On October 12, 2021 Cellectis S.A. (NASDAQ: CLLS – EURONEXT GROWTH: ALCLS) (the "Company"), a gene-editing platform company with clinical-stage immuno-oncology programs using allogeneic chimeric antigen receptor (CAR)-T cells and gene therapy programs for genetic diseases, reported that pre-clinical data that support anti-tumor activity of UCARTMESO will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 36th Annual Meeting (SITC 2021), to be held in Washington, D.C. and virtually on November 10 to 14, 2021 (Press release, Cellectis, OCT 12, 2021, View Source [SID1234591101]).

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Cellectis will present a poster on UCARTMESO, an allogeneic CAR-T cell product candidate targeting mesothelin – expressing solid tumors. Mesothelin is a tumor-associated antigen that is highly and consistently expressed in mesothelioma and pancreatic cancer and is also over-expressed in subsets of other solid tumors (ovarian cancer, non-small cell lung cancer, gastric cancer, triple-negative breast cancer). UCARTMESO also leverages its TALEN gene editing technology to resist immune suppression mediated by TGFβ.

Last May, during its Innovation Days, Cellectis announced the development of the new pre-clinical UCART product candidates targeting B-cell lymphomas and venturing for the first time into the solid tumor space.

Presentation Details:

Title: Mesothelin (MSLN) targeting allogeneic CAR-T cells engineered to overcome tumor immunosuppressive microenvironment

Poster Number: 143

Presenter: Roman Galetto, Ph.D, Director, Preclinical and Program Management

Date/Time: Friday November 12, 7:00AM – 8:30PM, Walter E. Washington Convention Center, Poster Hall (Hall E)

Full text of the abstracts will be released on the SITC (Free SITC Whitepaper) website at 7:00 a.m. ET on November 12, 2021.

On October 12, 2021 Sutro Biopharma, Inc. (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation cancer and autoimmune therapeutics, and BioNova Pharmaceuticals Limited (BioNova), a company dedicated to the discovery, development and commercialization of innovative medicines for the treatment of diseases with unmet medical needs, reported an option agreement for BioNova to develop and commercialize STRO-001, a CD74-targeting Antibody-Drug Conjugate (ADC), for patients with hematologic cancers, in Greater China, including mainland China, Hong Kong, Macau and Taiwan (Press release, Sutro Biopharma, OCT 12, 2021, View Source [SID1234591100]).

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Under the terms of the agreement, BioNova has the option to obtain exclusive rights to develop and commercialize STRO-001 in Greater China. BioNova will pursue the clinical development, regulatory approval, and commercialization of STRO-001 in multiple indications, including non-Hodgkin’s lymphoma, multiple myeloma, and leukemia in the licensed territory. Sutro will retain development and commercial rights of STRO-001 globally outside of Greater China, including the United States. BioNova will pay to Sutro an initial licensing option payment of $4 million, with potential payments totaling up to $200 million related to option exercise, development, regulatory, and commercial milestones. Sutro will provide STRO-001 to BioNova under appropriate clinical and commercial supply service agreements. Upon commercialization, Sutro will receive tiered, double-digit royalties based on annual net sales of STRO-001 in Greater China.

"This strategic partnership of STRO-001 at this stage of its clinical development demonstrates the shared vision of Sutro and BioNova of the potential for this promising ADC," said Bill Newell, Chief Executive Officer of Sutro. "We believe BioNova is an ideal partner, having demonstrated success in business and clinical development and backed by marquee healthcare investors, to realize the potential for STRO-001 in multiple hematological cancers in Greater China, where there is a large unmet medical need."

"We are excited for the therapeutic potential of STRO-001 to be studied in new hematological cancers and in earlier disease settings," said Arturo Molina, Chief Medical Officer of Sutro. "In our clinical studies in the United States, we are exploring STRO-001 as a treatment for patients in later stages of multiple myeloma and non-Hodgkin’s lymphoma, including diffuse large B-cell lymphoma, mantle cell lymphoma, and follicular lymphoma. We are approaching optimized dose levels in our dose-escalation trial—5.0 mg/kg in the multiple myeloma cohort and 4.2mg/kg in the non-Hodgkin’s lymphoma cohort."

Ye Hua, MD, MPH, founder, Chairman and Chief Executive Officer of BioNova added, "We are excited to collaborate with Sutro, a leading ADC technology company with a proprietary protein synthesis platform, to develop and commercialize STRO-001 in Greater China. STRO-001 has shown encouraging early efficacy signals and good tolerability profile in relapsed/refractory hematologic malignancies in the Phase 1 dose-escalation study. Given our strength in drug development in Greater China, we are committed to expedite the development of STRO-001 into Phase 2 expansion in multiple hematologic malignancies to fully explore the therapeutic potential of this ADC. The partnership further strengthens BioNova’s position in hematology and brings synergistic potential to our existing pipeline."

About STRO-001
STRO-001 is a CD74-targeting ADC, based on Sutro’s integrated cell-free protein synthesis and site-specific conjugation platform, XpressCF+, currently being investigated in a Phase 1 clinical trial. Sutro is currently enrolling patients with multiple myeloma and non-Hodgkin’s lymphoma in a dose-escalation trial and the maximum tolerated dose has not yet been reached. STRO-001 was granted Orphan Drug Designation by the FDA for multiple myeloma in October 2018.

On October 12, 2021 Eli Lilly and Company (NYSE: LLY) reported that it will announce its third-quarter 2021 financial results on Tuesday, October 26, 2021 (Press release, Eli Lilly, OCT 12, 2021, View Source [SID1234591099]). Lilly will also conduct a conference call on that day with the investment community and media to further detail the company’s financial performance.

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The conference call will begin at 9 a.m. Eastern time. Investors, media and the general public can access a live webcast of the conference call through a link that will be posted on Lilly’s website at View Source A replay will also be available on the website following the conference call.

On October 12, 2021 Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, reported the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for TARA-002, an investigational cell-based therapy being developed for the treatment of non-muscle invasive bladder cancer (NMIBC) (Press release, Protara Therapeutics, OCT 12, 2021, View Source [SID1234591095]). Protara expects to initiate a Phase 1 clinical trial of TARA-002 in adults with high-grade NMIBC by the end of 2021.

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"We are thrilled to have reached this important milestone and look forward to quickly initiating our Phase 1 study in patients with NMIBC," said Jesse Shefferman, Chief Executive Officer of Protara Therapeutics. "There is an urgent need for new treatments for NMIBC. We are seeing significant increases in recurrence and disease progression, as well as an escalating number of patients requiring cystectomies. Supported by the strength of the existing clinical data in NMIBC for OK-432, the originator therapy for TARA-002, we believe this treatment represents a promising new option for NMIBC patients."

The Phase 1 dose-finding, open-label trial will evaluate TARA-002 in treatment-naïve and treatment-experienced NMIBC patients with high-grade carcinoma in situ (CIS) and high-grade papillary tumors (Ta). In the initial dose escalation phase of the trial, patients will receive six weekly intravesical doses of TARA-002. The primary objective of the trial is to evaluate the safety, tolerability and preliminary signs of anti-tumor activity of TARA-002, with the goal of establishing a maximum tolerated dose and recommended dose for a future Phase 2 clinical trial.

TARA-002 is manufactured from the same cell bank as OK-432, an approved therapy in Japan and Taiwan for multiple oncologic indications. In 2020, Protara successfully demonstrated initial manufacturing comparability between TARA-002 and OK-432. The confirmatory, GMP-scale comparability data for TARA-002 in relation to OK-432 have been completed and were reviewed by FDA as part of the clearance of the IND.

About TARA-002
TARA-002 is an investigational cell therapy in development for the treatment of non-muscle invasive bladder cancer and lymphatic malformations (LMs) for which it has been granted Rare Pediatric Disease Designation by the U.S. Food and Drug Administration. TARA-002 was developed from the same master cell bank of genetically distinct group A Streptococcus pyogenes as OK-432, a broad immunopotentiator marketed as Picibanil in Japan and Taiwan by Chugai Pharmaceutical Co., Ltd. Protara has successfully demonstrated manufacturing comparability between TARA-002 and OK-432.

When TARA-002 is administered, it is hypothesized that innate and adaptive immune cells within the cyst or tumor are activated and produce a strong immune cascade. Neutrophils, monocytes and lymphocytes infiltrate the abnormal cells and various cytokines, including interleukins IL-6, IL-8, IL-12, interferon-gamma (IFN-γ)-, tumor necrosis factor-alpha (TNF-α), and vascular endothelial growth factor (VEGF) are secreted by immune cells to induce a strong local inflammatory reaction and destroy the abnormal cells.

About Non-Muscle Invasive Bladder Cancer
Bladder cancer is the 6th most common cancer in the United States, with NMIBC representing approximately 80% of bladder cancer diagnoses. Approximately 65,000 patients are diagnosed with NMIBC in the United States each year. NMIBC is cancer found in the tissue that lines the inner surface of the bladder that has not spread into the bladder muscle.

On October 12, 2021 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported through a subsidiary, a cash tender offer to purchase all outstanding shares of common stock of Acceleron Pharma Inc. (Nasdaq: XLRN) (Press release, Merck & Co, OCT 12, 2021, View Source [SID1234591094]). On Sept. 30, 2021, Merck announced that it had entered into a definitive agreement to acquire Acceleron.

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Upon the successful closing of the tender offer, stockholders of Acceleron will receive $180 in cash for each share of Acceleron common stock validly tendered and not validly withdrawn in the offer, without interest and less any required tax withholding. Following the purchase of shares in the tender offer, Acceleron will become a subsidiary of Merck.

Merck will file today with the U.S. Securities and Exchange Commission (the "SEC") a tender offer statement on Schedule TO, which provides the terms of the tender offer. Additionally, Acceleron will file with the SEC a solicitation/recommendation statement on Schedule 14D-9 that includes the recommendation of the Acceleron board of directors that their stockholders accept the tender offer and tender their shares.

The tender offer will expire at 5:00 p.m., Eastern Time, on Nov. 10, 2021, unless extended in accordance with the merger agreement and the applicable rules and regulations of the SEC. The closing of the tender offer is subject to certain conditions, including the tender of shares representing at least a majority of the total number of Acceleron’s outstanding shares, receipt of applicable regulatory approvals, and other customary conditions. The transaction is expected to close in the fourth quarter of 2021.