Innate Pharma, AUG 1, 2024, View Source [SID1234645283]). Participants will include Yannis Morel, EVP, Chief Operating Officer and Arvind Sood, EVP, President of US Operations.

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BTIG Virtual Biotechnology Conference
Dates: August 5 – 6 2024 | Virtual

On August 1, 2024 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, reported recent operational highlights and financial results for the second quarter ended June 30, 2024 (Press release, Oncolytics Biotech, AUG 1, 2024, View Source [SID1234645282]). All dollar amounts are expressed in Canadian currency unless otherwise noted.

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"In the second quarter, we continued to build regulatory and clinical momentum for our differentiated and potentially leading immunotherapeutic agent, pelareorep, which is poised to advance to registration-enabling studies for the treatment of breast and pancreatic cancers," said Wayne Pisano, Chair of Oncolytics’ Board of Directors and Interim CEO. "Notably, we are pleased to have aligned with the FDA on key elements for the path forward in HR+/HER2- metastatic breast cancer (mBC). Based on guidance from regulators and compelling data from two randomized breast cancer studies, we are confident in pelareorep’s potential to demonstrate a clinically meaningful benefit in a future registration-enabling study, and we remain on track to report overall survival results from the BRACELET-1 trial in the second half of 2024."

Mr. Pisano continued, "In parallel, we initiated dosing in the mFOLFIRINOX cohort of the GOBLET study, an exciting opportunity to evaluate the combination of pelareorep with another first-line pancreatic cancer chemotherapy regimen that could result in a second registration program in this indication. The study builds on positive data demonstrating that the combination of pelareorep, atezolizumab, gemcitabine, and nab-paclitaxel in pancreatic cancer patients more than doubled tumor response rates compared to earlier trials of chemotherapy treatment alone. That combination received Fast Track Designation from the FDA and, through our collaboration with the Global Coalition for Adaptive Research (GCAR), will be evaluated in an adaptive registration-enabling trial. Taken together, we are encouraged by the robust clinical and translational data supporting pelareorep’s unique mechanism of action, and we look forward to providing updates on our progress."

Second Quarter Highlights

Received productive feedback from the Type C meeting with the FDA, supportive of the planned potential registration-enabling study for pelareorep in HR+/HER2- mBC. The FDA supports progression-free survival as the primary endpoint of the study and overall survival as a secondary endpoint. The patient population is expected to include those who have failed hormonal therapy and have received no more than one line of antibody-drug conjugate (ADC) therapy (link to the PR). The control arm is expected to be paclitaxel monotherapy, and the test arm is expected to be pelareorep combined with paclitaxel. Notably, the combination of pelareorep and paclitaxel has already shown a meaningful patient benefit compared to paclitaxel in two previous randomized studies (BRACELET-1 and IND-213).

First patient dosed in the new GOBLET study pancreatic cancer cohort supported by PanCAN. The fifth cohort of the GOBLET study has been initiated and will evaluate pelareorep plus modified FOLFIRINOX (mFOLFIRINOX) with or without atezolizumab in newly diagnosed pancreatic ductal adenocarcinoma (PDAC) patients (link to the PR). The Pancreatic Cancer Action Network (PanCAN) awarded Oncolytics the Therapeutic Accelerator Award and US$5 million to evaluate this treatment regimen, which includes mFOLFIRINOX, a commonly used chemotherapy for PDAC patients. Having already reported compelling data for pelareorep in combination with another chemotherapy regimen (gemcitabine + nab-paclitaxel) and atezolizumab in pancreatic cancer in cohort 1 of the GOBLET study, similar data with this treatment regimen could result in another registrational opportunity for pelareorep in this challenging indication.

Announced preliminary collaboration with GCAR for adaptive registrational pancreatic cancer study. The preliminary collaboration has enabled planning activities to begin for the evaluation of pelareorep in the treatment of first-line metastatic PDAC as part of GCAR’s anticipated master protocol for metastatic pancreatic cancer (link to the PR). An anticipated outcome of the study is to produce registration-enabling data. The treatment regimen expected to be evaluated is pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab, which has already more than doubled the objective response rate compared to historical trials (link to the PR, link to the poster) and received Fast Track Designation from the FDA. This innovative adaptive Phase 2/3 design allows for multiple investigational therapies to be evaluated and could accelerate the registrational study timeline and provide substantial cost savings compared to traditional trial designs. This collaboration and the new cohort of the GOBLET study are part of the Company’s strategy to improve treatment options and outcomes for patients with pancreatic cancer.

Two presentations at the Annual Meeting of the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper). A poster presented at ASCO (Free ASCO Whitepaper) included a trial-in-progress update for cohort 5 of the GOBLET study evaluating the combination of pelareorep and mFOLFIRINOX with and without atezolizumab in newly diagnosed PDAC patients. There will be a three-patient safety run-in for each treatment arm followed by enrollment of 15 total patients per arm if the safety criteria are met. One or both arms could expand enrollment by 17 patients per arm to stage 2 if certain efficacy criteria are met (link to the poster). The study cohort is being conducted in collaboration with AIO-Studien-gGmbH (AIO), a medical oncology working group within the German Cancer Society, as part of GOBLET, a Phase 1/2 multiple indication study evaluating pelareorep-based combinations in gastrointestinal cancers. An abstract presented at the meeting detailed pelareorep’s unique ability to induce the expansion of tumor-infiltrating lymphocytes (TILs) via intravenous administration across multiple cancers, including breast, pancreatic, and colorectal (link to the abstract). The abstract also discussed the correlation between TIL expansion and tumor response while noting pelareorep’s ability to expand TILs, highlighting its immunotherapeutic mechanism of action and potential as a backbone immunotherapy for multiple indications (link to the PR).

Announced Wayne Pisano, Chair of Oncolytics’ Board of Directors, will serve as Interim CEO during Dr. Matt Coffey’s medical leave of absence. Chair of the Oncolytics Board since 2013, Mr. Pisano has more than 30 years of experience as a pharmaceutical industry executive, including as a CEO on multiple occasions. In 2010, he was recognized as Pharma Executive of the Year by the World Vaccine Congress.

Financial Highlights

As of June 30, 2024, the Company reported $24.9 million in cash and cash equivalents, with a projected cash runway through key milestones and into 2025.
The net loss for the second quarter of 2024 was $7.3 million, compared to a net loss of $7.4 million for the second quarter of 2023. The basic and diluted loss per share was $0.10 in the second quarter of 2024, compared to a basic and diluted loss per share of $0.12 in the second quarter of 2023.
Research and development expenses for the second quarter of 2024 were $4.6 million, compared to $3.7 million for the second quarter of 2023. The increase was primarily due to higher clinical trial expenses, including BRACELET-1 data analysis and the GCAR collaboration, and higher share-based compensation expense. The increase was partly offset by lower production run and process and analytical development activities.
General and administrative expenses for the second quarter of 2024 were $3.4 million, consistent with $3.5 million for the second quarter of 2023.
Net cash used in operating activities for the six months ended June 30, 2024 was $14.3 million, compared to $16.3 million for the six months ended June 30, 2023. The decrease reflects non-cash working capital changes, partly offset by higher net operating activities in 2024.
Recent and Anticipated Milestones

H2 2024: Overall survival results from the randomized BRACELET-1 trial in HR+/HER2- mBC
H2 2024: Guidance on the registration path for HR+/HER2- mBC
H2 2024: Finalize master protocol for the adaptive registration-enabling trial for pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab in first-line PDAC with GCAR
H1 2025: GOBLET mFOLFIRINOX cohort safety run-in update
Webcast and Conference Call

Management will host a conference call for analysts and investors at 4:30 p.m. ET today, August 1, 2024. To access the call, please dial (800) 836-8184 (North America) or (646) 357-8785 (International), and if needed, provide Conference ID: 34386. To join the conference call without operator assistance, please click here. A live webcast of the call will also be available by clicking here or on the Investor Relations page of Oncolytics’ website, available by clicking here, and will be archived for three months. A dial-in replay will be available for one week and can be accessed by dialing (888) 660-6345 (North America) or (289) 819-1450 (International) and using replay code: 34386#.

On August 1, 2024 BridGene Biosciences, Inc., a leader in the discovery of small molecule drugs for traditionally "hard-to-drug" targets, reported an expansion to its strategic collaboration and licensing agreement with Galapagos NV (Euronext: GLPG) (NASDAQ: GLPG) (Press release, Bridgene Biosciences, AUG 1, 2024, View Source [SID1234645281]). This new collaboration builds upon the partnership initiated in January 2024, focusing on the discovery of a highly selective oral SMARCA2 small molecule proteolysis targeting chimera (PROTAC).

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Under the expanded agreement, BridGene will leverage its PROTAC discovery engine in combination with Galapagos’ expertise in selective ATPase small molecules. The collaboration aims to advance the molecule into a preclinical candidate, with Galapagos holding exclusive rights for further development and commercialization. Galapagos will provide BridGene with upfront and preclinical milestone payments, alongside additional payments based on clinical and commercial milestones, potentially bringing the total deal value to $159 million. BridGene is also eligible to receive tiered royalties on net sales of each product resulting from the collaboration.

"We are excited to deepen our collaboration with Galapagos to discover new drugs targeting critical and challenging oncology targets," stated Ping Cao, Ph.D., Co-Founder and CEO of BridGene Biosciences. "The depth of Galapagos’ scientific expertise in oncology aligns perfectly with our capabilities. This collaboration will further reinforce our strong track record in identifying drugs for difficult targets. We aim to create partnerships that significantly boost the likelihood of success by integrating our innovative discovery platform with the wide-ranging scientific and clinical expertise of partners like Galapagos."

"We are pleased to expand our partnership with BridGene Biosciences, a company which has a strong track record in small molecule drug discovery for hard-to-drug targets," said Pierre Raboisson, Ph.D., Senior Vice President and Head of Small Molecules Discovery at Galapagos. "Our expanded collaboration leverages the unique strengths of both companies and allows us to combine our in-house expertise and technological platforms with BridGene’s cutting-edge PROTAC discovery engine to develop precision medicines for cancer patients with critical unmet needs."

This expanded collaboration highlights the validation of BridGene’s innovative approach through strategic partnerships, emphasizing the importance of these alliances to advance drug development efforts. Both BridGene and Galapagos are committed to improving patient outcomes by developing potential best-in-class precision medicines that tackle challenging targets in cancer, with a strong focus on addressing high unmet medical needs through targeted protein degradation technology.

On August 1, 2024 Immunovia (Nasdaq Stockholm: IMMNOV), the pancreatic cancer diagnostics company, reported enhanced performance for its next-generation test for detecting stage 1 and 2 pancreatic ductal adenocarcinomas (PDAC) in high-risk individuals, which are potentially curable with surgery and modern treatments (Press release, Immunovia, AUG 1, 2024, View Source [SID1234645280]).

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On 22 April 2024, Immunovia announced positive results from the initial model-development study for its next-generation pancreatic cancer detection test. Subsequent efforts to increase test performance have now enhanced test accuracy, substantially improving the sensitivity of the next-generation test to 85% with a specificity of 98% in detecting stage 1 and 2 PDAC.

A sensitivity of 85% means the new test is capable of detecting pancreatic cancer in approximately 6 out of every 7 people with early-stage disease. Specificity of 98% means this new test should return a false positive result just once for every 50 people tested who do not have pancreatic cancer. Test performance was refined by leveraging additional samples with more complete and detailed clinical information and through more sophisticated statistical modeling. Test performance was independently confirmed by ACOMED, a statistical analysis firm with deep expertise in diagnostic studies.

In this study, Immunovia’s next-generation test outperformed the sensitivity of CA19-9, a commonly used pancreatic cancer biomarker, by 20 percentage points (85% vs 65%, respectively, p<0.001).

In 294 patients aged 65 years and older, the next-generation test achieved 91% sensitivity and 98% specificity. Results in this group are particularly important since the average age of PDAC diagnosis is near 70 years.

"Results from this study serve as a promising step that a simple blood test may detect pancreatic cancer early in at-risk patients who have limited early detection options," said Randall Brand, MD, gastroenterologist, professor of medicine at the University of Pittsburgh School of Medicine, and director of the UPMC GI Malignancy Early Detection, Diagnosis and Prevention Program. Dr. Brand was an advisor on the study.

"We have now completed research and development efforts for our next-generation test and are thrilled with the accuracy of the test," said Jeff Borcherding, CEO of Immunovia. "This is a critical milestone for the company. Our next-generation test shows tremendous promise for improving pancreatic cancer surveillance with a highly accurate, convenient and affordable test. We are very optimistic about the clinical impact of the test when we launch in the U.S. in 2025."

The model development study included 624 patient samples from 13 different clinical sites. 129 samples were from patients with stage 1 or 2 PDAC and 495 control samples came predominantly from people at high-risk for hereditary and/or familial pancreatic cancer, and also included people with pancreatic cysts, diabetics, and healthy individuals.

The Company will submit these results shortly for peer-reviewed publication as well as for presentation at medical conferences. A large, independent clinical validation study will be conducted in the fourth quarter of 2024 to confirm the accuracy of the Immunovia test in a larger set of patient samples. Immunovia remains on track to launch the new test in the United States in 2025.