The Daily Biotech Pulse: FDA Signs Off Cancer Therapy Trials For NexImmune, Omega Therapeutics, Endo To Develop Rare Hereditary Skin Disease Candidate

Zinger Key Points
  • HUTCHMED Says HMPL-A83 is thirteenth oncology drug candidate from its in-house discovery platform.
  • The IND clearance represents Omega Therapeutics' first program to enter the clinic.
The Daily Biotech Pulse: FDA Signs Off Cancer Therapy Trials For NexImmune, Omega Therapeutics,  Endo To Develop Rare Hereditary Skin Disease Candidate

Here's a roundup of top developments in the biotech space over the last 24 hours:

Stocks In Focus

NexImmune Receives IND Clearance For Its First Cellular Therapy Candidate For Solid Tumors

The FDA signed off NexImmune Inc's NEXI Investigational New Drug application for NEXI-003, an autologous antigen-specific T cell product for relapsed or refractory human papillomavirus (HPV)-related cancers.

The proposed two-part Phase 1 study will characterize the safety and clinical activity of NEXI-003 in HPV-related oropharyngeal cancers.

Depending on the number of dose escalations, the expansion phase will enroll 24 to 36 patients. All patients will be followed for at least one year.

NexImmune plans to expand the NEXI-003 development program to include other HPV-related malignancies and evaluate potential SOC combination options.

Shares gained 23.1% during the after-hours session.

FDA Clears Omega's IND Application For Liver Cancer Trial

The FDA has cleared Omega Therapeutics Inc's OMGA Investigational New Drug application to initiate a Phase 1/2 study of OTX-2002 for hepatocellular carcinoma (HCC).

OTX-2002 is an mRNA therapeutic designed to downregulate c-Myc (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.

The trial will start in 2H of 2022.

Oncternal Inks Trial Collaboration Zilovertamab Combo Study In Lymphoma Setting

Oncternal Therapeutics Inc ONCT entered into a clinical trial collaboration with Pharmacyclics, an AbbVie Inc ABBV company that includes a supply of ibrutinib for its Phase 3 trial.

The supply of ibrutinib will support the company's global registrational Phase 3 trial (ZILO-301 study) of zilovertamab for relapsed or refractory mantle cell lymphoma, expected to start in the third quarter of 2022.

The agreement also includes the supply of ibrutinib for Study ZILO-302, an open-label companion study of zilovertamab plus ibrutinib for patients with progressive disease during the initial four months of ibrutinib monotherapy from Study ZILO-301.

Click here to access Benzinga's FDA Calendar.

Endo Agrees To Develop, Commercialize and Supply Quoin Pharmaceuticals' QRX003 in Canada

Endo International plc ENDP has agreed to develop, supply, commercialize, and distribute Quoin Pharmaceuticals Inc's QNRX QRX003 on an exclusive basis in Canada. 

If the product is approved, Paladin Labs Inc, an operating company of Endo, will be responsible for all commercial activities in Canada.

QRX003 is Quoin's lead product for Netherton syndrome. Netherton syndrome, a form of ichthyosis, is a rare hereditary skin disorder caused by a mutation in the SPINK5 gene.

QNRX shares are up 5.87% at 50 cents during the premarket session.

HUTCHMED Starts Early-Stage HMPL-A83 Trial In Chinese Patients With Advanced Malignant Neoplasms

HUTCHMED (China) Limited HCM has initiated a Phase 1 trial in China of HMPL-A83, an investigational novel IgG4-type humanized anti-CD47 monoclonal antibody. 

The first patient received their first dose on July 15.

The Phase 1 trial evaluates the safety, tolerability, pharmacokinetics and preliminary efficacy of HMPL-A83 in advanced malignant neoplasms. 

The primary endpoints are dose-limiting toxicity, safety, tolerability, recommended phase 2 dose, and maximum tolerated dose. The secondary endpoints include pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy profile. 

Data Presentation 

Adverum Biotechnologies Inc ADVM: New data from the Phase 1 OPTIC study of ADVM-022 in wet age-related macular degeneration at the American Society of Retina Specialists (ASRS) 2022 Annual Meeting.

On The Radar

Stock Split

Enveric Biosciences Inc ENVB: Reverse stock split of 1 for 50.

Quoin Pharmaceuticals Ltd QNRX: Reverse ADS Split of 1:12.5.

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