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Alpine Immune Sciences Provides Corporate Update and Reports Third Quarter 2019 Financial Results

On November 13, 2019 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer, autoimmune/inflammatory, and other diseases, reported a corporate update and financial results for the third quarter ended September 30, 2019 (Press release, Alpine Immune Sciences, NOV 13, 2019, View Source [SID1234551138]).

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"The third quarter of 2019 included several significant milestones for Alpine, highlighted by completion of enrollment in our Phase 1 study in healthy volunteers for our lead program, ALPN-101," said Mitchell H. Gold, MD, Executive Chairman and Chief Executive Officer of Alpine. "We believe ALPN-101 has the potential to deliver significantly differentiated efficacy outcomes across a range of inflammatory and autoimmune diseases. We look forward to highlighting our upcoming Phase 1/2 BALANCE study of ALPN-101 during an oral presentation at the ASH (Free ASH Whitepaper) annual meeting next month."

"In addition, we are actively preparing for the initiation of the Phase 1 NEON-1 study of our lead immuno-oncology program, ALPN-202," Dr. Gold said. "At Alpine, we share a deep commitment and drive to deliver the next generation of immunotherapies to patients suffering from debilitating and deadly diseases and I am proud of the work our entire team has done in the transformation of Alpine to an established, clinical-stage company."

Recent Pipeline and Company Highlights

ALPN-101 Clinical Advancement

Completed enrollment of Phase 1 Study of ALPN-101: On October 30, 2019, Alpine announced completion of enrollment of its Phase 1 study of ALPN-101, a first-in-class dual ICOS/CD28 antagonist. Results from this trial will help inform further development of ALPN-101 in serious autoimmune and inflammatory diseases.
Overall, ALPN-101 was generally well-tolerated, without evidence of cytokine storm, cytokine release, or clinical immunogenicity while being dosed as single or multiple doses, intravenously or subcutaneously.
Preliminary analyses indicate well-behaved pharmacokinetics and pharmacodynamics, including on-target inhibition of immune functionality, such as antibody responses to keyhole limpet hemocyanin (KLH) and ex vivo staphylococcal enterotoxin B (SEB)-induced cytokine responses.
These initial findings will be included as part of an oral presentation at ASH (Free ASH Whitepaper) next month, and further details after completion of final analyses are expected to be reported in presentations in the first half of 2020.
New ALPN-101 Data Presented at American College of Rheumatology (ACR) Annual Meeting: Earlier this week, Alpine presented new preclinical data on ALPN-101 in two posters during sessions at ACR. The new data highlighted ALPN-101’s novel dual mechanism of action which modulates unique inflammatory pathways, distinct from the other biologic therapies singly targeting the ICOS or CD28 pathways, and results in potent efficacy in multiple disease models. The full posters from ACR can be viewed here.
Upcoming Oral Presentation at American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting: Alpine will present on its upcoming Phase 1/2 BALANCE study of ALPN-101 in steroid-resistant or steroid-refractory acute Graft-versus-Host Disease (GvHD). Dr. Jan Hillson, Senior Vice President, Clinical Development for Alpine, will present on December 8, 2019 at 11:00 a.m. ET. The full abstract can be viewed here.
ALPN-202 Preparing for Phase I Study

New ALPN-202 Data Presented at Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting: On November 8, 2018, Alpine presented two posters with new preclinical data on its lead oncology program ALPN-202, a conditional CD28 costimulator and dual checkpoint inhibitor. The new preclinical data further highlight ALPN-202’s novel mechanism of action and its superior anti-tumor activity, as well as its potential to be uniquely effective as a monotherapy and in combination with immune checkpoint inhibitors or chemotherapy. The full posters from SITC (Free SITC Whitepaper) can be viewed here.
Data presented at SITC (Free SITC Whitepaper) supports the advancement of ALPN-202 towards its first Phase 1 clinical trial, which Alpine expects to initiate, upon authorization, in the first quarter of 2020.
Financial Results for Third Quarter and Nine Months Ended September 30, 2019

Alpine recorded a net loss of $11.5 million and $12.1 million for the third quarters ended September 30, 2019 and 2018, respectively, and $35.7 million and $25.4 million for the nine months ended September 30, 2019 and 2018, respectively.

Research and development expenses for the third quarter ended September 30, 2019 were $9.5 million compared to $10.5 million for the third quarter ended September 30, 2018. For the nine months ended September 30, 2019 and 2018, research and development expenses were $30.0 million and $20.0 million, respectively. The company expects a continued increase to research and development activities to support the clinical advancement of its ALPN-101 and ALPN-202 programs.

General and administrative expenses for the third quarter ended September 30, 2019 were $2.5 million compared to $1.9 million for the third quarter ended September 30, 2018. For the nine months ended September 30, 2019 and 2018, general and administration expenses were $7.4 million and $5.8 million, respectively. The increase was primarily attributable to professional and legal services and an increase in facility costs to support the growth and expansion of our business.

Cash Position

As of September 30, 2019, Alpine had cash, cash equivalents, restricted cash, and short-term investments totaling $47.0 million. For the nine months ended September 30, 2019, net cash used in operating activities was $29.7 million compared to $19.0 million for the nine months ended September 30, 2018.

Management will provide updates to cash guidance on the conference call scheduled to discuss third quarter 2019 financial results.

Conference Call and Webcast Details

Alpine will host a conference call to discuss key data, clinical highlights and provide an update on third quarter 2019 results on Wednesday, November 13, 2019 at 4:30 p.m. ET. To access the live call by phone, dial (877) 407-0789 (domestic) or (201) 689-8562 (international). To access a live webcast of the call, please visit the Investor Relations section of the Alpine Immune Sciences website at www.alpineimmunesciences.com. The recorded webcast will be available for replay for approximately 30 days following the call.

About ALPN-101

ALPN-101 is a novel Fc fusion protein of a human inducible T cell costimulator ligand (ICOSL) variant immunoglobulin domain (vIgD), and a first-in-class therapeutic designed to inhibit simultaneously the CD28 and ICOS inflammation pathways. CD28 and ICOS are closely related costimulatory molecules with partially overlapping roles in T cell activation likely connected to multiple autoimmune and inflammatory diseases. In preclinical models of graft versus host disease, inflammatory arthritis, connective tissue disease and multiple sclerosis, ALPN-101 demonstrates efficacy superior to blockade of the CD28 or ICOS pathways alone.

About ALPN-202

ALPN-202 is a first-in-class, conditional CD28 costimulator and dual checkpoint inhibitor, which has the potential to improve upon the efficacy of combined checkpoint inhibition without significant toxicities. Preclinical studies of ALPN-202 have successfully demonstrated superior efficacy in tumor models compared to checkpoint inhibition alone. We anticipate initiation, upon authorization, of the first-in-human clinical study of ALPN-202 to begin in the first quarter of 2020.

Heron Therapeutics to Present at the Stifel 2019 Healthcare Conference

On November 13, 2019 Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, reported that Barry Quart, Pharm.D., President and Chief Executive Officer of Heron Therapeutics, will present at the Stifel 2019 Healthcare Conference on Tuesday, November 19, 2019 at 8:35 a.m. EST at the Lotte New York Palace hotel (Press release, Heron Therapeutics, NOV 13, 2019, View Source [SID1234551137]).

A live webcast of the presentation will be available on the Company’s website at www.herontx.com in the Investor Resources section. A replay of the presentation will be archived on the site for 60 days.

Xencor to Present at Upcoming Investor Conferences

On November 13, 2019 Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of cancer, autoimmune disease, asthma and allergic diseases, reported that company management will participate in two upcoming conferences (Press release, Xencor, NOV 13, 2019, View Source [SID1234551136]):

Jefferies 2019 London Healthcare Conference
Date: Wednesday, November 20, 2019
Presentation Time: 3:20 p.m. GMT
Location: London
Piper Jaffray 31st Annual Healthcare Conference
Date: Tuesday, December 3, 2019
Presentation Time: 8:00 a.m. EST
Location: New York
Live webcasts of these presentations will be available under "Events & Presentations" in the Investors section of the Company’s website located at www.xencor.com. A replay of the events will be posted on the Xencor website approximately one hour after the live events and will be available for 30 days following the presentations.

DCprime to Present Long-term Follow-up and Survival Data for Lead Relapse Vaccine Candidate DCP-001 in High-Risk AML and MDS Patients

On November 13, 2019 DCprime, the front-runner in the field of relapse vaccines, reported the presentation of updated clinical results for its lead product DCP-001 at the upcoming 61st Annual Meeting and Exposition of the American Society of Hematology (ASH) (Free ASH Whitepaper), December 7-10, 2019, Orlando, FL, USA (Press release, DCPrime, NOV 13, 2019, View Source [SID1234551134]). The long-term follow-up and survival data generated in the Phase 1 clinical trial with DCP-001 in patients with high-risk Acute myeloid leukemia (AML) or Myelodysplastic syndromes (MDS) demonstrate the potential to prolong relapse-free survival (RFS) and overall survival (OS) using an allogeneic, off-the-shelf cell-based vaccine in the post-remission setting. The full abstract is available via the ASH (Free ASH Whitepaper) Annual Meeting’s website.

"Our deep dive into the Phase 1 clinical trial results, which we will present in full at the upcoming ASH (Free ASH Whitepaper) Annual Meeting, confirms our thinking on when and how our cell-based vaccine DCP-001 can have the greatest impact on patients in the post-remission setting. Treated early and while still in remission, vaccination with DCP-001 can strengthen the immune system’s ability to sustainably control residual disease with one patient surpassing an overall survival of 6 years since inclusion in the trial," commented Erik Manting PhD, CEO of DCprime.

"The Phase 1 data have evolved since we last updated the clinical community and provide a strong rationale to further investigate the relapse vaccine approach. With the progress made in the clinical community to implement the assessment of minimal residual disease, or MRD, we have designed the currently active Phase 2 clinical trial for DCP-001 to look even more specifically into DCP-001’s ability to support a long-term immune control of the tumour," commented Jeroen Rovers MD PhD, CMO of DCprime.

In the Phase 1 clinical trial, seven out of twelve patients responded to treatment, the other five patients showed progressive disease. These five patients had relapsed or refractory disease at the start of vaccination with detectable circulating peripheral blasts. Moreover, they were vaccinated after induction and consolidation therapy with a median time between diagnosis and first vaccination of 611 days compared to 240 for the responding patients. Of the latter, all were in complete remission (CR) (n=5) or had morphologic marrow blast counts <10% (n=2) at the start of vaccination.

While the median overall survival (OS) for the non-responders was 144 days, the median OS for the responding patients was 1,090 days, with a longest survivor of 2,160 days after vaccination. The median relapse-free survival in those patients who were in CR at vaccination was 420 days, ranging up to 1,849 days in the longest survivor. Patients in the responding group all had intermediate or high-risk disease, based on cytogenetics, indicating their poor prognosis based on the ELN risk classification for AML or the Revised International Prognostic Scoring System (IPSS-R) for MDS. In the responder group, two patients died early in complete remission due to infection at day 90 and 184, respectively. More details on patient characteristics and cytogenetics will be presented by Dr. Luca Janssen and Prof. Dr. Arjan van de Loosdrecht (PI) at ASH (Free ASH Whitepaper).

DCprime’s lead cancer relapse vaccine candidate DCP-001 is generated by transforming a proprietary leukemic cell, DCOne, into a whole cell-based cancer vaccine. Whereas the parental leukemic cells are poorly immunogenic, DCP-001 is highly immunogenic, making it an attractive cancer vaccine candidate. DCP-001 is currently being evaluated in an international Phase II trial in AML patients in complete remission and with presence of MRD who are ineligible for hematopoietic stem cell transplantations. First results of the (ADVANCE-II) trial are expected to become available in 2020.

Agios Announces Closing of Public Offering and Full Exercise of Option to Purchase Additional Shares

On November 13, 2019 Agios Pharmaceuticals, Inc. (Nasdaq: AGIO) reported the closing of its previously announced underwritten public offering of common stock, including the exercise in full by the underwriters of their option to purchase an additional 1,237,500 shares at the public offering price of $31.00 per share (Press release, Agios Pharmaceuticals, NOV 13, 2019, View Source [SID1234551132]). The exercise of the option to purchase additional shares brought the total number of shares of common stock sold by Agios to 9,487,500 shares and increased the amount of gross proceeds, before underwriting discounts and expenses, to approximately $294.1 million.

J.P. Morgan Securities LLC, Goldman Sachs & Co. LLC and Cowen and Company, LLC acted as joint book-running managers for the offering.

The shares were offered by Agios pursuant to an automatically effective shelf registration statement that was previously filed with the Securities and Exchange Commission ("SEC"). The offering was made only by means of a prospectus and prospectus supplement that form a part of the registration statement. The final prospectus supplement relating to, and describing the terms of, the offering has been filed with the SEC and is available on the SEC’s web site at www.sec.gov.

Copies of the final prospectus supplement and the accompanying prospectus relating to this offering can be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, telephone: 866-803-9204; Goldman Sachs & Co. LLC, Attn: Prospectus Department, 200 West Street, New York, New York 10282, telephone: 866-471-2526, facsimile: 212-902-9316, e-mail: [email protected]; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, by email at [email protected], or by telephone at (833) 297-2926.

This press release does 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.