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

On June 21, 2022 AVEO Oncology (Nasdaq: AVEO), a commercial stage, oncology-focused biopharmaceutical company, reported the National Comprehensive Cancer Network (NCCN) has elevated FOTIVDA (tivozanib) to Category 1 status as a subsequent therapy for RCC patients who have received two or more prior therapies in the latest Kidney Cancer Treatment Guidelines released on June 17, 2022 (Press release, AVEO, JUN 21, 2022, View Source [SID1234616134]).

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"Category 1 is the highest Category recommendation offered by NCCN, which is based on strong clinical evidence and perception of the product among the NCCN Panel Members. The NCCN guidelines are recognized and followed by both academic and community oncologists when selecting appropriate therapeutic options for their patients," said Michael Bailey, president and chief executive officer of AVEO. "This year we presented encouraging long-term, progression free survival (PFS) and overall survival (OS) follow-up data from the Phase 3 TIVO-3 study. These new data demonstrate the durability of FOTIVDA’s anti-tumor activity which has translated into an improving OS hazard ratio."

The NCCN Clinical Practice Guidelines are the recognized standard for clinical policy in cancer care and are developed through review of evidence and recommendations from physicians and oncology researchers. The current NCCN RCC guidelines make treatment recommendations for first-line or subsequent therapy options for RCC patients and are referenced in the development of other clinical pathways.

About FOTIVDA (tivozanib)
FOTIVDA (tivozanib) is an oral, next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI). It is a potent, selective inhibitor of VEGFRs 1, 2, and 3 with a long half-life designed to improve efficacy and tolerability. AVEO received U.S. Food and Drug Administration (FDA) approval for FOTIVDA on March 10, 2021 for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. FOTIVDA was approved in August 2017 in the European Union and other countries in the territory of its partner EUSA Pharma (UK) Limited for the treatment of adult patients with advanced RCC. FOTIVDA has been shown to significantly reduce regulatory T-cell production in preclinical models.1 FOTIVDA was discovered by Kyowa Kirin.

INDICATIONS

FOTIVDA is indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Hypertension and Hypertensive Crisis: Control blood pressure prior to initiating FOTIVDA. Monitor for hypertension and treat as needed. For persistent hypertension despite use of anti-hypertensive medications, reduce the FOTIVDA dose.

Cardiac Failure: Monitor for signs or symptoms of cardiac failure throughout treatment with FOTIVDA.

Cardiac Ischemia and Arterial Thromboembolic Events: Closely monitor patients who are at increased risk for these events. Permanently discontinue FOTIVDA for severe arterial thromboembolic events, such as myocardial infarction and stroke.

Venous Thromboembolic Events: Closely monitor patients who are at increased risk for these events. Permanently discontinue FOTIVDA for severe venous thromboembolic events.

Hemorrhagic Events: Closely monitor patients who are at risk for or who have a history of bleeding.

Proteinuria: Monitor throughout treatment with FOTIVDA. For moderate to severe proteinuria, reduce the dose or temporarily interrupt treatment with FOTIVDA.

Thyroid Dysfunction: Monitor before initiation and throughout treatment with FOTIVDA.

Risk of Impaired Wound Healing: Withhold FOTIVDA for at least 24 days before elective surgery. Do not administer for at least 2 weeks following major surgery and adequate wound healing. The safety of resumption of FOTIVDA after resolution of wound healing complications has not been established.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Discontinue FOTIVDA if signs or symptoms of RPLS occur.

Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception.

Allergic Reactions to Tartrazine: The 0.89 mg capsule of FOTIVDA contains FD&C Yellow No.5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible patients.

ADVERSE REACTIONS
The most common (≥20%) adverse reactions were fatigue, hypertension, diarrhea, decreased appetite, nausea, dysphonia, hypothyroidism, cough, and stomatitis, and the most common Grade 3 or 4 laboratory abnormalities (≥5%) were sodium decreased, lipase increased, and phosphate decreased.

DRUG INTERACTIONS

Strong CYP3A4 Inducers: Avoid coadministration of FOTIVDA with strong CYP3A4 inducers.

USE IN SPECIFIC POPULATIONS

Lactation: Advise not to breastfeed.
Females and Males of Reproductive Potential: Can impair fertility.
Hepatic Impairment: Adjust dosage in patients with moderate hepatic impairment. Avoid use in patients with severe hepatic impairment.

To report SUSPECTED ADVERSE REACTIONS, contact AVEO Pharmaceuticals, Inc. at 1-833-FOTIVDA (1-833-368-4832) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see FOTIVDA Full Prescribing Information which is available at www.FOTIVDA.com.

About Advanced Renal Cell Carcinoma

According to the American Cancer Society’s 2021 statistics, renal cell carcinoma (RCC) is the most common type of kidney cancer, which is among the ten most common cancers in both men and women. Approximately 73,750 new cases of kidney cancer will be diagnosed annually and about 14,830 people will die from this disease. In patients with late-stage disease, the five-year survival rate is 13%. Agents that target the vascular endothelial growth factor (VEGF) pathway have shown significant antitumor activity in RCC.2 According to a 2019 publication, 50% of the approximately 10,000 patients who progress following two or more lines of therapy choose not to receive further treatment,3 which may be attributable to tolerability concerns and a lack of data to support evidence-based treatment decisions in this highly relapsed or refractory patient population.