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Voltron Therapeutics, Inc., a Lucius Partners Portfolio Company, Announces Definitive Proof of Concept Data for its Lead Oncology Candidate (VTX-067) in an HPV Related Tumor Challenge Study

On July 14, 2022 Voltron Therapeutics, Inc., a Lucius Partners portfolio company, reported that data from the previously announce Study ‘098 demonstrated clear Proof-of Concept for VTX-067 in the treatment of HPV related cancers. This is a well-validated murine model of HPV related cancers (Press release, Voltron Therapeutics, JUL 14, 2022, View Source [SID1234616692]).

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VTX-067, a Self-Assembling Vaccine (SAV) targeting select peptides from HPV related cancers, was developed using Voltron’s Self Assembling Vaccine Platform. Voltron has executed an exclusive worldwide license for this technology from The Massachusetts General Hospital’s (MGH) Vaccine and Immunotherapy Center (VIC).

Study ‘098 was a double blind, preclinical study evaluating VTX-067 in TC-1 tumor injected mice to evaluate its impact on Overall Survival of the mice, as well as other key efficacy and safety endpoints. The Primary Endpoint of the study was the vaccine’s impact on Overall Survival of the mice.

Results of the study demonstrated:

Improved Overall Survival: VTX-067/SAV had a highly significant, positive survival effect in the TC-1 tumor injected mice
Tumor volume reduction: VTX-067 significantly reduced TC-1 tumor volume
Dose response: there was a clear dose-response to SAV, with the overall best survival benefit to the TC-1 tumor bearing mice at the highest dose of SAV.
Safety Profile: the SAV construct once again demonstrated it is well tolerated with no observed reactogenicity.
Commented Dr. Mark Poznansky, Director, Vaccine and Immunotherapy Center, MGH: "The data clearly demonstrate that the inclusion of highly immunogenic epitopes derived from HPV in our self-assembled vaccine significantly controlled tumor growth and augmented survival in a well-established mouse model of HPV induced cancer, in comparison to control animals treated with saline or immunogenic peptides. Treatment with our vaccine also generated significant HPV targeted cell mediated immunity with no detectable reactogenicity. These results met, and indeed exceeded, our expectations for efficacy and immunogenicity in this important model"

Patrick J. Gallagher, Voltron’s Chief Executive Officer commented, "We are tremendously excited about the results of this rigorously designed, double blind study for many reasons. First, our vaccine eradicated tumors in a number of mice in this aggressive tumor model at higher doses. Second, the data once again supports the SAV’s incredible flexibility: Voltron has demonstrated success in producing a significant immune response in four different disease/animal models by using between two and 11 disease specific peptides. Finally, we have gained additional confidence in the utility of combing the SAV with a PD-1 inhibitor to drive targeted, durable responses."

James Ahern, Managing Partner, Laidlaw & Company (UK) and Founder of Lucius Partners, stated, "The team’s expertise and commitment to driving this proof-of-concept study forward with a view to first in human trials has produced compelling results. We continue to identify additional programs for Voltron, which we will pursue in both oncology and infectious disease, that leverage our highly flexible vaccine platform to create new solutions for clinicians and patients. We remain focused on de-risking our programs and to provide value to our shareholders."

Neurocrine Biosciences Announces Conference Call and Webcast of Second Quarter 2022 Financial Results

On July 14, 2022 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported that it will report second quarter 2022 financial results after the Nasdaq market closes on Thursday, August 4, 2022 (Press release, Neurocrine Biosciences, JUL 14, 2022, View Source [SID1234616691]). Neurocrine will then host a conference call and webcast to discuss its financial results and provide a company update that day at 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time).

Participants can access the live conference call by dialing 800-895-3361 (US) or 785-424-1062 (International) using the conference ID: NBIX. The webcast can also be accessed on Neurocrine’s website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.

Omega Therapeutics Announces FDA Clearance of IND Application for OTX-2002, First Omega Epigenomic Controller, for MYC Driven Hepatocellular Carcinoma

On July 14, 2022 Omega Therapeutics, Inc. (Nasdaq: OMGA) ("Omega"), reported that it has received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate a Phase 1/2, first-in-human, clinical study of OTX-2002 for the treatment of hepatocellular carcinoma (HCC) (Press release, Omega Therapeutics, JUL 14, 2022, View Source [SID1234616690]). OTX-2002, an Omega Epigenomic Controller (OEC), is designed to downregulate c-Myc (MYC) expression pre-transcriptionally through epigenetic modulation while potentially overcoming MYC autoregulation.

"We are thrilled to obtain clearance to advance OTX-2002 into the clinic and are excited about the prospects of what this new class of medicines may mean for patients in need," said Mahesh Karande, President and Chief Executive Officer of Omega Therapeutics. "This is an important milestone for our company, representing our first program to receive FDA clearance to enter the clinic and the first ever clinical trial to evaluate an epigenomic controller. This new class of programmable mRNA therapeutics leverages our groundbreaking science and has broad potential applicability in many therapeutic areas."

About OTX-2002
OTX-2002 is a first-in-class Omega Epigenomic Controller in development for the treatment of HCC. OTX-2002 is an mRNA therapeutic delivered via lipid nanoparticles (LNPs) and is designed to downregulate MYC expression pre-transcriptionally through epigenetic modulation while potentially overcoming MYC autoregulation. The MYC oncogene is associated with aggressive disease in up to ~70% of patients with HCC. An IND application for OTX-2002 has been cleared by the FDA.

Illumina to Announce Second Quarter 2022 Financial Results on Thursday, August 11, 2022

On July 14, 2022 Illumina, Inc. (NASDAQ:ILMN) reported that it will issue results for the second quarter 2022 following the close of market on Thursday, August 11, 2022 (Press release, Illumina, JUL 14, 2022, View Source [SID1234616689]).

On the same day, at 2:00 pm Pacific Time (5:00 pm Eastern Time) Francis deSouza, Chief Executive Officer, and Joydeep Goswami, Chief Strategy and Corporate Development Officer and Interim Chief Financial Officer, will host a conference call with analysts, investors, and other interested parties to discuss financial and operating results.

Conference Call Details

The conference call will begin at 2:00 pm Pacific Time (5:00 pm Eastern Time) on Thursday, August 11, 2022. Interested parties may access the live teleconference through the Investor Info section of Illumina’s website under the "company" tab at www.illumina.com. Alternatively, individuals can access the call by dialing 866.409.1555 or +1.313.209.4906 outside North America, both with Conference ID 6659694. To ensure timely connection, please dial in at least ten minutes before the scheduled start of the call.

A replay of the conference call will be posted on Illumina’s website after the event and will be available for at least 30 days following.

Immune-Onc Therapeutics Announces Appointment of Christopher Whitmore as Chief Financial Officer and Provides Clinical Progress Update

On July 14, 2022 Immune-Onc Therapeutics, Inc. ("Immune-Onc"), a private, clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting myeloid checkpoints, reported the appointment of Christopher Whitmore as chief financial officer (Press release, Immune-Onc Therapeutics, JUL 14, 2022, View Source [SID1234616688]). In addition, the company provided a clinical progress update on IO-108, its first-in-class antagonist antibody targeting the Leukocyte Immunoglobulin-Like Receptor subfamily B2 (LILRB2, also known as ILT4) of myeloid checkpoints.

"Chris brings a wealth of industry experience to Immune-Onc at an exciting stage in the company’s evolution," said Charlene Liao, Ph.D., chief executive officer of Immune-Onc. "His impressive track record of success and diverse experience across disciplines, including finance and operations, will be impactful to Immune-Onc’s continued success."

"It’s an incredibly exciting time to join Immune-Onc, as the company continues to advance its promising pipeline of novel myeloid checkpoint inhibitors. I look forward to working with this talented and passionate management team to accelerate the development of Immune-Onc’s portfolio of products that may improve outcomes for cancer patients who currently have limited treatment options," said Mr. Whitmore.

Mr. Whitmore is a highly accomplished financial executive who has more than 20 years of experience in strategic finance, accounting, operations, investor relations and organizational development. He joins Immune-Onc from Notable Labs, where he served as chief financial officer since 2021. Prior to that, he served as vice president of finance and administration for Harpoon Therapeutics. During his tenure there, he supported the company’s crossover financing, initial public offering, licensing and collaboration, follow-on financings and public company operations. Mr. Whitmore previously held management positions at Immune Design (now part of Merck & Co.), AcelRx Pharmaceuticals and Sangamo Therapeutics. He started his career at KPMG LLP, where he served in the audit practice. He received his B.A. in business economics from the University of California, Santa Barbara, and holds an active CPA license.

Immune-Onc also announced successful completion of dose escalation in the first-in-human clinical trial (NCT05054348) of IO-108, a novel antagonist antibody targeting the myeloid checkpoint Leukocyte Immunoglobulin-Like Receptor B2 (LILRB2, also known as ILT4), for the treatment of solid tumors.

In the study, adult patients with advanced or refractory solid tumors were treated with IO-108 at 60, 180, 600 or 1,800 mg in monotherapy and at 180, 600 or 1,800 mg in combination with 200 mg of pembrolizumab, an anti-PD-1 antibody, administered intravenously every three weeks. IO-108 has been well-tolerated at up to 1,800 mg, either as a monotherapy or in combination with pembrolizumab, without dose-limiting toxicity so far.

Additionally, early signals of clinical activity were observed in multiple tumor types with demonstrated monotherapy efficacy. This supports the clinical development plan to advance IO-108 into select cancers for dose expansion as monotherapy and in combination with anti-PD-(L)1 and/or standard of care therapies. A biomarker strategy will include evaluation of a specific, sensitive and proprietary LILRB2 antibody for immunohistochemistry to enable tumor selection with an increased probability of success.

"We are very pleased with the rapid enrollment and early completion of dose escalation of IO-108 in solid tumor patients. Emerging data from our first-in-human study demonstrate that IO-108 has an excellent safety and tolerability profile. We are also encouraged by signals of clinical activity in multiple tumor types," said Paul Woodard, M.D., chief medical officer of Immune-Onc. "We look forward to advancing IO-108 into multiple expansion cohorts in specific tumor types as monotherapy and in combination with T cell checkpoint inhibitors."

ABOUT IO-108

IO-108 is a fully human IgG4 monoclonal antibody with high affinity and specificity towards LILRB2 (also known as ILT4). It blocks the interaction of LILRB2 with multiple ligands that are involved in cancer-associated immune suppression, including HLA-G, ANGPTLs, SEMA4A and CD1d. Preclinical data presented at the 2020 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s annual meeting and the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting demonstrate that IO-108 functions as a myeloid checkpoint inhibitor and promotes innate and adaptive anti-cancer immunity.

In the ongoing Phase 1 study of IO-108 in adult patients with advanced or refractory solid tumors in the U.S. (NCT05054348), to date, IO-108 has been well tolerated with demonstrated clinical activity in multiple tumor types, both as a monotherapy and in combination with pembrolizumab. This data enables the company to accelerate the global development of IO-108 in multiple expansion cohorts in select cancers as a monotherapy and in combination with T cell checkpoint inhibitors. The company has received the IND clearance in China and plans to evaluate IO-108 in solid tumors in China in 2H 2022.