On May 6, 2022 Hoffmann-La Roche reported investors and analysts to participate in our virtual event on Monday, 6 June 2022, highlighting Roche data presented during the congress scientific program from June 3 – 7 2022 and our early-stage oncology portfolio (Press release, Hoffmann-La Roche, MAY 6, 2022, View Source [SID1234613757]).

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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

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The webinar will start with a presentation, followed by a Q&A session (live access to the speakers). The slides will be available for download at 15:00 CEST on the day of the event. > click here

On May 5, 2022 Phosplatin Therapeutics Inc., a clinical stage pharmaceutical company focused on oncology therapeutics, reported that the Company has changed its name to Promontory Therapeutics Inc. ("Promontory") (Press release, Promontory Therapeutics, MAY 5, 2022, View Source [SID1234615801]). The new name reflects the Company’s growth and evolution, and its goal to become the leading company within oncology therapeutics advancing small molecule immunotherapies.

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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

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"Our new corporate identity is aspirational, as we continue our growth and research and development efforts because we believe that small molecule immunotherapy has arrived, and that we are leaders within this area of cancer care," said Robert Fallon, Promontory President and Chief Executive Officer. "Through our internal work, coupled with our ongoing collaborations with global leaders in the field, we’ve developed unique insight into the development of highly-differentiated small molecule immunogenic agents, including our lead therapeutic candidate, PT-112."

Promontory is led by a strong management team, board of directors, and Scientific Advisory Board with in-depth industry knowledge. The company’s lead agent, PT-112, is a small molecule therapeutic agent that promotes immunogenic cell death (ICD), a rare form of cancer cell death based upon the release of damage associated molecular patterns (DAMPs), which engage specific pattern recognition receptors on dendritic cells that promote the adaptive anti-cancer immune response. PT-112’s highly potent induction of ICD has been validated in relevant cancer models and the drug is currently being studied in three Phase 2 trials for metastatic castration-resistant prostate cancer, thymoma and thymic carcinoma, and in combination with PD-L1 checkpoint inhibitor avelumab for non-small cell lung cancer.

To learn more about Promontory Therapeutics’ mission, as well as PT-112 visit promontorytx.com.

On May 5, 2022 Novartis reported the European Commission (EC) has approved Jakavi (ruxolitinib) for the treatment of patients aged 12 years and older with acute or chronic GvHD who have inadequate response to corticosteroids or other systemic therapies (Press release, Novartis, MAY 5, 2022, View Source [SID1234614189]).

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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

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"Today, 30-60% of patients with GvHD do not respond to first-line steroid treatment, underscoring the need for new approaches to ensure long-term treatment goals are met," said Dr. Robert Zeiser, University Hospital Freiburg, Department of Haematology, Oncology and Stem Cell Transplantation, Freiburg, Germany. "The approval of Jakavi offers healthcare providers and patients with GvHD who remain dependent on or refractory to steroids a new way to manage this debilitating and life-threatening condition."

The approval of Jakavi follows the positive opinion granted in March by the Committee for Medicinal Products for Human Use of the European Medicines Agency, based on the Phase III REACH2 and REACH3 trials in which Jakavi demonstrated superiority in overall response rate (ORR) compared to best available therapy (BAT). Results of REACH2 showed 62% ORR with Jakavi at Day 28, compared to 39% for BAT; and REACH3 demonstrated a significantly improved ORR at week 24 (50% vs. 26%) with a higher best ORR (76% vs. 60%) vs. BAT, among steroid-refractory/dependent chronic GvHD patients2,3.

"Five out of ten patients who receive allogeneic stem cell transplants experience the serious and sometimes fatal symptoms of graft-versus-host disease," says Marie-France Tschudin, Novartis President of Innovative Medicines International and Chief Commercial Officer. "Jakavi, with this new indication in GvHD, will help to redefine treatment for patients who do not respond to first-line care."

GvHD occurs when donor cells see the recipient’s healthy cells as foreign and attack them. Symptoms of GvHD can appear in the skin, gastrointestinal tract, liver, mouth, eyes, genitals, lungs and joints. Approximately 50% of allogeneic stem cell transplant recipients will develop either acute or chronic GvHD. Both acute and chronic GvHD can be fatal and until now both have lacked an established standard of care for patients who do not adequately respond to first-line steroid treatment1,4-9. Currently, there are no other approved therapies for the treatment of GvHD after steroid failures1,2.

About Jakavi (ruxolitinib)
Jakavi (ruxolitinib) is an oral inhibitor of the JAK 1 and JAK 2 tyrosine kinases. Jakavi is approved by the European Commission for the treatment of adult patients with polycythemia vera (PV) who are resistant to or intolerant of hydroxyurea and for the treatment of disease- related splenomegaly or symptoms in adult patients with primary myelofibrosis (MF) (also known as chronic idiopathic MF), post-polycythemia vera MF or post-essential thrombocythemia MF, and also for patients aged 12 years and older with acute or chronic GvHD who have inadequate response to corticosteroids or other systemic therapies. Jakavi is approved in over 100 countries for patients with MF, including EU countries, Switzerland, Canada, Japan and in more than 85 countries for patients with PV, including EU countries, Switzerland, Japan and Canada. The exact indication for Jakavi varies by country. Additional worldwide regulatory filings are underway in MF and PV.

Novartis licensed ruxolitinib from Incyte for development and commercialization outside the United States. Ruxolitinib is marketed in the United States by Incyte as Jakafi for adults with PV who have had an inadequate response to or are intolerant of hydroxyurea, for adults with intermediate or high-risk MF, for adult and pediatric patients 12 years and older with steroid-refractory acute GvHD, and adult and pediatric patients 12 years and older with chronic GvHD after failure of one or two lines of corticosteroids or other systemic therapy.

Jakavi is a registered trademark of Novartis AG in countries outside the United States. Jakafi is a registered trademark of Incyte. The safety and efficacy profile of Jakavi has not yet been established outside of its approved indications.

On May 5, 2022 Novartis reported a temporary, voluntary suspension of production at its radioligand therapy production sites in Ivrea, Italy and Millburn, New Jersey (Press release, Novartis, MAY 5, 2022, View Source [SID1234614187]). The company has taken this action out of an abundance of caution as it addresses potential quality issues identified in its manufacturing processes. Novartis is conducting a thorough review of the situation and currently expects to resolve the issues and resume some supply in the next six weeks.

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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

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As a result, the company is temporarily suspending delivery of Lutathera (USAN: lutetium Lu 177 dotatate; INN: lutetium (177Lu) oxodotreotide) in the US and Canada, and 177Lu-PSMA-617 (INN: lutetium (177Lu) vipivotide tetraxetan), marketed as Pluvicto (lutetium Lu 177 vipivotide tetraxetan) in the US. Some doses of Lutathera (lutetium (177Lu) oxodotreotide) will be available in Europe and Asia from Novartis radioligand therapy production site in Zaragoza, Spain, although there may be some delays in supply.

In addition, Novartis is putting a temporary hold on screening and enrollment for 177Lu-PSMA-617 clinical trials globally, and Lutathera clinical trials in the US and Canada.

Quality and patient safety are our top priorities. There is currently no indication of any risk to patients from doses previously produced at these sites. Novartis has notified treatment sites to closely monitor patients who have recently been injected and asked them to report any adverse events to Novartis patient safety.

We recognize that this situation affects patients, their families and care teams. Novartis takes this very seriously and the company is doing everything it can to resolve this issue and resume patient doses as quickly as possible. Health authorities have been informed and will receive additional updates as they are available.

On May 5, 2022 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a clinical-stage precision oncology company designing and developing novel targeted therapies for cancer treatment, reported that it has entered into an exclusive license agreement with LaNova Medicines Limited (LaNova) to develop and commercialize LM-302, a novel antibody drug conjugate (ADC) targeting Claudin18.2, in the U.S. and rest of the world, excluding Greater China and South Korea (Press release, Turning Point Therapeutics, MAY 5, 2022, View Source [SID1234614124]). Claudin18.2 is a protein expressed in many gastrointestinal cancers, including gastric, gastroesophageal junction and pancreatic cancer. LM-302, which going forward will be identified as TPX-4589, is currently in Phase 1 clinical trials in both the U.S. and China.

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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

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Under the terms of the licensing agreement, LaNova will receive an upfront payment of $25 million and will be eligible to receive up to an additional $195 million in development and regulatory milestone payments; in addition, LaNova is eligible to receive commercial sales milestones, and tiered royalties ranging from mid-single digit to mid-teens percentages on net sales (subject to customary deductions). As part of the agreement, both parties agreed to potentially broaden the partnership by collaborating on up to three additional ADC programs.

TPX-4589 (LM-302) is a potentially first-in-class anti-Claudin18.2 ADC discovered by LaNova that suppresses cell proliferation of gastric and pancreatic cell lines with nanomolar potency in preclinical models. It also has demonstrated efficacy in gastric and pancreatic cancer xenograft models.

"We are excited to announce our first in-license as a company and strategically expand our clinical stage portfolio, specifically within GI tumors. Claudin18.2 is continuing to emerge as an important target," said Athena Countouriotis, M.D., President and Chief Executive Officer of Turning Point. "We chose TPX-4589 based on it potentially being a first-in-class ADC to target Claudin18.2 and its preclinical data that show the potential to target tumors with low and high expression levels, which we believe could be an important differentiator versus other investigational therapies."

"LaNova Medicines is focused on discovery and development of innovative medicines in oncology. We are very pleased to partner with Turning Point for LM-302, an innovative drug molecule with the potential as a novel treatment for gastric and pancreatic cancers. This partnership is an example of our discovery and development capabilities and our ambition for global innovation and patients," said Dr. Crystal Qin, Chairman and CEO of LaNova.

It is estimated that the annual incidence of gastric and gastroesophageal junction cancers in the U.S. and EU5 is approximately 27,000 and 50,000, respectively1. The estimated annual incidence of pancreatic cancer in the U.S. and EU5 is approximately 60,000 and 70,000, respectively1. Approximately 65% of patients in pancreatic2, gastric and gastroesophageal junction3 cancers have tumors that express Claudin18.2.

Webcast/Conference Call Information
Turning Point will host a webcast and conference call on May 5, 2022 at 6 p.m. ET / 3 p.m. PT to discuss this announcement. Athena Countouriotis, M.D., President and Chief Executive Officer, will host the virtual event for investors and will be joined by Kumar Srinivasan, Chief Business Officer.

The event will be accessible through the "Investors" section of www.tptherapeutics.com or by dialing (844) 256-2297 (in the United States) or (236) 714-3006 (outside the U.S.) using conference ID 8780394. A replay will be available shortly after the live event through the "Investors" section of www.tptherapeutics.com.