Immutep Lung Cancer Candidate Shows Encouraging Efficacy As 2nd-Line Treatment

 

• Immutep Limited 
  IMMP-0.44%+ Free Alerts
   announced new interim data from 2nd line non-small cell lung cancer (NSCLC) patients (Part B) in the Phase 2 TACTI-002 trial. 
• Part B evaluates Immutep's lead product candidate, eftilagimod alpha (efti or IMP321), in combination with Merck & Co Inc's 
  MRK+0.06%+ Free Alerts
   Keytruda (pembrolizumab) in 36 patients.
• Median overall survival (OS) was 9.7 months for those who received chemo-free therapy of efti in combination with pembrolizumab, comparable with the current standard of care chemotherapy options in this 2nd line setting.
• Favorable sustained survival with 36.5% of patients alive at 18 months.
• Disease Control Rate (DCR) was 36.1%, and disease control (progression-free) in 25% of patients at six months.
• Durable responses of 10+ months in 5.6% (2/36) of patients, with both patients continuing in the trial for over 11 months and 24+ months.
• Efti, combined with pembrolizumab, continues to be safe and well-tolerated, with no new safety signals.
• Efti's good safety profile to date compares favorably to the standard of care chemotherapy options.

https://www.benzinga.com/general/biotech/22/08/28292723/immuteps-lung-cancer-candidate-shows-encouraging-efficacy-as-second-line-treatment

Atlanta Fed Slashes Q3 GDP Growth As PMI Plunges

 Following two quarters of negative GDP growth - which is definitely not a recession remember - The Atlanta Fed's GDPNOW model initiated its Q3 GDP forecast for the US economy at +2.1% on July 29th.

However, after this morning's data, The GDPNow model estimate for real GDP growth (seasonally adjusted annual rate) in the third quarter of 2022 is 1.3 percent on August 1, down from 2.1 percent on July 29.

Following the Manufacturing ISM Report On Business from the Institute for Supply Management and the construction spending report from the US Census Bureau, the nowcasts of third-quarter real personal consumption expenditures growth and real gross private domestic investment growth declined from 2.5 percent and -1.4 percent, respectively, to 1.5 percent and -2.1 percent, respectively.

So to summarize - we are a third of the way to a 3rd negative quarterly GDP print after just one day of data in Q3.

But of course, 3 negative quarters of GDP would absolutely, definitely not be a recession remember.

Finally, in case you needed any convincing, this morning's ISM data had some interesting subcomponent action under the surface.

As @charliebilello notes, the last 4 times the spread between New Orders and Inventories in the ISM Manufacturing Index was this negative, the US was already in a recession. The 2001, 1990-91, and 1981-82 recessions never had readings this low...

But of course, it's different this time right... because President Biden is in office?

https://www.zerohedge.com/markets/atlanta-fed-slashes-q3-gdp-growth-pmi-plunges

FDA Accepts Gamida's Filing For Stem Cell Transplant Candidate Under Priority Review

 The U.S. Food and Drug Administration (FDA) has accepted for filing the Gamida Cell’s 

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 Biologics License Application (BLA) for omidubicel in the treatment of patients with blood cancers in need of an allogenic hematopoietic stem cell transplant.

The regulatory agency has granted Priority Review for the BLA and has set a target action date of January 30, 2023.

The BLA submission is supported by the statistically significant results from the pivotal Phase 3 study, the results were published in Blood, the official journal of the American Society of Hematology.

Julian Adams, Chief executive officer, commented: The FDA's acceptance of our BLA with Priority Review signifies a critical milestone in our mission to deliver a new stem cell therapy option for patients in need of a donor for an allogeneic stem cell transplant. We look forward to working with the FDA throughout the review process to bring omidubicel to patients as quickly as possible."

The agency has indicated that it is not planning an advisory committee meeting as part of the BLA review.

The company underscored that if approved, omidubicel could become a treatment of choice for patients in need of an allo-HSCT transplant.

https://www.benzinga.com/general/biotech/22/08/28293657/fda-accepts-gamidas-filing-for-stem-cell-transplant-candidate-under-priority-review

Stealth BioTherapeutics Enters Going Private Agreement

 

• Stealth BioTherapeutics Corp 
  MITO+20.8%+ Free Alerts
   will be acquired by a consortium of investors led by Morningside Venture (I) Investments Ltd and J. Wood Capital Advisors LLC in an all-cash transaction. 
• Each Stealth Bio will be canceled and cease to exist for the right to receive $0.03125 in cash. Each American Depositary Share representing 12 shares will be canceled for the right to receive $0.375.
• The merger consideration represents a premium of 34.4% to the closing price on June 24, the last trading day before the company announced its receipt of the original "going-private" proposal.
• The merger is expected to close during the second half of 2022.

https://www.benzinga.com/general/biotech/22/08/28293928/stealth-biotherapeutics-enters-going-private-agreement