On February 10, 2021 Adicet Bio, Inc. ("Adicet") (Nasdaq: ACET), a biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer and other diseases, reported the pricing of an underwritten public offering of 9,230,770 shares of its common stock at a public offering price of $13.00 per share (Press release, Adicet Bio, FEB 10, 2021, View Source [SID1234574902]). Adicet also granted the underwriters a 30-day option to purchase up to an additional 1,344,743 shares of common stock at the public offering price, less underwriting discounts and commissions. The gross proceeds from the offering, before deducting underwriting discounts and commissions and offering expenses, are expected to be approximately $120.0 million, excluding any exercise of the underwriters’ option to purchase additional shares. All of the shares in the offering are to be sold by Adicet. The offering is expected to close on or about February 12, 2021, subject to customary closing conditions.

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In connection with the offering, Adicet intends to enter into a stock purchase agreement with certain existing investors for $15.0 million of shares of its common stock at a price per share equal to the public offering price, with an initial closing for certain investors to be held simultaneous with the closing of the offering and a subsequent closing for certain additional investors.

The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. The consummation of the private placement will be contingent upon the closing of the offering.

Guggenheim Securities is acting as book-running manager for the offering. Canaccord Genuity LLC, Wedbush Securities Inc. and JMP Securities LLC are acting as co-managers for the offering.

The shares are being offered by Adicet pursuant to a shelf registration statement that was previously filed with, and subsequently declared effective on February 12, 2019 by, the U.S. Securities and Exchange Commission (SEC). A preliminary prospectus supplement relating to and describing the terms of the offering was filed with the SEC on February 9, 2021. The final prospectus supplement relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offered securities may be obtained, when available, from Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by telephone at (212) 518-9544, or by email at [email protected].

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

On February 10, 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 healthcare-focused institutional investors to raise approximately $17.5 million through the issuance of 2,777,778 shares of its common stock at a purchase price of $6.30 per share of common stock in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Cancer Genetics, FEB 10, 2021, View Source [SID1234574891]). The closing of the offering is expected to occur on or about February 16, 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 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 shares described above are being offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-239497) filed with the Securities and Exchange Commission (SEC) on June 26, 2020 and declared effective on July 21, 2020. The offering of the securities described herein will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the securities being offered will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (646) 975-6996, or email at [email protected].

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 February 10, 2021 BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical need, reported its results for the fourth quarter and full year 2020 (Press release, BerGenBio, FEB 10, 2021, View Source [SID1234574887]).

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A presentation and live webcast by BerGenBio’s senior management will take place at 10.00 am CET today, please see below for details.

Operational Highlights – fourth quarter (including post-period end)

First patient enrolled in South Africa and India as part of Company sponsored randomised Phase II trial assessing bemcentinib as a potential treatment for COVID-19 (October)

Randomised Phase II study will recruit 120 hospitalised COVID-19 patients across five sites in South Africa and seven sites in India
Post period-end, the trial’s independent data monitoring committee has met twice and confirmed no safety concerns and recommended the continuation of patient recruitment into the study
First patient dosed with bemcentinib in combination with pembrolizumab in relapsed malignant pleural mesothelioma investigator sponsored Phase IIa study (October)

Trial assessing bemcentinib in combination with pembrolizumab, in relapsed malignant pleural mesothelioma patients, sponsored by the University of Leicester and in collaboration with Merck.
Part of world’s first molecularly stratified umbrella study in mesothelioma named Mesothelioma Stratified Therapy (MiST)
Updated clinical and translational analysis from Phase II bemcentinib combination study in NSCLC (BGBC008) Cohort B presented at annual SITC (Free SITC Whitepaper) meeting (November)

The combination with pembrolizumab was shown to be well tolerated and signs of clinical activity were observed in evaluable CPI-refractory composite AXL (cAXL) positive NSCLC patients
Median progression-free survival among cAXL positive patients was reported as 2.5 fold greater than cAXL-negative patients
Updated clinical data from two Phase II studies of bemcentinib in AML and MDS patients presented at ASH (Free ASH Whitepaper) 2020 (December)

In relapsed AML patients, interim data from an ongoing study (BGBC003 cohort B5, bemcentinib combination with LDAC) reported clinical benefit rate of 8/11 (73%) in evaluable patients, with encouraging duration of treatment of 6.2 months in CR/CRi patients.
In the High Risk MDS patient cohort of the BERGAMO investigator led study, an Overall Response Rate of 36% and CR/CRi rate of 18% was reported, median response duration was reported as over 8 months with some patients remaining on study, and encouraging biomarker correlation was also reported.
ACCORD 2 clinical trial in the UK in hospitalised COVID-19 patients reinitiated patient recruitment

Funding for the study was suspended by UKRI in July due to the falling number of hospitalised COVID-19 patients, but reinstated in September following a rise in UK cases, and the trial recruitment resumed in December.
Q4 2020 / FY 2020 Financial Highlights

(Figures in brackets = same period 2019 unless otherwise stated)

Revenue amounted to NOK 0.6 million (NOK 0.2 million) for the fourth quarter and NOK 0.6 million (NOK 8.9 million) for the full year 2020
Total operating expenses for the fourth quarter were NOK 72.4 million (NOK 59.3 million) and total operating expenses for the full year 2020 amounted to 261.7 million (NOK 213.3 million)
The operating loss for the quarter came to NOK 71.8 million (NOK 59.1 million) and NOK 261.1 million (NOK 204.4 million) for the full year 2020
Cash and cash equivalents amounted to NOK 721.6 million at the end of December 2020 (NOK 253.6 million by end of December 2019)
Richard Godfrey, Chief Executive Officer of BerGenBio, commented: ""In the final quarter of 2020, we maintained our focus on progressing the broad Phase II clinical development programme investigating our lead product candidate bemcentinib, a highly selective, potent, once-a-day oral inhibitor of AXL kinase, in several indications and settings.

During the period we continued to make progress in our clinical trials, presenting new data and translational research at several leading international congresses. As reported in November at The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) conference, the combination of bemcentinib and CPI pembrolizumab continued to report encouraging clinical activity, the median progression-free survival was 2.5 times greater for cAXL positive patients. At the American Society of Hematology (ASH) (Free ASH Whitepaper) conference (ASH) (Free ASH Whitepaper) in December, we were pleased to share updated preliminary clinical data from two ongoing Phase II studies of bemcentinib in acute myeloid leukaemia (AML) and high-risk myelodysplastic syndrome (MDS), in particular the clinical benefit rate of over 70% in relapsed AML patients. Collectively, these continuing promising data readouts strengthen our confidence in bemcentinib as a potential therapy in these relapsed haematological cancer indications.

"In addition, we have been able to push ahead with two trials assessing the potential of bemcentinib as a treatment for hospitalised patients with COVID-19. We remain optimistic that bemcentinib could play an important role in the global effort to combat the disease.

"I am encouraged by our continued research and clinical development progress which has of course been achieved against the backdrop of the COVID-19 pandemic. I am pleased to report that our operations and trials have all been able to remain active throughout the year and our mitigation plans have been successful in limiting the impact of the pandemic on operations."

The Q4 2020 Financial report and presentation are available on the Company’s website in the Investors/Financial Reports section and a recording of the webcast will be made available shortly after the webcast has finished.

On February 10, 2021 GEMoaB, a biopharmaceutical company focused on the development of next-generation immunotherapies for hard-to-treat cancers, reported the acceptance of a presentation on translational data obtained from their ongoing Phase I study of their lead asset UniCAR-T-CD123 in relapsed/refractory acute myeloid leukemia (rrAML) at the 2021 AACR (Free AACR Whitepaper) Annual Meeting, being held from April 9-14 (Press release, GEMoaB, FEB 10, 2021, View Source [SID1234574880]).

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The data of UniCAR-T-CD123 in rrAML provided as poster presentation at the AACR (Free AACR Whitepaper) congress highlight key features of GEMoaB’s rapidly switchable universal CAR-T platform UniCAR and focus on expansion kinetics, cytokine profiles and UniCAR-T persistence in heavily pre-treated rrAML patients.

"We have recently presented our initial clinical data on UniCAR-T-CD123 in rrAML, highlighting the advantages of our rapidly switchable UniCAR platform in terms of an extremely encouraging benefit/risk profile, the ability to abrogate and avoid acute and long-term side effects and the ability to re-activate UniCAR-T cells during a 2nd cycle with our soluble adapter molecule termed Targeting Module," said Dr. Armin Ehninger, Chief Scientific Officer of GEMoaB. "We are running an extensive translational program with our clinical studies to fully understand the unique mode-of-action of UniCAR and are very pleased that the data obtained are underpinning our vision of a highly active, controllable and persistent CAR-T product for multiple hematology and solid tumor indications as we enter into the next phase of our clinical development program."

Phase I studies of UniCAR-T-CD123 for the treatment of rrAML and UniCAR-T-PSMA directed against CRPC and other PSMA-expressing late-stage solid tumors are ongoing.

About the UniCAR-T-CD123 Phase IA Study

This first-in-human phase I study is an open-label, non-randomized, dose-finding study designed to evaluate the safety and activity of UniCAR-T-CD123 in up to 16 CD123 positive patients with relapsed/refractory AML. Its purpose is to determine the maximum tolerated dose (MTD) as well as Dose limiting toxicities (DLT) of the combined application of a single dose of UniCAR-T and the continuous infusion of TM123 over 25 days. Application follows post bridging therapy and lymphodepletion. The study also investigates response rates, response duration, persistence of UniCAR-T cells over time as well as the ability to rapidly switch UniCAR-T cells on and off in case of side effects through stopping TM infusion. The study takes place at selected Phase I, Acute Leukemia and CAR-T experienced University centers in Germany. The study is supported by a grant from the German Federal Ministry for Education and Research (project "TurbiCAR"). To learn more about the trial, please visit clinicaltrials.gov.

About UniCAR

GEMoaB is developing a rapidly switchable universal CAR-T platform, UniCAR, to improve the therapeutic window and increase efficacy and safety of CAR-T cell therapies in challenging cancers, including acute leukemias and solid tumors. Conventional CAR-T cells depend on the presence and direct binding of cancer antigens for activation and proliferation. An inherent key feature of the UniCAR platform is a rapidly switchable on/off mechanism (less than 4 hours after interruption of TM supply) enabled by the short pharmacokinetic half-life and fast internalization of soluble adaptors termed TMs. These TMs provide the antigen-specificity to activate UniCAR gene-modified T-cells (UniCAR-T) and consist of a highly flexible antigen-binding moiety, linked to a small peptide motif recognized by UniCAR-T.

On February 10, 2021 I-Mab (the "Company") (Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, reported that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has cleared the Investigational New Drug (IND) application for TJ210/MOR210 to initiate a phase 1 clinical trial to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of TJ210/MOR210 monotherapy in patients with advanced solid tumors (Press release, I-Mab Biopharma, FEB 10, 2021, View Source [SID1234574879]).

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TJ210/MOR210 is a monoclonal antibody developed by MorphoSys that is directed against complement factor C5a receptor 1 (C5aR1). Produced in the tumoral microenvironment, its ligand C5a acts as a chemoattractant to recruit tumor-promoting cells such as myeloid-derived suppressor cells, M2 macrophages and neutrophils. TJ210/MOR210 is designed to induce anti-tumor properties by blocking the activation and migration of C5aR1-expressing myeloid cells.

Preclinical studies have shown that targeting the C5aR-C5a axis exerts anti-tumor activity with immune checkpoint inhibitors. Furthermore, in vitro activity was observed for blocking the C5a/C5aR pathway also at very high C5a concentrations, leading to a long duration of action. TJ210/MOR210 demonstrated a good safety profile with no observed adverse effects up to the highest dose tested in non-clinical safety studies.

The phase 1 clinical trial is an open-label dose escalation study with multiple doses to evaluate the safety, tolerability, and PK/PD and preliminary efficacy of TJ210/MOR210 in subjects with relapsed or refractory advanced solid tumors. I-Mab is also conducting a phase 1 dose escalation clinical trial in patients with r/r advanced solid tumors in the U.S. The first patient in the U.S. study was dosed in January 2021.

"We are pleased to obtain the IND clearance for TJ210/MOR210 into clinical trials in China. Now with clinical trials both in the U.S. and China, we expect to accelerate this investigational drug development. The clinical data generated will enable us to further explore TJ210/MOR210’s potentials in treating patients with cancers, especially those who failed with or relapsed from the existing therapies," said Dr. Joan Shen, CEO of I-Mab.

About TJ210/MOR210

TJ210/MOR210 is a novel human antibody directed against C5aR1 derived from MorphoSys’s HuCAL Platinum technology. C5aR1, the receptor of the complement factor C5a, is investigated as a potential new drug target in the field of immuno-oncology and autoimmune diseases. Tumors have been shown to produce high amounts of C5a, which, by recruiting and activating myeloid-derived suppressor cells (MDSCs), M2 macrophages and neutrophils, is assumed to contribute to an immune-suppressive pro-tumorigenic microenvironment. TJ210/MOR210 is intended to block the interaction between C5a and its receptor, thereby potentially neutralizing the immune suppressive function of C5a and enabling immune cells to attack the tumor.

HuCAL Platinum is a registered trademark of MorphoSys AG.