2022 Q2 Outlook: Which clinical developments are worth watching?

The second quarter of 2022 has begun, and both large pharmaceutical companies and small and medium-sized biotech companies are looking forward to a number of clinical developments in the second quarter
.
Recently, industry media Evaluate published three articles in a row to introduce potential milestones in the biomedical field in the second quarter

Tiragolumab and giredestrant (Roche)

Roche recently announced that the TIGIT antibody tiragolumab failed to meet the primary endpoint in a phase 3 clinical trial in the treatment of patients with small cell lung cancer, which also made the results of the phase 3 clinical trial of tiragolumab in the treatment of non-small cell lung cancer with high PD-L1 expression even more interesting
.
Unlike small cell lung cancer, tiragolumab has achieved excellent results in phase 2 clinical trials for the treatment of non-small cell lung cancer, and in patients with high PD-L1 expression, the combination of PD-L1 antibody Tecentriq reduced the risk of disease progression or death in patients 71%

Additionally, a Phase 2 trial of Roche's oral selective estrogen receptor degrader (SERD) giredestrant in patients with ER-positive, HER2-negative breast cancer is expected to report data
.
This SERD has potential "best-in-class" activity, inhibiting the activity of the estrogen receptor before it degrades it

Tirzepatide (Lilly)

Eli Lilly's dual GIP/GLP-1 receptor agonist, tirzepatide, has significantly reduced glycated hemoglobin and body weight in patients with type 2 diabetes in multiple clinical trials
.
Its New Drug Application for the treatment of type 2 diabetes is under review by the FDA, with a response expected by mid-year

▲ Potential mechanism of action of Tirzepatide (Image source: Eli Lilly's official website)

Respiratory syncytial virus vaccine (GSK, Pfizer)

Two respiratory syncytial virus (RSV) vaccine candidates will usher in pivotal Phase 3 clinical trials by mid-year
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They are GlaxoSmithKline's RSV vaccine GSK3844766A, and Pfizer's RSVpreF

KarXT (Karuna Therapeutics)

Results from a Phase 3 clinical trial of Karuna's investigational therapy, KarXT, in patients with schizophrenia are expected by mid-year
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KarXT is composed of two active ingredients, xanomeline and trospium chloride, designed to activate muscarinic acetylcholine receptors in the brain while reducing the effect on peripheral muscarinic acetylcholine receptors

Repotrectinib (Turning Point Therapeutics)

Repotrectinib is a potential "best-in-class" ROS1 and NTRK targeted inhibitor
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It has a unique structure, the binding site to the target protein is located in the "ATP pocket", and it is not affected by multiple drug resistance mutations

Last October, Turning Point announced updated results for repotrectinib in patients with ROS1-positive advanced NSCLC
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These patients had previously received platinum-based chemotherapy and an up-front tyrosine kinase inhibitor (TKI)

TRx0237 (Taurx Pharmaceuticals)

TRx0237 (also known as LMTX) is an inhibitor of tau protein aggregation.
The neurofibrillary tangles formed by tau protein aggregation are one of the classic features of brain tissue in patients with Alzheimer's disease
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Furthermore, tau pathology and spread in the brain are more closely associated with cognitive decline in Alzheimer's patients
.

In a phase 3 clinical trial called LUCIDITY, TRx0237 at doses of 8 mg or 16 mg will be used to treat patients with mild to moderate disease who have not received prior cholinesterase inhibitors or memantine
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Results of the primary endpoint of the trial are expected in May of this year
.

CTP-543 (Concert Pharmaceuticals)

CTP-543, an oral selective inhibitor of JAK1 and JAK2, is a deuterated ruxolitinib analog with different pharmacokinetic profiles
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It has been granted Breakthrough Therapy Designation by the US FDA for the treatment of alopecia areata
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In a phase 2 clinical trial, high-dose CTP-543 improved an average of more than 75% in the severity of hair loss in patients at 24 weeks
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A Phase 3 clinical trial testing CTP-543 for the treatment of alopecia areata is expected to have primary endpoint results in May of this year
.

▲ Phase 2 clinical trial results of CTP-543 (Image source: Concert's official website)

There is still no FDA-approved targeted therapy for alopecia areata, but several JAK inhibitors have shown positive results in clinical trials and are expected to bring the first approved therapy to patients
.

ATA188 (Atara Biotherapeutics)

ATA188 is an allogeneic T-cell immunotherapy targeting Epstein-Barr virus (EBV)
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It reduces the attack on nerve myelin by targeting latent EBV antigens, destroying EBV-infected B cells and plasma cells
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Recent studies suggest that EBV infection may be the main cause of multiple sclerosis (MS)
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Antibodies produced by the body to attack EBV may cross-react with its own proteins, mediating the attack on nerve myelin
.

▲The mechanism of action of ATA188 (Image source: Atara Biotherapeutics official website)

In an ongoing phase 1 clinical trial, ATA188 not only improved disability symptom scores in some patients, but also showed signs of remyelination
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Its Phase 2 clinical trial in patients with multiple sclerosis will have an interim analysis in the second quarter of this year
.

References:

[1] Significant readouts for small players.
Retrieved March 31, 2022, from https:// Significant readouts for small players.
Retrieved March 31, 2022, from https:// [2] Biotech catalysts on the horizon.
Retrieved March 31, 2022, from https:// Biotech catalysts on the horizon.
Retrieved March 31, 2022, from https:// [3] Big pharma's key second-quarter data.
Retrieved March 31, 2022, from https:// Big pharma's key second-quarter data.
Retrieved March 31, 2022, from https://