Lantern Pharma Newsletter January 2023

‍LP-284 was granted an FDA Orphan Drug Designation (ODD) based on its demonstrated anti-tumor activity across a comprehensive number of in vitro and in vivo models of mantle cell lymphoma (MCL).

• Most recently at ASH, LP-284 treatment was demonstrated to have between 91-105% greater tumor growth inhibition (TGI) in mice implanted with MCL tumors, when compared to treatment with the standard-of-care (SOC) agents Ibrutinib or Bortezomib.
• Additionally, LP-284 treatment was also able to inhibit the growth of mouse MCL tumors that had grown resistant to either Ibrutinib or Bortezomib.

Why it matters: The FDA grants ODDs to drugs to treat rare diseases affecting fewer than 200,000 people in the US. Receiving an ODD provides drug developers with a number of benefits including:

• Expedited drug development programs.
• Market exclusivity for 7 years upon FDA approval.
• Eligibility for tax credits, reduced registration and product fees.

What’s next: Lantern is targeting filing the IND with the FDA and initiating a first-in-human Phase 1 trial for LP-284 in B-cell non Hodgkin’s lymphomas, including MCL, by mid 2023.

The big picture: Therapies for MCL rarely achieve cures and have a high percentage of relapse and resistance. There are significant needs for additional late stage options, like LP-284, for these patients.

• In the US, MCL is diagnosed in approximately 4,500 patient seach year and has an estimated annual market potential of $600million.

One more thing: In addition to the ODD granted for LP-284 in MCL,Lantern was previously granted ODDs by the FDA for its drug candidateLP-184 for the treatment of malignant gliomas, atypical teratoidrhabdoid tumors (ATRT), and pancreatic cancer.

Lantern activated its fourth Harmonic™ clinical trial site in Dallas, TX at Texas Oncology. Across its four sites, Harmonic™ has 11different locations across the US, with multiple additional sites expected to be activated this quarter.

What's next: All four clinical trial sites, Gabrail Cancer Center, Northwest Oncology, New York Cancer and Blood Specialists, and Texas Oncology are in the process of screening patients and are targeting to enroll the first patients in Q1 2023.

The Harmonic™ app provides patients and caregivers with mobile access to up-to date information on the Harmonic™ trial including:

• How NSCLC is different in never-smokers versus in tobacco users.
• What taking part in the Harmonic™ trial involves.
• Ability to contact the Harmonic™ clinical trial team.
• Information on the investigational new drug, LP-300.
• Locations of all currently active clinical trial sites where prospective patients can gain additional information about the trial and the discuss options with clinicians.
• Download the Harmonic™ app on your iPhone here.

The big picture: In Q4 2022, Lantern requested a pre-investigational new drug (IND) meeting with the FDA for feedback on the company’s planned LP-184 IND application.

The positive FDA responses were in line with Lantern’s clinical, CMC and preclinical development plans and solidified a timeline for an IND submission and clinical trial initiation in Q2 2023.

What's next: The upcoming LP-184 Phase 1 trial is expected to enroll patients with solid tumors and central nervous system (CNS) cancers including:

1. Pancreatic cancer
2. Select solid tumors with DNA damage repair deficiency
3. Recurrent high grade gliomas, including glioblastoma (GBM)

Go deeper: Patients with central nervous system (CNS) cancers, including GBM, have some of the lowest 5 year survival rates and have had no meaningful treatment progress in two decades.

LP-184’s anti-tumor synthetic lethality mechanism of action, favorable blood brain permeability, and compelling pre-clinical efficacy for CNS cancers give it the potential to become the next generation standard-of care agent for CNS cancer patients.