On February 4, 2022 Kureha Corporation reported that it has updated its earnings forecast for the fiscal year ending March 31, 2022 (FY2021) in light of the recent performance trends (Press release, Kureha Corporation, FEB 4, 2022, View Source [SID1234607748]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Changes from the previous forecast, which was announced on November 9, 2021, are detailed below.

1. FY2021 Earnings Forecast (April 1, 2021 through March 31, 2022)(Reasons for the revision) Revenue is expected to exceed our previous forecast due to better-than-expected performances of polyvinylidene fluoride resins in the Advanced Materials segment, which are used primarily as a lithium-ion battery binder, and ‘NEW Krewrap’ and other plastic products in the Specialty Plastics segment. Operating profit, profit before taxes and profit attributable to owners of Kureha Corporation are also projected to rise on the back of higher operating profit generated by these high-margin products and due partly to a decrease in SG&A expenses.

2. Revised Forecast for FY2021 Year-End Dividend(Reasons for the revision) Kureha’s basic policy regarding dividend distribution is to pay a steady dividend to shareholders over a long period of time, while strengthening the Company’s financial structure to sustain long-term growth and future business development. Based on this policy, Kureha has maintained a consistent dividend payout over the years regardless of occasional swings in its financial performance. As stated in the above section ‘

1. FY2021 Earnings Forecast,’ our current earnings forecast for the fiscal year ending March 31, 2022 exceeds our previous forecast, which has been upwardly revised and announced on November 9, 2021. Given this financial outlook, we have come to a decision to improve returns to our shareholders in appreciation for their continued supports, and will raise the FY2021 year-end dividend to 125 yen, up from 100 yen of our most recent forecast. Payment of the year-end dividend will proceed following a resolution of the Board of Directors at its meeting scheduled in April 2022

On February 4, 2022 Kureha Corporation reported (Press release, Kureha Corporation, FEB 4, 2022, View Source [SID1234607747])

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

I. FY2021 3Q Results (Period April 1 – December 31, 2021)

Revenue growth driven by Advanced Materials, Specialty Chemicals and Specialty Plastics more than offsetting slower sales in Construction and Other Operations
• Higher core operating profit resulting from improved gains in Advanced Materials, Specialty Chemicals and Specialty Plastics, partially offset by a decline in Other Operations
• Operating profit increased as a result of higher core operating profit
• Profit attributable to the Company increased as a result of higher operating profit and profit before taxes

Factors attributing to changes in operating profit AM: Higher sales volumes of PVDF, PPS and other plastic products SC: Higher organic chemicals volumes
SP: Higher home products and fishing lines volumes
CO: Impact of delays in civil engineering projects, partially offset by a higher number of construction projects in the private sector
OO: Absence of post-typhoon waste treatment projects Advanced plastics PPS: Revenue up, operating profit up Increased production capacity and sales volume; an increase in equity in PPS-related affiliate earnings PVDF: Revenue up, operating profit up Higher sales volume; improved production volume for value-added specialty polymers; pricing efforts to align with rising costs for raw materials and fuels

PGA: Revenue up, operating profit down Higher frac plug sales volume; increased costs associated with the U.S. PGA manufacturing plant (due to the lack of production activity) Carbon products Revenue up, operating profit up Increased carbon fiber volumes for applications as automotive sliding materials and insulation materials for industrial highheat furnaces Other Revenue up, operating profit up Higher sales volumes of plastic products manufactured by Group companies

Agrochemicals & Pharmaceuticals Revenue up, operating profit flat Sales volume growth for agrochemical fungicides and a therapeutic agent for chronic kidney failures (‘Kremezin’); impact of mandatory drug price revisions; higher raw material costs Industrial chemicals Revenue up, operating loss narrowed Sales of organic chemicals and other key products recovered in the industries resuming production activities

On February 4, 2022 Roswell Park Comprehensive Cancer Center reported that it is the first center to treat patients in a newly opened advanced-stage clinical trial utilizing the brain cancer vaccine SurVaxM, offering a new treatment option for patients who are dealing with a rare but deadly form of the disease (Press release, MimiVax, FEB 4, 2022, View Source;utm_medium=rss&utm_campaign=roswell-park-opens-phase-2b-randomized-clinical-trial-of-promising-brain-cancer-immunotherapy [SID1234607746]). The multicenter randomized clinical trial is sponsored by MimiVax LLC, a company spun off from Roswell Park in 2012.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Currently recruiting, the phase 2B randomized SURVIVE trial is open to newly diagnosed adult glioblastoma patients. At Roswell Park, the trial will be under the direction of Principal Investigator Ajay Abad, MD, a neurologic oncologist and faculty member in the Department of Neuro-Oncology. Altogether, the trial is expected to be open across 15 sites in the United States and China.

Glioblastoma, though rare, is the most common primary brain cancer. Fast-growing and aggressive, the cancer is typically treated with surgery, chemotherapy and radiation, but frequently recurs within a year of initial treatment. Median survival for patient with standard therapy is 16 months.

SurVaxM, an immunotherapy developed at Roswell Park by Robert Fenstermaker, MD, Chair of the Department of Neurosurgery and Michael Ciesielski, PhD, Assistant Professor of Oncology and now being developed by MimiVax, is a unique treatment vaccine that targets survivin, a protein that helps cancer cells stay alive. A recent single-arm phase II study in 63 patients with newly diagnosed glioblastoma demonstrated significantly longer survival time for patients treated with SurVaxM, with 93.7% alive a year after diagnosis, compared to expected 65% survival based on historical studies.

"For years, we’ve struggled to move the needle as far as good treatment options for glioblastoma. Our hope is that SurVaxM will offer patients both longer survival and better quality of life," says Dr. Abad, who is also an Assistant Professor of Oncology at Roswell Park. "To hopefully be on the precipice of meaningful progress against glioblastoma and to be able to possibly see my patients outside of the hospital — years after their diagnosis — would be incredible."

"Glioblastoma is a notoriously aggressive and hard-to-treat cancer. We are encouraged by the results from our earlier studies and excited to bring this treatment option to more brain cancer patients at more centers," says Dr. Fenstermaker.

The research team gratefully acknowledge donations to Roswell Park, directly and through events like the Ride for Roswell, as critical support of their work through all phases.

On February 4, 2022 UCLB reported that Researchers say the findings offer new hope to adult patients with ‘relapsed B-cell acute lymphoblastic leukaemia’ (r/r B-ALL), for which there is currently no approved ‘curative’ treatment available. Patients typically have further chemotherapy and the prognosis is poor (Press release, UCLB, FEB 4, 2022, View Source [SID1234607745]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

For the ALLCAR19 trial, published in the Journal of Clinical Oncology, 20 adult patients with relapsed B-ALL had their own T cells genetically modified with CAT-41BB-Z, a new type of CD19* CAR, which has been named obe-cel.

Like all CD19 CAR T-Cell therapies, this treatment programmes immune T cells to make an artificial protein called a CD19 chimeric antigen receptor (CAR) on their surface, directing them to specifically recognise cancerous cells.

However, in designing obe-cel, scientists in Dr Martin Pule’s lab at UCL Cancer Institute – in work that is supported by the National Institute for Health Research UCLH Biomedical Research Centre (BRC) – aimed to overcome two common constraints associated with existing CAR T-cell therapies.

The ALLCAR19 Chief Investigator Professor Karl Peggs, Honorary Clinical Professor at UCL Cancer Institute and Director of the Sir Naim Dangoor Centre for Cellular Immunotherapy at UCLH, explained: "While CAR T therapy is very effective for some patients, current CAR T-cell treatments have limitations.

"The immune system can become over-activated causing a toxic reaction called ‘cytokine release syndrome’; another consequence of over-activation is that the engineered T-cells become immunologically exhausted and no longer persist in the patient’s body. This lack of persistence can allow the cancer to relapse.

"These two problems have proven to be particularly difficult in adults with relapsed B-ALL and consequently there is no licensed CAR T-cell therapy in this age group for this type of cancer."

Obe-cel has been designed so that CAR T-cells bind with the target leukemic cancer cells less tightly and for shorter periods than other CD19CARs. This shortens the time of interaction, limiting over stimulation of the CAR T-cells, and they move between killing one leukaemia cell, then on to the next, thereby reducing over-exhaustion. This new type of therapy design is known as a "fast off-rate CAR".

Scientists hoped this design would reduce cytokine release syndrome toxicity and allow the CAR T-cells to divide, grow and live in the patient for months to years to prevent relapse.

Results of Phase I trial

In the ALLCAR19 trial modified obe-cel was used to treat 20 adult patients with relapsed B-ALL at UCLH.

Obe-cel was shown to have an excellent safety profile with none of the patients having cytokine release syndrome.

In regards durability, the CAR T-cell levels remained high in patients and persistence was evident in 75% patients at a median of six months.

Of the 20 patients, 85% were in complete remission at one month. Furthermore, the CAR T cells persisted well in nearly all patients and 50% remained in remission at 12 months.

Trial investigator, Dr Claire Roddie, Associate Professor at UCL Cancer Institute and consultant haematologist at UCLH, said: "This new type of CD19 CAR is designed so the interaction between CAR T-cell and target cancerous cell is faster than with standard CD19 CARs.

"As both scientists and doctors, we are delighted with the results; they are important because they show the new C19 CAR design allows for the safe treatment of CAR T-Cell therapy to adult patients with relapsed B-ALL. Moreover, this treatment may allow patients to have long-term remissions with no other treatment."

What next?

Based on the success of the ALLCAR19 study, Autolus Therapeutics (Nasdaq: AUTL), a spin-off company from UCL, has initiated the FELIX study, a phase Ib/II global registration study of obe-cel in adults with relapsed B-ALL.

The FELIX trial has a Phase Ib component prior to proceeding to a single arm Phase II clinical trial. The primary endpoint is overall response rate, and the key secondary endpoints include molecular complete remission rate, duration of response, and safety. The trial is designed to enroll approximately 100 patients across 30 of the leading academic and non-academic centers in the United Kingdom (including UCLH), Europe and the United States.

The ALLCAR19 trial is sponsored by UCL, funded by the NIHR i4i scheme and Autolus Therapeutics and supported by UCLH and the NIHR UCLH BRC.

The UCL CAR T cell programme based in the UCL Cancer institute is one of the largest CAR T cell programmes in the world and has a complete pipeline of CAR T cell discovery, pre-clinical testing, GMP and regulatory capabilities and an experimental phase I programme.

Trial patient case study

Claire Evans was diagnosed with Acute Lymphoblastic Leukaemia (ALL) in June 2015 and received treatment at her local hospital. This included a bone marrow transplant in December 2015, and she went into remission.

In May 2019, after she had been in pain for some time due to pressure fractures in the spine, she was referred to hospital for an MRI scan in August 2019 and doctors found that her leukaemia had returned.

Options were explored and she was eventually referred to UCLH for inclusion on the ALLCAR19 clinical trial. She had two infusions in November 2019 and was discharged from UCLH in December 2019. Her follow up care takes place at her local hospital. In November 2021 and it will be 24 months post CAR T and her latest follow up (in Nov 2021) showed she remains in remission.

Claire said: "I first heard about CAR-T after watching the documentary ‘War in the Blood’. I’d previously been diagnosed with leukaemia in 2015 and was in remission but I suffered a relapse in 2019. The doctors initially treated me with chemotherapy before one of them mentioned CAR-T and I was referred to UCLH who assessed me for participation in their clinical trial.

"As I was deemed suitable, I was able to start CAR-T treatment fairly quickly. I’d been made aware that the side effects could be very unpleasant but fortunately for me, I didn’t have any adverse effects.

"I’m so glad that I was able to take part in the trial, it has made all the difference and I’m still here. The initial results from my latest biopsy show no evidence of disease."

On February 4, 2022 Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, reported the pricing of its initial public offering of 8,250,000 shares of common stock at a public offering price of $15.00 per share (Press release, Arcellx, FEB 4, 2022, View Source [SID1234607743]). The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Arcellx, are expected to be approximately $123.8 million. In addition, Arcellx has granted the underwriters a 30-day option to purchase up to an additional 1,237,500 shares of common stock at the initial public offering price, less underwriting discounts and commissions. All of the shares of common stock are being offered by Arcellx. Arcellx’s common stock is expected to begin trading on the Nasdaq Global Select Market on February 4, 2022, under the ticker symbol "ACLX." The offering is expected to close on February 8, 2022, subject to the satisfaction of customary closing conditions.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

BofA Securities, SVB Leerink, Barclays and William Blair are acting as joint book-running managers for the offering.

A registration statement relating to the offering has been filed with the Securities and Exchange Commission and became effective today. The offering is made only by means of a prospectus, copies of which may be obtained, when available, from: BofA Securities, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by email at [email protected]; SVB Securities LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, Massachusetts 02109, by telephone at 1-800-808-7525, ext. 6105, or by email at [email protected]; Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717 or by email at [email protected] or by telephone at (888) 603-5847; or William Blair & Company, LLC, Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, by telephone at 1-800-621-0687, or by email at [email protected]. Copies of the final prospectus, when available, related to the offering will be available at www.sec.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.