On June 4, 2021 Amgen (NASDAQ:AMGN) reported that it will present at the Goldman Sachs 42nd Annual Global Healthcare Conference at 4:40 p.m. ET on Wednesday, June 9, 2021 (Press release, Amgen, JUN 4, 2021, View Source [SID1234583555]). David M. Reese, M.D., executive vice president of Research and Development and Peter H. Griffith, executive vice president and chief financial officer at Amgen will present at the conference. Live audio of the conference call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

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The webcast, as with other selected presentations regarding developments in Amgen’s business given at certain investor and medical conferences, can be accessed on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

On June 4, 2021 Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of several eye disorders, reported it has entered into a securities purchase agreement with institutional investors for the purchase and sale of 3,076,923 shares of the Company’s common stock (the "Shares") and warrants to purchase 1,538,461 shares of the Company’s common stock (the "Warrants", and together with the Shares, the "Securities") at a combined purchase price of $4.875 per one Share and 0.5 Warrant in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Rexahn, JUN 4, 2021, View Source [SID1234583554]). The Warrants will have an exercise price of $6.09 per share, will be exercisable on issuance date, and will expire five years following the issuance date. The closing of the offering is expected to occur on or about June 8, 2021, subject to the satisfaction of customary closing conditions.

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A.G.P./Alliance Global Partners is acting as sole placement agent for the offering.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-252715) previously filed with the U.S. Securities and Exchange Commission (the "SEC"). A prospectus supplement describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the prospectus supplement may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at [email protected]. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about the Company and such offering.

This press release shall 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.

On June 4, 2021 Harpoon Therapeutics, Inc. (NASDAQ: HARP), a clinical-stage immunotherapy company developing a novel class of T cell engagers, reported interim data from the ongoing dose-escalation portion of a Phase 1/2a trial for HPN424 in patients with metastatic castration-resistant prostate cancer (mCRPC) at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Harpoon Therapeutics, JUN 4, 2021, View Source [SID1234583553]). HPN424 targets prostate-specific membrane antigen (PSMA) and is based on Harpoon’s proprietary Tri-specific T cell Activating Construct (TriTAC) platform designed to recruit a patient’s own immune cells to kill tumor cells.

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As of April 23, 2021, the data cutoff date for the ASCO (Free ASCO Whitepaper) presentation, 89 patients have been dosed across 13 cohorts at fixed doses of 1.3 to 160 ng/kg and in step dosing cohorts up to 300ng/kg administered as a weekly intravenous infusion. These interim data demonstrated:

HPN424 was active and generally well tolerated
Antitumor activity included a confirmed PR per RECIST, PSA declines and circulating tumor cell (CTC) reductions
Treatment duration > 24 weeks observed in 15 of 74 (20%) pts, including 8 of 17 (47%) chemo-naïve patients
Cytokine release syndrome (CRS) has been transient and manageable with 4% of patients experiencing Grade 3 CRS
CRS and transaminitis events observed most often in Cycle 1, with diminished frequency and severity in subsequent cycles
Introduction of step dose regimens has allowed for the administration of higher target doses, currently at 300ng/kg
"These encouraging data for HPN424 are continuing to show clinical activity, target engagement, and a manageable safety profile in this heavily pretreated patient population," stated Jerry McMahon, Ph.D., President and CEO, Harpoon Therapeutics. "As our step dose cohorts continue to enroll patients, we believe we are nearing the dose we intend to explore in the first expansion cohort that we plan to initiate this year."

"We are excited to share this clinical update from our HPN424 clinical trial. These data suggest that HPN424 is active and that the expected cytokine-mediated adverse events can be managed," said Natalie Sacks, M.D., Chief Medical Officer of Harpoon. "Our goal is to develop an effective immunotherapy treatment option for patients with prostate cancer."

Trial Design and Interim Results from the HPN424 Phase 1/2a Clinical Trial

This Phase 1/2a trial is a multicenter, open-label study designed to evaluate the safety, tolerability, pharmacokinetics and activity of HPN424 in patients with mCRPC who are progressing at the time of enrollment and have had at least two prior systemic treatments for metastatic disease. The initial ongoing phase of the trial is dose escalation, with the goal of determining a recommended dose for the expansion phase. The escalation phase began with single patient cohorts and transitioned to a 3×3 design when Grade 2 toxicity was observed. A step dosing regimen was introduced in December 2020. HPN424 is being administered to patients once weekly by intravenous infusion and the primary outcome measures are an assessment of safety and tolerability, pharmacokinetics, and pharmacodynamics. Secondary endpoints include duration of response, progression free and overall survival. Tumor assessments include PSA, CT and bone scans performed every 9 weeks.

As of the April 23, 2021 cut-off date, 89 patients have been treated in 13 cohorts with fixed doses ranging from 1.3 to 160 ng/kg and step dosing up to 300ng/kg using various regimens. Enrolled patients had a median of 5 prior therapies, including 73% with prior chemotherapy, and a median of two prior novel hormonal agents. Median PSA level was 129, with a range of 0.1-5000 ng/ml. The most frequent adverse events were cytokine release syndrome (CRS) ((all grade n=61 (69%), grade >3 n=4 (4%)), chills ((all grade n=60 (67%), grade >3 n=0 (0%)), and pyrexia ((all grade n=58 (65%), grade >3 n=2 (2%)). The majority of CRS events occurred with the first dose.

Dose Limiting Toxicities (DLTs) were observed at doses ranging from 96 to 300ng/kg and did not limit escalation and Maximum Tolerated Dose has not been reached. The most common DLTs were Transaminitis G4 (n=6) and Cytokine Release Syndrome G3 (n=4). The most common reason for study discontinuation was progressive disease; two of 89 (2%) patients discontinued treatment due to treatment-related AEs.

HPN424 demonstrated dose proportional increase in Cmax and AUC. Reduction in CTCs was seen in 36 of 64 (56%) patients with available baseline and on-treatment CTC counts. Fifteen of 74 (20%) pts with >1 post-baseline value had PSA decreases from baseline ranging from -2% to -76%, including 4 pts with PSA50 response and 2 pts with PSA30 response. A confirmed PR was observed in a patient treated at 160 ng/kg and that patient remains on study at 41 weeks.

Patients continue to be enrolled in the escalation and step dosing phase of the trial, with a goal to identify a dose for an expansion phase. The expansion phase of the trial will further evaluate the safety and activity of HPN424 in patients with mCRPC. This trial is titled, "Study of HPN424 in Patients with Advanced Prostate Cancer". For additional information about the trial, please visit www.clinicaltrials.gov using the identifier NCT03577028.

Conference Call and Webcast Today

Harpoon’s management will host a webcast and conference call at 4 p.m. ET / 1 p.m. PT on Friday, June 4, 2021 to review the data and provide an update on other pipeline programs. The live call may be accessed by dialing 866-951-6894 for domestic callers or 409-216-0624 for international callers and using conference ID # 2657278.

A live webcast of the call will be available from the Events and Presentations section of the company’s website at View Source and will be archived there shortly after the live event.

On June 4, 2021 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, reported that presentation of initial data from NEON-1, the company’s Phase 1 clinical trial of ALPN-202, a conditional CD28 costimulator and dual checkpoint inhibitor, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Annual Meeting (Press release, Alpine Immune Sciences, JUN 4, 2021, View Source [SID1234583552]). NEON-1 is a first-in-human, dose escalation and expansion study of ALPN-202 monotherapy in advanced malignancies.

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Presentation highlights include:

ALPN-202 has been generally well-tolerated as of the data cutoff date. The most common treatment-related adverse events have included immune-related toxicities, particularly cutaneous reactions.
Although most enrolled participants have had tumors considered classically non-responsive to immunotherapies, 61% (14 of 23 evaluable) appeared to derive clinical benefit as defined as a best outcome of stable disease or better, as of the data cutoff date. One of these participants, with metastatic colorectal cancer, achieved an unconfirmed partial response.
Dose-dependent pharmacokinetics and pharmacodynamics have been observed, accompanied by expansion of circulating CD4+ T cells with upregulation of the ICOS activation and Ki-67 proliferation markers. An expansion of central memory T cells, and a downregulation of regulatory T cells, were also observed.
"These data represent, to our knowledge, the first demonstration of safe, controlled CD28 agonism in humans, with measurable physiological consequences," commented Dr. Stanford Peng, Alpine’s President and Head of Research and Development. "The circulating T cell changes are particularly exciting and consistent with the expected biology of CD28. Together with the early suggestion of clinical benefit for some cancers not traditionally considered immune-responsive, these findings strongly encourage us to further develop ALPN-202."

The poster is now live on the ASCO (Free ASCO Whitepaper) meeting website. A copy of the presented data is available on the Scientific Publications page of Alpine’s website.

Additionally, Alpine will hold an investor event on Friday, June 4th, 2021 at 7:00pm EDT. During the investor event, Alpine will review these data. Following the presentation, Alpine will hold a question-and-answer discussion.

Investor Event – Conference Call and Webcast Details

Alpine will hold an investor event on Friday, June 4th, 2021 at 7:00pm ET, to coincide with the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Annual Meeting. To access the investor event by phone, dial (800) 816-3005 (domestic) or (857) 770-0069 (international) and reference conference ID: 3439769.

A live webcast of the investor event will be available online in the investor relations section of the company’s website at View Source A replay will be available on the company website for 90 days following the webcast.

About ALPN-202

ALPN-202 is a first-in-class, conditional CD28 costimulator and dual checkpoint inhibitor with the potential to improve upon the efficacy of combined checkpoint inhibition while limiting significant toxicities. Preclinical studies of ALPN-202 have successfully demonstrated superior efficacy in tumor models compared to checkpoint inhibition alone. NEON-1 (NCT04186637), a Phase 1 study of ALPN-202 in patients with advanced malignancies, is currently enrolling. Alpine also plans the initiation of NEON-2, a combination study of ALPN-202 and a PD-1 inhibitor, later this year.

On June 4, 2021 Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, reported that updated immunogenicity and clinical response data from the GEN-009 Phase 1 trial that continue to validate the company’s unique and differentiated approach to identifying clinically meaningful immunotherapy targets through the proprietary ATLAS selection process (Press release, Genocea Biosciences, JUN 4, 2021, View Source [SID1234583551]). Data on the neoantigen vaccine combined with PD-1 inhibition in advanced solid tumors will be shared by Maura Gillison, M.D., Ph.D., Lead Investigator, MD Anderson Cancer Center, during a poster presentation (Abstract #2613) at the virtual 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from June 4-8, 2021. The poster is available for on-demand viewing on the ASCO (Free ASCO Whitepaper) website and also posted to the Scientific Resources section of the Genocea website at View Source
Long-term results demonstrate that GEN-009 continues to generate broad immune responses against neoantigens that can lead to sustained clinical responses. In Part A of the study, designed to measure safety and immunogenicity only, eight patients with no measurable disease were vaccinated with GEN-009 as a monotherapy. Six of the eight patients continue without recurrence with a median follow up of 25 months post start of the vaccination. Notably, as previously reported, GEN-009 elicited T cell immune responses to 99% of the ATLAS-selected neoantigens, the highest seen across neoantigen vaccine programs.
In Part B, patients were enrolled at the initiation of a PD-1 checkpoint inhibitor (CPI)-based standard of care (SOC) regimen for advanced or metastatic disease; patients who were controlled on SOC and did not require alternate therapy are labeled CPI-sensitive, patients who required alternate therapy before vaccination are labeled CPI-refractory. Of the nine CPI-sensitive patients, the latest data show four patients experienced novel reduction in tumor volume post-GEN-009 dosing and achieved independent RECIST responses after vaccination, including three partial responses (PRs) and one complete response (CR). This is an increase from the two PRs and one CR previously reported at SITC (Free SITC Whitepaper) 2020. The remaining five CPI-sensitive patients all achieved disease stabilization. Across the CPI-sensitive cohort, the median duration without disease progression after initial GEN-009 vaccination was 15 months. Of the seven CPI-refractory patients, two achieved stable disease after initial GEN-009 vaccination for up to 10 months. GEN-009 has been well tolerated with only mild adverse events associated with the vaccine adjuvant.

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Expanded immunogenicity data from Part B of the study revealed that vaccine-specific T cell responses were detected ex vivo after the first dose of the vaccine and continued to rise with each subsequent dose. Vaccine-specific T cell responses remained significantly elevated over baseline and post-CPI, pre-vaccine timepoints for at least 6 months, showing persistence of the vaccine response. CPI-sensitive subjects had a greater number of neoantigens identified with ATLAS at baseline compared with patients in the CPI-refractory cohort, and also had evidence of epitope spread for CD8+ T cells post-dosing. Additionally, the magnitude of CD4+ T cell responses were greater for the CPI-refractory than CPI-sensitive subjects, despite a reduced proportion of peptides to which CD4+ T cell responses were measured, suggesting that the breadth and not the magnitude of response could be associated with favorable outcomes.
"We are very encouraged that GEN-009 can generate broad and diverse immune responses through ATLAS-selected neoantigens" said Thomas Davis, M.D., Chief Medical Officer of Genocea. "The deepened and durable responses in the CPI-sensitive patients and durable disease control in refractory patients are notable. We believe the cumulative long-term GEN-009 data continues to support our unique approach to identifying clinically meaningful immunotherapy targets and provides a strong foundation for our novel cell therapy candidate, GEN-011, which can target up to 30 ATLAS selected neoantigens and is currently in the clinic."
ASCO POSTER SESSION: Developmental Therapeutics – Immunotherapy
Abstract 2613: View Source
Title: Long term results from a phase 1 trial of GEN-009, a personalized neoantigen vaccine, combined with PD-1 inhibition in advanced solid tumors
GEN-009 is an adjuvanted personalized neoantigen vaccine being evaluated in eligible patients with advanced cancer who received standard-of-care (SOC) PD-1 checkpoint inhibitor (CPI) +/- chemotherapy during vaccine manufacturing and received 5 vaccine doses over 6 months along with continuation of PD-1 CPI. Genocea’s proprietary ATLAS platform selects tumor neoantigens for synthesis into GEN-009 peptides and identifies each patient’s own peripheral blood T cells and antigen-presenting cells. Patients who progressed prior to vaccination could receive alternate therapy followed by GEN-009 alone or in combination with a salvage regimen, as well as accelerated vaccine dosing. The contributions from GEN-009 are assessed using each patient as their own control based upon changes in tumor volume pre- versus post-vaccination.