Immunomedics gets FDA Orphan Drug Designation for Trodelvy in glioblastoma

Trodelvy (sacituzumab govitecan-hziy) is the lead product and the most advanced program in Immunomedics’ unique antibody-drug conjugate (ADC) platform. Trodelvy is an ADC that is directed against Trop-2, a cell-surface protein expressed in many solid cancers. Trodelvy binds to Trop-2 and delivers the anti-cancer drug, SN-38, to kill cancer cells. 

Immunomedics has an extensive development program for Trodelvy, including multiple ongoing studies in triple-negative breast cancer, metastatic urothelial cancer, hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer, and metastatic non-small cell lung cancer, either as a monotherapy or in combination with other agents. 

VBL Therapeutics granted European patent on Anti-MOSPD2 antibodies for inflammation

VBL has recently demonstrated ex-vivo activity of anti-MOSPD2 antibodies in patients with relapsing-remitting and progressive multiple sclerosis (MS), as well as in animal models of rheumatoid arthritis (RA), nonalcoholic steatohepatitis (NASH) and inflammatory bowel disease (IBD).

The Company recently held a pre-IND meeting with the FDA and has reached alignment with the Agency on the path forward for its lead anti-MOSPD2 candidate. A first-in-human study is planned to commence in the second half of 2021.

 

The claims in the granted patent cover the use of such an antibody/antibody fragment to treat a wide range of inflammatory and autoimmune conditions. The patent is expected to provide protection for VBL’s MOSPD2 antibodies for inflammation, until at least July 2036.

Mallinckrodt Chapter 11 proceedings to reduce total debt by ~$1.3B

The entities that filed Chapter 11 petitions include Mallinckrodt plc, substantially all of its U.S. subsidiaries, including its specialty generics-focused subsidiaries (collectively, “Specialty Generics”) and specialty brands-related subsidiaries (collectively, “Specialty Brands”), and certain of its international subsidiaries.

The current consolidated cash balance of the Chapter 11 filing entities is more than $650 million. Together with cash generated from ongoing operations, this is expected to provide ample liquidity to support continued operations during the court-supervised process.

The Company has filed a number of customary motions seeking court authorization to continue to support its business operations during the court-supervised process, including the continued payment of employee wages and benefits without interruption. The Company intends to pay vendors and suppliers in full under normal terms for goods received and services rendered on or after the filing date. The Company expects to receive court approval for all of these routine requests. The Company’s foreign non-debtor affiliates will continue to operate their businesses in the ordinary course.

Separating the Specialty Generics and Specialty Brands businesses remains one of Mallinckrodt’s goals. The Company will continue to evaluate strategic options for the Specialty Generics business at an appropriate time and when market conditions are favorable.

The Company intends to use the Chapter 11 process to provide a fair, orderly, efficient and legally binding mechanism to implement a restructuring support agreement (“RSA”) that, among other things, provides for an amended proposed opioid claims settlement and a financial restructuring that would:

  • Reduce the Company’s total debt by approximately $1.3 billion, improving the Company’s financial position and better positioning it for long-term growth;
  • Resolve opioid-related claims against the Company, its subsidiaries and related entities; and
  • Resolve various Acthar Gel-related matters, including the CMS Medicaid rebate dispute, an associated False Claims Act (“FCA”) lawsuit and an FCA lawsuit relating to Acthar’s previous owner’s interactions with an independent charitable foundation.