On June 21, 2022 Nordic Nanovector ASA (OSE: NANOV) reported an update following its comprehensive review and independent data evaluation of PARADIGME, its ongoing Phase 2b trial of Betalutin (177Lu lilotomab satetraxetan) in 3rd-line relapsed rituximab/anti-CD20 refractory follicular lymphoma (3L R/R FL) (Press release, Nordic Nanovector, JUN 21, 2022, View Source [SID1234616140]).

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The independent expert panel reviewed the efficacy data collected to date. Betalutin, at the selected dose of 15 MBq/kg after a pre-dose of 40 mg lilotomab (40/15), has continued to display an attractive safety profile. While Betalutin showed signs of efficacy in this frail, elderly and difficult-to-treat patient population, the independent expert panel reported that the efficacy data are less promising than the data reported from the Phase 2a LYMRIT 37-01 trial. The Company intends to seek further guidance from the competent regulatory authorities, including the US Food and Drug Administration (FDA), regarding the way forward for PARADIGME. Pending regulatory feedback, the study will remain open for recruitment.

Following interaction with the regulatory authorities, the Company will provide an additional update, which is expected in August. The Company will not be commenting further until then. The Company’s Q2 results will be rescheduled to August and a new date will be confirmed in due course.

Given the continuing slow patient recruitment, Nordic Nanovector does now not expect to deliver preliminary top line data from PARADIGME in H2 2022.

On June 21, 2022 Rakuten Medical Taiwan, Inc. reported that their ASP-1929 Photoimmunotherapy Phase 2 clinical trial (ClinicalTrials.gov Identifier: NCT05265013) has enrolled and treated its first patient (Press release, Rakuten Medical, JUN 21, 2022, View Source [SID1234616139]). This trial is using ASP-1929 photoimmunotherapy based on the Alluminox platform in combination with anti-PD1 therapy in head and neck squamous cell carcinoma to measure patient’s Objective Response Rate (ORR) . The trial will be conducted in 3 medical centers in North Taiwan and 2 medical centers in Central Taiwan.

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According to official cancer registration report, head and neck cancer ranks third in male cancer incidence and fourth in male cancer mortality in Taiwan, with an annual incremental of about 10,000 patients. Majority1 of the patients are males between the ages of 40 and 60. Local recurrence or metastasis is one of the leading causes of death in head and neck cancer patients2, and nearly one-half of recurrent or metastatic patients survive for less than one year3. After receiving treatment, about 40% of patients will still face in situ or local recurrence4.

Dr. Chun Wei Huang from Department of Otorhinolaryngology, Head and Neck Surgery of China Medical University Hospital, who participated in the trial, explained: "Currently patients have limited treatment options after recurrence. When surgery, chemotherapy combined with targeted therapy, radiotherapy, etc. fail to show obvious efficacy in treating head and neck cancer, not only the patients but the medical teams are disappointed. Patients are also prone to losing confidence for further treatment. In addition to this phase II clinical trial, Taiwan is also expected to join more clinical trials. The introduction of more clinical trials presents not only new chances for patients, but also new possibilities for head and neck cancer treatment."

"ASP-1929 has been conditionally approved by the MHLW in Japan and we are establishing more clinical evidence to help cancer patients around the world. The investment of this Phase 2 trial reiterates our long-term commitment in developing Taiwan as the foothold to Asia expansion. The enrollment of first patient also demonstrates the robust momentum and tight-knit collaboration of Rakuten Medical around the globe. We look forward to providing patients with impactful new treatment options as soon as possible," said Mickey Mikitani, Co-CEO of Rakuten Medical, Inc.

Reference
[1] Health Promotion Administration, Ministry of Health and Welfare, 2019 Cancer Registration Report
[2] A Novel CXCR4-Targeted Diphtheria Toxin Nanoparticle Inhibits Invasion and Metastatic Dissemination in a Head and Neck Squamous Cell Carcinoma Mouse Model. Pharmaceutics. 2022 Apr 18;14(4):887. doi:10.3390/pharmaceutics14040887
[3] Argiris A, Harrington KJ, Tahara M, Schulten J, Chomette P, Ferreira Castro A, Licitra L. Evidence-Based Treatment Options in Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck. Front Oncol. 2017 May 9;7:72. doi: 10.3389/fonc.2017.00072.
[4] Daniela Alterio, Giulia Marvaso, Annamaria Ferrari, Stefania Volpe, Roberto Orecchia, Barbara Alicja Jereczek-Fossa (2019.) Modern radiotherapy for head and neck cancer

On June 21, 2022 Agenus (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of therapeutics designed to activate the immune response to cancers and infections, reported the Company will host a hybrid webcast to discuss botensilimab/balstilimab combination data in microsatellite stable colorectal cancer (MSS-CRC) presented earlier that day in a late-breaking oral presentation at the ESMO (Free ESMO Whitepaper) World Congress on Gastrointestinal Cancer in Barcelona, Spain (Press release, Agenus, JUN 21, 2022, View Source [SID1234616137]).

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The webcast will take place on Wednesday, June 29 at 10:00 AM EST (4:00 PM local time) and will include the following speakers:

Steven O’Day, M.D., Agenus’ Chief Medical Officer,
Dr. Anthony El-Khoueiry, M.D., Phase I Program Director at the USC Norris Comprehensive Cancer Center, Keck Medicine of USC,
Dr. Manuel Hidalgo, Chief of the Division of Hematology and Medical Oncology at Weill Cornell Medicine/NewYork-Presbyterian Hospital, and
Dr. Heinz-Josef Lenz, M.D., Professor of Medicine and J. Terrence Lanni Chair in Gastrointestinal Cancer Research, Keck Medicine of USC
Formal remarks will be followed by a Q&A session. For those attending in person, the webcast will take place at:

AC Hotel by Marriott Barcelona Forum
Gracia Room (3rd Fl.)
Paseo Taulat 278
Barcelona, Spain, 08019

Registration for the webcast can be accessed on the Investors section of the Agenus website at investor.agenusbio.com, as well as here. Following the webcast, an archived version will also be available on the website.

On June 21, 2022 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, reported the publication of a peer-reviewed journal article in Clinical and Experimental Vaccine Research (Press release, Anixa Biosciences, JUN 21, 2022, View Source [SID1234616136]). The article is titled, "Formulation of an ovarian cancer vaccine with the squalene-based AddaVax adjuvant inhibits the growth of murine epithelial ovarian carcinomas." This paper authored by Suparna Mazumder, Ph.D., Valerie Swank, MS, Nina Dvorina, MD, Justin M. Johnson, Ph.D. and Vincent K. Tuohy, Ph.D. of Cleveland Clinic, discusses pre-clinical studies of a preventative ovarian cancer technology that has been licensed to Anixa.

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This ovarian cancer vaccine targets the extracellular domain of anti-Müllerian hormone receptor 2 (AMHR2-ED), which is expressed in the ovaries but disappears as a woman reaches and advances through menopause. However, AMHR2-ED is expressed again in the majority of ovarian cancers.

The journal article highlights study data demonstrating formulation of the AMHR2-ED vaccine with AddaVax adjuvant induced high serum titers of immunoglobulin G and significant inhibition and destruction of epithelial ovarian cancer with significantly enhanced overall survival of animals in both prevention and therapeutic protocols.

Anixa’s CEO, Amit Kumar, Ph.D., stated, "We are pleased by the publication of this scientific paper authored by our partners at Cleveland Clinic. This unique technology has the potential to be the first vaccine to prevent ovarian cancer, which remains one of the most aggressive and difficult-to-treat cancers." Dr. Kumar added, "Preclinical work to advance the vaccine is ongoing with support from the PREVENT Program at the National Cancer Institute (NCI), which supports preclinical innovative interventions and biomarkers for cancer prevention and interception."

The Clinical and Experimental Vaccine Research article is available to view at the following link: View Source

On June 21, 2022 Kiromic BioPharma, Inc. (NASDAQ: KRBP), a clinical-stage biotherapeutics company using its proprietary DIAMOND AI (artificial intelligence) and data mining platform to discover and develop cell therapies with a focus on immuno-oncology, reported a strategic pipeline shift to prioritize its allogeneic, non-engineered off-the-shelf product candidate, Deltacel/KB-GDT (Press release, Kiromic, JUN 21, 2022, View Source [SID1234616135]).

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Kiromic expects to submit its first new investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) in the second half of 2022. The IND will seek to evaluate Deltacel in combination with a standard antitumor modality, with the expected beginning of trial activation by year-end. Deltacel consists of Gamma Delta T-cells (GDT) that are expanded, enriched, and activated through a proprietary method. Kiromic will also pursue INDs for its Procel and Isocel product candidates in combination with a standard antitumor modality in 2023.

These three additional IND filings will expand the Company’s pipeline to five allogeneic GDT clinical trials and three product candidates.

This reprioritization and expansion of Kiromic’s pipeline follows a recently announced sponsored research agreement to generate in vivo preclinical data. The Company believes that, through this agreement, we will be able to efficiently generate data for our GDT allogeneic therapies and other pre-clinical assets to support our anticipated IND filings.

"We are well positioned to prioritize Deltacel/KB-GDT in combination with a standard antitumor modality as our first IND, which we intend to submit to the FDA during the second half of this year with the expected beginning of trial activation by year-end. We believe that this shift both de-risks and accelerates our immediate path forward, enabling us to advance our non-viral, non-engineered product candidate while also reducing costs and mitigating current supply chain headwinds associated with a virus-based approach," stated Pietro Bersani, Chief Executive Officer of Kiromic BioPharma.

"Against the backdrop of a global cancer cell therapy market that’s expected to exceed $33 billion by 2027, Kiromic’s product pipeline now encompasses three additional Gamma Delta T-cell therapeutic candidates, Deltacel, Procel, and Isocel. Each is being developed to target solid tumors – which represent 90% of all cancers – and each is ideally positioned to address unmet medical needs. We look forward to advancing these candidates into the clinic with the goal of providing new treatment options to patients with cancer," added Mr. Bersani.

These three IND applications will expand Kiromic’s therapeutic pipeline to five allogeneic GDT clinical trials (see accompanying graphic), including:

New IND #1: Deltacel in combination with a standard antitumor modality, with clinical activation expected to begin by the end of the fourth quarter of 2022
New IND #2: Procel in combination with a standard antitumor modality, with clinical activation expected to begin by the end of the second quarter of 2023
ALEXIS – PRO-1 Procel as a monotherapy, with clinical activation expected to begin by the end of second quarter 2023
New IND #3: Isocel in combination with a standard antitumor modality, targeting clinical activation to begin by the end of the fourth quarter of 2023
ALEXIS – ISO-1 Isocel as a monotherapy, targeting clinical activation to begin by the end of the fourth quarter of 2023