On May 12, 2021 Novasep, a leading supplier of services and technologies for the life sciences industry, reported a further expansion of its Highly Potent Active Pharmaceutical Ingredients (HPAPIs) manufacturing capabilities on its Le Mans (72 – France) site (Press release, NOVASEP, MAY 12, 2021, View Source [SID1234580012]). This new step underlines customers’ confidence in Novasep’s expertise in HPAPIs & ADCs and reinforces Novasep’s position as a leading CDMO for the production of innovative and targeted molecules to treat cancer.

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This site, which has already benefitted from significant investment, continues to exhibit strong growth as a result of longstanding collaborations with major pharmaceutical companies & new partnerships with biotechnology innovators. To support this growth and sustain the increase in both clinical & commercial production capacity, Novasep is recruiting more than 30 people on this site, combined with an investment of more than €4 million.

Novasep has been a key partner to innovators in the ADC arena for more than 15 years. With a strong pipeline of customer’s clinical drug candidates leading to a number of recent ADC drug approvals, Novasep’s strategy of offering integrated development and manufacturing services for both payloads & bioconjugation is now bearing fruit. The state-of-the-art bioconjugation facility, launched in 2017 with an investment of €12 million, delivers cGMP ADC batches to customers and was successfully inspected by the ANSM (French regulatory drug authorities) in 2021. This demonstrates once again Novasep’s ability to offer flexible and reliable manufacturing solutions to oncology drug innovators, leveraging specialist technologies and expertise.

Dr. Michel Spagnol, Chairman and CEO of Novasep said "We are pleased to continue our development in strategic markets such as HPAPIs and ADCs, and to participate in the fight against cancer for the benefit of patients. Specifically, this expansion allows us to create more than 30 full-time jobs in Le Mans".

On May 12, 2021 Knight Therapeutics Inc. (TSX: GUD) ("Knight"), a leading pan-American (ex-US) specialty pharmaceutical company, reported that Samira Sakhia, President and Chief Operating Officer, is scheduled to participate in a fireside chat at the 2021 RBC Capital Markets Global Healthcare Conference on Tuesday, May 18, 2021 at 8:35 am ET (Press release, Knight Therapeutics, MAY 12, 2021, View Source [SID1234579947]). A live webcast of the event will be available at the following link: Event. A copy of the presentation will be available at www.gud-knight.com.

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On May 12, 2021 Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) reported that it is scheduled to participate in the following upcoming events (Press release, Arrowhead Pharmaceuticals, MAY 12, 2021, View Source [SID1234579946]):

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2021 RBC Capital Markets Global Healthcare – May 18-20, 2021

May 18, 2021, 11:30 a.m. ET – Chris Anzalone, Ph.D., Arrowhead’s president and CEO, will participate in a fireside chat presentation

UBS Global Healthcare Virtual Conference – May 24-26, 2021

May 26, 2021, 3:00 p.m. ET – Chris Anzalone, Ph.D., Arrowhead’s president and CEO, will participate in a fireside chat presentation

A copy of the presentation materials and/or webcast links may be accessed on the Events and Presentations page under the Investors section of the Arrowhead website.

On May 12, 2021 Prescient Therapeutics reported that it has inked a new deal with leading research organisation Peter MacCallum Cancer Centre to advance work on its revolutionary OmniCAR platform (Press release, Prescient Therapeutics, MAY 12, 2021, View Source;utm_medium=rss&utm_campaign=peter-maccallum-cancer-centre-signs-agreement-with-asx-listed-prescient-therapeutics [SID1234579900]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Under the terms of the deal, Peter MacCallum senior research fellow Professor Philip Darcy will lead a team of researchers undertaking preclinical development of Prescient’s OmniCAR programs.

OmniCAR is a next generation CAR-T platform designed to improve the safety, effectiveness, and control of existing CAR-T treatments.

CAR-T treatments involve extracting and genetically modifying T cells within a patient’s immune system to better identify and attack cancerous cells.

The modified cells are then ‘expanded’ (replicated to create more) and infused back into the patient, where they recognise and eliminate cancer.

Professor Darcy said: "We are excited by the opportunity and potential offered by the OmniCAR platform to make headway into solid tumours and other blood cancers, and to greatly enhance and improve the clinical control and efficacy of existing CAR-T cancer therapies."

This agreement will see the two organisations focus on developing next generation CAR-T products using the OmniCAR technology for three types of cancer: acute myeloid leukemia (AML), Her2+ solid tumors, and glioblastoma multiforme (GBM).

Steven Yatomi-Clarke, CEO of Prescient, said the company is committed to completing the development work both quickly, and to the highest standards.

"Our latest research program with Peter Mac is an important part of our development plans, which include institutional and commercial laboratories," he said.

"We continue to work very closely with Professor Darcy and the team at Peter MacCallum as we progress this exciting development of controllable and adaptable next generation CAR-T therapies."

The resulting intellectual property will be owned by Prescient Therapeutics.

This agreement marks the second research collaboration between the two organisations, having announced a similar agreement focusing on Cell Therapy Enhancement programs last year.

Prescient increases dosage in separate clinical trial
The deal comes hot on the heels of a dosage increase in Prescient’s Phase 1b clinical study of its oncology drug PTX-200 and cytarabine in patients with AML.

PTX-200 is a ‘novel domain inhibitor’, which works to inhibit an important tumor survival pathway known as ‘Akt’ and is currently in clinical trials for a range of cancers including HER2-negative breast cancer and persistent platinum-resistant ovarian cancer.

Three AML patients were being treated with 35mg/m2 with no ‘dose limiting’ toxicities being reported, and no other clinical responses recorded.

Following a safety review of this data, Prescient is now looking to enrol a new cohort to test the drug at a dosage of 45mg/m2.

Dr Terrence Chew, the company’s Chief Medical Officer, said the results of the 35mg/m2 tests are promising.

"AML remains a very difficult disease to treat, especially in the relapsed and refractory setting, with patients often too sick to endure vigorous treatment," he said.

"It is therefore pleasing to see the completion of this cohort without dose limiting toxicities."

AML affects approximately 158,000 people worldwide, and inhibits the formation of new blood cells.

If you would like to stay updated on all future announcements and receive invites to upcoming company investor briefings, please register your details on Prescient’s investor centre.

Reach Markets have been engaged to assist PTX with investor communications.

On May 12, 2021 Kuraray hereby reported that due to the impact of the cold wave that struck the United States in the first quarter of the fiscal year ending December 31, 2021, it has posted an extraordinary loss as part of consolidated quarterly operating results for said period (Press release, Kuraray, MAY 12, 2021, https://pdf.irpocket.com/C3405/eq9A/Kj61/qLHN.pdf [SID1234579899]). In addition, Kuraray has revised its consolidated operating results forecasts for the first six months of said fiscal year, as detailed below, from the previous operating results forecasts announced on February 10, 2021.

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1. Posting of Extraordinary Loss and Its Details With regard to the impact of the severe cold wave that struck many parts of the United States in mid-February 2021, in its March 10, 2021 press release "Notice Regarding the Impact of a Cold Wave in the United States," Kuraray announced that a number of Group manufacturing sites located in a Houston, Texas, suburb and run by local subsidiary Kuraray America, Inc., suspended operations from Mid-February onward. Full production, except for certain lines, resumed as of April 2, 2021 as announced in a subsequent press release issued on the same date. Having assessed the impact of the cold wave on its consolidated operating results, Kuraray recorded an extraordinary loss of ¥3,016 million as a disaster loss for the first quarter of the fiscal year ending December 31, 2021.

2. Revisions to consolidated earnings forecast for the second quarter of fiscal 2021 (January 1-June 30, 2021)

(2) Reason for the revisions
In the consolidated first quarter, shipments in Kuraray’s businesses mainly in the Vinyl acetate and Isoprene segments increased due to growth in demand, including for mainstay applications for automobiles, displays, and electronic and electric devices. We assume that demand will remain firm in the second quarter as well. Furthermore, in the first quarter, we recorded a loss on litigation of ¥3,054 million related to a fire that occurred at our U.S. subsidiary in May 2018. As stated above, we also recorded a disaster loss of ¥3,016 million due mainly to the suspension of production for some equipment at our U.S. subsidiary caused by a severe cold wave in the southern United States in February. Based on these circumstances, the forecast of consolidated operating results for the second quarter of fiscal 2021 (January 1, 2021 to June 30, 2021) is as shown above.