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G1 Therapeutics Announces Permanent J-Code from Centers for Medicare and Medicaid Services

On October 1, 2021 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported that the permanent J-code for COSELA (trilaciclib) that was issued in July 2021 by the Centers for Medicare & Medicaid Services (CMS) is now effective for provider billing for all sites of care (Press release, G1 Therapeutics, OCT 1, 2021, View Source [SID1234590614]). The permanent J-code for COSELA, J1448 (Injection, trilaciclib, 1mg.), published online on the CMS website here (page 5).

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J-codes are permanent, product specific reimbursement codes assigned to outpatient and physician administered "buy and bill" products under Medicare Part B and are used by commercial insurers and government payers to facilitate and standardize claims submissions and reimbursements for medications like COSELA. With the permanent J-code now in effect, all hospital outpatient departments, ambulatory surgery centers and physician offices in the United States will have one consistent Healthcare Common Procedure Coding System (HCPCS) code to standardize the submission and payment of COSELA insurance claims across Medicare, Medicare Advantage, Medicaid and commercial plans.

"Given the emergent presentation of extensive-stage small cell lung cancer, and the clinical benefits of COSELA as a proactive multilineage myeloprotection drug when give prior to chemotherapy, it is absolutely essential that patients have timely access to it," said Jack Bailey, Chief Executive Officer of G1 Therapeutics. "We are pleased to receive this new permanent J-code for all sites of care as it will enable a more efficient billing process, which will ultimately help facilitate patient access to COSELA."

G1’s new technology add-on payment (NTAP) for COSELA which provides additional payment to inpatient hospitals above the standard Medicare Severity Diagnosis-Related Group (MS-DRG) payment amount also became effective for provider billing today, October 1, 2021.

About COSELA (trilaciclib) for Injection

COSELA (trilaciclib) was approved by the U.S. Food and Drug Administration on February 12, 2021.

Indication
COSELA (trilaciclib) is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer.

Important Safety Information
COSELA is contraindicated in patients with a history of serious hypersensitivity reactions to trilaciclib.

Warnings and precautions include injection-site reactions (including phlebitis and thrombophlebitis), acute drug hypersensitivity reactions, interstitial lung disease (pneumonitis), and embryo-fetal toxicity.

The most common adverse reactions (>10%) were fatigue, hypocalcemia, hypokalemia, hypophosphatemia, aspartate aminotransferase increased, headache, and pneumonia.

This information is not comprehensive. Please click here for full Prescribing Information. View Source

Juntendo University and Astellas Establish "Direct Reprogramming Regenerative Medicine Course" for Scientific Breakthroughs

On October 1, 2021 Juntendo University (President: Hajime Arai, M.D., Ph.D.) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") reported that the parties have established, inside Juntendo University Graduate School of Medicine, a joint research course entitled, "Direct Reprogramming Regenerative Medicine Course" （Professor & Director, Diagnostics and Therapeutics of Interactable Diseases, Intractable Disease Research Center, Genome Medical Center: Yasushi Okazaki M.D., Ph.D., Specially Appointed Professor: Masahito Matsumoto, Ph.D.） (Press release, Astellas, OCT 1, 2021, View Source [SID1234590612]). The course will be retained for a term of three years from October 2021.

This joint research course aims to create a new modality that maximizes the therapeutic effect for diseases with high unmet medical needs, such as type 1 diabetes, by direct reprogramming using the K factor*1 . Itwill also conduct research to expand this modality to other diseases. Juntendo University Graduate School of Medicine will be acquiring the basic data including the study of the optimal combination of direct reprogramming factors that include the K factor, and Astellas will be conducting the applied research for disease treatment by gene therapy using this factor and selection of the optimal modality.

Direct reprogramming is a biology that directly converts the fate of cells without passing through the pluripotent state. The technology that enables direct reprogramming in vivo has attracted attention as a new regenerative medicine technology. Unlike conventional therapies, direct reprogramming not only removes unwanted cells or replenishes necessary cells; it also converts unnecessary cells into necessary cells. It is therefore expected to show high efficacy against intractable diseases that have been thought to be incurable.

Juntendo University and Astellas have been conducting joint research collaboration on the establishment of differentiation methods for therapeutic cells by direct reprogramming based on the agreement executed in 2018. This time, as part of this joint research collaboration, the two parties have established this joint research course to further strengthen the partnership and progressively conduct research on direct reprogramming as a new therapeutic paradigm.

Through this joint research course, Juntendo University and Astellas will take on the challenge of drug discovery based on direct reprogramming technology, with the aim of providing patients with new treatment options.

Boehringer Ingelheim and OSE Immunotherapeutics Announce First Patient Dosed in Phase 1 Expansion Trial of BI 765063 in combination with anti-PD-1 Antibody Ezabenlimab, in Patients with Advanced Endometrium or Colorectal Tumors

On September 30, 2021 Boehringer Ingelheim and OSE Immunotherapeutics reported that the first patient has been dosed in the expansion phase of the Phase 1 clinical trial evaluating BI 765063, a first-in-class monoclonal antibody antagonist of SIRPα, in combination with ezabenlimab, an anti-PD1 monoclonal antibody (BI 754091) in patients with microsatellite stable (MSS) advanced endometrium or colorectal cancer (Press release, OSE Immunotherapeutics, SEP 30, 2021, View Source [SID1234646968]). Both tumors are with a high unmet medical need. BI 765063 is a first-in-class SIRPα inhibitor on the CD47/ SIRPα "Don’t eat me" pathway being developed under collaborative agreement between OSE Immunotherapeutics and Boehringer Ingelheim.

Alexis Peyroles, Chief Executive Officer of OSE Immunotherapeutics, said: "In Step 2 of the Phase 1 trial, we look forward to hopefully confirming the safety and expanding on the early signals of clinical efficacy of BI 765063 in two debilitating tumor types, advanced colorectal and advanced endometrium. This also marks the next planned milestone in our collaboration agreement with Boehringer Ingelheim which provides OSE with a continued stable financial base to steadily grow our first-in-class immunooncology pipeline."

The dose escalation part of the Phase 1 trial (Step 1), evaluating BI 765063 alone and in combination with ezabenlimab, has been completed with a total of 18 patients enrolled in combination. Patients with advanced solid tumours and who failed or were not eligible for standard therapy were enrolled from two prespecified groups: (1) patients who are genetically SIRPα homozygous (V1/V1) or (2) heterozygous (V1/V2). Two dose levels of BI 765063 (18 and 24 mg/kg IV every 3 weeks) were evaluated in combination with ezabenlimab (240 mg IV every 3 weeks).

During the dose escalation, BI 765063 alone or in combination was well tolerated with no haematologic toxicity and the maximum tolerated dose (MTD) was not reached. The recommended Phase 2 dose (24 mg/kg) and optimal treatment schedule of BI 765063 was established with assays determining full receptor occupancy from cycle 1 and using a once every three week dosing schedule. In addition, promising early efficacy of BI 765063 was observed both alone and in combination, especially in advanced hepatocellular carcinoma, endometrium and colorectal cancer, including microsatellite stable (MSS) tumors. Promising early efficacy was observed with one partial response (PR) in monotherapy in a patient with advanced hepatocellular carcinoma and three partial responses in combination in patients with MSS advanced endometrium or colorectal cancer.

The trial expansion aims to further assess preliminary efficacy of BI 765063 in combination with ezabenlimab in two selected tumor types of V1/V1 homogygous patients from whom a clinical benefit has been observed: MSS advanced colorectal cancer (around 30 patients) and MSS advanced endometrium cancer (around 10 patients) whose disease relapsed after standard of care and who received no prior anti-PD-L1 inhibitors.

The study is being conducted by OSE Immunotherapeutics as part of a collaboration and license agreement under which Boehringer Ingelheim obtained exclusive rights to BI 765063. Under the terms of the collaboration and license agreement, dosing of the first patient in expansion of this Phase 1 trial triggers a milestone payment of €8 million to OSE Immunotherapeutics from Boehringer Ingelheim.

ABOUT BI 765063 (formerly OSE-172)
BI 765063 is a monoclonal antibody antagonist of the key myeloid cell checkpoint inhibitor SIRPα. BI 765063 prevents the SIRPα ligand CD47, from binding to SIRPα thereby preventing cellular signalling that can reduce the anti-tumorigenic properties of myeloid cells such as macrophages and dendritic cells. In March 2019, OSE Immunotherapeutics received Clinical Trial Authorization for a Phase 1 study by two health agencies (France and Belgium) to evaluate BI 765063 in patients with advanced solid tumors. The study is conducted by OSE Immunotherapeutics as part of a collaboration and license agreement under which Boehringer Ingelheim obtained exclusive rights to BI 765063, originally signed in April 2018.

Optieum Biotechnologies Raises JPY 290 million ($ 2.6 million) in Seed Round Funding

On September 30, 2021 Optieum Biotechnologies reported that the company has raised JPY 290 million ($ 2.6 million) in seed round funding (Press release, Optieum Biotechnologies, SEP 30, 2021, View Source [SID1234639140]). The round was led by ANRI and the participation of Real Tech Fund, Iyogin Capital and an angel investor.

Optieum Biotechnologies Inc. is a biotechnology company committed to develop innovative scFv antibody-based therapies for the treatment of cancer patients. Our proprietary platform technology, Eumbody System, enables us to develop and detect scFv-based product candidates that specifically bind, modulate, and ultimately enhance the immune-cell function for oncology targets.

With this funding, we will continue to expand the platform technology and accelerate the collaboration with pharmaceutical companies as well as the development of in-house CAR-T cell programs.

We are committed to go beyond the limits of immuno-oncology drug development and deliver the most appropriate treatment for the cancer patients in needs.

PharmaMar announces the approval of Zepzelca™ (lurbinectedin) for the treatment of relapsed stage III or metastatic small cell lung cancer in Canada

On September 30, 2021 PharmaMar (MSE:PHM) reported that its licensing partner, Jazz Pharmaceuticals plc (Nasdaq: JAZZ), has received conditional approval from Health Canada for ZepzelcaTM (lurbinectedin) for the treatment of adult patients with relapsed stage III or metastatic small cell lung cancer (SCLC), with disease progression on or after platinum-based chemotherapy (Press release, PharmaMar, SEP 30, 2021, View Source [SID1234596671]). Lurbinectedin will be available in Canada later this year.

This new approval of lurbinectedin is based on the same monotherapy clinical data from the open-label, multi-center, single-arm study in 105 adult patients with relapsed SCLC (including patients with platinum-sensitive and platinum-resistant disease) that the Food and Drug Administration (FDA) used to grant accelerated approval for lurbinectedin in the US. The data, which was published in the May 2020 issue of The Lancet Oncology, showed that in relapsed SCLC, lurbinectedin demonstrated an Objective Response Rate (ORR) of 35% and a median Duration of Response (DoR) of 5.3 months as measured by investigator assessment (30% and 5.1 months respectively, as measured by an independent review committee (IRC)).

The conditional approval is subject to confirmation in a Phase III study in 2 nd line SCLC, planned to be initiated by the end of 2021.

"We are pleased to bring a new treatment choice to Canadian patients with relapsed SCLC," said José María Fernández, PhD, President of PharmaMar. "Canada is the fifth country to approve lurbinectedin for the treatment of SCLC, following in the footsteps of the United States, the United Arab Emirates and, more recently, Australia and Singapore. We are confident that further approvals will be granted soon in more countries.