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Integral Molecular Partnership: Context Therapeutics® Nominates CTIM-76 Bispecific Antibody Candidate to Develop Treatment for Claudin 6-Positive Solid Tumors

ON November 29, 2022 Context Therapeutics Inc. ("Context" or the "Company") (Nasdaq: CNTX), a women’s oncology company developing novel treatments for breast and gynecologic cancers, reported the selection of CTIM-76, a T cell-engaging bispecific antibody, as its lead clinical development candidate to target Claudin 6 (CLDN6) positive cancers, resulting from its research collaboration and licensing agreement with Integral Molecular (Press release, Integral Molecular, NOV 29, 2022, View Source [SID1234624604]).

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CLDN6 is differentially expressed on cancer cells with no or very low expression in normal, healthy tissue. CLDN6-enriched cancers include ovarian, endometrial, testicular, and gastric, among others. With the potential to reach a large patient population and selective expression on cancer cells, CLDN6 has emerged as an exciting drug target.

Context’s lead candidate, CTIM-76, is a CLDN6 x CD3 bispecific antibody that incorporates a highly selective CLDN6 binding arm and a CD3 binding single-chain Fv domain in an IgG format with a silenced Fc that is designed to be functionally monovalent to avoid aberrant T-cell activation and to enhance the safety profile. Research has demonstrated that CTIM-76 is potent with specific lysis of CLDN6+ cancer cells over normal cells and can activate cytotoxic T cells without concomitant activation of free cytokines – critical determinants of immunotherapy safety and activity. Preclinical studies suggest the potential for convenient dosing with low immunogenicity risk and manufacturing can be scalable to address the significant number of patients who are potentially eligible for CTIM-76 therapy.

"This year has been marked by several exciting and significant milestones for Context, culminating in naming our lead CLDN6 clinical development candidate, CTIM-76, a bispecific antibody showing high selectivity for CLDN6," said Martin Lehr, CEO of Context Therapeutics. "We selected this bispecific based on the specificity which suggests its potential to address the need for potent therapeutic modalities for cancer without compromising patient safety. With the selection of CTIM-76 as our lead CLDN6 candidate, we are well-positioned to rapidly advance our clinical development plan in CLDN6-positive tumors including, but not limited to, ovarian cancer. We have initiated IND-enabling studies and expect to submit our Investigational New Drug Application (IND) for CTIM-76 to the U.S. Food and Drug Administration in Q1 2024."

"Despite being an attractive target, therapeutic monoclonal antibodies (MAbs) targeting CLDN6 are difficult to discover due to an abundance of closely related family members and an absolute need for high specificity. Context and Integral Molecular have been able to isolate and optimize rare antibodies against CLDN6 that do not cross-react with other CLDN family members," said Joseph Rucker, Ph.D., VP of R&D at Integral Molecular.

R&D Webinar
On Thursday, December 1, 2022, at 11 a.m. ET, members of the Context team, including management, and Integral Molecular will host a webinar to discuss the selection process and nomination of CTIM-76. There will be a question-and-answer period following the formal presentation. To register for the webinar, please visit View Source

Entry into a Material Definitive Agreement

On November 29, 2022, bluebird bio, Inc. (the "Company") reported that it has entered into an asset purchase agreement (the "PRV Transfer Agreement") with argenx BV ("Buyer"), pursuant to which the Company agreed to sell a Rare Pediatric Disease Priority Review Voucher ("PRV") to Buyer (Press release, bluebird bio, NOV 30, 2022, View Source [SID1234624594]). The Company was awarded the voucher under a U.S. Food and Drug Administration ("FDA") program intended to encourage the development of certain rare pediatric disease product applications. The Company received the PRV when SKYSONA (elivaldogene autotemcel) received accelerated approval by the FDA for the treatment of early, active cerebral adrenoleukodystrophy. Pursuant to the PRV Transfer Agreement, Buyer agreed to pay the Company $102 million, payable in cash, upon the closing of the sale.

The PRV Transfer Agreement contains customary representations, warranties, covenants, and indemnification provisions subject to certain limitations. The transaction remains subject to customary closing conditions, including the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.

The foregoing description of the PRV Transfer Agreement does not purport to be complete and is qualified in its entirety by the full text of the PRV Transfer Agreement, a copy of which is filed as Exhibit 2.1 to this Current Report on Form 8-K and incorporated herein by reference.

Bausch Health Announces the Unrestricting of Bausch + Lomb Under Bausch Health Debt Documents

On November 29, 2022 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company") has designated 1261229 B.C. Ltd., the entity that directly or indirectly holds 88.7% of the issued and outstanding shares of Bausch + Lomb Corporation ("Bausch + Lomb"), as an unrestricted subsidiary of the Company in accordance with the terms of the Company’s debt documents (Press release, Bausch Health, NOV 29, 2022, View Source [SID1234624592]). In connection therewith, all of the subsidiaries of 1261229 B.C. Ltd., including Bausch + Lomb and its subsidiaries, are also now unrestricted subsidiaries of the Company and, as a result, are no longer subject to the covenants under the Bausch Health debt documents.

The Company continues to evaluate potential options to maximize stakeholder value, which include its ongoing focus on its balance sheet and liquidity.

Immutep Enters into Second Clinical Trial Collaboration Agreement with Merck KGaA, Darmstadt, Germany, and Pfizer for New Combination Study of its First-in-Class LAG-3 Candidate, Eftilagimod Alpha, and Avelumab to Treat Urothelial Cancer

On November 29, 2022 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, reported it has signed a Clinical Trial Collaboration and Supply Agreement ("Agreement") with Merck KGaA, Darmstadt, Germany and Pfizer for a new Phase I clinical study in patients with urothelial cancer, called INSIGHT-005 (Press release, Immutep, NOV 29, 2022, View Source [SID1234624573]).

"We are very pleased to be deepening our collaboration with Merck KGaA, Darmstadt, Germany and Pfizer through this new study in patients with urothelial cancer, the sixth most common cancer in the US, who are in need of treatment options," said Immutep CEO, Marc Voigt. "INSIGHT-005 builds on the encouraging clinical efficacy and safety previously reported from the combination of efti and avelumab in various solid cancers, including deep and durable responses in patients with low or no PD-L1 expression and in indications that typically do not respond to immune checkpoint therapy."

INSIGHT-005 will be an investigator-initiated explorative, open-label study evaluating the safety and efficacy of Immutep’s lead product candidate, efti, in combination with avelumab (BAVENCIO) in up to 30 patients with metastatic urothelial cancer. The study will take place in Germany. The first patient is expected to be enrolled and dosed in H1 of calendar year 2023, after completing the necessary ethics and regulatory steps.

Urothelial cancer is a type of cancer in the bladder or urinary tract. In the US alone, it is estimated there will be 81,180 new cases of bladder cancer in 2022 and an estimated 17,100 people will die of this disease.1 Avelumab is a checkpoint inhibitor that works by targeting and blocking a protein called PD-L1 on the surface of certain immune cells, activating the cells to find and kill cancer cells. It is approved in more than 60 countries around the world as a monotherapy for first-line maintenance treatment for adult patients with advanced urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy. Avelumab is co-developed and co-commercialized by Merck KGaA, Darmstadt, Germany and Pfizer.

US National Cancer Institute: View Source

Efti was previously evaluated in combination with avelumab via the INSIGHT-004 study in patients with advanced solid cancers, including colorectal, pleural mesothelioma, squamous anal cell, cervical, and gastroesophageal carcinomas. Immutep announced final data from INSIGHT-004 in June 2021, reporting encouraging efficacy signals from the combination with a response rate of 41.7% according to RECIST 1.1.

Under the Agreement, Immutep and Merck KGaA, Darmstadt, Germany will jointly fund the INSIGHT-005 study. It will be conducted by the Institute of Clinical Cancer Research, Krankenhaus Nordwest (IKF) as part of the investigator-initiated INSIGHT platform for studies investigating efti in different combination treatments and routes of administration. INSIGHT consists of 5 different arms from stratums A to E (INSIGHT-005 is Stratum E).

For more information on INSIGHT, visit clinicaltrials.gov (INSIGHT identifier NCT03252938).

The study announced today modifies the previously announced protocol for INSIGHT-005 evaluating efti in combination with bintrafusp alfa. The former INSIGHT-005 study did not advance based on previously generated results for bintrafusp alfa in other studies.

About Eftilagimod Alpha (Efti)

Efti is Immutep’s proprietary soluble LAG-3 clinical stage candidate that is a first-in-class antigen presenting cell (APC) activator for the treatment of cancer, capitalising on LAG-3’s unique characteristics to stimulate both innate and adaptive immunity. Efti binds to and activates antigen presenting cells via MHC II molecules leading to expansion and proliferation of CD8+ (cytotoxic) T cells, CD4+ (helper) T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like CXCL10 that further boost the immune system’s ability to fight cancer.

Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and HER2–/HR+ metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy and/or chemotherapy. Efti has received Fast Track Designation in 1st line HNSCC and in 1st line NSCLC from the United States Food and Drug Administration (FDA).

BGI Preparing to Launch Improved Non-invasive Colorectal Cancer Screening Test, COLOTECT™ 3.0

On November 29, 2022 COLOTECT 3.0 is a non-invasive colorectal cancer screening test developed by BGI, and will be launched in early 2023 (Press release, BGI, NOV 29, 2022, View Source [SID1234624572]). BGI plans to release pre-clinical case-control data for COLOTECT 3.0 at the 2023 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium. The sensitivity for detecting CRC is 96.08%. The sensitivity for detecting advanced precancerous lesions (APL) is 52.5%, which is better than FIT products.

COLOTECT 3.0 is a non-invasive colorectal cancer (CRC) self-sampling test that can detect the methylation status of exfoliated cell genes and the Fecal Occult Blood in the stool. It can help screen for colorectal cancer and advanced precancerous lesions (APL) even in the absence of active bleeding lesions.

Colorectal cancer is the third most common cancer and the second deadly cancer worldwide. There were more than 1.9 million new cases of colorectal cancer in 2020. Older age, a history of bowel disease, a family history of related diseases, having type 2 diabetes, overweight or obesity, certain types of diet, smoking, and drinking are all risk factors that can lead to colorectal cancer. In recent years, the incidence rate of colorectal cancer among people younger than 50 has been increasing significantly.

As the tumor grows, patients may experience one or multiple symptoms, including blood in the stool, abdominal pain, and bloating. However, colorectal cancer usually does not produce symptoms in the early stages, which makes some patients undiagnosed until they are at the third or fourth stage and miss the best time for treatment. If colorectal cancer is diagnosed at early stages, the 5-year relative survival rate can be as high as 90%. Conversely, if it is diagnosed at stage IV, the 5-year survival rate will be only about 10%.