On June 3, 2021 Novartis reported that More than two years after splashing out $2.1 billion on Endocyte, is pulling the curtain on full phase 3 data for the radiopharmaceutical it picked up in that deal (Press release, Novartis, JUN 3, 2021, View Source [SID1234583610]).

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The treatment, given alongside standard of care, added four months to the lives of patients with metastatic castration-resistant prostate cancer, helping them live a median of 15.3 months and reducing the risk of death by 38%. The combination nearly doubled the time patients had before their disease got worse, staving off cancer progression for a median of 8.7 months, while standard of care alone kept cancer at bay for 3.4 months.

It could help patients whose "prognosis isn’t terrific" and who have run out of treatment options, said Michael Morris, M.D., the lead author of the study and head of the Prostate Cancer Section at Memorial Sloan Kettering Cancer Center.

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RELATED: Novartis’ radioligand hits goal in phase 3 prostate cancer trial

The phase 3 data, to be presented this weekend at the annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), come from 831 patients who received standard of care alone or along with the treatment, known by the unwieldy moniker of 177-Lu-PSMA-617.

The patients were "at the end of this disease’s course," Morris said. They had undergone chemotherapy and treatment with androgen receptor pathway inhibitors, a family of drugs that "works quite well." But after their cancer outsmarts those treatments and develops resistance, as many as 90% of these patients have no other options.

"Most of these patients will not have particularly good treatment options at all, save for a handful of those who might be receiving genetically defined therapies or radium," Morris said. "This is a space where a lot of people get supportive care … This drug will fill a real unmet medical need."

Side effects struck more patients taking 177Lu-PSMA-617 than those taking standard of care alone, with severe effects affecting about half of patients taking the radiopharmaceutical and just over two-thirds of those taking standard of care alone.

RELATED: Novartis bolsters radioligand stable with iTheranostics deal

That said, those effects were unsurprising, given the nature of the treatment and how sick the patients were, Morris said. The most common side effects affected nearly half of the patients and included fatigue and bone marrow suppression, which causes patients to produce fewer blood cells. About 40% of patients suffered dry mouth, but that’s typical for treatments that target the PSMA membrane protein because it is also found in the salivary glands, Morris said.

"We have experience in this drug from several other studies, both single-arm and comparison studies, that have been done previously … There was no new [safety] signal here," said Morris, who compared the treatment’s safety profile favorably to that of chemotherapy.

Radiotherapy is not new to cancer, but treatments like Novartis’ 177Lu-PSMA-617 deliver radiation more precisely than traditional radiotherapy, killing cancer cells while sparing healthy cells. Known as radioligand therapies, these medicines combine a small molecule or peptide that targets a protein found in cancer cells with a radioactive material that blocks tumor growth by damaging DNA. In the case of 177Lu-PSMA-617, the ligand zeroes in on PSMA in prostate cancer cells to deliver radiation from a radioactive isotope of lutetium.

"It allows us to actually deliver this high-dose radioactive lutetium directly to a cancer cell—very similar to DoorDash," said Jeff Legos, Ph.D., senior vice president, global head of oncology development at Novartis, during a press briefing.

RELATED: Novartis inks $2.1B Endocyte buyout, furthering radiotherapy push

As Novartis prepares a regulatory submission for the treatment, it has already set up its on-demand manufacturing process, which can deliver a treatment course two weeks after it’s ordered, said Susanne Schaffert, Ph.D., president of Novartis Oncology, during the briefing.

It’s not as simple as manufacturing small molecules or biologics, which can be stored on a shelf or in a refrigerator. Because the radiopharmaceutical decays so quickly, Novartis must account for the journey the treatment takes through the manufacturing site, to the hospital and the patient’s bedside.

"Time is of [the] essence given the short shelf life of the radioligand therapy, because it’s dependent on the level of decay," Schaffert said.

On June 3, 2021 Resverlogix Corp. ("Resverlogix") (TSX:RVX) and EVERSANA, the pioneer of next generation commercial services to the global life sciences industry, reported a partnership to support planned commercialization of apabetalone in the United States, Canada (where authorization has been granted to conduct clinical studies of apabetalone for COVID-19) and/or potentially expanding to additional global markets, as Emergency Use Authorization and/or a New Drug Application or equivalent is issued or approved (Press release, EVERSANA, JUN 3, 2021, View Source [SID1234583609]).

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In preparation for launch, Resverlogix will utilize EVERSANA’s fully integrated commercialization services that include market access, agency services, clinical and commercial field teams, medical science liaisons, channel management, patient services, health economics and outcomes research, and compliance, with each service optimized by data and predictive analytics.

Apabetalone is an investigational, phase 3 clinical candidate with safety data in more than 4,200 man years of treatment. As previously published, apabetalone has the potential to combat COVID-19 through a unique dual mechanism. First, apabetalone treatment prevents SARS-CoV-2 from infecting human cells; and second, it reducesthe inflammation and cytokine storm response, which can result in organ damage and long-term negative impacts. Apabetalone is also being studied for important benefits for patients with high-risk cardiovascular disease, chronic kidney disease and other indications while maintaining a well-described safety profile.

"With EVERSANA’s integrated commercialization solution, we are poised to swiftly and efficiently deliver apabetalone to patients who desperately need it," said Donald McCaffrey, President and CEO of Resverlogix. "We are proud to be on the front line with the global scientific medical community as we fight the ongoing threat of this and future pandemics."

"We believe in apabetalone’s potential to save the lives of patients still facing the tragic impact of COVID-19 and its numerous growing variants as well as the millions of patients facing multiple diseases that have the potential to be treated by this much-needed therapy," said Jim Lang, Chief Executive Officer of EVERSANA. "Our COMPLETE end-to-end commercialization engine is mobilized and ready to move swiftly in anticipation of authorizations and approvals."

There can be no assurance that regulatory approval will be obtained.

On June 3, 2021 Almac Group, the global contract development and manufacturing organization, is delighted to reported that the organization was named the 2020 "Pillar of the Community" by the Indian Valley Chamber of Commerce (Press release, Almac, JUN 3, 2021, View Source [SID1234583525]). The award was presented at the Chamber’s annual awards dinner, held this year on June 1 in Telford.

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The Pillar of the Community is awarded annually to a large business, actively involved in the Chamber that has demonstrated a significant commitment to the community by the company and its employees. Nominations are submitted by a Chamber Executive Committee, and the final decision to award Almac was made by the Chamber’s Board of Directors.

Almac was named this year’s Pillar of the Community due to the exceptional contributions of Almac and its employees during the COVID-19 pandemic. As an essential business, Almac continued its operations through the pandemic, ensuring no interruption in the supply chain of the hundreds of essential medicines the company supports through its integrated range of services across the drug development lifecycle. In addition, Almac contributed to over 140 treatment and vaccine options to combat COVID-19, notably supporting the Pfizer-BioNTech vaccine clinical trial, which upon authorization, has led to millions of vaccinations across the globe and a distinct turning point in the pandemic.

Mark Rohlfing, VP of Operations, Almac Clinical Services, accepted the award with remarks on behalf of Almac. He commented: "Almac’s mission is to advance human health, and we believe this extends to supporting the health and well-being of our local communities. Therefore, we are proud to support the Indian Valley community and Chamber of Commerce."

"We’re also proud to acknowledge that with this award, the Chamber has recognized the exceptional dedication of hundreds of Almac employees in Pennsylvania, whose contributions directly supported COVID-19 relief efforts, as well as the continued supply of hundreds of other essential medications for patients across the globe. Our people are essential to our success and we are grateful to the Chamber for acknowledging the impact of their hard work during unprecedented times."

Steven Hunsberger, Executive Director at Indian Valley Chamber of Commerce, commented: "We are thrilled to recognize Almac as the Indian Valley Chamber of Commerce’s 2020 Pillar of the Community. Through their contributions to human health and most recently, the COVID-19 pandemic, Almac has the distinction of providing significant service to not just our community, but the world. We are proud to watch them thrive in the Indian Valley and look forward to a continued prosperous future together."

On June 3, 2021 Tmunity Therapeutics reported that it has stopped development of its lead CAR-T therapy after two patients died of a form of neurotoxicity (Press release, Tmunity Therapeutics, JUN 3, 2021, View Source [SID1234583514]). The news, details of which were first reported by Endpoints and confirmed by Tmunity, has implications for the broader push to establish cell therapies as treatments for solid tumors.

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Founded by Carl June, M.D., and Oz Azam, M.D., Tmunity is at the forefront of the push to expand use of CAR-T beyond hematological malignancies and into solid tumors. The University of Pennsylvania, which spawned Tmunity, took dual PSMA-specific, TGFβ-resistant CAR modified autologous T cells into an 18-subject phase 1 prostate cancer trial in 2017. Tmunity began a second, larger study late in 2019.

The work has identified potential barriers to the use of CAR-T therapies in solid tumors. Notably, the investigators saw cases of immune effector cell-associated neurotoxicity syndrome (ICANS). Two patients died.

ICANS is a known side effect of CAR-T therapy, particularly in acute lymphoblastic leukemia patients, but the complication didn’t prevent products coming to market in blood cancers. In such indications, the management of cytokine release syndrome was the big concern, and the identification of IL-6 as a key factor enabled the development of strategies to improve the safety profile.

Knowledge of the mechanism of ICANS is hazier. If, as Tmunity thinks, the adverse event will be an issue for other developers of CAR-Ts in solid tumors, researchers will need to firm up understanding of the mechanism and design ways around the barrier to advance.

At Tmunity, the setback has led to the winding down of the CART-PSMA-TGFβRDN study and the start of work on a follow-up candidate designed to have a better safety profile. Tmunity is aiming to file an IND in the second half of the year.

Tmunity CEO Azam discussed the setback in a post on Twitter. "The journey in biotech is a hard one, but it’s from these challenges we learn and emerge stronger," Azam, who helped guide Novartis through its early CAR-T challenges, wrote.

On June 3, 2021 Sanofi reported that it launched a €3 million Planet Mobilization fund to support employee ideas and projects that will further contribute to a healthier environment (Press release, Sanofi, JUN 3, 2021, View Source [SID1234583513]). This year, three Sanofi teams will have their projects funded.

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For several years, Sanofi has been implementing a global environmental roadmap, Planet Mobilization, which is embedded in Sanofi’s long-term strategy. The program covers all Sanofi activities and sites and the entire lifecycle of products, from raw materials used in production all the way to their disposal.

"Because the fight against climate change is also a fight for the health and well-being, Sanofi commits to Planet Mobilization" says Philippe Luscan, Executive Vice President, Global Industrial Affairs. "We strongly believe our employees are the most powerful agents of positive change for people, and for the planet. It’s with this ambition and objectives in mind that we decided to create a fund of €3 million to finance ideas and projects coming from our employees in support of our environmental ambition. Today, it is fair to say that teams all over the world took up the challenge, even beyond our expectations. That’s collective intelligence in motion."

An Entrepreneurial Program to Support Employee Ideas
This year, more than 500 employees from 63 sites in 29 countries participated in the company’s environmental sustainability ideation program. A full program of bootcamps, hack-a-thons, and design thinking workshops led by Sanofi’s Innovation Lab helped the teams turn their ideas into sustainable projects.

Three winning projects were selected this inaugural year. The projects will be implemented and financed by Sanofi’s Planet Mobilization fund:

Vietnam: "Rice is the New Green" is a project from Sanofi’s Hô Chi Minh team to implement the first green and circular large-scale rice husk biomass. Rice husk is a byproduct of paddy processing in the rice mills and can provide a convenient and environmentally sustainable, convenient source of dry biomass energy. This will allow Sanofi’s Hô Chi Minh site to become a fossil fuel free site​, eliminating 2.3 thousand tons of carbon dioxide a year and reduce steam costs by 40%.
Europe: "IDRA" is a project from three country sites in Europe, including Anagni, Italy; Compiègne, France; and Geel, Belgium. The project aims at recycling treated wastewater from the sites to be directly reused on site. The three pilot plants could save up to 220 million liters of water per year. This is the equivalent of filling nearly 70 Olympic pools.
Ireland: "Waterford Loves Planet Not Plastic" is an education project to help reduce plastic waste. Through information via school programs, nature restoration programs such as coastal clean-ups, and an app measuring plastic waste and incentivizing reduced consumption, Sanofi Ireland ‘ambassadors’ will contribute to their communities more balanced use of plastic and the management of its waste.

Sanofi Aims for Carbon Neutrality
Sanofi has committed to reduce its greenhouse gas emissions by 55% by 2030 in line with limiting global warming to 1.5°C and is aiming for carbon neutrality by 2050. The new carbon reduction objectives are validated by the Science Based Target initiative, a partnership between Carbon Disclosure Project, the United Nations Global Compact, World Resources Institute, and WWF.

To that order and to minimize the potential direct and indirect impacts of its business on the environment throughout the whole lifecycle of its products, the company intends to:

protect ecosystems by introducing biodiversity protection plans at all its sites located near sensitive areas by 2025;
implement water stewardship and water efficiency plans on 100% of its manufacturing sites by 2030;
foster eco-design for all its new products and packaging by 2025 and for its top-selling products by 2030, and remove all pre-formed plastic packaging (blister packs) for its vaccines by 2027;
reduce, recycle, and recover more than 90% of its waste by 2025;
use 100% renewable electricity across its operations and target a carbon-neutral car fleet, both by 2030; and
prevent any impact of its medicines on the environment across 100% of its manufacturing sites by 2025.
Sanofi also supports and works with its suppliers all over the world to reduce their greenhouse gas emissions and environmental impact to create more sustainable sourcing of raw materials.

To date, the company has already notably:

reduced GHG emission from its activities by 27% since 2015;
designed a new entirely recyclable cardboard packaging for vaccines, which replaces aluminum and PVC blisters;
reused, recycled, or recovered 73% of its waste; and
reduced by 22% its water withdrawal from 2015 to 2020.
More on Sanofi’s environmental management and achievements: View Source