On April 19, 2021 Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) reported they will supply an additional 100 million doses of COMIRNATY, the companies’ COVID-19 vaccine, to the 27 European Union (EU) member states in 2021 (Press release, BioNTech, APR 19, 2021, View Source [SID1234578230]). This announcement is a result of the European Commission’s (EC) decision to exercise its option to purchase an additional 100 million doses under its expanded Advanced Purchase Agreement signed on February 17, 2021. This brings the total number of doses to be delivered to the EU to 600 million.

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"We remain committed to moving as quickly and safely as possible to bring this vaccine to more people in Europe, as the deadly virus continues to wreak havoc across the continent," said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. "To date, we have met all of our supply commitments to the EC and we plan to deliver 250 million doses to the European Union in Q2, a fourfold increase on Q1’s agreed quantity."

"The additional 100 million doses from this option exercise will further help to support the acceleration of the vaccination campaigns throughout the EU. We now intend to deliver a total of 600 million doses to the EU this year, which covers two thirds of the EU population and represents the largest cumulative supply agreement for COMIRNATY that we have agreed to date globally," said Sean Marett, Chief Business and Chief Commercial Officer of BioNTech.

COMIRNATY will be produced in BioNTech’s and Pfizer’s manufacturing sites in Europe.

AUTHORIZED USE IN THE EU:
COMIRNATY ▼ (the Pfizer-BioNTech COVID-19 vaccine) has been granted conditional marketing authorisation by the European Medicines Agency to prevent coronavirus disease 2019 (COVID-19) in people from 16 years of age. The European Medicines Agency’s (EMA’s) human medicines committee (CHMP) has completed its rigorous evaluation of COMIRNATY, concluding by consensus that sufficiently robust data on the quality, safety and efficacy of the vaccine are now available.

IMPORTANT SAFETY INFORMATION:

Events of anaphylaxis have been reported. Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of the vaccine.
The efficacy, safety and immunogenicity of the vaccine has not been assessed in immunocompromised individuals, including those receiving immunosuppressant therapy. The efficacy of COMIRNATY may be lower in immunosuppressed individuals.
As with any vaccine, vaccination with COMIRNATY may not protect all vaccine recipients. Individuals may not be fully protected until 7 days after their second dose of vaccine.
In clinical studies, adverse reactions in participants 16 years of age and older were injection site pain (> 80%), fatigue (> 60%), headache (> 50%), myalgia and chills (> 30%), arthralgia (> 20%), pyrexia and injection site swelling (> 10%) and were usually mild or moderate in intensity and resolved within a few days after vaccination. A slightly lower frequency of reactogenicity events was associated with greater age.
There is limited experience with use of COMIRNATY in pregnant women. Administration of COMIRNATY in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and fetus.
It is unknown whether COMIRNATY is excreted in human milk.
Interactions with other medicinal products or concomitant administration of COMIRNATY with other vaccines has not been studied.
For complete information on the safety of COMIRNATY always make reference to the approved Summary of Product Characteristics and Package Leaflet available in all the languages of the European Union on the EMA website.
The black equilateral triangle denotes that additional monitoring is required to capture any adverse reactions. This will allow quick identification of new safety information. Individuals can help by reporting any side effects they may get. Side effects can be reported to EudraVigilance or directly to BioNTech using email [email protected], telephone +49 6131 9084 0, or via the website www.biontech.de.

On April 19, 2021 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation for CA-4948, a first-in-class, small molecule inhibitor of IRAK4 and Curis’s most advanced therapeutic in clinical development. CA-4948 targets IRAK4-L, the oncogenic isoform of IRAK4 preferentially expressed by the majority of patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) and has shown broad clinical activity in Phase 1 trials in patients with relapsed or refractory (R/R) AML/MDS (Press release, Curis, APR 19, 2021, View Source [SID1234578178]).

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"We are pleased to take this important next step in unlocking the potential of CA-4948 to offer a safe and transformative, disease-modifying alternative treatment for patients on the AML/MDS spectrum," said James Dentzer, chief executive officer of Curis. "Receiving Orphan Drug designation for CA-4948 in AML and MDS represents a significant milestone in our mission of slowing or preventing the progression of disease in patients with these rare hematological malignancies."

Orphan Drug Designation is granted by the FDA to drugs intended to treat rare disorders that affect fewer than 200,000 people in the U.S. The designation can provide development and commercial incentives, including eligibility for seven years of market exclusivity in the U.S. after product approval, FDA assistance in clinical trial design and exemption from FDA user fees.

On April 19, 2021 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of agents which includes checkpoint antibodies, cell therapies, adjuvants, and vaccines designed to activate immune response to cancers and infections, reported the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) (Press release, Agenus, APR 19, 2021, View Source [SID1234578194]). The BLA has been submitted for the accelerated approval of balstilimab, Agenus’ anti-PD-1 antibody, for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy, and includes data from its pivotal Phase 2 single-arm clinical trial, presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020. These clinical data, along with preclinical data, suggest that balstilimab demonstrates differentiated features from other anti-PD-1 antibodies.

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"Women with recurrent or metastatic cervical cancer have a very poor prognosis and limited treatment options. Data suggest balstilimab may bring benefit to patients beyond what is available in this disease setting today," said Jennifer Buell, PhD, President and Chief Operating Officer at Agenus. "This submission also marks a significant step in our transition to a commercial company and the advancement of our oncology combination strategy."

The balstilimab BLA submission is based on an update to data presented at the ESMO (Free ESMO Whitepaper) Virtual Congress 2020 and published in an Oncogene editorial, which demonstrate that balstilimab shows potential differentiation from other anti-PD-1 antibodies. This updated dataset includes maturation of late patient responses, with the overall data showing response rates of 20% in PD-L1 positive tumors, 15% in all tumors (PD-L1 positive and negative), and a median duration of response of 15.4 months.

"We expect that the potential approval of balstilimab will enable us to better pursue our oncology combination strategy for our own extensive pipeline of agents as well as for existing and future partner products," said Steven O’Day, MD, Chief Medical Officer at Agenus. "In particular, we hope to use this potential approval to allow us to rapidly proceed with our anti-CTLA-4 combination strategy, which we believe can add significantly to the benefit provided by our anti-PD-1 agent. There are currently limited treatment options available for recurrent or metastatic cervical cancer patients, and our vision is to bring effective treatments to these patients."

In April 2020, the FDA granted Fast Track designation for balstilimab in recurrent or metastatic cervical cancer based on its potential to provide benefit to patients with a serious condition and unmet medical need.

A global, randomized, Phase 3 confirmatory clinical trial designed to support global registration is planned.

About Cervical Cancer
Nearly 14,000 women are expected to be diagnosed with invasive cervical cancer in the United States this year and more than 4,000 are expected to die. Cervical cancer remains one of the leading causes of cancer death in women globally, annually killing more than 300,000 women worldwide.1 Despite advances in routine medical examinations and HPV vaccines, cervical cancer remains prevalent. When left undetected, recurrent or metastatic cervical cancer often develops, for which there are limited treatment options and a low chance of survival. Current therapies for recurrent or metastatic cervical cancer are limited to a small subset of patients with limited benefit.

About balstilimab
Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. PD-1 is a negative regulator of immune activation that is considered a foundational target within the immuno-oncology market. Balstilimab is currently in clinical trials as monotherapy and in combination with Agenus’ anti-CTLA-4, zalifrelimab, in an ongoing Phase 2 study for recurrent/metastatic cervical cancer.

On April 19, 2021 Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, reported a business update and financial highlights for Q1 2021 for Nicox SA and its subsidiaries (the "Nicox Group"), and updated key expected value-inflection milestones (Press release, NicOx, APR 19, 2021, View Source [SID1234578179]).

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Key Expected Milestones
NCX 470 Phase 3 program in glaucoma: Nicox’s lead clinical product candidate, NCX 470, is a novel nitric oxide (NO)-donating prostaglandin analog currently in two multi-regional Phase 3 trials for the evaluation of the safety and efficacy of NCX 470 ophthalmic solution, 0.1%, against latanoprost ophthalmic solution, 0.005%, for lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Top-line results are currently expected in Q2 2022 for Mont Blanc and in Q4 2022 for Denali.
NCX 4251 Phase 2b trial, Mississippi in blepharitis: NCX 4251 is a novel patented ophthalmic suspension of fluticasone propionate nanocrystals. Mississippi is evaluating once-daily dosed NCX 4251 0.1% versus placebo for the treatment of acute exacerbations of blepharitis. Top-line results are currently expected in Q4 2021.
We expect to enter into additional agreements for ZERVIATE (cetirizine ophthalmic solution), 0.24%, further expanding the licensed territories and increasing potential future revenue.
Bausch + Lomb is planning to launch VYZULTA (latanoprostene bunod ophthalmic solution), 0.024%, in Taiwan in 2021 and in South Korea in 2022.
First Quarter 2021 and Recent Operational Highlights
Innovative pipeline

50% of patients in the NCX 470 Mont Blanc Phase 3 glaucoma clinical trial have now been randomized with top-line results currently on track to be announced during Q2 2022.
Ocumension Therapeutics, Nicox’s partner for NCX 470 in China and Southeast Asia, received approval from China’s Center for Drug Evaluation of the National Medical Products Administration to conduct the Chinese part of the ongoing NCX 470 Denali Phase 3 trial for the lowering of IOP in patients with open angle glaucoma or ocular hypertension. Ocumension is also currently evaluating ZERVIATE in a confirmatory Phase 3 clinical trial in China, which was initiated in December 2020 to support a New Drug Application there for the treatment of ocular itching associated with allergic conjunctivitis.
Pre-clinical IOP-lowering results on a new class of non-prostaglandin analog, NO-donating compounds, were published in the Journal of Ocular Pharmacology and Therapeutics, a leading scientific journal. Elevated IOP is one of the principal risk factors of open-angle glaucoma. The NO-mediated IOP-lowering effect in this new class of compounds is enhanced by concomitant action of phosphodiesterase type-5 inhibition within the same molecule. NCX 1728 is the first in this new class of compounds to be selected for development.
Commercial products

VYZULTA has been approved in Brazil, the largest market in Latin America. VYZULTA is commercialized by Nicox’s exclusive worldwide partner Bausch + Lomb in the U.S. (2017), Canada (2019), Argentina (2020), Mexico (2020) and Hong Kong (2020), and is now approved in 5 other territories – Brazil, Colombia, South Korea, Taiwan and Ukraine.
The number of prescriptions1 for VYZULTA in the U.S. increased by 10.6% in the first quarter of 2021 compared to the first quarter of 2020.
ZERVIATES. prescriptions2 increased by 29.1% in the first quarter of 2021 over the fourth quarter of 2020. ZERVIATE has been commercialized in the U.S. since March 2020 by Nicox’s U.S. partner Eyevance Pharmaceuticals. Eyevance has entered into a partnership with Hikma Pharmaceuticals for the co-promotion of ZERVIATE in the U.S. who will be responsible for promoting ZERVIATE to U.S. healthcare professionals working outside the eyecare specialty, with all sales continuing to be booked by Eyevance, and on which Nicox will receive royalties.
Corporate

Nicox amended its bond financing agreement with Kreos Capital, introducing an additional one-year period of interest-only payments on the outstanding principal starting on February 1, 2021, and an extension of the overall period of the loan by 6 months to July 2024. The new one-year interest-only period is expected to provide approximately €5.5 million of additional flexibility for investment in development activities in 2021. The interest rate of the bonds remains unchanged as a result of this amendment.
We continue to closely watch the spread and impact of the COVID-19 pandemic and we will provide an update of any delays.

First Quarter 2021 Financial Highlights
As of March 31, 2021, the Nicox Group had cash and cash equivalents of €42.0 million as compared with €47.8 million at December 31, 2020. Net revenue3 for the first quarter of 2021 was €0.6 million (entirely composed of net royalty payments). Net revenue3 for the first quarter of 2020 was €1.7 million (including €0.7 million of net royalty payments).

As of March 31, 2021, the Nicox Group had financial debt of €17.8 million consisting of €15.8 million in the form of a bond financing agreement with Kreos Capital signed in January 2019 and a €2 million credit agreement with Société Générale and LCL, guaranteed by the French State, and granted in August 2020 in the context of the COVID-19 pandemic.

On April 19, 2021 Stand Up To Cancer (SU2C) and Mirati Therapeutics Inc. (NASDAQ: MRTX) – a late-stage targeted oncology company – reported that Mirati will contribute a $4 million grant to SU2C to develop new approaches to treat patients with KRAS mutant cancers, as a part of the SU2C Catalyst program (Press release, Stand Up To Cancer, APR 19, 2021, View Source;to-Support-Research-on-KRAS-Mutant-Cancers/default.aspx [SID1234578195]).

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The research will focus on cancer types with unmet medical needs, and the application of tumor-agnostic strategies and molecular testing to address those needs. Certain cancers can sometimes have mutations in the KRAS gene, which makes a protein involved in cellular growth and death. In KRAS mutant cancers, that protein can cause cancers to grow and spread. KRAS proteins were once considered undruggable, but recent research advances have resulted in the identification and development of investigational drugs against cancers that have specific KRAS mutations. Preliminary data from these investigational drugs have demonstrated early signs of clinical activity and studies are ongoing.

The grant from Mirati will leverage the SU2C Catalyst innovative research process, which uses funding and materials from the pharmaceutical, biotechnology, diagnostic and medical devices industries to accelerate research on cancer prevention, detection and treatment. The research will explore new treatment strategies with a KRASG12C inhibitor currently being developed by Mirati.

"The SU2C Catalyst program encourages a collaborative yet nimble and transparent process that accelerates the pace of research and identifies new or unexpected uses for cancer drugs and technologies," said Nobel laureate Phillip A. Sharp, PhD, chair of Stand Up To Cancer’s Scientific Advisory Committee and an institute professor at the David H. Koch Institute for Integrative Cancer Research at Massachusetts Institute of Technology. "Combined with our rigorous review and milestone-driven process, the program provides a unique framework with the objective to get treatments to patients as quickly and safely as possible."

SU2C’s Catalyst program began in 2016, with contributions from industry supporters Merck, Bristol Myers Squibb and Genentech, a member of the Roche Group. Through the program, companies donate funds to collaborative research studies, in which use of the companies’ products and materials is strongly encouraged. Those materials might include new pharmaceutical compounds that companies are developing or approved agents that can be investigated for other uses. A primary goal of SU2C Catalyst is to encourage collaborative research between academics and companies and shorten the time it takes to get new treatments to patients.

"We are excited to collaborate with Mirati Therapeutics and are thankful for their contribution to the SU2C Catalyst program," said Sung Poblete, PhD, RN, CEO of Stand Up To Cancer. "The opportunity to test the utility of KRAS inhibitors in several different cancer types is a great example of SU2C’s cancer-agnostic approach to research."

"We are proud to support the SU2C Catalyst program and the innovative research it makes possible," said Joseph Leveque, M.D., executive vice president and chief medical officer, Mirati Therapeutics, Inc. "So much progress has been made in understanding and treating cancers through collaborative research. Industry and academic scientists, working together, offer the best chance to move ideas forward that can make a real difference for patients."

As a part of the collaboration with Mirati, SU2C will convene a day-long innovation summit to bring together experts in KRAS signaling, clinical trial design, tumor agnostic approaches to cancer therapy development and other disciplines. The summit will be headed by members of SU2C’s scientific leadership team as well as Mirati representatives. These experts will consider the most pressing research needs in the field and define a grants process that provides a pathway for applicants, and the eventual grantees, to address those issues. Attention will be given to the current state of KRAS genetic testing in different cancer types and approaches that may be considered to appropriately expand testing both across tumor types and among traditionally underserved and minority populations.