On April 25, 2022 Cerus Corporation (Nasdaq: CERS) reported that it has signed a five-year contract with the American Red Cross for the INTERCEPT Blood System for Platelets (Press release, Cerus, APR 25, 2022, View Source [SID1234612900]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the terms of this contract, Cerus will continue to supply the Red Cross the INTERCEPT Blood System used to produce pathogen reduced platelets, in support of the Red Cross goal to transition toward a full pathogen reduced platelet supply for its hospital customers across the U.S.

"The Red Cross is a global leader in transfusion medicine, with a track record of establishing blood safety protocols that have provided a blueprint for many blood centers globally. Cerus is proud of our long history of collaborating with the Red Cross, as they have played a critical role in the deployment of the INTERCEPT Blood System to safeguard the U.S. blood supply," stated William "Obi" Greenman, Cerus’ president and chief executive officer. "Thanks to their leadership and commitment to blood safety, the Red Cross is now the largest producer of INTERCEPT treated blood components in the world. Our partnership has made thousands of INTERCEPT treated platelets available for patients across the country each day, and we are excited to extend this relationship and continue advancing the INTERCEPT Blood System."

Supplying about 40 percent of the nation’s blood supply, the Red Cross is the largest provider of blood products in the United States, collecting more than 4.6 million blood donations and 1 million platelet donations for its approximately 2,500 hospital and transfusion center customers in 2021.1

"The safety and sustainability of the blood supply is of paramount importance for us, as well as for the hospitals, physicians and patients who we serve," said Chris Hrouda, president, Biomedical Services at American Red Cross. "INTERCEPT treated platelets meet the FDA’s bacterial safety requirements and also protect patients against a broad spectrum of transfusion-transmitted infections caused by known and unknown pathogens. The Red Cross remains committed to finding proactive ways to ensure the safety and availability of the blood supply."

On April 25, 2022 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a precision oncology medicine company pioneering the discovery and development of MasterKey therapies, reported that it is realigning its resources to focus on key near-term value drivers and to extend its cash runway into the third quarter of 2024, supporting the execution of important clinical and preclinical milestones (Press release, Black Diamond Therapeutics, APR 25, 2022, View Source [SID1234612899]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Black Diamond’s mission of expanding the reach of precision cancer medicines through the development of our novel MasterKey therapies is at the core of our daily work, and we believe that our MAP discovery engine offers a novel approach to addressing major unmet needs within the oncology treatment landscape," said David Epstein, Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. "In order to increase our operational efficiency and execute on our mission, we have made the difficult decision to reduce our workforce by approximately 30%. We are incredibly grateful to every member of the Black Diamond team who has helped to advance MasterKey therapies for the many patients in need of new therapeutic options as well as to the patients and investigators involved in the clinical trial of BDTX-189. The actions announced today enable us to focus and strengthen our organizational priorities, reduce our operating expenses, and continue to invest in value generating clinical development activities to bring us to the next inflection points for BDTX-1535 and BDTX-4933."

Black Diamond has discontinued the development of BDTX-189 and realigned its workforce to focus on progressing its pipeline through important upcoming milestones for BDTX-1535, BDTX-4933 and discovery efforts. Since its announcement regarding the status of BDTX-189 in January 2022, the Company has been reviewing the development program for BDTX-189, an orally available, irreversible small molecule inhibitor targeting oncogenic driver mutations of the epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) kinases, while continuing to enroll patients in the safety expansion cohort of the Phase 1 study. As part of its strategic review, Black Diamond has decided to discontinue development of the program due to the rapid evolution of the treatment landscape in non-small cell lung cancer (NSCLC) harboring either EGFR or HER2 Exon 20 insertion mutations.

Black Diamond is aligning its operational and scientific efforts on two priority programs, in addition to its discovery efforts.

BDTX-1535

BDTX-1535 is designed as a potent, selective, brain-penetrant and irreversible MasterKey inhibitor of EGFR mutations expressed in glioblastoma multiforme and of intrinsic and acquired resistance EGFR mutations to third generation EGFR inhibitors in NSCLC.
Black Diamond initiated the Phase 1 study of BDTX-1535 in the first quarter of 2022 and expects to provide a clinical data update in 2023.
BDTX-4933

BDTX-4933 is a central nervous system (CNS)-penetrant BRAF inhibitor against a family of Class I, II, III canonical and non-canonical mutations being developed for the treatment of patients with or without brain tumors driven by oncogenic BRAF mutations. BDTX-4933 is designed to be highly selective and potent, with the ability to avoid paradoxical activation.
Black Diamond initiated investigational new drug (IND)-enabling studies in the first quarter of 2022 and expects to submit an IND for BDTX-4933 in the first half of 2023.
Discovery Efforts

Black Diamond will continue the advancement of its discovery efforts generated from its Mutation-Allostery-Pharmacology (MAP) Drug Discovery Engine focused on predicting and validating novel oncogenic mutant families from population level tumor genomics. Black Diamond anticipates announcing a development candidate for its FGFR program in 2022 in addition to disclosing a new small molecule development candidate in 2023.

On April 25, 2022 Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported data from the ANCHOR Phase 1 study of KUR-502 during an oral presentation by Carlos Ramos, M.D., professor, Center for Cell and Gene Therapy, Baylor College of Medicine, at the Tandem Meetings of the American Society of Transplantation and Cellular Therapy (ASTCT), and the Center for International Blood & Marrow Transplant Research (CIBMTR), taking place April 23 to 26, in Salt Lake City, UT (Press release, Athenex, APR 25, 2022, View Source [SID1234612898]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Encouraging data from the interim update of the ANCHOR study further support the promising efficacy and favorable safety profile of KUR-502 in heavily pretreated patients with hematological malignancies," said Dan Lang, M.D., President of Athenex Cell Therapy. "It is exciting to see the therapeutic benefit of our CAR-NKT cell therapy persists as the ANCHOR study matures, particularly in patients who have already progressed on autologous CAR-T therapy. We intend to collect additional patient data as we expand the study to include more sites and look forward to providing another update later this year."

Highlights from the interim update include response data from seven evaluable patients, including two additional patients who were previously too early to assess (1 NHL, 1 ALL):

One patient with NHL had stable disease (SD), and a second patient with ALL had progressive disease (PD) at the 4-week assessment
Two CRs persisted for more than 6 months with one at 34 weeks and still ongoing
Two responses (1 CR and 1 PR) were observed in patients who had relapsed after previous autologous CAR-T therapy
Excellent safety with no immune effector cell-associated neurotoxicity syndrome (ICANS) and no graft versus host disease (GvHD) attributable to CAR-NKT cells
Grade 1 cytokine release syndrome (CRS) in 2 ALL patients
NHL Patients
(n=5) ALL Patients
(n=2) Total
(n=7)
CR 2 40% 1* 50% 3 43%
PR 1 20% 0 - 1 14%
ORR 3 60% 1* 50% 4 57%
DCR 4 80% 1* 50% 5 71%
*Patient B1 from the ALL cohort had a complete response with incomplete hematologic recovery (CRi)

About the Phase I Study of KUR-502 (Allogeneic CD19 CAR-NKT Cells) in Patients with Relapsed or Refractory B-Cell Malignancies (ANCHOR)

The Phase 1 study is an open-label, dose-escalation trial. NKT cells were isolated from the leukapheresis product of one HLA-unmatched healthy individual, transduced with the CAR, expanded ex vivo for 14 days (99.8% NKT purity), and cryopreserved. Subjects were treated in an outpatient setting and received 107 (DL 1) or 3×107 (DL 2) CAR-NKT cells per square meter of body surface area following lymphodepleting conditioning with cyclophosphamide/fludarabine. Adverse events were evaluated per NCI criteria. When accessible, patients underwent core biopsies of an involved site at 2-5 weeks post-infusion. Response to therapy was assessed at 4 weeks per Lugano Criteria (for NHL) or NCCN guidelines (for ALL).

For further information about the study, visit ClinicalTrials.gov, identifier: NCT03774654. The abstract "Allogeneic NKT Cells Expressing a CD19-Specific CAR in Patients with Relapsed or Refractory B-Cell Malignancies" presented at the 2022 Transplantation & Cellular Tandem Meetings of ASTCT and CIBMTR can be viewed here.

On April 25, 2022 Astellas Pharma US, Inc. ("Astellas") reported that it is accepting applications for the sixth annual Astellas Oncology C3 Prize (Changing Cancer Care), a global challenge that funds and advances the best non-treatment ideas to improve cancer care for patients, caregivers and the broader oncology community (Press release, Astellas, APR 25, 2022, View Source [SID1234612897]). The C3 Prize awards a total of $100,000 in grants and additional resources to advance ideas that address everyday challenges facing people impacted by cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The C3 Prize is focused on advancing innovations in cancer care beyond medicine to make every day better for those impacted by cancer," said Anthony Yanni, M.D., Senior Vice President and Global Head of Patient Centricity, Astellas. "Through the C3 Prize, we aim to fuel innovations that address patient and caregiver challenges and foster connections and empowerment throughout the cancer journey. In particular this year, solutions that address some of today’s most pressing issues, such as mental health, caregiver support and health disparities and equity, are encouraged."

Sparking Innovation to Make an Impact for the Cancer Community
Innovation through the lens of patients and caregivers fuels the C3 Prize. Many previous C3 Prize innovators have a personal connection to cancer, which aligns with Astellas’ philosophy that understanding the patient journey is critical to driving meaningful advancements in cancer care.

"As soon as I learned about the C3 Prize, it was clear to me that the Oncopadi app was exactly the kind of innovation Astellas was seeking to support," said Dr. Omolola Salako, 2020 C3 Prize Grand Prize winner, Founder and CEO, Oncopadi and 2022 C3 Prize Judge. "The funds and resources we received have enabled our team to close the cancer gap, strengthen the cancer care system and create new paths to improving the patient experience. The C3 Prize has fueled my personal mission and cemented the legacy of my sister, whose cancer journey motivated me to become an oncologist and launch Oncopadi."

Astellas Oncology will award one Grand Prize winner $100,000 USD in grants, and name two Innovation Prize winners. All winners will be provided with access to tools and resources to help them develop and advance their idea, including a yearlong complimentary membership to MATTER, a global healthcare startup incubator, community nexus and corporate innovation accelerator. The Grand Prize Winner will also receive hands-on support, expertise and resources from Slalom, a global consulting firm focused on strategy, technology and business transformation.

The C3 Prize finalists will participate in a virtual pitch event with an expert panel of volunteer judges, who are experts in cancer care and advocacy, healthcare innovation, and business strategy and consultation.

Details About the C3 Prize Application Process
The C3 Prize is open to applicants through June 3, 2022. Astellas will select three finalists who will participate in a virtual pitch event with the panel of judges to determine the Grand Prize winner and two Innovation Prize winners. Winners will be publicly announced in July 2022.

All eligible entries will be evaluated on the following criteria: potential to make a positive impact on people affected by cancer, originality/differentiation from existing solutions, scalability and financial viability of idea, and the effect of the C3 Prize to help further the idea. The C3 Prize is not just for complex solutions – ideas can be in the form of support tools, educational efforts, technology solutions and beyond. Past winners include people who have lived with cancer, caregivers, healthcare providers, patient advocates, entrepreneurs and more.

On April 25, 2022 Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) reported that it has formed a joint venture, Visirna Therapeutics, with Vivo Capital to expand the reach of innovative medicines in Greater China (Press release, Arrowhead Research Corporation, APR 25, 2022, View Source [SID1234612896]). The company also announced that it has entered into a license agreement with Visirna, pursuant to which Visirna will have exclusive rights to develop and commercialize four of Arrowhead’s investigational RNA interference (RNAi) therapeutics for cardiometabolic diseases in mainland China, Hong Kong, Macau, and Taiwan. Funds affiliated with Vivo provided initial funding of $60 million to Visirna and Vivo will leverage its network in Greater China to support Visirna, particularly in recruiting Visirna’s leadership team and actively engaging in corporate development, clinical, and regulatory strategies in the region. Arrowhead has a majority stake in Visirna, after accounting for shares reserved for the employee stock ownership plan, and is further eligible to receive potential royalties on commercial sales.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Greater China is an important region for global pharmaceutical products broadly, and specifically for medicines that treat cardiovascular and metabolic diseases. We believe that the best way to get important new medicines to patients in China as quickly and effectively as possible is to have a dedicated entity with its own management and development staff that understand and are solely focused on the intricacies of China’s clinical, regulatory, and commercial environment. We believe

this structure will allow us to maximize the value of key Arrowhead assets, without losing focus on our core business opportunities," said Christopher Anzalone, Ph.D., Arrowhead’s president and CEO. "Our colleagues at Vivo Capital have a broad network in the Chinese biopharma ecosystem, which makes them an invaluable partner as we look to recruit the best people to run this new business."

"We deeply appreciate our partners at Arrowhead entrusting us with the development of these valuable assets for Chinese patients," commented Dr. Hongbo Lu, Managing Partner of Vivo Capital. "Anchored by these four assets in an advanced development stage, Visirna will be well positioned to be a leading nucleic acid therapeutics platform company and further build its competitive advantage via internal R&D and strategic acquisitions of additional products. This deal continues to demonstrate Vivo’s unique capability to leverage its platform and ecosystem approach in creating proprietary investment opportunities. We look forward to embarking on this exciting journey with our partners at Arrowhead." Drs. Hongbo Lu and Gaurav Aggarwal, managing director of Vivo Capital, will join the Visirna board.

Under the terms of the agreement, Visirna receives an exclusive license to develop and commercialize four undisclosed investigational RNAi therapeutics targeting cardiovascular and metabolic diseases (Licensed Products) in Greater China (Licensed Territory). Visirna will be wholly responsible for clinical development and commercialization of the Licensed Products in the Licensed Territory. Arrowhead is eligible to receive royalties on net commercial product sales in the Licensed Territory. Arrowhead also received the right to appoint members to the Visirna board of directors. Visirna will be headquartered in Shanghai, and recruitment of management and development staff is currently underway.