AMPE Suspends Recruitment In Study On Virus Risks, IMAC Rockets, SCPH On Watch
Today’s Daily Dose brings you news about CytomX Therapeutics’ collaboration with Astellas Pharma to develop cancer therapies, IMAC Holdings’ launch of telehealth option in the wake of the COVID-19 pandemic, Ampio suspending patient enrollment in its phase III knee osteoarthritis trial as a result of the challenges faced due to the coronavirus outbreak, and scPharmaceuticals’ upcoming catalyst.
Ampio Pharmaceuticals Inc. (AMPE) has suspended patient enrollment in its phase III clinical trial of Ampion for the treatment of severe osteoarthritis of the knee.
The trial, dubbed AP-013, was designed to enroll 1,034 patients between 40 and 85 years of age with severe osteoarthritis of the knee. The average and maximum age of a patient in the AP-013 clinical trial is 65 and 87 years old, respectively.
With the COVID-19 pandemic sweeping the world, the Centers for Disease Control and Prevention has indicated that older adults, 65 years and older, are at higher risk for severe illness. The number of injected patients is 1,019, sufficiently close to the sample size of 1,034.
The Contract Research Organization (“CRO”) running the AP-013 clinical trial for the Company has notified the Company that due to the COVID-19 virus, all travel has been suspended for clinical study monitors, severely limiting the ability to monitor the conduct of the AP-013 clinical trial.
While other options to enable the completion of the trial are being explored, the Company has warned that the COVID-19 pandemic may prevent completion of the AP-013 trial at this time or at all.
AMPE closed Tuesday’s trading at $0.37, down 15.55%.
CytomX Therapeutics Inc. (CTMX) and Astellas Pharma Inc. have entered into a strategic collaboration agreement to develop cancer therapies, utilizing CytomX’s Probody therapeutic technology platform, as well as its proprietary bispecific formats and CD3 modules.
Astellas will make an upfront cash payment of $80 million to CytomX with CytomX eligible to receive future preclinical, clinical and commercial milestones of over $1.6 billion. CytomX is also eligible to receive tiered royalties on global net sales that range from high-single digits to mid-teens.
CytomX’s pipeline and near-term catalysts:
— A phase II study evaluating anti-PD-L1 Probody CX-072, in combination with the anti-CTLA-4 antibody Yervoy (ipilimumab), in patients with relapsed or refractory melanoma is underway, with initial data anticipated in 2020.
— A phase II expansion study of CX-2009 monotherapy in patients with hormone receptor (ER, PR) positive, HER2-negative breast cancer is ongoing, with initial data anticipated in 2021.
— A phase I/II trial of the anti-CTLA-4 Probody BMS-986249, a Probody version of the anti-CTLA-4 antibody Yervoy, in combination with Opdivo in patients with metastatic melanoma is underway.
— A phase I/II study, partnered with AbbVie, evaluating CX-2029 as monotherapy in patients with solid tumors is ongoing, with initial data from Phase 1 dose-escalation arm anticipated in 2020 with proof-of-concept data from the first cohort expansion studies in specific tumor types anticipated in 2021.
— In September 2019, Bristol-Myers Squibb initiated the dose-escalation phase of phase I/IIa clinical study of a second anti-CTLA-4 Probody, BMS-986288, based on a modified version of Yervoy, administered as monotherapy and in combination with Opdivo in patients with selected advanced solid tumors.
— In December 2019, CytomX obtained exclusive worldwide development and commercial rights to ImmunoGen’s preclinical epithelial cell adhesion molecule (EpCAM)-targeting program that was developed utilizing CytomX’s Probody technology and ImmunoGen’s drug conjugate technology.
CTMX closed Tuesday’s trading at $6.53, up 32.45%.
Iovance Biotherapeutics Inc. (IOVA) surged nearly 35 percent on Tuesday to close at $32.14 on no specific news.
Iovance is a late-stage biotechnology company developing novel T cell-based cancer immunotherapies (tumor-infiltrating lymphocyte, TIL and peripheral-blood lymphocyte, PBL). The lead assets are Lifileucel in metastatic melanoma, under a pivotal phase II study and LN-145 in recurrent, metastatic, or persistent cervical cancer, also under a pivotal phase II study.
The topline data from the melanoma trial and cervical cancer trial are anticipated this year.
A phase I/II study of IOV-2001 in the blood cancer indication, relapsed or refractory CLL or small lymphocytic lymphoma (SLL), is underway.
Last month, there were reports that the Company is exploring a possible sale.
IOVA closed Tuesday’s trading at $32.14, up 34.99%.
IMAC Holdings Inc. (IMAC) jumped a whopping 1,000% on Tuesday, following the implementation of a new telehealth option that will allow active care patients for non-contact visits with IMAC medical professionals via a simple platform.
IMAC is a provider of regenerative rehabilitation orthopedic treatments without the use of surgery or opioids.
To avail IMAC’s telehealth option, patients will need to provide an email address and they will receive an invitation directly from their provider, which can be accessed on any Internet-connected device. The newly launched telemedicine platform is compatible with all currently used platforms, including iPhone, Android, Mac, Windows and iPadOS.
Matt Wallis, chief operating officer of IMAC, said, “We are now utilizing this telemedicine platform because we take the COVID-19 pandemic very seriously, but also recognize the serious nature of movement disorder conditions that worsen with lapses of care.”
IMAC closed Tuesday’s trading at $4.95, up 1,000.49%.
scPharmaceuticals Inc. (SCPH) is all set to resubmit FUROSCIX New Drug Application under the current 505(b)(2) approval pathway with the FDA by mid-year 2020.
FUROSCIX, a subcutaneous formulation of Furosemide, the most widely used oral and parenteral diuretic in the treatment of edema associated with congestive heart failure, is the Company’s lead program.
In June 2018, the FDA had turned down FUROSCIX NDA, indicating the need for additional human factors studies, device modifications, and potentially a clinical validation study. The Company noted that the work to resubmit the FUROSCIX NDA is nearing completion.
According to the Company, FUROSCIX has a market potential of $8 billion in the U.S.
SCPH closed Monday’s trading at $7.88, up 35.63%.
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