On July 24, 2023 ARTBIO, Inc. (ARTBIO), a clinical-stage radiopharmaceutical company developing a new class of targeted alpha radioligand therapies (ART), and SpectronRx, a leading radiopharmaceutical developer and manufacturer, reported a global strategic partnership agreement to support manufacturing of components of ARTBIO’s AlphaDirectTM isotope isolation technology (Press release, ARTBIO, JUL 24, 2023, View Source [SID1234637912]).

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As part of the agreement, SpectronRx will be responsible for manufacturing a critical component of ARTBIO’s proprietary AlphaDirectTM technology. AlphaDirectTM is a first-of-its-kind system that delivers highly pure Pb212 from widely available raw materials. The multi-year agreement covers an initial technology transfer and development phase, followed by qualification and release of the technical components.

"We have a long history in managing complicated technology projects involving radioactive materials," said SpectronRx co-founder and CEO John Zehner. "We understand the importance of collaboration for companies developing new technologies aimed at creating radioligand therapies. SpectronRx is well-equipped and proud to partner with ARTBIO to develop and supply key components of AlphaDirectTM."

ARTBIO pioneered the AlphaDirectTM technology to create an optimized and proprietary Pb212 isotope isolation technology with unique advantages, including:

Benchtop format, which can be operated in facilities of any size.
Simple process with no fluid separation that results in 99.9%+ purity.
Streamlined supply chain with starting materials derived from accessible nuclear industry stockpiles that minimize uncertainty and cost.
SpectronRx will tap into its expertise for handling and producing rare medical radioisotopes such as Ac-225 (actinium-225) and Pb-212, along with its infrastructure for Radiopharmaceutical Contract Development (rCDMO) and Radiopharmaceutical Contract Manufacturing (rCMO). This unique combination and its extensive regulatory track record will enable ARTBIO to effectively improve and validate its manufacturing processes to get them ready for FDA and EMA review.

"We are pleased to partner with SpectronRx, a company with extensive experience and capabilities in managing nuclear chemistry projects," said Emanuele Ostuni, Ph.D., Chief Executive Officer of ARTBIO. "Handling high doses of radioactivity is an extremely complex process, and it was critical that we work with a partner that understands the specific requirements needed and can create a customized solution for our proprietary AlphaDirectTM technology. With SpectronRx’s expertise, we are a step closer to the establishment of the ARTBIO manufacturing network."

"ARTBIO’s technology has the potential to revolutionize the field of cancer treatment," added SpectronRx President Anwer Rizvi. "We are thrilled to be a part of their incredible journey."

On July 24, 2023 Overland ADCT BioPharma, a joint venture of Overland Pharmaceuticals (CY) Inc. and ADC Therapeutics SA (NYSE: ADCT), reported that the China National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for ZYNLONTA (loncastuximab tesirine-lpyl), which is seeking an indication for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy in China (Press release, ADC Therapeutics, JUL 24, 2023, View Source [SID1234634578]). The BLA has been granted priority review by the NMPA.

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The application was made based on the positive results from OL-ADCT-402-001, a Phase 2 bridging clinical trial for ZYNLONTA. The study was designed to evaluate the efficacy and safety of ZYNLONTA as a single-agent treatment for Chinese patients with r/r DLBCL.

Professor Zhu Jun, principal investigator of the OL-ADCT-402-001 study and Party Secretary of Beijing Cancer Hospital and Director of Internal Medicine, said: "Safer and more effective treatments are still urgently needed to address significant unmet medical needs among r/r DLBCL patients after two or more lines of systemic therapy in China. I hope ZYNLONTA will be accessible to Chinese r/r DLBCL patients soon."

"We are pleased with the swift progress of the development program for ZYNLONTA in China as evidenced by the NMPA’s recent acceptance of the BLA and priority review designation," said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. "This is a significant step forward in our commitment to making ZYNLONTA available to benefit patients worldwide."

Ed Zhang, Co-founder and CEO of Overland Pharmaceuticals, said: "This is a meaningful milestone. Our partnership with ADC Therapeutics began in December 2020, and it took us only two and a half years to complete the clinical study and submit the first BLA. We would like to extend our sincere gratitude to participating patients, clinical investigators, the health authority and our partner ADC Therapeutics for their strong support in making this achievement possible. We look forward to our continued collaboration with all stakeholders to maximize the potential benefits of ZYNLONTA for patients in China."

Overland ADCT BioPharma holds the exclusive rights to develop and commercialize ZYNLONTA in Greater China and Singapore. The BLAs for ZYNLONTA have already been submitted in Singapore, Hong Kong and Taiwan. It is expected to address the unmet needs of patients with r/r DLBCL across these regions.

About ZYNLONTA (loncastuximab tesirine-lpyl)

The U.S. Food and Drug Administration (FDA) and the European Medicines Agency have approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including DLBCL not otherwise specified, DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval and in the European Union under conditional approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Please see full prescribing information including important safety information about ZYNLONTA at www.ZYNLONTA.com.

On July 24, 2023 Teva Pharmaceuticals, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), a global leader in generic and innovative medicines and Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, reported that they have agreed to expand their existing strategic partnership agreement (Press release, Teva, JUL 24, 2023, View Source [SID1234633400]). Teva will also acquire subordinated convertible bonds to be issued by Alvotech.

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The partners continue working closely on matters concerning pending approval in the U.S. for AVT02, an interchangeable high-concentration biosimilar candidate for Humira (adalimumab). The existing strategic partnership agreement also includes four other biosimilar candidates, one of which is AVT04, a proposed biosimilar for Stelara (ustekinumab), which is currently pending U.S. Food and Drug Administration (FDA) approval.

The expansion to the existing strategic partnership agreement pertains to exclusive commercialization in the U.S. by Teva of two new biosimilar candidates and line extensions of two current biosimilar candidates in the partnership, to be developed, and manufactured by Alvotech. The agreement includes milestone payments, the majority paid following product approvals and upon achieving significant sales milestones. Teva and Alvotech will share profit from the commercialization of the biosimilars. All other financial terms and product details remain confidential.

The agreement also includes increased involvement by Teva regarding manufacturing and quality at Alvotech’s manufacturing facility. Teva is actively supporting Alvotech on-site in Iceland to be fully ready for an FDA inspection.

Teva has agreed to acquire subordinated convertible bonds to be issued by Alvotech pursuant to a convertible bond instrument, dated December 20, 2022, for $40 million. Teva’s investment will be used by Alvotech as part of the funding for continued development of its biosimilars pipeline over the near-term.

"We welcome Teva’s continued partnership and this expansion of our partnership agreement," said Robert Wessman, Chairman and CEO of Alvotech. "We remain focused on preparing for a successful pre-approval inspection and resolving any outstanding issues identified by the FDA to be able to bring our biosimilar candidates to patients in the U.S. with Teva as soon as possible."

"Teva remains fully committed to its leadership in biosimilars and the partnership with Alvotech," said Sven Dethlefs, Executive Vice President, North America Commercial. "We remain optimistic about additional compounds in the pipeline and continued progress with AVT02 and ATV04."

About AVT02
AVT02 is a monoclonal antibody and has been approved as a biosimilar to Humira (adalimumab) in several countries globally, including the 27 member states of the European Union, Norway, Lichtenstein, Iceland, the UK, Switzerland, Canada, Australia, and Saudi Arabia. It is currently marketed in multiple European countries and in Canada. Dossiers are also under review in multiple countries globally.

About AVT04 (ustekinumab)
AVT04 is a monoclonal antibody and a biosimilar candidate to Stelara (ustekinumab). Ustekinumab binds to two cytokines, IL-12 and IL-23, that are involved in inflammatory and immune responses [1]. AVT04 is an investigational product and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed. Stelara is a registered trademark of Johnson & Johnson.
[1] View Source

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On July 24, 2023 Crescendo Biologics Ltd (Crescendo), a clinical stage immuno-oncology company developing novel, targeted T cell enhancing therapeutics, reported that it plans to augment the ongoing Phase 1b clinical trial of CB307 through the addition of a new pembrolizumab (anti-PD-1) combination expansion cohort (Press release, Crescendo Biologics, JUL 24, 2023, View Source [SID1234633399]). Additional financing of $32 million has been secured with the support of all major existing shareholders, including Sofinnova Partners, Andera Partners, IP Group BioNTech, Takeda and Quan Capital, and new investor Kreos Capital to fund the additional combination expansion arm of the adaptive clinical protocol.

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CB307, Crescendo’s lead proprietary programme, is now entering the cohort expansion part of the ongoing Phase 1b clinical trial. The monotherapy expansion cohort is already underway in individuals with PSMA+ metastatic castration-resistant prostate cancer (mCRPC) in a last-line setting. The additional pembrolizumab combination expansion cohort is expected to be initiated in Q3 2023 and will be open to those with PSMA+ mCRPC.

"We are delighted to have secured this additional financing which will enable us to accelerate the clinical development of CB307," commented Theodora Harold, CEO at Crescendo Biologics. "Preclinical data generated by Crescendo, such as those recently presented at AACR (Free AACR Whitepaper) in Orlando, as well as clinical data presented by others earlier this year, illustrate the profound effect that adding PD-1 antagonism can have to the co-stimulation of T cells, including via CD137 agonism. We are very excited to further investigate the activity of the combination of CB307 plus pembrolizumab in our clinical study and would like to thank everyone involved in the trial and our existing investors for their ongoing support as well as the team at Kreos Capital for joining us and sharing our vision."

Sonia Benhamida, Principal at Kreos Capital commented, "We have been very impressed with the Crescendo team, and the power and potential of the Humabody VH platform is evident across their proprietary and partnered programmes. Our investment model is ideally suited to Crescendo’s needs at this time, and we are pleased to partner with the Crescendo management team and to enable the acceleration and execution of the expanded clinical plan for CB307."

On July 24, 2023 CG Oncology, Inc., reported completion of patient enrollment for BOND-003, a single arm, Phase 3, monotherapy study evaluating cretostimogene grenadenorepvec in patients with high-risk non-muscle invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG) (Press release, CG Oncology, JUL 24, 2023, View Source [SID1234633398]).

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In the BOND-003 study there are 110 patients enrolled with BCG-Unresponsive High-Risk NMIBC across North America and the Asia-Pacific regions. The primary endpoint of the study is complete response (CR) at any time. Secondary endpoints include CR at 12 months, duration of response, progression-free survival, cystectomy-free survival, and safety. For more information about BOND-003, visit www.clinicaltrials.gov (NCT04452591).

"As a patient advocacy organization, it is exciting to see new treatments get closer to being available to bladder cancer patients with BCG-unresponsive disease, who have so few options available. Many will only have the option of bladder removal, which is not always available due to other health concerns," said Andrea-Maddox Smith, Chief Executive Officer, Bladder Cancer Advocacy Network (BCAN). "We have consistently advocated for increased funding for research and encouraged patients to seek out appropriate trials."

"We would like to thank all those who partnered with us to complete this study especially patients, care givers, physicians and health care teams in the United States and globally who helped us reach this important milestone," said Arthur Kuan, Chief Executive Officer, CG Oncology. "We are intensely focused on developing bladder-sparing therapeutics and are actively engaged in making cretostimogene available to patients as soon as possible."

About Cretostimogene Grenadenorepvec

Cretostimogene grenadenorepvec is an intravesically delivered oncolytic immunotherapy agent in a Phase 3 trial for the treatment of BCG-unresponsive non-muscle invasive bladder cancer. Cretostimogene grenadenorepvec is also in a Phase 2 study in combination with KEYTRUDA (pembrolizumab) in the same indication. Other types of bladder cancer are being evaluated with cretostimogene grenadenorepvec in combination with OPDIVO (nivolumab).

About Bladder Cancer

More than 82,000 people are estimated to be diagnosed with bladder cancer this year. NMIBC is the most common form of bladder cancer, representing approximately 75% of cases. Four times more men are diagnosed with bladder cancer than women and is the fourth most common type of cancer in men in the United States.