On July 6, 2021 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel LAG-3 related immunotherapy treatments for cancer and autoimmune disease, reported it has completed all the necessary competent authority steps with the US Food and Drug Administration (FDA) and has received IRB approval to commence its phase IIb TACTI-003 trial in the United States. Patient recruitment for the TACTI-003 trial is expected to begin within this quarter (Press release, Immutep, JUL 6, 2021, View Source [SID1234584655]).

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TACTI-003 will evaluate the Company’s lead product candidate, eftilagimod alpha ("efti" or "IMP321"), in combination with MSD’s KEYTRUDA (pembrolizumab) as a first line therapy in approximately 154 patients with Head and Neck Squamous Cell Carcinoma (HNSCC). It is a randomised, controlled clinical study that will take place across Australia, Europe and the United States of America in up to 35 clinical sites.

Immutep was granted Fast Track designation for efti to treat 1st line HNSCC patients by the US FDA in early April 2021.

Pending approval by the European and Australian competent authorities and ethics committees, Immutep expects to broaden its recruitment sites into these regions.

Commenting on the start of the TACTI-003 trial, Immutep CSO and CMO Frédéric Triebel said: "We are delighted to start our new TACTI-003 trial in 1st line HNSCC patients to evaluate efti in combination with pembrolizumab vs pembrolizumab monotherapy. Results we reported from this therapeutic combination earlier in June at ASCO (Free ASCO Whitepaper) in the 2nd line setting were robust, with sustained and durable responses. We look forward to deepening these results with a larger group of 1st line HNSCC patients in TACTI-003."

About TACTI-003

TACTI-003 is a Phase IIb clinical trial in 1st line Head and Neck Squamous Cell Carcinoma (HNSCC). It will evaluate efti in combination with MSD’s KEYTRUDA (pembrolizumab) as a first line therapy in unresectable recurrent or metastatic HNSCC patients with PD-L1 negative and PD-L1 positive (CPS ³1) tumors. It will be a randomised, controlled clinical study in approximately 154 first line HNSCC patients and will take place across Australia, Europe and the United States of America in up to 35 clinical sites.

The study will evaluate the safety and efficacy of efti in combination with pembrolizumab, compared to pembrolizumab
alone in 1st line metastatic or recurrent HNSCC patients with PD-L1 positive (CPS ³1) tumors (cohort A), and determine the efficacy and safety of efti plus pembrolizumab in patients with PD-L1 negative tumors (CPS <1) (cohort B). According to the current plans, about 130 patients in cohort A will be randomised 1:1 to receive either efti plus pembrolizumab or pembrolizumab alone. Subjects in cohort B (up to 24 patients) will receive a combination of efti and pembrolizumab.

The primary endpoint of the study is the Overall Response Rate (ORR) according to RECIST 1.1. and iRECIST will be used for treatment decisions. Secondary endpoints include OS and Progression Free Survival (PFS).

On July 6, 2021 Genpre reported that it’s lead drug candidate, REQORSA Immunogene Therapy that uses our proprietary, non-viral ONCOPREX Nanoparticle Delivery System was highlighted in a Key Opinion Leader event hosted by Alliance Global Partners (AGP) for their institutional customers (Press release, Genprex, JUL 6, 2021, View Source [SID1234584654]).

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The event, titled, "Advances in Gene Therapy for Oncology: New Opportunities with REQORSA (TUSC2)," was moderated by James Molloy, Managing Director, Equity Research at AGP and featured discussions with experts Andrew Becker, M.D., Ph.D. and COL (ret) George Peoples, M.D., FACS.

The presentation gave an overview of REQORSA and ONCOPREX, including discussions suggesting that REQORSA could be the first systemic gene therapy used for cancer in humans. It also featured the large markets that REQORSA is addressing, as well as REQORSA and ONCOPREX’s potential to address a range of cancers.

The discussion also reviewed highlights from Genprex’s two previous clinical trials, ONC-001, a REQORSA monotherapy clinical trial; and ONC-002, a combination of REQORSA and Roche’s Tarceva in NSCLC.

The KOLs also discussed the importance of the positive preclinical data presented in April at the 2021 American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting that supported the use of REQORSA in combination with immunotherapies and with targeted therapies for the treatment of NSCLC.

On the Company’s Acclaim-1 and upcoming Acclaim-2 clinical trials:

"What I like about these trial designs is the potential to get added value and added time for patients out of Keytruda and Tagrisso, in order to delay the time before the patient has to begin a more toxic chemotherapy regimen," said Dr. Becker. "The ability to continue on a PD-1 inhibitor or a targeted therapy longer, in patients that we know are tolerating it, is a benefit to the patient because it not only extends life, but it extends quality of life."

On the positive preclinical data presented by our academic collaborators at the AACR (Free AACR Whitepaper) annual meeting supporting REQORSA:

"These AACR (Free AACR Whitepaper) studies are incredibly important because they are addressing the use of REQORSA in combination with what is the most current way we treat NSCLC patients clinically," said Dr. Peoples. "What you will see with the AACR (Free AACR Whitepaper) studies, is that Genprex is encompassing all of the patients in the first-line therapy setting, whether they have EGFR mutations and fall into the targeted therapy category, or if they are PD-L1 positive patients who will get pembrolizumab or a pembrolizumab combination with platinum chemotherapy. The data covers the majority of the first-line patients in these two AACR (Free AACR Whitepaper) presentations."

Learn more about the KOLs by reading Dr. Becker’s and Dr. Peoples’ bios. To watch the presentation in its entirety, a replay of the event can be found on the Genprex website. Since the KOL event recording on April 27, 2021, Genprex has initiated its Acclaim-1 clinical trial and has updated the Acclaim-2 protocol to include all late-stage NSCLC patients who have progressed after treatment with Keytruda, regardless of PD-L1 expression.

On July 6, 2021 Cleveland BioLabs, Inc. (NASDAQ: CBLI), an innovative biopharmaceutical company developing novel approaches to activate the immune system, reported that the Company and Cytocom Inc., a leading biopharmaceutical company developing next generation therapeutics that target immune restoration and homeostasis, will host an investor call and live webcast on Wednesday, July 7 at 8:30 a.m. ET (Press release, Cytocom, JUL 6, 2021, https://www.cytocom.com/2021/07/06/cleveland-biolabs-inc-and-cytocom-inc-announce-call-to-discuss-stockholder-meeting-vote-results-and-proposed-merger/?utm_source=rss&utm_medium=rss&utm_campaign=cleveland-biolabs-inc-and-cytocom-inc-announce-call-to-discuss-stockholder-meeting-vote-results-and-proposed-merger [SID1234584652]).

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During the call, Michael K. Handley, President and Chief Executive Officer of Cytocom, and members of the Cleveland BioLabs Board of Directors will discuss the results of the vote on the merger transaction, scheduled to take place July 6, 2021, during a Special Meeting of Cleveland BioLabs shareholders. Mr. Handley will also discuss the strategic vision for the combined companies including the opportunities in COVID-19, Crohn’s disease, pancreatic cancer, hematology, and acute radiation syndrome. The company is developing therapies and plans to launch therapies into the $48.7 billion gastrointestinal market, the $84.3 billion therapeutic oncology market, the $82.5 billion hematology market and the $125.0 billion autoimmune market. The combined company could have the broadest Toll-like receptor therapeutic platform in the industry, allowing it to potentially treat a multitude of immune-related diseases and significantly expand the size of its total addressable markets.

Conference Call Information:

Investors and interested participants may access the conference call or live webcast via the following:

An archive of the audio webcast will remain available for 90 days beginning at approximately 11:30 a.m. ET on July 7, 2021. The recording can be accessed at View Source

On July 6, 2021 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company developing onvansertib to treat cancers with the greatest medical needs for new treatment options, including KRAS-mutated colorectal cancer, pancreatic cancer and castrate-resistant prostate cancer, reported that Dr. Mark Erlander, chief executive officer of Cardiff Oncology, will participate in a fireside chat and virtual 1×1 investor meetings at the William Blair Biotech Focus Conference 2021 taking place virtually from July 14-15, 2021 (Press release, Cardiff Oncology, JUL 6, 2021, View Source [SID1234584650]).

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Details on the fireside chat can be found below.
Date: Thursday, July 15, 2021
Time: 12:00 – 12:45 PM ET
Webcast Link:
View Source

A replay of the fireside chat will be available by visiting the "Events" section of the Cardiff Oncology website after its conclusion and will be archived on the Company website for 30 days.

On July 6, 2021 AIM ImmunoTech Inc. (NYSE American: AIM) reported that it will host an investor update webcast at 11:00 a.m. Eastern Time on Wednesday, July 14, 2021, to discuss recent accomplishments and upcoming milestones (Press release, AIM ImmunoTech, JUL 6, 2021, View Source [SID1234584642]). Investors and other interested parties are invited to submit questions to management prior to the call’s start via email to [email protected].

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The webcast may be accessed at View Source or on the Company’s website at View Source For those unable to participate at that time, a replay of the webcast will be available until Thursday, July 14, 2022 on the Company’s website.