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).

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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.

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"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]).

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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.

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"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.

Children’s Hospital Los Angeles Offers MIBG Therapy for Neuroblastoma

On July 14, 2022 Children’s Hospital Los Angeles reported that Children with high-risk neuroblastoma can now access a specialized, targeted radiation treatment called MIBG therapy at —one of the largest neuroblastoma programs in the country and the only pediatric facility in Southern California and the Southwestern United States to offer this treatment (Press release, Children’s Hospital Los Angeles, JUL 14, 2022, View Source [SID1234616687]).

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MIBG (metaiodobenzylguanidine) is a compound that was once a blood pressure medicine and is easily absorbed by neuroblastoma cells. In MIBG therapy, this chemical is combined with a radioactive iodine called I-131 and given to patients through an IV infusion, allowing it to kill tumor cells throughout the body.

Neuroblastoma is the second-most common solid tumor in children (after brain tumors). The cancer develops from immature nerve cells and typically affects children between the ages of 2 and 4. Nearly half of patients are diagnosed with high-risk, metastatic disease, which has a 50% mortality rate.

"Bringing MIBG therapy to Children’s Hospital Los Angeles will allow many more patients to access this promising treatment," says Araz Marachelian, MD, MS, Director of the Neuroblastoma Program in the Cancer and Blood Disease Institute at Children’s Hospital Los Angeles. "Previously, families in Southern California, as well as nearby states like Arizona and Nevada, have had to travel long distances for MIBG treatment. We are excited to give them an option much closer to home."

Alan S. Wayne, MD, Director of the Cancer and Blood Disease Institute, adds that the Neuroblastoma team at Children’s Hospital Los Angeles is dedicated to developing the most advanced and promising new therapies for children with high-risk neuroblastoma. "MIBG therapy is one more example of our commitment to provide the highest quality cancer care to children from Southern California and around the globe," he says.

Parents can stay with their child

Patients receive MIBG therapy while in the hospital, staying in a special room specifically designed for this treatment. After a one-time infusion, which takes about two hours, children must remain in the room for two to five days, or until radiation levels in their body are low enough for them to safely go home.

Children’s Hospital Los Angeles—which began offering MIBG therapy in March—is one of only a few institutions in the country to enable parents to stay in the same room with their child during the treatment. This is possible because the room is very large, allowing parents to be a safe distance from radioactivity.

The room also contains extensive radiation shielding, including special shields on wheels around the patient’s bed. These use an innovative clear material—an extremely dense liquid encased in plexiglass—that allows the parent and child to see each other at all times. Parents can also be at their child’s bedside for short periods, with monitors tracking their radiation exposure.

"Distance is very effective in stopping radiation," says Chuck Pickering, Vice President of Facilities and Support Services at Children’s Hospital Los Angeles. "By using a combination of distance, shielding and monitors, we are able to keep parent radiation exposures to very low, safe levels, enabling them to be with their child."

Multiple clinical trials

MIBG therapy is not approved by the Food and Drug Administration and is being studied in multiple clinical trials at Children’s Hospital Los Angeles and select sites around the country.

One of these trials, led by the Children’s Oncology Group national consortium, is a phase 3 randomized controlled trial studying the effectiveness of MIBG when added to standard therapy for newly diagnosed patients with high-risk neuroblastoma.

And while MIBG therapy has long been given to children with relapsed or treatment-resistant disease, another multicenter trial is evaluating a novel combination for those patients: giving MIBG along with immunotherapy. That phase 1 trial is led by the New Approaches to Neuroblastoma Therapy (NANT) consortium, which is headquartered at Children’s Hospital Los Angeles.