On 28 January 2021 mAbxience reported the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for two biosimilar medicinal products, bevacizumab (Alymsys) and bevacizumab (Oyavas), intended for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix (Press release, mAbxience, JAN 28, 2021, View Source [SID1234575101]).

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The applicant for Alymsys is Mabxience Research SL. The applicant for Oyavas is STADA Arzneimittel AG.

Alymsys will be available as 25 mg/ml concentrate for solution for infusion. Oyavas will be available as 25 mg/ml concentrate for solution for infusion. The active substance of Alymsys and Oyavas is bevacizumab, a monoclonal antibody (ATC code: L01XC07). It binds to vascular endothelial growth factor (VEGF), the key driver of vasculogenesis and angiogenesis, thereby inhibiting the binding of VEGF to its receptors on the surface of endothelial cells. Neutralising the biological activity of VEGF reduces vascularisation of tumours, normalises remaining tumour vasculature, and inhibits the formation of new tumour vasculature, thereby inhibiting tumour growth.

Alymsys and Oyavas are biosimilar medicinal products. They are highly similar to the reference product Avastin (bevacizumab), which was authorised in the EU on 12 January 2005. Data show that Alymsys and Oyavas have comparable quality, safety and efficacy to Avastin (bevacizumab).

The full indications for Alymsys and Oyavas are:

in combination with fluoropyrimidine-based chemotherapy for the treatment of adult patients with metastatic carcinoma of the colon or rectum.
in combination with paclitaxel for first-line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status, it should be refered to section 5.1.
in combination with capecitabine for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Alymsys and Oyavas in combination with capecitabine. For further information as to HER2 status, it should be referred to section 5.1.
in addition to platinum-based chemotherapy for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent NSCLC other than predominantly squamous cell histology.
in combination with erlotinib, for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous NSCLC with epidermal growth factor receptor (EGFR) activating mutations.
in combination with interferon alfa-2a for first-line treatment of adult patients with advanced and/or metastatic RCC.
in combination with carboplatin and paclitaxel for the front line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer.
in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents.
in combination with topotecan, or pegylated liposomal doxorubicin for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents.
in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix.
It is proposed that Alymsys and Oyavas be prescribed by physicians experienced in the use of antineoplastic medicinal products.

Detailed recommendations for the use of these products will be described in the summaries of product characteristics, which will be published in the European public assessment reports and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

Summaries of positive opinions are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinions.

On January 28, 2021 Onxeo S.A. (Euronext Growth: ALONX; Nasdaq First North: ONXEO), a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage Response (DDR), in particular against rare or resistant cancers, reported that it has secured a €5 million financing with a group of French banks, in the form of State Guaranteed Loans (Press release, Onxeo, JAN 28, 2021, View Source [SID1234575011]).

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This non-dilutive financing is part of the measures put in place by the French government to support French companies in the context of the COVID-19 pandemic. It will enable the Company to strengthen its cash position and extend its financial visibility through the 3rd quarter of 2022, taking into account programs already planned.

Nicolas Fellmann, Chief Financial Officer of Onxeo, commented: "We are very pleased with the commitment alongside our banking partners as well as Bpifrance and we would like to thank them. This significant financing allows the company to gain financial visibility good economic terms, while we are currently experiencing a challenging context. This funding secures the progress of our R&D programs with AsiDNA, which is currently being evaluated in two ongoing trials, and OX401, a new drug candidate from platON which has a particularly promising profile."

The loans are 90% guaranteed by the French government and have a maturity of 12 months. At the end of this initial period, the Company may, at its discretion, defer repayment of the principal amount for up to five additional years.

On January 28, 2021 Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, reported that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on patient enrollment and dosing in an ongoing Phase 1/2 dose-escalation clinical trial evaluating BPX-601 and rimiducid in patients with previously treated metastatic pancreatic or prostate cancer (Press release, Bellicum Pharmaceuticals, JAN 28, 2021, View Source [SID1234574988]).

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Bellicum worked diligently with the FDA over the past two months to respond to the clinical hold and has been informed by FDA that the company has satisfactorily addressed all clinical hold issues. Bellicum may now resume enrollment without modification to the current study protocol. The company plans to work with clinical investigators to resume patient enrollment.

"I am pleased that our team was able to address the FDA’s clinical hold questions in a timely manner, enabling us to evaluate BPX-601 in a cohort of patients with previously treated metastatic prostate cancer," said Rick Fair, President and CEO of Bellicum Pharmaceuticals. "I remain optimistic about the safety and potential clinical benefit of our BPX-601 product candidate in these patients."

About BPX-601

BPX-601, the company’s first GoCAR-T product candidate, incorporates iMC, Bellicum’s inducible co-activation domain. iMC (inducible MyD88/CD40) is designed to provide a powerful boost to T cell proliferation and persistence, production of immunomodulatory cytokines and enable the CAR-T to override key immune inhibitory mechanisms, including PD-1 and TGF-beta. BPX-601 is being evaluated as a treatment for pancreatic and prostate tumors expressing prostate stem cell antigen (PSCA).

On January 28, 2021 Scandion Oncology A/S ("Scandion" or the "Company") reported it has submitted an amendment to the Danish Medicines Agency regarding the PANTAX study (Press release, Scandion Oncology, JAN 28, 2021, View Source,c3275994 [SID1234574547]). The amendment is based on the learnings obtained from treating the first 12 patients in the CORIST study and will contribute to an optimization of the PANTAX clinical trials. The processing time for the amendment is expected to be approximately four weeks, which on top of the current impact of the COVID-19 pandemic could delay the planned readout from the study into Q4 2021.

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In Scandion’s PANTAX Ib study, patients with inoperable or metastatic pancreatic cancer are offered SCO-101 treatment as a first line therapy add-on to their standard chemotherapy. The submitted amendment will optimize the PANTAX study based on the learnings obtained from treating the first 12 patients in the CORIST study: The Company’s other study with SCO-101 in clinical phase. The amendment describes that patients will receive standard doses of chemotherapy with adjusted escalating doses of SCO-101 in cohorts of three patients in each dose level.

Updated timelines:

Scandion now expects delays in the planning of the PANTAX Ib study as a result of the additional time needed for approval of the amendment. The Company is also foreseeing potential delays due to uncertainties relating to the COVID-19 pandemic, which has impacted Scandion’s clinical sites. Scandion’s assessment is that the planned readout from the PANTAX study might be delayed into Q4 2021 from previously planned Q2-Q3 2021.

Scandion expands to international sites to secure recruitment at a higher pace:

In order to recruit patients at a higher pace, Scandion is planning to include more national and international oncology centers in the PANTAX study.

The first cohort in the Company’s CORIST study provided important learnings:
CMO Peter Michael Vestlev: "The PANTAX study is our second clinical study where SCO-101 is combined with chemotherapy. We have selected pancreatic cancer as one of the key indications for SCO-101 treatment, since these patients have a poor prognosis, with most patients being chemotherapy resistant at the time of diagnosis and with most of the remaining patients developing drug resistance during the course of therapy. Thus, the medical need for new treatment interventions is high and I am looking forward to finalizing this phase Ib study which will lead us to the phase II PANTAX clinical study."

CEO Bo Rode Hansen: "I find it very productive to internationalize our trials and that we use an adaptive design between our clinical protocols and thereby optimize our clinical trials. This ensures that we perform the clinical studies within the shortest time frame and reduces the cost of the studies to the benefit of patients and our shareholders."

This information is information that Scandion Oncology A/S is obliged to publish in accordance with the EU Market Abuse Regulation. The information was provided by the contact person above for publication on 28 January 2021.

On January 28, 2021 Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, reported a milestone publication in Cancer Discovery, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (Press release, Genocea Biosciences, JAN 28, 2021, View Source [SID1234574439]). The paper, titled, "An empirical antigen selection method identifies neoantigens that either elicit broad anti-tumor T cell responses or drive tumor growth," builds on years of preclinical research and clinical experience. It shows that ATLAS zeroes in on tumor mutations that are either neoantigens that activate anti-tumor responses or inhibitory antigens (Inhibigens) that are targets of pro-tumor responses, in both CD8+ (killer) and CD4+ (helper) T cells. This breakthrough improves neoantigen immunotherapies by potentially ensuring they are targeting the right neoantigens and excluding Inhibigens.

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ATLAS profiling of neoantigen-specific T cell responses in a cohort of lung cancer patients revealed three critical observations. First, many of these tumor-specific helper and killer T cells were inhibitory and shut off neighboring beneficial T cell responses. Second, none of the common features used for in silico predictions, currently in use for identifying neoantigens for vaccine or cell therapy targeting, accurately identify either Inhibigens or neoantigens. Third, patients have existing T cell responses to a much greater proportion of neoantigens than previously reported by others using epitope prediction algorithms.

Preclinical results demonstrate the biological relevance of Inhibigens. In the B16F10 mouse melanoma model, T cell responses to Inhibigens stifle protective anti-tumor immune responses in vivo. ATLAS-identified Inhibigens on their own, or more importantly, when combined in an otherwise protective vaccine formulation and administered to tumor-bearing mice, led to tumor growth that was comparable to, or in some cases surpassed, tumor growth in control animals. In contrast, when an ATLAS-identified anti-tumor neoantigen was added to the same formulation, tumor growth was either significantly delayed or completely abrogated, an effect that was durable and protected animals upon tumor re-challenge.

"To effectively treat cancer patients with neoantigen-targeted therapies, it is essential to identify the correct tumor antigens, both presented by the tumor and recognized by the immune system, against which to direct T cell responses," said Jessica Baker Flechtner, Chief Scientific Officer of Genocea. "Our research in both humans and mice has consistently shown that Inhibigens are negatively associated with responses to tumor immunotherapy and must be excluded from treatments because of their tendency to completely undermine efficacy. In this way, Genocea’s ATLAS platform is proving to be an invaluable tool in identifying what does – and what does not – belong in an immunotherapy."

More evidence of the relevance of ATLAS is emerging from Genocea’s GEN-009 neoantigen vaccine Phase1/2a trial evaluating its safety, immunogenicity and efficacy. The study authors found that participants immunized with GEN-009 generated broad CD4+ and CD8+ T cell responses to 99% of the vaccinated peptide neoantigens. Importantly, CD8+ killer T cell responses were measurable directly from the blood without any requirement for specialized amplification in the laboratory – a remarkable and unprecedented result based on peer-reviewed neoantigen vaccine clinical trial publications to date.

"Our ongoing Phase 1/2a study evaluates the GEN-009 vaccine in combination with standard-of-care immunotherapy regimens," said Thomas Davis, M.D., Chief Medical Officer of Genocea. "The ability to selectively elicit a T cell response against relevant personalized targets, those presented by the tumor and recognized by the T cells, while avoiding specific suppression of immunity by Inhibigens, is a novel and fundamental concept that can drive the development of safer and more effective vaccines and cell therapies for patients. The results to date suggest that GEN-011, a personalized cell therapy targeting up to 30 neoantigens, should have broad and potent anti-tumor effects in the ongoing phase 1 TITAN study."