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Thursday, June 30, 2022

InflaRx Update For Vilobelimab In Skin Disorder, COVID-19

 

  • InflaRx N.V.  provided a development update for its monoclonal anti-C5a antibody, vilobelimab, in pyoderma gangrenosum (PG) and severe COVID-19.
  • The FDA and the European Medicines Agency (EMA) have granted orphan drug designation to vilobelimab for PG.
  • PG is a rare condition that causes large, painful sores (ulcers) to develop on the skin.
  •  In addition, the company had a productive FDA end-of-phase II meeting to its plans for a Phase 3 development program in PG. 
  • The FDA indicated its support for a randomized, controlled Phase 3 study and offered to review the study protocol. 
  • Based on the agency's feedback and recommendations, InflaRx is now finalizing the design for a Phase 3 trial.
  • InflaRx requested a meeting with the FDA to obtain guidance for a potential emergency use authorization submission of vilobelimab in COVID-19 patients.
  • This has been scheduled as a Type B meeting for early Q3. In addition, the company is in ongoing dialogue with the EMA about the next steps in developing vilobelimab in mechanically ventilated severe COVID-19 patients.

Genmab Applies to FDA on Large B-Cell Lymphoma Trials

 Genmab A/S (Nasdaq: GMAB) today announced its intent to submit a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) for subcutaneous epcoritamab (DuoBody®-CD3xCD20), an investigational bispecific antibody, for the treatment of patients with relapsed/refractory large B-cell lymphoma (LBCL), in the second half of 2022.

The BLA submission is supported by results from the large b-cell lymphoma (LBCL) cohort of the pivotal EPCORE™ NHL-1 open-label, multi-center trial evaluating the safety and preliminary efficacy of epcoritamab in patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin lymphoma (B-NHL). In April 2022, Genmab and AbbVie announced the topline results from EPCORE™ NHL-1 trial. In June 2022, primary results were presented in a late-breaking oral presentation as part of the Presidential Symposium at the 27th Annual Meeting of the European Hematology Association (EHA2022) in Vienna, Austria.

https://finance.yahoo.com/news/genmab-submit-biologics-license-application-182400689.html

Blueprint Draws Combined $1.25B Investment in Tough Market

 Blueprint Medicines announced strategic financing collaborations with Sixth Street and Royalty Pharma totaling up to $1.25 billion. The deals with the life science-focused investors provide capital to expand Blueprint’s pipeline toward commercialization and will enable the company to continue pursuing business development opportunities.

The collaboration with Sixth Street has three main components. First, Sixth Street will pay Blueprint a $250 million upfront cash payment in exchange for 9.75% royalties on the latter's products AYVAKIT and BLU-263, both potential treatments for systemic mastocytosis (SM). There is an annual cap of $900 million in net sales and a cumulative cap of 1.45 times the invested capital.

Second, Sixth Street offered up to $400 million in a senior secured credit facility from which Blueprint can draw in delayed tranches. And third, Blueprint gets $260 million in a potential credit facility to support business development opportunities.

"Blueprint Medicines is an impressive and differentiated biopharmaceutical company, with a proven track record of success in developing and commercializing precision therapies. We are particularly excited about the opportunity for AYVAKIT to meet the substantial need in patients with non-advanced systemic mastocytosis," Vijay Mohan and Jeff Pootoolal, partners at Sixth Street, said in a statement. 

Blueprint's NSCLC/Thyroid Cancer Drug Attracts Royalty Pharma

In the second collaboration, Royalty Pharma plans to monetize royalties receivable from Blueprint’s drug Gavreto, a treatment Blueprint developed with Roche for certain types of non-small cell lung cancer and thyroid cancer. Royalty Pharma will receive royalties from net sales outside of the U.S., not including Greater China, with $175 million cash paid to Blueprint upfront and up to $165 million in potential milestone payments based on future sales.

"Gavreto is an important precision therapy that has been incredibly meaningful for patients with metastatic, RET fusion-positive non-small cell lung cancer who may have otherwise had limited options," Pablo Legorreta, Royalty Pharma's founder and CEO, said in a statement. "We are pleased to establish a partnership with the experienced team at Blueprint Medicines to help fuel their execution on the significant commercial and development opportunities they have ahead."

Blueprint CEO Kate Haviland added, "This attractive deal puts Blueprint Medicines in a very strong financial position to drive rapid growth while maintaining our path to profitability in the coming years."

Blueprint Drawing Investment in Tough Market 

These collaborations are the latest in a series of successes for Blueprint. At the European Hematology Association (EHA) 2022 Congress in early June, the company announced positive data for AYVAKIT, showing that the drug significantly improved overall survival in advanced SM.

In February, Blueprint forged another collaboration, this time with Proteovant Therapeutics to advance novel targeted protein degrader therapies. In March, AYVAKIT (branded AYVAKYT) received approval from the European Commission to treat adults with SM. Ayvakyt was the first approved therapy in the European Union designed to selectively target the KIT D816V mutation.

Now with the two latest collaborations, Blueprint is confident in its successful future. 

"Executing this deal with such favorable terms in the current market environment speaks to the quality of the assets, the aligned confidence in the commercial opportunities, and the investment opportunity that Blueprint Medicines represents overall for firms like Sixth Street and Royalty Pharma, with whom we are building long-term strategic relationships," Haviland said.

https://www.biospace.com/article/blueprint-medicines-forges-two-collaborations-totaling-1-25b/

Aura Biosciences Gets Fast Track Designation for AU-011 Bladder Cancer Treatment

 Aura Biosciences Inc. said the U.S. Food and Drug Administration has granted Fast Track designation for belzupacap sarotalocan AU-011 for the treatment of non-muscle invasive bladder cancer.

The company said its planned Phase 1 clinical trial with belzupacap sarotalocan, a virus-like drug conjugate product candidate, would evaluate the safety and early proof of mechanism, assess distribution, local necrosis and evidence of immune activation.

Aura expects to initiate the trial in the second half of 2022, with initial Phase 1 data expected in 2023.

Fast Track designation is an FDA process designed to facilitate the development of products that address high unmet medical needs and may expedite the review of drugs intended to treat serious or life-threatening diseases.

Belzupacap sarotalocan has also been previously granted Fast Track and Orphan Drug designations by the FDA for the treatment of choroidal melanoma and is currently in Phase 2 clinical development in this indication.

https://www.marketscreener.com/quote/stock/AURA-BIOSCIENCES-INC-128747413/news/Aura-Biosciences-Gets-Fast-Track-Designation-for-AU-011-Bladder-Cancer-Treatment-40865868/

Sanofi's Phase 3 Trials of Multiple Sclerosis Drug Partially Paused by FDA

 Sanofi SA said Thursday that the Food and Drug Administration has paused some U.S.-based Phase 3 trials of drug tolebrutinib for treatment of multiple sclerosis and the muscle-weakness condition myasthenia gravis.

The U.S. regulator based its actions on a limited number of drug-induced liver injury cases, the French pharmaceutical company said.

Sanofi said new enrollments in the U.S. have been paused, and those who have taken part in the trial for fewer than 60 days will stop taking the drug.

Patients who have completed at least 60 days in the studies should continue treatment, Sanofi said.

The majority of affected patients were found to have pre-existing conditions that made them predisposed to drug-induced liver injuries, which were reversible after discontinuing the drug, the company said.

Study enrollment outside of the U.S. continues with revised study protocols and safety monitoring, Sanofi said.

The company said it is still confident in tolebrutinib's potential as an oral treatment for multiple sclerosis.

https://www.marketscreener.com/quote/stock/SANOFI-4698/news/Sanofi-s-Phase-3-Trials-of-Multiple-Sclerosis-Drug-Partially-Paused-by-FDA-40863385/

UHS: UPDATE ON 2Q OPERATING RESULTS, REVISES 2022 FULL YEAR EARNINGS GUIDANCE

 Universal Health Services, Inc. (NYSE: UHS) announced today that, due to a significant shortfall in operating results experienced during April and May of 2022, as compared to the comparable periods included in our previously provided annual operating results forecast, we are revising our forecast for the year ended December 31, 2022.

Based upon our consolidated results of operations for April and May of 2022, we estimate that our adjusted net income attributable to UHS will approximate $2.05 to $2.15 per diluted share for the three-month period ended June 30, 2022. The lower than expected earnings projected for the second quarter of 2022 was due primarily to lower than expected patient volumes, revenues and income generated at our acute care hospitals. During April and May of 2022, our acute care hospitals experienced a significant decline in COVID-related patients, as compared to the first quarter of 2022. The decrease in COVID-related patient volumes during the second quarter of 2022 was not offset by an equivalent increase in non-COVID-related patients resulting in significant shortfalls in revenues and earnings as compared to our original forecasts for that period. Although the decreased patient volumes at our acute care hospitals has relieved some of the staffing shortages and related cost escalations previously experienced at those facilities, recovery from the effects of the labor pressures has been occurring at a somewhat slower pace than expected.  During April and May of 2022, patient volumes, revenues and income generated at our behavioral health care facilities were also below our expectations. However, the shortfalls from internal expectations experienced within our behavioral health segment were relatively consistent with those experienced during the first quarter of 2022.

In the announcement of our financial results for the first quarter of 2022 (as released on April 25, 2022), we indicated that, given the continued uncertainties related to the COVID-19 pandemic, as well as the healthcare staffing shortage and its unfavorable impact on our labor costs and behavioral health patient volumes, we may make reductions to our 2022 full year operating results forecast at a future date if the unfavorable operating trends experienced during the first quarter of 2022 did not improve.  Based upon the operating trends and financial results experienced during April and May of 2022, as discussed above, along with our financial results for the first quarter of 2022, we are decreasing our guidance ranges for the year ended December 31, 2022 for each of the following: (i) net revenues; (ii) earnings before interest, taxes, depreciation & amortization, and the impacts of other income/expense and net income attributable to noncontrolling interests ("Adjusted EBITDA, net of NCI"), and; (iii) adjusted net income attributable to UHS per diluted share ("Adjusted EPS-diluted").


Nurix Application Cleared for More Indications

 NX-1607 is being evaluated in multiple immuno-oncology indications, including a range of solid tumor types

Phase 1 clinical trial now enrolling patients in U.K. with plans to expand to clinical sites in the U.S.

https://finance.yahoo.com/news/nurix-therapeutics-announces-clearance-investigational-120000588.html