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 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 Alkermes plc (Nasdaq: ALKS) reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to nemvaleukin alfa (nemvaleukin), the company’s novel, investigational, engineered interleukin-2 (IL-2) variant immunotherapy, in combination with pembrolizumab, an anti-PD-1 antibody, for the treatment of platinum-resistant ovarian cancer (Press release, Alkermes, OCT 25, 2021, View Source [SID1234591900]). The FDA previously granted Fast Track designation and Orphan Drug designation to nemvaleukin for the treatment of mucosal melanoma.

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"This Fast Track designation in platinum-resistant ovarian cancer highlights the potential clinical utility of nemvaleukin in combination with pembrolizumab in this difficult-to-treat disease for which there is no approved immunotherapy and there remains significant need for new treatment options," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes. "We are excited to initiate our planned ARTISTRY-7 phase 3 trial in platinum-resistant ovarian cancer, as we advance nemvaleukin toward potential registration and seek to help patients living with this disease."

Fast Track is an FDA process designed to facilitate the development, and expedite the review, of potential therapies that seek to treat serious conditions and fill an unmet medical need. A drug candidate that receives Fast Track designation is eligible for more frequent communication with the FDA throughout the drug development process and a rolling and/or priority review of its marketing application if relevant criteria are met. For more information on Fast Track designation, please visit the FDA’s website, available at View Source

About Nemvaleukin Alfa (nemvaleukin)
Nemvaleukin is an investigational, novel, engineered fusion protein comprised of modified interleukin-2 (IL-2) and the high affinity IL-2 alpha receptor chain, designed to preferentially expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by selectively binding to the intermediate-affinity IL-2 receptor complex. The selectivity of nemvaleukin is designed to leverage the proven anti-tumor effects of existing IL-2 therapy while mitigating certain limitations.

About the ARTISTRY Clinical Development Program
ARTISTRY is an Alkermes-sponsored clinical development program evaluating nemvaleukin as a potential immunotherapy for cancer. The ARTISTRY program is comprised of multiple clinical trials evaluating intravenous and subcutaneous dosing of nemvaleukin, both as a monotherapy and in combination with the anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with advanced solid tumors. Ongoing trials in the ARTISTRY program include: ARTISTRY-1, ARTISTRY-2, ARTISTRY-3 and ARTISTRY-6.

On October 25, 2021 Exact Sciences Corp. (NASDAQ: EXAS) reported that data from modeling analyses that demonstrate Cologuard (mt-sDNA), with its included patient navigation system, provides a greater reduction in incidence and mortality from colorectal cancer (CRC) compared to annual fecal immunochemical test (FIT), when it included outreach, with or without a mailed annual FIT, using real world adherence rates in a simulated Medicaid population (Press release, Exact Sciences, OCT 25, 2021, View Source [SID1234591899]). Cologuard remained cost-effective in all the real-world adherence scenarios modeled. The modeling analyses were consistent with the CISNET Colorectal Working Group models when using 100% adherence rates.

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Cologuard Data Models Impact on CRC Incidence, Mortality and Cost Effectiveness in a Medicaid Population
The Exact Sciences Laboratories Patient Navigation Program features on-demand phone support, reminder phone calls, texts and emails at no additional cost with each Cologuard test ordered.

These new data, generated from the CRC-AIM microsimulation model, will be presented in an ACG Presidential Award-winning poster titled, "Cost-Effectiveness of Stool-Based Colorectal Cancer Screening Using Reported Real-World Adherence Rates in a Medicare Population." (P1181)

"Colorectal cancer screening rates need improvement, and they are particularly low in vulnerable populations,"1 said Paul Limburg, M.D., Chief Medical Officer, Screening at Exact Sciences. "Exact Sciences Laboratories’ patient navigation program answers any question around sample collection and offers phone and text reminders to complete the testing process. It is a way to help all patients, including vulnerable patients, prioritize their health and get up to date with CRC screening."

Colorectal cancer is the second deadliest cancer impacting both men and women in the U.S. Earlier detection of colorectal cancer through effective screening has been shown to improve clinical outcomes.2,3

All abstracts and posters presented at the meeting can be accessed through this link. Additional Cologuard abstracts accepted for presentation include:

Adherence to colorectal cancer screening and associated healthcare resource utilization, a longitudinal analysis in US Medicare population with ten years follow-up (PO246)

Colorectal cancer screening rates and associated characteristics among US Medicare beneficiaries aged 66-75 years old in 2016-2018 (PO245)

Impact of mt- sDNA in a colorectal cancer screening clinical practice: a real-world survey (PO247)

Multitarget stool DNA testing has a high positive predictive value for colorectal neoplasia on the second round of testing (P1318)

Initial colorectal cancer screenings after turning 50-year-old and follow-up screening patterns after positive FIT or multitarget stool DNA testing among average-risk population (P1330)

Colorectal cancer screening and adherence rates among average-risk population enrolled in a national health insurance provider during 2009-2018 (P2345)

On October 25, 2021, AnaptysBio, Inc. ("AnaptysBio") reported that it entered into a Royalty Purchase Agreement (the "Royalty Purchase Agreement") with Sagard Healthcare Royalty Partners, LP ("Sagard") to monetize a portion of AnaptysBio’s future JEMPERLI royalties and milestones under AnaptysBio’s Collaboration and Exclusive License Agreement, as amended (the "Collaboration Agreement"), with Tesaro, Inc. and Tesaro Development, Ltd., each a wholly-owned subsidiary of GlaxoSmithKline ("GSK") (Filing, 8-K, AnaptysBio, OCT 25, 2021, View Source [SID1234591898]).

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Upon closing of the transaction with Sagard, which is anticipated by the end of 2021, Sagard will pay AnaptysBio $250 million upfront in exchange for royalties payable to AnaptysBio under the Collaboration Agreement on annual global net sales of JEMPERLI below $1 billion starting October 2021. The royalty rate applicable below the $1 billion annual net sales threshold is 8%. Sagard may also receive up to a total of $105 million in potential cash milestones, of which $15 million are subject to certain future JEMPERLI regulatory filing and approval milestones and up to $90 million are subject to certain commercial sales milestones due prior to JEMPERLI achieving the $1 billion in annual global net sales threshold.

Royalties payable above $1 billion JEMPERLI annual global net sales, which are paid by GSK at 12% to 25%, and certain milestones payable on annual sales at or above $1 billion are retained by AnaptysBio and are not subject to the Royalty Purchase Agreement. Royalties and milestones due upon development and commercialization of the AnaptysBio-generated anti-TIM-3 antagonist (cobolimab) or anti-LAG-3 antagonist (GSK4074386) antibodies under the Collaboration Agreement, including in combination with JEMPERLI, are also not subject to the Royalty Purchase Agreement. In addition, royalties due to AnaptysBio from GSK’s global net sales of ZEJULA (niraparib) are excluded from the Royalty Purchase Agreement. The closing of the transaction is subject to the satisfaction of customary closing conditions.

The aggregate JEMPERLI royalties and milestones to be received by Sagard under this Agreement is capped at certain fixed multiples of the upfront payment based upon time. Once Sagard receives an aggregate of either $312.5 million (125% of the upfront) by the end of 2026, or $337.5 million (135% of the upfront) during 2027 or $412.5 million (165% of the upfront) at any time after 2027, the Royalty Purchase Agreement will expire resulting in AnaptysBio regaining all subsequent JEMPERLI royalties and milestones.

The foregoing summary of the Royalty Purchase Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Royalty Purchase Agreement and the Collaboration Agreement. A copy of the Collaboration Agreement is available as Exhibit 10.10 to AnaptysBio’s Registration Statement on Form S-1, as amended, filed on May 10, 2016 and as Exhibit 10.16 to AnaptysBio’s Annual Report on Form 10-K for the year ended December 31, 2020. A copy of the Royalty Purchase Agreement will be filed as an exhibit to AnaptysBio’s Annual Report on Form 10-K for the year ended December 31, 2021.