VISTA

As a young scientist, Jay Rothstein asked fellow immunologists what they thought the biggest unsolved problem in the field was. “Give me a non-toxic steroid and we’re done,” they told him. Corticosteroids have been used for decades. The drugs powerfully suppress runaway immune systems, but their side effects can be brutal. Chronic use can break down bone and muscle, weaken the skin, impair eyesight and increase the risk of diabetes, forcing most patients to stop taking them. Over the years, chemists have tried, and largely failed, to separate the benefits of steroids from their many limitations. “That’s been the holy grail,” Rothstein said. The problem is that steroid receptors are found not just in immune cells, but in pretty much every cell of the body. It’s a drug delivery problem. And Rothstein’s solution was to have steroids hitch a ride on an antibody that selectively targets immune cells. That antibody-drug conjugate, or ADC, approach is a hot technology in cancer, where companies are attaching potent chemotherapies to antibodies that target tumors. But apart from a brief effort to turn AbbVie’s drug Humira into an ADC, the idea has gained little traction in immunology. Rothstein developed an ADC that carries the powerful steroid budesonide at ImmuNext, a small New Hampshire company that was spun out of Dartmouth professor Randolph Noelle’s lab. ImmuNext successfully licensed experimental drugs to Eli Lilly and Sanofi, but when its leaders decided they wanted to retire and wind down the company’s research operations, Rothstein began searching for a new home for his ADC program. Last year, he called Steve Gillis, a managing partner at ARCH Venture Partners who trained as an immunologist at Dartmouth. Gillis was fascinated by the possibility of using steroids without side effects “for the first time in history,” he said. “There is nothing more prescribed for autoimmune disease than steroid hormones. The problems are, nobody likes taking them, nobody likes prescribing them,” Gillis said. “We really do have the opportunity here to essentially bring steroids back to a frontline therapy that people will really want to have.” Gillis recruited Bruce Booth from Atlas Venture and Arthur Tzianabos from 5AM Ventures to form the new company, Lifordi Immunotherapeutics. Tzianabos, the startup’s CEO, told Endpoints News in an exclusive interview that Lifordi raised a $70 million Series A from those three firms last fall and is on track to start testing its drug in a clinical trial next year. Lifordi’s name is an allusion to the New Hampshire motto, “Live Free or Die,” proudly emblazoned on the state’s license plates. The company licensed its ADC drug and technology from ImmuNext for a stake in the startup and undisclosed financial terms “back-loaded” in milestones and royalties, Tzianabos said. Lifordi also subsumed ImmuNext’s roughly 10-person research group, which Rothstein continues to lead. The startup’s drug targets an immune protein called VISTA, which was discovered in Noelle’s lab at Dartmouth. It’s widely found on the surface of both adaptive immune cells (like B cells and T cells) and innate immune cells (like dendritic cells and macrophages), but not in other parts of the body. Once the drug binds to VISTA, it gets rapidly pulled into the cell where each antibody unloads eight steroid molecules. The company hasn’t published its preclinical data yet, but Tzianabos said that in monkey experiments, a subcutaneous injection of the ADC given every other week delivered similar efficacy as a daily dose of steroids, and without the side effects. “We’re not hitting the immune system constantly, and that’s why we can see this drug potentially being used for the lifetime of the patient,” Tzianabos said. But ADCs are expensive drugs. Even if Lifordi’s compound is successful, the company may struggle to convince doctors and payers to switch from cheap steroids. Tzianabos wouldn’t name the specific condition Lifordi is going after first, but he said it’s a “very large autoimmune disorder” with “multiple cytokines involved” in the disease. “And if you show efficacy and safety in that disease, there’s no reason to think that you couldn’t go after other large autoimmune disorders as well,” he added. This pipeline-in-a-product potential, which is already common among immune disease programs, is especially pronounced at Lifordi. “It would be a true panacea,” Rothstein said. “IBD, asthma, psoriasis, all these diseases get treated with steroids. And Lifordi’s goal would be that almost all of these diseases would be a space for this drug.” Key backers: 5AM Ventures, ARCH Venture Partners, Atlas Venture Find the full list of 2024 Endpoints 11 winners here .

Kineta will be trading under the symbol “KANT” on OTC Pink Kineta will continue to pursue strategic alternatives as previously announced TuHURA Biosciences has an exclusivity right and a right of first offer for Kineta’s KVA12123 program The ongoing KVA12123 Phase 1 study is open for new patient enrollment and following those patients previously enrolled. SEATTLE, Sept. 19, 2024 (GLOBE NEWSWIRE) -- Kineta, Inc., a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, announced today that it has transitioned from Nasdaq to the OTC Market. Kineta stock now trades under the ticker symbol “KANT” on the OTC Pink Open Market platform operated by OTC Markets Group Inc. Kineta remains committed to maintaining the highest standards of corporate governance and transparency through this transition which went into effect at the beginning of trading on September 19, 2024. Kineta has previously received a notice from The Nasdaq Stock Market LLC that it has determined to delist the Company’s common stock from The Nasdaq Capital Market due to the Company’s failure to satisfy the $1.00 minimum bid price listing requirement under Nasdaq Listing Rule 5550(a)(2) and failure to maintain a minimum of $2,500,000 in stockholders’ equity required under Nasdaq Listing Rule 5550(b)(1). Kineta stock has seamlessly transitioned to the OTC Markets. Shareholders will not need to take any action as their investments remain secure and tradable. “As we navigate this transition, our primary focus remains on delivering value to our shareholders, continue the Phase 1 clinical program and to focus on advancing the strategic alternates that we have previously disclosed.” said Craig W. Philips, President of Kineta. In August, the Company announced the reopening of enrollment into the ongoing VISTA-101 Phase 1/2 clinical trial. In July, the Company announced that it had entered into an exclusivity and right of first offer agreement (the “Agreement”) with TuHURA Biosciences, Inc. (“TuHURA”). As part of the Agreement, Kineta received a $5 million nonrefundable payment. Kineta and TuHURA are also cooperating on the reinitiation of patient enrollment into this trial. About KinetaKineta (OTC Pink: KANT) is a clinical-stage biotechnology company with a mission to develop next-generation immunotherapies that transform patients’ lives. Kineta has leveraged its expertise in innate immunity and is focused on discovering and developing potentially differentiated immunotherapies that address the major challenges with current cancer therapy. The Company’s immuno-oncology pipeline includes KVA12123, a novel VISTA blocking immunotherapy currently in a Phase 1/2 clinical trial in patients with advanced solid tumors, and a preclinical monoclonal antibody targeting CD27. For more information on Kineta, please visit www.kinetabio.com. Through the combination of unique epitope binding and an optimized IgG1 Fc region, KVA12123 has demonstrated strong tumor growth inhibition as both a monotherapy and in combination with other checkpoint inhibitors in preclinical models. KVA12123 provides a novel approach to address immune suppression in the tumor microenvironment with a mechanism of action that is differentiated and complementary with T cell focused therapies. KVA12123 may be an effective immunotherapy for many types of cancer including non-small cell lung (NSCLC), colorectal, renal cell carcinoma, head and neck, and ovarian cancer. In February 2024, Kineta announced a significant corporate restructuring to substantially reduce expenses and preserve cash. The restructuring included a significant workforce reduction and the suspension of enrollment of new patients in its ongoing VISTA-101 Phase 1/2 clinical trial evaluating KVA12123 in patients with advanced solid tumors. At that time, Kineta also announced that it was exploring strategic alternatives to maximize stockholder value. Cautionary Statements Regarding Forward-Looking StatementsThis press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. The use of words such as, but not limited to, “believe,” “expect,” “estimate,” “project,” “intend,” “future,” “potential,” “continue,” “may,” “might,” “plan,” “will,” “should,” “seek,” “anticipate,” or “could” and other similar words or expressions are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements relating to the anticipated benefits of the Agreement and statements relating to Kineta’s exploration of strategic alternatives and reinitiation of the VISTA-101 Phase 1/2 clinical trial. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on Kineta’s current beliefs, expectations and assumptions regarding the future of Kineta’s business, future plans and strategies, clinical results and other future conditions. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including, but not limited to: Kineta’s ability to successfully initiate and complete clinical trials; the difficulty in predicting the time and cost of development of Kineta’s product candidates; Kineta’s plans to research, develop and commercialize its current and future product candidates, including, but not limited to, Kineta’s reinitiation of the VISTA-101 Phase 1/2 clinical trial for KVA12123; the timing and anticipated results of Kineta’s planned pre-clinical studies and clinical trials and the risk that the results of Kineta’s pre-clinical studies and clinical trials may not be predictive of future results in connection with future studies or clinical trials; the timing of the availability of data from Kineta’s clinical trials; the timing of any planned investigational new drug application or new drug application; the risk of cessation or delay of any ongoing or planned clinical trials of Kineta or its collaborators; the clinical utility, potential benefits and market acceptance of Kineta’s product candidates; Kineta’s commercialization, marketing and manufacturing capabilities and strategy; developments and projections relating to Kineta’s competitors and its industry; the impact of government laws and regulations; the timing and outcome of Kineta’s planned interactions with regulatory authorities; Kineta’s ability to protect its intellectual property position; Kineta’s ability to prevail in litigation against investors who failed to close an anticipated private placement; risks relating to volatility and uncertainty in the capital markets for biotechnology companies; availability of suitable third parties with which to conduct contemplated strategic transactions; whether Kineta will be able to pursue a strategic transaction, or whether any transaction, if pursued, will be completed on attractive terms or at all; whether Kineta’s cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital requirements; and those risks set forth under the caption “Risk Factors” in Kineta’s most recent Annual Report on Form 10-K filed with the SEC on March 21, 2024 and Quarterly Reports on Form 10-Q filed with the SEC on May 15, 2024 and August 8, 2024, as well as discussions of potential risks, uncertainties and other important factors in Kineta’s subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Except as required by law, Kineta undertakes no obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise. FOR FURTHER INFORMATION, PLEASE CONTACT: Investor Relations:info@kineta.usSource: Kineta, Inc.

BOSTON, Sept. 04, 2024 (GLOBE NEWSWIRE) -- Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage immuno-oncology company focused on the discovery and development of next-generation therapeutics for cancer patients, today announced that preclinical data on SNS-103 will be presented in a poster session at the CRI-ENCI Eighth International Immunotherapy Conference, being held September 8-11, 2024, at the Gaylord National Resort & Convention Center in National Harbor, MD. Presentation Details: CRI-ENCI Eighth International Cancer Immunotherapy Conference Title: Pre-clinical characterization of monoclonal antibodies targeting CD39 activity in the acidic tumor microenvironment Presenter: F. Donelson Smith, Ph.D., Senior Director, Biologics Discovery & Early Development Poster Number: 195A Date and time: Sunday, September 8, 2024, 12:05 – 2:05 p.m. EDT About Sensei Biotherapeutics  Sensei Biotherapeutics (Nasdaq: SNSE) is a clinical stage immuno-oncology company focused on the discovery and development of next-generation therapeutics for cancer patients. Through its TMAb™ (Tumor Microenvironment Activated biologics) platform, Sensei develops conditionally active therapeutics designed to disable immunosuppressive signals or activate immunostimulatory signals selectively in the tumor microenvironment. Sensei’s lead investigational candidate is SNS-101, a conditionally active antibody designed to block the V-domain Ig suppressor of T cell activation (VISTA) checkpoint selectively within the low pH tumor microenvironment, where VISTA acts as a suppressor of T cells by binding the receptor PSGL-1. The company is also developing SNS-102, a conditionally active monoclonal antibody targeting V-Set and Immunoglobulin Domain Containing 4 (VSIG-4); SNS-103, a conditionally active monoclonal antibody targeting ecto-nucleoside triphosphate diphosphohydrolase-1 (ENTPDase1), also known as CD39; and SNS-201, a conditionally active VISTAxCD28 bispecific antibody consisting of a CD28 agonist arm and a pH-sensitive anti-VISTA arm. For more information, please visit  , and follow the company on X @SenseiBio and  LinkedIn . Investor Contact: Michael Biega Senior Director, Investor Relations Sensei Biotherapeutics mbiega@senseibio.com Media Contact: Joyce Allaire LifeSci Advisors Jallaire@lifesciadvisors.com