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Autolus Therapeutics to Report Third Quarter 2021 Financial Results and Host Conference Call on November 3

On October 25, 2021 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported that it will release its third quarter 2021 financial results and operational highlights before open of U.S. markets on Wednesday, November 3, 2021 (Press release, Autolus, OCT 25, 2021, View Source [SID1234591904]).

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Management will host a conference call and webcast at 8:30 am ET/1:30 pm GMT to discuss the company’s financial results and provide a general business update. To listen to the webcast and view the accompanying slide presentation, please go to the events section of Autolus’ website.

The call may also be accessed by dialing (866) 679-5407 for U.S. and Canada callers or (409) 217-8320 for international callers. Please reference conference ID 6984737. After the conference call, a replay will be available for one week. To access the replay, please dial (855) 859-2056 for U.S. and Canada callers or (404) 537-3406 for international callers. Please reference conference ID 6984737.

AC Immune to Present at the Jefferies London Healthcare Conference

On October 25, 2021 AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, reported that Company management will participate in a fireside chat and one-on-one investor meetings during the virtual portion of the Jefferies London Healthcare Conference, taking place November 18-19, 2021 (Press release, AC Bioscience, OCT 25, 2021, View Source [SID1234591903]).

During the fireside chat, Prof. Andrea Pfeifer, CEO, AC Immune SA, will discuss the Company’s corporate strategy while highlighting its precision medicine approach, clinical stage vaccine programs in neurodegenerative diseases, and data from the Lauriet Phase 2 trial evaluating semorinemab in mild-to-moderate Alzheimer’s disease.

The fireside chat will be available on-demand for attendees during the virtual conference beginning on November 18, 2021. A replay of the fireside chat will also be available on the Events Page of AC Immune’s website following the conference’s conclusion.

Kiromic BioPharma, Now Clinical Stage, Reports Significant Progression Free Survival Benefit in Metastatic Pancreatic Cancer Patient Treated with KiroVax/BSK01, Company’s Phase 1 Cell Therapy Cancer Vaccine Candidate for Solid Tumors

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]).

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.

$18.4 Million Equity Investment by the Cancer Prevention and Research Institute of Texas

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.

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.

Alkermes Receives FDA Fast Track Designation for Nemvaleukin Alfa in Combination With Pembrolizumab for the Treatment of Platinum-Resistant Ovarian Cancer

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.

"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.