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Targovax enters collaboration with Leidos to add checkpoint inhibitor functionality to ONCOS viruses

On June 4, 2020 Targovax ASA (OSE: TRVX), a clinical stage immuno-oncology company developing oncolytic viruses to target hard-to-treat solid tumors, reported that it has entered into a collaboration agreement with the Explorations in Global Health (ExGloH) Division of Leidos to evaluate the potential of using ONCOS oncolytic adenoviruses as a vector to encode Microtide checkpoint inhibitor peptides (Press release, Targovax, JUN 4, 2020, View Source [SID1234564001]).

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Targovax’s clinical program is focused on combining ONCOS viruses with checkpoint inhibitors. This combination is promising since checkpoint inhibition complements oncolytic virotherapy by blocking the tumor’s main defense mechanism against the anti-tumor immune response generated by the oncolytic virus.

ExGloH has developed a unique, proprietary portfolio of microbially-derived peptides, called MicrotideTM, that act as immune checkpoint inhibitors. The simple structure and small size of Microtide peptides make them well-suited for delivery by DNA vectors, and the parties will explore whether this capability can be extended to ONCOS viruses. If successful, this could potentially circumvent the need to combine ONCOS with classical systemically delivered checkpoint inhibitors.

Under the agreement, Leidos and Targovax will investigate the technical feasibility, in vitro and in vivo immune modulatory, and anti-cancer properties of encoding Microtide checkpoint peptides in the ONCOS adenovirus backbone. If successful, the combined ONCOS and Microtide constructs may serve as a platform where additional functionality can be built in to stimulate multiple complementary anti-tumor mechanisms.

Dr. Erik Digman Wiklund, Chief Business Officer of Targovax, said: "We are continuously looking for new strategies to enhance the immune activation potential and explore novel payloads for our ONCOS viruses. In ExGloH we have found a collaborator with a unique class of checkpoint inhibitors that we believe perfectly complements ONCOS. We are very excited to jointly explore whether the ONCOS and Microtide combination can enhance the second generation of ONCOS viruses and serve as a platform for future clinical product candidates to fulfil important medical needs."

Myriad Genetics Announces Publication of a Prospective Clinical Study of the EndoPredict® Test in Women with Early-Stage Breast Cancer

On June 4, 2020 Myriad Genetics, Inc. (NASDAQ: MYGN, "Myriad" or the "Company"), a global leader in molecular diagnostics and precision medicine, reported the publication of a prospective study demonstrating that the EndoPredict test predicts which patients with ER+, HER2- early-stage breast cancer will benefit from neoadjuvant therapy (Press release, Myriad Genetics, JUN 4, 2020, View Source [SID1234561737]). The article titled, "The EndoPredict score predicts response to neoadjuvant chemotherapy and neoendocrine therapy in hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer patients from the ABCSG-34 trial," appeared online in the European Journal of Cancer.

"This study demonstrated that the EndoPredict (EP) test predicted response to neoadjuvant chemotherapy or neoadjuvant endocrine therapy in women with ER+, HER2 negative early-stage breast cancer," said Peter Dubsky, M.D., lead author, speaking on behalf of the Austrian Breast and Colorectal Cancer Study Group (ABCSG). "Based on these findings and prior studies, we are confident the EndoPredict test can add valuable information to aid in personalized treatment selection in neoadjuvant therapy and provides an important basis for future design of neoadjuvant clinical trials."

The primary objective of this prospective study was to test the predictive value of the EndoPredict test regarding tumor response after neoadjuvant chemotherapy (NaCT) or neoadjuvant endocrine therapy (NET) within the ABCSG-34 trial. The analysis included data from 217 women with HR+ breast cancer. Of these, 134 patients were assigned to receive NaCT (eight cycles of anthracycline/taxane) according to aggressive clinico-pathologic tumor features. The remaining 83 patients were clinically identified as having luminal A-like types of breast cancer and were assigned to receive NET (six months of letrozole). The primary endpoint was residual cancer burden RCB0/I (i.e., good tumor response) vs. RCB II/III (i.e., poor tumor response) at time of surgery.

In the neoadjuvant chemotherapy group, 125 patients had high EP scores and nine had a low EP score. The results show that 26.4 percent of those with a high score showed a good tumor response (RCB0/I) to neoadjuvant chemotherapy, while all patients with a low score showed only a poor tumor response (Table 1). In the "luminal A" group receiving neoendocrine therapy, 39 patients had a high EP score and 44 had a low EP score. The results show that 27.3 percent of those with a low EndoPredict score and 7.7 percent with a high score achieved excellent tumor response (RCB0/I) to neoendocrine therapy (Table 1).

Table. 1

EndoPredict
Low Score

EndoPredict
High Score Predictive Performance
EndoPredict Score
(p-value)
Response to Neoadjuvant Chemotherapy

0.0

26.4

p=0.0001
Response to
Endocrine Therapy 27.3 % 7.7 % P=0.015
"In this prospective study, we demonstrated that the EndoPredict test is a useful tool pre-operatively," said Ralf Kronenwett, M.D., director of International Medical Affairs at Myriad. "In two distinct ER-positive, HER2-negative cohorts selected by clinicians to receive neoadjuvant chemotherapy or neoadjuvant endocrine therapy, EndoPredict identified patients with poor neoadjuvant treatment response. Clinicians can use information to determine who might forgo these therapies prior to surgery."

About EndoPredict
EndoPredict is a second-generation, 12-gene molecular prognostic test for patients diagnosed with breast cancer. The test provides vital information that helps clinicians devise personalized treatment plans for their patients. EndoPredict has been validated in more than 4,000 patients with node-negative and node-positive cancer and has been used clinically in more than 20,000 patients. In contrast to first-generation multigene prognostic tests, EndoPredict detects the likelihood of late metastases (i.e., metastasis formation after more than five years) and, therefore, can guide treatment decisions regarding the need for chemotherapy, as well as extended anti-hormonal therapy. Accordingly, therapy decisions backed by EndoPredict confer a high level of diagnostic safety. For more information, please visit: www.endopredict.com.

Atara Biotherapeutics to Participate at Two Upcoming Conferences

On June 4, 2020 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a pioneer in T-cell immunotherapy leveraging its novel allogeneic EBV T-cell platform to develop treatments for patients with severe diseases including solid tumors, hematologic cancers and autoimmune disease, reported that Pascal Touchon, the Company’s President and Chief Executive Officer, will participate at two upcoming virtual conferences in June (Press release, Atara Biotherapeutics, JUN 4, 2020, View Source [SID1234560880]).

Goldman Sachs 41st Annual Global Healthcare Conference
Video Fireside Chat: Thursday, June 11, 2020 at 3:50 p.m. EDT

A live video webcast of the Goldman Sachs presentation will be available by visiting the Investor Events and Presentations section of atarabio.com. An archived replay will be available on the Company’s website for approximately 14 days following the live webcast.

BIO Digital
Company Presentation: available on-demand via the BIO website, June 8-12, 2020

Aileron Therapeutics Announces Pricing of Public Offering of Common Stock

On June 4, 2020 Aileron Therapeutics (NASDAQ: ALRN) reported that the pricing of an underwritten public offering of 9,090,910 shares of its common stock at a public offering price of $1.10 per share, for aggregate gross proceeds of $10.0 million, before deducting underwriting discounts and commissions and offering expenses payable by Aileron (Press release, Aileron Therapeutics, JUN 4, 2020, View Source [SID1234560864]). In addition, Aileron has granted the underwriter a 30-day option to purchase up to 1,363,636 additional shares of common stock at the public offering price, less the underwriting discounts and commissions. All of the shares are being sold by Aileron. The offering is expected to close on June 8, 2020, subject to the satisfaction of customary closing conditions.

Aileron expects to use the net proceeds from the offering, together with its existing cash, cash equivalents and short-term investments, to fund clinical development of ALRN-6924 as a chemoprotective agent and for working capital and other general corporate purposes.

William Blair & Company, L.L.C. is acting as sole book-running manager for the offering.

The shares are being offered pursuant to an effective shelf registration statement that was filed with the Securities and Exchange Commission (SEC) on July 1, 2019 and declared effective by the SEC on July 15, 2019.

This offering is being made only by means of a prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement relating to and describing the terms of the offering has been filed with the SEC and may be obtained for free by visiting the SEC’s website at www.sec.gov. The final prospectus supplemented relating to the offering will be filed with the SEC. When available, copies of the final prospectus supplement and the accompanying prospectus may also be obtained by contacting William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, or by calling (800) 621-0687, or emailing [email protected].

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.

AETERNA ZENTARIS RECEIVES EXTENSION FROM NASDAQ TO SATISFY CONTINUING LISTING REQUIREMENTS

On June 4, 2020 Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) ( the "Company"), a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests, reported that the Company has received a positive decision from the staff of the Listing Qualifications Department of The Nasdaq Stock Market LLC(the "Staff"), granting the Company’s request for an extension through October 5, 2020 to achieve compliance with the minimum $2.5 million stockholders’ equity requirement for continued listing on The Nasdaq Capital Market (Press release, AEterna Zentaris, JUN 4, 2020, View Source [SID1234560860]). The Staff’s determination followed the Company’s submission of its compliance plan for the Staff’s consideration on May 26, 2020.

The Company is pursuing a number of initiatives to increase stockholders’ equity, the completion of which are expected to enable it to achieve compliance with the minimum stockholders’ equity requirement by no later than October 5, 2020 and to thereafter maintain compliance with the listing requirements.