GTHX Gains On Breast Cancer Trial Data, RCKT Soars On Danon Disease Study Results, XBIO Abuzz

(RTTNews) - Today's Daily Dose brings you news about Rocket Pharma's Danon Disease trial results, how Xenetic Biosciences' PolyXen technology is helping a Russian company in developing a drug for anemia in patients with chronic kidney disease, Immutep's breast cancer trial results and GI Therapeutics' final data from its phase II trial of Trilaciclib in metastatic triple-negative breast cancer.

Read on…

1. G1 Therapeutics Gains On Breast Cancer Trial Data

Shares of G1 Therapeutics Inc. (GTHX) were up more than 11% in after-hours Wednesday, following final data from its phase II trial of Trilaciclib in metastatic triple-negative breast cancer.

The final data showed that there was a significant improvement in overall survival in metastatic triple-negative breast cancer patients treated with Trilaciclib in combination with a chemotherapy regimen of gemcitabine/carboplatin (GC) compared with GC alone.

A pivotal trial of Trilaciclib in metastatic triple-negative breast cancer is expected to be initiated in early 2021.

The company also presented updated monotherapy data from the phase I portion of its ongoing clinical trial of Rintodestrant in patients with ER+, HER2- breast cancer. The findings included data from the 600 mg and 1,000 mg dose expansion cohorts. As per the results, Rintodestrant showed evidence of clinical activity, including 5% (3/67) of patients with confirmed partial responses, 36% (24/67) with stable disease, and a clinical benefit rate of 30% (20/67).

GTHX closed Wednesday's trading at $18.80, down 7.41%. In after-hours, the stock was up 11.23% at $20.90.

2. Immutep Reports Encouraging Overall Survival follow up data in Breast Cancer Trial

Immutep Ltd.'s (IMMP) ongoing phase IIb study of lead drug candidate Eftilagimod alpha in combination with paclitaxel chemotherapy in patients with HER2-negative/HR positive metastatic breast cancer has yielded encouraging first Overall Survival follow up data.

In the phase IIb study, dubbed AIPAC, when the total patient population is taken into account, the median overall survival was 20.2 months for the treatment arm of Eftilagimod alpha in combination with paclitaxel chemotherapy while it was 17.5 months for the comparator arm of placebo and paclitaxel chemotherapy. This reflects a survival benefit of 2.7 months for the Eftilagimod alpha arm.

In key predefined patient groups, the survival benefit was even higher with Eftilagimod alpha and paclitaxel chemotherapy. The survival benefit for patients under the age of 65 years was 7.1 months and for patients with a low starting monocyte count the survival benefit was 9.4 months when compared to the comparator arm of placebo and paclitaxel chemotherapy.

In related news, the company announced that its Chinese partner, EOC Pharma will commence a new Phase II clinical trial of Eftilagimod alpha in combination with paclitaxel in up to 152 HER2-negative/HR positive metastatic breast cancer patients who have progression after endocrine therapy in China.

IMMP closed Wednesday's trading at $2.15, up 3.37%. In after-hours, the stock was up 62.79% at $3.50.

3. Rocket Pharma Hits New High on Danon Disease Trial Results

Shares of Rocket Pharmaceuticals Inc. (RCKT) touched a new high on Wednesday, following positive preliminary data from its open-label, phase I clinical trial of RP-A501 for the treatment of Danon Disease.

Danon Disease is a rare X-linked inherited disorder caused by genetic mutations in the LAMP2 gene resulting in accumulation of autophagosomes and glycogen, particularly in cardiac muscle and other tissues, which ultimately leads to severe and frequently fatal cardiomyopathy. An estimated 15,000 to 30,000 patients in the U.S. and the European Union have Danon Disease. There are no specific therapies available for the treatment of Danon Disease and heart transplant is an option to treat this disease.

RP-A501 is an adeno-associated viral vector (AAV)-based gene therapy candidate expressing LAMP2B.

In the phase I trial, all three low dose participants demonstrated evidence of cardiac LAMP2B expression - with two patients achieving more than 50% of normal LAMP2B - one at Month 9 and one at Month 12.

Two of the three low dose patients demonstrated key clinical biomarker improvements consistent with improved cardiac function. Brain natriuretic peptide (BNP), a key marker of heart failure, improved in all three patients, including greater than 50% in the two patients with closely monitored immunosuppressive regimen compliance.

Additionally, creatine kinase myocardial band (CPK-MB) either improved or stabilized in these two patients. Notably, all three patients showed visible improvements in autophagic vacuoles, a hallmark of Danon Disease pathology, as assessed by electron microscopy, the company added.

RCKT touched a new high of $63.94 in intraday trading Wednesday, before closing at $58.74, up 83.39%.

4. Xenetic Bio Soars On Partner's Epolong Study

Shares of Xenetic Biosciences Inc. (XBIO) jumped as much as more than 440% on Wednesday, following positive data of its partner PJSC Pharmsynthez' pivotal phase III clinical study of Epolong as a treatment for anemia in patients with chronic kidney disease.

PJSC Pharmsynthez developed its investigational drug Epolong leveraging Xenetic's patent-protected platform technology PolyXen.

The phase III trial was designed to study the efficacy, safety and tolerability of Epolong in comparison with Aranesp, the current leader in the long-acting erythropoietin segment, in roughly 150 patients with chronic kidney disease across 36 medical institutions.

According to the trial results, Epolong was non-inferior to Aranesp with respect to primary and secondary endpoints.

During the evaluation period, 74% of patients in the Epolong arm achieved the target hemoglobin range (10.0-12.0 g/dL inclusive) compared to 52% in the Aranesp group. The proportion of patients who exceeded the target threshold level of hemoglobin (12.0 g/dL) was 3.5 times greater in the Aranesp group than in the Epolong group.

Pharmsynthez is expected to make regulatory filing for Epolong in Russia next year.

XBIO touched an intraday high of $5.85 on Wednesday, before closing at $3.17, up 193.52%.

5. Stocks That Hit New Highs/Lows

GeoVax Labs Inc. (GOVX) closed Wednesday's trading at an all-time high of $5.73, up 79.06%.

SELLAS Life Sciences Group Inc. (SLS) closed at a 52-week high of $6.39, 73.17%.

Editas Medicine Inc. (EDIT) closed at an all-time high of $50.58, up 17.14%.

Nabriva Therapeutics plc (NBRV) closed at an all-time low of $3.40, down 7.86%.

Homology Medicines Inc. (FIXX) closed at an all-time low of $8.92, down 4.50%.