NHS-IL-12

USA News Group Commentary VANCOUVER, BC, May 28, 2024 /PRNewswire/ -- USA News Group – Rates of cancer of the colorectal and anal regions have been on the rise for years in young adults, according to surgeons at Yale Medicine. As well, there are now alarming reports around the world of rising diagnoses of HIV, which is being linked to higher anal cancer mortality for women. Worldwide, improved access to testing led to a 4.2% increase in HIV diagnoses in the EU and a whopping 120% increase in Montreal, Canada. With sufferers of these types of cancers seemingly getting younger, and at increased danger for those also diagnosed with HIV, biotech companies are working to improve our chances to beat this category of cancers, including work from O ncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), TScan Therapeutics, Inc. (NASDAQ: TCRX), Bristol-Myers Squibb Company (NYSE: BMY), PDS Biotechnology Corporation (NASDAQ: PDSB), and C4 Therapeutics, Inc. (NASDAQ: CCCC). Among the more promising methods of tackling the issue is coming from the field of immunotherapies that help the body's immune system fight diseases, including cancer. One immunotherapy in particular that's gaining a lot of traction is pelareorep, the flagship asset of O ncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) — which gained its second FDA fast track designation 14 months ago. Most recently, Oncolytics shared an update involving an enrollment expansion of its anal cancer cohort for its GOBLET study evaluating pelareorep in combination with atezolizumab (Tecentriq®) in patients with second-line or later unresectable squamous cell carcinoma of the anal canal (SCCA). The expansion of the study comes on the heels of positive data from Stage 1 of the study that was presented last year at the International Multidisciplinary Anal Cancer Conference (IMACC). Pelareorep combined with atezolizumab showed promising results in treating anal cancer, achieving a 37.5% response rate and good tolerability, significantly better than the 10-14% response rates seen with traditional checkpoint inhibitor therapy. "One of the most difficult challenges in my practice is the limited number of treatment options that are available for patients with advanced anal cancer who have progressed on first-line therapy," said Dirk Arnold, M.D., Ph.D., Director of Asklepios Tumorzentrum Hamburg, and primary investigator of the GOBLET trial. "I am enthusiastic about the expansion of this cohort because it will enable the continued evaluation of the pelareorep/atezolizumab combination and could provide important confirmatory data that may lead to better treatment options for patients with this late-stage disease." As per the update, Oncolytics is set to build upon the oncology community's enthusiastic response to the IMACC 2023 data with this enrollment expansion and add new sites to the study. After reviewing the clinical trial results, Oncolytics believes that a modest expansion of fewer than 20 patients will be sufficient to solidify the efficacy signal they've seen to date on the road to a future registrational study in this population. "There is currently no established standard therapy for patients with anal carcinoma who have failed first-line treatment," said Dr. Matt Coffey, President and CEO of Oncolytics. "Continued positive results could potentially expand the opportunity for pelareorep beyond the lead indications of breast cancer and pancreatic cancer and open the door to a rapid regulatory pathway in this rare and significantly under-served patient population." Another therapy that's under clinical development is TSC-200-A0201 from TScan Therapeutics, Inc. (NASDAQ: TCRX), which is currently in Phase I for anal cancer. TSC-200-A0201 targets HPV16 on HLA type A*02:01. This form of cellular therapy is being tested in a basket study across multiple solid tumors, as the company kicked off the year by announcing its 2024 clinical pipeline plans. "We have now cleared INDs for four [T cell receptors] (TCRs), including TCRs for PRAME, HPV16, and MAGE-A1, and have regulatory clearance to treat patients with multiple TCRs sequentially in our Phase 1 study," said Gavin MacBeath, Ph.D., CEO of TScan. "Additionally, we submitted INDs for two additional TCRs in December and the 30-day review period with the FDA is ongoing. We look forward to dosing the first patient in the Phase 1 solid tumor clinical study in the first quarter and reporting clinical data, initially on patients treated with singleplexed therapy, and then on patients treated with multiplexed therapy, in 2024." At the end of January, Bristol-Myers Squibb Company (NYSE: BMY) released encouraging findings from its CheckMate -8HW clinical study, showcasing data from its asset Opdivo (nivolumab) combined with Yervoy (ipilimumab) as a front-line treatment choice for microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC). As per the data, this combination therapy reduced the risk of disease progression or death by 79% versus chemotherapy in patients with these conditions. "With research from the full CheckMate clinical development program, BMS has revolutionized the oncology landscape and helped change survival expectations for people with cancer," said Dana Walker, M.D., M.S.C.E., vice president, global program lead, gastrointestinal and genitourinary cancers, Bristol Myers Squibb. "These results build on the benefit of Opdivo and Yervoy in MSI-H/dMMR metastatic colorectal cancer as previously demonstrated in CheckMate -142 and reinforce our commitment to exploring the potential of these therapies to help more patients in need." For PDS Biotechnology Corporation (NASDAQ: PDSB) and its asset PDS-01ADC, the company is developing a treatment for many types of metastatic solid tumors, including colorectal and anal cancer. Back in November, PDS delivered a corporate update along with its Q3 2023 results, that included interim safety and immune response data for its Phase 1/2 clinical trial evaluating docetaxel and PDS01ADC in metastatic prostate cancer patients, with Prostate-Specific Antigen (PSA) decline seen in all 18 patients and 61% of patients had at least a 60% decrease in PSA levels. "As the development of our IL12 fused antibody-drug conjugate or ADC, PDS01ADC, continues to progress, its potential to overcome key safety and efficacy limitations associated with existing cytokine therapy is reinforced," said Frank Bedu-Addo, PhD, President and CEO of PDS Biotech. "We are excited about the strides we are making across our pipeline, fueled by our commitment to developing groundbreaking therapies that revolutionize cancer treatments." Looking ahead in 2024, clinical-stage company C4 Therapeutics, Inc. (NASDAQ: CCCC) is anticipating new milestones for its asset CFT1946 in the first half of the year, including presenting preclinical data demonstrating differentiated activity in preclinical models of BRAF V600X melanoma, colorectal cancer and more. As well, C4 anticipates presenting data from the ongoing Phase 1 dose escalation trial in several of these cancers with these types of mutations in the second half of 2024. Dosing of the first patient in CFT1946's Phase 1/2 clinical trial was announced at the beginning of 2023. "Dosing the first patient in the CFT1946 Phase 1/2 clinical trial marks the first degrader to enter clinical development to target BRAF-driven cancers," said Adam Crystal, M.D., Ph.D., Chief Medical Officer of C4 Therapeutics. "Preclinically, in in vivo models, CFT1946 has demonstrated deeper and more durable activity than approved BRAF inhibitors, and promising activity in the setting of resistance to BRAF inhibitors. We look forward to advancing CFT1946 for patients with BRAF V600 mutant cancers including non-small cell lung cancer, colorectal cancer, and melanoma." At the time of the release, CFT1946 was C4's third oncology program to enter clinical studies from its proprietary TORPEDO® platform. Article Source: Contact: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. 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Provided Positive, Updated Data from Phase 2 VERSATILE-002 Clinical Trial with Versamune® HPV in Combination with KEYTRUDA® in Recurrent or Metastatic Head and Neck Cancer Expanded Global Intellectual Property Surrounding Versamune® Platform PRINCETON, N.J., May 15, 2024 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines, today provided a business update and reported financial results for the first quarter of 2024. The press release will be available in the Investor Relations section of the Company’s website at www.pdsbiotech.com. Recent Developments Hosted a Key Opinion Leader event on May 8, 2024, during which prominent experts in head and neck squamous cell cancer (“HNSCC”) discussed positive, updated VERSATILE-002 data and the unmet need in HPV16-positive HNSCC. A replay of the event can be found here.Announced updated results from the VERSATILE-002 Phase 2 trial evaluating first line treatment of patients with HPV16-positive recurrent or metastatic HNSCC using Versamune® HPV + KEYTRUDA® (pembrolizumab) (n=53). Median overall survival is 30 months; Published results for immune checkpoint inhibitors are 7-18 months. The cohort met its primary endpoint of best overall response (BOR). BOR by investigator assessment is 34% (Combined Positive Score (CPS) ≥1; n=18/53); 48% (CPS≥20; n=10/21); Published results for ICIs are <20% (CPS>1) and <25% (CPS≥20). CPS is used to assess PD-L1 expression Progression free survival is 6.3 months (CPS≥1); 14.1 months (CPS≥20); Published results for immune checkpoint inhibitors 2-3 months.VERSATILE-002 data to date indicate a durable response in first line recurrent or metastatic HNSCC patients with CPS≥1.The combination of Versamune® HPV + pembrolizumab was well tolerated. Announced an updated clinical strategy with a two-part registrational trial focused on the triple combination of Versamune® HPV + PDS01ADC + pembrolizumab as a first line treatment in HPV16-positive recurrent or metastatic HNSCC. PDS01ADC is the Company’s novel, investigational tumor-targeting IL-12-fused antibody-drug conjugate (ADC), which has shown promise in a clinical trial of Versamune® HPV + PDS01ADC + an investigational ICI conducted by the National Cancer Institute.Part one of the clinical trial will focus on dose optimization with a data readout based on safety and objective response rate.The randomized second part of the trial will include an interim data readout with overall survival as its primary endpoint. Further strengthened management with the addition of Stephan Toutain, M.S., MBA, as Chief Operating Officer. Mr. Toutain brings extensive operational and commercial experience to PDS Biotech. Versamune® Platform Intellectual Property Company received patents granted by the Israel Patent Office and IP Australia that will extend protections for the Company’s novel investigational T cell activating Versamune® platform through Dec. 2038 and Nov. 2036, respectively. The Israel Patent Office granted patent No. 275154 titled, “Methods and compositions comprising cationic lipids for stimulating type I interferon genes,” extending protections for compositions using the Versamune® platform and comprising of cationic lipid for activating type I interferons. This patent covers all formulations and compositions that include Versamune to activate a T cell response.IP Australia granted patent No. 2016354590 titled, “Lipids as synthetic vectors to enhance antigen processing and presentation ex-vivo in dendritic cell therapy.” This patent covers the use of Versamune® compositions that reduce the populations of immune suppressive cells in the tumor and its application for the development of dendritic cell-based approaches to immunotherapy. First Quarter 2024 Financial ResultsReported net loss was approximately $10.6 million, or $0.30 per basic share and diluted share, for the three months ended March 31, 2024, compared to a net loss of $9.7 million, or $0.32 per basic share and diluted share, for the three months ended March 31, 2023. The increase was due to higher operating and net interest expenses. Research and development expenses increased to approximately $6.7 million for the three months ended March 31, 2024, from $5.8 million for the three months ended March 31, 2023. The increase of $0.9 million was primarily attributable to an increase of $1.2 million in clinical studies and medical affairs offset by a decrease of $0.1 million in personnel costs, $0.1 million in professional fees and $0.1 million in manufacturing expenses. General and administrative expenses decreased to approximately $3.4 million for the three months ended March 31, 2024, from approximately $3.6 million for the three months ended March 31, 2023. The decrease of $0.2 million was primarily attributable to an increase of $0.3 million in professional fees offset by a decrease of $0.5 million in personnel costs. Total operating expenses increased to approximately $10.1 million for the three months ended March 31, 2024 from $9.4 million for the three months ended March 31, 2023. Net interest expenses increased to approximately $0.5 million for the three months ended March 31, 2024 from $0.2 million for the three months ended March 31, 2023. Cash and cash equivalents as of March 31, 2024, totaled approximately $66.6 million. About PDS BiotechnologyPDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines. The Company plans to initiate a pivotal clinical trial in 2024 to advance its lead program in advanced head and neck squamous cell cancers (HNSCC). PDS Biotech’s lead program is a proprietary dual-acting combination of IL-12 fused antibody drug conjugate (ADC) PDS01ADC and T-cell activator Versamune® HPV in regimen with a standard-of-care immune checkpoint inhibitor. We believe that proof-of-concept long-term data have shown positive survival results and tumor shrinkage with this combination and indicate favorable tolerability. We believe that with a novel investigational “inside-outside” mechanism, the PDS01ADC and Versamune® HPV immunotherapy has shown compelling results with potential to successfully disrupt a tumor’s inside defenses, while also generating potent, targeted killer T-cells to attack the tumor from the outside. We believe that data from more than 350 patients, as well as ongoing clinical trials across multiple tumor types and standard treatment regimens, have validated the potential for both platforms and point to potential broad utility. Our Infectimune® based vaccines have demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T-cell responses, including long-lasting memory T-cell responses in pre-clinical studies to date. For more information, please visit www.pdsbiotech.com. Forward Looking StatementsThis communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS01ADC, PDS0101, PDS0203 and other Versamune® and Infectimune® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS01ADC, PDS0101, PDS0203 and other Versamune® and Infectimune® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the Company’s ability to continue as a going concern; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.   Versamune® and Infectimune® are registered trademarks of PDS Biotechnology Corporation. Keytruda® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, N.J., USA. Investor Contact:Mike MoyerLifeSci AdvisorsPhone +1 (617) 308-4306 Email: mmoyer@lifesciadvisors.com Media Contact:Gina Mangiaracina6 DegreesPhone +1 (917) 797-7904Email: gmangiaracina@6degreespr.com PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARYUnaudited Consolidated Statements of Operations and Comprehensive Loss Three Months Ended March 31, 2024 2023Operating expenses: Research and development expenses $6,704,164 $5,843,686 General and administrative expenses $3,393,463 $3,578,728 Total operating expenses $10,097,627 $9,422,414 Loss from operations $(10,097,627) $(9,422,414) Interest income (expense), net Interest income $668,895 $729,341 Interest expense $(1,174,745) $(966,845)Interest income (expense), net $(505,850) $(237,504) Net loss and comprehensive loss $(10,603,477) $(9,659,918) Per share information: Net loss per share, basic and diluted $(0.30) $(0.32)Weighted average common shares outstanding basic and diluted 34,815,870 30,428,053 PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY Unaudited selected Balance Sheet Data March 31,December 31, 20242023 Cash and cash equivalents$66,634,417.00 $56,560,517.00 Working Capital $53,622,075.00 $45,425,100.00 Total assets$69,006,366.00 $59,390,082.00 Long term Debt$16,651,420.00 $19,506,183.00 Accumulated Deficit$(155,104,092.00)$(144,500,613.00) Total stockholders’ equity$37,183,045.00 $26,130,949.00