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EpimAb Biotherapeutics Appoints Yonghong Zhu, M.D., Ph.D., as Chief Medical Officer

On June 8, 2023 EpimAb Biotherapeutics, a clinical stage biotechnology company specializing in the development of bispecific antibodies, reported the appointment of Yonghong Zhu, M.D., Ph.D., as Chief Medical Officer (CMO) (Press release, Adaptimmune, JUN 8, 2023, View Source [SID1234648260]). As CMO, Dr. Zhu will be responsible for overseeing all clinical development activities for the company’s clinical stage assets. This strategic addition to the executive team further strengthens the company’s commitment to innovation and mission of advancing cutting-edge bispecific therapies. Dr. Zhu replaces EpimAb’s previous CMO, Dr. Bin Peng, who recently retired from EpimAb after five years of service at the company.

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With around two decades of experience in the biotech industry, Dr. Zhu brings an outstanding track record and expertise that spans across early to late-stage development in oncology and immunology to EpimAb. Before joining EpimAb, Dr. Zhu was the CMO at MaxiNovel Pharmaceuticals, and prior to this, he held leadership positions in Clinical Development and Translational Medicine at Roche, Takeda and Henlius, where he made significant contributions to developing and executing overall clinical strategies, and evaluating and driving strategic collaborations. Dr. Zhu obtained his Bachelor’s and Medical Degrees (combined 7-year program) at Nanjing University Medical School, and completed his Ph.D. training in Microbiology & Immunology (Major in Virology) at the University of Rochester School of Medicine & Dentistry.

"We are excited to welcome Dr. Zhu as our new Chief Medical Officer," said Dr. Chengbin Wu, Founder and CEO of EpimAb. "His extensive knowledge in the oncology and immunology fields, plus a wealth of experience designing and leading early and late-stage clinical programs align perfectly with our vision. We are confident that Dr. Zhu’s leadership skills and expertise will accelerate our mission of developing breakthrough therapies for diseases with significant unmet need."

Dr. Zhu commented, "I am honored to join and collaborate with the dedicated team at EpimAb. With its multiple proprietary and unique platform technologies and an exceptional R&D team, EpimAb has generated several differentiated clinical programs with tremendous potential. I look forward to further advancing these programs and contributing to the future success of the company."

Lantern Pharma Leverages AI Platform, RADR®, to Develop Breakthrough Antibody Drug Conjugates (ADCs) in Collaboration with Bielefeld University

On June 08, 2023 Lantern Pharma Inc., a clinical-stage biopharmaceutical company using its proprietary RADR artificial intelligence ("AI") and machine learning ("ML") platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported it will be leveraging its AI platform, RADR, in a research collaboration with Bielefeld University (Bielefeld, Germany) to develop antibody-drug conjugates (ADCs) with high therapeutic and antitumor potential (Press release, Lantern Pharma, JUN 8, 2023, View Source [SID1234634303]). The collaboration will leverage insights from Lantern’s recently developed RADR AI ADC module in combination with research from Professor Norbert Sewald, Ph.D., the principal investigator for Bielefeld and leader of Magicbullet::reloaded, a European consortium focused on developing novel drug delivery mechanisms, including ADCs. Outcomes from the collaboration are expected to pave the way for next-generation ADCs and other drug conjugates that are designed using AI and that can be developed with potentially higher efficacy, at a faster pace, and with significantly reduced costs.

The initial aim of the collaboration will be to synthesize and evaluate novel ADCs linked to cryptophycins, which are promising antitumor molecules, in part because of their potency at ultra-low, picomolar, concentrations. The cryptophycin-ADCs will be tested across multiple cancer cell lines and initial results are expected during 2023.

"We have ample experience in structure-activity relationships of cryptophycins as well in the synthesis of ADCs and small molecule-drug conjugates (SMDCs). Teaming up with top researchers from European academia and industry in the consortium of Magicbullet::reloaded further reinforced this capacity. We now look forward to the collaboration with Lantern," said Dr. Sewald.

"Cryptophycins are an exciting family of highly potent heterocyclic peptides from Cyanobacteria that have demonstrated antitumor potency and can inhibit tumor growth by strongly interfering with microtubule stability and assembly," stated Kishor Bhatia, Ph.D., Lantern’s Chief Scientific Officer. "Dr. Sewald and his group are experts in the synthesis of cryptophycin derivatives and have established extensive groundwork to support the targeted ADC delivery of cryptophycins. By leveraging our RADR platform’s AI ADC development module and partnering with Dr. Sewald, we expect to be able to select and advance cryptophycin-ADCs towards the clinic with better targeting and therapeutic efficacy for patients with advanced cancers with limited therapeutic options," continued Dr. Bhatia.

After the initial aims of the collaboration are completed, Lantern plans to leverage its AI ADC development module, which is fully integrated into RADR, to launch multiple ADCs that can leverage cryptophycins or other promising payloads. Lantern also expects to use the AI ADC development module with other collaborators, both academic and commercial, to develop promising ADC candidates for launch into targeted clinical trials.

This AI-guided strategy has the potential to de-risk the ADC drug development process, while simultaneously enhancing the creation of effective and targeted ADCs. The rapidly growing global ADC market is currently valued at over $4.0 billion and is projected to reach $14.0 billion by 2027. There are currently 12 ADCs that have been approved by the US Food and Drug Administration (FDA) for the treatment of cancer and approximately 37 ADCs in current late-stage oncology trials.

Under the terms of the collaboration, Dr. Sewald and his group will synthesize, optimize, and provide initial testing of the cryptophycin-ADCs. Lantern is also receiving an exclusive and worldwide option to license intellectual property (IP) from Bielefeld University related to the collaboration and IP generated from the collaboration.

Ionis prices private placement of convertible senior notes

On June 8, 2023 Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) reported the pricing of $500.0 million aggregate principal amount of 1.75% Convertible Senior Notes due 2028 (the "notes") in a private placement (the "offering") to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act") (Press release, Ionis Pharmaceuticals, JUN 8, 2023, View Source [SID1234632661]). Ionis also granted the initial purchasers of the notes an option to purchase, within the 13-day period beginning on, and including, the date on which the notes are first issued, up to an additional $75.0 million aggregate principal amount of notes from Ionis. The sale of the notes is expected to close on June 12, 2023, subject to customary closing conditions.

The notes will be general unsecured obligations of Ionis, and will accrue interest payable semiannually in arrears on June 15 and December 15 of each year, beginning on December 15, 2023, at a rate of 1.75% per year. The notes will mature on June 15, 2028, unless earlier converted or repurchased.

Ionis estimates that the net proceeds from the offering will be approximately $487.6 million (or approximately $560.8 million if the initial purchasers exercise their option to purchase additional notes in full), after deducting the initial purchasers’ discounts and commissions and estimated offering expenses payable by Ionis. Ionis expects to use approximately $420.4 million of the net proceeds from the offering to repurchase $434.1 million in aggregate principal amount of its 0.125% Convertible Senior Notes due 2024 (the "2024 notes") in privately negotiated transactions. Ionis expects to use the remaining net proceeds from the offering for additional repurchases of the 2024 notes from time to time following the offering, including the repayment of any remaining 2024 notes at maturity, and for general corporate purposes.

Before March 15, 2028, holders will have the right to convert their notes only upon the satisfaction of specified conditions and during certain periods. On or after March 15, 2028 until the close of business on the second scheduled trading day immediately preceding the maturity date, holders may convert all or any portion of their notes at any time. Upon conversion, Ionis will pay or deliver, as the case may be, cash, shares of its common stock or a combination of cash and shares of its common stock, at its election. The conversion rate for the notes will initially be 18.6120 shares of Ionis’ common stock per $1,000 principal amount of notes (equivalent to an initial conversion price of approximately $53.73 per share of Ionis’ common stock). The initial conversion price represents a premium of approximately 32.5% over the last reported sale price of $40.55 per share of Ionis’ common stock on June 7, 2023. The conversion rate will be subject to adjustment in some events but will not be adjusted for any accrued or unpaid interest.

Ionis may not redeem the notes prior to June 20, 2026. Ionis may redeem for cash all or any portion of the notes (subject to certain limitations), at its option, on or after June 20, 2026 if the last reported sale price of Ionis’ common stock has been at least 130% of the conversion price for the notes then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on, and including, the trading day immediately preceding the date on which Ionis provides notice of redemption at a redemption price equal to 100% of the principal amount of the notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date. However, Ionis may not redeem less than all of the outstanding notes unless at least $100.0 million aggregate principal amount of notes are outstanding and not called for redemption as of the time Ionis sends the related notice of redemption. No sinking fund is provided for the notes.

If Ionis undergoes a "fundamental change" (as defined in the indenture that will govern the notes), then, subject to certain conditions and limited exceptions, holders may require Ionis to repurchase for cash all or any portion of their notes at a fundamental change repurchase price equal to 100% of the principal amount of the notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date. In addition, following certain corporate events that occur prior to the maturity date or if Ionis delivers a notice of redemption, Ionis will, in certain circumstances, increase the conversion rate for a holder who elects to convert its notes in connection with such a corporate event or convert its notes called (or deemed called) for redemption in connection with such notice of redemption, as the case may be.

In connection with any repurchase of the 2024 notes, Ionis expects that holders of the 2024 notes who agree to have their 2024 notes repurchased and who have hedged their equity price risk with respect to such notes (the "hedged holders") will unwind all or part of their hedge positions by buying Ionis’ common stock and/or entering into or unwinding various derivative transactions with respect to Ionis’ common stock. The amount of Ionis’ common stock to be purchased by the hedged holders or in connection with such derivative transactions may be substantial in relation to the historic average daily trading volume of Ionis’ common stock. This activity by the hedged holders may result in an increase in the effective conversion price of the notes.

The notes and any shares of Ionis’ common stock issuable upon conversion of the notes have not been and will not be registered under the Securities Act, any state securities laws or the securities laws of any other jurisdiction, and unless so registered, may not be offered or sold in the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and other applicable securities laws.

This press release is neither an offer to sell nor a solicitation of an offer to buy any of these securities nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification thereof under the securities laws of any such state or jurisdiction.

Aviko Radiopharmaceuticals and Neutron Therapeutics Form Strategic Partnership to Advance Boron Neutron Capture Therapy

On June 8, 2023 Aviko Radiopharmaceuticals, a Deerfield Management-founded biotechnology company developing medicines to unlock the potential of boron neutron capture therapy (BNCT), and Neutron Therapeutics, the leading provider of accelerator-based neutron systems for targeted radiation therapy of solid tumors, reported the formation of a strategic partnership to advance BNCT to treat cancer (Press release, Aviko Radiopharmaceuticals, JUN 8, 2023, View Source [SID1234632629]). The partnership aligns the companies’ efforts to build the first BNCT treatment center in the United States and to establish additional BNCT facilities through collaborations with premier academic medical centers.

"To bring BNCT to patients in need, it’s critical to foster collaboration among key stakeholders who are working to advance this precision medicine modality," said Dave Greenwald, Ph.D., chief executive officer of Aviko and vice president of business development at Deerfield. "This strategic partnership brings together Aviko’s expertise in drug development and Neutron’s industry-leading neutron delivery technology with the goal of improving outcomes for patients with a variety of cancers."

BNCT involves a non-toxic boron medicine that is designed to accumulate in cancer cells. The boron medicine remains inert until it is irradiated by safe, low-energy neutrons at the site of the tumor, releasing alpha particles that destroy cancerous cells. Aviko has developed a pipeline of boron medicines that exhibit properties to enable effective BNCT, including high tumor selectivity. Neutron’s nuBeam system is a comprehensive BNCT treatment suite with an accelerator that produces the highest neutron flux available in the clinical setting, leading to potentially shorter treatment times and improved patient experience.

"BNCT has demonstrated the ability to eradicate tumors in as few as one or two treatments, while minimizing damage to healthy tissue," said Elizabeth Reczek, Ph.D., chief executive officer of Neutron Therapeutics. "We’re thrilled to partner with Aviko in our efforts to expand BNCT as a treatment modality in the U.S. and globally."

Neutron has installed its nuBeam system at Helsinki University Hospital in Helsinki, Finland, and at Shonan Kamakura General Hospital in Kamakura City, Kanagawa prefecture, Japan.

"Recent innovations related to neutron acceleration have expanded the opportunities for BNCT to be used in a wide range of medical centers," said Bill Buckley, co-founder of Neutron Therapeutics and founder of New Zealand-based Buckley Systems. "This partnership is an example of how two companies can collaborate to advance a promising therapy to help patients who are in need of more effective treatment options."

Ted Smick, chief technology officer and co-founder of Neutron Therapeutics, added: "Together, Aviko and Neutron Therapeutics offer a complete solution for BNCT, enabling more medical centers to provide this powerful new treatment to patients."

Perspective Therapeutics to Present at the 2023 Annual Society for Nuclear Medicine and Molecular Imaging Conference

On June 8, 2023 Perspective Therapeutics, Inc. ("Perspective" or "the Company") (NYSE AMERICAN: CATX), a precision oncology company developing alpha-particle therapies and complementary diagnostic imaging agents and an innovator in seed brachytherapy treatment options for multiple cancers, reported it will have four presentations at the 2023 Annual Society for Nuclear Medicine and Molecular Imaging (SNMMI) Conference being held in Chicago from June 24-27, 2023 (Press release, Perspective Therapeutics, JUN 8, 2023, View Source [SID1234632616]).

"Our team at Perspective Therapeutics continues to make progress across all aspects of development, including the generation of promising clinical data. We are delighted to present the latest research on our products at the SNMMI annual conference. Targeted alpha therapies are emerging as a class of drugs with significant potential to revolutionize cancer treatment, and our team and collaborators keep building on the increasingly strong foundation of solid scientific data coming from our platform," said Thijs Spoor, Perspective’s Chief Executive Officer.

Michael Schultz, Chief Science Officer of Perspective Therapeutics, stated, "I would like to thank our excellent team of scientists and our collaborators for the work they continue to do across the spectrum of drug development. The data to be presented at this conference reflects the breadth of our expertise, from target discovery to isotope generation, finished product manufacture, preclinical experiments in cancers with high unmet need, and finally translation of these products into patient care. We believe that our work has the potential to make a real difference in the lives of cancer patients and we have a world class team driving us forward."

Presentation Summaries

Presentation #1: "Targeted imaging of melanoma for alpha-particle radiotherapy (TIMAR) trial"

This will be a presentation of the initial First-in-Human data from Perspective’s MC1R-targeted VMT01/02 imaging study conducted at the Mayo Clinic, Rochester. The presented results will discuss the safety and suitability of [203Pb]VMT01 or [68Ga]VMT02 for selection of patients and organ and tumor dosimetry calculations for the therapeutic alpha emitter [212Pb]VMT01.

The presentation will be during the Scientific Session 25 (Head/Neck and Melanoma) on Monday, June 26, 2023, 10:15 AM – 10:25 AM, by Geoffrey B. Johnson MD PhD, Head of Nuclear Medicine, Mayo Clinic (Rochester, MN USA).

Presentation #2: "Targeted alpha therapy of [212Pb] VMT-α-NET in a metastatic neuroblastoma model"

This presentation will discuss the Company’s continued work to expand the use of its clinical stage [212Pb]VMT-α-NET product into additional oncology indications with high unmet need, such as pediatric neuroblastoma. Preclinical model development and the results of therapy with Perspective’s product will be presented.

The presentation will occur during the Scientific Session 36 New Directions in Oncology – Preclinical and Translational 2 on Tuesday, June 27, 2023, 10:05 AM – 10:15 AM by Dijie Liu PhD DVM, Principal Research Scientist, Perspective Therapeutics.

Presentation #3: "Radiosynthesis of 212Pb labelled VMT-α-NET for clinical use"

Targeted alpha-particle radiotherapies (TATs) have been evolving as promising treatments in management of cancers. 212Pb represents an isotope with decay properties and half life that are well-suited for peptide based radiopharmaceutical therapies. Investigators from Fortis Hospital have reported responses to treatment with [212Pb]VMT-a-NET. Here, the radiopharmaceutical production and quality control of [212Pb]VMT-a-NET is presented for clinical use.

The Presentation will occur during the Integrated Session 11 Novel Radiometals on Tuesday, June 27, 2023, 2:00 PM – 3:15 PM by A by Parul Thakral, PhD, Clinical Research Officer at Fortis Memorial Research Institute, Gurgaon – India (Co-author Michael K Schultz PhD, CSO Perspective Therapeutics).

Presentation 4: "Production and purification of high specific activity lead-203 (203Pb) for preclinical applications"

Lead-203 (203Pb) and Lead-212 (212Pb) have emerged as a matched pair for the development of elementally matched theranostic radiopharmaceuticals. 203Pb decays to 203Tl by electron capture (EC) and emits photons suitable for SPECT imaging (279 keV, 81%, t1/2 = 2.16 d) while 212Pb (t1/2 = 10.64 h) decays by emission of β– and α-particles suitable for targeted radiotherapy. Here, the investigators aimed to develop robust methods for production and separation of 203Pb from enriched Tl (205Tl) target material suitable for radiochemistry and preclinical studies.

The Presentation will occur during the Integrated Session 11 Novel Radiometals on Tuesday, June 27, 2023, 2:00 PM – 3:15 PM by A. Shefali Saini, PhD Candidate, University of Alabama, Birmingham (Mentor Professor Suzanne Lapi PhD) (Co-author Michael K Schultz PhD, CSO Perspective Therapeutics).