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New medicines #12 - July 25, 2020 - July 31, 2020
A weekly overview of the development of new medicines.
- Bluebird Bio with Bristol Myers Squibb announced the resubmission of their Biologics License Application (BLA) to the FDA for idecabtagene vicleucel (ide-cel; bb2121), for the treatment of adult patients with relapsed and refractory multiple myeloma - https://www.businesswire.com/news/home/20200729005776/en/Bristol-Myers-Squibb-bluebird-bio-Announce-Submission
- Genocea Biosciences released preliminary data from its Phase 1/2a trial evaluating its neoantigen vaccine GEN-009, combined with immune checkpoint inhibitor-based regimens in patients with solid tumors:
Three of five patients achieved separate RECIST responses after GEN-009 administration
- Onconova Therapeutics announced that the required number of survival events for the pivotal Phase 3 INSPIRE trial has been reached - https://www.globenewswire.com/news-release/2020/07/29/2069696/0/en/Onconova-Therapeutics-Announces-that-the-Required-Number-of-Survival-Events-Has-Been-Reached-for-the-Pivotal-Phase-3-INSPIRE-Trial-Data-Analysis.html
- Roche announced that its phase 3 trial of Actemra (tocilizumab; anti-IL-6) did not meet its primary endpoint of improved clinical status in hospitalized adult patients with severe COVID-19 associated pneumonia - https://www.businesswire.com/news/home/20200728006091/en/Genentech-Update-Phase-III-COVACTA-Trial-Actemra
Moreover, Roche announced that the FDA approved Tecentriq (atezolizumab) plus Cotellic (cobimetinib) and Zelboraf (vemurafenib) for the treatment of BRAF V600 mutation-positive advanced melanoma patients:
Helped people live longer without disease worsening or death compared to placebo plus Cotellic and Zelboraf (median PFS 15.1 months versus 10.6 months respectively; hazard ratio, HR=0.78; confidence interval: 0.63-0.97; P=0.025)
The most common adverse reactions (rate ≥20%) in patients who received Tecentriq plus Cotellic and Zelboraf were rash (75%), musculoskeletal pain (62%), fatigue (51%), hepatotoxicity (50%), pyrexia (49%), nausea (30%), pruritus (26%), edema (26%), stomatitis (23%), hypothyroidism (22%), and photosensitivity reaction (21%)
- Spectrum Pharmaceuticals announced that it met the pre-specified primary endpoint in the phase 2 clinical trial evaluating poziotinib in previously treated non-small cell lung cancer (NSCLC) patients with HER2 exon 20 insertion mutations (Cohort 2):
Objective response rate (ORR) of 27.8%
- TCR2 Therapeutics announced that patients showed unconfirmed partial responses in its phase 1 trial of TC-210 in patients with mesothelin-expressing solid tumors:
Two other patients exhibited stable disease through six months
https://finance.yahoo.com/news/tcr2-therapeutics-releases-positive-solid-143407440.html
Source: BPC, SY, Bioworld