On September 12, 2022 Novo Nordisk reported that initiated a share repurchase programme in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (the "Safe Harbour Rules") (Press release, Novo Nordisk, SEP 12, 2022, View Source [SID1234619489]). This programme is part of the overall share repurchase programme of up to DKK 24 billion to be executed during a 12-month period beginning 2 February 2022.

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Under the programme initiated 3 August 2022, Novo Nordisk will repurchase B shares for an amount up to DKK 4.4 billion in the period from 4 August 2022 to 31 October 2022.

The details for each transaction made under the share repurchase programme are published on novonordisk.com.

With the transactions stated above, Novo Nordisk owns a total of 20,012,478 B shares of DKK 0.20 as treasury shares, corresponding to 0.9% of the share capital. The total amount of A and B shares in the company is 2,280,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 24 billion during a 12- month period beginning 2 February 2022. As of 9 September 2022, Novo Nordisk has since 2 February 2022 repurchased a total of 18,301,699 B shares at an average share price of DKK 769.09 per B share equal to a transaction value of DKK 14,075,566,796

Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 50,800 people in 80 countries and markets its products in around 170 countries. Novo Nordisk’s B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn and YouTube.

On September 12, 2022 Tubulis reported that Together with our collaborators at LMU Klinikum Munich, the German Cancer Consortium DKTK and the Leibniz-Forschungsinstitut für Molekulare Pharmakologie (FMP) we have published a new paper in Blood, highlighting the great potential of a next-generation ADC for the effective & safe treatment of acute myeloid leukemia (AML) in preclinical in vivo models (Press release, Tubulis, SEP 12, 2022, View Source [SID1234619486]).

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With a 5-year overall survival rate of 29.5% in America, AML treatment remains a challenge and the demand for new therapeutic options is high. Therefore, we utilized our novel P5 conjugation platform to create 20D9-ADC targeting a commonly occurring FTL3 mutation in AML. We could not only show a significant and durable tumor reduction but also reduced liver toxicity in preclinical cancer models. Moreover, a combined treatment with the marketed therapeutic midostaurin, a tyrosine kinase inhibitor, showed a synergistic effect broadening possible application scenarios for 20D9-ADC.

On September 12, 2022 Advaxis, Inc. (OTCQX: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, reported its financial results for the third quarter ended July 31, 2022 and provides a business update (Press release, Advaxis, SEP 12, 2022, View Source [SID1234619481]).

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Third Quarter Ended July 31, 2022 Financial Results and Recent Key Accomplishments:

Announced completion of first dose level in investigator-sponsored study in biochemically recurrent prostate cancer.
The preliminary clinical assessment showed that at the first dose level ADXS-504 monotherapy is safe and well tolerated.
The company plans to present clinical data and PSA values, for patients in both cohorts at a future medical conference.
Announced enrollment initiation for second dose level cohort of investigator-sponsored clinical trial of ADXS-504 (HOT Prostate) in biochemically recurrent prostate cancer at Columbia University.
Management Commentary

Kenneth A. Berlin, President and Chief Executive Officer of Advaxis said, "We continue to make progress in our development of ADXS-504. We announced that we have completed the first dose level in our investigator-sponsored trial of ADXS-504 in biochemically recurrent prostate cancer and the data suggest that this novel therapeutic is safe and well-tolerated. In addition, we have initiated enrollment for the second dose cohort and look forward to reporting safety and initial clinical data in the first half of 2023." Mr. Berlin added, "Given the measures we have undertaken to control expenses, we continue to expect that our cash runway will reach into the third fiscal quarter of 2024."

Third Quarter Ended July 31, 2022 Financial Results

Research and development expenses for the third quarter of fiscal year 2022 were $2.2 million compared with $1.7 million for the third quarter of fiscal year 2021. The increase of $0.5 million was primarily attributable to patient recruitment and manufacturing costs associated with our ADXS-503 clinical trial program. General and administrative expenses for the three months ended July 31, 2022 were approximately $2.1 million, compared to $2.7 million in the same three-month period in 2021. The decrease of $0.6 million primarily relates to legal and consulting fees with a previously proposed merger transaction and proxy solicitation fees in the prior period, partially offset by settlements from stockholder demand letters in the current period.

As of July 31, 2022, the Company had approximately $28.2 million in cash and cash equivalents.

On September 12, 2022 REVEAL GENOMICS, S.L., a Barcelona-based biotechnology start-up seeking to revolutionize precision oncology through biomarker innovation, reported another validation of HER2DX️, the world’s first specialized genomic test for HER2+ breast cancer (Press release, REVEAL GENOMICS, SEP 12, 2022, View Source [SID1234619479]).

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Her2dx
Her2dx
Prof. Valentina Guarneri from the University of Padova presented the data at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022 held in Paris, France. The data obtained from the analysis of tumor samples from the PerELISA phase II clinical trial showed that the HER2DX️ pCR-score and the HER2DX️ ERBB2-score predicted the probability of a patient responding to the triple-drug combination of trastuzumab, pertuzumab and letrozole, when given before surgery (i.e., the neoadjuvant setting). These findings in patients with newly diagnosed HER2+/hormone receptor positive (HER2+/HR+) breast cancer can help identify better who might benefit from dual HER2 blockade with trastuzumab and pertuzumab.

"This is the first study to show the ability of HER2DX️ to predict response to trastuzumab and pertuzumab in the absence of chemotherapy. The performance of the test in PerELISA is remarkable and supports the predictive value of the test in the neoadjuvant setting", said Prof. Guarneri.

Dr. Aleix Prat, CSO of REVEAL GENOMICS️, added: "The ability of HER2DX️ to predict response to trastuzumab-based neoadjuvant therapies has now been demonstrated in more than 590 patients across 5 studies. Our commitment is to keep providing patients and physicians with the highest level of test evidence to help them make the right treatment decision".

HER2DX️ in the PerELISA trial

The PerELISA trial led by Prof. Valentina Guarneri and Prof. Pierfranco Conte, investigators from the University of Padova, evaluated the efficacy of a chemotherapy-free neoadjuvant regimen of trastuzumab and pertuzumab in 64 patients with HER2+/HR+ breast cancer. The results of the trial were published in 2019 in Annals of Oncology.

Patients recruited in PerELISA were first treated with 2-weeks of letrozole monotherapy and a tumor biopsy was performed. A relative decrease of Ki67 of more than 20% was observed in 44 (69%) patients; these patients continued in the trial and received trastuzumab, pertuzumab and letrozole for 5 cycles, after which surgery was performed. The overall response to this non-chemotherapy-based regimen, measured as the rate of pathological complete response (pCR), was observed in approximately 1 out of 5 patients.

HER2DX️ was evaluated in pre-treatment baseline tumor samples from 55 patients. HER2DX️ pCR score fairly accurately predicted the probability of responding to 2-weeks of letrozole monotherapy (AUC=0.780). In addition, in 40 patients who responded to letrozole and received 5 cycles of trastuzumab, pertuzumab and letrozole, HER2DX️ pCR score and HER2DX️ ERBB2-score predicted the probability of response with a good level of accuracy (AUC=0.80 and 0.90, respectively). The rates of pCR in HER2DX️ pCR-high, -medium and -low groups were 100%, 46% and 8%, respectively. The rates of pCR in HER2DX️ ERBB2-high, -medium and -low groups were 53%, 8% and 0%, respectively.

Results obtained in this new study endorse the value of HER2DX️ in predicting response to anti-HER2-based treatments before surgery and supports the prospective incorporation of HER2DX️ in dedicated trials focused on HER2+ breast cancer.

About HER2DX️

HER2DX️ is the world’s first diagnostic test formulated specifically for HER2+ breast cancer. Marketed by REVEAL GENOMICS️ since January 2022, the HER2DX is a standardized 27-gene expression test for patients with early-stage HER2+ breast cancer.

HER2DX️ is a prognostic and predictive assay based on clinical and genomic data. The test integrates clinical information (i.e., tumor size and nodal status) with biological information tracking immune response, luminal differentiation, tumor cell proliferation, and expression of the HER2 17q12-21 chromosomal amplicon, including the ERBB2 gene.

HER2DX️ predicts:

Risk of relapse score (high vs. low): the risk of recurrence in patients with newly diagnosed HER2+ breast cancer.
pCR likelihood score (high vs. medium vs. low): the likelihood of a patient responding to anti-HER2-based treatment before surgery.
ERBB2 score (high vs. medium vs. low): the quantitative expression of ERBB2 mRNA across HER2-negative, HER2-low and HER2+ breast cancer.
About HER2+ breast cancer

HER2+ breast cancer accounts for 20% of all diagnosed breast tumors. This represents more than 390,000 new cases diagnosed worldwide every year, meaning that, on average, 3 women are diagnosed with HER2+ breast cancer every 4 minutes. HER2+ breast cancer is clinically and biologically heterogeneous, and standard clinical-pathological assessment has proven insufficient in capturing this heterogeneity. Understanding this biological heterogeneity is key to identifying the prognosis of each patient and the benefit from systemic therapies that target HER2.

About this research collaboration

This study was led by investigators of the Translational Genomics and Targeted Therapeutics (TGTT) group at the Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS, Barcelona, Spain) and the University of Padova (Italy). The HER2DX️ Research Use Only (RUO) test was performed at the TGTT laboratory.

On September 12, 2022 NeoImmuneTech, Inc. (NIT), a T cell-focused therapeutics company, reported data that suggests that NT-I7 plus pembrolizumab combination treatment enhances infiltration of PD-1+ T cells in cold tumors, at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in Paris, France, September 9-13, 2022 (Press release, NeoImmuneTech, SEP 12, 2022, View Source [SID1234619478]).

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While initial results from the phase 2a study NIT-110 had showed that subjects responding to NT-I7 plus pembrolizumab had enhanced lymphocyte infiltration, NeoImmuneTech conducted a new biomarker analysis of the immune-associated changes in the tumor microenvironment (TME) after NT-I7 plus pembrolizumab. The overall goal was to continue to understand how the combination of the long-acting human IL-7 and a checkpoint inhibitor (CPI) can induce a stronger immune response, since CPIs alone are usually considered ineffective in cold tumors with low T cell infiltration.

New data presented in a poster[1] at ESMO (Free ESMO Whitepaper) Congress 2022 suggest that the combination of NT-I7 and pembrolizumab induces infiltration of CD8 T cells into the tumor microenvironment in more than 80% of analyzed samples. The infiltration of CD8 T cells showed an increase of over 5-fold in over 50% of on-treatment samples after only one dose of NT-I7. Treatment with NT-I7 and pembrolizumab increased the immunogenicity of the TME. The analysis also revealed that treatment-induced reduction of the tumor volume was associated with the magnitude of CD8 T cell infiltration.

Dr. Se Hwan Yang, Ph.D., President and Chief Executive Officer of NeoImmuneTech said: "We continue to gather evidence to demonstrate that the combination of NT-I7 and pembrolizumab has promising clinical efficacy in very cold and immunosuppressive indications. Our latest data presented at ESMO (Free ESMO Whitepaper) indicate that the enhanced tumor-specific CD8 T cell infiltration into the tumor microenvironment may trigger enhanced clinical efficacy. This represents an encouraging path to potentially provide one day more therapeutic options to patients with cold tumors where CPIs are usually ineffective."

About NT-I7 (efineptakin alfa) (rhIL-7-hyFc)

NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7 and is being developed in oncologic and immunologic indications, where T cell amplification and increased functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T cell development and sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). NT-I7 exhibits favorable PK/PD and safety profiles, making it an ideal combination partner. NT-I7 is being studied in multiple clinical trials in solid tumors and as vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.