On June 9, 2022 Curia, formerly AMRI, a leading contract research, development and manufacturing organization, and Replicate Bioscience, a company pioneering ways to prevent drug resistance in cancer and to treat autoimmune and inflammatory disorders and other diseases using self-replicating RNA (srRNA), reported that they will collaborate on a robust development platform for Replicate’s srRNA therapeutics (Press release, Replicate Bioscience, JUN 9, 2022, View Source [SID1234615838]). The strategic collaboration unites two RNA therapeutics industry leaders.

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As part of the collaboration, Curia’s experienced process development team will support the GMP production of Replicate Bioscience’s srRNA vectors up to eight-liter scale (8L), which can be used in Phase 1 through pivotal clinical trials. Curia’s global mRNA development and manufacturing facility is ISO-13485 certified and located near Boston, Massachusetts. This facility also supports innovators engaged in vaccine and other mRNA therapy development and manufacture through Phase 2 and 3, including GMP assays. Additional Curia facilities support manufacture of srRNA through commercial production scales.

"Replicate’s approach to srRNA is unique, in that we create our own virally-derived synthetic vectors to customize srRNAs to deliver specific proteins," said Replicate Co-founder and Chief Development Officer Andrew Geall, Ph.D., who previously has set up srRNA CMC frameworks for companies including Novartis, Synthetic Genomics, and Precision Nanosystems. "This customization has important therapeutic advantages—versatility of application, lower dosing, and longer duration of therapeutic effect compared to other RNA modalities—but requires built-for-purpose processes to solve the challenges of manufacturing longer RNAs. Curia’s unprecedented expertise in process development and end-to-end integration of longer RNAs makes them a perfect partner for us as we transition from research into clinical development and the production of our srRNA for trials in patients."

"The manufacture of these longer mRNAs is more technically challenging than non-replicating mRNAs and to date we have succeeded with mRNAs up to 16,000 bases," said Norman Garceau, Ph.D., Vice President, Global R&D Technology, Curia. "Curia’s platform offers versatility and streamlined manufacturing times that can handle such complex molecules. Our collaboration with Replicate Bioscience is enabling us to create entirely new methods of manufacturing longer RNAs. We have built our platform from the ground up, using our combined experience in biologics and chemistry to create end-to-end solutions covering mRNA synthesis, lipid synthesis, formulation, and liquid nanoparticle fill-finish. We are proud to apply our capabilities and expertise to support the Replicate Bioscience team and its innovative approach."

On June 9, 2022 DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Global Select Market: DBVT), a clinical-stage biopharmaceutical company, reported an aggregate $194 million private investment in public equity (PIPE) financing (corresponding to €181 million on the basis of an exchange rate of $1.0739 = €1.00 published by the European Central Bank on June 8, 2022) from the sale of 32,855,669 ordinary shares, as well as pre-funded warrants to purchase up to 28,276,331 ordinary shares (Press release, DBV Technologies, JUN 9, 2022, View Source [SID1234615927]). The ordinary shares will be sold to the purchasers at a price per ordinary share of €3.00 (corresponding to $3.22), and the pre-funded warrants will be sold to the purchasers at a pre-funded price of €2.90 (corresponding to $3.11) per pre-funded warrant, which equals the per share price for the ordinary shares less the remaining €0.10 exercise price for each such pre-funded warrant. Gross proceeds from the PIPE financing total approximately $194 million (corresponding to €181 million), before deducting private placement expenses. The closing of the PIPE financing is subject to customary closing conditions and is expected to close on June 13, 2022.

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The ordinary shares, including the ordinary shares issuable upon exercise of the pre-funded warrants, have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements. The Company has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the ordinary shares, including the ordinary shares underlying the pre-funded warrants.

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

Goldman Sachs Bank Europe SE and SVB Securities LLC acted as placement agents in the private placement.

Braidwell LP, funds advised by Baker Bros. Advisors LP and BpiFrance Participations SA, each a current shareholder of the Company, and Venrock Healthcare Capital Partners, have subscribed respectively an aggregate of $11 million, $38 million, $8 million and $30 million of ordinary shares. Braidwell LP, Baker Bros. Advisors LP and Venrock Healthcare Capital Partners have subscribed respectively an aggregate of $19 million, $41 million, $28 million of pre-funded warrants. Other investors in the private placement include Fairmount, RA Capital Management and Vivo Capital. The price of the ordinary shares and the price of the pre-funded warrants was equal to the average of the closing prices of the Company’s ordinary shares on Euronext Paris over the five (5) trading days prior to the launch of the global offering (i.e. June 8th, 7th, 6th, 3rd and 2nd), with a premium of 0.8%. The new ordinary shares and pre-funded warrants will be issued through a capital increase without shareholders’ pre-emptive rights by means of a reserved offering to specific categories of investors under the provision of Article L. 225-138 of the French Commercial Code and pursuant to the decisions of the Chief Executive Officer dated June 9, 2022 and the Company’s Board of Directors (Conseil d’Administration) dated June 8, 2022, in accordance with the delegations granted pursuant to resolution 18 adopted at the 2022 ordinary and extraordinary meeting of the Company’s shareholders (Assemblée Générale Mixte) held on May 12, 2022. The representatives of Baker Bros. Advisors LP and BpiFrance Participations SA to the Company’s Board of Directors (Conseil d’Administration) did not take part in the vote on the decisions at the meeting of the Board of Directors held on June 8, 2022.

Application will be made to list the new ordinary shares to be issued pursuant to the PIPE financing on the regulated market of Euronext Paris pursuant to a listing prospectus subject to the approval by the Autorité des Marchés Financiers ("AMF") and comprising (i) the 2021 universal registration document filed with the AMF on March 9, 2022 (document d’enregistrement universel 2021) under number D. 22-0081, as completed by an amendment to the 2021 universal registration document to be filed with the AMF on June 9, 2022 and (ii) a Securities Note (Note

d’opération), including (iii) a summary of the prospectus. Copies of the Company’s 2021 universal registration document, as amended, will be available free of charge at the Company’s head office located at 177-181 avenue Pierre Brossolette – 92120 Montrouge – France. The listing prospectus will be published on the AMF’s website at www.amf-france.org.

On June 9, 2022 Genmab A/S (Nasdaq: GMAB) reported that it has commenced a new arbitration under its license agreement with Janssen Biotech, Inc. (Janssen) for daratumumab (Press release, Genmab, JUN 9, 2022, View Source [SID1234615823]).

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This new arbitration follows from the award in the prior arbitration, where the tribunal ruled in favor of Janssen on the question as to whether Genmab is required to share in Janssen’s royalty payments to Halozyme Therapeutics, Inc. for its technology used in the subcutaneous formulation of daratumumab (marketed as DARZALEX FASPRO in the United States), cf. Company Announcement No 14. The tribunal based its ruling on the finding that DARZALEX FASPRO constitutes a new licensed product under the license agreement.

In this new arbitration, Genmab is consequently seeking an award of $405 million plus interest in accrued milestone payments for DARZALEX FASPRO and a declaration that it is entitled to a new 13-year royalty term from the date of DARZALEX FASPRO’s first commercial sale.

Under the agreement, the arbitration will be conducted in New York pursuant to the rules of the CPR Institute for Dispute Resolution for Non-Administered Arbitration before a panel of three arbitrators. While Genmab intends to vigorously enforce its rights, the outcome of any arbitration proceeding, as well as its duration, is inherently uncertain. The arbitration will be confidential, subject to the parties’ disclosure obligations under applicable law. Other than pursuant to these obligations, Genmab does not intend to comment or provide additional information regarding the arbitration until an award on the merits or other material order is issued in the arbitration or the arbitration is otherwise concluded. While the arbitration is pending, Genmab’s various collaborations with Janssen will continue.

On June 9, 2022 Molecular Targeting Technologies, Inc. (MTTI), a clinical stage oncology company, reported that it will highlight advances on its EvaTheraTM radiotheranostics platform at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) meeting in Vancouver, BC, on June 11-15, 2022 (Exhibit booth #1715) (Press release, Molecular Targeting Technologies, JUN 9, 2022, View Source [SID1234615839]). The EvaThera platform includes EBTATETM (177Lu-DOTA-EB-TATE) for Neuroendocrine Neoplasms (NENs), Hürthle cell thyroid and nasopharyngeal cancers and EBRGDTM (177Lu-DOTA-EB-RGD) for glioblastoma multiforme and non-small cell lung cancer

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A video featuring the EBTATE story (see link below) will be released at the meeting.

View Source

In addition, two abstracts highlighting MTTI’s EBTATE & our PET imaging agent,18F-glucarate, were selected for oral and poster presentations:

(i) Evaluation of Safety, Biodistribution and Dosimetry of a long-Acting Radiolabeled Somatostatin Analogue 177Lu-DOTA-EB-TATE with and without Amino Acid Infusion by Qingxing Liu, Yuanyuan Jiang, Koon Pak, Guochang Wang, Jingjing Zhang, Xiaoyuan Chen and Zhaohui Zhu (oral presentation)

EBTATE treatment without amino acid infusion, normally used in current treatments to block drug impact on non-target organs, has acceptable, minor effects on the kidneys and does no harm to kidney function. EBTATE may significantly improve patient comfort vs. current treatments.

(ii) Assessment of 18F-glucarate as a potential PET tracer for cancer imaging by Junling Li, Huaiyu Zheng, Levi Beverly, Brian Gray, Koon Pak and Chin K. Ng (poster presentation)

18F-glucarate uptake in both in vitro and in vivo correlated well with the degree of cell death and shows early tumor response to chemotherapy, enabling faster assessment of treatment efficacy.

On June 9, 2022 Anaveon, a clinical-stage immuno-oncology company, reported that the U.S. Food and Drug Administration (FDA) has cleared the IND application for ANV419-101, a Phase I/II mono treatment dose confirmation and combination dose-finding, global study, in patients with advanced cutaneous melanoma (Press release, Anaveon, JUN 9, 2022, View Source [SID1234616639]).

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ANV419, a potent IL-2Rbg agonist, preferentially proliferates CD8 and NK cells over regulatory T cells. The safety profile seen to date will allow for the administration of doses inducing maximal pharmacodynamic effects. The most frequent drug related AEs seen in an ongoing trial include mild Grade 1 chills and low-grade fever a few hours after dosing, which resolved with antipyretic treatment.

"We are excited to bring ANV419 to patients who are most likely to benefit from a truly IL-2Rbg-selective high-dose IL-2 approach," said Christoph Bucher, Chief Medical Officer at Anaveon. "We look forward to expanding our clinical program to the US and maximizing the therapeutic potential of ANV419 for patients suffering from cancer."

About the Phase I/II Clinical Trial

The clinical trial is a Phase I/II multiple arm, open-label study in patients with unresectable or metastatic cutaneous melanoma. The study will be a sequential, multi-part clinical trial to evaluate the safety and efficacy of different monotherapy doses of ANV419, as well as in combination with anti-PD1 or anti-CTLA4. Up to 130 patients will be enrolled in the clinical trial.