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Elicio Therapeutics to discuss novel lymph node vaccine targeting seven key mKRAS mutations at RAS – Targeted Drug Discovery Summit in Vienna, Austria

On February 19, 2020 Elicio Therapeutics, a next generation immuno-oncology company, reported Peter DeMuth, PhD., Elicio Vice President of Research, will present "Targeting the Lymph Nodes to Enhance Mutant KRAS-Specific Vaccine Responses," at the upcoming RAS-Targeted Drug Discovery Summit in Vienna, Austria, from February 25 to 27, 2020 (Press release, Elicio Therapeutics, FEB 19, 2020, View Source [SID1234554495]).

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"By precisely targeting the immune cells which orchestrate anti-tumor responses in lymph nodes, ELI-002 has been shown in preclinical studies to enhance the magnitude and functional characteristics of KRAS-specific immunity important for a robust anti-tumor effect" said Peter DeMuth, PhD, Vice President of Research of Elicio Therapeutics. "These responses were able to simultaneously target all 7 common KRAS mutants, indicating the potential to prevent tumor recurrence likely to arise from therapies specific to individual mutants."

At the conference Dr. DeMuth will discuss Elicio’s:

Amphiphile technology which allows "AMP KRAS-vaccine" ELI-002 to simultaneously generate immune response to the seven mutations commonly present in KRAS driven cancers by targeting peptides with a powerful adjuvant directly to the lymph nodes;
In vivo data showing the significant benefits of lymph node targeting versus systemic drug delivery;
Data showing induction of potent mKRAS-specific T cell responses using ELI-002, a first-in-class lymph node immunotherapy, and;
Plans for a prospective, multicenter First-in-Human Phase 1/2 Trial of ELI-002 Lymph Node Immunotherapy as Treatment for Minimal Residual Disease in Patients with KRAS mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors.
Elicio has demonstrated in multiple tumor models that improving the targeting of immunogens and cell-therapy activators to lymph nodes, where resident immune cells potently orchestrate immunity, can substantially amplify their ability to induce effective tumor-killing immune responses. ELI-002 is an "AMP KRAS-vaccine" containing seven Amphiphile mKRAS peptides and a proprietary Amphiphile adjuvant, administered subcutaneously.

KRAS mutations are present in 90% of pancreatic cancers, 40% of colorectal cancers, 30% of non-small cell lung, 30% of bile duct, 14% of endometrial, and 14% of ovarian cancers. ELI-002has completed preclinical validation, IND-enabling GLP toxicology studies, and a pre-IND meeting with the FDA. P1/2 trials will be multi-site, starting with an open label dose escalation, progression to expansion cohorts in KRAS mutated solid tumors, and seamlessly progressing into a randomized, controlled cohort.

About the Amphiphile Platform

The Elicio Amphiphile platform enables precise targeting and delivery of immunogens and cell-therapy activators directly to the lymphatic system, the "brain center" of the immune response, to significantly amplify and enhance the body’s own system of defenses, defeat solid and hematologic cancers, and prevent their recurrence. Once in the lymph nodes, Amphiphile immunotherapies are taken up by antigen presenting cells (APC’s) to orchestrate signaling to natural or engineered immune cells in order to maximize therapeutic immune responses to disease. This strategy has been used to improve the activity of immunostimulatory agents, antigens, adjuvants, and cell-therapies that generate little to no response when used in the conventional forms. By precisely targeting these immunotherapies to the lymph nodes, Amphiphiles can unlock their full potential to generate and amplify anti-tumor immune responses. This substantially enhanced anti-tumor functionality and long-term protective memory may someday unlock the full potential of the immune response to eliminate cancer.

Eagle Pharmaceuticals to Discuss Fourth Quarter and Full Year 2019 Financial Results on March 2, 2020

On February 19, 2020 Eagle Pharmaceuticals, Inc. ("Eagle" or the "Company") (Nasdaq: EGRX) reported that the Company will release its 2019 fourth quarter and full year financial results on Monday, March 2, 2020, before the market opens (Press release, Eagle Pharmaceuticals, FEB 19, 2020, View Source [SID1234554494]).

Scott Tarriff, Chief Executive Officer, and Pete Meyers, Chief Financial Officer, will host a conference call to discuss the results as follows:

Date

Monday, March 2, 2020

Time

8:30 a.m. EST

Toll free (U.S.)

877-876-9173

International

785-424-1667

Webcast (live and replay)

www.eagleus.com, under the "Investor Relations" section

A replay of the conference call will be available for one week after the call’s completion by dialing 800-839-3020 (US) or 402-220-7234 (International) and entering conference call ID EGRXQ419. The webcast will be archived for 30 days at the aforementioned URL.

DelMar Pharmaceuticals [Nasdaq:DMPI] Enrolls Final Patient in Phase 2 Clinical Trial of VAL-083 For First-Line Treatment of Brain Tumors

On February 19, 2020 DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported it has enrolled and begun dosing the final patient in its ongoing Phase 2 clinical study investigating the first-line treatment of VAL-083 with radiation therapy in newly-diagnosed, MGMT-unmethylated glioblastoma multiforme (GBM) (Press release, DelMar Pharmaceuticals, FEB 19, 2020, View Source [SID1234554493]). The trial, which is being conducted at the Sun Yat-sen University Cancer Center (SYSUCC) in Guangzhou, China, and in collaboration with Guangxi Wuzhou Pharmaceutical Company, is designed to enroll up to 30 patients to determine whether first-line therapy with VAL-083 treatment improves progression free survival (PFS). The current standard of care is first-line temozolomide (TMZ) with radiation.

"We are very pleased to have enrolled and started dosing our final patient in this important study. This earlier than predicted full enrollment is encouraging and will allow an earlier topline data readout," commented Professor Zhong-ping Chen, founder chairman of the Department of Neurosurgery/Neuro-oncology at Sun Yat-sen University Cancer Center, and who is also the study’s principal investigator. "The enrollment of the final patient also provides us the opportunity to corroborate the preliminary data we’ve recently published, which supports the possibility that VAL-083 can provide a new and valuable treatment option in this difficult-to-treat indication."

The Phase 2 trial is a single-arm, open-label study testing VAL-083 in combination with standard radiotherapy in GBM patients who have an unmethylated promoter of the methylguanine DNA-methyltransferase (MGMT) gene. The clinical trial in newly-diagnosed GBM patients is designed to determine if first-line treatment with VAL-083 plus radiotherapy can provide improvements over the historical efficacy of standard of care TMZ plus radiotherapy. Efficacy will be measured based on tumor response to treatment, progression-free survival, progression-free survival at six months, and overall survival compared to historical results in the target population.

"Having completed enrollment of our first-line study ahead of schedule, we expect to complete analysis for the topline data in our most important Phase 2 trial for first-line GBM patients earlier than anticipated. We are optimistic that we will receive the initial data readout before the end of August 2020," commented Saiid Zarrabian, DelMar’s Chief Executive Officer. "In the meantime, we continue to rapidly advance our other Phase 2 program in the adjuvant and recurrent settings for VAL-083 at MD Anderson Cancer Center and look forward to providing further updates on the progress of our ongoing open label GBM trials at upcoming scientific meetings."

DelMar has been monitoring the coronavirus situation in China. Based on discussions with our principal investigator at SYSUCC, we believe the coronavirus outbreak will not have a significant impact on our patient treatment timeline.

In addition to the Phase 2 clinical trial in first-line treatment, DelMar is conducting an additional two-arm Phase 2 clinical trial in GBM. The adjuvant arm, which initiated in late 2019 will enroll up to 24 newly-diagnosed patients who have undergone surgery and chemoradiation with TMZ but will now receive VAL-083 in place of standard of care TMZ for adjuvant therapy. The second arm treats patients with recurrent disease, administering VAL-083 in patients who have been heavily pre-treated with TMZ prior to disease recurrence. The recurrent arm will allow a total of 83 patients to be enrolled. Both arms are being conducted at the University of Texas MD Anderson Cancer Center.

About VAL-083

VAL-083 (dianhydrogalactitol) is a "first-in-class", bifunctional DNA-targeting agent that introduces inter-strand DNA cross-links at the N7-position of guanine leading to DNA double-strand breaks and cancer cell death. VAL-083 has demonstrated clinical activity against a range of cancers including GBM and ovarian cancer in historical clinical trials sponsored by the U.S. National Cancer Institute (NCI). DelMar has demonstrated that VAL-083’s anti-tumor activity is unaffected by common mechanisms of chemoresistance, including MGMT, in cancer cell models and animal studies. Further details regarding these studies can be found at:

View Source

Deciphera Pharmaceuticals Announces Closing of Public Offering of Common Stock

On February 19, 2020 Deciphera Pharmaceuticals, Inc. (Nasdaq:DCPH), a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, reported the closing of its previously announced registered underwritten public offering. 3,181,818 shares of the Company’s common stock at a price to the public of $55.00 per share were issued and sold in the offering (Press release, Deciphera Pharmaceuticals, FEB 19, 2020, View Source [SID1234554492]). The gross proceeds to Deciphera from the offering, before deducting the underwriting discounts and commissions and other estimated offering expenses, are expected to be approximately $175.0 million. In addition, the Company has granted the underwriters a 30-day option to purchase up to 477,272 additional shares of its common stock.

J.P. Morgan, Piper Sandler and Jefferies acted as joint book-running managers for the offering. Guggenheim Securities acted as lead manager for the offering. SunTrust Robinson Humphrey acted as co-manager for the offering.

Deciphera intends to use the net proceeds from the offering to fund continued growth of its commercial and medical affairs capabilities to support its transition from a development-stage company toward a commercial-stage company including pursuing development and potential commercialization in second-line GIST; clinical trials for ripretinib, including the expansion stage of its current Phase 1 clinical trial, its ongoing pivotal Phase 3 clinical trial, and additional clinical trials, as well as clinical research outsourcing and manufacturing of clinical trial material, and pre-commercialization manufacturing process development and validation; clinical trials for DCC-3014, including the expansion stage of its current Phase 1 clinical trial, and additional clinical trials as well as clinical research outsourcing and manufacturing of clinical trial material; clinical trials for rebastinib, including its current Phase 1b/2 clinical trials, and additional clinical trials as well as clinical research outsourcing and manufacturing of clinical trial material; IND-enabling studies and the potential development of DCC-3116; new and ongoing research activities for future drug candidates using its proprietary kinase switch control inhibitor platform; and working capital purposes, including general operating expenses.

The offering was made only by means of a prospectus supplement and accompanying prospectus forming part of an automatic shelf registration statement on Form S-3 previously filed with the Securities and Exchange Commission (SEC) on February 12, 2020. The final prospectus supplement and the accompanying prospectus was filed with the SEC and is available on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained from J.P. Morgan Securities LLC c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, Attention: Prospectus Department, by telephone at (800) 747-3924 or by email at [email protected]; and Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388 or by email at [email protected].

AVEO Announces Effectiveness of 1-for-10 Reverse Stock Split

On February 19, 2020 AVEO Oncology (NASDAQ: AVEO) reported that it will effect a 1-for-10 reverse stock split of its common stock that will be effective as of 5:00 p.m. Eastern Time , February 19, 2020 (Press release, AVEO, FEB 19, 2020, View Source [SID1234554491]). AVEO’s common stock will begin trading on the Nasdaq Capital Market on a split-adjusted basis when the market opens on Thursday, February 20, 2020. The new CUSIP number for AVEO’s common stock following the reverse stock split is 053588 307.

On February 13, 2020, the holders of a majority of AVEO’s outstanding shares of common stock approved the reverse stock split and gave AVEO’s board of directors discretionary authority to select a ratio for the split ranging from 1-for-5 to 1-for-15. The board of directors approved the reverse stock split at a ratio of 1-for-10 on February 13, 2020.

The reverse stock split affects all issued and outstanding shares of AVEO’s common stock, as well as the number of authorized shares of AVEO’s common stock and the number of shares of common stock available for issuance under AVEO’s equity incentive plans. The reverse stock split will reduce the number of shares of the AVEO’s issued and outstanding common stock from approximately 160.8 million to approximately 16.1 million. In addition, the reverse stock split will effect a reduction in the number of shares of common stock issuable upon the exercise of stock options and warrants outstanding immediately prior to the reverse stock split, with a proportional increase in the respective exercise prices. The reverse stock split will proportionately reduce the number of authorized shares of common stock from 500 million shares to 50 million shares. The reverse stock split will not change the par value of the common stock or the authorized number of shares of preferred stock of AVEO.

The reverse stock split will affect all holders of common stock uniformly and will not alter any stockholder’s percentage ownership interest in AVEO, except to the extent that the reverse stock split would result in a stockholder owning a fractional share. No fractional shares of common stock will be issued in connection with the reverse stock split; stockholders who otherwise would be entitled to a fractional share of common stock will be entitled to receive a proportional cash payment.

AVEO’s transfer agent, Computershare, is acting as the exchange agent for the reverse stock split. For those stockholders holding physical stock certificates, Computershare will send instructions for exchanging those certificates for shares held in book-entry form representing the post-split number of shares. Stockholders holding their shares in book-entry form or in brokerage accounts need not take any action in connection with the reverse stock split. Beneficial holders are encouraged to contact their bank, broker or custodian with any procedural questions.