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.

On July 10, 2023 Iovance Biotherapeutics, Inc. (Nasdaq: IOVA) ("Iovance" or "Company"), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte ("TIL") therapies for patients with cancer, reported the pricing of an underwritten public offering of 20,000,000 shares of its common stock at a public offering price of $7.50 per share (Press release, Iovance Biotherapeutics, JUL 11, 2023, View Source [SID1234633136]). The gross proceeds from the offering, before deducting the underwriting discounts and commissions and other estimated offering expenses payable by Iovance, are expected to be approximately $150 million. In addition, Iovance has granted the underwriters a 30-day option to purchase up to 3,000,000 additional shares of common stock at the public offering price, less the underwriting discounts and commissions. The offering is expected to close on or about July 13, 2023, subject to customary closing conditions.

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Iovance intends to use the proceeds from this offering to fund preparations for the commercial launch of lifileucel (if approved), including continuing to prepare the Iovance Cell Therapy Center, the Company’s manufacturing facility in Philadelphia, to support ongoing clinical programs including its NSCLC registration-directed study and its frontline advanced melanoma Phase 3 confirmatory trial, to expand the combination of TIL and immune checkpoint inhibitors ("ICIs") in ICI naïve patient cohorts, to support the continued development of our pipeline candidates, to support Proleukin integration activities and for other general corporate purposes.

Goldman Sachs & Co. LLC and Jefferies LLC are acting as joint lead book-running managers for the offering.

The shares of common stock described above are being offered by Iovance pursuant to its shelf registration statement on Form S-3 that became automatically effective upon filing with the Securities and Exchange Commission on June 16, 2023. The offering may be made only by means of a prospectus supplement and accompanying prospectus, copies of which may be obtained by contacting Goldman Sachs & Co. LLC by mail at 200 West Street, New York, NY 10282, Attention: Prospectus Department, by telephone at (866) 471-2526, or by email at [email protected] or Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, New York, 10022, by telephone at (877) 547-6340, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.