ZetaMet™ (Zeta-BC-003) Receives Breakthrough Device Designation from U.S. Food and Drug Administration (FDA) for Treatment of Metastatic Bone Cancers

On December 1, 2021 Zetagen Therapeutics, a private, clinical-stage, biopharmaceutical company dedicated to driving breakthrough innovation in the treatment of metastatic bone cancers and osteologic interventions, reported it has received Breakthrough Device designation from the Centers for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) for its ZetaMet (Zeta-BC-003) technology (Press release, Zetagen Therapeutics, DEC 1, 2021, View Source [SID1234643705]). Previously known as ZetaFuse, ZetaMet (Zeta-BC-003) is a synthetic, small-molecule, inductive biologic technology being developed to target and resolve metastatic bone lesions while inhibiting future tumor growth and regenerating bone.

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"We are pleased to receive this important designation from the Agency and look forward to partnering with them," said Joe C. Loy, CEO of Zetagen Therapeutics. "Our researchers have discovered an entirely new pathway for an established molecule which, if proven successful in human clinical trials, could create a new treatment paradigm for the hundreds of thousands of patients living with cancers that involve metastatic bone lesions."

ZetaMet (Zeta-BC-003) works through a mechanism of action (MOA) which is a novel and patented molecular pathway. The small molecule, precisely-dosed, delivered to the affected area through a proprietary drug-eluting carrier, stimulates stem cells, activating cells to grow healthy bone known as "osteoblasts", and inhibits cells associated with bone degradation called "osteoclasts". The combination technology has, thus far, in preclinical studies, demonstrated its ability to resolve existing metastatic bone lesions, inhibit pain and stimulate targeted bone regeneration.

Bone metastases are common among cancer patients and occur when cells from the primary cancerous tumor relocate to the bone. When these cancers relocate, they can cause changes to the bone, damaging it in a process called osteolysis. Osteolysis can cause small holes within the bone, weakening it and increasing the risk of breakage. These holes are called "lytic lesions." Among cancers which metastasize to bone, Breast and Prostate are most prevalent, amounting to approximately 70-percent of cases.[1]

ZetaMet (Zeta-BC-003) has successfully passed its preclinical trials and is being prepared for its first human clinical trial in early 2022.

Accropeutics Bioscience inks over $50M series B round

On December 1, 2021 Accro Bioscience (Suzhou) Limited ("Accropeutics Bioscience"), a China-based leadingbiotechnology company, reported that the company has recently raised over $50 million in an oversubscribed Series B round (Press release, Accro Bioscience, DEC 1, 2021, View Source [SID1234632773]). The financing was led by HongtaiAplus with participation from South China Venture Capital, Shenzhen Capital Group, Suzhou Oriza Holdings, and others.

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"Accropeutics Bioscience will leverage the funds to advance clinical development, pre-clinical research and international partnerships," said Dr. Xiaohu Zhang, co-founder and CEO of Accropeutics Bioscience, "We are very pleased with the support and confidence of our current and new investors."

"We appreciate the R&D and execution capabilities of the team, and look forward to the continuous breakthroughs of Accropeutics Bioscience in the future," said Morningside.

"We are optimistic about the development of Accropeutics Bioscience," said HongtaiAplus, "We are delighted to lead this round of financing and look forward to the in-depth cooperation with Accropeutics Bioscience in the future."

MTTI partners with Evergreen to manufacture EvaThera platform of radiopharmaceuticals

On December 1, 2021 Molecular Targeting Technologies, Inc. (MTTI) and Evergreen Theragnostics, Inc., reported an agreement in which Evergreen will manufacture MTTI’s EvaThera platform of radiopharmaceuticals (Press release, Molecular Targeting Technologies, DEC 1, 2021, View Source [SID1234632260]).

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The EvaThera platform is a new generation of Evans blue-based molecules with strong affinity for albumin, which extends the blood half-life of the radiopharmaceutical, potentially leading to improved outcomes. MTTI’s leading pipeline candidates are both Lu-177 based radiotherapeutics: EBTATE, targeting neuroendocrine and other SSTR2 expressing tumors, and EBRGD, targeting integrin expressing cancers like glioblastoma multiforme.

"The Evergreen team brings deep experience in manufacturing and nationwide distribution of Lu-177 products. This agreement is key to a robust and reliable supply in North America for our upcoming clinical trials and beyond," said Chris Pak, President & CEO of MTTI.

Evergreen will manufacture MTTI clinical supplies from its newly commissioned facility in Springfield, NJ and will leverage the team’s broad experience with Lu-177 based radiotherapeutics by providing comprehensive supply chain management from isotope sourcing to drug delivery at the clinical trial site.

"We are very pleased to support MTTI by providing quality GMP manufacturing for their very promising platform of products. The technology behind the EvaThera platform has the potential to make a meaningful improvement in the lives of patients," said James Cook, President & CEO of Evergreen.

Presentation: MedInvest Oncology Conference (December 7-10, 2021)

On December 1, 2021 Propella Therapeutics, Inc. reported that Presented at the MedInvest Oncology Conference on December 7, 2021 (Press release, Propella Therapeutics, DEC 1, 2021, https://propellatx.com/2021/12/01/presentation-forthcoming-medinvest-oncology-conference-december-7-10-2021/ [SID1234596636]).

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Karyopharm to Host Virtual Investor Day on December 8, 2021

On December 1, 2021 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported it will host a virtual Investor Day on Wednesday, December 8, 2021 from 10:00 a.m. to 12:30 p.m. ET (Press release, Karyopharm, DEC 1, 2021, View Source,-2021 [SID1234596382]). Karyopharm’s executive management team will be joined by six recognized thought leaders in multiple myeloma, gynecological malignancies, myelodysplastic syndromes and myelofibrosis, including:

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Rafael Fonseca, MD, Mayo Clinic
Cristina Gasparetto, MD, Duke University Medical Center
Vicky Makker, MD, Memorial Sloan Kettering Cancer Center
Robert Coleman, MD, US Oncology Research
Guillermo Garcia-Manero, MD, MD Anderson Cancer Center
Srinivas Tantravahi, MBBS, MRCP, University of Utah
The virtual event will outline the Company’s commercial opportunities, refined corporate vision, pipeline priorities and corporate milestones that will support Karyopharm’s continued evolution toward a sustainable, fully-integrated development and commercialization organization.

To access the event, please dial (833) 989-2978 (local) or (236) 714-4042 (international) at least 10 minutes prior to the start time and ask to be joined into the Karyopharm Therapeutics call. A live video webcast of the event will be available under "Events & Presentations" in the Investor section of the Company’s website, View Source An archived webcast will be available on the Company’s website approximately two hours after the event.