On July 20, 2022 Biocytogen Pharmaceuticals (Beijing) Co., Ltd. ("Biocytogen") reported that it entered a strategic collaboration with LiberoThera Co., Ltd ("LiberoThera") to co-develop fully human GPCR antibodies using Biocytogen’s advanced antibody discovery platform based on fully human antibody RenMabTM mice combined with LiberoThera’s outstanding membrane antigen preparation technology (Press release, Biocytogen, JUL 20, 2022, View Source [SID1234616817]). In around a year since the collaboration was established, the two parties have screened out a number of fully human therapeutic antibody clones with excellent anti-tumor activity in vitro and in vivo against the first mutually selected GPCR target, CCR8, which has the potential to become a best-in-class product. These antibody clones exhibit high affinity binding to human CCR8 with species cross-reactivity and good manufacturability. Mechanistically, these clones can deplete Tregs from the tumor micro-environment through enhanced ADCC activity, and can also inhibit the activities of Tregs in the tumor micro-environment by inhibiting CCR8 signaling mediated by its ligand CCL1, thereby enhancing the anti-tumor immune response. In the future, the collaborations between two parties will also be extended to other GPCR targets.

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GPCRs are seven-transmembrane proteins with short extracellular domains and high homology among them which make it difficult to find antibodies against them with high specificity and desired functions. However, both the success rate and the speed of GPCR antibody discovery have greatly increased by combining Biocytogen’s target knocked-out fully human antibody mice RenMab KO, various immunization and antibody discovery technologies, high-throughput in vitro and in vivo screening platform and LiberoThera’s deep understanding of GPCR target structures plus membrane antigen preparation technologies.

"We are very pleased that with the joint efforts of us and LiberoThera, the drug development of CCR8, a potential target for tumor immunotherapy, is progressing smoothly." said Dr. Yuelei Shen, Founder, Chairman and CEO of Biocytogen. "This undoubtedly validates that LiberoThera’s advanced antigen preparation technology synergizes with our RenMice KO platform to generate diverse fully human antibodies. Furthermore, our high-throughput in vivo and in vitro screening capabilities ensured that antibodies against GPCRs can be efficiently obtained. We look forward to advancing our CCR8 antibodies into the clinic soon and we also look forward to continue working with LiberoThera to tackle more GPCR targets."

"Many GPCRs are important drug targets for a variety of indications. However, due to the special structure of such targets, the development of antibody drugs against them has always been challenging," said Dr. Toru Kanke, CEO of LiberoThera. "The structural GPCR antigens prepared with LiberoThera’s proprietary cell-free membrane synthesis technologies together with non-natural amino acid incorporation methods can provide a solution for generating quality antibodies against the challenging targets. Biocytogen’s streamlined fully human antibody development platform greatly accelerates the translation of GPCR research. We are very happy to see the rapid progress and discovery of the best-in-class therapeutic antibodies against CCR8 under the collaboration of both parties. We also look forward to the collaborations in the future with Biocytogen to work on more GPCR targets so that to benefit more patients around the world."

On July 20, 2022 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported an upcoming presentation on DecisionDx-Melanoma, the Company’s risk stratification gene expression profile (GEP) test, at the 2022 American Academy of Dermatology (AAD) Innovation Academy, being held in Vancouver, Canada, July 21-24 (Press release, Castle Biosciences, JUL 20, 2022, View Source [SID1234616815]).

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DecisionDx-Melanoma is designed to inform two clinical questions in the management of cutaneous melanoma:

a patient’s individual risk of sentinel lymph node positivity; and
a patient’s personal risk of recurrence and/or metastasis.
Integrating a patient’s tumor biology and their clinicopathologic features, DecisionDx-Melanoma provides comprehensive and actionable results to guide risk-aligned patient care.

Aaron Farberg, M.D., FAAD, dermatologist and Mohs surgeon at Derm Texas and Baylor Scott & White Health System in Dallas, Texas, will be sharing an overview of the test and data highlights that demonstrate how incorporating DecisionDx-Melanoma test results into decision-making between a patient and his/her clinician can help guide cutaneous melanoma management decisions and improve patient outcomes. The presentation details are as follows:

Presentation Title: The 31-Gene Expression Profile Test for Cutaneous Melanoma
Session: Future of Dermatology Session 2: Advanced Diagnostics
Date: Thursday, July 21, 2022
Location: Ballroom B
Time: 2:40-2:55 p.m. Pacific time

"DecisionDx-Melanoma provides clinically actionable and personalized risk stratification information, based on each patient’s tumor biology, that I cannot obtain through any other test," said Farberg. "It gives me confidence that I am making more informed, risk-based treatment plan decisions aligned with each patient’s risk of metastasis or recurrence."

About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma (CM) metastasis or recurrence, as well as the risk of sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 9,000 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. To predict risk of recurrence and likelihood of sentinel lymph node positivity, the Company utilizes its proprietary algorithms, i31-ROR and i31-SLNB, to produce an Integrated Test Result. Additionally, Castle has an ongoing collaboration with the National Cancer Institute (NCI) to link DecisionDx-Melanoma testing data with data from the Surveillance, Epidemiology and End Results (SEER) Program’s registries on CM cases. This collaboration resulted in a study to evaluate melanoma-specific survival and overall survival where the patients tested with DecisionDx-Melanoma had better survival rates than untested patients. This data suggests that DecisionDx-Melanoma can accurately risk-stratify for disease progression to aid in risk-aligned treatment plans for improved patient outcomes and survival. DecisionDx-Melanoma has been validated in four archival risk of recurrence studies of more than 900 patients and six prospective risk of recurrence studies including more than 1,600 patients. Impact on patient management plans for one of every two patients tested has been shown in five multi-center/single-center studies including more than 800 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results. Through March 31, 2022, DecisionDx-Melanoma has been ordered 97,288 times for patients with cutaneous melanoma.

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.