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.

On July 10, 2023 Alphamab Oncology (stock code: 9966.HK) reported that the phase Ⅱ clinical research results of anti- PD-L1/CTLA-4 bispecific antibody KN046 monotherapy in advanced NSCLC were published online in the European Journal of Cancer (EJC) (IF: 8.4001). Professor Caicun Zhou from Shanghai Pulmonary Hospital is the corresponding author of this paper.

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KN046-201 is an open-label, multi-center, multiple cohorts, single arm study to evaluate the efficacy, safety andtolerability of KN046 in NSCLC. Subjects with NSCLC who had failed from first line platinum-based doublet chemotherapy without PD-(L)1 immune checkpoint blockade were enrolled in cohort A and cohort B. All subjects enrolled will receive KN046 3 mg/kg (Cohort A) and 5mg/kg (Cohort B) Q2W IV administration, respectively. Primary endpoint was objective response rate (ORR) per RECIST version 1.1 by BICR.

All 64 patients were enrolled, 30 and 34 patients were included in the 3 mg/kg (cohort A) and 5 mg/kg (cohort B), respectively. On August 31, 2021, the median follow-up duration was 24.08 months and 19.35 months in the 3 mg/kg and 5 mg/kg cohorts, respectively. BICR-assessed ORRs were 13.3% and 14.7% in the 3 mg/kg and 5 mg/kg cohorts, respectively. Median progression-free survival (PFS) were 3.68 and 3.68 months, while overall survival (OS) were 19.70 and 13.04 months, respectively. Furthermore, the ORR was 17.1%, mPFS was 3.68 months and mOS was 19.81 months in non-squamous NSCLC (n=41). And in squamous NSCLC(n=20), the ORR was 10.0%, mPFS was 7.43 months and mOS was 12.88months.

All 64 enrolled patients were evaluable for safety, the most common treatment-related adverse events (TRAEs) were anemia (28.1%), hyperglycemia (26.7%), and infusion-related reactions (26.7%). The incidence rates of grade ≥3 TRAEs and TRAEs leading to treatment discontinuation were 42.2% and 14.1%, respectively.

Conclusion: Both 3 mg/kg and 5 mg/kg KN046 showed promising efficacy and favorable safety profile in advanced squamous and non-squamous NSCLC patients after failure of or intolerance to previous platinum-based chemotherapy. This study provided more basis for further development of KN046 in NSCL.

About KN046

KN046 is PD-L1/CTLA-4 bispecific antibody independently developed by Jiangsu Alphamab. Its innovative designs include: a novel mechanism – CTLA-4 fused with PD-L1 single domain antibody; engineered to target the tumor microenvironment with high PD-L1 expression, and Treg (suppress tumor immunity) clearing function.

There are about 20 clinical trials of KN046 in different stages covering more than 10 types of tumors including NSCLC, pancreatic cancer, thymic cancer, HCC, ESCC and TNBC in Australia, the US and China. The results of these clinical trials have shown an advantage in survival for patients. Alphamab Oncology has received FDA clearance to enter phase II trial of KN046 based on the clinical results in China and Australia. Moreover, KN046 has obtained the U.S. FDA’s orphan drug designation for thymic epithelial tumor in September 2020. Several pivotal clinical trials are currently being conducted, among which the interim analysis of the phase III clinical study of KN046 combined with chemotherapy as the first-line treatment of NSCLC successfully met the prespecified PFS endpoint.

(Press release, Alphamab, JUL 10, 2023, View Source [SID1234657025])

On July 10, 2023 Elsie Biotechnologies, Inc., a biopharmaceutical company unlocking the full potential of oligonucleotide therapeutics, reported a research collaboration agreement with GSK plc (LSE/NYSE: GSK) to advance the discovery and development of Elsie’s innovative oligonucleotide discovery platform with the aim of finding novel oligonucleotides optimized for safety, efficacy, and delivery (Press release, Elsie Biotechnologies, JUL 10, 2023, View Source [SID1234644227]). The collaboration combines GSK’s extensive expertise in DNA encoded library technologies with Elsie’s drug discovery platform. The companies will begin an initial research period where GSK and Elsie will explore the platform capabilities. Throughout the research term, GSK may exercise an option to a non-exclusive license from Elsie for the discovery platform and P(V) chemistry technologies to employ in GSK’s own oligonucleotide drug discovery research.

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Kevin Green, Chief Operating Officer, Elsie Biotechnologies, said: "Our next generation oligonucleotide therapeutics, which include RNA medicines, enable new opportunities to treat intractable human diseases, including those with no current or limited therapeutic options. This collaboration combines GSK’s expertise as leaders in the field of DNA encoded library technologies with the unique capabilities of Elsie’s scientists and discovery platform with P(V) chemistry with the goal to discover new RNA medicines."

Elsie’s discovery platform is an unparalleled ultra-high throughput proprietary process that allows for the complete evaluation of oligonucleotide chemical space. By applying proprietary encoding technology to oligonucleotide therapeutic candidates, all possible sequences or chemical modification patterns can be evaluated to increase activity, reduce toxicity, and improve delivery. Elsie also applies proprietary P(V) chemistry technologies, encompassing a suite of novel reagents and processes, to synthesize diverse oligonucleotide therapeutics with complete synthetic control.

Phil Baran, Ph.D., Cofounder, Elsie Biotechnologies, said, "By leveraging all the tools across Elsie’s platform, we can explore the entire chemical oligonucleotide space and uniquely define inter-nucleotide linkages and stereo chemistry to tune safety, activity, and delivery of oligonucleotide therapeutics." Phil Dawson, Ph.D., Cofounder, Elsie Biotechnologies, concluded, "We believe this approach will overcome the historical drug development limitations of this space and expand the use case for oligonucleotide medicines to previously intractable diseases."

Under the terms of the agreement, Elsie will receive an upfront collaboration payment from GSK to conduct initial research activities. Upon exercising the option during the research term, GSK would be obligated to make further payments including licensing fees, development, and commercial milestones.