Geron Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

On October 19, 2023 Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, reported that it has granted non-statutory stock options to purchase an aggregate of 401,220 shares of Geron common stock as inducements to newly hired employees in connection with commencement of employment with the Company (Press release, Geron, OCT 19, 2023, View Source [SID1234636143]).

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The stock options were granted on October 18, 2023 at an exercise price of $1.77 per share, which is equal to the closing price of Geron common stock on the date of grant. Stock options representing an aggregate of 396,000 shares have a 10-year term and vest over four years, with 12.5% of the shares underlying the options vesting on the six-month anniversary of commencement of employment for the respective employees and the remaining shares vesting over the following 42 months in equal installments of whole shares, subject to continued employment with Geron through the applicable vesting dates. Stock options representing an aggregate of 5,220 shares have a 10-year term and vest in full upon achievement of a certain regulatory milestone, subject to continued employment with Geron through the applicable vesting date. All of the stock options were granted as material inducement to employment in accordance with Nasdaq Listing Rule 5635(c)(4) and are subject to the terms and conditions of the stock option agreements covering the grants and Geron’s 2018 Inducement Award Plan, which was adopted December 14, 2018 and provides for the granting of stock options to new employees.

Emergent BioSolutions to Release Third Quarter 2023 Financial Results and Conduct Conference Call on November 2, 2023

On October 19, 2023 Emergent BioSolutions Inc. (NYSE: EBS) reported that it will host a conference call on Thursday, November 2, 2023, at 5:00 pm eastern time to discuss the financial results for the third quarter of 2023, recent business developments, and financial outlook for full year 2023 (Press release, Emergent BioSolutions, OCT 19, 2023, View Source [SID1234636142]).

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Conference Call Information
Participants can access the conference call live via webcast from the Investors page of Emergent’s website. To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call.

A replay of the call can be accessed from the Investors page of Emergent’s website.

Circio: circRNA poster to be presented at the 30th European Society for Gene and Cell Therapy (ESGCT)

On October 19, 2023 Circio Holding ASA (OSE: CRNA) reported that an abstract describing its circular RNA technology has been accepted for poster presentation at the 30th i European Society for Gene and Cell Therapy in Brussels, Belgium (Press release, Circio, OCT 19, 2023, View Source [SID1234636141]).

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The poster is scheduled for presentation 25-26 October 2023 and will be available on Circio’s website after the presentation.

Poster title: circVec, a versatile circular RNA vector cassette for enhanced and durable intra-cellular protein expression
Date and time: Wednesday 25 October 2023, 17:00- 18:16 CEST and Thursday 26 October 2023, 20:30-21:30 CEST
Location: Brussels, Belgium
Poster number: P803
Presenter: Thomas Birkballe Hansen, VP and Head of Research, Erik Digman Wiklund, CEO

Phase 3 CheckMate -67T Trial of Subcutaneous Nivolumab (nivolumab and hyaluronidase) Meets Co-Primary Endpoints in Advanced or Metastatic Clear Cell Renal Cell Carcinoma

On October 19, 2023 Bristol Myers Squibb (NYSE: BMY) reported that the Phase 3 CheckMate -67T noninferiority trial evaluating the subcutaneous formulation of Opdivo (nivolumab) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20) (herein referred to as "subcutaneous nivolumab") compared to intravenous (IV) Opdivo in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have received prior systemic therapy met its co-primary pharmacokinetics endpoints and key secondary endpoint (Press release, Bristol-Myers Squibb, OCT 19, 2023, View Source;67T-Trial-of-Subcutaneous-Nivolumab-nivolumab-and-hyaluronidase-Meets-Co-Primary-Endpoints-in-Advanced-or-Metastatic-Clear-Cell-Renal-Cell-Carcinoma/default.aspx [SID1234636139]). Subcutaneous nivolumab demonstrated noninferiority of Cavgd28 (time-averaged Opdivo serum concentration over 28 days) and Cminss (trough serum concentration at steady state) compared to IV Opdivo, the study’s co-primary endpoints. Additionally, subcutaneous nivolumab showed a noninferior objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) vs. IV Opdivo, a key secondary endpoint. The safety profile of subcutaneous nivolumab was consistent with the IV formulation.

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"Intravenous Opdivo has helped transform the treatment of several solid tumor types over the past decade, but there remains a need for additional administration options to address treatment burden on patients and improve efficiencies in healthcare systems," said Gina Fusaro, Ph.D., vice president, global program lead, Bristol Myers Squibb. "We are delighted that the results of CheckMate -67T demonstrate that subcutaneous nivolumab delivers noninferior pharmacokinetics, in addition to objective response rate and safety data consistent with IV Opdivo. We believe this new option, given as a single injection administered in less than five minutes, could transform the treatment experience for both patients and physicians."

The company will complete a full evaluation of the available CheckMate -67T trial data and work with investigators to present the results at an upcoming medical conference. The company also looks forward to discussing next steps for subcutaneous nivolumab with health authorities across multiple indications. Study follow-up is ongoing to assess additional secondary efficacy and safety endpoints.

Bristol Myers Squibb thanks the patients and investigators involved in the CheckMate -67T clinical trial.

About CheckMate -67T

CheckMate -67T is a Phase 3 randomized, open-label trial evaluating subcutaneous administration of Opdivo co-formulated with Halozyme’s proprietary recombinant human hyaluronidase, rHuPH20, or subcutaneous nivolumab (nivolumab and hyaluronidase) compared to intravenous (IV) Opdivo, in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have received prior systemic therapy. This trial presents an opportunity to potentially bring a subcutaneous formulation of Opdivo to patients. A total of 495 patients were randomized to either subcutaneous nivolumab or IV Opdivo. The co-primary endpoints of the trial are time-averaged serum concentration over 28 days (Cavgd28) and trough serum concentration at steady-state (Cminss) of subcutaneous nivolumab vs. IV Opdivo. Objective response rate (ORR) is a key secondary endpoint.

About Renal Cell Carcinoma

Renal cell carcinoma (RCC) is the most common type of kidney cancer in adults, accounting for more than 431,000 new cases and 179,000 deaths worldwide each year. RCC is approximately twice as common in men as in women, with the highest rates of the disease in North America and Europe. Clear cell renal carcinoma (ccRCC) is the most common form of RCC, affecting about 7 out of 10 people with RCC. The five-year survival rate for those diagnosed with metastatic, or advanced, kidney cancer is 14% and five-year disease-free survival (DFS) rates for those with localized disease that can be resected are just over 50%.

BioNTech Expands Late-Stage Clinical Oncology Portfolio with Initiation of further Phase 2 Trial with mRNA-based Individualized Neoantigen Specific Immunotherapy in New Cancer Indication

On October 19, 2023 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported that the first patient has been treated in a Phase 2 clinical trial evaluating the mRNA-based individualized neoantigen-specific immunotherapy (iNeST) candidate autogene cevumeran (also known as BNT122, RO7198457) in resected pancreatic ductal adenocarcinoma (PDAC) (Press release, BioNTech, OCT 19, 2023, View Source [SID1234636138]). PDACs are solid tumors with a poor prognosis reflected in a 5-year overall survival rate of only 8-10%1,2, high recurrence rates3 and limited treatment options.

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Autogene cevumeran, which is being jointly developed by BioNTech and Genentech, a member of the Roche Group, is a therapeutic, individualized cancer vaccine candidate encoding up to 20 patient-specific cancer mutations selected for their proficiency to serve as neoantigens. Neoantigens are proteins that are produced by cancer cells that differ from the proteins produced by healthy cells. The investigational treatment aims to induce a neoantigen-directed immune response against the patient’s individual tumor.

The open-label, multicenter, randomized Phase 2 trial (NCT05968326), sponsored by Genentech, will evaluate the efficacy and safety of autogene cevumeran in combination with anti-PD-L1 immune checkpoint inhibitor atezolizumab and chemotherapy compared to the current standard-of-care chemotherapy (mFOLFIRINOX). The Phase 2 study is expected to enroll 260 patients with resected PDAC, who have not received prior systemic anti-cancer treatment and showed no evidence of disease after surgery. The trial will be conducted at various sites in the United States, followed by Europe and Asia Pacific region. The primary endpoint is disease-free survival. Secondary endpoints include disease-free survival rates, overall survival, overall survival rate and safety profile.

The Phase 2 initiation is based on data from an investigator-initiated, single-center Phase 1 trial (NCT04161755) evaluating the combination of autogene cevumeran (BNT122, RO7198457), atezolizumab, and chemotherapy (mFOLFIRINOX) in patients with resected PDAC. Preliminary data of the Phase 1 trial were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting in June 2022 and complete study results were recently published in Nature, demonstrating a favorable safety profile and substantial vaccine-induced T cell responses that may correlate with delayed PDAC recurrence.

"PDAC is a tumor type for which the relapse rate after surgery is extremely high at nearly 80%. The recent Phase 1 study has shown that individualized neoantigen vaccination is feasible for this tumor type with low mutational burden and an immunosuppressive microenvironment3. We have been evaluating cancer mutations since the start of the first clinical trial based on our mRNA technology in 2014 with the hypothesis that they could be suitable targets for individualized cancer vaccines," said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. "The Phase 2 study will provide additional data whether our approach with autogene cevumeran has the potential to provide a benefit for patients in this high unmet medical need setting. Our aim is to prevent relapses and thus ensure that the disease is managed at the earliest possible stage."

Autogene cevumeran (BNT122, RO7198457) is part of BioNTech’s and Genentech’s worldwide strategic collaboration to develop, manufacture and commercialize novel mRNA-based, individualized cancer vaccines, which was initiated in 2016. Autogene cevumeran is currently being evaluated in various solid tumor indications, including a Phase 2 trial (NCT04486378) in the adjuvant treatment of surgically resected colorectal cancer, a Phase 2 proof-of-concept study (NCT03815058) of autogene cevumeran in combination with pembrolizumab in the first-line treatment of advanced melanoma and a Phase 1a/b trial in locally advanced or metastatic tumors (NCT03289962). The Phase 2 trial of autogene cevumeran in patients with PDAC is the third later-stage trial based on BioNTech’s individualized cancer vaccine platform iNeST.

About resected pancreatic ductal adenocarcinoma (PDAC)
PDAC is amongst the leading causes of cancer-related deaths in the United States4 with approximately 90% of patients dying within two years of their diagnosis5. A combination of surgical removal and systemic cytotoxic chemotherapy has shown to improve clinical outcomes, however, even with surgical resection, the relapse rate remains high, and the 5-year overall survival is only approximately 20%6 in patients who undergo surgery followed by adjuvant chemotherapy ("ACT") and only 8-10%1,2 in those who do not receive ACT. Thus, there is a high unmet medical need for novel therapies for patients with resected PDAC. The individualized neoantigen specific immunotherapy ("iNeST") candidate autogene cevumeran (BNT122, RO7198457) provides a novel treatment strategy aimed to induce de-novo immune responses against cancer-specific neoantigens, recognize residual cancer cells and to prevent relapse.

About iNeST (individualized Neoantigen Specific immunoTherapy)
iNeST immunotherapies are individualized cancer therapies tailored to a specific patient’s tumor. They contain unmodified, pharmacologically optimized mRNA encoding up to 20 patient-specific neoantigens, identified using real-time next generation sequencing and bioinformatic neoantigen discovery. Neoantigens are proteins that are produced by cancer cells that differ from the proteins produced by healthy cells and are recognized by immune cells. The mRNA is encapsulated in BioNTech’s proprietary intravenous RNA-lipoplex delivery formulation which is designed to enhance stability as well as enable targeted delivery to dendritic cells. By analyzing each patient’s tumor, BioNTech is able to identify the cancer mutations that may act as neoantigens. Each individual cancer vaccine encodes for neoantigen candidates with the highest likelihood to help the immune system to recognize the cancer. For this purpose, BioNTech has developed an on-demand manufacturing process, following Good Manufacturing Practice (GMP) conditions.

An iNeST Fact Sheet and images from the iNeST manufacturing process are available in the newsroom section on BioNTech’s website at this link.