Kivu Bioscience Selects Sterling Pharma Solutions for cGMP Manufacturing of Lead Oncology Antibody-Drug Conjugate KIVU-107
SAN FRANCISCO--(BUSINESS WIRE)-- Kivu Bioscience, a biotech company developing next-generation antibody-drug conjugates, announced today a manufacturing partnership with Sterling Pharma Solutions, a global contract development and manufacturing organisation, to produce cGMP-quality material for Phase 1 clinical trials of its lead oncology antibody-drug conjugate (ADC) candidate, KIVU-107.
Under the agreement, Sterling will manufacture cGMP clinical material for KIVU-107 at its dedicated bioconjugation facility in Deeside, UK. The collaboration includes process familiarisation, analytical development, process optimisation, and scale-up activities in preparation for a cGMP manufacturing campaign.
'We chose Sterling as our manufacturing partner based on their deep expertise in ADC development, proven track record of clinical supply, and commitment to quality,' said Mohit Trikha, Ph.D., President and Chief Operating Officer, Kivu Bioscience. 'This partnership marks an important milestone as we advance KIVU-107 toward first-in-human studies and deliver on our mission to bring kinder, gentler and efficacious next-generation ADC therapies to patients.'
KIVU-107 is a potential first-in-class antibody-targeted conjugate which enables site-specific conjugation. The resulting structure positions the linker-payload in a natural cavity in the antibody, providing excellent stability, reduced hydrophobicity, and an increased therapeutic index relative to first-generation ADC therapies.
'Our team at Deeside has extensive experience supporting complex ADC programs from early development through clinical manufacturing,' said Chad Telgenhof, Chief Commercial Officer at Sterling Pharma Solutions. 'We're excited to support Kivu to bring this promising new oncology candidate into the clinic, leveraging our expertise and investment in world-class ADC development and clinical manufacturing capabilities.'
Sterling's 6,500-square-metre Deeside facility offers a range of ADC services, from discovery-stage development through to clinical supply. In October 2024, Sterling announced a £10 million investment at the site to double its GMP manufacturing capacity, as the second phase of an ongoing strategy to increase the capabilities that it can offer customers.
About Kivu Bioscience
Kivu Bioscience is pioneering next-generation antibody-drug conjugates (ADCs) in oncology. The company's proprietary linker-payload technology delivers enhanced safety and efficacy, minimizing off-target effects to improve patient outcomes. With multiple ADC programs in development and a team of industry veterans, Kivu is advancing its lead candidates to clinical trials. The company is headquartered in San Francisco, CA. For more information, visit www.kivubioscience.com.
About Sterling Pharma Solutions
Sterling Pharma Solutions is a global contract development and manufacturing organisation (CDMO) with more than 50 years' experience in providing small molecule API development and manufacturing services to the pharmaceutical industry, specialising in handling challenging chemistries. Sterling manages the most complex API challenges from proof-of-concept to commercial manufacture, as well as antibody-drug conjugate (ADC) research and development bioconjugation services.
Sterling has six facilities employing more than 1,350 people: its HQ in Dudley, Northumberland, UK; a chemistry services business in Newcastle upon Tyne, UK; a site in Ringaskiddy, Co. Cork, Ireland; a dedicated bioconjugation and ADC facility in Deeside, North Wales, UK; and two sites in the US, in Cary, North Carolina and Germantown, Wisconsin. Find out more
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
an hour ago
- Yahoo
'Scouse Paul', the untraceable ghost, and a £180k criminal empire
A drug dealer at the helm of an £180,000 'Scouse Paul' county lines operation was found in possession of Greater Manchester's first untraceable 'ghost gun'. Police found a 'significant amount' of crack cocaine and heroin valued at around £28,500 when they raided Veke Koissia Soumahoro's Bolton home in November 2024. In a GMP first, detectives also uncovered a Polymer80 'ghost gun' that had been assembled from a kit containing parts with no serial numbers. READ MORE: Missing Brit Greg Monks who disappeared after Portugal stag do found dead READ MORE: Arrests in major murder probe after ex-rugby league player Mick Martindale dies A 'ghost gun' is a viable weapon that is untraceable as it has no identifiers and can be made from a kit or from separate parts, or even a 3D printer. At a hearing at Bolton Crown Court on Tuesday (June 3), Soumahoro pleaded guilty to a slew of drugs and firearms offences and was sentenced to seven years and six months behind bars. Police said it was estimated that over 1.8kg of drugs had been distributed within Bolton between February and November 2024 as part of the 'Scouse Paul' operation. Soumahoro, of Mornington Road, pleaded guilty to possession of a firearm, possession of ammunition for a firearm without a certificate, being concerned in the supply of heroin, being concerned in the supply of crack cocaine, possession with intent to supply heroin, and possession with intent to supply crack cocaine. Detective Constable Daniel Woodburn, of our County Lines Team, said: 'This was an investigation into a Class A drugs line branded 'Scouse Paul' that was based in Bolton. 'It was estimated that just over 1.8kg of drugs had been distributed within Bolton between February and November 2024. 'Not only have we taken a significant drugs line off the streets, but also a viable 'ghost gun' that could have been used for further criminality. 'What started out as an investigation into a drugs line ended with a viable firearm being removed from the streets. 'We will continue to pursue those who engage in such criminal activities across Greater Manchester. 'We rely on information from the public to be our eyes and ears on the streets - help us to rid your communities of drugs and related crime by reporting information about drug dealing and other issues. 'You can also report information and crimes on our website using the 'report' tool. "Alternatively, you can report information anonymously to the independent charity Crimestoppers on 0800 555 111. Always call 999 in an emergency.'
Fox Sports
5 hours ago
- Fox Sports
Arsenal in talks with Partey over new deal as Jorginho and Sterling depart
Associated Press LONDON (AP) — Arsenal is in talks with Thomas Partey to extend the midfielder's contract, the club said Wednesday, while confirming the departure of a slew of other players including Jorginho and Raheem Sterling. Partey's contract is due to expire on June 30 and Arsenal said 'discussions are on going.' The Ghana international has been with Arsenal since 2020. Italy midfielder Jorginho, Scotland left back Kieran Tierney, Brazilian goalkeeper Neto and Sterling — at one stage a key player for England — are among those confirmed to be leaving Arsenal. Sterling was only on a season-long loan from Chelsea. Arsenal has just finished second in the Premier League for the third straight season. ___ AP soccer:
Associated Press
5 hours ago
- Associated Press
Moleculin Reports Positive Topline Efficacy Results from U.S. Phase 1B/2 Clinical Trial Evaluating Annamycin for the Treatment of Soft Tissue Sarcoma Lung Metastases (MB-107)
Annamycin delivering better performance 7thline than would be expected even in 2ndline for monotherapy Responders (Stable Disease or Partial Response) after 2 cycles of Annamycin showed improvement in OS and Progression Free Survival ('PFS') Clinical Benefit Rate ('CBR') was 59.4% (n=32), comprised of 18 subjects with stable disease and 1 subject with a partial response Potential to address 13,500 new incidents of STS each year and market opportunity expected to grow to $2.6B by 20301 On-demand video webcast with members of the Moleculin management team and internationally renowned Key Opinion Leaders available Thursday, June 5th HOUSTON, June 04, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ('Moleculin' or the 'Company'), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat cancers and viruses, today reported positive topline efficacy results from its completed U.S. Phase 1B/2 clinical trial evaluating Annamycin for the treatment of soft tissue sarcoma lung metastases ('STS lung mets') (MB-107). The MB-107 trial was a multi-center, open-label, single-arm monotherapy study that in Phase 1B determined the Maximum Tolerable Dose and Recommended Phase 2 Dose ('MTD', 'RP2D' respectively) and safety of Annamycin and in Phase 2 explored the efficacy of Annamycin as a single agent for the treatment of subjects with STS lung mets for which chemotherapy was considered appropriate. For more information about the MB-107 trial visit and reference identifier NCT04887298. 'These positive topline results from MB-107 are incredibly encouraging. The impact Annamycin demonstrated on median overall survival, particularly with patients who received multiple prior chemotherapy regimens, exceeded expectations. Additionally, the improvement seen with PFS after two doses represents a real potential for Annamycin to provide a meaningful treatment option for the treatment of STS lung mets,' commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin. 'Looking ahead, we believe these results strongly support further evaluations of Annamycin for the treatment of STS lung mets and we look forward to exploring opportunities to potentially bring this important treatment option to patients.' Topline Efficacy Results Summary Annamycin currently has Fast Track Status and Orphan Drug Designation from the FDA for the treatment of relapsed or refractory acute myeloid leukemia, in addition to Orphan Drug Designation for the treatment of soft tissue sarcoma. Furthermore, Annamycin has Orphan Drug Designation for the treatment of relapsed or refractory acute myeloid leukemia from the EMA. On-Demand Webcast Details An on-demand Virtual STS Lung Mets KOL Webcast to discuss the MB-107 data will be available for investors, analysts, and other interested parties on Thursday, June 5, 2025 beginning at 8:30 AM ET. For the event, Walter Klemp, Chairman and Chief Executive Officer, and Dr. Paul Waymack, Senior Chief Medical Officer of Moleculin will be joined by Key Opinion Leaders: Mohamad Cherry, MD, Medical Director of Hematology at Atlantic Health System; Prof. Bernd Kasper, Sarcoma Unit of the Mannheim Cancer Center (MCC) at the Mannheim University Medical Center, University of Heidelberg; and Sant P. Chawla, MD, Director, Sarcoma Oncology Center, Director, Cancer Center of Southern California. Interested participants and investors may access the on-demand video webcast on the Events page of the Investors section of the Moleculin website, The webcast will be accessible for 90 days. About STS Lung Mets Soft tissue sarcoma is a type of cancer that originates in the soft tissues of the body, including muscles, tendons, fat, blood vessels and nerves. Lung metastases are a common occurrence in STS, and can impact overall survival. According to The American Cancer Society approximately 13,500 individuals, both adults and children, will be diagnosed with soft tissue sarcoma in 20252. Soft tissue sarcomas account for 1% of all adult cancers, 7% of cancers in children up to age 15, and 3% of cancers in children under the age of 14. The Soft Tissue Sarcoma Market was valued at USD 1.58 Billion in 2024, and is expected to reach USD 2.57 Billion by 2030, rising at a CAGR of 8.43%. OS for standard of care for metastatic STS has been estimated at 8-12 months and certain experimental targeted and cytotoxic therapies (as monotherapies or some in combination) have yielded OS of 13.4 months as second line therapy.3 MB-107 Study Design In Phase 2, Annamycin was administered as an intravenous (IV) infusion over 2 hours on Day 1, followed by 20 days off (1 cycle = 21 days). Subjects visit the study site every 21 days (±3 days) at which time safety monitoring – including for adverse events (AEs), as well as a physical examination, laboratory evaluations (clinical chemistry, complete blood count), vital signs, weight measurements, Eastern Cooperative Oncology Group (ECOG) performance status, and electrocardiograms (ECGs) – is performed, followed by an IV infusion of study drug. Cardiac function is followed by echocardiogram (ECHO) scans at screening, at the end of the first two cycles and then following every other cycle thereafter, at the End of Treatment visit, and if feasible, during follow up at 6 months (±1 month) and 1 year (±1 month) after study drug discontinuation. As long as the Investigator considers that the benefits of treatment with Annamycin continue to outweigh the risks, treatment will continue every 21 days until tumor progression is observed or unacceptable toxicity occurs. Tumor response is monitored every 6 weeks (±1 week) from Cycle 1 Day 1 during treatment, at the End of Treatment visit, and then every 3 months (±1 month) until disease progression using RECIST 1.1 criteria. Those subjects who leave the study after a maximum response is achieved and who do not start another therapy will be followed every 3 months (±1 month) for progression-free survival (PFS). If a subject receives further therapy after discontinuing from the study, they will be followed only for overall survival (OS) and if feasible, follow-up ECHO scans at 6 months (±1 month) and 1 year (±1 month) were conducted after study drug discontinuation. About Moleculin Biotech, Inc. Moleculin Biotech, Inc. is a Phase 3 clinical stage pharmaceutical company advancing a pipeline of therapeutic candidates addressing hard-to-treat tumors and viruses. The Company's lead program, Annamycin, is a next-generation highly efficacious and well tolerated anthracycline designed to avoid multidrug resistance mechanisms and to lack the cardiotoxicity common with currently prescribed anthracyclines. Annamycin is currently in development for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases. The Company has begun the MIRACLE (Moleculin R/R AML AnnAraC Clinical Evaluation) Trial (MB-108), a pivotal, adaptive design Phase 3 trial evaluating Annamycin in combination with cytarabine, together referred to as AnnAraC, for the treatment of relapsed or refractory acute myeloid leukemia. Following a successful Phase 1B/2 study (MB-106), with input from the FDA, the Company believes it has substantially de-risked the development pathway towards a potential approval for Annamycin for the treatment of AML. This study remains subject to appropriate future filings with potential additional feedback from the FDA and their foreign equivalents. Additionally, the Company is developing WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic and other cancers. Moleculin is also engaged in the development of a portfolio of antimetabolites, including WP1122 for the potential treatment of pathogenic viruses, as well as certain cancer indications. For more information about the Company, please visit and connect on X, LinkedIn and Facebook. Forward-Looking Statements Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the timing of the release of the initial data on the first 45 subjects in the trial and the Company's ability to reconcile the US and EU protocols with the FDA and EMA, respectively. Moleculin will require significant additional financing, for which the Company has no commitments, in order to conduct its clinical trials as described in this press release, and the milestones described in this press release assume the Company's ability to secure such financing on a timely basis. Although Moleculin believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin has attempted to identify forward-looking statements by terminology including 'believes,' 'estimates,' 'anticipates,' 'expects,' 'plans,' 'projects,' 'intends,' 'potential,' 'may,' 'could,' 'might,' 'will,' 'should,' 'approximately' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. 'Risk Factors' in our most recently filed Form 10-K filed with the Securities and Exchange Commission (SEC) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events. Investor Contact: JTC Team, LLC Jenene Thomas (908) 824-0775 [email protected] 1 2 American Cancer Society. Cancer Facts & Figures 2025. Atlanta: American Cancer Society; 2025. Available at 3 Comandone A, et al; 'Salvage Therapy in Advanced Adult Soft Tissue Sarcoma: A Systematic Review and Meta-Analysis of Randomized Trials'; The Oncologist 2017;22:1518–1527
