On January 13, 2022 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health") reported that, in connection with its previously announced intention to separate its eye health business, its wholly owned subsidiary, Bausch + Lomb Corporation ("Bausch + Lomb"), has publicly filed a Registration Statement on Form S-1 with the U.S. Securities and Exchange Commission ("SEC") and a preliminary base post-receipt pricing procedure ("PREP") prospectus with the securities regulatory authorities in each of the provinces and territories of Canada (other than Quebec) ("Canadian Regulators") relating to a proposed initial public offering ("IPO") of Bausch + Lomb’s common shares concurrently in the United States and Canada (Press release, Bausch Health, JAN 13, 2022, View Source [SID1234605449]). All of the shares being offered will be sold by a wholly owned subsidiary of Bausch Health. The number of common shares to be offered and the price range for the IPO have not yet been determined.

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Morgan Stanley and Goldman Sachs & Co. LLC are acting as joint lead book-running managers for the IPO. J.P. Morgan, Citigroup, Barclays, BofA Securities, Guggenheim Securities, Jefferies, Evercore ISI, Wells Fargo Securities and Deustche Bank Securities are acting as joint book-running managers for the IPO, and DNB Markets, HSBC and Truist Securities are acting as co-managers for the IPO.

The IPO will be made only by means of a prospectus. Copies of the prospectus and the preliminary base PREP prospectus, when available, may be obtained from Morgan Stanley & Co. LLC, Attn: Prospectus Department, 180 Varick Street, 2nd Floor, New York, N.Y. 10014 or Goldman Sachs & Co. LLC, Attn: Prospectus Department, 200 West Street, New York, N.Y. 10282, by telephone at (866) 471-2526 or by email at [email protected].

The Registration Statement relating to the proposed offering has been filed with the SEC but has not yet become effective. The preliminary base PREP prospectus contains important information relating to the common shares and remains subject to completion or amendment. The common shares may not be sold, nor may offers to buy be accepted, prior to the time the Registration Statement becomes effective, and a receipt for the final long form base PREP prospectus has been issued by the Canadian Regulators.

This news release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction. Any offers, solicitations or offers to buy, or any sales of securities will be made in accordance with the registration requirements of the Securities Act of 1933, as amended and otherwise in accordance with applicable securities laws in any other jurisdiction. The IPO is subject to market conditions, and there can be no assurance as to whether or when the IPO may be completed, or as to the actual size or terms of the IPO.

About Bausch + Lomb
Bausch + Lomb, a leading global eye health business of Bausch Health Companies, Inc., is dedicated to protecting and enhancing the gift of sight for millions of people around the world – from the moment of birth through every phase of life. Its comprehensive portfolio of more than 400 products includes contact lenses, lens care products, eye care products, ophthalmic pharmaceuticals, over-the-counter products and ophthalmic surgical devices and instruments. Founded in 1853, Bausch + Lomb has a significant global research and development, manufacturing and commercial footprint with more than 12,000 employees and a presence in nearly 100 countries. Bausch + Lomb is headquartered in Vaughan, Ontario with corporate offices in Bridgewater, New Jersey.

On January 13, 2022 BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, reported a non-exclusive clinical collaboration with Amgen Inc (Press release, BridgeBio, JAN 13, 2022, View Source [SID1234598653]). (Amgen) to evaluate the combination of BBP-398, a potentially best-in-class SHP2 inhibitor, with LUMAKRAS (sotorasib), a KRASG12C inhibitor, in patients with advanced solid tumors with the KRAS G12C mutation.

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The Phase 1/2 study will include a dose escalation period followed by dose expansion and optimization, and is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of BBP-398 in combination with LUMAKRAS. Under the terms of the non-exclusive collaboration, BridgeBio will sponsor the study and Amgen will provide a global supply of LUMAKRAS.

BBP-398 is a potent small-molecular inhibitor of SHP2 developed in collaboration with The University of Texas MD Anderson Cancer Center’s Therapeutics Discovery division. SHP2 is a protein-tyrosine phosphatase that links growth factor, cytokine and integrin signaling with the downstream RAS/ERK MAPK pathway to regulate cellular proliferation and survival. By combining SHP2 inhibition with KRASG12C inhibition in patients with the KRAS G12C mutation, there is potential that the investigational combination could prevent oncogenesis and overactive cellular proliferation.

"Overactivity of the MAPK pathway is a significant cause of many types of difficult-to-treat cancers and by combining these two agents, we aim to reduce the oncogenic potential of tumor cells," said Frank McCormick, Ph.D., chairman of oncology at BridgeBio. "Building on our collaborations with Bristol Myers Squibb and LianBio, we are excited to be working with Amgen on this new collaboration. By harnessing the power of BBP-398 as a potentially best-in-class SHP2 inhibitor with LUMAKRAS, we are hopeful that we will be able to provide substantial relief for cancer patients in need. We will continue to pursue additional collaborations that we believe hold promise for patients."

KRAS mutations occur in approximately 17% of malignant solid tumors. BBP-398, as a monotherapy or in combination with other targeted therapies, could potentially be a promising therapy for patients with the KRAS G12C mutation.

BridgeBio is currently advancing its Phase 1 clinical trial of its SHP2 inhibitor, BBP-398, in patients with solid tumors driven by mutations in the MAPK signaling pathway, including RAS and receptor tyrosine kinase genes. BBP-398 is part of BridgeBio’s growing precision oncology pipeline and is one of 14 programs in the broader portfolio that are being advanced in the clinic or commercial setting.

About BBP-398
BBP-398 is a potentially best-in-class SHP2 inhibitor. Earlier this year, BridgeBio entered a non-exclusive, co-funded clinical collaboration with Bristol Myers Squibb to evaluate the combination of BBP-398 with OPDIVO (nivolumab) in patients with advanced solid tumors with KRAS mutations. BridgeBio previously also entered into a strategic collaboration with LianBio for clinical development and commercialization of BBP-398 in combination with various agents in solid tumors such as non-small cell lung cancer, colorectal cancer and pancreatic cancer in mainland China and other major Asian markets.

On January 13, 2022 AstraZeneca reported that it will present new data in liver, biliary tract and prostate cancers illustrating its ambition to revolutionise cancer care at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI) and the 2022 ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU) (Press release, AstraZeneca, JAN 13, 2022, View Source [SID1234598652]).

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A total of 35 abstracts from AstraZeneca will be featured across the two meetings. There will be two oral presentations at ASCO (Free ASCO Whitepaper) GI taking place 20 to 22 January, and an additional two oral presentations at ASCO (Free ASCO Whitepaper) GU taking place 17 to 19 February.

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: "There is an urgent need for new effective treatment options to delay disease recurrence and improve survival for patients with advanced liver, biliary tract and prostate cancers. Our data for Imfinzi and Lynparza at these two meetings will illustrate how AstraZeneca is extending the benefits of our medicines into new areas where progress for patients has been limited."

Cristian Massacesi, Chief Medical Officer and Oncology Chief Development Officer, AstraZeneca, said: "Our data will demonstrate the potential of our medicines to transform patient outcomes in liver, biliary tract and prostate cancers. Results from HIMALAYA and TOPAZ-1 will underscore our commitment to improving long-term survival for patients with liver and biliary tract cancers, and data from PROpel will raise the bar in treating 1st-line metastatic castration-resistant prostate cancer."

Aiming to transform treatment of liver and biliary tract cancers with immunotherapy combinations at ASCO (Free ASCO Whitepaper) GI
A late-breaking presentation will feature results from the HIMALAYA Phase III trial showing a statistically significant and clinically meaningful overall survival (OS) benefit with a single priming dose of tremelimumab added to Imfinzi (durvalumab) in 1st-line unresectable liver cancer.

This trial used a novel dose and schedule called the STRIDE (Single Tremelimumab Regular Interval Durvalumab) regimen. HIMALAYA is the first Phase III trial to show that a dual immunotherapy regimen has improved OS in this setting.

A second late-breaking presentation will highlight results from the TOPAZ-1 Phase III trial for Imfinzi plus chemotherapy in advanced biliary tract cancer, which was unblinded early at an interim analysis in October 2021 due to clear evidence of efficacy.

The combination demonstrated a statistically significant and clinically meaningful OS benefit versus chemotherapy alone in 1st-line advanced biliary tract cancer, making it the first immunotherapy combination to demonstrate superior clinical outcomes over standard of care in a global, randomised trial in this setting.

Also at the meeting, the first data from Imfinzi plus bevacizumab in the Study 22 Phase II trial will provide the efficacy and safety profile of this combination in unresectable liver cancer. This regimen is being tested in the EMERALD-1 Phase III trial of transarterial chemoembolisation in combination with Imfinzi alone and with bevacizumab in patients with locoregional liver cancer, as well as in the EMERALD-2 Phase III trial with liver cancer patients who are at high risk of recurrence after curative hepatic resection or ablation.

Challenging the status quo in prostate cancer with an industry-leading PARP inhibitor at ASCO (Free ASCO Whitepaper) GU
A late-breaking presentation will showcase the results from the PROpel Phase III trial of Lynparza (olaparib) plus abiraterone, which showed the combination significantly delayed disease progression in 1st-line metastatic castration-resistant prostate cancer (mCRPC) regardless of biomarker status. Lynparza is the first PARP inhibitor to demonstrate clinical benefit in combination with a new hormonal agent in this setting.

Additionally, an oral presentation will feature the results of the BAYOU Phase II trial evaluating the combination of Lynparza and Imfinzi in unresectable, Stage IV bladder cancer. Data will show comparable efficacy of Imfinzi monotherapy to that of other immune checkpoint monotherapy data in similar trial populations and will suggest additional research into a potential role for PARP inhibition in subsets of patients with specific gene mutations.

Harnessing the potential of antibody drug conjugates across HER2-targetable cancers
At ASCO (Free ASCO Whitepaper) GI, data will include an encore presentation of the OS results of the DESTINY-Gastric01 Phase II trial of Enhertu (trastuzumab deruxtecan) in HER2-positive metastatic gastric and gastro-oesophageal junction adenocarcinoma (GEJA), and initial results from the DESTINY-Gastric03 Phase Ib/II trial in HER2-positive gastric cancer and GEJA.

In January 2021, Enhertu became the first HER2-directed medicine approved for patients with gastric cancer in a decade.

Additional Enhertu data at ASCO (Free ASCO Whitepaper) GI will include encore results from the DESTINY-CRC01 Phase II trial showing clinically meaningful activity in HER2-positive unresectable and/or metastatic colorectal cancer. The overall safety and tolerability profile of Enhertu in DESTINY-CRC01 was consistent with that seen in previously reported Enhertu trials. There are currently no medicines approved to specifically treat HER2-positive colorectal cancer.

At ASCO (Free ASCO Whitepaper) GU, results will be shared from the primary analysis of a Phase Ib trial of Enhertu in combination with nivolumab in HER2-expressing bladder cancer.

Collaboration in the scientific community is critical to improving outcomes for patients. AstraZeneca is collaborating with MSD (Merck & Co., Inc. in the US and Canada) to develop and commercialise Lynparza, and with Daiichi Sankyo Company Limited to develop and commercialise Enhertu.

Key AstraZeneca presentations during ASCO (Free ASCO Whitepaper) GI 2022

Lead author

Abstract title

Presentation details

Immuno-Oncology

Alfa-Abou, GK

Phase 3 randomized, open-label, multicenter study of tremelimumab (T) and durvalumab (D) as first-line therapy in patients (pts) with unresectable hepatocellular carcinoma (uHCC): HIMALAYA.

Abstract Presentation 3

Oral Abstract Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract

21 January 2022

17:07 – 17:17 ET

22:07 – 22:17 GMT

Oh, D-Y

A phase 3 randomized, double-blind, placebo-controlled study of durvalumab in combination with gemcitabine plus cisplatin (GemCis) in patients (pts) with advanced biliary tract cancer (BTC): TOPAZ-1.

Abstract Presentation 2

Oral Abstract Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract

21 January 2022

16:45 – 16:55 ET

21:45 – 22:55 GMT

Wang, L

A phase 3 randomized, double-blind, placebo-controlled, multicenter, global study of durvalumab with and after chemoradiotherapy in patients with locally advanced, unresectable esophageal squamous cell carcinoma: KUNLUN.

Trials in Progress Poster Session A: Cancers of the Esophagus and Stomach and Other GI Cancers

Antibody drug conjugates

Yamaguchi, K

Trastuzumab deruxtecan (T-DXd; DS-8201) in patients with HER2–positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma: Final overall survival (OS) results from a randomized, multicenter, open-label, phase 2 study (DESTINY-Gastric01).

Rapid Abstract Session A: Cancers of the Esophagus and Stomach

Janjigian, YY

Dose-escalation and dose-expansion study of trastuzumab deruxtecan (T-DXd) monotherapy and combinations in patients (pts) with advanced/metastatic HER2+ gastric cancer (GC)/gastroesophageal junction adenocarcinoma (GEJA): DESTINY-Gastric03.

Poster Session A: Cancers of the Esophagus and Stomach and Other GI Cancers

Meric-Bernstam, F

A phase 2, multicenter, open-label study evaluating trastuzumab deruxtecan (T-DXd) for the treatment of select human epidermal growth factor receptor 2 (HER2)-expressing solid tumors (DESTINY-PanTumor02).

Trials in Progress Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract

Yoshino, T

Trastuzumab deruxtecan (T-DXd; DS-8201) in patients (pts) with HER2-expressing metastatic colorectal cancer (mCRC): Final results from a phase 2, multicenter, open-label study (DESTINY-CRC01).

Rapid Abstract Session C: Cancers of the Colon, Rectum, and Anus

Raghav, KPS

Trastuzumab deruxtecan in patients with HER2-overexpressing locally advanced, unresectable, or metastatic colorectal cancer (mCRC): A randomized, multicenter, phase 2 study (DESTINY-CRC02).

Trials in Progress Poster Session C: Cancers of the Colon, Rectum, and Anus

Key AstraZeneca presentations during ASCO (Free ASCO Whitepaper) GU 2022

Lead author

Abstract title

Presentation details

Immuno-Oncology

Rosenberg, JE

BAYOU: A phase II, randomized, multicenter, double-blind, study of durvalumab (D) in combination with olaparib (O) for the first-line treatment of platinum-ineligible patients with unresectable, stage IV urothelial carcinoma (UC).

Oral Abstract Session B: Urothelial Carcinoma

18 February 2022

17:42 – 17:52 ET

22:42 – 22:52 GMT

Powles, T

A phase 3, randomized, open-label, multicenter, global study of the efficacy and safety of durvalumab (D) + tremelimumab (T) + enfortumab vedotin (EV) or D + EV for neoadjuvant treatment in cisplatin-ineligible muscle-invasive bladder cancer (MIBC) (VOLGA).

Trials in Progress Poster Session B: Urothelial Carcinoma

DNA Damage Response

Saad, F

PROpel: Phase III trial of olaparib (ola) and abiraterone (abi) versus placebo (pbo) and abi as first-line (1L) therapy for patients (pts) with metastatic castration-resistant prostate cancer (mCRPC).

Oral Abstract Session A: Prostate Cancer

17 February 2022

16:00 – 16:10 ET

21:00 – 21:10 GMT

Notes

AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

On January 13, 2022 AstraZeneca reported that has signed a collaboration agreement with Scorpion Therapeutics to discover, develop and commercialise precision medicines against previously hard-to-target cancer proteins, with the potential to transform oncology treatment (Press release, AstraZeneca, JAN 13, 2022, View Source [SID1234598651]).

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The new collaboration focuses on a class of proteins called transcription factors, which control gene expression and can regulate important cellular processes including cell growth and survival. Many transcription factors have long been identified as important targets for new cancer treatments and as drivers of disease,1 but have previously been considered ‘undruggable’ using conventional drug discovery approaches.

To overcome the challenges of targeting transcription factors and to reach underserved patient populations, the collaboration will combine Scorpion’s fully integrated discovery platform with AstraZeneca’s leadership in developing and commercialising precision medicines for cancer treatment.

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "Unlocking potentially transformative biology is pivotal for delivering the next wave of cancer treatments. Scorpion’s innovative platform is a strong strategic fit as we explore a range of new modalities across our broad drug discovery toolbox with promise to disrupt the activity of these highly-validated cancer targets."

Axel Hoos, MD, PhD, Chief Executive Officer, Scorpion, said: "We are pleased to enter into this collaboration with AstraZeneca, whose expertise in drug development and commercialisation complements our discovery platform, which leverages cutting-edge advances in cancer biology and medicinal chemistry, including chemical proteomics, structure-based drug design and machine learning. We expect this collaboration will accelerate Scorpion’s efforts to deliver the promise of ‘Precision Oncology 2.0’: optimised, transformational therapies for more patients living with cancer."

Under the terms of the collaboration agreement, Scorpion will lead discovery and certain preclinical activities. AstraZeneca has the exclusive option to licence worldwide rights for up to three drug candidates. AstraZeneca would be responsible for development and commercialisation activities worldwide following opt-in, while Scorpion would retain the option to co-develop and co-promote up to two of these programmes in the US under certain conditions, including if AstraZeneca exercises three licence options.

Financial considerations
Scorpion will receive an upfront cash payment of $75m and is eligible to receive additional success-based payments in the form of option fees and milestone payments, as well as tiered royalties on net sales ranging from mid-single digit to low-double digits.

In the event Scorpion opts into co-developing and co-promoting a nominated programme, Scorpion will participate in the operating costs and be entitled to a proportionate share of the economics in the US, subject to certain adjustments.

Notes

AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

On January 12, 2022 Lirum Therapeutics reported the company entered into a license agreement with IGF Oncology, LLC ("IGF Oncology"), for 765IGF-MTX, now named LX-101. Under the agreement, IGF Oncology has granted us an exclusive, royalty-bearing, worldwide license under certain patent rights, know-how and materials to research, develop, make, have made, formulate, use, sell, offer to sell and import LX-101 and two other earlier stage compounds, and any products containing or comprising such compounds in finished dosage pharmaceutical form, for the diagnosis, and/or treatment of any disease or condition in humans.

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We are required to pay IGF Oncology an upfront payment, which is divided into six payments. To date, Lirum has paid $1,180,378 of the upfront payment to IGF Oncology across payments made in November 2022, January 2023, July 2023, and January 2024. The next payments of the upfront payment are due as follows: (i) $200,000 plus daily compounded interest of 15% from January 12, 2024, upon the earlier of an equity financing totaling at least $10,000,000 or April 12, 2024; and (ii) $200,000 plus daily compounded interest of 15% from January 12, 2024, upon the earlier of an equity financing totaling at least $10,000,000 or July 12, 2024. In addition, IGF Oncology is eligible for milestone payments based on clinical and regulatory events, as well as for sales-based milestones. IGF Oncology is also eligible for a royalty based on all net sales, by us or our sublicensees, of products containing the licensed compound. For additional information, see the section titled "Intellectual Property".

We have licensed three patent families, including seven issued U.S. patents that we believe provide patent protection for the LX-101 composition or methods of treatment. The first licensed patent family, expiring in 2035, includes composition patents relating to proprietary fusion proteins of IGF-1 (including the IGF-1 variant of LX-101) and conjugates to anti-cancer chemotherapeutic agents (including methotrexate, the LX-101 payload), as well as methods of treating cancer with these agents. This patent family includes four issued U.S. patents, as well as issued or pending patents in Europe, Japan, Canada, Australia, and India. The second licensed patent family, expiring in 2038, covers methods of treating certain diseases including some myeloid malignancies with IGF-1R ligands conjugated to an anti-cancer chemotherapeutic agent. This patent family includes one issued U.S. patent, as well as issued and pending patents in Europe, China, Japan, Australia, Canada, India, and South Korea. The third licensed patent family, expiring in 2025 or 2026, includes composition of matter patents covering other IGF-1 variants conjugated to anti-cancer chemotherapeutic agents, as well as methods of treating cancer with these agents. This patent family includes two issued U.S. patents that protect the LX-101 composition and methods of treatment, as well as issued patents in Europe, Canada, and Japan.

Furthermore, the Company has filed two Patent Cooperation Treaty applications for methods of treating TED and other autoimmune diseases with IGF-1R ligands conjugated to disease-modifying agents. Any patent that grants from these families would have an expiration of 2043, not including future extensions. The Company has also filed two provisional patent applications for methods of treating IGF-1R-related pediatric and adult cancers with IGF-1R ligands conjugated to a cytotoxic agent. Any patent that grants from these families would have an expiration of 2044, not including future extensions.

Other patents and patent applications in the Lirum portfolio are related to IGF-1R ligands conjugated to bacterial toxins or radionuclides for the treatment of cancer expiring in 2025 or 2028 and proprietary fusion proteins of epidermal growth factor receptor ligands, conjugates to anti-cancer chemotherapeutic agents, and methods of treating cancer with these agents expiring in 2035. Lirum’s portfolio also includes three U.S. patents expiring in 2025 or 2027 covering methods of treating certain cancers with agents unrelated to LX-101.