Fennec Pharma completes NDA submission for Pedmark

Fennec Pharmaceuticals (NASDAQ:FENC) has completed its rolling submission of a New Drug Application (NDA) to the FDA for PEDMARK (a unique formulation of sodium thiosulfate) for intravenous use.

The company has also submitted a marketing application to the European Medicines Agency for sodium thiosulfate (tradename to be determined).

The PEDMARK indication is for the prevention of ototoxicity induced by cisplatin chemotherapy in patients one month to < 18 years of age with localized, non-metastatic, solid tumors.

The FDA has a 60-day review period to determine if NDA is acceptable for filing. If granted a priority review, the PDUFA action date is expected in Q3.

https://seekingalpha.com/news/3540386-fennec-pharma-completes-nda-submission-for-pedmark

Seattle Genetics combo shows positive effect in advanced bladder cancer

Seattle Genetics (NASDAQ:SGEN) and collaboration partner Astellas Pharma (OTCPK:ALPMF) announce updated results from an open-label Phase 1b/2 clinical trial evaluating the combination of antibody-drug conjugate (ADC) PADCEV (enfortumab vedotin-ejfv) and Merck’s Keytruda (pembrolizumab) in previously untreated patients with locally advanced or metastatic urothelial cancer who are ineligible for treatment with cisplatin-based chemo. The data will be presented at the ASCO GU Cancers Symposium in San Francisco.

The objective response rate (ORR) was 73.3% (n=33/45) after a median follow-up period of 11.5 months. The complete response rate was 15.6% (n=7/45). Median progression-free survival (PFS) was 12.3 months. Median overall survival (OS) has not been reached.

On the safety front, 57.8% (n=26/45) of participants experienced a serious or life-threatening treatment-related adverse event. The most common were lipase increase (17.7%), rash (13.3%), hyperglycemia (13.3%) and peripheral neuropathy (4.4%). 17.7% (n=8/45) experienced treatment-related immune-mediated adverse events grade serious or higher that required the use of systemic steroids. There were six discontinuations. There was one treatment-related death due to multiple organ dysfunction syndrome.

The FDA approved PADCEV in December 2019 for locally advanced/metastatic urothelial cancer.

https://seekingalpha.com/news/3540411-seattle-genetics-adc-combo-shows-positive-effect-in-advanced-bladder-cancer

Exelixis’ cabozantinib combo shows encouraging action in prostate cancer

Exelixis (NASDAQ:EXEL) announces positive results from an open-label Phase 1b clinical trial, COSMIC-021, evaluating the combination of Cabometyx (cabozantinib) and Roche’s Tecentriq (atezolizumab) in patients with solid tumors.

Data from the metastatic castration-resistant prostate cancer cohort showed an objective response rate (ORR), the primary endpoint, of 32%, including two complete responders. The disease control rate (responders + stable cancer) was 80%. Median duration of response was 8.3 months, Median follow-up was 12.6 months.

On the safety front, the most common serious/life-threatening treatment-related adverse events were fatigue (7%), diarrhea (7%) and hyponatremia (low sodium levels in the blood) (7%). There was one treatment-related death due to dehydration (90-year-old patient).

Collaboration partner Ipsen (OTCPK:IPSEY) is participating in the study and is contributing funding. Roche is providing product.

The results will be presented on Thursday at the ASCO GU Cancers Symposium in San Francisco

https://seekingalpha.com/news/3540434-exelixis-cabozantinib-combo-shows-encouraging-action-in-prostate-cancer

Karyopharm teams up with Promedico to commercialize Xpovio

Karyopharm Therapeutics (NASDAQ:KPTI) and Promedico, a member of the Neopharm Group, have entered into an exclusive distribution agreement for the commercialization of XPOVIO (selinexor), Karyopharm’s lead SINE compound, in Israel and the Palestinian Authority.

Under the terms of the agreement, Karyopharm will receive certain prespecified payments and is eligible to receive additional payments if regulatory and commercial milestones are achieved by Promedico.

KPTI is also eligible to receive double-digit royalties on future net sales of XPOVIO in the covered territory. In exchange, Promedico will receive exclusive rights to commercialize XPOVIO in the covered territory and is responsible for all regulatory filings and obligations required for registering XPOVIO.

Karyopharm has retained exclusive production rights and will supply finished product for commercial use in the territory.

https://seekingalpha.com/news/3540469-karyopharm-teams-up-promedico-to-commercialize-xpovio

Interpace Bio up 6% on improved reimbursement for ThyraMIR

Thinly traded nano cap Interpace Biosciences (NASDAQ:IDXG) perks up 6% premarket on light volume in reaction to its announcement that Medicare has upped its reimbursement for ThyraMIR miRNA classifier from ~$1,800 to $3,000.

Medicare beneficiaries account for ~30% of ThyraMIR test volume

https://seekingalpha.com/news/3540467-interpace-bio-up-6-on-improved-reimbursement-for-thyramir

Advaxis teams up with Personalis for ADXS-503 program

Advaxis (NASDAQ:ADXS) and Personalis (NASDAQ:PSNL) have collaborated to leverage Personalis’ ImmunoID NeXT Platform in Advaxis’ ongoing Phase 1/2 ADXS-503 (HOT Lung) program evaluating ADXS-503 alone and in combination with pembrolizumab in patients with non-small cell lung cancer (NSCLC).

Under the terms of the expanded agreement, Personalis will conduct comprehensive tumor immunogenomic profiling to enable the identification of predictive composite biomarkers and/or signatures of response, as well as the broad evaluation of potential mechanisms of therapy resistance.

The platform is an end-to-end solution for immuno- and precision oncology biomarker discovery and CDx development.

This new agreement builds upon the prior two-year collaboration for the genomic analysis of clinical tumor samples to manufacture the Company’s ADXS-NEO drug construct neoantigen-directed immunotherapy to treat a variety of late stage cancers.

ADXS and PSNL shares are up 13% and 8% premarket, respectively.

https://seekingalpha.com/news/3540482-advaxis-teams-up-personalis-for-adxsminus-503-program-shares-up-13-premarket

Moderna advancing CMV vaccine, adds coronavirus vaccine to pipeline

Moderna (NASDAQ:MRNA) announces that enrollment in its Phase 2 clinical trial evaluating its mRNA vaccine (mRNA-1647) against cytomegalovirus (CMV) is proceeding ahead of schedule with preliminary data now expected in Q3.

It has added three new pipeline programs: mRNA-1189 (Epstein-Barr vaccine), mRNA-1345 (RSV vaccine) and mRNA-1273 (coronavirus vaccine).

It also announces that the first patient has been enrolled in a Phase 1/2 study of mRNA-3704 in patients with a rare inborn error of metabolism called isolated methylmalonic acidemia due to MUT deficiency, an Orphan Drug-, Fast Track- and Rare Pediatric Disease-tagged indication in the U.S.

Shares down 6% premarket in reaction to its planned equity offering.

https://seekingalpha.com/news/3540483-moderna-advancing-cmv-vaccine-adds-coronavirus-vaccine-to-pipeline