Summit Biosciences, Inc.

WOODBURY, Minn. & ST. LOUIS & LEXINGTON, Ky.--(BUSINESS WIRE)-- Kindeva Drug Delivery (“Kindeva”), a global leader in drug-device combination products, announced today that it has acquired Summit Biosciences Inc. (“Summit”), an intranasal drug-delivery contract development and manufacturing organization (CDMO), from its founding family shareholders. Established in 2009, Summit has an extensive track record of innovation in the unit dose nasal spray market. The acquisition of Summit enhances Kindeva’s existing drug-delivery capabilities by adding a new drug-delivery platform, further expanding Kindeva’s ability to serve biopharma customers across a wider range of complex drug-device combination products (pulmonary, injectable, transdermal, and nasal). “Nasal drug delivery is becoming a preferred dosage format for a growing number of indications, as it allows users to non-invasively administer medications in an acute or emergency setting,” said Kindeva CEO Milton Boyer. “Summit brings a differentiated understanding of how to effectively formulate drugs for nasal delivery and the capability to manufacture them at commercial scale. This addition not only fits Kindeva’s ambition to be a global leader in the drug-device combination products CDMO market, but also expands the toolbox we can offer our customers to help improve patient outcomes and experience of care globally.” Departing Summit Chairman and CEO Richard D. Cohen added, “Joining Kindeva strengthens our ability to deliver best-in-class nasal product development and manufacturing. Under Kindeva’s leadership, our dedicated and talented workforce will further drive our founder’s vision of increasing the availability of nasal drug-delivery options.” Summit’s 55,000-square-foot cGMP facility in Lexington (Kentucky) adds to Kindeva’s global manufacturing footprint of nine development and manufacturing facilities across the U.S. and U.K. The facility is approved by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) and features specialized laboratories and integrated manufacturing operations with a long track record in bringing intranasal medicines to market. Kirkland & Ellis acted as legal counsel to Kindeva. Frost Brown Todd acted as legal counsel, and Bourne Partners served as the exclusive financial advisor, to Summit. About Kindeva Drug Delivery Kindeva is a global contract development manufacturing organization (CDMO) focused on drug-device combination products. The company develops and manufactures products across a broad range of drug-delivery formats, including pulmonary & nasal, injectable, and transdermal. Kindeva’s service offerings span early-stage feasibility through commercial scale drug product fill-finish, container closure system manufacturing, and drug-device product assembly. Kindeva serves a global client base from our nine manufacturing, research, and development facilities located in the U.S. and U.K. For more information, please visit .

Life science companies made adjustments to their leadership teams with multiple appointments for chief commercial officers, chief business officers, and more with this week’s Movers & Shakers. Intrommune Therapeutics New York-based Intrommune Therapeutics added two members to its leadership team. Stuart Loesch, who currently serves as chief commercial officer, was named president and William Berger was tapped to serve as head of clinical development. Loesch’s responsibilities with the company will expand under his new title. Loesch will continue to manage all commercial activities, as well as oversee the clinical, regulatory and manufacturing functions of Intrommune’s pipeline, including INT301 for peanut-allergic patients, which is currently in clinical development. Throughout his career, Loesch has held roles at multiple pharmaceutical companies, including Altana Pharmaceuticals, Nycomed, Schering-Plough, Merck, Teva and Meda Pharmaceuticals. Before joining Intrommune in 2021, Loesch served as vice president of marketing, BD and commercial strategy at ALK. A world-renowned allergist, Berger founded the Allergy and Asthma Associates of Southern California Medical Group. He also established the Southern California Research Center, which focused on respiratory and allergy clinical research projects. Discovery Life Sciences Suso J. Platero joined Alabama-based Discovery Life Sciences as chief scientific officer. Platero brings over 20 years of leadership in managing biomarker development organizations at leading pharmaceutical and diagnostics companies. Before joining Discovery, Platero served as vice president of biomarkers, imaging, and diagnostics at Vertex Pharmaceuticals. Before that, Platero led the development of a biomarker solution center for cell and gene therapy at Labcorp. He also had prior leadership at Janssen and Bristol Myers Squibb. Recludix Pharma Matthew Caldemeyer was appointed chief business officer of San Diego-based Recludix Pharma. He most recently served as vice president of business development at Shanghai-based Everest Medicines. Caldemeyer previously served as head of business development at Ambrx and as director of the corporate strategy and business development at Array BioPharma. Before that, he held roles of increasing responsibility in strategy and corporate development at Amgen, and before that, at Eli Lilly. Femasys, Inc. Michael Meier is the new vice president of sales and marketing at Atlanta-based Femasys. His hiring coincided with the commercial availability of FemCerv, an endocervical tissue sampler designed to improve women’s health. Meier was previously the head of business development and payor relations at Gravity Diagnostics. Prior to that, he served as vice president of sales and commercialization at Caldera Medical. AlivaMab Discovery Services Larry Green reassumed the role of chief executive officer at AlivaMab. He was the founding CEO of the San Diego-based company. Green will continue to serve as CEO of Ablexis, LLC. He takes over the role from Justin Mika, who held the position for the past two years. Kaléo Ted A. Marcuccio joins Virginia-based Kaléo as chief business officer. Marcuccio previously held a similar role at Summit Biosciences prior to joining Kaléo. He also held leadership positions at Meridian Medical Technologies, King Pharmaceuticals and Baxter International. As CBO, Marcuccio is expected to help the company scale through product acquisition and partnership deals for its Aerio Auto-Injection Platform. Radionetics Oncology Umesh Gangadharmath joins San Diego-based Radionetics as SVP of technical operations. Gangadharmath previously served as chief operating officer at Optimal Tracers, a radiopharmaceutical-focused contract development and manufacturing company. He also served as a member of the United States Pharmacopeia Radioactive Drugs Expert Panel and played a key role in developing a molecular imaging program at Loma Linda University Medical Center. Mursla Karin Schmitt joined U.K.-based Mursla as chief operating officer. Schmitt previously held leadership roles in the U.S. at Exelixis and Millennium Pharmaceuticals and in the U.K. at Thermo Fisher Scientific, Horizon Discovery Group, PredictImmune, and most recently Mogrify. Lyell Immunopharma Rahsaan W. Thompson joins Bay Area-based Lyell Immunopharma as chief legal officer. Thompson has more than 20 years of experience with development-stage and commercial companies. Prior to joining Lyell, Thompson was executive vice president and general counsel at Gritstone bio. He was also general counsel for Opiant Pharmaceuticals. Previously, as the vice president of law for Actelion Pharmaceuticals. Before that, Thompson was the associate general counsel at Abraxis Bioscience before its acquisition by Celgene.

GAITHERSBURG, Md., March 22, 2021 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, announced today that it has retained Summit Biosciences, a world-wide leader in nasal spray pharmaceuticals, to manufacture a metered nasal spray presentation of AdCOVID, its intranasal COVID-19 vaccine candidate. AdCOVID is an adenovirus-vector vaccine designed to stimulate a broad immune response following a single vaccination that includes both systemic immunity (neutralizing antibody) and local immunity (mucosal IgA and resident memory T cells) in the nasal cavity and respiratory tract. “As we continue to build our manufacturing consortium and progress the development of AdCOVID, we are pleased to partner with Summit Biosciences to manufacture AdCOVID in a customized multidose nasal spray delivery device. We expect this device may be a convenient and efficient option when vaccinating patients in high-demand settings where our vaccine candidate’s anticipated room temperature stability profile will also be important,” said Vipin K. Garg, President and Chief Executive Officer of Altimmune. “In addition, Altimmune will continue to produce a single dose presentation of AdCOVID to provide alternative forms of administration. Summit Biosciences has expertise in intranasal product innovation, and we are excited to align with their highly experienced team in our fight against COVID-19.” Gregory Plucinski, President and COO, Summit Biosciences, said, “I am pleased that Altimmune, a recognized leader in intranasal vaccine development, selected Summit in this exciting endeavor. Summit has a proven track record in bringing nasal spray medicines from concept to market with its state-of-the-art capabilities that are ideal for this program. Together, we will combine our respective expertise and capabilities with the goal of ultimately introducing a potentially novel, needle-free, nasal spray vaccine for the SARS-CoV-2 pandemic.” AdCOVID is currently being evaluated in a Phase 1 clinical trial. The Phase 1 trial is evaluating the safety and immunogenicity of AdCOVID in healthy adult volunteers between the ages of 18 and 55. Subjects will receive AdCOVID at one of three dose levels administered as a nasal spray. In addition to the primary study endpoint of safety and tolerability, the immunogenicity of AdCOVID will be evaluated by serum IgG binding and neutralizing antibody titers, mucosal IgA antibody from nasal samples, and T cell responses. Altimmune anticipates having a data readout from this Phase 1 trial in Q2 2021. While traditional vaccines delivered by an intramuscular injection can stimulate systemic immunity as measured in the blood, they have not been shown to induce mucosal immunity in the nasal cavity, which may be critical for blocking transmission of the virus. AdCOVID is designed to deliver vaccine directly to the site of viral entry and replication to stimulate mucosal and cellular immunity in the nasal cavity and respiratory tract, thereby potentially offering an important early defense against the SARS-CoV-2 virus. The ability to stimulate mucosal and resident T cell immunity in the respiratory tract would be a key differentiator for AdCOVID and may play a critical role in blocking transmission of the SARS-CoV-2 virus. About AdCOVID AdCOVID is a single-dose intranasal vaccine candidate for COVID-19. It is designed to stimulate a broad immune response including both systemic immunity (neutralizing antibody) and local immunity (mucosal IgA, resident memory T cells) in the nasal cavity and respiratory tract. In published preclinical studies () conducted in collaboration with the University of Alabama at Birmingham, potent serum neutralizing antibody responses, T cell responses, and a robust induction in mucosal immunity were observed in mice following a single intranasal dose of AdCOVID. Mucosal immunity was characterized by IgA antibody and resident memory T cell responses in the respiratory tract, both of which are believed to be important in fighting infection, and importantly, transmission. In preclinical efficacy studies, AdCOVID provided 100% protection against lethal SARS-CoV-2 challenge and a 3-log reduction in viral titer in the nasal cavity and respiratory tract. Based on data from Altimmune’s other intranasal platform vaccine candidates, AdCOVID is expected to have extended stability at room temperature that would allow for cold chain-free shipment of the vaccine. If demonstrated, AdCOVID could be stored in the common refrigerators found in community-based doctors’ offices and pharmacies for two years or more. The Company believes that these simple and convenient handling requirements, together with the potential ability to block SARS-CoV-2 transmission, could position AdCOVID as a leading intranasal COVID-19 vaccine. About Summit Biosciences Founded in 2009, Summit Biosciences, Inc. of Lexington, KY is a privately-held, specialized pharmaceutical company focused on developing, manufacturing and commercializing generic and innovative nasal spray medicines. It collaborates on the development of products with its clients and manufactures them at an industrial scale primarily for commercialization in the US and Europe. For more information on Summit Biosciences, please visit . About Altimmune Altimmune is a clinical stage biopharmaceutical company focused on developing intranasal vaccines, immune modulating therapies and treatments for liver disease. Our diverse pipeline includes proprietary intranasal vaccines for COVID-19 (AdCOVID™), anthrax (NasoShield™) and influenza (NasoVAX™); an intranasal immune modulating therapeutic for COVID-19 (T-COVID™); and next generation peptide therapeutics for NASH (ALT-801) and chronic hepatitis B (HepTcell™). For more information on Altimmune, please visit . Follow @Altimmune, Inc. on LinkedIn Follow @AltimmuneInc on Twitter Forward-Looking Statement for Altimmune Any statements made in this press release relating to future financial or business performance, conditions, plans, prospects, trends, or strategies and other financial and business matters, including without limitation, the timing of key milestones for our clinical assets, the timing of the data readout from the AdCOVID Phase 1 clinical trial in Q2 2021, the potential immunization effects of AdCOVID, the potential of AdCOVID to block SARS-CoV-2 transmission, the shipping and storage requirements for AdCOVID, the prospects for regulatory approval, our ability to manufacture AdCOVID for our clinical trials and commercial needs, and commercializing or selling any product or drug candidates, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Altimmune, Inc. (the “Company”) may identify forward-looking statements. The Company cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward looking statements or historical experience include risks and uncertainties, including risks relating to: potential impacts due to the COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, access to clinical sites, enrollment, adverse effects on healthcare systems and disruption of the global economy; the reliability of the results of studies relating to human safety and possible adverse effects resulting from the administration of the Company’s product candidates; the Company’s ability to manufacture clinical trial materials and commercial supply on the timelines anticipated; the Company’s ability to secure manufacturing approval from its SARS-CoV-2 cell licensor on the timelines anticipated; and the success of future product advancements, including the success of future clinical trials. Further information on the factors and risks that could affect the Company's business, financial conditions and results of operations are contained in the Company’s filings with the U.S. Securities and Exchange Commission, including under the heading “Risk Factors” in the Company’s annual report on Form 10-K for the fiscal year ended December 31, 2020 filed with the SEC, which is available at . Investor & Media Contacts: