Target $21
Friday, March 12, 2021
ContraFect Wins BARDA Contract, Provides Business Outlook
ContraFect Corporation (Nasdaq: CFRX), a clinical-stage biotechnology company focused on the discovery and development of direct lytic agents (DLAs) as new medical modalities for the treatment of life-threatening, antibiotic-resistant infections, today announced that it has been awarded a cost-share contract from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS). Under the terms of the contract, the Company will receive $9.8 million in initial funding and up to an additional $77.0 million. The initial funding will be used to support ContraFect’s ongoing pivotal Phase 3 DISRUPT (Direct Lysis of Staph aureus Resistant Pathogen Trial) superiority study of exebacase in patients with Staph aureus bacteremia, including right-sided endocarditis. Under the terms of the agreement, and if supported by Phase 3 DISRUPT study data, BARDA may provide the Company with additional funding upon achievement of key milestones to continue the advancement of exebacase through FDA product approval and completion of post-approval commitments.
“We are grateful for, and thrilled by, BARDA’s support to fund the advancement of exebacase toward the completion of our ongoing Phase 3 study and a potential product approval. This award represents a critical milestone and a transformational infusion of funds for ContraFect. Exebacase, which received Breakthrough Therapy Designation last year from the FDA, is the first direct lytic agent in Phase 3 trials and the lead program of our DLA platform, representing a completely new medical modality to address life-threatening infectious diseases. We believe that this award, and the expected acceleration of Phase 3 study enrollment, provides ContraFect with strong momentum as we move toward the interim futility analysis, currently anticipated in the second half of 2021,” said Roger J. Pomerantz, M.D., President, Chief Executive Officer, and Chairman of ContraFect.
“Antibiotic-resistant infections are rising at an alarming rate, and developing effective medical countermeasures against these infections has become one of the most pressing health security challenges of this century,” said BARDA Director Gary Disbrow, Ph.D. “ContraFect Corporation is the latest partner to work with BARDA on potential solutions to life-threatening infections and help save lives in future public health emergencies.”
Overview of Programs and Anticipated Milestones
Exebacase: a first-in-class recombinantly-produced lysin with the potential to become a new standard-of-care, compared to using antibiotics alone, for the treatment of Staph aureus bacteremia.
In 2020, the Company began enrolling patients in the Phase 3 DISRUPT study and exebacase was granted Breakthrough Therapy designation by the FDA for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) bloodstream infections, including right-sided endocarditis, when used in addition to standard-of-care anti-staphylococcal antibiotics in adult patients. The Phase 3 DISRUPT study is a randomized, double-blind, placebo-controlled clinical study conducted in the U.S. to assess the efficacy and safety of exebacase in approximately 350 patients with Staph aureus bacteremia, including right-sided endocarditis.
Despite the onset of the COVID-19 pandemic shortly after the initiation of the DISRUPT study, the Company has continued to enroll patients and has expanded the number of clinical trial sites to over 40 sites across the United States. The pandemic has caused delays in patient enrollment, as hospitals have struggled to support intensive care units and the critical care of patients with severe COVID-19 infections. Assuming that the recent initiation of nationwide COVID-19 vaccinations expands to encompass a significant portion of the population, the Company believes the hospital burden will lighten during the first half of 2021 and expects an acceleration of DISRUPT study enrollment. ContraFect expects to conduct an interim futility analysis to assess the superiority of exebacase versus SOC alone, based on approximately 60% of the study population, in the second half of 2021. Topline data for the full study population are expected in 2022.
CF-370: a first-in-class, engineered lysin with the potential to become the first direct lytic agent in clinical development for the treatment of Pseudomonas aeruginosa infections.
In 2020, the Company began IND-enabling activities to advance CF-370 towards clinical development and received a CARB-X (Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator) award for up to $18.9 million in non-dilutive capital to progress CF-370 through these activities.
The Company continues to progress the IND-enabling studies of CF-370 towards completion and expects to initiate Phase 1 studies of CF-370 in the first half of 2022.
Amurin peptides: a new class of direct lytic agents with the potential to become an entirely new modality for broad-spectrum coverage of Gram-negative pathogens.
Characterization of the Company’s lead amurin peptides is ongoing and the Company expects to select an amurin peptide as its next IND candidate by the end of 2021.
Conference Call and Webcast Information
ContraFect will host a live conference call and webcast at 8:30 a.m. ET on March 12, 2021. To access the live conference call, please dial (866) 691-5817 and refer to conference ID 4278833. A webcast of the call will also be available under “Events” in the Investors & Media section of the ContraFect website at www.contrafect.com. The archived webcast will be available on the Company’s website after the conference call.
https://finance.yahoo.com/news/contrafect-announces-barda-contract-award-210500328.html
Prometheus Biosciences Upsizes Pricing of IPO
Prometheus Biosciences, Inc. (Nasdaq: RXDX), a biotechnology company pioneering a precision medicine approach for the discovery, development, and commercialization of novel therapeutic and companion diagnostic products for the treatment of inflammatory bowel disease (IBD), today announced the pricing of its upsized initial public offering of 10,000,000 shares of common stock at a public offering price of $19.00 per share. All of the shares are being offered by Prometheus. The shares are expected to begin trading on the Nasdaq Global Select Market on March 12, 2021 under the ticker symbol "RXDX". The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Prometheus, are expected to be $190 million. The offering is expected to close on March 16, 2021, subject to satisfaction of customary closing conditions. In addition, Prometheus has granted the underwriters a 30-day option to purchase up to an additional 1,500,000 shares of common stock at the initial public offering price, less underwriting discounts and commissions.
SVB Leerink, Credit Suisse, Stifel and Guggenheim Securities are acting as joint bookrunning managers for the offering.
Africa proves rocky terrain for Russian and Chinese vaccines
Russia and China are racing to plug the COVID-19 vaccine gap in Africa, hoping to cement their influence on a continent where many countries have yet to administer a single shot.
But, so far, vaccine donations from Beijing and Moscow have been small, the commercial deals they offer are costly, and some African governments are wary about a lack of data.
As rich countries ramp up their inoculation drives, Africa, without the resources to pre-order Pfizer, AstraZeneca , Moderna and Johnson & Johnson vaccines, is being left behind.
With Western nations facing criticism for hoarding supplies, flooding Africa with life-saving shots would be a soft-power coup for Russia and China.
Moscow has offered 300 million doses with financing to an African Union (AU) purchasing scheme.
Beijing has pledged nearly a quarter of all its vaccine donations to Africa, according to data compiled by Bridge Consulting, a Beijing-based health sector advisory.
"This is a vivid manifestation of China-Africa friendship," China's foreign ministry told Reuters.
"Africa is one of the key markets for Sputnik V," said the Russian Direct Investment Fund (RDIF), the sovereign wealth fund marketing its Sputnik V vaccine abroad.
French President Emmanuel Macron says Europe and the United States risk losing influence in Africa over the issue.
However, John Nkengasong, head of the Africa Centres for Disease Control and Prevention, cautioned against "vaccine diplomacy", saying powers must not use token allocations to curry political influence.
"Africa will refuse to be that playing ground where we use COVID as a tool to manage relationships," he said on a webinar hosted by the Atlantic Council think tank in late February.
"It becomes like you're trying to sprinkle water on a very hot day on children ... Then you can tick the box that you did that," he said. "That's not what we are after as a continent."
While other developing regions have turned to Russia or China, in Africa their engagement has translated into few shots in arms.
Africa has received around 3.15 million shots from China - or less than 4% of its vaccine exports - Bridge Consulting data showed.
"The numbers of vaccines China is donating are not going to move the needle in any of these countries. But it's as much about the optics," said Eric Olander, co-founder of The China-Africa Project.
Russia has shipped a total of around 100,000 vaccine doses to Algeria, Tunisia and Guinea.
The global vaccine sharing scheme COVAX, meanwhile, delivered nearly 15 million shots to 22 African countries in its first 10 days.
The facility co-led by the World Health Organization, GAVI and others aims to ship 35 million doses to Africa by the end of the month and 720 million by the end of 2021.
That will still only be enough to inoculate those at greatest risk.
DATA DEFICIT
China's leading vaccines - from the China National Pharmaceutical Group (Sinopharm) and Sinovac - are not yet approved for emergency use by the WHO. Neither is Russia's Sputnik V vaccine.
China offered South Africa - the African nation hardest hit by the pandemic - 2 million shots, its health minister said.
But a government official involved in procurement told Reuters the lack of trial data meant Chinese vaccines were not being seriously considered for now. Sputnik V was also relegated to a second tier of vaccines South Africa says need more study, according to the health ministry.
Even some countries that accepted donations have shied away from purchases.
Uganda considered buying Chinese vaccines but is focused on COVAX due to their cost and the availability of data, said Ombeva Malande, director of the East Africa Centre for Vaccines and Immunization, which advised the government. Kenya is taking a similar line, he said.
Diana Atwine, permanent secretary in Uganda's health ministry, said authorities would consider affordable vaccines approved by the WHO.
The head of Kenya's vaccine task force confirmed it was not in talks to procure Chinese vaccines, and health ministry plans do not include Russian vaccines.
DOLLARS AND DOSES
While COVAX shots are free for most African nations, countries doing commercial deals are paying a premium.
Senegal paid $20 a shot for 200,000 doses of Sinopharm, a two-shot vaccine.
"The worst thing that could happen now is for countries to not start vaccinating," said Tandakha Ndiaye Dieye, a member of Senegal's vaccine advisory group, explaining the decision.
By comparison, India's Serum Institute is selling AstraZeneca shots it manufactures for $3. The Indian government has also donated over a half million of those shots to eight African countries, according to a Reuters tally.
Beijing has so far not announced financing packages that would make vaccine deals more affordable in Africa.
At around $10 per dose, Sputnik V is cheaper, and RDIF told Reuters it would be even more competitive if subsidised via COVAX.
RDIF said it was in "advanced negotiations" with the WHO to be included in COVAX and could offer a one-shot version to reduce the cost. A spokesperson for GAVI, the global vaccine alliance helping lead COVAX, said all vaccines would be considered but they first needed approval from the WHO or another stringent regulatory authority.
RDIF said some deliveries of the Sputnik V doses offered via the AU plan could start in May.
A senior AU diplomat told Reuters that talks were taking place but no agreement had been reached. No details have been announced about the finance package. RDIF did not respond to Reuters questions about the potential deal.
Both China and Russia must increase production if they hope to become major global vaccine suppliers. For Moscow, exporting shots is politically sensitive when its own population still needs vaccinating.
"I'm not worried about whether Russia's going to be able to deliver the doses," said W. Gyude Moore of the Center for Global Development, a Washington think tank.
"I'm worried about how African countries are going to pay for them ... COVAX is just not going to be enough."
Daiichi Sankyo begins producing AstraZeneca's COVID-19 vaccine in Japan
Daiichi Sankyo Co said on Friday it had begun the production of AstraZeneca Plc's COVID-19 vaccine in Japan.
The drugmaker said in a release it will prepare the vaccine in Japan, including vial filling and packaging, using the bulk solution provided by AstraZeneca.
The Japanese government has already arranged to buy 120 million doses of AstraZeneca's vaccine, enough for 60 million people. Most of the doses will be made in Japan by Daiichi Sankyo, JCR Pharma and other local partners.
NLS Pharma in Licensing Deal for Sanorex With Novartis
NLS Pharmaceutics Ltd. said it has entered into a license agreement with Novartis Pharma AG to obtain, on an exclusive basis in the U.S., all of the available data referred to and included in the original NDA for Sanorex mazindol submitted to the Food and Drug Administration in February 1972.
The clinical-stage pharmaceutical company said the agreement encompasses all preclinical and clinical studies, data used for manufacturing including stability and other chemistry manufacturing and controls data, formulation data and know-how for all products containing mazindol as an active substance, and all post-marketing clinical studies and periodic safety reports from 1973 forward.
NLS has obtained the same rights on an non-exclusive basis in all territories outside of the U.S, except for Japan, with the right to cross-reference the Sanorex NDA with non-U.S. regulatory agencies in the licensed territories. The agreement includes the right to sublicense or assign the license to third parties, subject to such third parties meeting certain obligations.
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