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

On June 3, 2021 Jeffrey Bogart, MD, interim director of the Upstate Cancer Center, reported that it will present findings of a lung cancer treatment clinical trial later this week at one of the largest gatherings of cancer experts in the world (Press release, SUNY Upstate, JUN 3, 2021, View Source [SID1234583512]).

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Bogart, who also serves as chair of the Department of Radiation Oncology at Upstate, will present the results of a clinical trial for patients with small cell lung cancer at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which runs June 4 to 8. Bogart will present evidence that shows when treating small cell lung cancer, once daily radiation therapy treatment for seven weeks is just as effective as twice daily radiation treatment for three weeks.

Bogart was principal investigator of the trial, which included more than 700 patients throughout the United States from 2008 to 2019. About 30,000 people are diagnosed with small cell lung cancer each year. That type of cancer, which is treated with chemotherapy and radiation, accounts for about 15 to 20 percent of all lung cancer patients, Bogart said.

A clinical trial about 30 years ago showed that radiation administered twice a day for three weeks was a more effective treatment than the same dose of radiation once a day for five weeks, Bogart said. Despite undergoing radiation for a shorter period of time – three weeks compared to five – receiving two doses of radiation in one day is difficult for many patients, he said. Twice daily radiation must be administered at least six hours apart, which means the patient has to be at the hospital twice in one day. That’s a tiring regimen and can be difficult for those who don’t live nearby.

The clinical trial, which is the largest trial in limited stage small cell lung cancer ever performed, showed minimal differences between the two regimens.

"Even though the trial from 30 years ago showed that more patients were cured and alive five years later with the twice a day, many patients are not able to make it twice a day and there was some concern that the side effects might be greater with the twice a day," he said. "So most patients in the country, even though we had good evidence to treat twice a day, were treated with once a day. It’s only until this study that we actually have evidence that supports that this is an appropriate thing to do."

Bogart said that prior to this study only about 15 percent of patients nationwide opted for twice daily radiation treatments.

"Before we had the results of this study, because we had good scientific evidence that twice a day was better, I would recommend twice a day for all of my patients," Bogart said. "There were some patients where it was not feasible, but now with the results of this study it opens up the options scientifically. There’s enough support to do either one now. This shows in a scientific fashion that patients are not being undertreated if they have the once a day."

The clinical trial was conducted with patients from across the United States, including at Upstate. The Alliance for Clinical Trials in Oncology, for which Bogart is chair of the Radiation Oncology Committee, oversaw the trial.

The ASCO (Free ASCO Whitepaper) annual meeting is virtual this year and Bogart is scheduled to present on Sunday, June 6. The meeting is attended by more than 40,000 people annually.

"Part of the excitement is that Upstate not only offers clinical trials, we have folks here who are involved in developing and designing and running those clinical trials for the country," Bogart said, noting that hundreds of trial participants were critical to its success. "It’s always good for the patients that were involved to know that their commitment really resulted in something we can use to help guide treatment for future patients."

On June 3, 2021 Stellanova Therapeutics, Inc. ("Stellanova"), a biotechnology company advancing cancer therapies targeting the tumor microenvironment, reported the closing of a $15.5 million Series A financing led by Sporos Bioventures, LLC (Press release, Stellanova Therapeutics, JUN 3, 2021, View Source [SID1234583511]). The funds will advance Stellanova’s lead antibody asset to first-in-human clinical trials for oncology, establish its discovery platform, and build its team.

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"For patients diagnosed with advanced cancers, aggressive chemotherapies and immune therapies often provide only marginal improvement due to the presence of resistance factors generated by fibroblasts present within the tumor microenvironment," commented Rosa Hwang, M.D., co-founder of Stellanova. "Our lead antibody targets DKK3, a factor secreted by cancer-associated fibroblasts, and shows robust anti-tumor activity, alone or together with immune therapy, in highly refractory preclinical models of pancreas and triple negative breast cancer."

Stellanova is focused on targeting the many pro-tumorigenic effects enabled by the activity of carcinoma-associated fibroblasts (known as CAFs) in the tumor microenvironment. CAFs play essential roles in promoting cancer growth and metastasis, spurring angiogenesis, suppressing anti-tumor immunity, and fostering chemoresistance. Stellanova’s lead antibody candidate is designed to neutralize DKK3, a factor secreted by CAFs that acts on neighboring cancer cells and immune cells to promote tumor progression and therapy resistance. In pre-clinical studies, treatment with anti-DKK3 monoclonal antibody and immune checkpoint inhibitor therapy has produced sustained tumor eradication in mouse models of pancreatic cancer which is refractory to current chemo or immune therapies.

Harold Levy, Stellanova and Sporos founder and board member, added, "We are thrilled to bring Stellanova into the Sporos group of companies. Stellanova means ‘new star’, and it is clear the Stellanova team embraces this namesake with their entirely new approach to treating cancer. We have been impressed by Stellanova’s accomplishments and look forward to being involved in the advancement of the company’s platform, one that we believe has the potential to directly combat the most devastating of cancers."

In conjunction with the Series A financing, Emmanuelle Schuler, Ph.D., MBA, has been appointed founding Chief Executive Officer. Dr. Schuler has been a member of the founding team at several companies, including JLABS @ TMC, where she spearheaded successful site operations and business development, and Corallis Consulting which focuses on improving therapeutic solutions in conjunction with biotech companies in United States and Europe.

Stellanova is a resident company at JLABS @ TMC, a Johnson & Johnson biotech incubator in Houston’s Texas Medical Center.

DISCLOSURES
Dr. Hwang receives compensation as a member of the SAB, and this financial relationship has been disclosed to her institution in accordance with its policy.