On June 17, 2020 Brickell Biotech, Inc. ("Brickell") (Nasdaq: BBI), a clinical-stage pharmaceutical company focused on developing innovative and differentiated prescription therapeutics for the treatment of debilitating skin diseases, reported the pricing of an underwritten public offering of 17,500,000 shares of common stock or common stock equivalents (which includes pre-funded warrants to purchase shares of common stock in lieu of shares of common stock) and investor warrants to purchase up to an aggregate of 17,500,000 shares of common stock (Press release, Vical, JUN 17, 2020, View Source [SID1234561204]). Each share of common stock (or pre-funded warrant in lieu thereof) is being sold together with one investor warrant to purchase one share of common stock at a combined offering price of $1.15, for total gross proceeds of approximately $20.1 million, before underwriting discounts and commissions and offering expenses payable by Brickell. The offering is expected to close on or about June 22, 2020, subject to the satisfaction or waiver of customary closing conditions.

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Brickell anticipates using the net proceeds from the offering for research and development, including clinical trials, working capital and general corporate purposes.
Oppenheimer & Co. Inc. is acting as the sole book-running manager in connection with the offering and Lake Street Capital Markets, LLC is acting as lead manager.
The securities will be offered pursuant to a registration statement on Form S-1 (File No. 333-238298), which was declared effective by the Securities and Exchange Commission (the "SEC") on June 17, 2020, and an additional registration statement filed with the SEC on June 17, 2020 pursuant to Rule 462(b) under the Securities Act of 1933, as amended. The offering is being made solely by means of a prospectus. A preliminary prospectus relating to and describing the terms of the offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus and, when available, copies of the final prospectus relating to this offering can be obtained at the SEC’s website at www.sec.gov or from Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad St., 26th Floor, New York, NY 10004, by telephone at (212) 667-8055 or by email at [email protected].
This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.

On June 17, 2020 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported that Ian Taylor, Ph.D., Chief Scientific Officer, will participate in a fireside chat at the BMO 2020 Prescriptions for Success Healthcare Conference on Tuesday, June 23 at 8:30 a.m. ET (Press release, Arvinas, JUN 17, 2020, View Source [SID1234561172]).

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A live audio webcast of the presentation will be available here and on the Company’s website at www.arvinas.com. A replay of the webcast will be archived on the Arvinas website for 30 days following the presentation.

On June 17, 2020 Orca Bio reported that it closed on a Series D financing worth $192 million, bringing the total raised since 2016 to $300 million (Press release, ORCA Biosystems, JUN 17, 2020, View Source [SID1234561188]). The round was co-led by Lightspeed Venture Partners and an undisclosed investor. New and existing investors included 8VC, DCVC Bio, ND Capital, Mubadala Investment Company, Kaiser Foundation Hospitals, Kaiser Permanente Group Trust and IMRF.

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Orca focuses on high-precision allogeneic cell therapy with the goal of being able to replace a patient’s diseased blood and immune system with a healthy one. Its approach is based on a proprietary mix of cells that can cure disease and eliminate dangerous side effects.

The funds will be used to continue advancing its cell therapy pipeline and novel manufacturing platform. The technology sorts blood at the single-cell level with a high level of purity. There can be a trade-off when it comes to bone marrow transplants, with using only a few cells with great precision or using a lot of cells and giving up some of that precision. The most common approach is to have less precision in order to utilize large numbers of cells to treat patients. Orca’s technology processes large numbers of cells while maintaining single-cell precision.

The most advanced program is TRGFT-201, a formulation of T-cells that includes subsets of regulatory T-Cells. Currently there is an ongoing Phase Ib trial in advanced hematologic malignancies that is projected to wrap in September 2022. The second trial is of OGFT-001, which is in a Phase I trial in acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndromes and acute leukemia. It is projected to be completed on July 1, 2022.

"The capital we have raised has formed the launch pad for a world-class, fully integrated allogeneic cell therapy company differentiated from all others," said Ivan Dimov, co-founder and chief executive officer of Orca Bio. "Replacing bone marrow transplants is a logical first step in next-generation allogeneic cell therapy. While a conventional bone marrow transplant administers an uncontrolled cell product, Orca Bio has been the first to deliver a high precision cell therapy. We are initially focused on advancing two clinical programs in patients with blood cancers and have successfully treated the largest-ever number of patients with a high precision cell therapy. We believe our approach has the potential to transform allogeneic cell therapy, and thus the treatment of not only blood cancer, but also many other diseases with significant unmet need, such as a variety of genetic diseases and autoimmune disorders."

The company’s leadership team also includes Nate Fernhoff, chief scientific officer and Jeroen Bekaert, chief operating officer, who all met at Stanford University and launched the company in 2016.

Orca’s board of directors and scientific advisory board includes Irv Weissman, director of the Stanford Institute for Stem Cell Biology and Regenerative Medicine; Ted Love, president and chief executive officer of Global Blood Therapeutics (GBT); Jonathan MacQuitty, Venture Partner at Lightspeed; Joe Jimenez, former chief executive officer of Novartis; Mike Knapp, founder and former chief executive officer of Caliper Life Sciences; Ronald Martell, president and chief executive officer of Nuvelution Pharma; Alex Kolicich, Founding Partner at 8VC; and Rich Klausner, founder and chief executive officer of Lyell Immunopharma, founder and director of Juno Therapeutics and GRAIL, former director of the National Cancer Institute.

"With precise reconstitution using highly defined cell preps and a swift reboot of the patient’s immune system, Orca Bio’s product candidates have the potential to eliminate fatal side effects, such as graft-versus-host disease, and infections commonly associated with bone marrow transplants while maintaining or enhancing anti-tumor efficacy," said Klausner. "The possibility of improving cure rates and minimizing toxicity holds the promise of expanding the eligible patient population for successful bone marrow transplantation in cancer."

On July 17, 2020 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that four abstracts showcasing non-clinical data from rucaparib and lucitanib development programs have been accepted for on-demand viewing and publication at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II, June 22 – 24, 2020 (Press release, Clovis Oncology, JUN 17, 2020, View Source [SID1234561173]).

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The accepted abstracts summarize findings from pre-clinical studies evaluating the PK, PD and anti-tumor activity of rucaparib,an oral, small molecule PARP inhibitor in orthotopic and intracranial mouse models, and its synergy with CHK1 inhibition in tumor cell lines. Additional abstracts include findings from a study of the pharmacokinetics of lucitanib, an oral, potent inhibitor of tyrosine kinase activity, in a simulated patient population to inform dosing-regimen selection, and from a pre-clinical study evaluating the anti-tumor efficacy and mechanism of action of lucitanib in combination with a mouse ortholog of ALKS 4230, a selective agonist of the intermediate affinity IL-2 receptor, in a mouse colon cancer model. Lucitanib and ALKS 4230 are both development-stage compounds.

"Data from our ongoing non-clinical studies underscore our commitment to pursuing innovative research that advances novel therapies for cancer patients," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "In particular, we are pleased to present new, non-clinical data exploring the PK/PD of our PARP inhibitor Rubraca, evaluating the synergies of PARP and CHK1 inhibition in combination, as well as important data for lucitanib to understand optimal dosing and use in combination with other anticancer agents to treat solid tumors."

The following Clovis-sponsored, collaborator-sponsored and investigator-sponsored abstracts will be available as AACR (Free AACR Whitepaper) 2020 Virtual Poster Session presentations. E-posters, and when available, accompanying audio descriptions, will be available for on-demand viewing beginning 9:00 a.m. EDT Monday, June 22, and will remain available for viewing by registered attendees for at least three months after the virtual meeting.

Abstract Number: 3026 / 14 – Evaluation of brain pharmacokinetics (PK) and tumor growth inhibition of PARP inhibitors in mouse xenograft models using semi-mechanistic PK/pharmacodynamic (PD) modeling

Presenting Author: Michelle Liao
Session: Pharmacokinetics / Pharmacodynamics
Abstract Number: 3027 / 15 – Application of machine learning and grid search approaches to minimize lucitanib pharmacokinetic variability following different dosing regimens

Presenting Author: Michelle Liao
Session: Pharmacokinetics / Pharmacodynamics
Abstract Number: 2202 / 7 – The combination of a mouse ortholog of ALKS 4230, a selective agonist of the intermediate affinity IL-2 receptor, and the angiogenesis inhibitor lucitanib enhances antitumor activity

Presenting Author: Jared E. Lopes
Session: Combination Immunotherapies 2
In addition, the three previous posters will be available on the Clovis Oncology website once they become available on the AACR (Free AACR Whitepaper) virtual meeting website.

Abstract Number: 1375 / 11 – Investigating synergy between CHK1 and PARP inhibitors in BRCA2 mutant and restored cells

Presenting Author: Hannah L. Smith
Session: Mechanisms of DNA Damaging Therapeutics
About Rubraca (rucaparib)

Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in multiple tumor types, including ovarian and metastatic castration-resistant prostate cancers, as monotherapy, and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway. Clovis holds worldwide rights for Rubraca.

In the United States, Rubraca is approved for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Rubraca is also approved in the United States for the treatment of adult patients with deleterious BRCA mutation (germline and/or somatic) associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies and selected for therapy based on an FDA-approved companion diagnostic for Rubraca. Additionally, Rubraca is indicated for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

In Europe, Rubraca is approved for the maintenance treatment of adults with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy. Rubraca is also approved in Europe for the treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum-based chemotherapy, and who are unable to tolerate further platinum-based chemotherapy. Rubraca is indicated for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy.

Rubraca is an unlicensed medical product outside of the U.S. and Europe.

About Lucitanib

Lucitanib is an oral, potent inhibitor of the tyrosine kinase activity of vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3), platelet-derived growth factor receptors alpha and beta (PDGFRα/β) and fibroblast growth factor receptors 1 through 3 (FGFR1-3). Emerging clinical data support the combination of angiogenesis inhibitors and immunotherapy to increase effectiveness in multiple cancer indications. Angiogenic factors, such as vascular endothelial growth factor (VEGF), are frequently up-regulated in tumors and create an immunosuppressive tumor microenvironment. Use of antiangiogenic drugs reverses this immunosuppression and can augment response to immunotherapy.

Lucitanib is an unlicensed medical product.

On June 17, 2020 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported the successful completion of the first dose cohort in a Phase 1/2a clinical trial of AFM24 (Press release, Affimed, JUN 17, 2020, View Source [SID1234561189]). This first-in-human study evaluates AFM24 as monotherapy in patients with advanced solid EGFR expressing malignancies whose disease has progressed after treatment with previous anticancer therapies. AFM24, a tetravalent, bispecific epidermal growth factor receptor (EGFR)- and CD16A-binding innate cell engager, is novel due to its activation of innate immunity to kill solid tumors, inducing both antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). Other therapies rely heavily on signal or checkpoint inhibition.

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The company reports that no dose limiting toxicity was observed and the study is cleared to proceed the next dose level (cohort 2). No efficacy yet was observed, however, efficacy was not expected at this dose level.

"As we progress to the 2nd dose cohort, we take another step closer to giving patients a new treatment option with a distinctive mechanism that mobilizes the innate immune system to attack cancer cells" said Dr. Andreas Harstrick, Chief Medical Officer of Affimed. "The innate immune system is inherently powerful, yet it has been largely untapped as a therapeutic approach to fight cancer. With the clinical progress we are making we are hopeful that AFM24 will become an important option to provide long-lasting, multilayered tumor control."

AFM24 has demonstrated preclinically the ability to bridge NK cells and macrophages to EGFR-expressing tumor cell lines, and to induce lysis through ADCC and ADCP, respectively, independent of RAS or BRAF mutational status.

The study is an open-label, non-randomized, multi-center, multiple ascending dose escalation/expansion study to evaluate AFM24 as monotherapy in adult patients with advanced solid malignancies known to be EGFR-positive. The aim of the dose escalation phase is the determination of the maximum tolerated dose and the establishment of a recommended Phase 2a dose. The dose expansion phase is intended to collect preliminary evidence of efficacy and to further confirm the safety of AFM24. For more information including eligibility criteria, visit www.clinicaltrials.gov, using Identifier NCT04259450.

About AFM24
AFM24 is a tetravalent, bispecific EGFR- and CD16A-binding innate cell engager generated from Affimed’s fit-for-purpose ROCK platform. AFM24 uses the cytotoxic potential of the innate immune system by redirecting and activating NK cells and macrophages to kill EGFR-positive cancer cells through antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), respectively. Due to its unique mechanism of action, AFM24 is potentially not limited to patient subtypes based on mutational status. Toxicology studies in cynomolgus monkeys with AFM24 showed a favorable safety profile, even when the animals were treated at high dose levels, demonstrating AFM24’s potential to have lower toxicities in humans compared to other EGFR-targeted therapies.