On November 9, 2022 Dong-A ST (Min Young Kim, President and CEO) (KRX: 170900) reported that they signed an exclusive license-out and supply agreement on November 4, 2022, with Polifarma (Mehmet Asri, CEO) for NESP biosimilar DA-3880 (Press release, Dong-A ST, NOV 9, 2022, View Source [SID1234623582]).

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According to the agreement, Dong-A ST will license out the exclusive rights for the development and commercialization of DA-3880 in Türkiye, Brazil, and Mexico to Polifarma. Dong-A ST will receive upfront and developmental/commercial milestone payments and will exclusively supply the finished product through STgen Bio, an affiliated Bio CDMO of Dong-A Socio Holdings. Meanwhile, Polifarma will be responsible for the development and commercialization in Türkiye, Brazil, and Mexico.

The details of the upfront, milestone payments, and supply profit structure remain undisclosed as per the consensus between both parties.

"DA-3880" is an ARANESP/NESP biosimilar for the treatment of anemic patients with chronic renal failure or those undergoing chemotherapy. Dong-A ST signed a license-out agreement with Sanwa Kagaku Kenkyusho in 2014 for the development and commercialization of DA-3880 in Japan. After regulatory approval from PMDA (Pharmaceuticals and Medical Devices Agency, Japan) in 2019, DA-3880 has been successfully commercialized in the Japanese market, making it one of the bestsellers among darbepoetin alfa biosimilar products.

Polifarma is a Türkiye pharmaceutical company with 100% domestic capital and 36 years of experience. It has established actual export records of 586 drugs to over 70 countries, including the US, Europe, Brazil, and Mexico. As the most well-known, and most preferred, hospital products brand in Türkiye, Polifarma’s goal is to maintain its lead in the Türkiye market and become one of the biggest global leaders by sustaining its quality and technological superiority.

Jae Hong Park (President and CSO of Dong-A ST) said, "This agreement provides an opportunity for Dong-A ST to introduce DA-3880 beyond the Japanese market and into the global biosimilar market including Türkiye and South & Central America. Dong-A ST will commit to expanding its global market presence by showcasing our biosimilar R&D and overseas business capabilities."

On November 9, 2022 Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of the LuViva Advanced Cervical Scan, based on its patented biophotonic technology, reported that the clinical trial for Chinese regulatory is back on track after experiencing delays due to Covid-19 lockdowns and is expected to be completed and filed with the Chinese National Medical Products Administration (NMPA) during the first half of 2023 (Press release, Guided Therapeutics, NOV 9, 2022, View Source [SID1234623580]).

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According to Guided Therapeutics Chinese partner, Shandong Yaohua Medical Instrument Corporation (SMI), the results so far indicate that LuViva meets or exceeds the success criteria as described in the current study protocol and has been demonstrated to be safe for use on nearly 200 women tested thus far in China. Hospitals participating in the study include Qilu Hospital of Shandong University, Fudan (Shanghai) University Hospital and Peking University People’s Hospital.

"We are very pleased to hear that the study is progressing well, both in terms of patient recruitment and the performance of LuViva," said Gene Cartwright, CEO of Guided Therapeutics. "Despite sporadic lockdowns due to Covid-19 prevention mandates, study enrollment is now accelerating, and SMI projects that the study results will be filed with the Chinese NMPA sometime in the first half of next year. These events trigger the start of a $2.5 MM purchase order from SMI for LuViva devices and disposables."

According to the World Health Organization, cervical cancer is one of the most frequent cancers worldwide and is the second most common cancer among Chinese women. China has a population of approximately 560 million women above 15 years of age who are at risk of developing cervical cancer. Current estimates indicate approximately 100,000 new cases of cervical cancer are diagnosed each year and 30,000 deaths occur annually due to cervical cancer in China.

On November 9, 2022 Ambrx Biopharma Inc., or Ambrx, (NYSE: AMAM), a clinical stage biopharmaceutical company using its proprietary Engineered Precision Biologics (EPBs) platform to create antibody drug conjugates (ADCs), reported the first patient has been dosed by Ambrx’s partner, NovoCodex Biopharmaceuticals, Inc. (NovoCodex) in its Phase 1 trial of ARX305 in patients with advanced solid tumors (Press release, Ambrx, NOV 9, 2022, View Source [SID1234623579]). ARX305 is the only anti-CD70 ADC in active development that targets CD70, a protein that is overexpressed in a broad range of solid and hematologic tumors, giving it the potential to treat a range of liquid and solid tumor cancers, where CD70 is overexpressed.

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According to their development agreement, NovoCodex and Ambrx will collaborate in the development of ARX305 up until the completion of Phase 1 clinical trials. Under the terms of the development agreement, Ambrx is eligible to receive up to $4.0 million in clinical milestones, as well as tiered royalties in the low teens percentage range of aggregate net sales of ARX305 in China from NovoCodex. As a result of the first patient being dosed in NovaCodex’s Phase 1 clinical trial in China, Ambrx will now receive a significant portion of the $4.0 million milestones payments.

Ambrx plans to leverage the safety data from NovoCodex’s Phase 1 dose escalation clinical trial to inform its own Phase 1a trial, thereby efficiently using the company’s cash and resources. Specifically, using the data gained from NovoCodex’s dose escalation trial, Ambrx can reduce the expense of conducting its own initial dose escalation clinical trial. Building on the NovoCodex Phase 1 data, Ambrx plans to expedite its Phase 1a trial of ARX305 by starting at higher doses (i.e., doses closer to a recommended Phase 2 dose). Following the completion of NovoCodex’s Phase 1 clinical trial, Ambrx’s Phase 1a clinical trial for ARX305 is expected to initiate in the second half of 2023. NovoCodex is also responsible for funding a majority of Ambrx’s development of ARX305 through the end of Phase 1 clinical trials, up to a certain cap, and will be able to leverage Ambrx’s data in its own development of ARX305.

"The dosing of the first patient with ARX305 by NovoCodex represents an important strategic benchmark that will not only advance another Ambrx-generated ADC asset into the clinic, but also will allow us to leverage findings from the study to inform our own clinical trial," said Daniel O’Connor, Chief Executive Officer of Ambrx. "Leveraging partner data will both expedite internal development and cut costs, establishing a strong foundation from which to begin our own Phase 1 trial."

Mr. O’Connor added, "CD70 is highly expressed on the surface of a variety of hematological and solid tumor cells, and I believe the stability of ARX305 conferred by our proprietary EBP platform uniquely positions it as a potential best-in-class treatment for CD70 expressing tumors. I want to thank NovoCodex for continuing our strong partnership and look forward to continued progress as they advance ARX305 through the clinic."

On November 9, 2022 TILT Biotherapeutics, a clinical-stage biotechnology company developing cancer immunotherapies, reported that the company has opened an office in Boston, to support its increasing US clinical development, partnering and fund-raising activities (Press release, TILT Biotherapeutics, NOV 9, 2022, View Source [SID1234623578]). The current US clinical trials are run in collaboration with MSD, a tradename of Merck & Co., Inc., Rahway, NJ, USA and the Merck-Pfizer-Alliance.

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TILT Biotherapeutics’ CEO, Akseli Hemminki, a cancer clinician who has personally treated hundreds of cancer patients with earlier versions of oncolytic viruses, said, "Boston is at the heart of one of the world’s biggest biotech clusters, and we’re delighted to become part of that vibrant community as we invest in this infrastructure and accelerate towards Phase 2 trials of our innovative armed oncolytic viruses."

TILT Biotherapeutics’ COO, and President of US operations, Aino Kalervo, who is responsible for initiating the US office operations, said "Our newly established US operations will help to drive our US clinical development in this leading global pharmaceutical market, including lining up several new clinical trial centers, building on our work with the Mayo Clinic, and supporting forthcoming IND filings."

John Goldfinch, TILT Biotherapeutics’ newly appointed US Clinical Lead, with over a decade’s phase I to IV clinical operations and program management experience at US life sciences companies including Athenex, said, "I’m delighted to join TILT to help advance our US program of phase I and II clinical trials. We believe our approach will deliver better outcomes for cancer patients."

TILT Biotherapeutics LLC’s new office is at the CIC in Boston, Massachusetts which has been a home for great entrepreneurs leading fast-growing companies since 1999. This follows its collaborations with US pharma partners and leading cancer centers.

The heart of TILT’s innovative approach revolves around the use of cancer cell specific oncolytic adenoviruses, armed with cytokines and other molecules to boost the patient’s T-cell immune response to better enable it to find and destroy cancer cells.

On November 9, 2022 InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, reported that it has dosed its first healthy volunteer in a randomized, double-blind, placebo-controlled Phase I trial of orally administered, small molecule C5aR inhibitor INF904 (Press release, InflaRx, NOV 9, 2022, View Source [SID1234623577]). This single ascending dose Phase I trial aims to evaluate the safety, tolerability and pharmacokinetics of INF904 in healthy volunteers.

"Our preclinical studies with our new orally administered, small molecule C5aR inhibitor INF904 have shown potential for INF904 to inhibit C5a-induced signaling through its receptor C5aR. We are excited to enter clinical development of this new drug candidate," said Renfeng Guo, M.D., Chief Scientific Officer and Founder of InflaRx. "INF904 is a promising addition to our pipeline of candidates controlling the terminal complement C5a / C5aR pathway. As an orally administered compound, we plan to study if INF904 is especially suitable for patients suffering from complement-mediated chronic autoimmune and inflammatory diseases requiring ongoing long-term treatment," he added.

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In the Phase I first-in-human trial, InflaRx plans to initially enroll approximately 62 healthy volunteers who will be randomly assigned to receive INF904 or placebo. The study will assess single ascending doses under fasted conditions. The main objective of the trial is to assess safety and tolerability. Secondary endpoints include several pharmacokinetic parameters. The effect of INF904 on C5a-induced downstream activity will also be explored.

As reported in January 2022, INF904 showed anti-inflammatory therapeutic effects in several preclinical disease models and there were no obvious toxicological findings in investigational new drug (IND)-enabling (preclinical) studies, including required good laboratory practice (GLP) toxicity analyses. In these preclinical studies, oral INF904 showed higher plasma exposure in animals, including non-human primates, and improved neutrophil-inhibitory activity in a hamster model compared to a marketed C5aR inhibitor. Further, in contrast to the marketed C5aR inhibitor, in vitro experiments demonstrated that INF904 has substantially less inhibition of the cytochrome P450 3A4/5 (CYP3A4/5) enzymes, which play an important role in the metabolism of a variety of metabolites and drugs, including glucocorticoids. InflaRx plans to study INF904 for the treatment of complement-mediated, chronic autoimmune and inflammatory diseases where oral administration is the preferred choice for patients.