Orbis Health Solutions is dedicated to the eradication of cancer and immune-mediated diseases. The company engages in both internal research and development, as well as collaborations with business and academic partners. Their primary focus is on creating personalized therapeutic cancer vaccines, known as tumor lysate or particle only vaccines, which are designed to stimulate the immune system to recognize and attack cancer cells specific to each patient.

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Neoplasms

Skin and Musculoskeletal Diseases

Therapeutic vaccine

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Disease Domain	Count

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Drugs associated with Orbis Health Solutions LLC

Tumour lysate particle loaded dendritic cell vaccine(Orbis Health Solutions)

Target-

Mechanism

Immunostimulants

Active Org.

Orbis Health Solutions LLC [+1]

Originator Org.

Orbis Health Solutions LLC

Active Indication

Melanoma

Inactive Indication

Metastatic melanoma

Drug Highest PhasePhase 3

First Approval Ctry. / Loc.-

First Approval Date-

100 Clinical Results associated with Orbis Health Solutions LLC

0 Patents (Medical) associated with Orbis Health Solutions LLC

Literatures (Medical) associated with Orbis Health Solutions LLC

01 Jan 2024·Cancer Treatment and Research Communications

Tumor lysate particle only vaccine (TLPO) vs. Tumor lysate particle-loaded, dendritic cell vaccine (TLPLDC) to prevent recurrence in resected stage III/IV melanoma patients: Results of a phase I/IIa trial

Article

Author: Bohan, Phillip M Kemp ; Vreeland, Timothy J. ; Berger, Adam C ; Peoples, George E. ; Berger, Adam C. ; O'Shea, Anne E. ; Adams, Alexandra M ; McCarthy, Patrick M. ; Carpenter, Elizabeth L ; O'Shea, Anne E ; Clifton, Guy T. ; Valdera, Franklin A ; Sussman, Jeffrey J. ; Stojadinovic, Alex ; Hyngstrom, John ; Cindass, Jessica L ; Hickerson, Annelies T ; Faries, Mark B. ; Adams, Alexandra M. ; Chick, Robert C. ; Jakub, James W ; Shaheen, Montaser ; Valdera, Franklin A. ; Faries, Mark B ; Hickerson, Annelies T. ; Clifton, Guy T ; McCarthy, Patrick M ; Van Decar, Spencer G. ; Chick, Robert C ; Peoples, George E ; Vreeland, Timothy J ; Yu, Xianzhong ; Tiwari, Ankur ; Hale, Diane F ; Cindass, Jessica L. ; Jakub, James W. ; Carpenter, Elizabeth L. ; Van Decar, Spencer G ; Hale, Diane F. ; Wagner, Thomas ; Sussman, Jeffrey J

BACKGROUNDThe autologous tumor lysate, particle-loaded, dendritic cell (TLPLDC) vaccine is produced from dendritic cells (DC) loaded ex vivo with autologous tumor lysate (TL). TLPLDC has been shown to decrease recurrence in resected Stage III/IV melanoma patients in a Phase IIb trial. The TL particle only (TLPO) vaccine is produced by loading of yeast cell wall particles with autologous TL and direct injection allowing for in vivo DC loading. We have compared the TLPO and TLPLDC vaccines in an embedded Phase I/IIa trial of a larger Phase IIb trial of the TLPLDC vaccine.METHODSPatients rendered clinically disease-free after surgery were randomized 2:1 to receive the TLPO or TLPLDC vaccine and followed for recurrence and death. Patients had scheduled intradermal inoculations at 0, 1, 2, 6, 12, and 18 months after enrollment. Kaplan-Meier and log-rank analysis were used to compare disease-free survival (DFS) and overall survival (OS) in an intention-to-treat (ITT) analysis.RESULTSSixty-three patients were randomized, 43 TLPO and 20 TLPLDC. Patients randomized to the TLPO arm were more likely to be female (37.2% vs. 10.0 %, p = 0.026), but otherwise no significant clinicopathological differences were identified. No differences in related adverse events (AE) were found between treatment arms. At a median follow-up of 20.5 months, the DFS (60.8% vs. 58.7 %, p = 0.714) and OS (94.6% vs. 93.8 %, p = 0.966) were equivalent between the TLPO and TLPLDC groups, respectively. No statistical differences were found in subgroup analyses between vaccine types, which accounted for receipt of immunotherapy and the use of G-CSF pre-blood draw.CONCLUSIONSIn a randomized, double-blind Phase I/IIa trial, there were no differences in DFS or OS in resected Stage III/IV melanoma patients receiving adjuvant TLPO versus TLPLDC vaccines. Given manufacturing advantages, further efficacy testing of TLPO is warranted in a Phase III trial.

01 Aug 2023·Journal for ImmunoTherapy of Cancer

Prospective, randomized, double-blind phase 2B trial of the TLPO and TLPLDC vaccines to prevent recurrence of resected stage III/IV melanoma: a prespecified 36-month analysis

Article

Author: Thomas, Katryna ; Van Decar, Spencer ; Hale, Diane ; Hyngstrom, John ; Yu, Xianzhong ; Vreeland, Timothy ; Kemp Bohan, Phillip ; Adams, Alexandra M ; Jakub, James ; Smolinsky, Todd ; Carpenter, Elizabeth Lee ; Hickerson, Annelies ; O'Shea, Anne E ; Cindass, Jessica ; Peoples, George E ; Valdera, Franklin A ; Faries, Mark ; Sussman, Jeffrey J ; Tiwari, Ankur ; McCarthy, Patrick ; Wagner, Thomas E ; Shaheen, Montaser F ; Chick, Robert Connor ; Berger, Adam C ; Clifton, Guy Travis

BackgroundThe tumor lysate, particle-loaded, dendritic cell (TLPLDC) vaccine is made by ex vivo priming matured autologous dendritic cells (DCs) with yeast cell wall particles (YCWPs) loaded with autologous tumor lysate (TL). The tumor lysate, particle only (TLPO) vaccine uses autologous TL-loaded YCWPs coated with silicate for in vivo DC loading. Here we report the 36-month prespecified analyses of this prospective, randomized, double-blind trial investigating the ability of the TLPO and TLPLDC (±granulocyte-colony stimulating factor (G-CSF)) vaccines to prevent melanoma recurrence in high-risk patients.MethodsPatients with clinically disease-free stage III/IV melanoma were randomized 2:1 initially to TLPLDC versus placebo (n=124) and subsequently TLPO versus TLPLDC (n=63). All patients were randomized and blinded; however, the placebo control arm was replaced in the second randomization scheme with another novel vaccine; some analyses in this paper therefore reflect a combination of the two randomization schemes. Patients receiving the TLPLDC vaccine were further divided by their method of DC harvest (with or without G-CSF pretreatment); this was not randomized. The use of standard of care checkpoint inhibitors was not stratified between groups. Safety was assessed and Kaplan-Meier and log-rank analyses compared disease-free (DFS) and overall survival (OS).ResultsAfter combining the two randomization processes, a total of 187 patients were allocated between treatment arms: placebo (n=41), TLPLDC (n=103), or TLPO (n=43). The allocation among arms created by the addition of patients from the two separate randomization schemes does not reflect concurrent randomization among all treatment arms. TLPLDC was further divided by use of G-CSF in DC harvest: no G-CSF (TLPLDC) (n=47) and with G-CSF (TLPLDC+G) (n=56). Median follow-up was 35.8 months. Only two patients experienced a related adverse event ≥grade 3, one each in the TLPLDC+G and placebo arms. DFS was 27.2% (placebo), 55.4% (TLPLDC), 22.9% (TLPLDC+G), and 60.9% (TLPO) (p<0.001). OS was 62.5% (placebo), 93.6% (TLPLDC), 57.7% (TLPLDC+G), and 94.6% (TLPO) (p=0.002).ConclusionsThe TLPO and TLPLDC (without G-CSF) vaccines were associated with improved DFS and OS in this clinical trial. Given production and manufacturing advantages, the efficacy of the TLPO vaccine will be confirmed in a phase 3 trial.Trial registration numberNCT02301611.

01 Mar 2023·Cancer Immunology, Immunotherapy

Divergent clinical outcomes in a phase 2B trial of the TLPLDC vaccine in preventing melanoma recurrence and the impact of dendritic cell collection methodology: a randomized clinical trial

Article

Author: Tiwari, Ankur ; Berger, Adam C ; Hickerson, Annelies T ; Jakub, James W ; Sussman, Jeffrey J ; Kemp Bohan, Phillip M ; Adams, Alexandra M ; Shaheen, Montaser F ; Carpenter, Elizabeth L ; Chick, Robert C ; Clifton, Guy T ; Vreeland, Timothy J ; Hyngstrom, John R ; Faries, Mark B ; Hale, Diane F ; O'Shea, Anne E ; Valdera, Franklin A ; Yu, Xianzhong ; Peoples, George E ; McCarthy, Patrick M ; Wagner, Thomas E

BACKGROUNDA randomized, double-blind, placebo-controlled phase 2b trial of the tumor lysate, particle-loaded, dendritic cell (TLPLDC) vaccine was conducted in patients with resected stage III/IV melanoma. Dendritic cells (DCs) were harvested with and without granulocyte-colony stimulating factor (G-CSF). This analysis investigates differences in clinical outcomes and RNA gene expression between DC harvest methods.METHODSThe TLPLDC vaccine is created by loading autologous tumor lysate into yeast cell wall particles (YCWPs) and exposing them to phagocytosis by DCs. For DC harvest, patients had a direct blood draw or were pretreated with G-CSF before blood draw. Patients were randomized 2:1 to receive TLPLDC or placebo. Differences in disease-free survival (DFS) and overall survival (OS) were evaluated. RNA-seq analysis was performed on the total RNA of TLPLDC + G and TLPLDC vaccines to compare gene expression between groups.RESULTS144 patients were randomized: 103 TLPLDC (47 TLPLDC/56 TLPLDC + G) and 41 placebo (19 placebo/22 placebo + G). Median follow-up was 27.0 months. Both 36-month DFS (55.8% vs. 24.4% vs. 30.0%, p = 0.010) and OS (94.2% vs. 69.8% vs. 70.9%, p = 0.024) were improved in TLPLDC compared to TLPLDC + G or placebo, respectively. When compared to TLPLDC + G vaccine, RNA-seq from TLPLDC vaccine showed upregulation of genes associated with DC maturation and downregulation of genes associated with DC suppression or immaturity.CONCLUSIONSPatients receiving TLPLDC vaccine without G-CSF had improved OS and DFS. Outcomes remained similar between patients receiving TLPLDC + G and placebo. Direct DC harvest without G-CSF had higher expression of genes linked to DC maturation, likely improving clinical efficacy.

News (Medical) associated with Orbis Health Solutions LLC

29 Feb 2024

·www.biospace.com

Novo Holdings, Forbion Lead Financing for Orbis Medicine’s $28M Seed Round

Pictured: Wall sign of the Novo Nordisk Foundation and Novo Holdings in Denmark/iStock, CR Danish biotech Orbis Medicines announced its emergence on the drug development scene Thursday with €26 million ($28.1 million) in seed financing backed by Novo Holdings and life sciences venture capital firm Forbion. According to Orbis, the funds will support its expansion. The company is focused on macrocycle drugs, described as a family of compounds with “highly desirable therapeutic properties” that have a cyclic structure. While Orbis did not provide the exact targets for its pipeline, the company will initially “focus on high-value oral alternatives to blockbuster biologic drugs and opening new targets to therapeutic intervention.” Orbis is also working on a pipeline of macrocycle drugs for “intra-and extra-cellular targets” but did not provide specifics. “After decades of challenging de novo synthesis, the universe of potential macrocycle targets is now available for exploration. Not only can Orbis reach a wealth of new targets, both inside and outside cells, but we can do this while preserving an oral format to pioneer a new therapeutic class of oral macrocycles. It’s a milestone for drug development,” Morten Døssing, chair of the Orbis board and partner at Novo Holdings said in a statement. Orbis was founded in 2021 by the Seeds Investment team of Novo Holdings, with the scientific foundation of the company being developed by Chrisitan Heinis and Sevan Habeshian, at the Swiss Federal Institute of Technology in Lausanne. Habeshian is also co-founder and CTO at Orbis. “We can generate hundreds of thousands of diverse compounds in record time and immediately apply a range of functional assays in a high-throughput fashion to each compound to home in on winners. Establishing this robust, reliable engine for candidate design was crucial for us as we look to bring macrocycle drugs to major patient populations,” Døssing said. Novo Holdings made a big splash earlier this month with its purchase of contract manufacturer Catalent for over $16 billion, providing a massive shot in the arm for Novo Nordisk to expand its production capacity for its hot-selling GLP-1 drugs. In September 2023, Forbion co-led a Series B for Mariana Oncology and invested in Calluna Pharma in January 2024. Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.

100 Deals associated with Orbis Health Solutions LLC

100 Translational Medicine associated with Orbis Health Solutions LLC

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Drug(Targets)	Indications	Global Highest Phase

Tumour lysate particle loaded dendritic cell vaccine(Orbis Health Solutions)	Melanoma More	Phase 3

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