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.

On October 25, 2021 BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) reported that management will participate in four upcoming virtual investor conferences (Press release, BioMarin, OCT 25, 2021, View Source [SID1234591918]). An audio webcast of the presentations will be available live. You can access the webcasts at: View Source An archived version of the remarks will also be available through the Company’s website for a limited time following the conference.

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On October 25, 2021 TCR2 Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage cell therapy company with a pipeline of novel T cell therapies for patients suffering from solid tumors, reported a clinical trial collaboration agreement with Bristol Myers Squibb (NYSE: BMY) to evaluate gavo-cel in combination with Opdivo (nivolumab) and Yervoy (ipilimumab) in its planned Phase 2 clinical trial in treatment refractory mesothelin-expressing solid tumors (Press release, TCR2 Therapeutics, OCT 25, 2021, View Source [SID1234591935]). The primary objective of the Phase 2 trial is to evaluate the efficacy of gavo-cel in patients with unresectable, metastatic or recurrent mesothelin-expressing cancers including non-small cell lung cancer (NSCLC), ovarian cancer, malignant pleural/peritoneal mesothelioma (MPM) and cholangiocarcinoma. TCR2 is sponsoring the Phase 2 trial.

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"We are very pleased to establish a collaboration agreement with Bristol Myers Squibb for our Phase 2 clinical trial as this enables us to evaluate the potential synergy between gavo-cel and immune checkpoint inhibitors," said Garry Menzel, Ph.D., President and Chief Executive Officer of TCR2 Therapeutics. "The new standard of care established by Opdivo in difficult-to-treat diseases is important for cancer patients around the world, including the recent approval of the combination of Opdivo and Yervoy as first-line treatment for adult patients with unresectable malignant pleural mesothelioma. We look forward to determining whether gavo-cel can provide additional clinical benefit to these patients."

The planned Phase 2 clinical trial will evaluate the antitumor activity and better characterize the safety of gavo-cel at the selected recommended Phase 2 dose (RP2D). Patients will receive gavo-cel at the RP2D and will be enrolled according to their cancer diagnosis to four distinct cohorts: NSCLC, ovarian cancer, MPM and cholangiocarcinoma. Patients with NSCLC, ovarian cancer, or cholangiocarcinoma will receive the combination of gavo-cel and Opdivo. Patients with MPM will be treated in three cohorts: the first will administer gavo-cel as a single agent, the second will treat patients with both gavo-cel and Opdivo, and the third will treat patients with gavo-cel, Opdivo and Yervoy.

Opdivo and Yervoy are trademarks of Bristol-Myers Squibb Company.

On October 25, 2021 Aadi Bioscience, Inc. ("Aadi") (Nasdaq: AADI), a clinical-stage biopharmaceutical company focusing on precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, reported the appointment of Loretta M. Itri, M.D., FACP, to the role of Chief Medical Officer (CMO) (Press release, Aadi Bioscience, OCT 25, 2021, View Source [SID1234591887]). Dr. Itri’s extensive career spans clinical and regulatory global-leadership roles at both major pharmaceutical and biopharmaceutical companies. Most recently, Dr. Itri was Chief Medical Officer at Immunomedics, Inc, where she oversaw the development program and approval of TRODELVY, the first TROP-2 directed antibody-drug conjugate for the treatment of unresectable locally advanced or metastatic triple-negative breast and urothelial cancers. Immunomedics was subsequently acquired by Gilead Sciences, Inc.

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"We are fortunate at Aadi to be able to tap into the experience of another valued former colleague from Immunomedics," stated Behzad Aghazadeh, Ph.D., Managing Partner and Portfolio Manager, Avoro Capital and member of Aadi’s Board of Directors. "Loretta’s insight and experience was critical to Immunomedics gaining FDA approval for TRODELVY. I am excited that she will be lending her extensive development experience to Aadi as we advance nab-sirolimus (ABI-009) forward."

"We are thrilled to have Loretta join Aadi as CMO," stated Neil Desai, Ph.D., Founder, President and Chief Executive Officer of Aadi. "Her deep drug development experience in targeted oncology therapeutics will be crucial as we drive forward our registrational study in TSC1 and TSC2 inactivating alterations. Her unparalleled expertise and track record in designing and executing clinical studies will be invaluable as we broaden the applications of our mTOR inhibitor."

Prior to joining Immunomedics, Dr. Itri was the Executive Vice President of Global Health Sciences and Regulatory Affairs at The Medicines Company (acquired by Novartis) where she oversaw the development and regulatory approval of a variety of products, including the early development of inclisiran, and other cardiovascular drugs and antibiotics. Before that, she was President of Pharmaceutical Development and Chief Medical Officer at Genta, Inc., playing a vital role in the development of diverse therapeutic agents that helped treat conditions such as breast cancer and chronic lymphocytic leukemia.

Dr. Itri has also previously served as Senior Vice President of Medical and Regulatory Affairs at Johnson & Johnson’s Pharmaceutical Research Institute, where she oversaw the development and approval of several therapeutic products, including Procrit, Cladribine, and Tramadol. In addition, she served as Senior Vice President of Clinical Affairs and Chief Medical Officer for Ortho Biotech Inc., where she was responsible for the hematology, oncology and immunology product lines. Dr. Itri began her career at Hoffmann-La Roche, where she served in various positions of increasing responsibility, including most recently as Assistant Vice President of Clinical Development in immunology, virology, hematology, and oncology.

Dr. Itri commented, "I feel fortunate to be joining Aadi at this critical time and ahead of the November 26, 2021 PDUFA target date of its investigational candidate for PEComa. I look forward to leveraging my drug development expertise to further advance and expand the opportunities for ABI-009. I believe that ABI-009 represents both a significant advance for patients with PEComa and potentially also a transformative medicine for patients with solid tumors harboring TSC1 or TSC2 inactivating alterations. With an outstanding group of new colleagues at Aadi, I look forward to initiating our registrational trial PRECISION-1 in this population."

Dr. Itri received her M.D. from New York Medical College, completed her medical residency at SUNY-Stony Brook and her fellowship in medical oncology at Memorial Sloan-Kettering Cancer Center where she was an adjunct attending physician for more than 15 years. Dr. Itri has served as a member of the National Cancer Institute Board of Scientific Counselors in both the Division of Cancer Treatment and the Division of Cancer Prevention and Control. She is the author or co-author of numerous articles in peer-reviewed journals, book chapters and abstracts related to the clinical development of therapeutic agents.