To Fight Coronavirus Outbreak, Doctors Deploy Drugs Targeting HIV, Malaria and Ebola

Despite flimsy evidence, trying these drugs in humans is the only way to know if they will work against COVID-19

As the scientific community scrambles to find a drug that can effectively treat tens of thousands of patients sickened by a new respiratory virus, they are trying some surprising remedies: medicines targeting known killers like HIV, Ebola, and malaria.
American drug makers have shipped two antiviral medications to China as doctors and public health officials there seek an effective treatment for patients sickened by the novel coronavirus, which has recently been named COVID19. The virus has afflicted tens of thousands of people worldwide and killed more than 1,300. Most of the cases and deaths occurred in Hubei province, China, where the outbreak began.
Among potential remedies is an HIV medication that may work to block an enzyme needed by the virus to mature. An unapproved medicine used to fight the Ebola virus is being tested in Chinese patients to see whether it can disrupt the new virus’s genetic material.
A third drug, widely used around the globe to fight the parasite that causes malaria, is also being tried in China to see if it can slow infection by preventing the virus from infiltrating cells.

 

Pathways to New Therapeutic Agents for Human Coronaviruses

No specific treatment is currently available for human coronaviruses to date, but numerous antiviral agents are being identified through a variety of approaches
Using the six previously discovered human coronaviruses – human CoV 229E (HCoV-229E), OC43 (HCoV-OC43), NL63 (HCoV-NL63), HKU1 (HCoV-HKU1); severe acute respiratory syndrome (SARS) CoV; and Middle East respiratory syndrome (MERS) CoV – the investigators examined progress in the use and development of therapeutic drugs, focusing on the potential roles of virus inhibitors.

⦁ Examining Extant Drugs

The first approach to identifying possible antiviral agents reevaluates known, broadly acting antiviral drugs that have been used for other viral infections or other indications. The initial research into coronavirus therapeutics, in particular, has examined current antiviral therapeutics for their effectiveness against both SARS-CoV and MERS-CoV, but with mixed results.

⦁ Developing New Antivirals

The second approach for anti-CoV drug discovery involves the development of new therapeutics based on the genomic and biophysical understanding of the individual CoV in order to interfere with the virus itself or to disrupt its direct metabolic requirements. This can take several approaches.

 

‘Incredible’ Results With Kidney Cancer Agent With Nobel Prize Ties

SAN FRANCISCO — For the first time, a clear cell renal cell carcinoma therapy targets a molecular driver of cancer that was previously believed to be “undruggable,” said investigator Toni Choueiri, MD, Dana-Farber Cancer Institute, Boston, Massachusetts, here at the Genitourinary Cancers Symposium (GUCS) 2020.

That driver, hypoxia-inducible factor (HIF) 2α, promotes new blood vessel growth that fuels kidney tumors and is the target of the experimental therapy, a once-a-day pill known as MK-6482 (Merck).

The first-in-class drug, an oral HIF-2α inhibitor, appears to be succeeding in hitting its mark at a high rate in this setting. MK-6482 had an overall response rate of 24% among 55 patients with heavily pretreated advanced clear cell disease, with all responses being partial, reported Choueiri. Median follow-up was 13 months.

The patients in this phase I/II study had a median of three prior lines of therapies (range 1-9), including vascular endothelial growth factor (VEGF) inhibitors and immune checkpoint inhibitors.

Monty Pal, MD, a renal cell carcinoma specialist, City of Hope Comprehensive Cancer Center, Duarte, California, placed the results in the context of both current practice and drug development.

“The response rate is incredible,” he told, given the previous lines of therapy.

 

Pemfexy Approval for Advanced/Metastatic Nonsquamous NSCLC Could Offer Price Alternative

Recently, the Food and Drug Administration (FDA) gave final approval to the novel product Pemfexy (pemetrexed for injection) for the treatment of patients with advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC).

Pemfexy is a branded alternative chemotherapy injection to Alimta (pemetrexed) and is meant for the treatment of locally advanced or metastatic nonsquamous NSCLC in combination with cisplatin chemotherapy as either a combination therapy, maintenance therapy after four cycles of progression-free chemotherapy, or after prior chemotherapy as a single agent. The ready to dilute formulation is meant to help oncology pharmacists make a patient’s chemotherapy the same way Alimta is, however, it is also meant to help reduce the cost of the treatment.

 

Padcev(Enfortumab vedotin) Combination Shows Promise in Patients with Metastatic Bladder Cancer

The combination use of Padcev (enfortumab vedotin) plus Keytruda (pembrolizumab) induced a high rate of durable objective response rates (ORR) in patients with locally advanced or metastatic urothelial cancer who were ineligible for cisplatin-based chemotherapy, according to updated results from the phase 1b/2 EV-103 trial presented during the 2020 Genitourinary Cancers Symposium.

“While platinum chemotherapy is the standard treatment for patients with metastatic urothelial carcinoma, some patients are not eligible for treatment with cisplatin,” according to a press release, issued by the American Society of Clinical Oncology (ASCO).

“Gemcitabine/carboplatin is poorly tolerated, and survival and durability of response are limited.”

Padcev, an antibody-drug conjugate, works by disrupting the formation and function of microtubules, to certain cells that are highly expressed in urothelial carcinoma.

 

A new approach for the manufacture of Advanced Therapy Medicinal Products

Akron Biotechnology, a leading supplier of ancillary materials to the regenerative medicine industry, today announces the publication of a white paper proposing a new pragmatic, unified and staged approach for the qualification of ancillary materials for the manufacture of Advanced Therapy Medicinal Products (ATMPs).
The proposed approach aims to meet the needs of both regulators and ATMP developers. The three-staged model creates a progressive method to enhance the compliance and quality of ancillary materials used for manufacturing.
It will also contribute to the management of high cost of goods in ancillary material manufacturing, where the major contributor to these costs stem from quality assurance and manufacturing requirements.