On July 2, 2021 Transcenta Holding Limited ("Transcenta"), a clinical stage global biotherapeutics company with fully-integrated capabilities in discovery, development and manufacturing of antibody-based therapeutics, reported that promising anti-tumor responses have been observed in the ongoing TST001 (anti-Claudin18.2 monoclonal antibody) trials (Press release, Transcenta, JUL 2, 2021, View Source [SID1234584579]).

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TST001 is currently in dose-escalation study as monotherapy in both US and China. In addition, Transcenta initiated combination study with chemotherapies in second line (paclitaxel) and first line (CAPOX) setting for gastric cancer in April and May 2021, respectively. Over forty patients have been evaluated and data from patients treated with the current doses of either TST001 alone or in combination with chemotherapies supports that TST001 is safe.

Promising early anti-tumor activities have also been observed from these studies. One heavily pretreated late-line gastric cancer patient out of the three patients at 6 mg/kg dose cohort in the monotherapy dose-escalation study achieved partial response according to RECIST1.1 criteria after 6 weeks of treatment. In addition, the patient also had rapid and significant tumor biomarker reduction post-TST001 treatment. The patient previously failed multiple lines of chemotherapies, PD-1 immunotherapy and anti-VEGF inhibitor. In addition, in the TST001 plus CAPOX combination study in first-line gastric cancer, a patient in the first dosing cohort achieved partial response after 6 weeks of treatment according to the RECIST1.1 criteria.

With these data, Transcenta plans to complete the ongoing dose-escalation study and initiate Phase 2a monotherapy studies in Q4 2021 in Claudin18.2-expressing solid tumors including gastric cancer, pancreatic cancer and other tumor types. Detailed data from the TST001 Phase 1a study will be submitted for presentation in a future medical conference.

"Recently, Claudin18.2 has emerged to be an exciting target for the treatment of gastric cancer. The ability of TST001 to induce significant anti-tumor activities in patient failed multiple previous treatments at 6mg/kg during dose-escalation indicated that TST001 is a very promising anti-Claudin18.2 targeting agent. I look forward to seeing even better anti-tumor responses in gastric cancer patients expressing high levels of Claudin18.2 at higher dose and in combination therapies." said Professor Lin Shen from Beijing Cancer Hospital.

"From the clinical studies, we are very excited to observe positive efficacy signals in heavily pre-treated late-line gastric cancer patients with high expression of Claudin18.2 who failed all available classes of front-line, second-line and third-line standard therapies in gastric cancer. In addition, we are quickly advancing TST001 in earlier lines of gastric cancer development in combination with chemotherapies and immunotherapies. The preliminary safety and efficacy of TST001 monotherapy and its combination with chemotherapies showed that TST001 has great potential for patients whose tumor expressed Claudin18.2. I look forward to additional clinical data in the future that will further reinforce TST001’s efficacy and safety profiles, and accelerate our clinical development programs in multiple tumor types targeting Claudin18.2." said Dr. Michael Shi, EVP, Head of Global R&D and CMO of Transcenta.

About TST001

TST001 is the second Claudin18.2 targeting antibody therapeutic candidate being developed globally after Zolbetuximab (IMAB362). TST001 is a high-affinity recombinant humanized monoclonal antibody targeted Claudin18.2 generated by Transcenta’s Immune Tolerance Breaking Technology (IMTB) platform. TST001 can kill Claudin18.2 expressing tumor cells by mechanisms of antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). Leveraging advanced bioprocessing technology, the fucose content of TST001 was significantly reduced during the production, which further enhanced the ADCC-mediated tumor killing activity of TST001. TST001 displayed more potent anti-tumor activities than IMAB362 analog in mouse xenograft experiments. Clinical trials for TST001 are ongoing in China and US since July 2020 (NCT04396821, NCT04495296/CTR20201281).

On July 2, 2021 Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, reported it will present new data on its personalized and tumor-informed molecular residual disease (MRD) assay, Signatera, at the 2021 European Society for Medical Oncology World Congress on Gastrointestinal Cancer (ESMO GI), taking place June 30 – July 3, 2021. Data will be presented in colorectal cancer (CRC) and pancreatic cancer (Press release, Natera, JUL 2, 2021, View Source [SID1234584578]).

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Natera will present updated results from the prospective, multi-center, randomized CIRCULATE-Japan trial, the largest MRD-guided study to date in CRC, designed to investigate ctDNA-guided treatment strategies for patients with stage I-IV resected CRC. With follow-up information now available in the first 808 patients in this trial, this readout is multiple times larger than any previous Natera MRD study in CRC, and as such, creates a new benchmark for evaluating test performance.

"We are very encouraged by how quickly we have been able to generate this large, high-quality dataset, and look forward to growing it even further through our collaboration with Natera," said the CIRCULATE-Japan study’s Principal Investigator, Dr. Takayuki Yoshino of the National Cancer Center Hospital East, Kashiwa-shi, Chiba, Japan. "We believe that personalized MRD testing is the future and will improve treatment decisions for tens of thousands of colorectal cancer patients in Japan and around the world."

"CIRCULATE-Japan is a landmark prospective trial, and based on these strong interim results, we are highly optimistic they will lead to changes in practice guidelines in early-stage colorectal cancer," said Alexey Aleshin, M.D., Natera’s vice president of medical affairs, oncology. "At our core, we are a data-driven company, and these data very clearly demonstrate that Signatera can be an important and accurate tool for helping patients avoid unnecessary treatment."

Details about the abstracts are as follows:

Abstract # O-11 | Oral Presentation | Presenter: Hiromichi Shirasu

Monitoring molecular residual disease by circulating tumor DNA in resectable colorectal cancer: Molecular subgroup analyses of a prospective observational study GALAXY in CIRCULATE-Japan

This oral presentation describes an updated interim analysis of the first 808 patients from CIRCULATE-Japan, the largest prospective MRD study to date in CRC. Personalized Signatera assays were performed preoperatively and then serially after surgery. Preoperative MRD was detected in 95% of patients with stage II–III CRC. Longitudinal MRD-positivity was significantly associated with inferior disease-free survival (hazard ratio = 46.8) and Signatera demonstrated a relapse sensitivity of 93.1%. MRD-positivity at 4 weeks after surgery was significantly associated with nodal positivity and MRD-negative patients had remarkably good prognosis, with recurrence-free survival >99% at six months of follow-up, across all stages and regardless of whether adjuvant treatment was administered.

Abstract # 271 | Poster Presentation | Presenter: Maen Abdelrahim, M.D.

Circulating tumor DNA for early relapse detection and monitoring disease status in patients with early-stage pancreatic adenocarcinoma

A prospective study of seven pancreatic adenocarcinoma patients and one ampullary adenocarcinoma patient who were monitored after surgery using Signatera, in addition to blood biomarkers carcinoembryonic antigen (CEA) and cancer antigen 19-9 (CA 19-9) and radiological imaging. MRD-positivity was found to be associated with poorer recurrence-free survival (HR 10.14, p=0.03). MRD findings correlated with, and preceded, imaging results in 100% of patients who relapsed. MRD was found to be a more specific prognostic biomarker compared to CEA and CA 19-9.

About Signatera

Signatera is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and molecular residual disease (MRD) assessment in patients previously diagnosed with cancer. The test is available for both clinical and research use, and has been granted three Breakthrough Device Designations by the FDA for multiple cancer types and indications. The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual’s tumor. This maximizes Signatera’s accuracy for detecting the presence or absence of residual disease in a blood sample, even at levels down to a single tumor molecule in a tube of blood. Signatera is intended to detect and quantify how much cancer is left in the body, to detect recurrence earlier and to help optimize treatment decisions.

Signatera test performance has been clinically validated in multiple cancer types including colorectal, non-small cell lung, breast, and bladder cancers. Signatera has been developed and its performance characteristics determined by Natera, the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the US Food and Drug Administration (FDA). CAP accredited, ISO 13485 certified, and CLIA certified.

On July 2, 2021 Kiromic BioPharma, Inc. (Nasdaq: KRBP) (the "Company"), an immuno-oncology target discovery and gene-editing company with a proprietary artificial intelligence neural network platform (Diamond AI) that is used to develop novel oncology therapeutics, reported the closing of its previously announced underwritten public offering of 8,000,000 shares of its common stock at a public offering price of $5.00 per share, resulting in gross proceeds to the Company of $40 million (Press release, Kiromic, JUL 2, 2021, View Source [SID1234584577]). In addition, the Company has granted the underwriters a 45-day option to purchase up to an additional 1,200,000 shares of common stock, solely to cover over-allotments.

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ThinkEquity, a division of Fordham Financial Management, Inc. acted as sole book-running manager for the offering.

The Company intends to use the net proceeds from the offering primarily for clinical trials for its ALEXIS-ISO-1 and ALEXIS-PRO-1 product candidates, GMP facility expansion, intellectual property protection and reinforcement, IND applications and IND enabling trials and working capital and the remainder for general corporate purposes.

A registration statement relating to the shares of common stock being sold in this offering was declared effective by the Securities and Exchange Commission (the "SEC") on June 29, 2021. The offering is being made only by means of a prospectus. Copies of the final prospectus may be obtained on the SEC’s website, www.sec.gov, or by contacting ThinkEquity, a division of Fordham Financial Management, Inc., 17 State Street, 22nd Floor, New York, New York 10004, by telephone at (877) 436-3673 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 2, 2021 CEL-SCI Corporation (NYSE American: CVM) reported that the discussion at the Annual Shareholder Meeting, on July 1, 2021 at 10:00 am EDT, regarding its Phase 3 head and neck cancer trial results is available at View Source (Press release, Cel-Sci, JUL 2, 2021, View Source [SID1234584576]).

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The discussion on the Phase 3 results was presented by Geert Kersten the Chief Executive Officer, Dr. Eyal Talor the Chief Scientific Officer and John Cipriano the Senior Vice President of Regulatory Affairs. In the landmark Phase 3 study, Multikine produced a significant 14.1% 5-year survival benefit (62.7% vs 48.6%) in the group of advanced primary head and neck cancer patients who received surgery plus radiotherapy. The Company plans to file for FDA approval in this patient population.

About Multikine

Multikine (Leukocyte Interleukin, Injection) is an investigational cancer immunotherapy that is known to contain 14 natural human cytokines, the body’s immune system regulators including interleukins, interferons, chemokines, and colony stimulating factors which are elements of the body’s natural mix of defenses against cancer and other diseases. A patented, mass-produced, off the shelf and ready to use non-autologous biological product, Multikine is manufactured using a proprietary process following Good Manufacturing Practice (GMP) requirements from Source Leukocytes, an FDA licensed product, at CEL-SCI’s manufacturing facility near Baltimore, Maryland.

On July 2, 2021 Orion reported that it will publish Half-Year Financial Report for January–June 2021 on Monday, 19 July 2021 at approximately 12.00 noon EEST (Press release, Orion , JUL 2, 2021, View Source [SID1234584575]). The release and related presentation material will be available on the company’s website at www.orion.fi/en/investors after publishing.

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Webcast and conference call

A webcast and a conference call for analysts, investors and media will be held on Monday, 19 July 2021 at 13.30 EEST. The event will be held only online and by conference call.

A link to the live webcast will be available on Orion’s website at www.orion.fi/en/investors. A recording of the event will be available on the website later the same day.