Biotech Daily: Trial Setback For Eliem Therapeutics, Allarity Drops Work On Cancer Monotherapies, Axcella Aces Long COVID Study

Zinger Key Points
  • KB407 is an investigational, redosable gene therapy for cystic fibrosis regardless of the underlying genetic mutation.
  • Subcutaneous Tecentriq reduces the treatment time to 3-8 minutes per injection, compared with 30-60 minutes for standard IV infusion.
Biotech Daily: Trial Setback For Eliem Therapeutics, Allarity Drops Work On Cancer Monotherapies, Axcella Aces Long COVID Study

Here's a roundup of top developments in the biotech space over the last 24 hours:

Stocks In Focus

Allarity To Shift Focus On Combination Cancer Therapies

Allarity Therapeutics Inc ALLR said it would refocus its oncology pipeline strategy away from the development of monotherapies toward combination therapies.

The combination therapy focus is expected to improve the company's future funding and commercial prospects.

The new pipeline strategy follows the Type C meeting held with the FDA regarding the dovitinib clinical development path for third-line metastatic renal cell carcinoma.

Shares are up 5.74% at $1.29 during the premarket session.

Xencor, Caris Life Sciences Ink Cancer Therapy Pact

Caris Life Sciences and Xencor Inc XNCR announced a multi-year strategic option and license agreement to research, develop and commercialize XmAb bispecific antibodies for cancer.

Xencor will receive exclusive options to research, develop and commercialize products directed to up to three targets. 

Caris will receive an upfront payment and be eligible for up to approximately $120 million in license fees, discovery, development, regulatory and sales-based milestones.

Axcella's NASH Candidate Shows Favorable Action In Long COVID-Related Fatigue

Axcella Health Inc AXLA has reported topline results from the Phase 2a study to evaluate the efficacy and safety of AXA1125 in patients with fatigue related to Long COVID.

Subjects who received AXA1125 showed improved mental and physical fatigue measures that were statistically significant and clinically relevant compared to those who received a placebo. 

Shares are up 5.67% at $2.05 during the premarket session.

Valneva Amends COVID-19 Vaccine Pact With Europe

Valneva SE VALN confirms the signing of the amendment to its Advance Purchase Agreement with the European Commission following the expiration of the Member States' opt-out period.

Under this amendment, the Member States' purchases consist of 1.25 million doses of VLA2001 in 2022, with the option to purchase an equivalent quantity later this year for delivery in 2022.

The company expects to deliver the first vaccine doses to Germany, Austria, Denmark, Finland, and Bulgaria in the coming weeks.

Krystal Biotech To Start Early-Stage Cystic Fibrosis Trial

The FDA accepted Krystal Biotech Inc KRYS Investigational New Drug application to evaluate KB407 in a clinical trial for cystic fibrosis.

The company anticipates initiating the clinical trial in 2H 2022.

The Phase 1 trial will utilize nebulized administration to deliver KB407 to up to 20 adults with CF. The study will enroll three cohorts sequentially to evaluate ascending doses of KB407. The trial's primary endpoint will be the safety and tolerability of nebulized KB407. 

Roche's Subcutaneous Tecentriq At Par With IV Administration

Roche Holdings AG's RHHBY Phase 3 IMscin001 study evaluating a subcutaneous formulation of Tecentriq (atezolizumab) with Halozyme Therapeutics Inc's HALO ENHANZE technology met its co-primary endpoints.

The study showed non-inferior levels of Tecentriq in the blood when injected subcutaneously, compared with intravenous infusion in cancer immunotherapy-naïve patients with locally advanced or metastatic non-small cell lung cancer. 

The safety profile of the subcutaneous formulation was consistent with IV Tecentriq.

AbbVie, Sosei Build In 2020 Pact With New Neurological Disease-Focused Agreement

Sosei Group Corporation and AbbVie Inc ABBV announced a new drug discovery collaboration and an option-to-license agreement for neurological disease.

The second collaboration follows the 2020 agreement focused on inflammatory and autoimmune diseases.

Sosei Heptares receives an upfront payment of $40 million and is eligible to receive up to $40 million in near-term research milestones.

AbbVie will also pay milestone payments of up to $1.2 billion.

Cellectis' Dual allogeneic CAR T Enters Human Trial For Blood Cancer

The FDA has cleared Cellectis SA's CLLS Investigational New Drug (IND) application to initiate a Phase 1/2a trial of UCART20x22 for relapsed or refractory Non-Hodgkin Lymphoma (r/r NHL).

The company plans to begin enrolling patients in the NatHaLi-01 study in the second half of the year.

UCART20x22 is Cellectis' first dual allogeneic CAR T candidate targeting CD20 and CD22 simultaneously.

On The Radar

Data Presentation

AC Immune SA ACIU: Initial data from crenezumab in Alzheimer's Disease to be presented at the Alzheimer's Association International Conference.

PDUFA Dates

Earnings

Rhythm Pharmaceuticals Inc RYTM: Before the market open.

Nautilus Biotechnology Inc NAUT: Before the market open.

Repligen Corporation RGEN: Before the market open.

Esperion Therapeutics Inc ESPR: Before the market open.

Blueprint Medicines Corp BPMC: Before the market open.

Incyte Corporation INCY: Before the market open.

SAGE Therapeutics Inc SAGE: Before the market open.

Sarepta Therapeutics Inc SRPT: After market close.

Rigel Pharmaceuticals Inc RIGL: After market close.

Lexicon Pharmaceuticals Inc LXRX: After market close.

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