On December 2, 2021 NOXXON Pharma N.V. (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported that hosted a Key Opinion Leader (KOL) event with Frank A. Giordano, M.D. on November 23, 2021, to discuss the combination of NOX-A12 and radiotherapy in brain cancer (glioblastoma, GBM) (Press release, NOXXON, DEC 2, 2021, View Source [SID1234596409]). Dr. Giordano is Director and Chair of the Department of Radiation Oncology, University Hospital Bonn, Germany, and lead investigator of the ongoing NOX-A12 Phase 1/2 study GLORIA in glioblastoma.

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"I have been involved in research and treatment of glioblastoma for many years, and we’ve not seen major changes in the management of this terrible disease for almost two decades. Although the development of an effective treatment for glioblastoma has proved extremely challenging, the data from the GLORIA study are very promising and, if confirmed in a pivotal clinical study, could be transformational for patients affected by this devastating disease," commented Dr. Frank Giordano.

"Dr. Giordano is a research pioneer and expert in precision radiation therapy and intraoperative irradiation of malignant tumors. He has brought together an exceptional team around the GLORIA study which was evident from the data presentation at SNO. His leadership of the trial will ensure that all the insights we can derive will be put to use in future trials of NOX-A12," commented Aram Mangasarian, CEO of NOXXON.

Glioblastoma is a devastating disease affecting 23,000 new patient each year in the US and Europe. The median overall survival for this patient population is only 14 months, and even lower in the MGMT unmethylated (chemotherapy refractory) patient subpopulation. The KOL webinar highlighted data from the Phase 1/2 GLORIA study presented at the Society for Neuro-Oncology (SNO) Annual Meeting, where tumor shrinkage for patients in the study was significantly stronger compared to those of a historic matched cohort that received standard of care. Eight of 9 MGMT unmethylated glioblastoma patients (89%) receiving NOX-A12 demonstrated tumor size reductions, while only 1 of 13 patients from a matched cohort (8%) showed any tumor shrinkage.

During the KOL event, Dr. Giordano emphasized several other important points, summarized in the Annex to this press release.

On December 2, 2021 Merus N.V. (Nasdaq: MRUS) ("Merus", "the Company", "we", or "our"), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), reported the publication of the abstract highlighting interim data, as of a July 14, 2021 cutoff, from the phase 1/2 trial of bispecific antibody MCLA-145 in patients with solid tumors (Press release, Merus, DEC 2, 2021, View Source [SID1234596408]). The e-poster will be presented at the ESMO (Free ESMO Whitepaper) Immuno-Oncology (ESMO IO) Congress 2021 being held December 8-11, 2021 in Geneva, Switzerland.

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Presentation Details:

Title: Phase I Dose Escalation Study of MCLA-145, a Bispecific Antibody Targeting CD137 and PD-L1 in Solid Tumors
Poster #: 136P

The e-poster will be available on the virtual platform, in the e-poster section as of Monday, December 6 at 6:00 am ET and on-site at the e-Poster stations starting on Wednesday, December 8. The poster will also be available on the Merus website.

The phase 1, open-label, single-agent clinical trial of MCLA-145 is ongoing. The trial consists of a dose escalation phase, followed by a planned dose expansion phase. MCLA-145 is the first drug candidate co-developed under Merus’ global collaboration and license agreement with Incyte, which permits the development and commercialization of up to 11 bispecific and monospecific antibodies from the Merus Biclonics platform. Merus retains full rights to develop and commercialize MCLA-145, if approved, in the United States; and Incyte holds full rights to develop and commercialize MCLA-145 outside the United States.

About MCLA-145
Discovered through an unbiased functional screening of multiple immunomodulatory target combinations, MCLA-145 is a Biclonics T-cell agonist that binds with high affinity and specificity to human PD-L1 and CD137 in preclinical models. The unique immunostimulatory profile of MCLA-145 derives from the potential to potently activate immune effector cells in the context of the tumor microenvironment while simultaneously blocking inhibitory signals in the same immune cell population.

On December 2, 2021 Onconova Therapeutics, Inc. (NASDAQ: ONTX), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, reported that early preliminary data from an investigator-initiated Phase 2 open label trial of rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC) were presented at the Austrian Society of Dermatology and Venerology Annual Conference 2021, which took place from November 25 – 27, 2021 (Press release, Onconova, DEC 2, 2021, View Source [SID1234596407]).

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RDEB is an ultra-rare condition caused by a lack of type VII collagen protein expression. Type VII collagen protein is responsible for anchoring the skin’s inner layer to its outer layer, and its absence leads to extreme skin fragility and chronic wound formation in RDEB patients. Over time, many of these patients develop squamous cell carcinomas (SCCs) that typically arise in areas of chronic skin wounding and inflammation. Preclinical investigations demonstrated overexpression of polo like kinase 1 (PLK1) in RDEB-associated SCC tumor cells. These tumors show a highly aggressive, early metastasizing course, making them the primary cause of death for these patients, with a cumulative risk of death of 70% and 78.7% by age 45 and 55, respectively1,2. These neoplasms show limited response rates of mostly short duration to conventional chemo- and radiotherapy as well as targeted therapy with epidermal growth factor and tyrosine kinase inhibitors1,3.

Data from the recent presentation are from a 24-year-old RDEB patient with a history of multiple, unresectable SCCs that were unresponsive to prior treatments including cemiplimab. Results showed that intravenously administered rigosertib had an acceptable safety profile and that the patient experienced sustained clinical and histological remission of all target lesions without signs of metastatic disease following 13 treatment cycles. The patient remains on study and the trial remains ongoing. The enrollment of additional patients is anticipated at sites in Salzburg, Austria; London, UK; and Philadelphia, Pennsylvania.

"Though the trial’s currently available data are from only a single patient, they represent an exciting and powerful finding that warrants further study," said Andrew South Ph.D., Associate Professor, Department of Dermatology & Cutaneous Biology, Thomas Jefferson University. "RDEB-associated SCC is an indication with an extremely high unmet medical need, as it is invariably fatal with treatment options that have so far yielded disappointing results. The data generated in preclinical models suggesting rigosertib’s robust activity against PLK1 have now been confirmed in the clinic and suggest that rigosertib may play a role in other more common cancers driven by PLK1."

The physicians caring for the patient, Dr. Bauer, Principal Investigator, and Dr. Laimer, Sponsor Medical Expert of the trial, added in a joint statement, "To see a complete response in a patient that has failed multiple prior therapies is highly encouraging and, together with preclinical data, suggests that rigosertib’s ability to inhibit PLK1 may position it as a novel treatment option that can significantly improve upon the current standard-of-care. We look forward to the further evaluation of this hypothesis through the continued advancement of the trial."

A copy of the poster, titled "Rigosertib for locally advanced/metastatic EB-associated SCC," is available on the "Scientific Presentations" section of the Onconova website.

References

Mellerio et al. Br J Dermatol. 2016 Jan; 174(1):56-67. doi: 10.1111/bjd.14104.
Fine et al. J Am Acad Dermatol. 2009 Feb; 60(2):203-11. doi: 10.1016/j.jaad.2008.09.035.
Stratigos et al. Eur J Cancer. 2020 Mar;128:83-102. doi: 10.1016/j.ejca.2020.01.008.

On December 2, 2021 IMV Inc. (NASDAQ: IMV; TSX: IMV), a clinical-stage company developing a portfolio of immune-educating therapies based on its novel DPX platform to treat solid and blood cancers, reported new translational data implicating B cells in the clinical benefit induced by MVP-S treatment in ovarian cancer patients (Press release, IMV, DEC 2, 2021, View Source [SID1234596405]). These data will be showcased at the European Society for Medical Oncology Immuno-Oncology (ESMO-IO) congress, December 8-10, 2021.

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"These data further extend our understanding of MVP-S therapeutic mechanism of action and strongly implicate B cells in the clinical benefit from MVP-S based therapy," said Jeremy Graff, Ph.D., Chief Scientific Officer at IMV Inc.

Oliver Dorigo, M.D., Ph.D., Director and Associate Professor, Division Gynecologic Oncology, Department of Obstetrics and Gynecology at the Stanford University, CA, commented: "Immunotherapies that provoke both a T and B cell response have the potential to provide patients with a new first line therapy for hard-to-treat cancers such as advanced, recurrent ovarian cancer. We are encouraged by the B cell infiltration demonstrated using MVP-S supporting its ability to create a strong immune response in patients who have failed on prior lines of treatment."

Twenty-two women with advanced, recurrent ovarian cancer were enrolled in the DeCidE1 study. In August of this year, IMV announced the completion of the study and shared final top results: Objective Response rates (ORR) of 26.3%, Median Overall Survival of 19.9 months, and a 45% overall survival rate at nearly 2 years. The abstract released today by the ESMO (Free ESMO Whitepaper)-IO congress highlights that:

Enriched B cell infiltration was detected in on-treatment tumor samples, especially in patients who showed tumor reduction; the strongest increase was observed within memory B cells,
The frequency of systemic plasmablasts increased on-study in most of assessed patients and was more pronounced in patients with tumor shrinkage,
Antibodies to all 5 survivin peptides were detected in plasma samples and were more prominent in patients with tumor shrinkage.
These translational data provide new insights into the therapeutic mechanism of action of MVP-S, indicating an important role for B cells in mediating MVP-S induced anti-cancer immunity. The next IMV-sponsored clinical trial in patients with advanced, recurrent ovarian cancer is expected to be initiated in 2022.

The poster will be presented by Oliver Dorigo, M.D., Ph.D., Director and Associate Professor, Division Gynecologic Oncology, Department of Obstetrics and Gynecology at the Stanford University, CA.

PosterTitle: Translational analyses of the DeCidE phase 2 clinical study in advanced ovarian cancer patients reveal a substantial role for B cells in the clinical benefit derived from maveropepimut-S (MVP-S) treatment
Poster Number: 51P
An e-poster presentation will be available on December 9, 2021, under the Scientific Publications & Posters section on IMV’s website

On December 2, 2021 Novartis reported that holds an investor event to provide a comprehensive overview of the company’s progress in advancing its industry-leading R&D engine (Press release, Novartis, DEC 2, 2021, View Source [SID1234596404]).

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Vas Narasimhan, CEO of Novartis, said "Novartis has transformed to become a focused medicines company, building depth in our core therapeutic areas and strength across key technology platforms. We expect to continue delivering strong operational performance, with 4%+ CAGR through to 2026*, driven by the momentum of our multi-billion dollar in-market growth drivers. Up to 20 new assets with significant sales potential could be approved by 2026, which will fuel the next phase of growth and address major unmet needs. We are building the foundation for long-term differential growth by investing in advanced technology platforms and data science. Novartis remains disciplined and shareholder focused in its capital allocation priorities, as we continue to deliver on our strategy".

New announcements at R&D Day 2021:

Cosentyx, our largest medicine by sales, showed topline results in moderate to severe hidradenitis suppurativa (HS), a potential new indication. Two Phase 3 studies (SUNRISE and SUNSHINE) met their primary endpoint, with more patients treated with Cosentyx achieving a HS Clinical Response (HiSCR), compared with placebo, at week 16. The safety of Cosentyx in HS was consistent with the therapy’s known safety profile. The trials are ongoing to 52 weeks and are expected to complete in H2 2022. Regulatory filings are planned for 2022.

Novartis presents T-Charge, a next generation CAR-T cell therapy platform, expected to increase CAR-T potency and have important process efficiencies to reduce turnaround time. In first-in-human trials to be presented at ASH (Free ASH Whitepaper) 2021, lead candidates YTB323 and PHE885 showed 75% Complete Response in Diffuse Large B-Cell Lymphoma (DLBCL) at three months and 100% Best Overall Response (BOR) in multiple myeloma, respectively. Novartis is developing T-Charge as the foundational platform for a wave of potentially transformative CAR-T cell therapies.2,3

Phase 3 study starts planned or ongoing across 5 core therapeutic areas include:

Cardio-Renal: Leqvio (CVRR-LDL-C), pelacarsen (CVRR-Lp(a)), iptacopan (C3G; IgAN)
IHD: Cosentyx (HS; GCA; lupus nephritis), ligelizumab (CSU; food allergy; CINDU), ianalumab (Sjögren’s syndrome), remibrutinib (CSU)
Neuroscience: Zolgensma (SMA IT), remibrutinib (MS)
Oncology: Kisqali (HR+/HER2- BC adjuvant), 177Lu-PSMA-617 (mCRPC, pretaxane; mHSPC), canakinumab (adjuvant NSCLC), NIS793 (PDAC), JDQ443 (NSCLC, 2/3L)
Hematology: Iptacopan (aHUS; PNH), Scemblix (CML 1L), sabatolimab (HR-MDS), and YTB323 (2L DLBCL)
(for abbreviations, see below)

Novartis announces a global co-development and co-commercialization agreement with UCB to bring disease-modifying therapies to people living with Parkinson’s Disease. The agreement covers UCB0599, a potential first-in-class, small molecule, alpha-synuclein misfolding inhibitor currently in Phase 2 clinical development. In addition, upon completion of the ongoing Phase 1 program, there is an opt-in to co-develop UCB7853, an anti-alpha-synuclein antibody. Both assets could transform care for 10 million people living with Parkinson’s Disease worldwide given the lack of disease-modifying therapies.4,5

Novartis also provides a comprehensive overview of its mid- and late-stage pipeline assets in five core therapeutic areas, highlighting: Leqvio, pelacarsen, iptacopan, Cosentyx, ligelizumab, remibrutinib, ianalumab, LNA043, branaplam, Zolgensma, Kisqali, 177Lu-PSMA-617, sabatolimab, JDQ443, TNO155, Scemblix and NIS793.

Additionally, Novartis highlights the continued expansion of its pipeline and capabilities in advanced technology platforms that are expected to drive multiple waves of biopharmaceutical innovation. These include: T-Charge, Targeted Protein Degradation, Cell Therapy, Gene Therapy, Radioligand Therapy and xRNA.