JNJ Acquires MNTA, FDA Strikes Down BMRN’s Gene Therapy, BLRX’s GENESIS On Track, TPTX On Watch

Today’s Daily Dose brings you news about the acquisition of Momenta by J&J, FDA refusing to approve BioMarin’s hemophilia gene therapy, ThermoGenesis’ COVID-19 combo kit getting red-flagged, Merck’s Keytruda KEYNOTE-590 study meeting trial goals, the anticipated milestones of NuCana, and Turning Point’s TRIDENT-1 study data.

Read on…

1. Momenta Snapped Up By J&J for $6.5Bln

Momenta Pharmaceuticals Inc. (MNTA) is all set to be acquired by Johnson & Johnson (JNJ) for $52.50 per share in an all-cash transaction, which equates to an equity value of $6.5 billion.

The acquisition adds Momenta’s FcRn inhibitor Nipocalimab that is being developed for the treatment of autoimmune disorders to Johnson & Johnson’s pipeline.

The transaction is expected to close in the second half of 2020.

MNTA was trading around $29 when we alerted readers to it on Jan.16, 2020. (https://www.rttnews.com/3060533/momenta-pharma-mnta-up-over-60-in-a-month-key-data-readouts-in-2020.aspx)

The stock closed Wednesday’s trading at $52.12, up 69.17%.

2. BioMarin’s Hemophilia Gene Therapy Fails to Pass FDA Muster

Shares of BioMarin Pharmaceutical Inc. (BMRN) took a beating on Wednesday, following the FDA’s refusal to approve Valoctocogene roxaparvovec gene therapy for severe hemophilia A.

BioMarin had sought approval for Valoctocogene roxaparvovec based on the interim analysis of a phase III study evaluating the efficacy and safety of Valoctocogene roxaparvovec in hemophilia A patients and three-year data from the phase I/II study.

In its complete response letter, the regulatory agency has asked the company to complete the ongoing phase III trial evaluating the efficacy and safety of Valoctocogene roxaparvovec in hemophilia A patients and submit two-year follow-up data on all study participants.

If approved, Valoctocogene roxaparvovec would have been the first gene therapy approved in any type of hemophilia.

BMRN closed Wednesday’s trading at $76.71, down 35.28%.

3. ThermoGenesis’ COVID-19 Combo Kit Red flagged

Shares of ThermoGenesis Holdings Inc. (THMO) have lost 18 percent of their value ever since the FDA warned about a risk of false results with Thermo Fisher Scientific TaqPath COVID-19 Combo Kit on August 17.

The TaqPath COVID-19 Combo Kit was granted Emergency Use Authorization by the FDA in March this year to detect nucleic acid from SARS-CoV-2, the virus that causes COVID-19. This test uses Applied Biosystems TaqPath Assay technology and is designed to provide patient results within four hours of a sample being received by a lab.

THMO closed Wednesday’s trading at $3.28, down 5.48%.

4. BioLineRx’s GENESIS at Work

BioLineRx Ltd.’s (BLRX) phase III trial of Motixafortide for the mobilization of hematopoietic stem cells for autologous transplantation in patients with multiple myeloma has enrolled roughly 65% of the sample size to allow for interim efficacy analysis.

The study, dubbed GENESIS, was initiated in December 2017, and enrollment is expected to continue until the originally planned sample size is met.

The company expects the interim analysis to be completed within the next few months and if the primary endpoint is met at the time of the interim analysis, the Company plans to immediately announce the cessation of further recruitment, without the need to enroll the full planned sample size.

The top-line results from the GENESIS trial are anticipated in the first half of 2021.

BLRX closed Wednesday’s trading at $2.19, up 3.79%.

5. Jaguar Health on Track

Jaguar Health Inc.’s (JAGX) pilot study of Mytesi in adult non-HIV patients, being conducted at The University of Texas Health Science Center at Houston, has started enrolling, with full enrollment expected to be achieved by this year-end. The study results are expected to be available by mid to late 2021.

Mytesi, approved in December 2012, is an antidiarrheal indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy (ART).

A phase II study of Mytesi for the symptomatic relief of diarrhea in HER2-positive breast cancer patients receiving chemotherapy with trastuzumab, pertuzumab, and docetaxel or paclitaxel with or without carboplatin is ongoing, with subjects in the study expected to complete treatment by the end of 2020. The final results of this study are expected to be available in mid-2021.

An investigator-initiated study of Mytesi will be conducted at a single center at Beth Israel Deaconess Medical Center, a Harvard Medical School institution in Boston, with enrollment expected to commence in the fourth quarter of 2020.

JAGX closed Wednesday’s trading at $0.52, down 3.90%.

6. Merck’s KEYNOTE-590 Study Meets Key Goals

Merck’s (MRK), pivotal phase III trial evaluating its blockbuster cancer drug KEYTRUDA in combination with chemotherapy, dubbed KEYNOTE-590 study, has met its primary endpoints of overall survival and progression-free survival for the first-line treatment of patients with locally advanced or metastatic esophageal cancer.

The study also met the key secondary endpoint of objective response rate, with significant improvements for KEYTRUDA in combination with chemotherapy compared with chemotherapy alone.

KEYTRUDA is currently approved in the U.S. and China as monotherapy for the second-line treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1.

In addition, the drug is approved for multiple indications say advanced skin cancer; lung cancer; small cell lung cancer; head and neck cancer; classical Hodgkin lymphoma in adults and children; primary mediastinal large B-cell lymphoma; cancer of the kidney, bladder, and urinary tract; liver; cancer of the cervix or uterus; advanced stomach cancer; hepatocellular carcinoma and renal cell carcinoma, to name a few.

MRK closed Wednesday’s trading at $85.03, up 0.56%.

7. NuCana Braces for a Busy Year ahead

NuCana plc (NCNA) has a couple of events lined up for the remainder of this year.

The company expects to present additional interim clinical data from the ongoing phase Ib study of NUC-3373 in combination with other agents typically combined with 5-FU in patients with advanced colorectal cancer, and the first-ever clinical data from the ongoing phase I study of NUC-7738 in patients with advanced solid tumors at the ESMO Virtual Congress 2020 to be held September 19-21, 2020.

A phase III trial of Acelarin combined with cisplatin as a first-line treatment for patients with advanced biliary tract cancer is ongoing, with enrollment expected to continue this year.

NCNA closed Wednesday’s trading at $5.42, up 0.37%.

8. Turning Point’s TRIDENT-1 Data Turns Heads

Turning Point Therapeutics Inc.’s (TPTX) early interim data from the registrational phase II portion of its phase I/II study evaluating Repotrectinib for the treatment of patients with ROS1+ advanced NSCLC and patients with ROS1+, NTRK+ or ALK+ advanced solid tumors, dubbed TRIDENT-1, has been found to be promising.

As per the interim phase II data, the confirmed response for an Objective Response Rate was 86 percent in the ROS1-positive TKI-naïve non-small cell lung cancer population, 40% in the ROS1-positive NSCLC population pretreated with one prior TKI with prior chemotherapy, 67 percent in ROS1-positive NSCLC population pretreated with one prior TKI without prior chemotherapy, and 50% in the NTRK-positive TKI-pretreated solid tumor population.

The company noted that it is modifying the TRIDENT-1 study sample sizes and adding new interim analyses that may support approval into two of its ROS1-positive TKI-pretreated patient cohorts. An update on the overall study timelines is expected to be provided in early 2021.

TPTX closed Wednesday’s trading at $67.10, up 5.29%.

9. Stocks That Moved On No News

9 Meters Biopharma Inc. (NMTR) closed Wednesday’s trading at $0.84, up 29.85%.

Ontrak Inc. (OTRK) closed Wednesday’s trading at $65.33, up 22%.

Lantern Pharma Inc. (LTRN) closed Wednesday’s trading at $14.37, up 21.68%.

CureVac N.V. (CVAC) closed Wednesday’s trading at $56.90, down 13.39%.

Solid Biosciences Inc. (SLDB) closed Wednesday’s trading at $2.65, down 13.11%.

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