On May 10, 2022 Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, reported that the first patient has been dosed in its open-label, multicenter ACLX-001 Phase 1 clinical trial (NCT04155749) to evaluate the company’s novel ARC-SparX program in patients with relapsed or refractory multiple myeloma (r/r MM) (Press release, Arcellx, MAY 10, 2022, View Source [SID1234614145]). ARC-SparX is a universal cell therapy platform comprised of SparX (soluble protein antigen-receptor X-linkers) proteins engineered to target BCMA on myeloma cells together with ARC-T (Antigen Receptor Complex-T) cells that are dosed separately and are engineered to activate only when engaged with a SparX protein bound to a myeloma cell. Both the ARC-T cells and SparX proteins utilize the company’s proprietary novel synthetic binding scaffold called the D-Domain.

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"Our ARC-SparX platform, powered by our proprietary D-Domain technology, has the potential to yield transformative therapies that can unleash the full potential of CAR-Ts to treat challenging conditions, including solid tumors. By addressing antigen heterogeneity and dose limiting toxicities, ARC-SparX could help many patients and address significant unmet clinical needs," said Rami Elghandour, Arcellx’s chairman and chief executive officer. "ACLX-001 is intended to demonstrate the advantages for our ARC-SparX platform technology and may potentially enable rapid development of future ARC-SparX programs in our portfolio. We look forward to enrolling additional patients in this study and evaluating the clinical outcomes."

"We are excited to be participating in this clinical trial to evaluate ACLX-001 in patients with relapsed or refractory multiple myeloma," said Binod Dhakal, M.D., M.S., associate professor of medicine, Division of Hematology/Oncology, Medical College of Wisconsin, and clinical investigator on both Phase 1 trials of CART-ddBCMA and ACLX-001. "ARC-SparX provides physicians with the ability to control the dose and frequency of SparX administration. This may allow the physician to better manage toxicities associated with traditional CAR-T therapies, potentially increasing patient access to this treatment option."

Initial data from the ACLX-001 Phase 1 study is expected in 2023. For more information about the clinical trial program, visit ClinicalTrials.gov (NCT04155749).

About the ARC-SparX Platform Technology
The ARC-SparX platform is designed to allow for controllability and adaptability to potentially reduce toxicities that are often associated with serious dose-limiting adverse events and to overcome tumor heterogeneity. It is a modular therapy which utilizes a universal ARC-T cell combined with an off-the-shelf SparX protein to separate the tumor-recognition and tumor-killing functions. SparX (soluble protein antigen-receptor X-linkers) proteins utilize our D-Domain technology engineered to recognize antigens on the surface of diseased cells and flags those cells for detection by the ARC-T cells. ARC-T cells express a D-Domain-based CAR engineered to specifically recognize a unique TAG in the SparX protein. ARC-T cells are dosed separately and only activated to kill the target cell when they encounter a SparX protein bound to the target antigen and thus are controlled through SparX dose modulation. Arcellx has developed a collection of SparX proteins that bind different antigens on the surface of diseased cells. Multiple SparX proteins with different antigen specificity can be administered to potentially address antigen heterogeneity or antigen escape that contribute to relapsed and refractory disease.

About the Phase 1 Study Evaluating ACLX-001 for Patients with Relapsed or Refractory Multiple Myeloma (NCT04155749)
The Phase 1 study evaluating ACLX-001 in adults with relapsed or refractory multiple myeloma (r/r MM) is a first-in-human, open-label, multicenter, dose escalation clinical trial designed to evaluate ARC-SparX, in which a matrix escalation of either ARC-T cells or SparX-001 or both may be escalated based on clinical correlative data, including pharmacokinetics of SparX-001 and ARC-T expansion. The primary objective of this study is to evaluate the safety and tolerability of ARC-SparX. A secondary objective is to identify a dosing strategy associated with ARC-T cell expansion kinetics that results in the best mix of efficacy, as determined by International Myeloma Working Group response criteria, and safety profile.

On May 10, 2022 Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company committed to identifying and accelerating the development of life-transforming therapies for patients with severe and rare diseases, reported that it has obtained worldwide exclusive rights to Sanofi’s KY1066, which will be referred to as RLYB331 going forward, a preclinical potentially first-in-class antibody (Press release, Sanofi, MAY 10, 2022, View Source [SID1234614177]). RLYB331 has the potential to address a significant unmet need for patients with severe anemia with ineffective erythropoiesis and iron overload, such as beta thalassemia (BT) and a subset of myelodysplastic syndromes (MDS), amongst others. The transaction expands Rallybio’s pipeline, is strategically consistent with Rallybio’s existing focus on hematology, and aligns with its mission to accelerate the development of life-transforming therapies for patients with severe and rare disorders.

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"With our strong focus on portfolio expansion, the in-licensing of RLYB331, our first as a public company, marks a pivotal moment for Rallybio. We believe RLYB331 is differentiated from all programs in clinical development based on its mechanism of action, with the potential to be first-in-class. We expect that RLYB331 may address a significant unmet need by correcting ineffective erythropoiesis, improving hemoglobin, reducing red blood cell transfusions and reducing iron overload in multiple hematological disorders such as beta thalassemia and myelodysplastic syndromes," said Martin Mackay, Ph.D., Chief Executive Officer of Rallybio. "This product candidate is a natural fit with our R&D expertise and our focus on hematological disorders. Along with our existing pipeline it provides an additional opportunity to leverage our deep expertise in rare diseases and to identify and accelerate the development of transformative therapies for patients with severe and rare diseases. We look forward to integrating RLYB331 into our portfolio and ultimately deliver this therapy to transform the treatment of patients with severe benign hematological disorders."

RLYB331 is a monoclonal antibody that inhibits Matriptase-2 (MTP-2). The inhibition of MTP-2 significantly increases levels of hepcidin, decreases iron load and treats ineffective erythropoiesis. The standard of care for many such hematological disorders leaves a significant unmet need in iron overload associated anemias with patients experiencing significant morbidity and consequent mortality.

Rallybio plans to prosecute preclinical activities for RLYB331 including CMC, and dose-range finding and toxicity studies, which will then support transition of the asset into clinical development.

Under the terms of the license agreement, Rallybio will make an upfront cash payment of $3 million to Sanofi, in addition to development and commercial milestones, and mid to high single digit royalties on net sales.

On MAY 9, 2022 PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to discovering, developing and commercialising highly differentiated medicines for devastating diseases, reported that, in connection with the $50 million share buyback programme announced on 5 May 2022, it is now commencing purchases of the Company’s ordinary shares of one pence each ("Ordinary Shares") (the "Programme") (Press release, PureTech Health, MAY 9, 2022, View Source [SID1234613864]). The Programme will be carried out in tranches and is in line with the Company’s previously announced capital allocation strategy to balance investment in the continued growth of its business with potential returns of capital to shareholders.1

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PureTech plans to execute the buyback in two tranches. In respect of the first tranche, PureTech announces that it has entered into an irrevocable non-discretionary instruction with Jefferies International Limited ("Jefferies") in relation to the purchase by Jefferies, acting as principal during the period commencing on 9 May 2022 and ending on the earlier of exhaustion of funds associated with the first tranche or 8 May 2023 (subject to any regulatory objections or concerns), of Ordinary Shares for an aggregate consideration (excluding expenses) of no greater than $25 million and the simultaneous on-sale of such Ordinary Shares by Jefferies to PureTech. Jefferies will make its trading decisions in relation to the Ordinary Shares independently of, and uninfluenced by, the Company. Purchases may continue during any close period to which the Company is subject. It is anticipated that the second tranche, subject to a separate instruction, will commence promptly on completion of the first tranche, subject to renewal of the requisite authority at the 2022 AGM.

The maximum number of Ordinary Shares that can be purchased under the first tranche of the Programme is 28,589,874 Ordinary Shares (being the maximum number of shares the Company is authorised to purchase pursuant to the authority granted by shareholders at the Company’s annual general meeting held on May 27, 2021).

The purpose of the Programme is to return capital to shareholders in line with the Company’s capital allocation strategy and to enable the Company to meet obligations arising from employee share option programmes, or other allocations of shares to employees of the Company or to members of the administrative, management or supervisory bodies of the Company, or an associate of the Company. Any shares repurchased for this purpose will be held in treasury.

Any purchase of Ordinary Shares under the first tranche of the Programme will be carried out on the London Stock Exchange and any other UK recognised investment exchange which may be agreed, in accordance with pre-set parameters and in accordance with, and subject to limits, including those limits related to daily volume and price, prescribed by the Company’s general authority to repurchase Ordinary Shares granted by its shareholders at its most recent annual general meeting on May 27, 2021, Chapter 12 of the Financial Conduct Authority’s UK Listing Rules, Article 5(1) of Regulation (EU) No. 596/2014 (as incorporated into UK domestic law by the European Union (Withdrawal) Act 2018) and Commission Delegated Regulation (EU) 2016/1052 (as incorporated into UK domestic law by the European Union (Withdrawal) Act 2018).

PureTech will announce any market repurchases of Ordinary Shares no later than 7.30 a.m. BST on the business day following the calendar day on which the repurchase occurred.

On May 9, 2022 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported financial results and operational updates for the quarter ended March 31, 2022 (Press release, ORIC Pharmaceuticals, MAY 9, 2022, View Source [SID1234613920]).

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"We continue to make steady progress in advancing our pipeline of novel oncology candidates," said Jacob M. Chacko, MD, chief executive officer, "We expect to report initial data from our three ongoing studies in the first half of 2023, which includes our Phase 1b single agent trials for ORIC-533, our orally bioavailable CD73 inhibitor, ORIC-114, our brain penetrant EGFR/HER2 inhibitor, and ORIC-944, our embryonic ectoderm development (EED) inhibitor."

First Quarter 2022 and Other Recent Highlights

Preclinical Data Presented at AACR (Free AACR Whitepaper): In April 2022, ORIC disclosed new preclinical data in three poster presentations and one oral presentation at the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.

ORIC-533: Oral Small Molecule CD73 Inhibitor
ORIC-533 is a highly potent, orally bioavailable small molecule inhibitor of CD73 that has demonstrated more potent adenosine inhibition in preclinical studies compared to an antibody approach and other small molecule inhibitors of the adenosine pathway. In preclinical studies, ORIC-533 overcame immune suppression and triggered significant lysis and cell death of multiple myeloma cells in an assay comprised of autologous bone marrow microenvironment. A Phase 1b trial with ORIC-533 as a single agent in multiple myeloma is enrolling patients, and the company expects to report initial Phase 1b data from this trial in the first half of 2023.

ORIC-114: EGFR/HER2 Inhibitor
ORIC-114 is a brain penetrant, orally bioavailable, irreversible inhibitor designed to selectively target EGFR and HER2 with high potency against exon 20 insertion mutations. In preclinical studies, ORIC-114 achieved tumor regressions in an EGFR exon 20 NSCLC model with superior efficacy relative to CLN-081 and demonstrated greater anti-tumor activity compared to mobocertinib (TAK-788) in an intracranial NSCLC model. A Phase 1b trial with ORIC-114 as a single agent is enrolling patients with advanced solid tumors with EGFR or HER2 exon 20 alterations or HER2 amplification and allows for patients with CNS metastases that are either treated or untreated but asymptomatic. The company expects to report initial Phase 1b data from this trial in the first half of 2023.

ORIC-944: PRC2 Inhibitor
ORIC-944 is a potent and selective allosteric inhibitor of polycomb repressive complex 2 (PRC2) that targets its regulatory embryonic ectoderm development (EED) subunit and has demonstrated single agent efficacy in multiple enzalutamide-resistant prostate cancer models in preclinical studies. A Phase 1b trial with ORIC-944 as a single agent is enrolling patients with metastatic prostate cancer, and the company expects to report initial Phase 1b data from this trial in the first half of 2023.

PLK4 Inhibitor Program
In March, the company announced a small molecule therapeutic program intended to address a mechanism of innate resistance found in a subset of breast cancers, specifically a synthetic lethal interaction of polo-like kinase 4 (PLK4) inhibition in tumors bearing a TRIM37 DNA amplification. ORIC discovered novel, potent, orally bioavailable small molecule inhibitors of PLK4 that are highly selective and achieved strong anti-tumor activity of TRIM37 high xenograft tumors, with corresponding pharmacodynamic effects and no body weight loss. The PLK4 inhibitor program is currently in lead optimization.

Anticipated Program Milestones

ORIC anticipates the following upcoming milestones:

ORIC-533: Initial Phase 1b data in 1H 2023
ORIC-114: Initial Phase 1b data in 1H 2023
ORIC-944: Initial Phase 1b data in 1H 2023
First Quarter 2022 Financial Results

Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments totaled $256.2 million as of March 31, 2022, which the company expects will fund its current operating plan into the second half of 2024.
R&D Expenses: Research and development (R&D) expenses were $16.8 million for the three months ended March 31, 2022, compared to $11.7 million for the same period in 2021, an increase of $5.1 million. The increase was primarily driven by an increase in external expenses related to the advancement of ORIC-533, ORIC-114, ORIC-944 and our other product candidates of $4.6 million, offset by a decrease in ORIC-101 costs of $0.7 million due to the discontinuation of the program in the first quarter of 2022. Higher internal expenses related to higher personnel costs, including additional non-cash stock-based compensation of $0.5 million, also contributed to the increase in research and development expenses.
G&A Expenses: General and administrative (G&A) expenses were $6.4 million for the three months ended March 31, 2022, compared to $4.9 million for the same period in 2021, an increase of $1.6 million. The increase was primarily due to higher personnel costs, including additional non-cash stock-based compensation of $0.7 million.

On May 9, 2022 Labcorp (NYSE: LH), a leading global life sciences company, and AtlantiCare, the largest health care organization in southern New Jersey, reported that they have closed a transaction to expand their long-term strategic relationship (Press release, LabCorp, MAY 9, 2022, View Source [SID1234613936]). Labcorp will acquire select assets from AtlantiCare’s clinical outreach business, which serves the AtlantiCare Physician Group and Affiliated Physicians and their patients across southern New Jersey. The transaction is the latest in a series of new and expanded collaborations between Labcorp and health systems across the country, demonstrating the value that Labcorp brings to improve laboratory services and help enhance patient care.

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"Labcorp is keenly focused on delivering value to our health system partners, physicians, and the broader community," said Bill Haas, senior vice president of Labcorp’s Northeast Division. "Our multi-year, comprehensive relationship with AtlantiCare is a prime example of that focus. Through this enhanced outreach relationship, Labcorp is furthering its commitment to AtlantiCare’s patients and providers to improve health and improve lives in the region, including through increased diagnostic testing access."

AtlantiCare’s patients will be able to access Labcorp’s expansive test menu and services through the company’s extensive network of patient service centers including Labcorp at Walgreens. Many of AtlantiCare’s physician office phlebotomy sites and outpatient collection services will now be operated by Labcorp.

"As a health system, we are committed to evolving the care and services we provide," said Lori Herndon, MBA, BSN, RN, president and CEO of AtlantiCare. "Our past collaboration with Labcorp has helped us provide comprehensive testing services to meet the growing needs of our community. Most recently, this has included Labcorp’s ability to provide critical testing, collections, lab equipment and supplies throughout the pandemic. This collaboration will enhance the breadth and quality of laboratory services patients and healthcare providers have come to expect from both of our organizations."