On July 27, 2022 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported that it will host a conference call on August 8, 2022, at 8:30 AM Eastern Time to discuss results for its second quarter ended June 30, 2022 (Press release, Delcath Systems, JUL 27, 2022, View Source [SID1234617000]).

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!

Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. (PRNewsfoto/Delcath Systems, Inc.)

Conference Call Information

To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call.

On July 27, 2022 Pharma Mar Group (MSE: PHM) reported total revenues of €101.4 million at 30 June 2022, up 3% year-on-year. Of total revenues, recurring revenues (sales plus royalties) continued to grow due to the strong performance of the oncology business, rising 5% to €86.7m in the first half. Of these revenues, net sales of Yondelis totalled €35.9 million at 30 June (Press release, PharmaMar, JUL 27, 2022, View Sourcepharmamar-group-reports-results-for-the-first-half-of-2022/" target="_blank" title="View Sourcepharmamar-group-reports-results-for-the-first-half-of-2022/" rel="nofollow">View Source [SID1234617016]). It is important to note that gross sales of Yondelis grew 6% in the first six months of the year and that it was price pressure in Europe which brought net sales of Yondelis to the same level as in the first half of last year.

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!

Sales of raw material to our partners, both for Yondelis and Zepzelca, increased notably in the first half of the year to €15.4 million, 54% more than in the same period of the previous year. This growth is mainly due to increased demand for Yondelis from Pharma Mar’s new partners in territories other than the US and Japan.

Zepzelca revenues from the early access programme in Europe totalled €11.1 million in the first six months of the year. This amount reflects the new law regulating in France the prices of drugs offered under the Temporary Authorisation for Use (ATU) system, which has led to significant discounts for those drugs.

This discount is the reason why, despite the increase in the number of patients treated with Zepzelca in the early access programme, revenues in the first half were below the €15.8 million of the first half of last year.

Royalty revenues totalled €21.5 million1 at 30 June, up 24% year-on-year.

Non-recurring revenues from licensing agreements amounted to €14.7 million at 30 June 2022 (€16.3 million at June 2021). This income corresponds to the recognition in revenues of the amounts received in 2020 as a result of the Zepzelca license agreement with Jazz Pharmaceuticals ($300 million), which are being recognized in the income statement based on the degree of progress with contractual commitments.

PharmaMar Group R&D investment in the first six months of the year increased by 39% to €40.3 million as a result of the progress in the various development areas, where, among other earlier trials, the company is currently conducting four Phase IIIs. Oncology is the area with the highest investment, with a total of €33.3 million euro, compared with €24.4 million in the same period of the previous year.

At 30 June, the PharmaMar Group generated €35.2 million in cash from operating activities. As a result, the Group’s cash and cash equivalents position increased to €251.5 million as of June 30 2022, compared with €212.6 million at the end of 2021. For its part, the company’s financial debt has been reduced by 10% compared to December 2021 and stands at €41.0 million, the Group’s lowest level of debt in more than 20 years. Thus, net cash has grown by 26% since the beginning of the year to €210.5 million.

As a result, PharmaMar Group obtained a net profit of €34.9 million in the first half.

Earnings videoconference call for analysts and investors

PharmaMar will host a videoconference for analysts and investors on Thursday 28 July 2022 at 13:00h (CET). The numbers to connect to the conference call are: +34 91 901 16 44 (from Spain), +1 646 664 1960 (from the US or Canada) or +44 20 3936 2999 (other countries). Participants’ access code: 307798

The videoconference and its recording can also be accessed via the following link: View Source on PharmaMar’s website, by visiting the Events Calendar section of the company’s website View Source

1 As our partner, Jazz Pharmaceuticals, has not yet reported its financial results for the first half of 2022, the royalties recorded in the first half of this year are an estimation based on our available information.

On July 27, 2022 Transcenta Holding Limited ("Transcenta") (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, reported that the interim safety and efficacy data of dose expansion cohort from the phase I study of TST001, a humanized anti-Claudin18.2 monoclonal antibody, in combination with Capecitabine and Oxaliplatin (CAPOX) as a first line treatment of advanced G/GEJ cancer will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022, which will be held on September 9-13, 2022 (Press release, Transcenta, JUL 27, 2022, View Source;301594398.html [SID1234617032]). Details will be provided upon Embargo release later.

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!

About TST001

TST001 is a high affinity humanized anti-Claudin18.2 monoclonal antibody with enhanced antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) activities and potent anti-tumor activities in tumor xenograft models. TST001 is the second Claudin18.2 targeting antibody therapeutic candidate being developed globally. TST001 is generated using Transcenta’s Immune Tolerance Breaking Technology (IMTB) platform. TST001 kills Claudin18.2 expressing tumor cells by mechanisms of antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). Leveraging advanced bioprocessing technology, the fucose content of TST001 was significantly reduced during the production, which further enhanced NK cells mediated ADCC activity of TST001. Clinical trials for TST001 are ongoing in China and US (NCT04396821, NCT04495296/CTR20201281). TST001 was granted Orphan Drug Designation in the US by FDA for the treatment of patients with gastric cancer or gastroesophageal junction (GC/GEJ).

On July 27, 2022 Celularity Inc. (Nasdaq: CELU) ("Celularity"), a clinical-stage biotechnology company developing placental-derived off-the-shelf allogeneic cell therapies, reported that the first patient has been treated with CYNK-101, a novel allogeneic off-the-shelf human placental CD34+ stem cell derived NK cell therapeutic candidate that is genetically modified to express high-affinity and cleavage-resistant CD16 (FCGRIIIA) variant to enhance antibody-dependent cell-mediated cytotoxicity (ADCC) (Press release, Celularity, JUL 27, 2022, View Source;utm_medium=rss&utm_campaign=treatment-of-first-patient-in-phase-1-2a-clinical-trial-for-nk-cell-therapy-cynk-101-in-development-for-the-first-line-treatment-of-advanced-her2-positive-gastric-and-gastroesophageal-junction-cancers [SID1234616983]). Earlier this year, CYNK-101 was granted both a Fast Track Designation and an Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of human epidermal growth factor receptor 2 (HER2) positive G/GEJ 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!

"It is well understood that gastric cancer has less than desirable survival outcomes," said Robert Hariri, M.D., Ph.D., Founder, Chairman and Chief Executive Officer of Celularity. "CYNK-101 is built on the foundation of our unique placental-derived source material, which as compared to other cell sources has naturally enhanced proliferative potential, or stemness, that has been shown to be a determinant of persistence and efficacy potential. Using novel genetic engineering, we enhance the ability of CYNK-101 cells to synergize with approved antibodies and provide a novel, potentially non-cross resistant therapy that we believe will be effective in improving the lives of patients with G/GEJ cancers as well as a broad range of other indications."

Dr. Darren Sigal, head of the gastrointestinal cancer section at The Scripps Cancer Research Institute, commented, "The dosing of the first patient in Celularity CYNK-101 gastric cancer program is an exciting milestone in the clinical development of cell therapies in solid tumors. NK cells possess inherent direct anti-solid tumor activity, recruit non-cross resistant anti-tumor T cells, and may induce memory T cells for long-term anti-cancer immune surveillance."

Dr. Martin Gutierrez, principal investigator and Chief of Thoracic Oncology at John Theurer Cancer Center – Hackensack Meridian Health who treated the first patient said, "We believe NK cells are poised to be the key components of multipronged therapeutic strategies for cancer. It is our understanding that we administered what is the highest dose of allogeneic NK cells so far over a 21-day period. Those cells were derived from human placental hematopoietic stem/progenitor cells and genetically modified to express a variant of CD16 to enable high affinity and enhance antibody dependent cell mediated cytotoxicity. We administered 36 X 106 transduced CYNK-101/kg weekly for four weeks in combination with pembrolizumab and trastuzumab to a patient with Her2 positive gastroesophageal carcinoma. All infusions occurred in the outpatient setting."

Phase 1/2a Clinical Trial of CYNK-101 in Gastric Cancer

CYNK-101 is currently being investigated in the Phase 1 portion of a multicenter Phase 1/2a clinical trial to evaluate the safety and preliminary efficacy of CYNK-101 in combination with trastuzumab and pembrolizumab, as a first-line treatment in patients with locally advanced unresectable or metastatic HER2 positive gastric/gastroesophageal (G/GEJ) adenocarcinoma. This study is utilizing a 3+3 open label design and will evaluate two escalating dosing cohort levels of CYNK-101 in combination with rhIL2 following an initial induction and lymphodepletion regimen. Once the maximum tolerated dose or recommended Phase 2 dose is determined in Phase 1, the Phase 2a portion of the study will commence (NCT05207722).

About Gastric Cancer

Gastric cancer is the fifth most common cancer worldwide. Advanced gastric cancer remains one of the hardest to cure, with a median overall survival (OS) of 10–12 months and a five-year OS of about 5–20%. Approximately 22% of patients with advanced gastric cancer have human epidermal growth factor receptor 2 (HER2) overexpression or amplification.

About CYNK-101

Celularity’s therapeutic candidate based on its placental-derived genetically modified NK cell type is CYNK-101, an allogeneic, off-the-shelf human placental CD34+-derived NK cell product genetically modified to express high-affinity and cleavage-resistant CD16 (FCGRIIIA) variant to drive antibody-dependent cell-mediated cytotoxicity. Currently CYNK-101 is being developed as a treatment in combination with standard chemotherapy, trastuzumab and pembrolizumab for HER2 positive overexpressing gastric or gastroesophageal junction adenocarcinoma. The safety and efficacy of CYNK-101 have not been established, and CYNK-101 has not been approved for any use by the FDA or any other analogous regulatory authority.

On July 27, 2022 Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as "Dr. Reddy’s") reported the launch of Bortezomib for Injection 3.5 mg, the generic equivalent of Velcade (bortezomib) Injection, in the U.S. market approved by the U.S. Food and Drug Administration (USFDA) (Press release, Dr Reddy’s, JUL 27, 2022, View Source [SID1234617001]).

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 Velcade Brand and generic had U.S. sales of approximately $1.2 billion MAT for the most recent twelve months ending in May 2022 according to IQVIA Health*.

Dr. Reddy’s Bortezomib for Injection, is supplied in a 3.5 mg per 10 mL single-dose vial presentation for subcutaneous (SQ) or intravenous (IV) use.

Velcade is a trademark of Takeda Pharmaceuticals U.S.A., Inc.

*IQVIA Retail and Non-Retail MAT May 2022

RDY-0722-430