On March 29, 2019 Bicycle Therapeutics, a biotechnology company pioneering a new class of therapeutics based on its proprietary bicyclic peptide (Bicycle) product platform, reported that Bicycle scientists have been selected to present two oral presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Atlanta (Press release, Bicycle Therapeutics, MAR 29, 2019, View Source [SID1234534762]). These presentations will focus on preclinical programs that have shown target-dependent anti-tumor activity across a range of patient-derived Nectin-4 and EphA2 expressing cancer models.

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"Because of their small size and profound efficacy, Bicycle’s toxin conjugates are able to do what many previous antibody drug conjugate approaches could not," said Nicholas Keen, Ph.D., Chief Scientific Officer of Bicycle Therapeutics. "Preclinical data from both our BT5528 and BT8009 programs show target-dependent anti-tumor activity across a range of EphA2-expressing and Nectin-4-expressing cancer models, respectively, and we’re proud that AACR (Free AACR Whitepaper) has chosen to highlight our work."

In addition, Bicycle has also been selected to present a poster on its CD137 program, intended to activate cytotoxic T-cells, a type of cell used in the body’s immune response.

Added Keen: "We believe Bicycle’s work on CD137 has produced the first fully-synthetic immune oncology modulators, which may confer several advantages over existing modalities because of the multivalency and pharmacokinetic characteristics of Bicycles."

Details on Bicycle’s presentations at the 2019 AACR (Free AACR Whitepaper) Annual Meeting are as follows:

Oral Presentation Title: BT8009: A bicyclic peptide toxin conjugate targeting Nectin-4 (PVRL4) displays efficacy in preclinical tumor models
Presenter: Michael Rigby, Ph.D., project leader for BT8009, a Nectin-4 targeted Bicycle Toxin Conjugate
Session Title: Novel Therapeutics
Abstract: #4479
Date and Time: April 2, 2019, 3:00 p.m. – 5:00 p.m. EDT

Oral Presentation Title: BT5528, an EphA2-targeting Bicycle Toxin Conjugate (BTC): Profound efficacy without bleeding and coagulation abnormalities in animal models
Presenter: Gavin Bennett, Ph.D., Director of Preclinical Development and project leader for BT5528, an EphA2 targeted Bicycle Toxin Conjugate
Session Title: Novel Therapeutics
Abstract: #4481
Date and Time: April 2, 2019, 3:00 p.m. – 5:00 p.m. EDT

Poster Presentation Title: Activation of CD137 using multivalent and tumor-targeted Bicyclic peptides
Presenter: Johanna Lahdenranta, Ph.D., Director of In Vivo Pharmacology
Session Title: Novel Immunomodulatory Agents 1
Abstract: #3257
Date and Time: April 2, 2019, 8:00 a.m. – 12:00 p.m. EDT

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.

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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.

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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]).

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"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]):

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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