On July 20, 2022 Daiichi Sankyo (TSE: 4568) reported that the first patient has been dosed in a global phase 2 trial evaluating the efficacy and safety of DS-7300 in patients with pretreated extensive-stage small cell lung cancer (SCLC) (Press release, Daiichi Sankyo, JUL 20, 2022, View Source [SID1234616814]). DS-7300 is a specifically designed potential first-in-class B7-H3 directed antibody drug conjugate (ADC) discovered and being developed by Daiichi Sankyo.

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Lung cancer is the second most common cancer and the leading cause of cancer-related deaths worldwide, with up to 14% being classified as SCLC in the U.S.1,2 Most patients with SCLC are diagnosed with extensive-stage disease and have a 5-year survival rate as low as 3%, highlighting the significant unmet need for more effective treatment options.3,4,5,6,7 B7-H3 is overexpressed in a wide range of cancer types, including SCLC, and its overexpression has been shown to correlate with poor prognosis in some cancers, making B7-H3 a promising therapeutic target.8,9,10,11,12,13

"Patients with pretreated extensive-stage small cell lung cancer have limited treatment options following disease progression," said Gilles Gallant, BPharm, PhD, FOPQ, Senior Vice President, Global Head, Oncology Clinical Development, Oncology R&D, Daiichi Sankyo. "Based on the encouraging results seen in the ongoing phase 1/2 trial, we have initiated this phase 2 trial of DS-7300 to further evaluate whether targeting B7-H3 with our DXd antibody drug conjugate technology may become a potential treatment option for patients with extensive-stage small cell lung cancer."

About the Phase 2 Trial

This global phase 2 trial is evaluating the efficacy and safety of two doses (8 mg/kg or 12 mg/kg) of DS-7300 in patients with histologically or cytologically confirmed extensive-stage SCLC that received at least one prior line of platinum-based chemotherapy.

Patients will be randomized 1:1 to receive either 8 mg/kg or 12 mg/kg of DS-7300. The primary endpoint of the trial is objective response rate (ORR) as assessed by blinded independent central review. Secondary endpoints include progression-free survival, duration of response, overall survival, time to response, disease control rate, investigator-assessed ORR, pharmacokinetics, immunogenicity and safety. The trial will enroll approximately 80 patients across Asia, Europe and North America. For more information about this trial, please visit ClinicalTrials.gov.

About B7-H3

B7-H3 is a transmembrane protein that belongs to the B7 family, which also includes PD-L1. B7-H3 is overexpressed in a wide range of cancer types, including SCLC, squamous non-small cell lung cancer and prostate cancer. B7-H3 overexpression has been shown to correlate with poor prognosis in some cancers, making B7-H3 a promising therapeutic target.8,9,10,11,12,13 Currently, no B7-H3 directed medicines are approved for the treatment of any cancer.

About Small Cell Lung Cancer

Lung cancer is the second most common cancer and the leading cause of cancer-related deaths worldwide, with up to 14% being classified as SCLC in the U.S.1,2 Extent of disease at initial diagnosis of SCLC is an important prognostic factor, as the 5-year survival rate is approximately 30% for patients with localized disease compared with only 3% of patients with extensive-stage disease.14

First-line standard of care for patients with extensive-stage SCLC consists of platinum-based chemotherapy with or without immunotherapy, depending on local availability.15 Treatment options beyond first-line have limited efficacy and are associated with rapid disease progression and high rates of hematologic toxicity, highlighting the unmet need for novel therapies.16

About DS-7300

DS-7300 is an investigational B7-H3 directed ADC and is one of five ADCs currently in clinical development in the oncology pipeline of Daiichi Sankyo. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, DS-7300 is comprised of a humanized anti-B7-H3 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

In addition to the phase 2 trial in extensive-stage SCLC, DS-7300 is being evaluated in a phase 1/2 trial in collaboration with the Sarah Cannon Research Institute in three cohorts of patients with metastatic squamous non-small cell lung cancer, esophageal squamous cell carcinoma and castration-resistant prostate cancer.

DS-7300 is an investigational medicine that has not been approved for any indication in any country. Safety and efficacy have not been established.

On July 20, 2022 Gilead Sciences, Inc. (Nasdaq: GILD) reported an $85 million contribution to the Gilead Foundation to further the company’s vision of creating a healthier world for all people (Press release, Gilead Sciences, JUL 20, 2022, View Source [SID1234616813]). This donation builds on the endowment Gilead announced last year to recapitalize the Gilead Foundation, with a new vision and mission to create impact in the community and society by encouraging a culture of giving, engaging in local communities and exploring innovative approaches to complex social issues.

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"Our additional contribution to the Gilead Foundation demonstrates our continued commitment to supporting communities and advancing health equity," said Andrew Dickinson, Chief Financial Officer, Gilead Sciences and Director, Gilead Foundation. "We are proud to dedicate our philanthropic resources in this way because we believe a more just society is a healthier one."

One of the Gilead Foundation’s giving pillars is the innovative Creating Possible Fund, which will announce its inaugural cohort of grants later this fall with the theme of Advancing Health Prosperity Through Education Equity, which is focused on addressing systemic barriers to equitable education for underserved and excluded adolescents. Research is clear that closing gaps in educational outcomes is necessary to promote health equity for underserved and excluded communities. The Gilead Foundation is committed to supporting efforts to ensure that all people have full and equal access to educational and economic opportunities that enable them to lead healthy lives.

The Gilead Foundation also supports charitable programs in local communities where Gilead employees live and work. Near its headquarters in San Mateo County, the Gilead Foundation recently provided the local school district with funding for STEM programming, as well as support for a mobile education and health program for underserved farmworker communities.

"Gilead is a pioneer in corporate stewardship and investing in the local community," said Annie Tsai, Board President, San Mateo-Foster City Education Foundation. "It has been an honor to collaborate with the Gilead Foundation on expanding opportunities for STEM learning at SMFCSD, San Mateo County’s largest public school district. As we live in an area with one of the largest wealth gaps in the country, achieving educational equity for all of our community’s children is our priority and we are thrilled that Gilead has chosen to invest their resources into this important initiative."

The Gilead Foundation also encourages a culture of employee giving through its donation matching program for employees, Giving Together.

"We have seen how generous our employees are – a recent matching donation program for employees in support of humanitarian relief efforts in Ukraine has raised more than $750,000 to date, in addition to the $3 million donated by the Gilead Foundation," said Jyoti Mehra, Executive Vice President, Human Resources, Gilead Sciences and Director, Gilead Foundation. "Gilead’s employees work hard to bring new possibilities to millions of patients around the world, and they are equally committed to creating new possibilities for health prosperity for all people through the Gilead Foundation."

The Gilead Foundation is one example of the philanthropic reach of the company, whose global corporate giving is recognized as the number one funder in HIV: View Source

On July 20, 2022 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported an informational update to stockholders regarding its proposed rights offering and the expected key dates and terms relative to the offering (Press release, Navidea Biopharmaceuticals, JUL 20, 2022, View Source [SID1234616812]). Stockholders of record on August 3, 2022 (the "Record Date") will be entitled to participate in the rights offering. Prospective stockholders who wish to participate in the rights offering are advised to ensure that they complete their open market purchases of Navidea’s common stock by August 1, 2022 to be considered a stockholder of record on the Record Date. Holders of certain of our outstanding warrants, Series D preferred stock and Series F preferred stock are also entitled to participate in the rights offering.

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Stockholders, warrant holders, preferred holders or interested parties are advised to direct all questions and informational requests to the contacts listed below.

Under the rights offering, Navidea will distribute one non-transferable subscription right for each one (1) share of common stock, each one (1) warrant and each one (1) share of preferred stock (on an as-if-converted-to-common-stock basis) held on the Record Date. Each subscription right will entitle the holder to purchase one unit, at a subscription price of $1,000 per unit, consisting of one share of the Company’s newly created Series I Convertible Preferred Stock with a face value of $1,000 (and immediately convertible into shares of Navidea’s common stock at a conversion price of $0.75 per share) and one (1) warrant to purchase 1,333 shares of Navidea’s common stock with an exercise price of $0.80 per share. The warrants will be exercisable for 5 years after the date of issuance.

The subscription rights will be non-transferable and may only be exercised during the anticipated subscription period of August 4, 2022 through 5:00 PM ET on August 17, 2022, unless extended by Navidea.

The expected calendar for the rights offering is as follows:

August 1, 2022: Ownership Day — in order to be considered a stockholder of record on August 3, shares should be acquired by this date.
August 3, 2022: Record Date
August 4, 2022: Distribution Date; Subscription Period Begins
August 17, 2022: Subscription Period Ends 5:00 PM ET (unless extended at Navidea’s sole discretion)
Holders who exercise their subscription rights in full will be entitled, if available, to subscribe for additional units that are not purchased by other stockholders, on a pro rata basis and subject to ownership limitations.

Navidea has engaged Maxim Group LLC as dealer-manager for the proposed rights offering. Questions about the rights offering or requests for copies of the preliminary and final prospectuses, when available, may be directed to Maxim Group LLC at 300 Park Avenue, New York, NY 10022, Attention Syndicate Department, or via email at [email protected] or telephone at (212) 895-3745.

A registration statement (Registration No. 333-262691) relating to these securities has been filed with the Securities and Exchange Commission ("SEC") but has not yet become effective. These securities may not be sold nor may offers to buy be accepted prior to the time the registration statement becomes effective. The rights offering, which is expected to commence following the effectiveness of the registration statement, is being made only by means of a written prospectus. A preliminary prospectus relating to and describing the proposed terms of the rights offering has been filed with the SEC as a part of the registration statement and is available on the SEC’s website at View Source Copies of the preliminary and final prospectuses for the rights offering may be obtained, when available, from Maxim Group LLC, 300 Park Avenue, New York, NY 10022, Attention Syndicate Department, email: [email protected] or telephone (212) 895-3745.

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor will there be any sale of these securities in any state or other 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 July 20, 2022 The Upstate Foundation reported that it has received an $81,770 grant to expand the Upstate Cancer Center’s She Matters breast cancer outreach and education program as well as support the launch of You Matter, a health careers pathway initiative for Syracuse youth (Press release, SUNY Upstate, JUL 20, 2022, View Source [SID1234616811]).

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The grant was awarded by Hologic, a global medical technology innovator primarily focused on improving women’s health and well-being through early detection and treatment.

"We are grateful for Hologic’s support of She Matters and You Matter," said Linda Veit, MPH, Upstate assistant vice president of community relations and interim chief of staff. "The generous gift from Hologic will help us to enhance and strengthen these important programs that benefit women’s health and provide youth with skills and opportunities to prepare them for careers in health care."

She Matters is a peer-to-peer outreach and education program created by the Upstate Cancer Center to reduce breast cancer disparities and improve health outcomes by making annual breast cancer screening a priority among low-income, primarily Black and Hispanic women living in public housing in Syracuse. The program, founded in 2014, works closely with the residents of the Syracuse Housing Authority.

Key to the success of the program is the recruitment of public housing residents to serve as specially trained Resident Health Advocates. As advocates, they provide culturally appropriate breast health education; navigation to screening mammography; and, when necessary, access to prompt diagnostic and treatment services. The goal of the program is to eliminate barriers to health care, change behavior, and make annual breast cancer screening a priority. Over the past eight years, She Matters has reached more than 6,000 women and facilitated breast screening in more than 800 women over 40.

Also funded by the Hologic grant is You Matter, a healthcare careers pathway for local youth. The program reaches out in non-traditional ways to elementary, middle, and high school-aged students, and works one-on-one with each student in exploring and identifying the academic pathway needed to gain a rewarding healthcare career. Upstate says that are more than 1,000 local youth are eligible to participate in the program.

The grant is part of Hologic’s pledge to donate $5 million to improve women’s health; science, technology, engineering and math (STEM) education, and social and racial inequity initiatives, particularly in healthcare.

"With support of these two important initiatives, we look forward to building a long-term relationship with Hologic, a new funding partner of the Upstate Foundation," said Terry Toscano Shenfeld, director of foundation relations at the Upstate Foundation.

On July 20, 2022 Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company focused on advanced therapies for autoimmune and inflammatory diseases, reported financial results for the quarter ended March 31, 2022, as well as research and development progress on nomacopan and long-acting PAS-nomacopan (Press release, Akari Therapeutics, JUL 20, 2022, View Source [SID1234616810]). Investigational nomacopan is a bispecific recombinant inhibitor of complement C5 and leukotriene B4 (LTB4) currently being investigated in two Phase 3 clinical trials for use in severe pediatric hematopoietic stem cell transplant related (HSCT) thrombotic microangiopathy (TMA) and bullous pemphigoid (BP). Akari also is advancing long-acting PASylated nomacopan for geographic atrophy (GA) in dry age-related macular degeneration (dAMD).

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"Akari is advancing our two Phase 3 programs with urgency, opening 10 clinical trial sites and beginning the screening of bullous pemphigoid patients, while also enrolling and dosing in the pediatric HSCT-TMA study at a rate that has exceeded my expectations and positions us well to meet our recruitment objectives," said Rachelle Jacques, President and CEO of Akari Therapeutics. "Akari also has made significant strides in the pre-clinical work on long-acting PAS-nomacopan as we advance the potential of this novel therapeutic to address significant unmet patient needs in geographic atrophy and build a solid foundation for human studies."

Akari Pipeline Highlights

Phase 3 Part A clinical trial in severe pediatric HSCT-TMA
Four patients have been enrolled in the Phase 3 Part A clinical trial of nomacopan in severe pediatric HSCT-TMA. The Phase 3 Part A clinical trial has a recruitment goal of seven patients over six months old. Sites are open and recruiting in the U.S., U.K., and Poland for the open-label study of pediatric patients who have undergone allogeneic or autologous HSCT and develop HSCT-TMA within a year of transplant.

Thrombotic microangiopathy following a stem cell transplant procedure is a rare but serious complication of HSCT that appears to involve complement activation, inflammation, tissue hypoxia and blood clots, leading to progressive organ damage and death. The mortality rate in patients who develop severe transplant-related TMAs is 80%.1 Currently, there are no approved treatment options in the U.S. or Europe.

ARREST-BP Phase 3 Part A clinical trial in BP
After resolving third-party supply chain issues, in May 2022 Akari began opening clinical trial sites. Ten of the clinical trial sites across the U.S., Germany, and the Netherlands are now opened and screening patients for the placebo-controlled Phase 3 Part A study of investigational nomacopan in BP. The Phase 3 Part A clinical trial is enrolling 48 patients with moderate-to-severe BP and will compare the efficacy and safety of nomacopan plus oral corticosteroids (OCS) against placebo plus OCS.

While BP is the most common autoimmune blistering skin disease, it is a rare disease. Prevalence rates vary in specific regions around the world and it has been estimated to be 12 to 23 cases per million people in the general population. It primarily affects people over the age of 65 and prevalence rises with age to approximately 190 to 312 cases each year per million people who are over 80 years of age.2 The mortality rate in BP is approximately three-fold higher than the general population, due to the disease itself, and infections and cardiovascular conditions that are more common in older patients and are exacerbated by treatment with high-dose OCS.3 There are no approved treatment options for BP.

Pre-clinical program in GA/dAMD
Akari has made significant progress on the pre-clinical program that is laying a foundation for potential clinical trials of long-acting PAS-nomacopan for geographic atrophy (GA) in dry age-related macular degeneration (dAMD). Recent progress was focused on tolerability and half-life of PAS-nomacopan to further clarify the potential of addressing three areas of significant unmet patient needs in GA: less frequent intravitreal injections into the back of the eye, lower dose volume of intravitreal injections, and, through LTB4 inhibition4, reduced risk of sight-threatening choroidal neovascularization (CNV), also known as wet age-related macular degeneration (wAMD), which can be a complication of certain complement-only inhibitors.5,6

Geographic atrophy is a chronic progressive degeneration of the macula, which occurs during late-stage dry AMD. GA can lead to irreversible vision loss. Approximately 5 million people are affected worldwide with GA,7 nearly 1 million in the U.S.8 There are no approved treatment options.

References

Rosenthal J. Hematopoietic cell transplantation-associated thrombotic microangiopathy: a review of pathophysiology, diagnosis, and treatment. J Blood Med. 2016;7:181-186. Published 2016 Sep 2.
Gudi VS, et al. Annual incidence and mortality of bullous pemphigoid in the Grampian Region of North-east Scotland. Br J Dermatol. 2005;153(2):424-427.
Tedbirt B, Gillibert A, Andrieu E, et al. Mixed Individual-Aggregate Data on All-Cause Mortality in Bullous Pemphigoid: A Meta-analysis. JAMA Dermatol. 2021;157(4):421-430.
Sasaki F, Koga T, Ohba M, et al. Leukotriene B4 promotes neovascularization and macrophage recruitment in murine wet-type AMD models. JCI Insight. 2018;3(18):e96902. Published 2018 Sep 20.
Liao DS, Grossi FV, El Mehdi D, et al. Complement C3 Inhibitor Pegcetacoplan for Geographic Atrophy Secondary to Age-Related Macular Degeneration: A Randomized Phase 2 Trial. Ophthalmology. 2020;127(2):186-195.
Jaffe GJ, Westby K, Csaky KG, et al. C5 Inhibitor Avacincaptad Pegol for Geographic Atrophy Due to Age-Related Macular Degeneration: A Randomized Pivotal Phase 2/3 Trial. Ophthalmology. 2021;128(4):576-586.
Wong WL, et al. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. Lancet Glob Health. 2014;2(2):e106-e116.
Friedman DS,, et al. Prevalence of age-related macular degeneration in the United States [published correction appears in Arch Ophthalmol. 2011 Sep;129(9):1188]. Arch Ophthalmol. 2004;122(4):564-572.
First Quarter 2022 Financial Results

At March 31, 2022, the Company had cash of approximately $16.7 million, compared to cash of approximately $9.4 million at December 31, 2021.

In March 2022, Akari entered into an agreement with Paulson Investment Company, LLC to serve as placement agent in connection with a registered direct offering and sold approximately 7.4 million of the Company’s ADSs for gross proceeds of approximately $8.9 million.

Research and development expenses for the first quarter of 2022 were approximately $2.1 million, as compared to approximately $3.5 million for the same period the previous year. This decrease was primarily due to lower manufacturing expenses to support ongoing clinical trials.

General and administrative expenses for the first quarter of 2022 were approximately $3.1 million, as compared to approximately $2.0 million for the same period the previous year. The increase was primarily due to expenses associated with the appointment of the Company’s new chief executive officer and the departure of the previous CEO.

For the first quarter of 2022, total other income was approximately $68,000, as compared to total other loss of approximately $290,000 for the same period the previous year. This change was primarily due to foreign currency exchange gains in the current period as compared to foreign currency exchange losses in the prior period.

Net loss for the first quarter of 2022 was approximately $5.2 million, as compared to net loss of approximately $5.8 million in the same period the previous year.