On October 25, 2021 X-Chem, the pioneer of DNA-encoded library (DEL) technology and recognized leader in generating actionable results to drive small molecule drug discovery, reported the acquisition of ComInnex, a leading European provider of synthetic chemistry services and novel chemical technologies to support early-stage drug discovery.

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With demand for high-quality discovery services increasing across the world, this complementary pairing of a North American leader in DEL and medicinal chemistry with a European leader in synthetic chemistry and custom DEL services delivers the capacity, footprint and expertise to better serve the demands of customers in a global market.

"As a united company, with an increased global presence, we are positioned to meet the increasing demand for innovative chemistry solutions and high-quality discovery services worldwide," noted Matt Clark, Ph.D., CEO of X-Chem. "The acquisition of ComInnex further extends X-Chem’s expertise and scale of DEL services to help biopharma clients of any size efficiently unlock exponential possibilities in small molecule drug discovery."

"Combining X-Chem, the world leader and pioneer of high-quality DEL technology, and ComInnex, a leader in the most important trends and novel approaches in early-stage drug discovery chemistry, will yield a powerhouse partner for innovative drug discovery solutions," commented Alex Drijver, CEO of ComInnex.

ComInnex’s technology expertise in flow chemistry, photochemistry and software development will expand X-Chem’s capabilities supporting the creation and delivery of innovative services for drug developers on a global scale.

(Press release, X-Chem, OCT 25, 2021, View Source [SID1234664774])

On October 25, 2021 OncoNano Medicine, Inc. reported that the Cancer Prevention and Research Institute of Texas (CPRIT) will convert $18.4 million in grant award funding into an equity investment in OncoNano (Press release, OncoNano Medicine, OCT 25, 2021, View Source [SID1234591901]). Proceeds of the financing will be used to support the clinical development of pegsitacianine, an innovative real-time imaging agent used in intraoperative surgical resection of solid tumors, and accelerate the advancement of the company’s first internal therapeutic development program, ONM-501, a novel immune therapeutic formulated with the company’s core delivery technology. This conversion will close OncoNano’s Series B financing round with $68.4 million in total committed capital.

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CPRIT awarded OncoNano with a grant totaling $15.4 million in 2019 to advance the company’s differentiated STING (STimulator of INterferon Genes) agonist development candidate, ONM 501, and provided a $9.97 million grant in 2020 to advance pegsitacianine, the company’s IV fluorescent nanoprobe for use in image-guided cancer surgeries. After this investment, OncoNano will still have $6.97 million of the 2020 grant available to advance the use of pegsitacianine in the visualization and resection of metastatic disease.

"CPRIT has played a crucial role in the establishment and advancement of the expanding life sciences research community in Texas. We are thrilled to continue our close partnership with CPRIT and welcome them as shareholders in OncoNano through this conversion of earlier grant awards to an equity investment in our over-subscribed Series B financing," said Martin Driscoll, CEO at OncoNano Medicine, Inc. "With the continued support of our investors, including this infusion of new capital from CPRIT, we can accelerate the development of our novel programs and expand our operations in North Texas. Our successful Series B financing will be instrumental in advancing pegsitacianine into a pivotal trial program in the U.S. and Europe and advance ONM 501 to a first in human trial in early 2023. We look forward to working together with CPRIT and our partners to bring important new interventions and treatments to cancer patients in need."

"CPRIT supported the initial research in Dr. Gao’s laboratory at The University of Texas Southwestern Medical Center that led to the therapies OncoNano Medicine is commercially developing today," said Wayne Roberts, CEO, CPRIT. "We’re thrilled to see the company translating that groundbreaking research into products to improve cancer patient care. With the additional equity investment in OncoNano Medicine, CPRIT helps secure Texas’ investment in, and ability to benefit from, this technology and the potential therapies it could produce."

About the Cancer Prevention and Research Institute of Texas
To date, CPRIT has awarded $2.9 billion in grants to Texas research institutions and organizations through its academic research, prevention and product development research programs. CPRIT has recruited 237 distinguished researchers, supported the establishment, expansion or relocation of 43 companies to Texas and generated over $5.7 billion in additional public and private investment. CPRIT funding has advanced scientific and clinical knowledge and provided 7.4 million life-saving cancer prevention and early detection services reaching Texans from all 254 counties. On November 5, 2019, Texas voters overwhelmingly approved a constitutional amendment to provide an additional $3 billion to CPRIT for a total $6 billion investment in cancer research and prevention.

On October 25, 2021 Varian, a Siemens Healthineers company, and the Cincinnati Children’s/UC Health Proton Therapy Center reported the completion of enrollment in FAST-01 (FeAsibility Study of FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases), the first human clinical trial of FLASH therapy (Press release, Varian Medical Systems, OCT 25, 2021, View Source [SID1234591917]).

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The FAST-01 trial, which is evaluating clinical workflow feasibility of the FLASH therapy and treatment-related side effects, met its enrollment target of 10 participants with bone metastases in the extremities. The clinical trial, informed by years of preclinical work, was designed by experts at Varian and multiple centers in the FlashForwardTM Consortium, including Cincinnati’s Children’s/UC Health Proton Therapy Center and the New York Proton Center.

The FAST-01 trial is being led by John C. Breneman, M.D., principal investigator, and Medical Director of the Cincinnati Children’s/UC Health Proton Therapy Center, UC Health radiation oncologist, and professor emeritus at the University of Cincinnati College of Medicine. "The completion of enrollment brings the clinical community one step closer to making an informed evaluation of FLASH therapy," said Dr. Breneman. "The team is looking forward to reviewing and sharing the findings, while also looking ahead toward the next clinical phase of research," he added.

The trial is supported by Emily Daugherty, M.D., assistant professor of radiation oncology at UC and a UC Health radiation oncologist, and Anthony Mascia, PhD, DABR, adjunct assistant professor of radiation oncology at UC and Director of Medical Physics at the Cincinnati Children’s/UC Health Proton Therapy Center.

"Clinical trial investigators have worked diligently to complete enrollment of FAST-01 over the last year. Achieving this significant milestone is a vital step forward to demonstrating the feasibility of using FLASH therapy in a clinical setting and not just in a laboratory," said Agam Sharda, Vice President of Flash Solutions at Varian. "We are grateful to the trial subjects who, by virtue of their participation, have contributed to the advancement of FLASH technology, for the potential future benefit of others who may one day need to undergo treatment for cancer."

"Initial findings indicate that the Varian ProBeam system, modified to deliver FLASH therapy, is performing as planned during the study. To date, none of the trial participants have suffered any serious adverse events related to FLASH," said Ricky Sharma, M.D. Ph.D., Vice President of Clinical Affairs at Varian. "There is still much work and research to be done, and we are eager to explore all the clinical trial data."

About FLASH Therapy

FLASH therapy, an experimental treatment modality delivering radiation therapy at ultra-high dose rates in typically less than one second, may be over 100 times faster compared to conventional radiation therapy. The concept of ultra-high dose rate radiation delivery has been studied for many years. Dedicated research and development by the team at Varian and the clinical collaborators in the FlashForward Consortium has led towards the advancement of FLASH therapy to the clinical study stage. The FlashForward Consortium, a 25-member group of institutions from around the world, includes over 150 experts in radiation oncology, translational sciences and medical physics. 

On October 25, 2021 Phyton Biotech reported that it will attend CPhI Worldwide 2021, both virtually and in-person to exhibit its capabilities and the wide range of applications for the company’s specialty fermentation solutions (Press release, Phyton Biotech, OCT 25, 2021, View Source [SID1234591934]).

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CPhI Worldwide is the largest pharmaceutical industry trade show, bringing together pharmaceutical industry suppliers and buyers from all over the world. This year, the conference is being held virtually and in-person in Milan, offering interested attendees two options to participate. The online portion of the conference will run from October 25-November 19 and the in-person portion will run from November 9-11.

Phyton Biotech has participated in the CPhI conference for over twelve years, and this year has put significant effort into showcasing its capabilities around specialty fermentation solutions and its broad application to pharmaceuticals, food ingredients, cosmetics, and traditional Chinese herbal medicines. This year, Phyton Biotech will be offering interested parties the opportunity to meet with its representatives in-person at the conference or in a virtual setting by visiting the online booth.

If you’re interested in visiting with representatives of Phyton Biotech in Milan, please email Jackie Labbe, VP Sales and Marketing, at [email protected] or Ron Chan, Business Development Manager, at [email protected].

Click here to visit Phyton Biotech’s booth at CPhI Online.

On October 25, 2021 Kiromic BioPharma, Inc. (NASDAQ: KRBP) ("Kiromic" or the "Company"), a clinical-stage fully integrated biotherapeutics company using its proprietary DIAMOND artificial intelligence (AI) platform to discover and develop cell and gene therapies with a therapeutic focus on immuno-oncology and other diseases, reported the results of a published pilot Phase 1 clinical trial that showed KiroVax/BSK01, Kiromic’s cell therapy cancer vaccine candidate, in combination with chemotherapy, demonstrated a significant progression free survival (PFS) benefit in one of the patients with metastatic pancreatic cancer who participated in the trial (Press release, Kiromic, OCT 25, 2021, View Source [SID1234591902]).

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Figure 1: stable disease in a pancreatic cancer patient with lung metastasis which initially increased in size to 270mm2 and then subsequently stabilized at 100mm2 after three months of treatment with KiroVax/BSK01 in combination with chemotherapy (Photo: Business Wire)
Figure 1: stable disease in a pancreatic cancer patient with lung metastasis which initially increased in size to 270mm2 and then subsequently stabilized at 100mm2 after three months of treatment with KiroVax/BSK01 in combination with chemotherapy (Photo: Business Wire)

The results from the pilot Phase 1 clinical trial demonstrated PFS of 7 months after treatment with KiroVAX/BSK01 and chemotherapy versus PFS of 3.9 months with second line chemotherapy.

"We are very proud of the results we achieved with KiroVax/BSK01 in addressing advanced metastatic pancreatic cancer. We believe that this is an exciting study, as we believe it demonstrates Kiromic’s early clinical success in the cellular therapy arena," stated Maurizio Chiriva Internati, DBSc, PhDs, President, Chief Executive Officer, Chairman, and Founder of Kiromic BioPharma. "By reaffirming this published clinical study we intend to illustrate Kiromic’s robust cellular therapy platform, and accordingly, we believe that KiroVAX/BSK01 may have a powerful and synergistic impact as an adjuvant to our novel and innate immunity cellular therapy pipeline. As we did with KiroVax/BSK01, we expect to be able to also progress Kiromic’s CAR-T therapies to the clinical arena."

Metastasis is the spread of cancer cells from the place where they first formed to another part of the body. In metastasis, cancer cells break away from the original (primary) tumor, travel through the blood or lymph system, and form a new tumor in other organs or tissues of the body. The new, metastatic tumor is the same type of cancer as the primary tumor.

The scans in figure 1 illustrate stable disease in a pancreatic cancer patient with lung metastasis which initially increased in size to 270mm2 and then subsequently stabilized at 100mm2 after three months of treatment with KiroVax/BSK01 in combination with chemotherapy, resulting in a progression free survival (PFS) of 7 months.

More information on this Phase 1 clinical trial may be found on the Company’s website.

Based on these encouraging results, the Company intends to evaluate the potential role of KiroVax/BSK01 as an adjuvant in combination with its growing innate immunity cellular therapy platform. Kiromic added to its innate immunotherapy portfolio by also developing multi-indication, Gamma Delta T-cells, which have the added commercial advantage of being "off-the-shelf" cellular therapeutic candidates to address solid tumor cancers.

About KiroVax/BSK01

KiroVax/BSK01, the Company’s Phase 1 cell therapy cancer vaccine candidate, consists of professional antigen presenting cells that are matured and pulsed with tumor specific antigens, yielding a tumor-targeted, next-generation cell therapy vaccine designed for the therapeutic treatment of multiple types of solid cancer tumors. The Company plans on progressing KiroVax/BSK01 into subsequent clinical trials.