On March 29, 2019 CEL-SCI Corporation (NYSE American: CVM) reported that the Independent Data Monitoring Committee (IDMC) for the Company’s pivotal Phase 3 head and neck cancer study of its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) has completed its recent review of the Phase 3 study data (Press release, Cel-Sci, MAR 29, 2019, View Source [SID1234534763]). The data from all 928 enrolled patients were provided to the IDMC by the clinical research organization (CRO) responsible for data management of this Phase 3 study.

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 IDMC made the following recommendation:

The IDMC recommendation is to continue the trial until the appropriate number of events have occurred.
IDMCs are committees commonly used by sponsors of clinical trials to protect the interests of the patients and the integrity of the study data in ongoing trials, especially when the trials involve patients with life threatening diseases, and when, as in cancer clinical trials, they extend over long periods of time.

On March 29, 2019 Aileron Therapeutics (NASDAQ: ALRN), the clinical-stage leader in the field of stabilized cell-permeating peptides to treat cancer and other diseases, reported that it has entered into a securities purchase agreement with a group of institutional accredited investors for the private placement of $26 million of Aileron common stock and warrants (Press release, Aileron Therapeutics, MAR 29, 2019, View Source [SID1234534815]). The private placement is expected to close on or about April 2, 2019 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!

The private placement was led by Satter Medical Technology Partners, L.P. with significant additional participation from Jennison Associates (on behalf of certain clients) and an undisclosed institutional investor, in addition to other new and existing investors.

The Company is selling in the private placement 11,838,582 units, consisting of 11,838,582 shares of common stock and associated warrants to purchase 11,838,582 shares of common stock, for a combined price of $2.01 per unit. In addition, the Company is also selling in the private placement 1,096,741 units, consisting of pre-funded warrants to purchase 1,096,741 shares of common stock and associated warrants to purchase 1,096,741 shares of common stock, for a combined price of $2.01 per unit.

William Blair & Company, L.L.C. will act as sole placement agent in connection with the financing.

Aileron expects to receive aggregate gross proceeds of approximately $26 million, before deducting placement agent fees and offering expenses, and excluding the exercise of any warrants. Aileron expects to use the net proceeds from the financing to fund the further advancement of its ALRN-6924 clinical trials and research programs, including its ongoing clinical trial collaboration with Pfizer testing ALRN-6924 in combination with palbociclib in MDM2-amplified cancers and its planned Phase 1b/2 clinical trial to evaluate ALRN-6924 as a myelopreservative agent, to protect against chemotherapy-induced toxicity. This use of proceeds reflects Aileron’s determination to cease enrollment and clinical development in AML/MDS in light of the Company’s resources and its assessment of the commercial opportunities, as well as the changed competitive landscape where seven drugs were approved for AML in the United States in the last two years.

The securities to be sold in the private placement have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws, and accordingly may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. Aileron has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the shares of

common stock issued in the private placement and the shares of common stock issuable upon the exercise of the warrants issued in the private placement.

This release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be by means of a prospectus.

On March 29, 2019 Arch Oncology, Inc., a clinical-stage immuno-oncology company focused on the discovery and development of best-in-class anti-CD47 therapies for cancer, reported the presentation of two posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting to be held March 29 – April 3, 2019 in Atlanta, GA (Press release, Arch Oncology, MAR 29, 2019, View Source [SID1234534764]).

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!

"We are excited to present these new sets of preclinical data at AACR (Free AACR Whitepaper), highlighting the progress our team is making with advancing our novel antibody programs," said Julie M. Cherrington, Ph.D., President and Chief Executive Officer of Arch Oncology. "The most recent data on AO-176 build on the growing body of research showing that our highly differentiated anti-CD47 antibody selectively binds to and directly kills tumor cells while sparing normal cells. We will continue to work hard to advance AO-176 in our ongoing Phase 1 clinical trial in patients with select solid tumors. In addition, we are presenting for the first time preclinical data from our novel, discovery-stage anti-SIRP antibody program."

Poster Presentations:
Title: AO-176, a normal cell sparing humanized anti-CD47 antibody
Session Date and Time: Sunday, March 31, 2019 1:00 PM – 5:00 PM ET
Session Category: Immunology
Session Title: Therapeutic Antibodies 1
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 23
Poster Board Number: 4
Abstract Number: 540

Title: Evaluation of novel anti-SIRP antibodies as potential cancer therapeutics
Session Date and Time: Sunday, March 31, 2019 1:00 PM – 5:00 PM ET
Session Category: Immunology
Session Title: Therapeutic Antibodies 1
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 23
Poster Board Number: 12
Abstract Number: 548

Copies of these posters will be available as poster sessions begin at View Source

About Arch Oncology’s Anti-CD47 Antibody AO-176

AO-176 is a humanized anti-CD47 IgG2 antibody with a best-in-class profile. Arch Oncology’s next-generation anti-CD47 antibody AO-176 is highly differentiated, with the potential to improve upon the safety and efficacy profile relative to other agents in this class of innate checkpoint inhibitors. AO-176 works by blocking the "don’t eat me" signal, the standard mechanism of anti-CD47 antibodies. Beyond blocking this signal, AO-176 also works by directly killing tumor cells. Importantly, AO-176 binds preferentially to tumor cells, instead of to normal cells, and binds even more potently to tumors in their acidic microenvironment (low pH). AO-176 is being evaluated in a Phase 1 clinical trial for the treatment of patients with select solid tumors. Additional information about this trial may be found at www.clinicaltrials.gov using the trial identification number NCT03834948.

On March 29, 2019 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported that the company will present at the following conferences in April (Press release, Iovance Biotherapeutics, MAR 29, 2019, View Source;p=RssLanding&cat=news&id=2392771 [SID1234534740]):

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!

American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Atlanta, March 29-April 3
Title: Persistence of cryopreserved tumor-infiltrating lymphocyte product lifileucel (LN-144) in C-144-01 study of advanced metastatic melanoma
Authors: Viktoria Gontcharova et al.
Session Title: Late-Breaking Research: Immunology 1
Session Type: Late-Breaking Poster Session
Section: 41
Abstract Number: LB-069

Location: Georgia World Congress Center
Date/Time: Monday, April 1, from 8:00 a.m. – 12:00 p.m. EDT
Jefferies 6th Annual IO Cell Therapy Summit in Boston, April 5
Location: Boston Harbor Hotel
Date/Time: Friday, April 5, at 10:35 a.m. EDT

HC Wainwright Global Life Science Conference in London, April 7-9
Location: JW Marriott Grosvenor House London
Date/Time: Tuesday, April 9, at 9:50 a.m. BST
A live and archived webcast of the presentation will be available by visiting the Investors section of the Iovance Biotherapeutics website at View Source

2019 Cell & Gene Meeting on the Mediterranean in Barcelona, April 23-25
Location: Hotel Arts Barcelona
Date/Time: Wednesday, April 24, at 12:00 p.m. CEST

15th European Association of Dermato-Oncology (EADO) Congress in Paris, April 24-27
Title: Safety and efficacy of cryopreserved autologous tumor infiltrating lymphocytes (LN-144, lifileucel) in previously treated metastatic melanoma patients (Encore presentation)
Location: Maison de la Chimie Conference Center
Date/Time: Thursday, April 25 at 2:07 p.m. CEST

On March 29, 2019 Advaxis, Inc. (NASDAQ: ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported the presentation of ADXS-NEO data in a poster discussion entitled "Safety and Immunogenicity of a Personalized Neoantigen-Listeria Vaccine in Cancer Patients" at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting underway in Atlanta (Press release, Advaxis, MAR 29, 2019, View Source [SID1234534765]). The discussion will be held on Sunday, March 31, 2019 from 1:00-5:00 p.m. ET and will be led by J. Randolph Hecht, M.D., Professor of Clinical Medicine, David Geffen School of Medicine at UCLA and Director of the UCLA Gastrointestinal Oncology Program.

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!

ADXS-NEO is a live, attenuated Listeria monocytogenes (Lm) immunotherapy, using personalized antigen delivery based on whole-exome sequencing of a patient’s tumor to identify personal neoantigens. The ongoing Phase 1 trial is designed to evaluate the safety, tolerability and preliminary clinical immunological activity of ADXS-NEO alone (Part A) and in combination with anti-PD-1 antibody therapy (Part B) in subjects with certain types of advanced or metastatic solid tumors. Part C of the trial will be an expansion of the combination therapy arm and will be initiated based on emerging data from the first two parts of the trial.

Preliminary findings from the ADXS-NEO Phase 1 study include the following:

Substantial anti-tumor immunity, including T cell responses to neoantigens and antigen spreading, was observed within one week of first dose at both dose levels
Dosing of ADXS-NEO at 1×108 colony forming units (CFU) has been well-tolerated in two patients
ADXS-NEO dosed at 1×109 CFU was beyond the maximum tolerated dose (MTD)
Reversible Grade 3 hypoxia (n=2) and Grade 3 hypotension (n=1) were dose-limiting toxicities (DLTs)
Manufacturing of ADXS-NEO, comprised of 40 personal neoantigens, was successfully completed within seven to eight weeks for each subject
"Advaxis’ ADXS-NEO is a novel, personalized vaccine encoding mutations specific to an individual patient’s tumor designed to induce anti-cancer immunity. Four patients have been evaluated across two dose levels thus far in this ongoing clinical trial. While dose level 1 (1×109 CFU) was determined to be above the MTD, dose level -1a (1×108 CFU) has been safe and well tolerated in two patients treated to date, with primarily Grade 1 and Grade 2 chills, fever and tachycardia. Substantial immunological activity was observed across both dose levels, including rapid neoantigen-specific CD8+ T cell generation, which is essential for potential clinical benefit. We look forward to the planned combination therapy arm with checkpoint inhibitors," said Dr. Hecht.

"The patients being evaluated for safety and tolerability in Part A all have late-stage disease and have been treated with numerous prior therapies. As a result, we did not expect to observe significant clinical activity in this cohort," said Andres Gutierrez, M.D. Ph.D., Chief Medical Officer of Advaxis. "Nevertheless, we have seen some encouraging clinical signals to date, including one patient at dose level 1 with non-small cell lung cancer who achieved stable disease after only two doses of ADXS-NEO, which is consistent with rapid immune activation." He concluded, "This is the first presentation of clinical data from our ADXS-NEO program at a major medical conference. We are continuing to enroll subjects and gather additional clinical and immune correlative data, and plan to share updated data from this study throughout this year."

The full abstract is available at www.advaxis.com and the poster will be available on the Company’s website on Sunday, March 31, 2019 at 1:00 p.m. ET.

About ADXS-NEO

ADXS-NEO is an investigational personalized Lm-based immunotherapy designed to generate immune response against mutation-derived tumor-specific neoantigens identified through DNA sequencing of a patient’s own tumor. The program focuses on creating a customized treatment for each patient targeting multiple neoantigens found in a biopsy of the patient’s tumor.