On May 16, 2023 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today described recently presented real-world data that confirm a consistent risk of myelosuppressive events (neutropenia, anemia, thrombocytopenia) across patients with small cell lung cancer (SCLC) being treated with chemotherapy (Press release, G1 Therapeutics, MAY 16, 2023, View Source [SID1234631773]). These findings were presented in a poster session at the 2023 meeting of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), held May 7-10, 2023.

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"Chemotherapy remains an effective cornerstone treatment for patients with small cell lung cancer; unfortunately, chemotherapy-induced myelosuppression is a known common and debilitating complication associated with these cytotoxic regimens," said Norman Nagl, Ph.D., Vice President of Medical Affairs at G1 Therapeutics. "Despite this, little data have been generated in this tumor type to help clarify and quantify the risk of myelosuppressive events across the spectrum of patients who are treated with chemotherapy for SCLC. For the first time, the results of these analyses show that all patients – of any age, gender, race, stage, ECOG or smoking status, or at any line of chemotherapy – are at similarly high risk for such myelosuppressive events. This continues to underscore the need to ensure that patients receive the most appropriate therapies to reduce that risk and to help improve their chemotherapeutic experience."

Results showed that, among adult patients in this data set diagnosed with SCLC who received chemotherapy, grade ≥3 myelosuppression occurred in 60.9% of patients in the overall population. Further, more than half of the patients experienced grade ≥3 myelosuppression in all subgroups among the overall population, except one subgroup of patients for whom their SCLC stage was not documented at diagnosis (n=15). Multivariate regression analyses identified no significant associations between patient characteristics and myelosuppression; similar findings were observed in age-specific and lineage-specific regression models.

The poster, titled, "An Analysis of Patient Characteristics Associated With Myelosuppression Among Small Cell Lung Cancer Patients Treated in US Community Cancer Care Practices" is available in the scientific publications section of G1’s website.

Study Design
This retrospective observational study used the electronic medical records (EMR) data from the Providence St. Joseph Health (PSJH) and the Providence Cancer Reporting Registry, which included data from 40 oncology clinics associated with community hospitals across seven U.S. states. Adult patients diagnosed with SCLC who received chemotherapy between 2016 and 2018 and had longitudinal laboratory data were included in this study. Patients were followed from the date of the first chemotherapy dose for 12 months, or until the date of the last visit, date of death, or the end of the study period (December 2019), whichever occurred earliest. Percentages of patients with grade ≥3 myelosuppression and grade ≥3 lineage-specific cytopenia were analyzed by patient characteristics. Multivariate logistic regressions were conducted to examine the association between patient characteristics (independent variable) and risk of experiencing at least one grade ≥3 myelosuppression (dependent variable) among the overall population and by age group. In addition, multivariate logistic regressions were conducted to examine association between patient characteristics and risk of myelosuppression in each lineage (anemia, neutropenia, thrombocytopenia).

About Small Cell Lung Cancer
In the United States, approximately 30,000 small cell lung cancer patients are treated annually. SCLC, one of the two main types of lung cancer, accounts for approximately 14% of all lung cancers. SCLC is an aggressive disease and tends to grow and spread faster than NSCLC. It is usually asymptomatic; once symptoms do appear, it often indicates that the cancer has spread to other parts of the body. About 70% of people with SCLC will have cancer that has metastasized at the time they are diagnosed. The severity of symptoms usually increases with increased cancer growth and spread. From the time of diagnosis, the general 5-year survival rate for people with SCLC is 6%. The five-year survival rates for limited-stage (the cancer is confined to one side of the chest) SCLC is 12% to 15%, and for extensive stage (cancer has spread to the other lung and beyond), survival rates are less than 2%. Chemotherapy is the most common treatment for ES-SCLC.

On May 16, 2023 Shorla Oncology (‘Shorla’), a U.S.-Ireland pharmaceutical company, and EVERSANA, a leading provider of commercialization services to the life science industry, reported the commercial launch of the company’s oncology drug, Nelarabine Injection, for the treatment of T-cell Acute Lymphoblastic Leukemia (T-ALL) and T-cell Lymphoblastic Lymphoma (T-LBL) in adult and pediatric patients aged one year and older whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens (Press release, EVERSANA, MAY 16, 2023, View Source [SID1234631772]).

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Nelarabine Injection, which received FDA approval in March of 2023, is now available for order through major wholesalers and specialty distribution partners. The new therapy provides patients with an alternative to a product that has historically been in shortage for the treatment of T-cell leukemia, an aggressive blood and bone marrow cancer that progresses quickly. While most leukemias target older people, T-cell leukemia is most common among children. This marks the first product approved in the U.S. market for Shorla.

"Patients are directly affected by therapy shortages. Our team is proud that Nelarabine Injection is now available across the United States for clinicians to prescribe as a new treatment option to help patients, particularly children, in their battle against leukemia," said Sharon Cunningham, CEO and Co-founder of Shorla Oncology. "We look forward to helping educate both the clinical and patient communities on this new therapy."

Shorla Oncology selected EVERSANA to support the commercialization launch for the therapy in 2021. EVERSANA will provide comprehensive launch support including field deployment sales and training solutions, medical information, pharmacovigilance and quality services, revenue management, agency solutions, 3PL channel and trade relations support.

"What a milestone for the Shorla Oncology team to officially have this new treatment option available to the oncology community across the U.S.," said Jim Lang, CEO, EVERSANA. "We’re honored to provide the full depth of our commercialization solutions to ensure a successful launch and look forward to helping the Shorla team bring this and future therapies to the U.S. and patients in need."

Founded in Ireland, Shorla specializes in developing innovative oncology drugs, with a focus on orphan and pediatric cancers. With strong support from scientists and clinicians, plus an extensive industry network, including key opinion leaders from top leading hospitals such as The Children’s Hospital of Philadelphia (CHOP), the company has an advanced pipeline of oncology therapies to treat a number of unmet patient needs.

On May 16, 2023 Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS) reported the pricing of its underwritten public offering of 11,764,706 shares of its common stock at a price to the public of $4.25 per share (Press release, Coherus Biosciences, MAY 16, 2023, View Source [SID1234631771]). All of the shares of the common stock to be sold in the offering will be offered by Coherus. In addition, Coherus has granted the underwriters a 30-day option to purchase up to an additional 1,764,705 shares of its common stock at the public offering price, less underwriting discounts and commissions.

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Coherus intends to use substantially all of the net proceeds from this offering for general corporate purposes, including the cost of manufacturing clinical and commercial supplies of product candidates and products. Coherus may also use a portion of the net proceeds from this offering, together with existing cash, cash equivalents and marketable securities, to in-license, acquire or invest in complementary businesses, technologies, products or assets. If there are any remaining net proceeds from this offering, Coherus intends to use them for working capital and other general corporate purposes.

The offering is expected to close on or about May 18, 2023, subject to satisfaction of customary closing conditions.

J.P. Morgan and Citigroup are acting as co-lead book-running managers for the offering. Mizuho is acting as lead manager for the offering.

A shelf registration statement (including a base prospectus) relating to these securities has been filed with the U.S. Securities and Exchange Commission (SEC) and became effective on November 17, 2022. This offering is being made solely by means of a prospectus supplement and the accompanying prospectus. A preliminary prospectus supplement and accompanying prospectus relating to the offering has been filed with the SEC and are available on the SEC’s website at www.sec.gov. When available, electronic copies of the final prospectus supplement and the accompanying prospectus may also be obtained by contacting J.P. Morgan Securities LLC c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, telephone: (866) 803-9204, email: [email protected] or Citigroup, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717 (Tel: 800-831-9146).

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, 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 registration or qualification under the securities laws of any such state or jurisdiction.

On May 16, 2023 Cimeio Therapeutics, a biotechnology company developing a novel approach to cell therapies, presented data for its CD45 Shielded Cell & Immunotherapy Pair (SCIP) program at the American Society of Gene and Cell Therapy’s Annual Meeting in Los Angeles (Press release, Cimeio Therapeutics, MAY 16, 2023, View Source [SID1234631770]). The findings build upon prior successful studies using CD117 and CD123 variants and collectively provide further proof of concept for Cimeio’s platform, which offers a novel and promising therapeutic approach to improve the outcomes for patients with benign and malignant hematological diseases in need of a hematopoietic stem cell (HSC) transplant.

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The new study demonstrates that a genetically engineered variant of the cell surface receptor CD45 is fully functional and, importantly, evades a paired immunotherapy directed against the wild-type molecule.

CD45 is a pan-hematopoietic marker critical for the function of immune cells. While eradication of CD45+ cells could represent a universal approach to reset the hematopoietic system for hematologic malignancies or severe autoimmune diseases, the current application of CD45-targeted cell-depleting therapies is limited by potentially severe toxicities due to the near ubiquitous expression of the target on hematopoietic cells. In contrast, the molecular shielding of CD45 will allow a patient to develop a healthy, protected and fully functional hematopoietic system, ensuring the paired immunotherapy targets just the diseased host cells.

A poster titled, "Molecular Shielding of the Pan-Hematopoietic Marker CD45 May Enable a Targeted Universal Approach for Replacement of the Hematopoietic System," was authored by Lukas T. Jeker, M.D., Ph.D., co-founder of Cimeio and Professor of Experimental Transplantation Immunology & Nephrology at the Department of Biomedicine, University of Basel and at the Basel University Hospital, Switzerland.

Key takeaways from the poster are as follows:

Engineered HSCs were generated expressing a stable variant of CD45 and demonstrated no binding to the paired immunotherapy
A novel, humanized, potent CD45-targeting antibody-drug conjugate (ADC) was developed that killed CD45 cancer cells in vitro while sparing edited cells from depletion
In vivo experiments showed efficient engraftment and differentiation of the engineered CD45 variant HSCs, as well as shielding and strong enrichment in combination with the CD45 immunotherapy
"Cimeio’s platform continues to show potential as a safe and efficient method to enable HSC transplants for patients suffering from a variety of severe diseases," said Dr. Jeker. "I look forward to the continued progress of the CD45 program, as well as the additional programs in the company’s deep pipeline of medicines."

On May 16, 2023 Catalent, the leader in enabling the development and supply of better treatments for patients worldwide, reported that George Buchman, Ph.D., Vice President, Pre-Clinical and Process Development, will present at the upcoming 26th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper), which is being held at the Los Angeles Convention Center on May 16-20, 2023 (Press release, Catalent, MAY 16, 2023, https://www.catalent.com/catalent-news/catalent-to-present-on-integrated-uptempo-gene-therapy-development-platform/ [SID1234631769]).

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Dr. Buchman’s presentation, on Friday, May 19, at 4:30 p.m. PDT, is entitled "One-stop Integrated Viral Vector Platform for Speed to Clinic," and will focus on a consolidated and standardized platform to help fast-track AAV vectors to the clinic with a scalable CGMP-ready process. The complete UpTempo℠ AAV platform, which was re-launched in its expanded form in March 2023, provides increased consistency and efficiency, reducing the time to manufacture clinical-quality drug product to just nine months, while delivering a process that will readily advance to late-stage CGMP manufacture.

Dr. Buchman works in Catalent’s Cell & Gene Therapy business, which provides research services and process development and enables the translation of programs into clinical trials and commercial CGMP manufacturing. He has worked more than 30 years in the biotech industry, including at Life Technologies (now Thermo Fisher Scientific), Celera Genomics, and GeneLogic. Dr. Buchman obtained his bachelor’s degree in biochemistry from Albright College, Reading, Pennsylvania, and his doctorate in biochemistry from the University of Maryland.

Catalent will also be exhibiting at the conference, in booth 229. To find out more information about this event, visit https://www.catalent.com/events/asgct-annual-meeting-2023/ and to find out more about Catalent’s UpTempo AAV platform, visit Catalent.com/UpTempo.