Bintrafusp alfa

Cancers of the head and neck can be treated with several drugs on the market, but for certain patients diagnosed with this this common type of cancer, outcomes are worse and better therapeutic options are needed. Bicara Therapeutics is developing a therapy that could provide a treatment alternative and the company now has $315 million in IPO cash to finance a pivotal study. Boston-based Bicara was able to raise more than it planned. In preliminary IPO terms set on Monday, the company aimed to offer 11.7 million shares priced in the range of $16 to $18 each. On Wednesday, Bicara increased the proposed stock sale to 14.7 million shares offered in the same targeted price range. When shares finally priced late Thursday, Bicara boosted the deal size yet again, offering 17.5 million shares for $18 each, right at the top of the targeted price range. Those shares now trade on the Nasdaq under the stock symbol “BCAX.” Most head and neck squamous cell carcinoma (HNSCC) cases come from exposure to carcinogens such as tobacco smoke or from human papillomavirus (HPV), Bicara says in its IPO filing. That virus can lead to cellular changes that over time, become precancerous and then cancerous. However, an estimated 80% of recurrent or metastatic HNSCC cases are HPV-negative. These tumors are associated with an increased risk of fatal tumor bleeding, excruciating pain, and difficulty swallowing. Sponsored Post What Healthcare Can Learn from Costco The path forward is clear: employers must evaluate their health plan the same way they do their Saturday shopping excursion. By Jeff Bak, Imagine360 CEO and President Bicara’s drugs are antibodies engineered to address solid tumors by hitting two validated cancer targets. The company’s lead program, ficerafusp alfa, is a bifunctional antibody drug designed to bind to epidermal growth factor receptor (EGFR) and human transforming growth factor beta (TGF-beta). TGF-beta is an important target because high signaling from this protein is associated with resistance to the class of immunotherapies called checkpoint inhibitors. For that reason, drugs that hit this target have been tested as a way to potentially overcome this resistance. GSK and Merck KGaA tried this approach with a bifunctional protein, bintrafusp alfa. But clinical trial results showed the experimental therapy fell short on measures of efficacy. In its IPO filing, Bicara said such failures may be due to insufficient anti-tumor activity, possibly because the immunotherapy is being expressed in immune tissue rather than the tumor microenvironment (TME) where it’s needed. Bicara says the dual approach of its drug blocks survival signaling from EGFR as well as immunosuppressive TGF-beta signaling in the TME. Bicara has been testing its experimental drug in combination with the blockbuster Merck immunotherapy pembrolizumab, brand name Keytruda, whose approved indications include HNSCC. An ongoing Phase 1/1b study of the Bicara drug includes a group of HNSCC patients who had not previously received treatment after their cancer had advanced. In this cohort, Bicara said the combination of the study drug and Keytruda led to a 54% overall response rate in patients who could be evaluated for efficacy. In patients whose disease was HPV negative, the overall response rate was 64%. For context, the historical response rate in a Phase 3 test of Keytruda monotherapy in HNSCC was 19%, the company said in the filing. The company expects to report more Phase 1/1b data at a medical meeting in 2025. “Based on the clinical data generated to date, we believe that ficerafusp alfa in combination with pembrolizumab has the potential to become a first-line standard of care therapy in HPV-negative [recurrent/metastatic] HNSCC,” Bicara said in the filing. “We also believe ficerafusp alfa has the potential to provide meaningful clinical benefit in other solid tumors where there is a strong biologic rationale for the dual inhibition of both EGFR and TGF-beta, such as colorectal cancer and other squamous cell carcinomas which typically overexpress EGFR and TGF-beta pathways.” presented by Sponsored Post The Promise of Value-Based Care and MedTech Innovation Monica Vajani, Executive Director for mHUB’s MedTech Accelerator, discusses how mHUB is helping innovators transition healthcare towards value-based care. By Monica Vajani - mHUB A pivotal Phase 2/3 clinical trial is planned that will test the Bicara therapy in combination with the Merck immunotherapy pembrolizumab, brand name Keytruda, as a first-line treatment for advanced HNSCC. Bicara expects this study will start by the end of this year or in the first quarter of 2025. Bicara formed in 2018. The following year, the company licensed certain fusion proteins from Biocon Limited. The most advanced of those fusion proteins was ficerasfusp alfa. There are no future milestone payments or royalties tied to the deal, Bicara said in the filing. The prospectus says Bicara has raised $353.1 million since its inception. The most recent financing was a $165 million Series C round announced last December. Biocon is Bicara’s largest shareholder, owning an 11.28% post-IPO stake, according to the filing. RA Capital Management owns a 10.5% stake after the IPO. As of the end of the second quarter of this year, Bicara reported a cash position of $203.9 million. Combined with the IPO proceeds, the company plans to spend about $265 million on the development of ficerafusp alfa in HNSCC, including the pivotal study and the filing of a biologics license application. Another $30 million is earmarked for the expansion of its lead drug candidate in additional HNSCC patient groups. And $25 million is set aside for advancing clinical development of the drug in additional types of solid tumors, such as colorectal cancer and other squamous cell carcinomas. Zenas’s IPO Pulls in $225M for Pipeline in a Product Opportunity in I&I Zenas Biopharma, a company developing antibody drugs to treat immunology and inflammation (I&I) disorders, raised $225 million. The company late Thursday priced more than 13.23 million shares at $17 each. When Zenas set preliminary financial terms this week, it aimed to offer 11.76 million shares in the range of $16 to $18 apiece, which would have raised $199.9 million at the pricing midpoint. Zenas’s shares will trade on the Nasdaq under the stock symbol “ZBIO.” Excessive activity of B cells, a type of immune cell, is associated with a range of autoimmune disorders. While antibody drugs are currently available that treat these conditions by depleting B cells, Zenas contends they don’t fully affect B cells in relevant tissue and the dosing regimen of these therapies can be improved. Another concern is that antibody drugs that target and block the proteins CD19 and CD20 on B cells may deplete these cells for six months or longer, which raises the risk of infection and could reduce a patient’s ability to respond to and benefit from vaccines. Zenas’s lead drug candidate is obexelimab, a bifunctional antibody designed to bind to CD19 and Fc gamma receptor IIb, both targets that are broadly expressed on B cells. According to Zenas, this approach mimics a natural antigen-antibody complex for inhibiting B cells. This mechanism of action is intended to inhibit the activity of B cells without completely depleting them. Zenas acquired global rights to obexelimab from Xencor in 2021. The company had previously licensed other programs from Xencor; those programs are still preclinical. While Zenas believes obexelimab has broad potential in I&I, the company is initially focusing on four indications: immunoglobulin G4-related disease (IgG4-RD), multiple sclerosis, systemic lupus erythematosus, and warm autoimmune hemolytic anemia (wAIHA). Zenas’s drug is furthest along in IgG4-RD, a chronic inflammatory condition that affects multiple organs. Standard of care includes corticosteroids. Roche’s CD20-targeting antibody drug, Rituxan, can also be used to treat the condition. Zenas is continuing a Phase 3 test of its lead drug in IgG4-RD. Since inception, Zenas said it had raised $358.3 million from investors. The company’s most recent financing was a $200 million Series C round in May led by SR One. That investor owns a 7% post-IPO stake in Zenas, according to the filing. Xencor is Zenas’s largest shareholder with an 8.1% post-IPO stake. As of the end of June, Zenas reported having $183.9 million in cash. That capital, along with the IPO proceeds, will broadly support the advancement of obexelimab. Zenas plans to spend about $100 million on clinical development of the drug, including the completion of a Phase 3 study in patients with IgG4-RD. This drug candidate will also be evaluated in separate Phase 2 tests in multiple sclerosis, lupus, and wAIHA. The company expects its capital will last for the next two years. MBX Bio’s Longer-Acting Peptide Drugs Land $163M for Clinical Trials MBX Biosciences’ IPO raised $163 million for a pipeline that includes a lead program in the clinic for a rare hormone deficiency with few FDA-approved treatments. Carmel, Indiana-based MBX priced its offering of 10.2 million shares at $16 each, which was the top of $14 to $16 per share price range it set earlier this week. The company was able to boost the deal size, offering 1.7 million more shares than it had initially planned. MBX’s shares will trade on the Nasdaq under the stock symbol “MBX.” MBX’s drugs come from a platform technology that engineering peptides with a longer duration of action that enables less frequent dosing intervals. This technology is based on research from Indiana University. Lead program MBX 2109 is a potential treatment for chronic hypoparathyroidism, a condition in which the parathyroid glands do not produce enough parathyroid hormone to regulate levels of calcium and phosphate in the blood. The first FDA-approved therapy for this condition is Takeda Pharmaceutical’s Natpara, an engineered version of the hormone. But Takeda has said it will stop offering Natpara due to ongoing manufacturing problems. Patients have a new alternative following FDA approval last month of Ascendis Pharma’s Yorvipath, a peptide injected once-daily to bring parathyroid hormone levels within the normal range. With MBX 2109, MBX aims to offer chronic hypoparathyroidism patients less burdensome once-weekly dosing. In Phase 1 testing, the company reported its engineered peptide achieved parathyroid hormone levels comparable to those achieved by a continuous infusion. A Phase 2 study dosed its first patient last month; preliminary data are expected in the third quarter of next year. Another engineered peptide, MBX 1416, in Phase 1 development for post-bariatric hypoglycemia (PBH). In this rare condition, bariatric surgery patients go on to develop dangerously low blood sugar levels. There are no FDA-approved therapies for this rare condition, but MBX isn’t alone in the pursuit for one. Amylyx Pharmaceuticals picked up its Phase 3-ready PBH peptide drug from the bankruptcy auction of Eiger BioPharmaceuticals. Another engineered peptide, MBX 4291, is in preclinical development for obesity. According to the IPO filing, MBX’s cash position at the end of June was $55.3 million. That capital, along with the IPO proceeds, will support clinical trials. MBX plans to spend $148.6 million to take its lead program through mid-stage development and into Phase 3 testing in chronic hypoparathyroidism and to advance its PBH drug through Phase 1 and Phase 2 testing. Another $31.2 million is set aside to advance the obesity program into the clinic.

Company to initiate Phase 3 VERSATILE-003 trial in Q4 2024 Conference Call Today at 8:00 a.m. Eastern Time PRINCETON, N.J., Aug. 01, 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 announced that it has received the official minutes from its meeting with the U.S. Food and Drug Administration (“FDA”) regarding next steps in its planned Phase 3 clinical trial of its Versamune® based investigational immunotherapy designed to stimulate a targeted T cell attack against HPV16-positive head and neck squamous cell carcinoma (“HNSCC”). The Company will host a conference call today at 8:00 a.m. ET to discuss details of the anticipated Phase 3 clinical trial of Versamune® HPV (formerly PDS0101) in this indication. PDS Biotech presented the FDA with recent data from both the VERSATILE-002 study of Versamune® HPV + pembrolizumab, and the triple combination of Versamune® HPV + PDS01ADC + bintrafusp alfa. The Company also provided an updated design of the Phase 3 VERSATILE-003 trial of Versamune® HPV + pembrolizumab which included updated statistical endpoints based on recent and more mature survival data. PDS Biotech proposed the addition of a third arm to the study which would be a triple combination of Versamune® HPV + PDS01ADC + pembrolizumab. The first part of the study would therefore involve a dose optimization of PDS01ADC in the novel combination. The FDA supported the strategy and development of the double and triple combinations. Also, the FDA requested additional safety analysis in the lead-in PDS01ADC dose optimization part of the study. To avoid potential delays in initiating the randomized trial, the FDA agreed that the dose optimization should be done separately and the registrational trial of the revised 2-arm double combination trial, VERSATILE-003, should proceed. The Versamune® HPV + pembrolizumab combination has received Fast Track designation. “We appreciate the FDA’s support in the development of both the double and triple Versamune® HPV-based combinations. We are also pleased to have aligned on initiating the updated VERSATILE-003 study,” said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. “The VERSATILE-002 results have matured significantly and positively over the last year, allowing us to revise the statistical endpoints of the study to provide additional robustness to the study design. We continue to believe that the combination, based on encouraging survival, disease control response rates and safety has the potential to significantly advance the treatment of HPV16-positive HNSCC. Our goal now is to investigate Versamune® HPV + pembrolizumab’s potential as the first targeted immunotherapy for HPV16-positive HNSCC. The addition of PDS01ADC in the future has the potential to provide further clinical benefit to an effective targeted immunotherapy.” Kirk Shepard, MD, Chief Medical Officer, continued, “We have contracted with a clinical research organization and the preparatory work is advancing to begin enrollment in the VERSATILE-003 Phase 3 clinical trial in first-line treatment of patients with recurrent or metastatic HPV16-positive HNSCC, with overall survival as the study’s primary endpoint. Our VERSATILE-003 trial has significant key opinion leader support, including from the investigators involved in VERSATILE-002, and we have lined up a significant number of the target sites that have indicated strong interest in participating in the trial.” Conference Call DetailsDate: August 1, 2024Time: 8:00 a.m. ET Dial-in: 1-877-704-4453 or 1-201-389-0920 Webcast Registration: Click HereCall MeTM Registration: Click Here (Available 15 minutes prior to call) About PDS Biotechnology PDS 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 HPV16-positive head and neck squamous cell cancers. PDS Biotech’s lead investigational targeted immunotherapy Versamune® HPV is being developed in combination with a standard-of-care immune checkpoint inhibitor, and also in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate (ADC), and a standard-of-care immune checkpoint inhibitor. For more information, please visit www.pdsbiotech.com. Forward Looking Statements This 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. 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