On March 30, 2023 ImmunoPrecise Antibodies Ltd. (NASDAQ: IPA) ("ImmunoPrecise" or "IPA" or the "Company") an AI-driven biotherapeutic research and technology company reported a research collaboration and exclusive option license agreement with Xyphos Biosciences, Inc. (a wholly owned subsidiary of Astellas Pharma Inc., "Astellas") (Press release, ImmunoPrecise Antibodies, MAR 30, 2023, View Source [SID1234629684]). Under the terms of the agreement, the companies will jointly conduct research activities to identify and optimize proprietary LENSai in silico generated antibodies, targeting an undisclosed target in the tumor microenvironment (TME), as potential therapeutic development candidates. Targeting this molecule has the potential to markedly enhance anti-tumor immunity with other Astellas therapies including chimeric antigen receptor-based (CAR) technologies. Astellas will have the exclusive option to license any development candidates generated as part of the collaboration.

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!

"We are proud to build upon the robust in silico antibody discovery capabilities developed by our team at BioStrand. Their LENSai software and core HYFT Index are uniquely positioned to analyze targets and design antibodies directed at otherwise challenging oncological proteins, especially those that mediate immune suppression in the TME," stated Dr. Jennifer Bath, President and CEO of IPA. "Third-party due diligence continues to support the industry’s excitement of recent BioStrand developments and the potential of LENSai to accelerate the discovery of more precise next-generation cancer therapies. We are excited to collaborate with Astellas to advance our joint mission of bringing safer and more effective treatments to patients in need."

Targeting this molecule in the TME with antibody therapeutics is a novel approach with no antibodies in clinical development. Developing next-generation checkpoint inhibitor immunotherapies using new modalities is promising as an innovative healthcare solution. Through this collaboration we expect to stimulate a highly specific and targeted attack on cancer cells by optimizing these development candidates and leveraging Astellas’ flexible convertibleCAR cell therapy technology.

On March 30, 2023 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a biopharmaceutical company focused on the localized treatment of solid tumors, reported that it will present detailed, open label, planned Phase III interim data analysis of its innovative RenovoGem therapy for pancreatic cancer patients at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting on April 17, 2023 in Orlando, Florida (Press release, Renovorx, MAR 30, 2023, View Source [SID1234629683]).

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 interim analysis shows a 6-month median overall survival benefit for patients. That is nearly a 60% improvement versus the study control arm and current standard of care: intravenous (IV) administration of gemcitabine and nab-paclitaxel for locally advanced pancreatic cancer ("LAPC"). RenovoGem patients also had greater than 65% reduction in adverse events. These can include nausea, fatigue, and a decline in white blood cells.

TIGeR-PaC study Principal Investigator, Michael J. Pishvaian, M.D., Ph.D. at Johns Hopkins Medicine, said, "Results from the interim analysis echo the Phase I/II data and observational studies. The TIGeR-PaC clinical trial is ongoing, but it appears RenovoGem enhances patient survival and has fewer side effects than the standard of care treatment that impacts the entire body of a patient rather than the targeted treatment area. This is important because treatment of LAPC is often limited to systemic, high dose, IV chemotherapy. It often has debilitating side effects."

Dr. Pishvaian added, "These positive results offer hope for a compelling new treatment option that could greatly benefit this important patient population and perhaps many others as the research advances."

Ramtin Agah, MD, Chief Medical Officer and Founder of RenovoRx, said, "This planned, early interim data analysis is a critical look into our Phase III randomized study. When you compare the results with other approved and widely adopted drugs used for treatment of pancreatic cancer, our six-month median survival benefit is dramatically better than other options currently available. It is worth noting that ten years ago, Celgene announced positive, Phase III trial results for pancreatic cancer patients. Its Abraxane drug, plus gemcitabine, provided an overall survival benefit of seven weeks."

"As a result, we will be advancing discussions with the FDA about expediting forward progress, while continuing our current trial enrollment," said Dr. Agah.

RenovoRx CEO, Shaun Bagai, commented, "We are more than a third way through our Phase III TIGeR-PaC study and are encouraged by these data. Every extra day these patients enjoy is invaluable. With decreased adverse events, the six-month survival benefit we are reporting is even more profound."

Mr. Bagai added, "We believe the current standard of care needs a disruptive therapy like RenovoGem. There is a growing consensus our platform has the potential to impact other cancers and more advanced cancer stages. Consequently, we are evaluating RenovoGem for additional indications and having ongoing discussions with possible strategic partner oncology companies."

About TIGeR-PaC Interim Analysis Data

TIGeR-PaC is a randomized multi-center Phase III open label clinical trial designed to investigate the Company’s first product candidate, RenovoGem, which utilizes RenovoRx’s proprietary therapy platform, RenovoTAMP, to provide targeted intra-arterial delivery of FDA-approved chemotherapy, gemcitabine, to treat LAPC following SBRT. The study is comparing treatment with RenovoGem versus standard of care treatment.

In this interim analysis, the control and treatment arms demonstrated divergence in median overall survival for patients. The study is designed to randomize 114 patients (57 in each arm) with all patients receiving upfront induction chemotherapy and SBRT. The TIGeR-PaC Data Monitoring Committee ("DMC") met and determined the interim data is promising and warrants continuation of this pivotal trial. As of the date of the analysis, 45 patients from U.S. sites had been randomized in this trial and the survival status of all subjects was used for the analysis.

Twenty-three patients were randomized to intra-arterial gemcitabine (RenovoGem investigational treatment) arm and 22 to continuation of IV gemcitabine and nab-paclitaxel (standard of care control) arm.
The median overall survival in the IV gemcitabine and nab-paclitaxel control arm was 10 months, versus 16 months in the intra-arterial RenovoGem arm from time of randomization. (NOTE: Both arms’ median overall survival calculations do not include 4 to 5-months of life from diagnosis to randomization during the induction chemotherapy and radiation phase of the trial).
Observed a positive trend in median overall survival by 24-weeks (6 months); in this interim analysis, the statistical significance was not reached to stop the study early (p=0.051).
Observed that patients had greater than 65% reduction in adverse events compared to the control arm: In the IV gemcitabine and nab-paclitaxel control arm there were 11 reported Serious Adverse Events (out of 22 patients) vs. 4 reported Serious Adverse Events (out of 23) intra-arterial RenovoGem patients.
The second interim analysis of this Phase III trial is expected in mid-2024.

About Locally Advanced Pancreatic Cancer (LAPC)

According to American Cancer Society’s Cancer Facts & Figures 2023, Pancreatic cancer has a 5-year combined overall survival rate of 12% (Stages I-IV) and is on track to be the second leading cause of cancer-related deaths before 2030. LAPC is diagnosed when the disease has not spread far beyond pancreas, however, has advanced to the point where it cannot be surgically removed. LAPC is typically associated with patients in stage 3 of the disease as determined by the TNM (tumor, nodes and metastasis) grading system.

About RenovoGem

RenovoGem is the first drug-device combination product candidate that utilizes the RenovoTAMP therapy platform via pressure-mediated delivery technology to deliver gemcitabine, an FDA-approved systemic chemotherapy, locally across the arterial wall to bathe tumor tissue in the chemotherapy. RenovoGem is currently being evaluated in the Phase III TIGeR-PaC clinical trial study in Locally Advanced Pancreatic Cancer (LAPC) patients. The Company plans to investigate RenovoGem in extrahepatic Cholangiocarcinoma (eCCA) in a clinical trial, which is anticipated to begin in the first half of 2023. RenovoGem is currently under investigation for the intra-arterial delivery of gemcitabine and has not been approved for commercial sale.

On March 30, 2023 RenovoRx, Inc. (the "Company") (Nasdaq: RNXT), a biopharmaceutical company focused on the localized treatment of solid tumors, reported that it has entered into a definitive securities purchase agreement with a certain institutional investor for the purchase and sale of 1,557,632 shares of the Company’s common stock (or common stock equivalents) at a purchase price of $3.21 per share of common stock (or common stock equivalent) in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Renovorx, MAR 30, 2023, View Source [SID1234629682]). The closing of the offering is expected to occur on or about April 3, 2023, subject to the satisfaction of customary closing conditions.

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!

In addition, in a concurrent private placement, the Company will issue to the investors warrants to purchase up to 1,947,040 shares of common stock. The warrants have an exercise price of $3.21 per share, will be exercisable immediately and will have a term of five and one-half years.

Roth Capital Partners is acting as the exclusive placement agent for the offering.

The gross proceeds to the Company from this offering are expected to be approximately $5 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering for working capital and other general corporate purposes.

The securities in the offering described above (but not the warrants issued in the concurrent private placement or the shares of common stock underlying the warrants) are being offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-268302) previously filed with the Securities and Exchange Commission (the "SEC") and declared effective by the SEC on November 21, 2022. The offering is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement, relating to the offering that will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting Roth Capital Partners, LLC at 888 San Clemente Drive, Newport Beach CA 92660, by phone at (800) 678-9147.

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall 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 the registration or qualification under the securities laws of any such state or other jurisdiction.

On March 30, 2023 Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, reported its full year 2022 audited financial results (Press release, Legend Biotech, MAR 30, 2023, View Source [SID1234629681]).

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!

"2022 was a year of significant milestones for Legend Biotech, marked by the regulatory approvals of CARVYKTI in the U.S., Europe, and Japan. In addition to launching our first commercial product, we advanced our clinical development program for cilta-cel, obtained FDA clearances on two investigational new drug applications targeting solid tumors, and critically, expanded our commercial infrastructure and manufacturing capabilities to support future growth" said Ying Huang, Chief Executive Officer of Legend Biotech.

"Our teams across the entire business delivered exceptionally during an incredibly busy year. Looking forward, we remain focused on the continued expansion of our manufacturing footprint and advancing our clinical program in order to bring CARVYKTI to more eligible patients."

Second Half 2022 Highlights and Recent Events

On January 27, 2023, Legend Biotech announced that CARTITUDE-4, the Phase 3 study evaluating CARVYKTI (ciltacabtagene autoleucel) for the treatment of adult patients with relapsed and lenalidomide-refractory multiple myeloma, met its primary endpoint of showing a statistically significant improvement in progression-free survival (PFS) compared to standard therapy at the study’s first pre-specified interim analysis

On January 2, 2023, Legend Biotech announced that China’s National Medical Products Administration (NMPA) has formally accepted the New Drug Application (NDA) for ciltacabtagene autoleucel (cilta-cel)

On November 21, 2022, Legend Biotech announced that the U.S. Food and Drug Administration (FDA) cleared Legend Biotech’s Investigational New Drug (IND) application to proceed with the clinical development of LB2102, an investigational, autologous chimeric antigen receptor T-cell (CAR-T) therapy for the treatment of adult patients with extensive stage small cell lung cancer (SCLC)

On September 27, 2022, Legend Biotech announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) approved CARVYKTI (ciltacabtagene autoleucel) for the treatment of adults with relapsed or refractory multiple myeloma, limited to cases meeting both of the following conditions: patients have no history of CAR-positive T cell infusion therapy targeting BCMA; and patients have received three or more lines of therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody, and in whom multiple myeloma has not responded to or has relapsed following the most recent therapy
Financial Results for Year Ended December 31, 2022

Cash and Cash Equivalents, Time Deposits, and Short-Term Investments

As of December 31, 2022, Legend Biotech had approximately $1.0 billion of cash and cash equivalents, time deposits, and short-term investments.

Revenue

Revenue for the year ended December 31, 2022 was $117.0 million compared to $68.8 million for the year ended December 31, 2021. The increase of $48.2 million was due to product sales for the commercial launch of CARVYKTI in the U.S. in connection with Legend Biotech’s collaboration agreement with Janssen Biotech, Inc. (the "Janssen Agreement").

Research and Development Expenses

Research and development expenses for the year ended December 31, 2022 were $335.6 million compared to $313.3 million for the year ended December 31, 2021. This increase of $22.3 million was primarily due to continued investment in cilta-cel for earlier lines of therapies and increase in Legend Biotech’s pipeline expenditures as it filed two Investigational New Drug applications and began preparation for Phase 1 clinical development in the U.S. in the year ended December 31, 2022.

Administrative Expenses

Administrative expenses for the year ended December 31, 2022 were $80.6 million compared to $47.0 million for the year ended December 31, 2021. The increase of $33.7 million was primarily due to the final phase of separation of certain information technology services from GenScript Biotech Corporation, required enhancements for cybersecurity and privacy, along with the required information technology infrastructure build to support manufacturing facilities.

Selling and Distribution Expenses

Selling and distribution expenses for the year ended December 31, 2022 were $93.4 million compared to $102.5 million for the year ended December 31, 2021. This increase of $9.1 million was primarily due to costs associated with the commercialization of CARVYKTI.

Other Income and Gains

Other income and gains for the year ended December 31, 2022 were $12.0 million compared to $3.1 million for the year ended December 31, 2021. The increase of $8.9 million was primarily due to increase in interest income, government grants and fair value gain from financial assets.

Other Expenses

Other expenses for the year ended December 31, 2022 were $9.8 million compared to $9.1 million for the year ended December 31, 2021. The increase was primarily due to foreign currency exchange loss in the year.

Finance Costs

Finance costs for the year ended December 31, 2022 were $10.8 million compared to $0.9 million for the year ended December 31, 2021. The increase was primarily due to interest on advance funding, which is interest-bearing borrowings funded by Janssen under the Janssen Agreement and constituted by principal and applicable interests upon such principal. Legend Biotech elected to borrow an incremental $130.3 million as of December 31, 2022 in accordance with the terms of the Janssen Agreement.

Fair Value Gain of Warrant Liability

Fair value gain of warrant liability for the year ended December 31, 2022 was $20.9 million caused by changes in the fair value of a warrant that Legend Biotech issued to an institutional investor through a private placement transaction in May 2021 with an initial fair value of $81.7 million at the issuance date. The warrant was assessed as a financial liability with a fair value of $67.0 million as of December 31, 2022.

Loss for the Period

For the year ended December 31, 2022, net loss was $446.3 million, or $1.40 per share, compared to a net loss of $403.6 million, or $1.43 per share, for the year ended December 31, 2021.

On March 30, 2023 OmniAb, Inc. (NASDAQ: OABI) reported financial results for the three and 12 months ended December 31, 2022, and provided operating and partner program updates (Press release, OmniAb, MAR 30, 2023, View Source [SID1234629680]).

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!

"Following the closing of the spin-off and business combination transactions last November, OmniAb is well-positioned for continued growth by offering cutting-edge antibody discovery platforms and complementary technologies," said Matt Foehr, Chief Executive Officer of OmniAb. "Leveraging a rich heritage of innovations designed to facilitate the discovery of novel therapeutics including those targeting ion channels and transporters, OmniAb is at the forefront of antibody discovery with the industry’s only four-species platform facilitating fully human and bispecific antibody discovery, supported by a highly dedicated staff and world-class scientific and business advisors.

"2022 was another terrific year for the business as we added a record-high 13 new partnerships and our partners continued to increase their number of programs. We are excited about the future as we leverage our highly scalable business model and invest in our technologies," he added. "We are planning to introduce new technologies and innovations later this year as we serve current partners and add new ones, while enhancing our best-in-class technology stack."

On November 1, 2022, OmniAb completed a spin-off from Ligand Pharmaceuticals Incorporated (NASDAQ: LGND), resulting in OmniAb becoming an independent publicly traded company. Financial results prior to November 1, 2022, are presented on a carve-out basis derived from Ligand’s historical accounting records, as if OmniAb were an independent company.

Fourth Quarter 2022 Financial Results

Revenue for the fourth quarter of 2022 was $35.3 million, compared with $15.3 million for the same period in 2021, with the increase primarily attributable to the recognition of a $25.0 million milestone payment related to the first commercial sale of TECVAYLI (teclistamab) in the U.S. OmniAb expects to recognize a $10.0 million milestone payment related to the first commercial sale in the European Union (EU) in 2023.

Research and development expense was $12.9 million for the fourth quarter of 2022, compared with $11.0 million for the same period in 2021, with the increase primarily due to investments in facilities, headcount and technology innovation. General and administrative expense was $10.2 million for the fourth quarter of 2022, compared with $4.3 million for the same period in 2021, with the increase primarily due to higher headcount related to becoming an independent publicly traded company.

Net income for the fourth quarter of 2022 was $6.8 million, or $0.07 per diluted share, compared with a net loss of $3.1 million, or $0.04 per share, for the same period in 2021.

Full Year 2022 Financial Results

Revenue for 2022 was $59.1 million, compared with $34.7 million for 2021, with the increase attributable to the recognition of the $25.0 million TECVAYLI (teclistamab) milestone payment following the first commercial sale in the U.S. and royalty revenue from our partners’ sales of zimberelimab and sugemalimab.

Research and development expense for 2022 was $48.4 million, compared with $39.2 million for 2021, with the increase primarily due to continued investments in facilities, headcount and technology innovation. General and administrative expense for 2022 was $24.9 million, compared with $16.9 million for 2021, with the increase primarily due to expenses associated with the spin-off and business combination, as well as headcount-related expenditures as we prepared to become an independent public company.

Net loss for 2022 was $22.3 million, or $0.26 per share, compared with a net loss of $27.0 million, or $0.33 per share, for 2021. Cash used to fund operating activities was $3.6 million for 2022.

As of December 31, 2022, OmniAb had cash, cash equivalents and short-term investments of $88.3 million. Subsequent to the close of the year, in January 2023 OmniAb received $35.0 million in milestone payments from Janssen related to TECVAYLI (teclistamab). The current cash, cash equivalents and short-term investments balance, along with the cash the Company generates from operations are expected to be sufficient to fund operations for the foreseeable future. The Company expects its 2023 year-end cash, cash equivalents and short-term investments balance to be slightly higher than year-end 2022.

Fourth Quarter 2022 and Recent Business Highlights

In 2022, the company signed 13 new licenses, including one in the fourth quarter with the Wistar Institute. In addition, during the quarter three new programs entered the clinic: M9140 (Merck KGaA), an antibody-drug conjugate anti-CEACAM5 in advanced solid tumors; GEN1053 (Genmab/BioNTech), a hexabody anti-CD27 in malignant solid tumors; and JNJ-79635322 (Janssen), a trispecific in relapsed or refractory multiple myeloma. As of December 31, 2022, the company had 69 active partners with 26 OmniAb-derived programs in clinical development or being commercialized, and a total of 291 programs being pursued or commercialized.

During the quarter, OmniAb entered into an agreement with mAbsolve Ltd. for STR, mAbsolve’s Fc-silencing platform technology. The agreement provides OmniAb with exclusive, sublicensable right to incorporate the STR technology with antibodies that have been generated using OmniAb’s antibody discovery platform.

Fourth quarter 2022 and recent partner highlights include the following:

TECVAYLI (teclistamab)

Janssen Biotech, Inc. received approval from the U.S. Food and Drug Administration for TECVAYLI (teclistamab) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy.
Batoclimab

Immunovant announced initiation of a Phase 3 clinical trial of batoclimab in thyroid eye disease and a Phase 2b clinical trial in chronic inflammatory demyelinating polyneuropathy.
Sugemalimab

EQRx announced the Marketing Authorization Applications for sugemalimab in combination with chemotherapy for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) were accepted for review by both the Medicines and Healthcare products Regulatory Agency in the United Kingdom and the European Medicines Agency for the EU.
CStone announced the National Medical Products Administration of China accepted the supplemental new drug application (sNDA) for sugemalimab in combination with chemotherapy as a first-line treatment of unresectable locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma. The sNDA is based on the GEMSTONE-303 study, in which sugemalimab in combination with chemotherapy as a first-line treatment for unresectable locally advanced or metastatic gastric adenocarcinoma/gastro-esophageal junction adenocarcinoma with PD-L1 expression ≥5% met one of its primary endpoints, progression-free survival. CStone also announced topline results from the GEMSTONE-304 study, in which sugemalimab in combination with chemotherapy as a first-line treatment of unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma met its primary endpoints.
Zimberelimab

Gilead Sciences and Arcus Biosciences announced positive results from the fourth interim analysis of the ARC-7 study in patients with first-line, metastatic NSCLC with PD-L1 tumor proportion score ≥50% without epidermal growth factor receptor or anaplastic lymphoma kinase mutations. ARC-7 is a Phase 2 multicenter, three-arm, randomized, open-label study evaluating the combinations of Fc-silent anti-TIGIT monoclonal antibody domvanalimab plus anti-PD-1 monoclonal antibody zimberelimab (doublet) and domvanalimab plus zimberelimab and etrumadenant, an A2a/b adenosine receptor antagonist (triplet), versus zimberelimab monotherapy.