On July 11, 2023 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) reported that Bristol Myers Squibb Company (NYSE:BMY) has exercised its option to enter into an exclusive global licence agreement (Press release, Evotec, JUL 11, 2023, View Source [SID1234633163]). The licence covers selected late-stage discovery programmes that were developed and progressed within the collaboration.

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Evotec and Bristol Myers Squibb originally entered their neurodegeneration partnership in 2016. The initial partnership proved highly productive in generating a promising pipeline of discovery to clinical-stage programmes. Based on this success, Bristol Myers Squibb and Evotec have extended and expanded the partnership for an additional 8 years in March to further broaden and deepen the strategic alliance.

Under the licence agreement, Bristol Myers Squibb has selected an undisclosed number of programmes that were rapidly developed and progressed using Evotec’s precision medicine platforms for further development within the expanded collaboration. Evotec receives a $ 40 m payment and is eligible to earn performance milestone payments, as well as tiered royalties up to low double-digit percentages on product sales.

Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented: "This licence agreement will further bolster our joint pipeline of programmes targeting several neurodegenerative conditions. We are confident that the strong collaboration of the experienced teams at Evotec and Bristol Myers Squibb will make novel innovative treatment options available to patients living with a broad range of neurodegenerative conditions."

Evotec and Bristol Myers Squibb aim to identify disease-modifying treatments for a broad range of neurodegenerative diseases. Currently approved drugs only offer short-term management of patients’ symptoms and there is a significant unmet medical need for therapies that slow down or reverse disease progression in the field of neurodegenerative diseases.

This partnership pursues an innovative approach to the discovery and development of novel medicines by leveraging several of Evotec’s modality-agnostic precision medicine platforms. The partnership has already been successful in generating a pipeline of discovery and pre-clinical-stage programmes. A first programme, BMS-986419 or EVT8683, targeting eIF2b, was in-licensed by Bristol Myers Squibb in September 2021, following the successful filing of an IND application with the FDA and has proceeded into the clinical Phase I.

On July 11, 2023 Enterome, a clinical-stage company developing first-in-class immunomodulatory drugs for cancer and immune diseases based on its unique Mimicry platform, reported that the first patient has been dosed at The University of Texas MD Anderson Cancer Center (Houston, TX) in the Phase 2 ‘CLAUDE’ trial evaluating EO2040, the Company’s fourth OncoMimics immunotherapy candidate to enter clinical development (Press release, Enterome, JUL 11, 2023, View Source [SID1234633161]). The CLAUDE trial will assess the immunogenicity and the preliminary efficacy of EO2040 in combination with nivolumab and as a monotherapy in patients with circulating tumor DNA (ctDNA) defined minimal residual disease (MRD) stage II-IV colorectal cancer (CRC) after completion of surgical resection and all other standard of care treatments.

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EO2040 is an innovative, off-the-shelf immunotherapy that combines two synthetic OncoMimics peptides. These non-self, microbial-derived peptides correspond to CD8 HLA-A2 epitopes that exhibit molecular mimicry with the tumor-associated antigens (TAAs) FOXM1 & BIRC5. EO2040 also includes universal cancer peptide 2 (UCP2), a helper peptide representing the CD4+ epitope.

The CLAUDE study (EOCRC1-22; NCT05350501) is the first trial to use liquid biopsy monitoring to measure ctDNA clearance as an indicator of OncoMimics immunotherapy efficacy. A total of 34 patients are expected to be enrolled in this multi-center, open-label Phase 2 study in the US and Europe.

Circulating tumor DNA (ctDNA) assays can reveal minimal residual disease after surgical resection of a tumor in patients who appear radiographically free of disease, by detecting and analyzing traces of tumor DNA in a blood sample. Detection of ctDNA after completion of curative-intent therapy predicts with nearly 100% specificity the risk of cancer recurrence. The lead time between ctDNA detection and radiographic evidence of cancer recurrence is up to nine months, providing a window for the evaluation of novel therapeutic strategies.

The primary objective of the CLAUDE trial is to assess the six-month ctDNA clearance rate – with ctDNA clearance being used as a surrogate endpoint for prolongation of disease-free survival (DFS). ctDNA clearance is characterized by the disappearance of all somatic mutations identified in the blood, as well as no appearance of any additional new somatic mutations, and radiographic investigations showing no evidence of CRC.

Dr Pierre Belichard, CEO of Enterome, said: "We are delighted to begin a new clinical study to evaluate the potential of our new OncoMimics immunotherapy EO2040 to treat a second colorectal cancer indication. This latest trial is particularly interesting due to its use of liquid biopsy monitoring to measure ctDNA clearance as an indicator of treatment efficacy. If CLAUDE is successful, then it could open multiple opportunities in other major cancer indications where the use of ctDNA monitoring to detect residual disease after surgery and other standard of care treatment is used. This would support Enterome’s ambition to build a significant and valuable OncoMimics franchise and provide the Company with a uniquely differentiated position and ability to deliver a broad pipeline of next-generation OncoMimics immunotherapies."

On July 11, 2023 Bristol Myers Squibb (NYSE: BMY) reported that the sub-study of the Phase 3 CheckMate -901 trial met the dual primary endpoints of overall survival (OS) and progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR) at final analysis (Press release, Bristol-Myers Squibb, JUL 11, 2023, View Source;901-Trial/default.aspx [SID1234633160]). Results of the sub-study showed that Opdivo (nivolumab) in combination with cisplatin-based chemotherapy followed by Opdivo monotherapy demonstrated statistically significant benefits in OS and PFS compared to standard-of-care cisplatin-based combinations as a first-line treatment for patients with unresectable or metastatic urothelial carcinoma who are eligible for cisplatin-based chemotherapy. The combination of Opdivo with cisplatin-based chemotherapy in first-line urothelial carcinoma had a tolerable safety profile consistent with the known safety profiles of the individual components of the regimen. No new safety concerns have been identified.

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"Today’s news is yet another example of the power of immunotherapy combinations to transform outcomes for patients with cancer. Opdivo with cisplatin-based chemotherapy is the first immunotherapy-based combination to improve both overall survival and progression-free survivalin patients with previously untreated unresectable or metastatic urothelial carcinoma who are eligible for cisplatin-based chemotherapy, reinforcing the benefits of Opdivo-based treatments seen across a variety of genitourinary cancers, including durable survival in advanced renal cell carcinoma and a reduced risk of recurrence in resectable muscle-invasive urothelial carcinoma," said Dana Walker, M.D., M.S.C.E., vice president, global program lead, genitourinary cancers, Bristol Myers Squibb. "We are encouraged by these positive results and remain steadfast in our commitment to bringing new solutions to patients with high unmet needs. We thank the patients, investigators and all site personnel involved in the CheckMate -901 trial."

The company will complete a full evaluation of the available data and looks forward to sharing the results with the scientific community at an upcoming medical conference as well as discussing the results with health authorities.

The CheckMate -901 primary study, evaluating Opdivo plus Yervoy (ipilimumab) vs. standard-of-care cisplatin- or carboplatin-based chemotherapy in patients with untreated, unresectable or metastatic urothelial carcinoma remains ongoing. Opdivo has previously shown clinical benefit across various stages of urothelial carcinoma, including in the second-line setting of metastatic urothelial carcinoma and the adjuvant setting of muscle-invasive urothelial carcinoma for patients who are at a high risk of recurrence post-radical surgery.

In addition to resectable or metastatic urothelial carcinoma, Opdivo and Opdivo-based combinations have shown significant improvements in OS in Phase 3 clinical trials across several tumors, including advanced renal cell carcinoma, non-small cell lung cancer, malignant pleural mesothelioma, metastatic melanoma and esophageal squamous cell carcinoma.

About CheckMate -901

CheckMate -901 is a Phase 3, randomized, open-label trial evaluating Opdivo in combination with Yervoy (primary study) or Opdivo in combination with chemotherapy (sub-study) compared to standard-of-care chemotherapy alone, in patients with untreated unresectable or metastatic urothelial cancer.

In this sub-study of CheckMate -901, a total of 608 patients eligible for cisplatin-based chemotherapy were randomized to receive either Opdivo 360 mg in combination with chemotherapy every 3 weeks or chemotherapy alone. The primary endpoints of the sub-study are overall survival (OS) and progression-free survival (PFS).

The OS and PFS outcomes for patients who are eligible for cisplatin-based chemotherapy are based on the final efficacy analysis for these endpoints of the CheckMate -901 sub-study.

About Urothelial Carcinoma

Bladder cancer is the 10th most common cancer in the world, with more than 573,000 new cases diagnosed annually. Urothelial carcinoma, which most frequently begins in the cells that line the inside of the bladder, accounts for approximately 90% of bladder cancer cases. In addition to the bladder, urothelial carcinoma can occur in other parts of the urinary tract, including the ureters and renal pelvis. The majority of urothelial carcinomas are diagnosed at an early stage, but approximately 50% of patients who undergo surgery will experience disease progression and recurrence within two-to-three years post-surgery. Additionally, approximately 20% to 25% of patients with urothelial carcinoma develop metastatic disease. The poor durability of responses seen with chemotherapy alone in the first-line setting presents a major challenge in the treatment of metastatic disease, and there are limited treatment options in the second-line setting for patients with advanced urothelial carcinoma.

On July 11, 2023 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that the Canadian Intellectual Property Office has issued Canadian Patent 2,989,807 covering Anixa’s novel Chimeric Antigen Receptor-T cell (CAR-T) cancer treatment technology, which has been licensed from The Wistar Institute and is being developed in partnership with Moffitt Cancer Center (Press release, Anixa Biosciences, JUL 11, 2023, View Source [SID1234633159]).

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The patent, entitled "Methods and Compositions for Treating Cancer," covers a nucleic acid that encodes a chimeric protein whose domains can be used to treat certain types of cancer by binding to specific hormone receptors and activating T cells. The patent was invented by Drs. Jose Conejo-Garcia and Alfredo Perales-Puchalt, both formerly of The Wistar Institute, to which the patent is assigned, along with Anixa’s majority-owned subsidiary, Certainty Therapeutics, Inc., which is the exclusive, world-wide licensee.

Dr. Amit Kumar, Chairman and CEO of Anixa, stated, "We are pleased that our CAR-T technology has received additional intellectual property protection in a market outside the U.S. Our novel CAR-T technology takes advantage of specific hormone-to-hormone receptor biology to address malignancies and has the potential to be the first successful CAR-T therapy against solid tumors. While our initial focus is on the treatment of ovarian cancer — with a Phase 1 clinical trial currently ongoing — the technology covered by the patent has broad application and could potentially also be used to treat other solid tumors by exploiting an anti-angiogenesis mechanism of action."

About Anixa’s CER-T Approach (Follicle Stimulating Hormone Receptor-Mediated CAR-T technology)

Anixa’s chimeric antigen receptor T-cell (CAR-T) technology approach is an autologous cell therapy comprised of engineered T-cells that target the follicle stimulating hormone receptor (FSHR). FSHR is found at immunologically relevant levels exclusively on the granulosa cells of the ovaries. Since the target is a hormone receptor and the target-binding domain is derived from its natural ligand, this technology is known as CER-T (chimeric endocrine receptor T-cell) therapy, a new type of CAR-T.

On July 11, 2023 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that its Chief Science Officer Peter Ellmark will hold a presentation on the company’s CD40 program at the 3rd Annual Tumor Myeloid-Directed Therapies Summit, taking place July 18-20, 2023, in Boston, as well co-hosting the Industry Leaders’ Fireside Chat: "Reviewing the Current Landscape & Future Potential of the Myeloid" (Press release, Alligator Bioscience, JUL 11, 2023, View Source [SID1234633158]).

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The presentation, entitled "Targeting CD40 on Myeloid Cells to Reverse the Suppressive Tumor Microenvironment & Enhance T Cell Priming", highlights the latest very promising interim results from the ongoing OPTIMIZE-1 Phase 2 study assessing the safety and efficacy of mitazalimab (CD40 mAb) in combination with chemotherapy, mFOLFIRINIOX, in previously untreated (1st line) patients with metastatic pancreatic ductal adenocarcinoma.

Preclinical data on mitazalimab as well as clinical efficacy and pharmacodynamic biomarker data from the OPTIMIZE-1 interim readout will also feature in the presentation, along with preclinical in vivo and in vitro data on ATOR-4066, a 3rd generation bispecific antibody targeting CD40 and CEACAM5. ATOR-4066 was developed by Alligator’s proprietary Neo-X-Prime platform that generates bispecific conditional antibody agonists able to ignificantly boost dendritic cells and T-cell activation by efficiently connecting them to CEACAM5-expressing tumor debris.

In summary, the latest OPTIMIZE-1 interim results include the continued follow-up on the futility analysis cohort (23 patients), which showed a deepening of tumor responses and an increase in the Objective Response Rate (ORR) to 57% from 52%. The interim ORR of 44% in the full OPTIMIZE-1 cohort (57 patients) confirms the benefit of mitazalimab added to mFOLFIRINOX. The median Duration of Response (DoR) of 8.7 months compares favorably with the 5.9[1] months reported with FOLFIRINOX in a similar patient population.

This year, mitazalimab has been granted orphan drug designation (ODD) in the U.S. by the Food and Drug Administration. Orphan designation is granted to medicines that treat rare diseases and qualifies the sponsor to regulatory and financial benefits, including marketing exclusivity once the product has been approved.