On May 26, 2021 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, reported that its ovarian cancer vaccine technology is part of an award from the National Cancer Institute (NCI) (Press release, Anixa Biosciences, MAY 26, 2021, View Source [SID1234580607]). Anixa Biosciences holds an exclusive worldwide license from Cleveland Clinic for this vaccine technology.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The award from the NCI, part of the National Institutes of Health, was made to Cleveland Clinic through the NCI-PREVENT program.

The PREVENT program is a peer-reviewed agent development program designed to support preclinical development of innovative interventions and biomarkers for cancer prevention and interception towards clinical trials. The scientific and financial resources of the PREVENT program will be allocated to four general milestones as follows:

Milestone 1: Immunogenicity and efficacy testing of the vaccine in mouse model
Milestone 2: Development of the expression vector for optimal vaccine production
Milestone 3: cGMP (current Good Manufacturing Practice) manufacturing of vaccine and pre-IND (Investigational New Drug) meeting with the US Food and Drug Administration
Milestone 4: IND enabling cGLP (current Good Laboratory Practice) studies and IND filing
All of this work will be performed at NCI facilities, by NCI scientific staff with NCI financial resources. Milestone 1 will begin shortly after execution of contracts and design of experiments. Milestones 2-4 will be performed successively as progress is achieved.

The technology subject to the application titled, Immunoprevention of Human Epithelial Ovarian Carcinoma (EOC), was invented by a research team led by Dr. Vincent Tuohy of Cleveland Clinic’s Lerner Research Institute. Dr. Tuohy stated, "This peer-reviewed collaboration will provide us the vast laboratory and financial resources of the NCI to aid in the development of our vaccine. Our vision with this technology is to eliminate ovarian cancer worldwide, especially since women who suffer from ovarian cancer tend to have poor outcomes."

Dr. Amit Kumar, President and CEO of Anixa Biosciences, stated, "This technology along with Dr. Tuohy’s breast cancer vaccine have the potential to eliminate two of the most common malignancies in women. We continue to be pleased to be collaborating on these programs."

On May 26, 2021 AIM ImmunoTech Inc. (NYSE American: AIM) reported that it has completed dosing of Cohort 3 in a Phase 1 clinical study to assess the safety, tolerability and biological activity of Ampligen as an intranasal therapy, reporting no serious adverse events (Press release, AIM ImmunoTech, MAY 26, 2021, View Source [SID1234580606]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This is consistent with results in the first two cohorts of the study and at escalating doses.The study protocol called for a total of 40 healthy subjects to receive repeated administration of either Ampligen or a placebo. Subjects in Cohort 1 received 75 μg of Ampligen, subjects in Cohort 2 received 200 μg of Ampligen and subjects in Cohort 3 received 500 μg. The study is already proceeding with Cohort 4, with subjects receiving 1250 μg.

The Centre for Human Drug Research (CHDR), an independent institute located in Leiden in the Netherlands, is conducting the Phase 1 clinical study AMP-COV-100 (CHDR2049), titled "A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Activity of Repeated Intranasal Administration of Ampligen (Poly I:Poly C12U) in Healthy Subjects." AIM is sponsoring and funding the clinical study.

On May 26, 2021 ADC Therapeutics SA (NYSE:ADCT), a commercial-stage biotechnology company leading the development of novel antibody drug conjugates (ADCs) to treat hematological malignancies and solid tumors, reported that results of the Phase 1 clinical trial of camidanlumab tesirine (Cami), an anti-CD25 ADC, in patients with relapsed or refractory Hodgkin and non-Hodgkin lymphomas have been published online in The Lancet Haematology (Press release, ADC Therapeutics, MAY 26, 2021, View Source [SID1234580605]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"There is a significant unmet medical need for novel therapies that improve outcomes in patients with relapsed or refractory Hodgkin lymphoma," said Mehdi Hamadani, MD, Professor of Internal Medicine at the Medical College of Wisconsin, Division of Hematology & Oncology and lead author of The Lancet Haematology paper. "This patient population is often heavily pretreated, as was the case in this published study in which patients experienced a median of five previous systemic therapies. The Phase 1 study demonstrates encouraging potential for Cami to provide a new treatment option for patients with relapsed or refractory Hodgkin lymphoma."

The multicenter, open-label, single-arm, dose escalation and dose expansion Phase 1 clinical trial enrolled 133 adult patients, 77 (58%) with classical Hodgkin lymphoma and 56 (42%) with non-Hodgkin lymphoma. Enrolled patients were required to have pathologically confirmed relapsed or refractory Hodgkin lymphoma or non-Hodgkin lymphoma and no therapies with established clinical benefit for their disease stage available to them.

"We’re pleased the results of our Phase 1 trial of Cami in patients with relapsed or refractory lymphoma have been published in The Lancet Haematology," said Jay Feingold, MD, PhD, Senior Vice President and Chief Medical Officer at ADC Therapeutics. "The positive results in patients with Hodgkin lymphoma guided the design of our pivotal Phase 2 trial, which has completed enrollment. We’re continuing to follow patients and look forward to presenting data from the Phase 2 Cami trial at an upcoming congress."

Key results include:

In the total patient population, the overall response rate (ORR) was 58%, with 38 (29%) of 130 patients reported to have a complete response.
In heavily pretreated patients with Hodgkin lymphoma, across all doses, the ORR was 71%, with 32 (42%) of 77 patients reported to have a complete response.
In Hodgkin lymphoma patients who received 45 μg/kg (the recommended Phase 2 starting dose), the ORR was 86%, with 18 (49%) of 37 patients reported to have a complete response.
In Hodgkin lymphoma patients who received 30 μg/kg, the ORR was 55%, with seven (35%) of 20 patients reported to have a complete response.
In patients with non-Hodgkin lymphoma, the ORR was 38%, with five (9%) of 53 patients reported to have a complete response.
The overall median duration of response was 6.6 months for all patients with Hodgkin lymphoma and 7.2 months for Hodgkin lymphoma patients who received 45 μg/kg.
Cami demonstrated an acceptable safety profile. The most commonly observed adverse events included elevated liver enzymes (without hepatic synthetic dysfunction), rash, fatigue, oedema or effusion, and nausea.
Based on the data from this Phase 1 clinical trial, a Phase 2 trial to further evaluate the safety and efficacy of Cami in patients with relapsed or refractory Hodgkin lymphoma is ongoing. Interim data from the pivotal Phase 2 trial presented at the 2020 American Society of Hematology (ASH) (Free ASH Whitepaper) meeting demonstrated encouraging antitumor activity as a single agent with an ORR of 83%, a complete response rate of 38% and no new safety signals. These data highlight the potential for Cami to address an unmet need in heavily pretreated patients (median of seven prior lines of systemic therapy).

For information about the ongoing pivotal Phase 2 clinical trial of Cami in patients with relapsed or refractory Hodgkin lymphoma, please visit View Source (identifier NCT04052997).

About Camidanlumab Tesirine (Cami)

Camidanlumab tesirine (Cami, formerly ADCT-301) is an antibody drug conjugate (ADC) comprised of a monoclonal antibody that binds to CD25 (HuMax-TAC, licensed from Genmab A/S), conjugated to the pyrrolobenzodiazepine (PBD) dimer payload, tesirine. Once bound to a CD25-expressing cell, Cami is internalized into the cell where enzymes release the PBD-based payload, killing the cell. This applies to CD25-expressing tumor cells and also to CD25-expressing Tregs. The intra-tumoral release of its PBD payload may also cause bystander killing of neighboring tumor cells, and PBDs have also been shown to induce immunogenic cell death. All of these properties of Cami may enhance immune-mediated anti-tumor activity.

Cami is being evaluated in a pivotal Phase 2 clinical trial in patients with relapsed or refractory Hodgkin lymphoma and a Phase 1b clinical trial as monotherapy and in combination with pembrolizumab in solid tumors.

On May 26, 2021 AbbVie (NYSE: ABBV) reported that it will participate in Bernstein’s 37th Annual Strategic Decisions Conference on Wednesday, June 2, 2021. Michael Severino, M.D., vice chairman and president, and Robert A. Michael, executive vice president and chief financial officer, will present virtually at 2:30 p.m. Central time (Press release, AbbVie, MAY 26, 2021, View Source [SID1234580604]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live audio webcast of the presentation will be accessible through AbbVie’s Investor Relations website at investors.abbvie.com. An archived edition of the session will be available later that day.

On May 26, 2021 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel therapies for serious rare and ultra-rare genetic diseases, reported that Emil D. Kakkis, M.D., Ph.D., the company’s Chief Executive Officer and President, will present at the Jefferies Virtual Healthcare Conference on Tuesday, June 1, 2021 at 4:30 PM ET (Press release, Ultragenyx Pharmaceutical, MAY 26, 2021, View Source [SID1234580603]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The live and archived webcast of the presentation will be accessible from the company’s website at View Source The replay of the webcast will be available for 90 days.