On February 8, 2021 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported that it has commenced an underwritten public offering of up to $100 million of its American Depositary Shares ("ADSs"), each ADS representing one ordinary share (Press release, Autolus, FEB 8, 2021, View Source [SID1234574929]). All ADSs to be sold in the proposed offering will be offered by Autolus. Autolus also intends to grant the underwriters a 30-day option to purchase up to an additional $15 million of ADSs at the public offering price, on the same terms and conditions. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed or the actual size or terms of the offering.

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J.P. Morgan and Wells Fargo Securities are acting as joint bookrunners for the offering. Kempen & Co, Mizuho Securities and Needham & Company are acting as co-managers.

The securities are being offered pursuant to an effective shelf registration statement that was previously filed with the Securities and Exchange Commission ("SEC"). A preliminary prospectus supplement relating to the securities will be filed with the SEC and will be available on the SEC’s website at www.sec.gov.

When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to these securities may be obtained for free from either of the joint book-running managers for the offering, J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at +1 866 803 9204 or by email at [email protected]; or Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 500 West 33rd Street, New York, New York, 10001, at (800) 326-5897 or email a request to [email protected]. For the avoidance of doubt, such prospectus will not constitute a "prospectus" for the purposes of Regulation (EU) 2017/1129 and will not have been reviewed by any competent authority in any member state in the European Economic Area.

This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.

On February 8, 2021 Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") reported the formation of ADNAB, Inc., a subsidiary Company, that will develop and commercialize a Mayo Clinic-developed technology platform for the manufacture of antibody-drug conjugates (ADC), each called an ADNAB (Press release, Sorrento Therapeutics, FEB 8, 2021, View Source [SID1234574827]).

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An ADNAB is an immune complex of nanoparticle albumin-bound drug products e.g., nab-paclitaxel, which are non-covalently conjugated with tumor-targeting monoclonal antibodies (mAb’s). The ADNAB platform was developed by Svetomir Markovic, M.D., Ph.D., and his research team at Mayo Clinic. To date, Dr. Markovic’s team have successfully formed nine (9) potential ADNAB candidates, including two (2) that are currently enrolling in an FDA supervised, investigator-initiated human trial.

Utilizing Sorrento’s G-MAB library of fully humanized monoclonal antibodies, the ADNAB platform will generate a broad portfolio of product candidates targeting liquid and solid tumors. "We believe this platform has broad potential." said Henry Ji, Ph.D., Chairman and CEO of the newly formed ADNAB, Inc. "Our Vision, is to extend the reach of this platform to therapeutic areas beyond oncology; we have already begun work on an ADNAB for auto-immune diseases."

Mayo Clinic physician Tom Habermann, M.D., serves as the Principal Investigator for Study LS1681, which is evaluating a rituximab-ADNAB in relapsed/refractory B-cell lymphomas. Relapsed-Refractory Diffuse Large B Cell Lymphoma (RR DLBCL), which accounts for approximately one-third of patients with DLBCL, remains a major cause of morbidity and mortality.

"I think this technology has the potential to be impactful" said Bradley J. Monk, M.D., Professor of Gynecologic Oncology at the University of Arizona College of Medicine. "I’m especially excited by the flexibility of this platform and I’m anxious to see what we might be able to do with a product that targets CA-125," added Dr. Monk.

"The Mayo team has spent years fine-tuning this technology and now we have a collaborator that can provide the resources necessary to accelerate and scale this program," said Svetomir Markovic, M.D., Ph.D., who discovered and developed the ADNAB platform technology.

"The published clinical studies testing this platform technology are encouraging and we are looking forward to working with the Mayo team on both the ongoing and future clinical studies. Unquestionably, Sorrento and Mayo share the common goal of utilizing this technology to develop multiple therapies for the possible benefit of cancer patients," noted Ji.

ADNAB, Inc. plans to file multiple INDs this year; and to request Breakthrough Therapy designation from the FDA in both ovarian and endometrial cancers.

On February 8, 2021, Iovance Biotherapeutics, Inc. (the "Company") reported that it entered into an Open Market Sale Agreement (the "Sales Agreement") with Jefferies LLC ("Jefferies") with respect to an "at the market" offering program, under which the Company may, from time to time in its sole discretion, issue and sell through Jefferies, acting as sales agent, up to $350.0 million of shares of the Company’s common stock, par value $0.000041666 per share (the "Common Shares") (Filing, 8-K, Iovance Biotherapeutics, FEB 8, 2021, View Source [SID1234574796]). The issuance and sale, if any, of the Common Shares by the Company under the Sales Agreement will be made pursuant to a prospectus supplement, dated February 8, 2020, to the Company’s registration statement on Form S-3ASR, originally filed with the Securities and Exchange Commission on May 27, 2020, which became effective immediately upon filing.

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Pursuant to the Sales Agreement, Jefferies may sell the Common Shares by any method permitted by law deemed to be an "at the market" offering as defined in Rule 415 of the Securities Act of 1933, as amended (the "Securities Act"). Jefferies will use commercially reasonable efforts consistent with its normal trading and sales practices to sell the Common Shares from time to time, based upon instructions from the Company (including any price or size limits or other customary parameters or conditions the Company may impose).

The Company will pay Jefferies a commission of up to 3.0% of the gross sales proceeds of any Common Shares sold through Jefferies under the Sales Agreement.

The Company is not obligated to make any sales of Common Shares under the Sales Agreement. The offering of Common Shares pursuant to the Sales Agreement will terminate upon the earlier to occur of (i) the issuance and sale, through Jefferies, of all Common Shares subject to the Sales Agreement and (ii) termination of the Sales Agreement in accordance with its terms.

The Sales Agreement contains representations, warranties and covenants that are customary for transactions of this type. In addition, the Company has agreed to indemnify Jefferies against certain liabilities, including liabilities under the Securities Act and the Securities Exchange Act of 1934, as amended.

The foregoing description of the Sales Agreement is not complete and is qualified in its entirety by reference to the full text of the Sales Agreement, a copy of which is filed herewith as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The legal opinion of DLA Piper LLP (US) as to the legality of the Common Shares is being filed as Exhibit 5.1 to this Current Report on Form 8-K.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the securities discussed herein, nor shall there be any offer, solicitation or sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

On February 8, 2021 SOPHiA GENETICS, a global leader in Data-Driven Medicine, reported a clinical research partnership initiative with the Spanish Lung Cancer Group to apply its radiomics and multimodal analysis capabilities to predict response to neoadjuvant chemoimmunotherapy in resectable stage IIIA non-small cell lung cancer (NSCLC) (Press release, Sophia Genetics, FEB 8, 2021, View Source [SID1234574766]).

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SOPHiA GENETICS and the Spanish Lung Cancer Group Team Up to Explore the Predictive Potential of Multimodal Health Data in Resectable Stage IIIA Non-Small Cell Lung Cancer
The collaboration with the Spanish Lung Cancer Group (Grupo Español de Cáncer de Pulmón — GECP), a Spanish cooperative group for the research on lung cancer, is to show the potential of SOPHiA Radiomics — a groundbreaking application that analyzes medical images for research use — put to use in an additional retrospective analysis of the data from the phase 2 NADIM clinical trial (NCT03081689) (the NADIM trial).

The NADIM trial, funded by Bristol-Myers Squibb and part of the European Union’s Horizon 2020 research and innovation program, aimed to assess the antitumor activity and safety of neoadjuvant chemoimmunotherapy for resectable stage IIIA NSCLC. The important results recently published in The Lancet Oncology supported the addition of neoadjuvant nivolumab to platinum-based chemotherapy in patients with resectable stage IIIA NSCLC. This very aggressive type of cancer is unfortunately terminal in most patients with locally advanced staged disease; these results could therefore support a change of perception of locally advanced lung cancer as a potentially lethal disease to one that is curable.

Additional data are expected to be generated through the analysis of the radiology images of NADIM patients through the SOPHiA Radiomics Platform. These data will then be combined with clinical, biological, and genomics data, and multimodal machine learning models will be developed to predict response to neoadjuvant treatment, using baseline and pre-surgery data. The predictive analysis will also aim to stratify patient cohorts with regard to progression-free and overall survival.

"We are very happy to collaborate in this innovative and revolutionary project that opens the door to a new precision medicine. Certainly, this partnership will improve the knowledge relating to the treatment for this group of patients and will allow to approach the best prospects for curing early-stage non-small cell lung cancer (NSCLC)," said Dr. Mariano Provencio, Head of the Medical Oncology Department at Puerta de Hierro University Hospital in Madrid and lead investigator of the NADIM trial.

"We are very excited to apply our radiomics and multimodal analytics capabilities to such an important clinical question," said Prof. Thierry Colin, Vice-President of Radiomics Research at SOPHiA GENETICS. "In the Spanish Lung Cancer Group, we have found visionary partners that clearly see the promise of next-generation health data such as radiomics being married with tech-enabled solutions in artificial intelligence to generate entirely novel clinical insights for the benefit of oncology patients."

"Unlocking the synergistic potential of multimodal health data through artificial intelligence holds revolutionary promise for the future of personalized medicine in oncology and many other health conditions. We are inspired by the potential to positively impact on patients by supporting their care providers in predicting the best course of treatment," said Dr. Philippe Menu, Chief Medical Officer at SOPHiA GENETICS.

The NADIM trial involved 18 centers from the Spanish Lung Cancer Network that will contribute their data to the joint project.

Results from the additional analysis of NADIM trial data are expected to be available later this year.

On February 8, 2021 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a synthetic lethality-focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported the effectiveness of the Investigational New Drug (IND) application for a Phase 1 clinical trial to evaluate IDE397, a potential best-in-class methionine adenosyltransferase 2a (MAT2A) inhibitor (Press release, Ideaya Biosciences, FEB 8, 2021, View Source [SID1234574764]).

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IDE397 is IDEAYA’s most advanced synthetic lethality program, and being developed in the clinic for cancer patients harboring methylthioadenosine phosphorylase (MTAP) deletion, which is prevalent in approximately 15% of all solid tumors. IDEAYA is targeting a Q1 2021 First-Patient-In for the Phase 1 clinical trial of IDE397 in patients having solid tumors harboring MTAP deletion.

IDEAYA also announced that Matthew Maurer, M.D., has joined the company as Vice President, Head of Clinical Oncology and Medical Affairs. "Matt brings extensive clinical development and oncology experience in both the pharmaceutical industry and academia. His background in clinical oncology will be invaluable as we advance IDE397 clinically in MTAP-deletion and target to select the Development Candidate for our wholly-owned PARG program in 2021," said Yujiro S. Hata, President and Chief Executive Officer at IDEAYA Biosciences.

Dr. Maurer has over 15 years of experience in oncology and previously worked at Bristol Myers Squibb (BMS) where he most recently led the clinical development of nivolumab and ipilimumab late phase studies in renal cell carcinoma and prostate cancer. Prior to BMS, Dr. Maurer was a physician investigator and Assistant Professor of Medicine at Columbia University College of Physicians and Surgeons, where he served as a breast cancer specialist. Dr. Maurer obtained his undergraduate degree from Princeton University and his medical degree from Mount Sinai School of Medicine, and then completed his residency at Columbia University Medical Center.

"I am thrilled to join the IDEAYA team and look forward to advancing the IDE397 clinical program and the broader Synthetic Lethality pipeline, including the PARG program, which has a potential application in breast cancer, an indication in which I have clinical experience as an oncologist," said Matthew Maurer, M.D., Vice President, Head of Clinical Oncology and Medical Affairs at IDEAYA Biosciences.