On April 25, 2022 ERYTECH Pharma (Euronext Paris: ERYP—Nasdaq: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported the sale of its U.S. manufacturing facility to Catalent, a leading contract development and manufacturing organization (CDMO) in advanced therapies (Press release, ERYtech Pharma, APR 25, 2022, View Source [SID1234612901]).

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Under the terms of an asset purchase agreement between ERYTECH and Catalent (the "APA"), Catalent agreed to acquire ERYTECH’s state-of-the-art commercial-scale cell therapy manufacturing facility in Princeton, New Jersey, for a total consideration of $44.5 million. ERYTECH’s current staff at the site of approximately 40 people will be offered Catalent’s employment.

The parties will also enter into a long-term supply agreement, under which Catalent will manufacture ERYTECH’s lead product candidate eryaspase (GRASPA) for clinical and commercial supply in the United States. ERYTECH has a Phase 1 trial in first-line pancreatic cancer ongoing in the United States and is in a continued dialogue with the U.S. FDA regarding a potential BLA submission for GRASPA in hypersensititve ALL, now targeted in the third quarter of 2022, subject to FDA agreement on remaining outstanding information requests.

Catalent will also offer their expertise in late-stage and commercial manufacturing of advanced therapy medicinal products with respect to product characterization, commercial production, regulatory inspections, and approvals.

ERYTECH’s Princeton facility is a 30,900 sqft cutting edge manufacturing facility, designed with the flexibility to expand to support various cell therapy production requirements and capacities. Catalent intends to expand the Princeton site and leverage ERYTECH’s experienced staff to manufacture a broader portfolio of cell therapies. ERYTECH will retain its manufacturing site in Lyon, France and its expertise and capabilities in manufacturing process science to continue innovating in cell therapy manufacturing.

"In Catalent we have found a great partner for the manufacturing of our innovative red blood cell derived products, and we believe that this strategic partnership will meet our long-term manufacturing needs in the United States," commented Gil Beyen, Chief Executive Officer of ERYTECH, "As we are turning this important page for ERYTECH, I wish to thank our entire Princeton team very much for their talent and dedication in building and developing our flagship facility since its inception in 2018. ERYTECH will now further focus capital resources on the development of potentially transformative therapeutics for serious diseases. We are also continuing to evaluate further strategic options for the company, including additional partnerships and addition of complementary assets, through which we can leverage our ERYCAPS platform and our development and manufacturing capabilities."

"This acquisition is strategically important to Catalent’s commitment to support the development, clinical, and commercial supply of cell therapies to meet rapidly growing demand," said Manja Boerman, Ph.D., President, Catalent Cell & Gene Therapy. "The talented and experienced staff already employed at the facility, the capabilities it has in place, and the opportunity to quickly add further capacity on the same site, allows Catalent to expand rapidly to create a U.S. campus and center of excellence for cell therapy development and manufacturing that will serve customers around the world."

ERYTECH reported cash and cash equivalents of €33.7 million ($38.1 million) as of December 31, 2021. Upon closing of the transaction, ERYTECH’s cash and cash equivalents are expected to be approximately €55 million ($60 million) with the addition of the $44.5 million (€40.8 million) purchase price payment. With a reduction in yearly cash disbursements of approximately $7.5 million related to running costs of the Princeton facility, this cash position is expected to fund ERYTECH’s operations under its current configuration to mid-2024.

KEY TRANSACTION TERMS

In connection with the transaction, ERYTECH’s board of directors has established an ad hoc committee in order to review the indications of interests received by ERYTECH and to issue a recommendation to its board of directors. After having assessed the transaction and potential strategic alternatives, ERYTECH’s board of directors has unanimously approved it on the basis, inter alia, of the recommendation of the ad hoc committee and the opinion of its works council.

Pursuant to the APA, Catalent paid a total consideration of $44.5 million to ERYTECH.

Pursuant to the APA, ERYTECH has made certain representations and warranties on the transferred assets. ERYTECH has also agreed to certain customary covenants and restrictions with respect to assets and liabilities comprising the transaction consistent with a transaction of this nature.

The parties will also enter into a long-term supply agreement for the manufacturing and supply of the lead product candidate eryaspase (GRASPA) by Catalent to ERYTECH.

Duane Morris is serving as legal counsel to Catalent. Cooley LLP and Gide Loyrette Nouel A.A.R.P.I. are serving as legal counsel to ERYTECH. Torreya Capital LLC is serving as exclusive financial advisor to ERYTECH.

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]).

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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]).

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"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]).

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"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.

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"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.