On January 28, 2021 Cancer Genetics, Inc. (the "Company") (Nasdaq: CGIX), a leader in drug discovery and preclinical oncology and immuno-oncology services, reported that it has entered into securities purchase agreements with certain institutional and accredited investors to raise approximately $10.0 million through the issuance of an aggregate 2,758,624 shares of its common stock (or pre-funded warrants in lieu thereof) and warrants to purchase up to an aggregate of 2,758,624 shares of common stock, at a combined purchase price of $3.625 per share of common stock (or common stock equivalent in lieu thereof) and associated warrant in a private placement priced at-the-market under Nasdaq rules (Press release, Cancer Genetics, JAN 28, 2021, View Source [SID1234576606]). The closing of the private placement is expected to occur on or about February 1, 2021, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The warrants have an exercise price of $3.50 per share, are exercisable immediately and have a term of five and one-half years.

The Company currently intends to use the net proceeds from the offering for general corporate purposes, including working capital and capital expenditures. The net proceeds are also expected to be available to the combined company once the previously announced merger with StemoniX closes, which is subject to stockholder approval.

The securities described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act") and Regulation D promulgated thereunder and in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

Under an agreement with the investors, the Company is required to file an initial registration statement with the Securities and Exchange Commission covering the resale of the shares of common stock to be issued to the investors by 9:30 a.m., Eastern Time, on February 2, 2021 and to use its best efforts to have the registration statement declared effective as promptly as practical thereafter, and in any event no later than 90 days after today in the event of a "full review" by the Securities and Exchange Commission.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state.

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.