CENTOGENE Extends Gene Testing Pact With Takeda

 

• The global market access and expansion partnership, initially established in 2015, aims to provide an efficient and timely diagnosis to patients with Lysosomal Storage Disorders (LSDs)

• Diagnosis plays a critical role in guiding patients towards appropriate and readily available therapies that can enhance their quality of life

Centogene N.V. (Nasdaq: CNTG), the essential life science partner for data-driven answers in rare and neurodegenerative diseases, today announced it has extended its partnership with Takeda (TSE: 4502/NYSE: TAK) to diagnose patients with Lysosomal Storage Disorders (LSDs).

Under the renewed one-year partnership agreement, CENTOGENE will continue to provide Takeda with access to diagnostic testing for patients around the world. The aim of the commercial fee-for-service agreement is to enhance patient access to rapid and reliable diagnostics for LSDs, including Fabry disease, Gaucher disease, and Hunter syndrome.

https://finance.yahoo.com/news/centogene-extends-strategic-partnership-takeda-103000272.html

Moderna: Flu Vax Testing To Continue As It Misses 'Early Success' Threshold

 

• Moderna Inc's (NASDAQ: MRNA) first vaccine candidate against influenza is mRNA-1010, which is being developed in adults.

• The independent Data and Safety Monitoring Board (DSMB) has completed the first interim efficacy analysis for the second Phase 3 trial (P302) conducted in the Northern Hemisphere to evaluate the safety and non-inferior efficacy compared to a licensed flu vaccine.

• The DSMB said mRNA-1010 did not meet the statistical threshold necessary to declare early success.

• The safety board recommended that the trial continues with efficacy follow-up towards the next analysis.

• The DSMB did not identify any safety concerns. Blinded follow-up for safety and efficacy is ongoing in this trial.

• In February, Moderna announced interim results from another Phase 3 trial (P301) of mRNA-1010 in adults.

• Non-inferiority was not met for seroconversion rates and geometric mean titer ratios for the influenza B/Victoria- and B/Yamagata-lineage strains. Meanwhile, mRNA-1010 showed an acceptable safety and tolerability profile.

• The company has developed an update to mRNA-1010 that is expected to have improved immunogenicity against influenza B strains and announced plans to initiate a confirmatory Phase 3 trial this month.

• Moderna's combination vaccine candidates cover respiratory viruses. Phase 1 combination studies with Covid+Flu (mRNA-1073), Flu+RSV (mRNA-1045), and Covid+Flu+RSV (mRNA-1230) have completed enrollment.

• An investigational new drug application for a next-generation Covid+Flu vaccine candidate (mRNA-1083) has been submitted.

• Moderna plans to have combination vaccines available by 2025. It expects six major vaccine product launches in the next few years.

• The company estimates respiratory product sales in 2027 of around $8 billion-$15 billion, with an operating profit of $4 billion-$9 billion.

• Moderna estimates the annual global endemic COVID-19 booster market to be approximately $15 billion. The company has COVID vaccine sales of approximately $5 billion currently contracted for 2023 delivery.

• The company plans R&D spending of $6 billion-$8 billion over the next few years

https://finance.yahoo.com/news/modernas-vaccine-day-influenza-vaccine-144434379.html

Chinook Pauses Phase 1 Trial After Adverse Effects

 Chinook Therapeutics, Inc. (Nasdaq: KDNY), a biopharmaceutical company focused on the discovery, development and commercialization of precision medicines for kidney diseases, today announced that dosing in the phase 1 clinical trial of CHK-336 in healthy volunteers has been voluntarily paused to allow a thorough investigation of a serious adverse event (SAE) that occurred in a single subject following the first dose in the 125 mg multiple ascending dose (MAD) group. Dosing was halted per trial protocol when the event occurred, followed by a voluntary pausing of the trial by Chinook to enable further investigation. The event has been reported to the U.S. Food and Drug Administration (FDA) through a Suspected Unexpected Severe Adverse Reaction (SUSAR) report.

The SAE had a rapid onset and rapid recovery; follow-up of the subject is ongoing. Based on evaluation to date with input from expert consultants, the underlying cause of the event is being investigated as a potential hypersensitivity reaction to the study drug or its excipients. Next steps will be determined once Chinook and the trial’s Safety Monitoring Committee have reviewed all safety data. Previously, CHK-336 was generally well tolerated in a total of 62 subjects at single doses up to 500 mg and multiple doses up to 60 mg daily for 14 days.

https://finance.yahoo.com/news/chinook-therapeutics-announces-voluntary-pause-120000018.html

IN8bio to Present New Positive Phase 1 Cell Therapy Trial Data

 

• Updated data on durability of responses and long-term complete responses (CRs) in leukemia patients treated with INB-100 will be presented; no dose-limiting toxicities have been observed
  
  

• New correlative data on immune reconstitution and gamma-delta T cell proliferation for Cohorts 1 and 2 will be presented

https://finance.yahoo.com/news/in8bio-present-positive-clinical-data-120000891.html

Regenxbio fast tracked for Duchenne gene therapy

 

• RGX-202 is a potential one-time AAV Therapeutic for the treatment of Duchenne and includes an optimized transgene for a novel microdystrophin and REGENXBIO's proprietary NAV® AAV8 vector

• Commercial-scale cGMP material from the REGENXBIO Manufacturing Innovation Center to be used in the clinical trial

• AFFINITY DUCHENNE™ Phase I/II trial of RGX-202 is active and recruiting patients; anticipated to report initial trial data in the second half of 2023

https://finance.yahoo.com/news/regenxbio-receives-fda-fast-track-110500400.html

Why Shares of Adaptimmune Therapeutics Jumped

 Shares of Adaptimmune Therapeutics (ADAP 7.08%) were up as much as 9.7% early Tuesday after the clinical-stage biotech announced that it had reached an agreement with GSK (GSK -1.37%) to return the rights to Adaptimmune's PRAME and NY-ESO cell therapy programs. The stock is down more than 17% this year.

Adaptimmune focuses on therapies to treat cancer in solid tumors through its SPEAR (for Specific Peptide Enhanced Affinity Receptor) T-cell platform. The company has four SPEAR T-cells in trials: MAGE-A10, MAGE-A4, AFP, and NY-ESO.

There were two important parts in the company's announcement. GSK, formerly known as GlaxoSmithKline, is paying Adaptimmune 30 million pounds (around $37 million) as part of the agreement, and Adaptimmune said it expects an Investigational New Drug Application with the Food and Drug Administration (FDA) this year for its PRAME targeted TCR T-cell therapy to treat solid tumors. 

The cash will help Adaptimmune as it tries to launch its first therapy, afami-cel, for which it submitted a Biologics Licensing Application with the FDA late last year. Afami-cel has the potential to be the first marketed TCR T-cell therapy to treat a solid tumor.

Adaptimmune, as of the fourth quarter, reported it had $108 million in cash. In 2022, it said it had yearly revenue of $27.1 million, up from $6.1 million in 2021, mostly from its collaboration agreement with Genentech, a subsidiary of Roche.

The company lost $165.5 million in 2022, or $0.17 per share, compared to losses of $158.1 million and $0.17 per share in 2021.

https://www.fool.com/investing/2023/04/11/why-shares-of-adaptimmune-therapeutics-jumped-tues/

Why Shares of Shockwave Medical Jumped

 Shares of Shockwave Medical (SWAV 10.64%) were up 10.69% early Tuesday afternoon after the Centers for Medicare and Medicaid Services (CMS) unveiled a proposed rule that detailed new payment codes for coronary intravascular lithotripsy (IVL), which is performed by a system that Shockwave manufactures. Shockwave's IVL uses sonic pressure waves to break up hardened plaque in arteries. 

Not only do the proposed new codes mean more money for Shockwave -- an estimated $4,000 to $5,000 more per procedure -- but it also shows that the CMS is recognizing the value of the IVL. This will go a long way toward getting more physicians to use the system.

Shockwave has estimated the procedure's total addressable market could be worth $8.5 billion a year. The stock is up more than 21% so far this year.

The news out of the CMS wasn't the only news that affected Shockwave recently. On Monday, the company announced it was completing its $75 million purchase of specialty medical-device company Neovasc.

Neovasc Reducer System has been approved in Europe to treat refractory angina, a chronic type of chest pain when the coronary arteries deliver an inadequate supply of blood to the heart muscle. Shockwave says this market is worth $5 billion a year.

Shockwave's financials have improved dramatically in the past year. Last year, it reported revenue of $489.7 million, up 107%, and net income of $216 million, compared to a loss of $9.1 million in 2021. Yearly earnings per share (EPS) in 2022 were $5.70, compared to an EPS loss of $0.26 in 2021. The company said it expects a rise of 35% to 39% this year in revenue, landing between $660 million to $680 million.

https://www.fool.com/investing/2023/04/11/why-shares-of-shockwave-medical-jumped-on-tuesday/