On December 16, 2020 Aethlon Medical, Inc. (Nasdaq: AEMD), a therapeutic medical device and technology company focused on unmet needs in viral diseases, oncology and inflammation, reported that the first patient has been treated in the Company’s first-in-human Early Feasibility Study (EFS) evaluating the HEMOPURIFIER in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (Press release, Aethlon Medical, DEC 16, 2020, View Source [SID1234572958]). The study is enrolling patients at UPMC Hillman Cancer Center in Pittsburgh, PA. (Hemopurifier Plus Pembrolizumab in Head and Neck Cancer – Full Text View – ClinicalTrials.gov).

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 EFS, which is the device equivalent of a Phase 1 clinical trial for a drug or biologic, is a single center, open label trial in 10 to 12 subjects. The study is evaluating the HEMOPURIFIER for reducing cancer-associated exosomes prior to the administration of standard-of-care pembrolizumab (KEYTRUDA), which is a first-line therapy for patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck. The primary endpoint for the study is safety of the HEMOPURIFIER in a clinical setting. Secondary endpoints include efficacy based on response rates, progression-free and overall survival, and changes in exosome concentration after HEMOPURIFIER treatment.

In cancer, exosomes have been shown to participate in the development and advancement of disease. Exosomes derived from tumor cells may promote immune suppression and seed the spread of metastasis. These tumor derived exosomes may also inhibit the activity of immuno-oncology drugs such as KEYTRUDA. Tumor derived exosomes are not currently addressed with any approved therapy.

Dan Zandberg, M.D., Medical Oncologist and Hematologist at UPMC Hillman Cancer Center, Associate Professor of Medicine at the University of Pittsburgh School of Medicine and Principal Investigator of the study, stated, "We are excited to have treated the first head and neck cancer patient with the HEMOPURIFIER. While KEYTRUDA can markedly improve outcome in some head and neck cancer patients, the majority of patients still do not respond. If clearance of exosomes with the HEMOPURIFIER prior to treatment with KEYTRUDA can increase the number of patients who are able to respond to KEYTRUDA, it could represent an important advance in the treatment of this disease. This trial represents the first step in this evaluation."

Charles J. Fisher, Jr., M.D., Chief Executive Officer of Aethlon, stated, "We are delighted to be working with Dr. Zandberg and his colleagues at the University of Pittsburgh and UPMC Hillman to treat the first head and neck cancer patient with the HEMOPURIFIER. By reducing the presence of immune suppressive exosomes from the circulatory system of head and neck cancer patients prior to treatment with KEYTRUDA, we believe the HEMOPURIFIER could have the potential to improve patient outcomes in this disease. The initiation of this first-in-human study addressing cancer-associated exosomes is a significant step towards evaluating the HEMOPURIFIER for potentially improving the efficacy of KEYTRUDA in head and neck cancer."

On December 16, 2020 Qualigen Therapeutics, Inc. (NASDAQ: QLGN) ("Qualigen" or the "Company"), reported it has entered into a definitive agreement with a single institutional investor for the purchase and sale for $12,000,000 of (i) 2,370,786 Common Shares, (ii) 1,000,000 Pre-Funded Warrants (iii) 1,348,314 Common Warrants exercisable immediately and (iv) 842,696 Common Warrants exercisable six (6) months after issuance at a combined purchase price of $3.56 in a registered direct offering (Press release, Qualigen, DEC 16, 2020, View Source [SID1234572956]). The Common Warrants will have an exercise price of $4.07 per share and have a term of two years. The closing of the offering is expected to occur on or about December 18, 2020, subject to the satisfaction of customary closing conditions.

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.G.P./Alliance Global Partners is acting as sole placement agent for the offering.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-232798) previously filed with the U.S. Securities and Exchange Commission (the "SEC"). A prospectus supplement describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the prospectus supplement may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy 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 December 16, 2020 Amphivena Therapeutics, a clinical-stage oncology company focused on developing a platform of bivalent T-cell engagers that restore anti-cancer immunity in patients, reported the first patient has been dosed in the Phase 1 dose expansion study evaluating AMV564, an investigational, first-in-class agent that depletes myeloid derived suppressor cells (MDSC) and activates T cells, in adult patients with selected solid tumor indications (Press release, Amphivena Therapeutics, DEC 16, 2020, View Source [SID1234572955]).

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 dose escalation phase of the first-in-human, multicenter, open-label study of AMV564 in solid tumors was initiated in October 2019 and established the safety, PK profile and clinical activity of AMV564 including a confirmed RECIST complete response.

The dose expansion study will explore AMV564 as a monotherapy in tumor-specific cohorts selected to enrich for patients with actionable antigens. The primary objectives of the study are to further characterize the safety and tolerability and to evaluate preliminary efficacy of AMV564 monotherapy administered subcutaneously.

"AMV564 has demonstrated an excellent safety profile and encouraging preliminary activity in heavily pretreated patients, and we look forward to seeing how this novel mechanism translates to clinical benefit in selected cancer patient populations including patients with inadequate benefit from checkpoint inhibitors, representing an area of high unmet need," said Curtis Ruegg, Ph.D., President and Chief Executive Officer of Amphivena Therapeutics.

The trial is being conducted at a planned 15 sites in the United States. Additional information on this trial, including comprehensive inclusion and exclusion criteria, can be accessed at www.ClinicalTrials.gov (NCT04128423).

About AMV564

AMV564 relieves immune suppression via targeted depletion of immunosuppressive MDSC and drives T cell activation and polarization to restore anti-cancer immunity. To date, over 95 patients have received AMV564 across three Phase 1 clinical trials for patients with solid tumors, acute myeloid leukemia (AML), and myelodysplastic syndromes (MDS).

On December 16, 2020 Luminex Corporation (Nasdaq: LMNX) reported that Nachum "Homi" Shamir, Chairman, CEO and President, and Harriss Currie, Senior Vice President and CFO, will present at the 39th Annual J.P. Morgan Healthcare Conference, to be held virtually, on January 13, 2021 at 3:30 p.m. Central Time (Press release, Luminex, DEC 16, 2020, View Source [SID1234572954]). A live webcast of the Luminex presentation may be accessed at the company’s website at View Source The presentation will be archived for six months on the website using the ‘replay’ link.

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!

On December 16, 2020 Amgen (NASDAQ:AMGN) reported submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for sotorasib, an investigational KRASG12C inhibitor for the treatment of patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, following at least one prior systemic therapy (Press release, Amgen, DEC 16, 2020, View Source [SID1234572953]).

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!

"Sotorasib was the first KRASG12C inhibitor to enter the clinic and now is on track to potentially be the first approved targeted therapy for patients with advanced NSCLC harboring the KRAS G12C mutation. In the U.S., about 13% of patients with NSCLC have the KRAS G12C mutation and face a significant unmet need," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "This submission, along with these other important regulatory achievements, underscore Amgen’s commitment to bringing this potential treatment option to patients as quickly as possible."

The NDA is being reviewed by the FDA under its Real-Time Oncology Review (RTOR) pilot program, which aims to explore a more efficient review process that ensures safe and effective treatments are made available to patients as early as possible.1

The submission is supported by positive Phase 2 results in patients with locally advanced or metastatic NSCLC from the CodeBreaK 100 clinical study, whose cancer had progressed despite prior treatment with chemotherapy and/or immunotherapy. In the study, treatment with sotorasib provided durable anticancer activity with a positive benefit-risk profile.2 These results will be presented at the International Association for the Study of Lung Cancer (IASLC) 2020 World Conference on Lung Cancer (WCLC) Presidential Symposium in January 2021.

About Sotorasib
Amgen has taken on one of the toughest challenges of the last 40 years in cancer research by developing sotorasib, an investigational KRASG12C inhibitor.3 Sotorasib was the first KRASG12C inhibitor to enter the clinic and is being studied in the broadest clinical program exploring 10 combinations with global sites spanning across four continents. In just over two years, the sotorasib clinical program has established the deepest clinical data set with more than 600 patients studied across 13 tumor types.

Sotorasib has demonstrated a positive benefit-risk profile with fast, deep and durable anticancer activity in patients with advanced NSCLC harboring the KRAS G12C mutation with a once daily oral formulation. Promising responses have also been observed in multiple other solid tumors.

KRAS G12C is the most common KRAS mutation in NSCLC.4,5 In the U.S., about 13% of patients with NSCLC harbor the KRAS G12C mutation.6 There is a high unmet need and poor outcomes in the second-line treatment of KRAS G12C-driven NSCLC and, currently, there are no KRASG12C targeted therapies approved.7

About CodeBreaK
The CodeBreaK clinical development program for Amgen’s investigational drug sotorasib is designed to treat patients with an advanced solid tumor with the KRAS G12C mutation and address the longstanding unmet medical need for these cancers. As the most advanced KRAS G12C clinical development program, CodeBreaK has enrolled more than 600 patients across 13 tumor types since its inception.

CodeBreaK 100, the Phase 1 and 2, first-in-human, open-label multicenter study, enrolled patients with KRAS G12C-mutated solid tumors. Eligible patients must have received a prior line of systemic anticancer therapy, consistent with their tumor type and stage of disease. The primary endpoint for the Phase 2 study was centrally assessed objective response rate. The Phase 2 trial in NSCLC enrolled 126 patients, 123 of whom had centrally evaluable lesions by RECIST at baseline. The Phase 2 trial in colorectal cancer (CRC) is fully enrolled and topline results are expected in 2021.

A global Phase 3 randomized active-controlled study comparing sotorasib to docetaxel in patients with KRAS G12C-mutated NSCLC (CodeBreaK 200) is currently recruiting. Amgen also has several Phase 1b combination studies across various advanced solid tumors (CodeBreaK 101) open for enrollment.

For information, please visit www.codebreaktrials.com.

About Amgen Oncology
Amgen Oncology is searching for and finding answers to incredibly complex questions that will advance care and improve lives for cancer patients and their families. Our research drives us to understand the disease in the context of the patient’s life – not just their cancer journey – so they can take control of their lives.

For the last four decades, we have been dedicated to discovering the firsts that matter in oncology and to finding ways to reduce the burden of cancer. Building on our heritage, Amgen continues to advance the largest pipeline in the Company’s history, moving with great speed to advance those innovations for the patients who need them.

At Amgen, we are driven by our commitment to transform the lives of cancer patients and keep them at the center of everything we do.

To learn more about Amgen’s innovative pipeline with diverse modalities and genetically validated targets, please visit AmgenOncology.com. For more information, follow us on www.twitter.com/amgenoncology.