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TG Therapeutics’ highly potential pipeline, is poised to fire up the market in the year 2021

TG Therapeutics umbralisib PDUFA date MZL and FL Marginal Zone Lymphoma (MZL) Follicular Lymphoma (FL)

TG Therapeutic (TGTX) is a biotechnology company focused on cancer & autoimmune disease with registration programs ongoing in:

In June 2020 the company updated about receiving $240 million in gross proceeds through a public offering and with four of their ongoing programmes in phase III, looking forward to put it here.

Key Triggers

  • Potential PDUFA date for umbralisib to treat rel/ref Marginal Zone Lymphoma (MZL) (Feb 15, 2021)
  • Potential PDUFA date for umbralisib to treat rel/ref Follicular Lymphoma (FL) (June 15, 2021)

Clinical Results Timeline to WATCH (Data can be presented anytime between 2H 2020 – Q1 2021)

  • Reporting topline data from our Phase 3 ULTIMATE program in Multiple Sclerosis.
  • Presenting of complete data from the UNITY-NHL FL and MZL single agent umbralisib cohorts
  • Presenting from the UNITY-CLL Phase 3 trial, as well as updated data from the triple combination trials, which is believed to set the stage for the future of U2 in CLL and non-Hodgkin’s Lymphoma.

TG therapeutics currently has a very strong pipeline of which 4 of their ongoing programmes in phase III.

The most advanced clinical programmes under TG Therapeutics’ pipeline

DRUG

INDICATION

STAGE

Trial ID

Key Updates

TGR-1202 (umbralisib) plus obinutuzumab

Relapsing or refractory Follicular Lymphoma

Phase 2

NCT03269669

Phase 2 initiation announced November 27, 2017.

TG-1101 (ublituximab)

Relapsing forms of Multiple Sclerosis (RMS)

Phase 2

NCT02738775

Phase 2 long term follow up data presented at ECTRIMS, September 12, 2019.

TG-1101 – ULTIMATE II

Multiple Sclerosis

Phase 3

NCT03277248

Phase 3 data due 2H 2020.

Umbralisib (TGR-1202) + Pembrolizumab + Ublituximab (TG-1101)

Relapsed or refractory Chronic Lymphocytic Leukemia (CLL)

Phase 1/2

NCT02535286

Phase 1/2 updated data noted 91% ORR for CLL patients; 38% for Richter’s transformation.

TG-1101 – ULTIMATE I

Multiple Sclerosis

Phase 3

NCT03277261

Phase 3 data due 2H 2020.

Umbralisib-UNITY-NHL

Follicular lymphoma (FL)

PDUFA

NCT02793583

PDUFA date June 15, 2021.

TG-1101 and IMBRUVICA (GENUINE trial)

Chronic Lymphocytic Leukemia (CLL) cancer

Phase 3

NCT 02301156

Phase 3 trial met primary endpoint – March 6, 2017. Data presented at ASCO 2017.

TG-1101 and TGR-1202 – UNITY-CLL study

Chronic Lymphocytic Leukemia (CLL) and non-Hodgkin’s Lymphoma (NHL)

Phase 3

NCT02612311

Phase 3 PFS primary endpoint met. Trial to be stopped due to superior efficacy – May 5, 2020. Full data to be presented 2H 2020.

TG-1801

Relapsed or Refractory B-cell Lymphoma

Phase 1

NCT03804996

Phase 1 trial initiation announced February 26, 2019.

Umbralisib + Ublituximab + Venetoclax-U2-Ven

Chronic Lymphocytic Leukemia

Phase 1/2

NCT03379051

Phase 1/2 data presented at ASH December 8, 2019 noted 100% ORR (9/9) including 44% CR after cycle 12 for the combination.

Umbralisib + Ublituximab + Venetoclax-ULTRA-V

Chronic Lymphocytic Leukemia

Phase 2

NCT03801525

Complete enrollment in ULTRA-V Phase 2b trial

TG-1701

Non-Hodgkin Lymphoma / Chronic Lymphocytic Leukemia

Phase 1

NCT03671590

Phase 1 data presented at ASH December 9, 2019. ORR 86%.

Umbralisib-UNITY-NHL

Marginal zone lymphoma (MZL)

PDUFA priority review

NCT02793583

PDUFA date under priority review February 15, 2021.

Ublituximab + TGR-1202 (Umbralisib) with or without Bendamustine-UNITY-NHL

Diffuse Large B-Cell Lymphoma|Follicular Lymphoma|Marginal Zone Lymphoma|Mantle Cell Lymphoma

Phase 2/3

NCT02793583

To present final data UNITY-NHL umbralisib monotherapy MZL & FL cohorts by 2H 2020 – Q1 2021

Data showing immense potential in TG Therapeutics’ ongoing clinical programmes

As per the latest updates available, TG Therapeutics’ ongoing programmes have shown immense potential in the data provided.

UNITY-CLL Phase III trial [NCT02612311]

The study is evaluating U2 (the combination of umbralisib and ublituximab) in patients with previously untreated and relapsed/refractory chronic lymphocytic leukemia (CLL). The study met its primary endpoint of PFS (p<.0001), as determined by an Independent Review Committee (IRC).

GENUINE Phase III study [NCT 02301156]

The study evaluating the combination of ublituximab plus ibrutinib compared to ibrutinib alone in patients with relapsed/refractory CLL with high-risk cytogenetics. The results indicated, addition of ublituximab to ibrutinib as compared to ibrutinib alone improved PFS, overall response rate, complete response rate.

UNITY-NHL Phase III study [NCT02793583]

The study is evaluating Umbralisib Monotherapy Cohorts in Relapsed/Refractory MZL & FL. MZL & FL Cohort’s Met Primary End Point of ORR, exceeding 40% ORR hurdle, Interim efficacy analysis of MZL cohort, n=42, showed 52% ORR, including 19% CR.

  • On June 15, 2020, the Company announced the completion of the rolling submission of a NDA to the FDA requesting accelerated approval of umbralisib as a treatment for patients with previously treated MZL and FL.
  • On August 12, 2020, the Company received notification from the FDA of its acceptance of the Company’s NDA for umbralisib as a treatment for patients with previously treated MZL and FL.

TG Therapeutics’ Market Opportunity

  • For Ublituximab Monotherapy in Multiple sclerosis
    • Estimate $1-2 Billion annual market opportunity in the US alone for ublituximab in MS with Global Market Size >$30 Billion by 2025
  • For Umbralisib + Ublituximab (U2) and Ublituximab + Ibrutinib- CLL Market Opportunity
    • 115,000 Americans living with CLL
    • 20,000 newly diagnosed patients each year
    • 20,000 previously treated patients seeking treatment each year

What makes TG Therapeutics’ pipeline highly potential and extraordinary?

TG Therapeutics’ Ublituximab (TG-1101) is a next generation glycoengineered monoclonal antibody targeting specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. It has shorter infusion time than other approved anti-CD20s. Umbralisib (TGR-1202) is an oral, once-daily, dual inhibitor of PI3K-delta and CK1-epsilon.

Both ublituximab and umbralisib, or the combination of which is referred to as “U2”, are in Phase 3 clinical development for patients with hematologic malignancies, with ublituximab also in Phase 3 clinical development for Multiple Sclerosis.

Additionally, the Company has recently brought into Phase 1 clinical development products, TG-1501, its anti-PD-L1 monoclonal antibody, TG-1701, its covalently-bound Bruton’s Tyrosine Kinase (BTK) inhibitor and TG-1801, its anti-CD47/CD19 bispecific antibody. 

Michael S. Weiss, TG Therapeutics’ Executive Chairman and Chief Executive Officer, said

“With one completed NDA submission, positive topline data from our UNITY-CLL Phase 3 trial, and a healthy balance sheet with over $275 million in cash, we are well positioned to execute on our remaining milestones for this year as well as transition from a development stage company to a fully-integrated commercial organization”

TG Therapeutics’ Market Strategy

  • The company will be using $275.6 millions of their cash, as well as future availabilities under the Company’s debt and ATM facility to fund the Company’s planned operations through the end of 2021.
  • TG Therapeutics is well positioned to achieve their remaining milestones for this year and are looking forward for transition from a development stage company to a fully integrated commercial organization.

TG Therapeutics’ Q2 financial report and the updates on the ongoing trials surely puts them at the top. Now the company aims to make its way pass 2020 with some top announcements and to capitalize the early 2021.

Currently, the company is at an advanced stage of clinical development with two experimental therapies targeting hematological malignancies and autoimmune diseases. TG Therapeutics’ ongoing U2 clinical program has the potential to address unmet needs in the CLL, MZL, FL and MS. Their ongoing clinical program has shown high efficacy as TG therapies expect to announce best outcomes by the end of 2020 or early 2021.

Submit your Request for Proposals at bd@mellalta.com

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