On April 25, 2022 Silence Therapeutics plc (Nasdaq: SLN), a leader in the discovery, development and delivery of novel short interfering ribonucleic acid (siRNA) therapeutics for the treatment of diseases with significant unmet medical need, reported that it will receive a $2.0 million cash payment from Hansoh Pharmaceutical Group Company Limited ("Hansoh") following the achievement of an undisclosed preclinical milestone (Press release, Silence Therapeutics, APR 25, 2022, View Source [SID1234612911]).

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Silence and Hansoh entered a collaboration in October 2021 to develop siRNAs leveraging Silence’s proprietary mRNAi GOLD platform for three undisclosed targets. Under the terms of the agreement, Silence has exclusive rights to the first two targets in all territories except the China region (Greater China, Hong Kong, Macau and Taiwan). Hansoh has the exclusive option to license rights to those two targets in the China region and global rights to the third target.

Hansoh made a $16 million upfront payment to Silence and Silence is eligible to receive up to $1.3 billion in additional development, regulatory and commercial milestones. This marks the first research milestone achieved under the collaboration. Silence is also eligible to receive royalties tiered from low double-digit to mid-teens on Hansoh net product sales.

On April 25, 2022 Quantum Leap Healthcare Collaborative (Quantum Leap) and Ambrx Biopharma Inc., or Ambrx, (NYSE: AMAM), a clinical stage biopharmaceutical company using an expanded genetic code technology platform to create Engineered Precision Biologics, reported the selection of Ambrx’s antibody drug conjugate (ADC) ARX788 for a new investigational treatment arm in the I-SPY 2.2 TRIAL for the treatment of HER2-positive breast cancer in the neoadjuvant setting (Press release, Ambrx, APR 25, 2022, View Source [SID1234612928]). Sponsored by Quantum Leap, the I-SPY 2.2 TRIAL is a continuation of the I-SPY 2 TRIAL that seeks to create personalized treatments by adapting therapies for each patient to optimize the clinical outcome.

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"We are particularly excited about this collaboration," stated Dr. Laura J. Esserman, MD, MBA, Director of the Breast Care Center at the UCSF Helen Diller Family Comprehensive Cancer Center, and Principal Investigator of I-SPY Family of Trials. "We hope this will usher in an era of more targeted, effective and less toxic therapies for people with HER2-positive breast cancers, leveraging decades of investment in science and drug development, and delivering better treatment to patients when they need it most. This is the right drug, for the right patient at the right time."

I-SPY 2.2 is an adaptive Phase 2 clinical trial that evaluates emerging targeted agents, allowing those agents to either be combined with less toxic chemotherapeutic regimens or to replace cytotoxic chemotherapy entirely. ARX788 will be evaluated as a monotherapy, and in combination with the PD-1 targeting checkpoint inhibitor cemiplimab, in HER2-positive early-stage breast cancer in the neoadjuvant setting. Ambrx anticipates the ARX788 arms to begin enrolling patients in May 2022.

Quantum Leap, sponsor of the I-SPY 2.2 TRIAL, leads a pre-competitive consortium that includes the U.S. Food & Drug Administration (FDA), industry, patient advocates, philanthropic sponsors, and clinicians from more than 16 major U.S. cancer research centers.

"I am thrilled that Quantum Leap has selected Ambrx’s antibody drug conjugate, ARX788, to be evaluated in the I-SPY 2.2 TRIAL," said Feng Tian, Ph.D., Chairman of the Board, President, and CEO of Ambrx. "We are encouraged by the favorable anti-tumor activity and safety profile of ARX788 for the treatment of early-stage breast cancer. It may provide a less toxic treatment option for patients through the precision conjugation of cytotoxic payloads targeting HER2 receptors. I look forward to collaborating with Quantum Leap and exploring the potential of our antibody drug conjugate in enabling effective chemo-free therapeutic treatments to patients."

ARX788 is an anti-HER2 antibody drug conjugate (ADC) that is being studied broadly in breast cancer, gastric/GEJ cancer and other solid tumors. ARX788 is a homogeneous and highly stable ADC that maximizes potential anti-tumor activity by optimizing the number and position of its payloads and the chemical bonds that conjugate the payloads to the antibody. The United States Food and Drug Administration (FDA) has granted ARX788 the Fast Track Designation for the treatment of HER2-positive metastatic breast cancer.

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.

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"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.

On April 25, 2022 Sorrento Therapeutics, Inc. (NASDAQ: SRNE, "Sorrento") reported that Dr. Henry Ji, Chairman and CEO of Sorrento and Executive Chairman of Scilex Holding Company ("Scilex"), will participate in the B. Riley Virtual Neuro & Opthalmology Healthcare Conference at 10:00AM ET on April 27, 2022 (Press release, Sorrento Therapeutics, APR 25, 2022, View Source [SID1234612912]). Live audio of the event can be accessed by visiting the "Events" page of Sorrento’s website at sorrentotherapeutics.com. Dr. Henry Ji will present on the Neuroscience programs and pipeline for Sorrento and Scilex.

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B. Riley 2022 Virtual Neuro & Opthalmology Healthcare Conference
Presentation will be available on April 27-28, 2022
Presentation Time: 10:00AM – 10:30AM ET or 7:00AM – 7:30AM PT
Webcast Link: View Source
An updated corporate presentation will also be available at www.sorrentotherapeutics.com

Scilex Holding Company and Vickers Vantage Corp. I (Nasdaq: VCKA) ("VCKA"), a special purpose acquisition company sponsored by Vickers Venture Fund VI Pte Ltd and Vickers Venture Fund VI (Plan) Pte Ltd, entered into a definitive business combination agreement ("BCA") on March 17, 2022. Upon the closing of the transaction, the combined company (the "Combined Company") will be renamed Scilex Holding Company, and its common stock is expected to be listed on Nasdaq under the ticker symbol "SCLX". The boards of directors of each of VCKA, Scilex and Sorrento have unanimously approved the proposed transaction. The closing of the transaction, which is expected to occur by the third quarter of 2022, is subject to the approval of VCKA’s shareholders and the satisfaction or waiver of certain other customary closing conditions.

A corporate presentation describing Scilex’s development plans can be found at www.scilexholding.com.

On April 25, 2022 Orca Bio, a clinical-stage biotechnology company developing purified, high-precision cell therapies for the treatment of cancer, genetic blood disorders and autoimmune diseases, reported that positive new data were presented at the 2022 Transplantation & Cellular Therapy ASTCT and CIBMTR Tandem Meetings in Salt Lake City, Utah (Press release, Orca Bio, APR 25, 2022, View Source [SID1234612929]).

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The new data on Orca Bio’s lead investigational high-precision cell therapy, Orca-T, include updated results from 137 patients with hematologic malignancies, which continued to show an increase in overall survival rates and a reduction of acute and chronic graft versus host disease (GvHD) compared to standard of care; positive outcomes in a subset of patients with myelofibrosis who received Orca-T; and new analyses demonstrating Orca Bio’s manufacturing platform is reliable, robust and scalable.

"These data from an expanded group of patients are very encouraging and demonstrate that Orca-T appears to improve survival while reducing GvHD. This could be a compelling option for patients battling serious hematological malignancies who currently face devastating transplant-related risks," said Everett Meyer, M.D., Ph.D., primary investigator. "These results, combined with the reliable and centralized Orca-T manufacturing, could potentially transform treatment options for patients and physicians."

Orca Bio presented pooled data from 137 patients in the single-center Phase 2 and multi-center Phase 1b trials of Orca-T with acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and myelodysplastic syndromes (MDS), with at least 100 days of follow-up and a median of 341 days. For comparison purposes, an independent CIBMTR-based control arm was identified, consisting of similar patients with hematologic malignancies who received a standard of care allogeneic hematopoietic stem cell transplant ("alloHSCT") over a similar timeframe. Results demonstrated that:

Rates of moderate-to-severe chronic GvHD were low among Orca-T recipients, occurring in only 5% of patients at one year compared to 38% who received a standard alloHSCT.
GvHD-free, relapse-free survival (GRFS) was 71% at one year for Orca-T patients compared to 21% in the CIBMTR-based control arm.
The overall survival for patients who received Orca-T was 90% at one year compared to 68% in the CIBMTR-based control arm.
Additionally, Orca Bio presented findings from a manufacturing reliability analysis of 100 Orca-T products in the Phase 1b trial. All investigational cell therapies were manufactured at Orca Bio’s cGMP facility in Sacramento, CA, and transplant centers and donor sites were located across the U.S. All products were successfully delivered and infused to patients within 72 hours or less.

"We produce a unique batch of drug for each patient who receives an Orca-T product, and this drug is made up of fresh, living cells that need to be infused on an extremely rapid timeline," said Nate Fernhoff, Ph.D., co-founder and chief scientific officer at Orca Bio. "Reliable and scalable manufacturing have been integral to the development of our therapies since day one. These results not only show that Orca-T continues to reduce GvHD and improve survival rates over time, but that we have maintained the ability to reliably manufacture, deliver and infuse all patients in a timely manner regardless of donor and patient location. This is an important indication of our ability to potentially deliver this therapy urgently and seamlessly to patients in need."

In a separate poster, Orca Bio presented updated data on the treatment impact of Orca-T in 12 patients with myelofibrosis compared to nine patients who received a standard of care alloHSCT. Orca-T recipients had lower incidence of acute and chronic GvHD (33% with Orca-T versus 100% with alloHSCT) and the data suggest Orca-T was well-tolerated. Treatment with Orca-T resulted in engraftment with regression of marrow fibrosis, indicating potential efficacy for the treatment of myelofibrosis.

Based on the favorable results of the Phase 1b and 2 clinical trials, a randomized registrational Phase 3 trial evaluating Orca-T against standard of care alloHSCT, named Precision-T, is now open. More details will be announced in the coming weeks.

Links to the abstracts follow:

Title: Orca-T Demonstrates Encouraging Overall Survival, Gvhd Reduction, and Tolerability in Patients with Hematologic Malignancies
Poster Number: 412

Title: Outcomes for Myelofibrosis Patients Following Myeloablative Allogeneic Stem Cell Transplantation Using the Orca-T Graft from HLA-Matched Related and Unrelated Donors
Poster Number: 413

Title: Manufacture and Distribution of High-Precision Orca-T Is Reliable, Robust, and Scalable
Poster Number: 415

About Orca-T
Orca-T is an investigational high-precision allogeneic cellular therapy consisting of infusions containing regulatory T-cells, conventional T-cells and CD34+ stem cells derived from peripheral blood from either related or unrelated matched donors. Orca-T has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration and is being studied to treat multiple hematologic malignancies.