Imugene Ltd.

Precision Biosciences has received clearance from regulators in the Eastern European country of Moldova to begin a human trial of a gene editor for chronic hepatitis B, marking the first such test in the world. Precision’s ultimate goal is to use gene editing to functionally cure chronic hepatitis B, which to date is treatable but not curable. It’s a herculean task — a cure thus far has been elusive because the hepatitis B virus hides in a stable form in liver cells where it continues to make more copies of itself. “This is a disease indication where new therapies have really had a challenge, and patients have really been looking for better treatment options for a really long time,” Precision CEO Michael Amoroso said. People with chronic HBV can receive daily antiviral pills and interferon injections to treat the disease. Functional cure rates are around 2% on the antiviral pills alone and around 10% when combined with the injections but with significant side effects. The company’s Phase 1 trial will recruit from Moldova and up to four other countries. Amoroso declined to name those countries in an interview ahead of the announcement, though he confirmed Precision is pursuing an IND in the US. Precision uses its own gene editing platform it calls ARCUS, which was developed by North Carolina scientists who founded the company in 2006. Instead of CRISPR/Cas9, ARCUS uses an editing enzyme derived from algae. For chronic hepatitis B, Precision calls its experimental therapy PBGENE-HBV. The gene editor is delivered via a fatty acid envelope called a lipid nanoparticle, which accumulates in the liver. The gene editor is targeted to a sequence in HBV DNA that codes for the virus’ polymerase, which is an enzyme that helps make more copies of viral DNA. In doing so, Precision hopes gene editing can eliminate two forms of the hepatitis B viral DNA in liver cells that other approaches can’t get to: covalently closed circular DNA, or cccDNA, as well as HBV DNA that has integrated into the host DNA. cccDNA is a feature of certain viruses including HBV where its genetic code makes a stable ring inside the cell, and it also makes the virus very hard to cure. “The factory that makes replicating virus is that cccDNA,” Amoroso said. “So we’re not looking to cure symptoms, we’re looking to go at the root cause.” In May, Excision BioTherapeutics reported that its attempt to gene edit HIV failed. Like Precision, Excision’s goal is to use gene editing to excise hidden viruses from cells. However, there are some key differences — including that HIV is found in cells beyond the liver and Excision used viral envelopes called AAVs to try to reach those cells. Excision is likewise developing a gene editing therapy for HBV, for which it hopes to start clinical studies in 2026. Beam Therapeutics was also working on a gene editing approach to HBV but the company stopped work on the program in October last year as part of larger cost cuts and layoffs. It’s been a long road to this moment for Precision, which once developed CAR-T therapies before offloading that work to Imugene and in April saw Eli Lilly end a partnership on three programs. Gilead had signed on to Precision’s hepatitis B program in 2018, but axed the partnership in 2020, returning the rights to the gene editing company. In a May note to investors, BMO Capital Markets analyst Kostas Biliouris wrote that Precision “remains a ‘show me’ story wherein positive clinical data from the PBGENE-HBV program are needed to improve investor sentiment.”

Cell therapy CDMO Kincell Bio has brought on an unnamed client to a multi-year deal to manufacture personalized, clinical-grade regenerative treatments. Kincell Bio, a CDMO focused on producing cell therapies, signed an unnamed client to a multi-year deal to manufacture personalized, clinical-grade regenerative treatments.The partnership is slated to add work at Kincell's site in Gainesville, Florida, the company said in a Sept. 16 press release. The client was described by Kincell as a clinical-stage cell therapy company investigating regenerative medicines for a variety of “critical” indications. Financial details of the deal weren’t disclosed.“We’re delighted to welcome another client to our Gainesville facility,” Bruce Thompson, Kincell’s chief executive, said in the release. “Our facility is GMP-ready, and our team thrives on providing critical CMC development and manufacturing expertise to support our clients’ clinical development plans to help patients.” Back in April, Kinsell said it would shell out $6 million over the next three years and kick in milestone-driven payments to take over immuno-oncology biotech Imogene’s North Carolina cell manufacturing facility and hire the site’s associated staffers.Under that deal, Kincell picked up a new 32,800-square-foot site in Research Triangle Park. Imugene, for its part, aimed to save $32 million through staff cost cuts, manufacturing efficiencies and overhead savings.

REDWOOD CITY, Calif., Sept. 04, 2024 (GLOBE NEWSWIRE) -- Bolt Biotherapeutics (Nasdaq: BOLT), a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer, today announced the appointment of Jakob Dupont, M.D., to its Board of Directors. Dr. Dupont brings more than two decades of experience in the field of oncology and immuno-oncology. With the appointment of Dr. Dupont, Executive Partner at Sofinnova Investments, Dr. Jim Healy, M.D., Ph.D., also at Sofinnova, will be stepping down as Lead Independent Director. In addition, Frank D. Lee will be departing the Board and Brian O’Callaghan, CEO of Deep Genomics, will be assuming the role of Chair. “Jakob has deep experience in successfully developing therapies that help cancer patients, and we are honored to have him join our Board of Directors. Jakob’s proven track record and knowledge in drug development will be beneficial as we continue to advance our pipeline and support our collaborations,” said Willie Quinn, Chief Executive Officer. “Jim and Frank have provided excellent counsel to Bolt and on behalf of the whole Board of Directors, I would like to thank them for their insights and dedication. I am also excited that Brian is stepping forward to be Chair of the board, and we all look forward to his leadership.” Dr. Dupont is Executive Partner, Private Equity at Sofinnova Investments. Prior to joining Sofinnova, Dr. Dupont was Global Head of Research & Development and Executive Vice President at Atara Biotherapeutics, where he led the development and regulatory approval of EBVallo ® . He also served as Chief Medical Officer at Gossamer Bio. Before Gossamer Bio, Dr. Dupont served as Vice President and Global Head of Breast and Gynecologic Cancer Development for Genentech/Roche, where he was responsible for the global development of Herceptin ® , Perjeta ® , Kadcyla ® , and Tecentriq ® , among others, and where he previously led the development of Avastin ® for Gynecologic and Breast Cancers when starting his industry career. He serves as a Board Member for Avenzo Therapeutics, Pyxis Oncology, and Imugene, and is on the Scientific Advisory Board for Flagship Pioneering. Dr. Dupont earned his bachelor’s degree from Vassar College, his master’s degree from New York University, and his M.D. from the Joan & Sanford I. Weill Medical College of Cornell University. “I’m pleased to join the Bolt Biotherapeutics Board of Directors,” said Jakob Dupont, M.D., Executive Partner, Private Equity, Sofinnova Investments. “The recent strategic restructuring has left Bolt in an enviable position of having an ongoing clinical trial with a first-in-class Dectin-2 agonist and a near-clinical ISAC program targeting Claudin 18.2. Additionally, Bolt has the resources, in the form of cash, platform technology, and a solid team, to pursue its mission of harnessing the power of the immune system to improve lives and eradicate cancer. I look forward to sharing my experience with the Bolt team as they advance their pipeline programs through clinical development.” About Bolt Biotherapeutics, Inc. Bolt Biotherapeutics is a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer. Bolt Biotherapeutics’ pipeline candidates are built on the Company’s deep expertise in myeloid biology and cancer drug development. The Company’s pipeline includes BDC-3042, a first-in-class agonist antibody that activates macrophages by targeting Dectin-2, and BDC-4182, a next-generation Boltbody™ Immune-Stimulating Antibody Conjugate (ISAC) clinical candidate targeting claudin 18.2. BDC-3042 is currently in a Phase 1 dose escalation trial that includes patients with any of seven different solid tumor types. BDC-4182 is supported by strong in vitro and in vivo data demonstrating potent anti-tumor activity, and activities are underway to support the initiation of clinical trials in 2025. Bolt Biotherapeutics is also developing additional Boltbody™ ISACs in strategic collaborations with leading biopharmaceutical companies. For more information, please visit . Forward-Looking Statements This press release contains forward-looking statements about us and our industry that involve substantial risks and uncertainties and are based on our beliefs and assumptions and on information currently available to us. All statements other than statements of historical facts contained in this press release, including statements regarding the advancement and success of our BDC-3042 clinical trial, the potential initiation of clinical trials for BDC-4182, the anti-tumor potency, safety and tolerability, and characteristics of our product candidates, the initiation of future clinical trials, the potential value of collaborations, and the expected duration of our cash runway, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “on track,” “plan,” “potential,” “predict,” “project,” “should,” “will,” or “would,” or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements represent our current beliefs, estimates and assumptions only as of the date of this press release and information contained in this press release should not be relied upon as representing our estimates as of any subsequent date. These statements, and related risks, uncertainties, factors and assumptions, include, but are not limited to: the potential product candidates that we develop may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release; such product candidates may not be beneficial to patients or become commercialized; and our ability to maintain our current collaborations and establish further collaborations. These risks are not exhaustive. Except as required by law, we assume no obligation to update these forward-looking statements, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future. Further information on factors that could cause actual results to differ materially from the results anticipated by our forward-looking statements is included in the reports we have filed or will the Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2023. These filings, when available, are available on the investor relations section of our website at investors.boltbio.com and on the SEC’s website at . Investor Relations and Media Contact: Matthew DeYoung Argot Partners (212) 600-1902 boltbio@argotpartners.com