On February 7, 2024 Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") reported that it will participate in and present at Oppenheimer’s 34th Annual Healthcare Life Sciences Conference, which will be held virtually. Summit will present on Wednesday, February 14, 2024, at 2:40PM ET (Press release, Summit Therapeutics, FEB 7, 2024, View Source [SID1234639927]). Dr. Maky Zanganeh, Chief Executive Officer and President, and Robert W. Duggan, Chairman and Chief Executive Officer, will present on behalf of our organization and provide details regarding the development of our innovative investigational bispecific antibody, ivonescimab.

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The presentation will be available live from our website: www.smmttx.com. An archived version will be available on our website following the presentation.

About Ivonescimab

Ivonescimab, known as SMT112 in Summit’s license territories, the United States, Canada, Europe, and Japan, and as AK112 in China and Australia, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with higher affinity when in the presence of both PD-1 and VEGF.

This could differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. Ivonescimab’s tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the tumor microenvironment with over 18-fold increased binding affinity to PD-1 in the presence of VEGF in vitro, and over 4-times increased binding affinity to VEGF in the presence of PD-1 in vitro (Zhong, et al, SITC (Free SITC Whitepaper), 2023). This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of this design is to improve upon previously established efficacy thresholds, in addition to side effects and safety profiles associated with these targets.

Ivonescimab was discovered by Akeso Inc. (HKEX Code: 9926.HK) and is currently engaged in multiple Phase III clinical trials. Summit has begun its clinical development of ivonescimab in NSCLC, commencing enrollment in 2023 in its two Phase III clinical trials. Over 1,600 patients have been treated with ivonescimab in clinical studies.

On February 7, 2024 MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, reported the publication of extensive work describing preclinical studies for lead candidate THIO in small cell lung cancer (SCLC) in the peer-reviewed scientific journal Nature Communications (Press release, MAIA Biotechnology, FEB 7, 2024, View Source [SID1234639926]). The reported findings from the research, conducted in collaboration with the University of Texas Southwestern (UTSW) scientists, led by corresponding author Dr. Esra Akbay, demonstrate the immune-enhancing, metastasis-reducing effects of MAIA’s telomere-targeting agent THIO (6TdG) in several well-characterized in vitro and in vivo models of SCLC.

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"This publication highlights a rather unique dual mechanism of action for THIO as a first-in-clinic telomere-targeted anticancer agent for potential treatment of SCLC," said Sergei M. Gryaznov, PhD., MAIA’s Chief Scientific Officer. "In addition to the direct and potent cancer cell depletion activity, the observed specific interferons stimulation, immune responses-enhancement, and metastasis-reducing effects of THIO provide solid scientific foundation for further advancement of this compound in clinical development."

A prominent characteristic of lung cancer small cells is their reliance on telomerase activity, a key enzyme essential for the continuous proliferation of SCLC. While 85-90% of all human cancers are telomerase positive, SCLCs are nearly all telomerase positive1, suggesting that telomerase targeting may be an effective strategy in the treatment of SCLC.

Key findings in the published paper include:

Human and mouse SCLC lines are sensitive to THIO (6TdG) treatment in vitro and in vivo
THIO decreases cancer initiating cells and diminishes tumor initiation potential in vitro and in vivo
Low doses of THIO are effective in treating metastatic mouse SCLC tumors
THIO activates type-I interferon pathway through cGAS-STING signaling
THIO is highly effective in combination with ionizing radiation treatment regiments
"With few, if any, effective treatments for small cell lung cancer, there is a widespread need for innovative therapeutic strategies. The positive outcomes reported in our publication show THIO’s potential as a new therapeutic approach," said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. "THIO already holds Orphan Drug Designation for SCLC, underscoring the FDA’s recognition of THIO’s potential to improve outcomes for this highly lethal disease. With the positive preclinical and clinical data we have obtained to date for THIO, we have entered the Phase 2 planning stage for a clinical trial of THIO in SCLC along with two other cancers."

Orphan Products Development grants orphan designation status to drugs and biologics that are intended for the treatment, diagnosis or prevention of rare diseases, or conditions that affect fewer than 200,000 people in the U.S. Orphan Drug Designation provides certain benefits, including financial incentives, to support clinical development and the potential for up to seven years of market exclusivity for the drug for the designated orphan indication in the U.S. if the drug is ultimately approved for its designated indication.

About the Publication

Nature Communications, volume 15, article number: 672 (2024), "A telomere-targeting drug depletes cancer initiating cells and promotes anti-tumor immunity in small cell lung cancer," published 22 January 2024. Co-author disclosures included in manuscript.

About Small Cell Lung Cancer

Small cell lung cancer (SCLC) accounts for 13% of lung cancers. As the deadliest of all lung cancers, SCLC is one of the leading causes of cancer-related mortality in United States with 30,000 deaths annually. It is less common than non-small cell lung cancer (NSCLC), but is more aggressive and rapidly spreads (metastasizes) throughout the body.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleoside 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei activating both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

On February 7, 2024 Humanetics Corporation (Humanetics), a clinical-stage specialty pharmaceutical company pioneering radiation countermeasures, adjunctive oncology therapies, and pulmonary protective therapies, reported that it will present and participate in several investor and partnering conferences in February (Press release, Humanetics, FEB 7, 2024, View Source [SID1234639925]). Ronald J. Zenk, Chief Executive Officer at Humanetics, along with members of management and the board of directors, will present an overview of the company and hold one-on-one meetings with potential investors and partners at the following conferences:

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Emerging Growth Conference, February 7-8, 2024 (virtual)

The Emerging Growth Conference features companies in a wide range of growth sectors with strong management teams, innovative products and services, and focused strategy and execution. The potential audience includes tens of thousands of individual and institutional investors, investment advisors, and analysts. For more information about the Emerging Growth Conference, visit Emerging Growth Conference – EmergingGrowth.com.

Presentation Date: Wednesday, February 7, 2024
Presentation Time: 1:45-2:15 PM Eastern Time
Webcast link: View Source;tp_key=d1cd45a6dc&sti=humanetics

Oppenheimer 34th Annual Healthcare Life Sciences Conference, February 13-14, 2024 (virtual)

This conference provides investors with a broad spectrum of public and private healthcare companies spanning all major sectors of the healthcare industry: bio and specialty pharmaceuticals; biotechnology; medical devices; life science tools and diagnostics; healthcare information technology and distribution; and healthcare providers and servicers.

Presentation date: Tuesday, February 13, 2024
Presentation time: 3:20-3:50 PM Eastern Time
Webcast link: View Source

BIO CEO & Investor Conference, February 26-27, 2024, New York, NY

Sponsored by the Biotechnology Industry Organization (BIO), the BIO CEO & Investor Conference is one of the largest investor conferences focused on established and emerging publicly traded, late-stage private biotech companies. Event registration: Register for the BIO CEO & Investor Conference.

Presentation date: Tuesday, February 26, 2024
Presentation time: 10:15 AM Eastern Time
Presentation location: New York Marriott Marquis, Royale Room

17th Annual European Life Sciences CEO Forum, February 28-29th, 2024, Zurich, Switzerland; March 6-8, 2024 (virtual)

The conference is expected to include 400+ delegates from all life sciences sectors, with a target audience that includes corporate and financial investors/partners, banks, and advisors. There will be a global company showcase of 50+ presentations by established public, private, emerging, and seed companies offering innovative solutions and seeking investment and partnering opportunities. This will include a limited number of live presentations on dedicated presentation tracks, alongside virtual company showcases available on demand during the virtual week. For more information, visit About the 17th Annual European Life Sciences CEO Forum (sachsforum.com).
Presentation location: Zurich Hilton Zurich Airport Hotel

On February 7, 2024 Delta-Fly Pharma reported that following the previous information on Jan. 5th. in 2024, we are excited to share our latest development status (Press release, Delta-Fly Pharma, FEB 7, 2024, View Source [SID1234639924]).

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A Phase I clinical dose-finding study of DFP-14927 in patients with solid tumors has been completed at MD Anderson Cancer Center and the University of California, Los Angeles in the United States. Subsequently, the concentration of DFP-10917, the active component of DFP-14927, delivering into cancer tissue in patients treated with DFP-14927 is being measured to confirm PK/PD relationship for the clinical efficacy of DFP-14927.

On 6th Feb. 2024, we are pleased to announce that we have submitted an abstract to the 2024 ASCO (Free ASCO Whitepaper) annual meeting to be held from May 31st this year in Chicago.

DFP-14927 is an amide bond of DFP-10917 to a carboxylic acid at the end of polyethylene glycol (PEG) with a molecular weight of 40,000, and it is extremely stable in human blood after intravenous administration, allowing for weekly treatment regimen. DFP-14927 is a drug delivery system (DDS) with a mechanism that allows selective release of DFP-10917 into cancer tissues by amidolysis of proteases that are highly expressed in them.

Compared to high molecular weight antibody-drug conjugates (ADCs), medium-sized PEG covalent conjugates are known to have retention in blood vessels around cancer and cancer cell membranes and higher permeability into tumors, and therefore, the concentration of DFP-10917 in cancer tissue can be measured by conventional analysis without the use of radioisotope technology.

Soon after the expected effective concentration of DFP-10917 in cancer tissue is confirmed in the study, we plan to conduct an expanded Phase I study, equivalent to a Phase II clinical trial, in patients with colorectal cancer who have failed existing approved drugs.

The composition of matter patent for DFP-14927 has been granted in the United States, Europe, Asian countries and others, which will enable global marketing of DFP-14927.

In collaboration with leading oncology hospitals in the U.S., we are considering the development of DFP-14927 in haematological cancers such as acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) in addition to solid tumors.

For our future global development and marketing strategy, we are considering collaboration with a major global pharmaceutical company that has strength and expertise in the oncology.

On February 7, 2024 I-Mab (the "Company") (NASDAQ: IMAB), a global biotech company exclusively focused on bringing highly differentiated immunotherapies and biologics for cancer treatment to patients around the world, reported that as part of its strategy to become a U.S.-based biotech, its Chinese subsidiaries have entered into definitive agreements with I-Mab Biopharma (Hangzhou) Co., Ltd. (the "Hangzhou Company"), an unconsolidated affiliate of the Company, and a group of China-based investors to divest the Company’s assets and business operations in China (Press release, I-Mab Biopharma, FEB 7, 2024, View Source [SID1234639923]).

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"This agreement to divest our operations in China marks an important milestone for I-Mab in bringing a greater focus on the U.S. and ex-China markets," said Raj Kannan, Director and Chief Executive Officer of I-Mab. "Importantly, we believe that this transaction allows us to reduce significant operational costs and enables us to reallocate our capital on current key priorities and new potential opportunities in further strengthening our portfolio while maintaining a strong balance sheet."

Pursuant to the definitive agreements, the Company will transfer 100% of the outstanding equity interest in I-Mab Biopharma Co., Ltd. ("I-Mab Shanghai"), a wholly owned subsidiary of the Company that operates the Company’s business in China, on a cash-free and debt-free basis, to the Hangzhou Company for an aggregate consideration of the RMB equivalent of up to US$80 million, contingent on the Hangzhou Company group’s achievement of certain future regulatory and sales-based milestone events. The Company also retains a right of first negotiation outside of Greater China related to three future investigational new drug candidates.

The definitive agreements also provide that the Company’s wholly owned subsidiary, I-Mab Biopharma Hong Kong Limited ("I-Mab Hong Kong"), will transfer the equity interests it holds in the Hangzhou Company to certain participating shareholders of the Hangzhou Company in exchange for extinguishment of the existing repurchase obligations owed by I-Mab Hong Kong to those shareholders in the amount of approximately US$183 million. The total amount of potential repurchase obligations owed by I-Mab Hong Kong and the Company to the non-participating shareholders of the Hangzhou Company upon the closing of the transaction is expected to range from US$30 million to US$35 million, an amount that includes actual or potential claims in legal proceedings by the non-participating shareholders against I-Mab Hong Kong and the Company in connection with the aforementioned transaction.

The Special Committee to the Board of Directors (the "Board") of the Company, consisting of Mr. Conor Chia-hung Yang, Dr. Ruyi He, and Mr. Shuai Chen, each of whom is an independent and disinterested director of the Board, led the evaluation and negotiation of the transaction on behalf of the Company. Kroll, LLC served as an independent financial advisor to the special committee and issued a fairness opinion. The Board, acting upon the unanimous recommendation of the special committee, resolved that the proposed transaction is in the best interest of I-Mab and is fair from a financial point of view to the Company and approved the transaction. The transaction is subject to closing conditions and is expected to close by the end of March 2024.

Once the transaction is completed, the Hangzhou Company will acquire I-Mab drug assets in China, including the Greater China rights for eftansomatropin alfa, felzartamab, uliledlimab, givastomig, and lemzoparlimab; bear all future development costs of these assets; and be responsible for the operations of the research & development (R&D) center of I-Mab Shanghai and the manufacturing facility of the Hangzhou Company.

Concurrent with the entry into definitive agreements and to support the ongoing strategic partnership, the Company participated in the Series C fundraising of the Hangzhou Company for an equity interest subscription of US$19 million in cash. Immediately after the closing of the transaction, the Company will directly and through I-Mab Hong Kong own a total of less than 10% of the Hangzhou Company’s registered capital.

To further its transition to a U.S.-based biotech company, I-Mab announced certain management and personnel changes. Pamela Klein, M.D., has accepted the appointment as the Interim Chairperson of the Company, as Jingwu Zang, M.D., Ph.D., steps down from the Board, effective February 10, 2024, to lead the Hangzhou Company. Andrew Zhu, M.D., Ph.D., will step down from the Board and resign from his executive position with the Company, effective February 10, 2024. Furthermore, Mr. Joseph Skelton has been appointed by the Board to serve as the Company’s Chief Financial Officer, effective February 5, 2024, succeeding Mr. Richard Yeh, who resigned from the Board and his executive positions with the Company. Mr. Skelton brings nearly ten years of experience in investment banking and has advised on transactions with an aggregate transaction value of more than US$20 billion. Mr. Skelton most recently served as a Senior Vice President at Truist Securities, covering the biopharma sector, and previously held roles at Cantor Fitzgerald and Amneal Pharmaceuticals, Inc.

"I want to express my gratitude to Dr. Zang for his unwavering commitment to I-Mab and wish him the greatest of success as he transitions to leading the Hangzhou Company. I also want to take the opportunity to thank Dr. Zhu for his leadership in advancing our pipeline assets and to Mr. Yeh for his contributions and service," Mr. Kannan continued. "I’m pleased to welcome Mr. Skelton and look forward to partnering with him in realizing the potential of our Company to bring innovative medicines to the patients we serve."

Dr. Klein’s appointment as Interim Chairperson of the Board advances I-Mab’s plan of becoming a U.S.-based biotech. "I am delighted with the opportunity to lead the Board as I-Mab continues to progress on its strategic plan. My deep appreciation goes to Dr. Zang, Dr. Zhu, and Mr. Yeh for their dedicated service on the board," Dr. Klein commented.