On October 3, 2022 Cardiff Oncology, Inc. (the "Company") Presented its corporate presentation (Presentation, Cardiff Oncology, OCT 3, 2022, View Source [SID1234621626]).

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On October 3, 2022 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported clinical data on the Company’s product candidate OMBLASTYS (131I-omburtamab) for the treatment of CNS/leptomeningeal metastasis from neuroblastoma (Press release, Y-mAbs Therapeutics, OCT 3, 2022, View Source [SID1234621625]). Data was presented by Dr. Kim Kramer from Memorial Sloan Kettering Cancer Center ("MSK") at the International Society of Pediatric Oncology ("SIOP") Annual Congress held September 28 through October 1, 2022, in Barcelona, Spain.

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In an oral presentation, Dr. Kramer presented interim results for 32 patients enrolled in the Company’s ongoing pivotal 101 multicenter study of omburtamab radiolabeled with Iodine-131. The results showed a twelve-month overall survival ("OS") of 73.5%, with a median follow-up of 25 months. Further, the interim results showed an objective response rate ("ORR") of 31.3% in the patients with measurable disease after central review based on Response Assessment in Neuro-Oncology ("RANO") criteria and European Association of Neuro-Oncology ("EANO")/European Society for Medical Oncology ("ESMO") criteria, and that a total of 75.0% of the patient with measurable disease achieved disease control. Serious Adverse Events ("SAE") was found in 40.6% of the patients and were mostly related to myelosuppression.

"We are excited to report these data that together with Study 03-133 is the basis of our BLA," said Thomas Gad, President, and Interim Chief Executive Officer. "The disease burden these patient and their families are facing represent a significant unmet medical need, which we hope to be able to address with OMBLASTYS after our PDUFA date on November 30, 2022.

Researchers at MSK developed omburtamab, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests in the compound.

On October 3, 2022 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported the 1st Symposium on IRAK4 in Cancer taking place virtually on October 7, 9:00am-1:00pm ET (Press release, Curis, OCT 3, 2022, View Source [SID1234621624]).

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Hosted by Drs. Guillermo Garcia-Manero, Hagop Kantarjian, and Amit Verma, this symposium will focus on IRAK4, an essential protein in innate immune response and promising target in the treatment of hematologic malignancies and other cancers. Experts across academia and industry will discuss IRAK4 biology, the present understanding of IRAK4 function, and the future of anti-cancer therapeutic development focused on this target.

"Following the success of the VISTA Symposium over the past two years, Curis is proud to be sponsoring the first symposium on IRAK4 in cancer," said James Dentzer, President, and Chief Executive Officer of Curis. "IRAK4 shows great promise as a potential immunotherapy target for the treatment of hematologic cancers, as well as solid tumors, and we look forward to advancing the conversation on how this promise is being translated into meaningful results for patients."

Symposium hosts:

Guillermo Garcia-Manero, M.D. – Symposium Co-Chair – Professor, Department of Leukemia; Chief, Section of Myelodysplastic Syndromes and Deputy Chair, Translational Research, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center
Hagop Kantarjian, M.D. – Symposium Co-Chair – Professor, Department Chair, and Samsung Distinguished University Chair in Cancer Medicine, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center; Associate Vice President for Global Academic Programs, MD Anderson Cancer Center
Amit Verma, M.B.B.S. – Symposium Co-Chair – Professor, Department of Oncology (Medical Oncology), Department of Medicine (Oncology & Hematology), and Department of Developmental & Molecular Biology, Albert Einstein College of Medicine; Director, Division of Hemato-Oncology, Montefiore Department of Oncology; Associate Director, Translational Science, Montefiore Einstein Cancer Center; Co-Director, Montefiore Einstein Blood Cancer Institute.
Joining our hosts will be the following speakers and participants:

Omar Abdel-Wahab, M.D. – Edward P. Evans Chair in MDS, Director, Memorial Sloan Kettering Cancer Center (MSK) for Hematologic Malignancies; Member, Human Oncology and Pathogenesis Program & Leukemia Service
Kian-Huat Lim, M.D., Ph.D. – Associate Professor, Division of Oncology, Department of Medicine, Washington University School of Medicine in St. Louis
Alan List, M.D. – Chief Medical Officer, Precision BioSciences
Robert Martell, M.D., Ph.D. – Head of Research and Development, Curis
Dr. Grzegorz Nowakowski, M.D., Professor of Oncology and Medicine, Division of Hematology, Mayo Clinic, Rochester, Minnesota, and Deputy Director, Clinical Research, Mayo Clinic Comprehensive Cancer Center
Marc Raaijmakers, M.D., Ph.D. – Professor of Hematology, Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands
Daniel Starczynowski, Ph.D. – Katherine Stewart Waters Endowed Chair of Hematologic Malignancies; Co-Leader, Hematologic Malignancies Program; Co-Chief Scientific Officer, Innovation Ventures; Associate Director for Basic Sciences, UC Cancer Center; Professor, Division of Experimental Hematology and Cancer Biology, Cincinnati Children’s Hospital Medical Center
Ulrich Steidl, M.D., Ph.D. – Professor, Department of Cell Biology, Department of Oncology, and Department of Medicine (Oncology & Hematology), Albert Einstein College of Medicine; Deputy Director, and Associate Director for Basic Science, Montefiore Einstein Cancer Center; Co-Director, Montefiore Einstein Blood Cancer Institute; Interim Director, Ruth L. and David S. Gottesman Institute for Stem Cell Research and Regenerative Medicine
The virtual event will address topics including:

IRAK4 Biology
Biology Overview – Amit Verma, M.B.B.S
Spliceosomes – Daniel Starczynowski, Ph.D.
IL1RAP as a common upstream mechanism of IRAK4 activation – Ulrich Steidl, M.D., Ph.D.
Role of IRAK4 in Innate Immunity
Myddosome signaling and the inflammasome – Alan List, M.D.
Inflammatory signaling and dysregulation & hematopoietic recovery- Marc Raaijmakers, M.D., Ph.D.
IRAK4 in Hematologic Cancers
Myelodysplastic Syndrome and Acute Myeloid Leukemia – Guillermo Garcia-Manero
B cell malignancies – Grzegorz Nowakowski, M.D.
Dissecting the Mechanism of Action – Omar Abdel-Wahab, M.D.
IRAK4 in Solid Tumors
Pancreatic cancer & biliary, colorectal and gastric cancers – Kian-Huat Lim, M.D., Ph.D.
Industry Panel: IRAK4 Therapeutic Strategies
IRAK4’s Role in Therapy Resistance – Daniel Starczynowski
IRAK4 Kinase Inhibitor – Robert Martell, M.D., Ph.D.

On October 3, 2022 Alloy Therapeutics, a biotechnology ecosystem company, reported that it has closed $42 million in Series D financing led by its existing investors 8VC and Mubadala Capital and joined by return investors Thiel Capital, Presight Capital, Founders Fund, and other unnamed family offices and sovereign wealth funds (Press release, Alloy Therapeutics, OCT 3, 2022, View Source [SID1234621623]). Alloy will use proceeds from the Series D financing to further support the drug discovery community with new pre-competitive drug discovery technologies in new biologic modalities and new partnership models designed to fuel innovation.

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Since Alloy’s Series C fundraise in March 2021, Alloy has expanded from its foundational antibody discovery technologies and discovery services into T-cell receptors (TCRs), with the launch of its Keyway TCR Discovery division, and genetic medicines through its collaboration with Dr. Sudhir Agrawal, the inventor of gapmer technology. Alloy has further expanded with three new research sites, in Basel, CH; Athens, GA; and San Francisco, CA.

"After three years of hard work and planning, we were proud to formally launch Keyway TCR Discovery in January 2022," said Dongxing Zha, CEO of Keyway and Alloy’s CTO for TCR Modalities. "We envision a future in 20 years where engineered TCRs and TCR mimics are as successful a modality as monoclonal antibodies are today. Keyway believes this is possible by providing unrestricted access to enabling technologies and discovery services without pharma having to spend billions of dollars to acquire companies for proprietary technologies and people."

In response to growing engagement from partners, Alloy will further leverage its Series D funds to continue to invest in expanded offerings across all six of its modalities. These will support the drug discovery community in the pursuit of multi-modal therapeutics while reducing or eliminating stacked downstream payments.

Through its affiliated venture studio, 82VS, Alloy supports scientist-entrepreneurs with seamless access to its cutting-edge technologies and discovery services. 82VS companies are often the first customers of Alloy’s innovations, having full access to the Alloy suite of technologies and discovery services to advance the best drug candidates and invent new applications that can benefit the broader Alloy ecosystem and, ultimately, patients and their caregivers.

To best serve the vast discovery needs of pharmaceutical companies, Alloy is pioneering an Innovation Subscription offering that gives its collaborators access to all current and future Alloy technology platforms for one flat, annual fee with no milestones or royalties. Partners benefit from Alloy as an ever-growing source of pre-competitive, foundational discovery technology. Alloy also supports complementary CROs, CDMOs and other discovery and development service providers as a critical part of the collaborative ecosystem to empower pharma in its mission to cure disease. In this subscription model, Alloy provides a new home for promising pre-competitive technologies and academic breakthroughs that have traditionally been underfunded or unavailable to all.

"Our Innovation Subscription model is available now as an exciting next step in furthering our collaborative mission and unlocking the potential for sharing foundational, pre-competitive drug discovery technologies with the global drug discovery community," said Alloy Therapeutics Chief Executive Officer and Founder Errik Anderson. "Including this financing, Alloy will have invested hundreds of millions of dollars in innovation that the largest pharma companies can access through a flat, annual subscription with no additional milestones or royalties. Emerging biotech and academics can access our tech through collaboration and more traditional and creative structures. Combined with the reinvestment of 100% of our revenue, including our subscription revenue, back into innovation and access to innovation, Alloy is a new for-profit business model that plays for the collective long game in a non-zero-sum way. The value of a subscription goes up every year, while the fees stay flat or even will decrease with scale. We price this so a single avoided royalty will pay for the entire platform access over a 20-plus-year period. We are grateful for our longstanding investors for supporting this vision of arming the drug discovery industry with the tools they need to discover and develop the best medicines for patients more quickly."

Alloy launched in 2017 to democratize foundational, pre-competitive technologies and capabilities for the discovery of therapeutic biologics and has since grown with over 130 partners across academia, biotech, and large biopharma. Its first platform was the ATX-Gx, a suite of transgenic mouse strains for human antibody discovery that was originally in-licensed from a major pharma company and made broadly available to the drug discovery ecosystem by Alloy, with open access to newly introduced strains. Through its DeepImmune Antibody Discovery services, Alloy helps partners find the best therapeutic antibody candidates against targets of interest, by deploying a bespoke blend of its proprietary in vivo, in vitro, and in silico technologies and workflows. In 2022, Alloy launched Keyway TCR Discovery as its second fully integrated technology and services offering for the discovery of therapeutic engineered TCRs and TCR mimics.

"Alloy has successfully expanded its flagship discovery offering in antibodies to multiple promising modalities to better serve the global drug discovery community," said Alaa Halawa, Head of Mubadala Capital’s US Ventures business, which first backed Alloy as an investor in its Series C financing. "We are proud to partner with the company as it executes on its promise of enabling scientists through the development of transformative drug discovery technologies. We look forward to seeing how the partnership with large pharma partners and other venture firms will leverage Alloy’s platform to enable their therapeutic discovery teams and emerging startups to advance the best medicines."

On October 3, 2022 Incyte (NASDAQ:INCY) reported that the Company has entered into an agreement to acquire Villaris Therapeutics, an asset-centric biopharmaceutical company seeded by Medicxi and focused on the development of novel antibody therapeutics for vitiligo (Press release, Incyte, OCT 3, 2022, View Source [SID1234621621]). Its lead asset, auremolimab (VM6), an anti-IL-15Rβ monoclonal antibody (mAb), is expected to enter clinical development in 2023.

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"People living with immune-mediated dermatologic diseases like vitiligo face significant challenges and we are committed to developing novel therapies like auremolimab, which may address these unmet needs."

Under the terms of the agreement, Incyte will acquire Villaris and the exclusive global rights to develop and commercialize auremolimab for all uses, including in vitiligo and other autoimmune and inflammatory diseases. Incyte will make an upfront payment of $70 million, and Villaris shareholders will be eligible for up to $310 million upon achievement of certain development and regulatory milestones, as well as up to an additional $1.05 billion in commercial milestones on net sales of the product.

"This acquisition complements our current portfolio, providing us the opportunity to further enhance treatment options for people with vitiligo, leveraging the expertise we established in the Dermatology space through our successful launch of Opzelura (ruxolitinib) Cream," said Hervé Hoppenot, Chief Executive Officer, Incyte. "People living with immune-mediated dermatologic diseases like vitiligo face significant challenges and we are committed to developing novel therapies like auremolimab, which may address these unmet needs."　

John E. Harris, M.D., Ph.D., Professor and Chair of Dermatology at the University of Massachusetts Chan Medical School and Founder of Villaris, commented, "I am really excited by the potential for auremolimab to treat vitiligo and other diseases with significant unmet need, and to see that it will now be driven forward with the capabilities and resources of Incyte. Back in 2019, I was very pleased to partner with Michèle Ollier and the Medicxi team to create Villaris as a single-purpose, asset-centric company with a laser focus on developing auremolimab for people with vitiligo who are in desperate need of better treatments. This next phase of development with Incyte will help to make that a reality."

"Our mission at Medicxi is to partner with world-class innovators like John Harris, who are developing novel treatments for major unmet needs," said Nick Williams, Partner at Medicxi. "Auremolimab has the potential to transform the lives of people living with vitiligo, and we are extremely excited to be partnering with Incyte, a pioneering company in this indication with the capabilities to explore the broader potential of auremolimab."

The agreement is subject to clearance by the U.S. antitrust authorities under the Hart-Scott-Rodino Act and will become effective as soon as this condition has been met.

PJT Partners advised Villaris on the transaction.

About Auremolimab

Auremolimab (VM6) is a novel, ultra-humanized, anti-IL-15Rβ (CD122) antibody designed to target and deplete autoreactive resident memory T cells (TRM) that has demonstrated efficacy as a treatment for vitiligo in preclinical models. IND-enabling studies are currently underway, and clinical development is expected to begin in 2023.

About Incyte Dermatology

Incyte’s science-first approach and expertise in immunology has formed the foundation of the company. In Dermatology, the Company’s research and development efforts are focused on leveraging our knowledge of the JAK-STAT pathway to identify and develop topical and oral therapies with the potential to modulate immune pathways driving uncontrolled inflammation and help restore normal immune function.

Currently, Incyte is exploring the potential of JAK inhibition for additional immune-mediated dermatologic conditions with a high unmet medical need, including hidradenitis suppurativa. To learn more, visit the Dermatology section of Incyte.com.