On September 7, 2023 Adamis Pharmaceuticals Corporation (NASDAQ: ADMP), a commercial-stage biopharmaceutical company, reported the company changed its name to DMK Pharmaceuticals Corporation in order to better reflect its new strategic focus on advancing small molecules for the treatment of substance use disorders (Press release, Adamis Pharmaceuticals, SEP 7, 2023, View Source [SID1234635000]). In conjunction with the name change, the company’s common stock is expected to trade under the new Nasdaq ticker symbol "DMK" on or about September 8, 2023. The CUSIP number for the common stock, 00547W307, will remain unchanged.

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"The new DMK Pharmaceuticals is committed to developing groundbreaking and innovative therapies to establish itself as a leader in the treatment of substance abuse including opioid and alcohol use disorders," said Eboo Versi, MD, PhD, CEO of Adamis, "Rebranding the company signifies our new strategic vision and reinforces our commitment to a renewed corporate strategy. Along with our flagship approved treatment for emergency treatment of opioid overdose, ZIMHI, our lead clinical stage compound, DPI-125 will be our core focus. DPI-125 is a novel molecule for the treatment of opioid use disorder. Currently approved therapies are old and the vast majority of sufferers are not getting this medical treatment. I believe this is because they have unfavorable drug scheduling resulting in limited access, and in many cases, patients have to undergo opioid withdrawal symptoms prior to starting treatment. It is my belief that DPI-125, if successfully developed, will receive a more favorable drug scheduling and be a more ‘patient friendly’ treatment. DPI-125 is also being developed for the treatment of moderate to severe pain. If clinical studies confirm what we suspect from animal studies, this drug will not be addictive and as such could even help to reduce the incidence of opioid use disorder."

DMK expects several potential significant milestones for DPI-125 by the end of 2024 including: manufacture of a transdermal delivery system; results of a respiratory depression safety study compared to fentanyl; results of a pharmacokinetic study in humans; and results of an abuse liability study compared to current treatments for OUD and pain relief, in each case assuming the availability of adequate funding and no unexpected developments or delays. There can be no assurances that any of these milestones will be achieved or will be achieved within the anticipated time periods.

On September 7, 2023 Gilead Sciences, Inc. (Nasdaq: GILD), a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, reported the pricing of senior unsecured notes in an aggregate principal amount of $2 billion, in an underwritten, registered public offering, consisting of $1 billion of 5.250% senior notes maturing in 2033 and $1 billion of 5.550% senior notes maturing in 2053 (Press release, Gilead Sciences, SEP 7, 2023, View Source [SID1234634999]). The offering is expected to close September 14, 2023, subject to customary closing conditions.

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Gilead intends to use the net proceeds from this offering for general corporate purposes.

Barclays Capital Inc. and Citigroup Global Markets Inc. are acting as lead joint book-running managers in the offering. The offering of the securities is being made only by means of a prospectus supplement and the accompanying base prospectus, which is filed as part of Gilead’s effective shelf registration statement on Form S-3 (File No. 333-273745), copies of which may be obtained from:

Barclays Capital Inc.

c/o Broadridge Financial Solutions,

1155 Long Island Avenue

Edgewood, NY 11717

(888) 603-5847

Email: [email protected]

Citigroup Global Markets Inc.

c/o Broadridge Financial Solutions,

1155 Long Island Avenue

Edgewood, NY 11717

(800) 831-9146

Email: [email protected]

An electronic copy of the prospectus supplement and the accompanying base prospectus and other documents Gilead has filed with the U.S. Securities and Exchange Commission ("SEC") may also be obtained at no charge at the SEC’s website at www.sec.gov. This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities, 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 September 7, 2023 IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage biotechnology company focused on developing DNA-mediated immunotherapy and next-generation vaccines, reported that it will hold a virtual R&D Day event on September 14th beginning at 4:00 p.m. Eastern time (Press release, IMUNON, SEP 7, 2023, View Source [SID1234634998]). Details about speakers and instructions on how to participate are below.

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The Event’s Speakers

IMUNON presenters include:

Dr. Corinne Le Goff, President and Chief Executive Officer
Khursheed Anwer, Ph.D., Executive Vice President and Chief Science Officer
Guest key opinion leader presenters include:

Sallie Permar, M.D., Ph.D., Chair of the Department of Pediatrics at Weill Cornell Medicine and Pediatrician-in-Chief at New York-Presbyterian/Weill Cornell Medical Center and New York-Presbyterian Komansky Children’s Hospital. She is also Nancy C. Paduano Professor and Chair, Weill Cornell Medicine.
Patrick Ott, M.D., Ph.D., Clinical Director of the Melanoma Disease Center and the Director, Clinical Sciences, of the Center for Immuno-Oncology at the Dana-Farber Cancer Institute. He is also an attending physician in the Department of Medicine at Brigham and Women’s Hospital and is an Associate Professor at Harvard Medical School.
Dr. Permar will focus her presentation on the "Vaccines of the Future" while Dr. Ott will discuss "Immuno-Oncology: The remaining unmet need."

Dr. Permar is a physician-scientist focusing on the prevention and treatment of neonatal viral infections and leads a research laboratory investigating immune protection against vertical transmission of neonatal viral pathogens, namely HIV and cytomegalovirus. Dr. Ott is a clinical investigator and a member of the clinical trials program at Dana Farber/Harvard Cancer Center, where he designs and conducts Phase 1 immunotherapy trials for patients with melanoma and other tumors.

How to Participate

The virtual program will be held online beginning at 4:00 p.m. Eastern Time and is expected to last approximately 90 minutes. There is no need to pre-register for the event. A live and archived webcast will be available in the Scientific Presentations section of IMUNON’s website. Following management’s presentations, a Q&A session will be available via the chat function of the webcast.

On September 7, 2023 Amgen (NASDAQ:AMGN) reported that it will present at the Morgan Stanley Global Healthcare Conference at 8:50 a.m. ET on Tuesday, Sept. 12, 2023 (Press release, Amgen, SEP 7, 2023, View Source [SID1234634997]). Robert A. Bradway, chairman and chief executive officer at Amgen will present at the conference. The webcast 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 by management at certain investor and medical conferences, can be found 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 September 7, 2023 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, reported the first patients have been dosed in the randomized, controlled Phase 2b study of VBI’s cancer vaccine immunotherapeutic candidate, VBI-1901, in patients with first recurrent glioblastoma (rGBM) (Press release, VBI Vaccines, SEP 7, 2023, View Source [SID1234634996]). The study will assess the safety, tolerability, tumor response rates, and survival following treatment with VBI-1901, as a monotherapy, at 10 leading neuro-oncology centers across the United States.

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Andrew B. Lassman, M.D., Chief of Neuro-Oncology at Columbia University Vagelos College of Physicians and Surgeons, Associate Director for Clinical Trials at the NCI-designated Herbert Irving Comprehensive Cancer Center, and principal investigator of the study, commented, "Based on the pre-clinical and clinical data seen in earlier stages of this study, I look forward to demonstrating the potential value of VBI-1901, relative to current standard of care, in my patients in this next phase of clinical development, with the hope to provide meaningful benefit against a brain tumor that is notoriously aggressive with a high mortality rate."

Francisco Diaz-Mitoma, M.D., Ph.D., VBI’s Chief Medical Officer, commented, "Median overall survival in the recurrent GBM setting is just eight months, making any advancement in patient care critical. As we work to offer new hope to the patients, family members, and caretakers who are battling this devastating and historically treatment-resistant brain tumor, we are excited to kick-off this next phase of development for VBI-1901."

In the Phase 1/2a study of VBI-1901 in the rGBM setting, extensive biomarker panels suggested normal baseline CD4+/CD8+ T-cell ratios, which is a measure of immunological fitness, along with boosting of cytomegalovirus (CMV) gB specific antibody responses were correlated with tumor and clinical responses. These learnings have been incorporated into patient enrollment eligibility criteria for the Phase 2b study to help identify patient populations that may be more likely to respond to treatment with VBI-1901.

Phase 1/2a Study Data Highlights – VBI-1901 10µg + GM-CSF Study Arms

(n=16)

44% disease control rate achieved (n=7/16) – disease control rate is defined as stable disease (SD) + partial tumor response (PR) + complete tumor response (CR)
2 partial responses (PR) were observed – 1 patient was on treatment for more than 28 months (2.33 years), surviving at least 40 months (3.33 years) as of August 1, 2023, with a maximum tumor reduction of 93% relative to baseline
5 additional patients demonstrated stable disease (SD) for a sustained period of time
All patients with a tumor response (PR or SD) (n=7/16) reached a minimum survival of 12 months
Median overall survival (mOS) was 12.9 months, comparing favorably to 8-month mOS for monotherapy standard-of-care2
Phase 2b Study Design

Multi-center, randomized, controlled, open-label study in up to 60 patients with first recurrent GBM

Patients will be randomized in a 1:1 ratio across two study arms:
Intradermal VBI-1901 + GM-CSF: 10 µg dose every 4 weeks until clinical disease progression
Monotherapy standard-of-care: either intravenous carmustine or oral lomustine, every 6 weeks until disease progression or intolerable toxicity
Endpoints include:
Safety and tolerability
Overall survival (OS) – median and overall
Tumor response rate (TRR)
Progression-free survival (PFS)
Immunologic responses
Reduction in corticosteroid use relative to baseline
Change in quality of life compared to baseline
The U.S. Food and Drug Administration (FDA) has considered demonstration of a statistically significant improvement in overall survival relative to a randomized control arm to be clinically significant and has recognized this as criteria to support the approval of new oncology drugs.1

For more information about the Phase 2b study, visit clinicaltrials.gov and reference trial identifier: NCT03382977.

About GBM and VBI-1901

Scientific literature suggests CMV infection is prevalent in multiple solid tumors, including glioblastoma (GBM). GBM is among the most common and aggressive malignant primary brain tumors in humans. In the U.S. alone, 14,000 new cases are diagnosed each year. The current standard of care for treating GBM is surgical resection, followed by radiation and chemotherapy. Even with aggressive treatment, GBM progresses rapidly and has a high mortality.

VBI-1901 is a novel cancer vaccine immunotherapeutic candidate developed using VBI’s enveloped virus-like particle (eVLP) technology to target two highly immunogenic cytomegalovirus (CMV) antigens, gB and pp65. The FDA has granted VBI-1901 Fast Track Designation and Orphan Drug Designation for the treatment of recurrent glioblastoma. These designations are intended to provide certain benefits to drug developers, including more frequent meetings with the FDA, and Accelerated Approval and Priority Review, if relevant criteria are met, among other benefits.