On June 4, 2021 Bristol Myers Squibb (NYSE: BMY) reported that the company will participate in a fireside chat at the Goldman Sachs 42nd Annual Global Healthcare Virtual Conference, which will be webcast on Thursday, June 10, 2021 (Press release, Bristol-Myers Squibb, JUN 4, 2021, View Source [SID1234583557]). Chris Boerner, Ph.D., Executive Vice President, Chief Commercialization Officer and Samit Hirawat, M.D., Executive Vice President, Chief Medical Officer, Global Drug Development, will answer questions about the company at 9:40 a.m. ET .

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Investors and the general public are invited to listen to a live webcast of the session at View Source An archived edition of the session will be available later that day.

On June 4, 2021 Ribon Therapeutics, a clinical stage biotechnology company developing therapeutics targeting stress support pathways, reported that positive interim clinical data from the dose escalation portion of its first-in-human Phase 1 trial evaluating RBN-2397, a small molecule inhibitor of PARP7, as a monotherapy in patients with advanced solid tumors (Press release, Ribon Therapeutics, JUN 4, 2021, View Source [SID1234583556]). Presenting the data in an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 4, 2021, will be Gerald S. Falchook, M.D., Director, Drug Development, Sarah Cannon Research Institute at HealthONE, Denver, CO and Clinical Investigator in the RBN-2397 Phase 1 trial.

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"We are pleased to see demonstration of target inhibition and preliminary signs of antitumor activity in this early stage of clinical development of a novel target," said Dr. Falchook. "In the expansion part of the study, we will seek to demonstrate definitive clinical activity in tumor types predicted to respond to RBN-2397."

The primary objectives of the study are to determine any dose limiting toxicities (DLTs), maximum tolerated dose (MTD), and establish the recommended phase 2 dose (RP2D). The dose escalation portion evaluated two dosing schedules with multiple ascending dose cohorts of RBN-2397. As of April 1, 2021, the dose escalation portion of the study, in which 50 patients were enrolled, is complete and the key results are as follows:

Single-agent RBN-2397 was well-tolerated at exposures predicted to be efficacious in preclinical studies
RP2D was 200 mg BID on a continuous dosing schedule
In this heavily pretreated, heterogenous patient population, preliminary antitumor activity was observed with one partial response (PR) in a patient with HR+ breast cancer and nine patients with stable disease (SD) > 4 months
Includes one patient with squamous cell carcinoma of lung (SCCL) who has been on study with SD for 17+ months and 29% tumor shrinkage post data cutoff date and a second SCCL patient with SD for 4+ months and 19% tumor shrinkage
Proof of mechanism demonstrated by increase in tumoral Type I interferon (IFN) response and immune cells after treatment with RBN-2397
Expansion phase is currently enrolling patients in a number of defined cohorts, including SCCL
"These results validate our approach to drug development by targeting cellular stress and modulating the immune system to induce antitumor activity," said Sudha Parasuraman, M.D., Chief Medical Officer, Ribon Therapeutics. "We expect the expansion part of the study to establish proof of concept for RBN-2397 monotherapy and look forward to expanding our development program with the initiation of a Phase 1b/2 combination study with pembrolizumab in SCCL in the second half of 2021."

About RBN-2397

RBN-2397 is an orally available small molecule inhibitor of PARP7 that Ribon Therapeutics is developing for the treatment of solid tumors. PARP7 is upregulated in response to cellular stress, including genomic instability in cancers, and acts as a brake on the cellular stress response by negatively regulating the Type I interferon response. By inhibiting PARP7 in tumor cells, RBN-2397 has been shown to directly inhibit cellular proliferation and restore interferon signaling to stimulate an innate and adaptive antitumor immune response. RBN-2397 is currently in a Phase 1 clinical trial as a monotherapy in patients with advanced solid tumors (NCT04053673). PARP7 is overexpressed in a number of tumors, including squamous cell carcinoma of the lung, or SCCL, which represents approximately 30% of all non-small cell lung cancers.

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.