On May 21, 2020 PDL BioPharma, Inc. ("PDL" or the "Company") (Nasdaq: PDLI) reported that it has completed its previously announced distribution of all of the Company’s 13,333,334 shares of common stock of Evofem Biosciences, Inc. ("Evofem") (Nasdaq: EVFM), which represented approximately 26.7% of the outstanding shares of Evofem common stock as of the close of business on May 15, 2020 (the "record date") (Press release, PDL BioPharma, MAY 21, 2020, View Source [SID1234558392]).

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The distribution was made today in the form of a pro rata common stock dividend to PDL stockholders of record as of the close of business on the record date. Based on the shares of PDL common stock outstanding as of the close of business on the record date, PDL stockholders of record as of the record date are entitled to receive 0.11591985 shares of Evofem common stock for every share of PDL common stock held as of the close of business on the record date.

No fractional shares of Evofem common stock were distributed. Instead, PDL stockholders will receive cash in lieu of any fraction of a share of Evofem common stock that they otherwise would have received.

An information statement describing the distribution is included as an exhibit to the Current Report on Form 8-K filed by PDL with the U.S. Securities and Exchange Commission (the "SEC") on May 18, 2020. Additional information on the distribution, including a copy of the information statement, will be posted to PDL’s website at View Source

On May 21, 2020 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported it will host a conference call and audio webcast on Friday, May 29 at 4:30 p.m. ET (Press release, MacroGenics, MAY 21, 2020, http://ir.macrogenics.com/news-releases/news-release-details/macrogenics-host-conference-call-and-webcast-review-preliminary [SID1234558390]). MacroGenics management will be joined by external guest presenters to review the preliminary clinical results from the ongoing Phase 1 studies of MGD013 and MGC018 that are part of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program.

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To participate in the MacroGenics ASCO (Free ASCO Whitepaper) 2020 Conference Call, please dial (833) 651-1036 (domestic) or (918) 922-6233 (international) ten minutes prior to the start of the call and provide the Conference ID: 7765546. The listen-only audio and slide webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company’s website at View Source A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days.

Selected Presentations at ASCO (Free ASCO Whitepaper) to be Reviewed on Conference Call

A phase I, first-in-human, open-label, dose-escalation study of MGD013, a bispecific DART molecule binding PD-1 and LAG-3, in patients with unresectable or metastatic neoplasms (Abstract #3004)
Preliminary dose escalation results from a phase I/II, first-in-human study of MGC018 (anti-B7-H3 antibody-drug conjugate) in patients with advanced solid tumors (Abstract #3071, Poster #135)
About MGD013

MGD013 is an investigational, first-in-class bispecific, tetravalent DART molecule targeting PD-1 and LAG-3. MGD013 has been engineered to concomitantly or independently bind to PD-1 and LAG-3 and disrupt these non-redundant inhibitory pathways to further restore exhausted T-cell function. MGD013 is being evaluated in a Phase 1 dose expansion study as monotherapy in several tumor types, including both solid tumors and hematological malignancies, and in combination with margetuximab, an investigational Fc-engineered monoclonal antibody targeting HER-2, in a cohort of patients with advanced HER2-positive cancers (NCT03219268). MGD013 will also be evaluated in combination with margetuximab and chemotherapy as part of the ongoing Phase 2/3 MAHOGANY study in patients with HER2-positive gastric or gastroesophageal junction cancer (NCT04082364). MacroGenics’ regional partner in Greater China, Zai Lab, plans to participate in MAHOGANY and is also evaluating MGD013 independently in Phase 1 combination studies with niraparib, a PARP inhibitor, and brivanib, a dual target tyrosine kinase inhibitor of the VEGF and FGF receptors, for the study of advanced gastric cancer and hepatocellular carcinoma, respectively.

About MGC018

MGC018 is an investigational antibody-drug conjugate (ADC) that is designed to target solid tumors expressing B7-H3, a protein in the B7 family of immune regulator proteins. B7-H3 is widely expressed on many different solid tumor types, with limited expression on normal tissues. Over-expression of B7-H3 is associated with disease severity, risk of recurrence, and reduced survival. MGC018 uses a synthetic duocarmycin-based payload with a cleavable peptide linker that was licensed from Byondis (formerly Synthon Biopharmaceuticals). Duocarmycins are potent cell cycle independent DNA-damaging alkylating agents and are not subject to multi-drug resistance. MGC018 is being evaluated in a Phase 1 dose escalation study in patients with advanced solid tumors (NCT03729596).

On May 21, 2020 GlaxoSmithKline and Samsung Biologics reported that have entered into a partnership to provide GSK with additional capacity to manufacture and supply GSK’s innovative biopharmaceutical therapies (Press release, GlaxoSmithKline, MAY 21, 2020, View Source [SID1234558389]).

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Under the terms of the agreement, Samsung Biologics will provide GSK with additional capacity for large-scale biopharmaceutical product manufacturing. This capacity will be flexible depending on GSK’s future needs and will supplement GSK’s existing manufacturing network.

Regis Simard, President, Pharmaceuticals Supply Chain, GSK, said, "Today’s agreement with Samsung Biologics complements and reinforces our existing world-class pharmaceutical manufacturing capability and will help ensure we can continue to deliver the transformative medicines that patients need."

"We are very proud and excited to announce this long-term agreement with GSK," said Dr. Tae Han Kim, CEO of Samsung Biologics. "Samsung Biologics entered the biopharma industry with the goal to help our clients bring valuable biological medicines to patients faster. We are thrilled to partner with GSK, a company who shares the vision."

The agreement is worth more than $231 million US over the next eight years. It will initially cover commercial production of Benlysta (belimumab), with technology transfer starting in 2020 and first commercial supply expected in 2022. The intention is to expand to additional specialty-care products in the future.

On May 21, 2020 Dynavax Technologies Corporation (Nasdaq: DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, reported that it intends to offer and sell, subject to market and other conditions, shares of its common stock in an underwritten public offering (Press release, Dynavax Technologies, MAY 21, 2020, View Source [SID1234558387]). Dynavax also expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the common stock being offered in the public offering. All of the shares in the offering will be sold by Dynavax. 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.

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Cowen, Evercore ISI and William Blair are acting as joint book-running managers for the offering. H.C. Wainwright & Co. is acting as co-manager for the offering.

Dynavax anticipates using the net proceeds from the offering to fund activities associated with the ongoing commercialization of HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted], to advance its CpG 1018 vaccine platform, including any scale up efforts in support of a potential COVID-19 vaccine by Dynavax and its collaborators, and for general corporate purposes, including working capital.

The securities described above are being offered by Dynavax pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was previously filed with and became effective by rule of the Securities and Exchange Commission (SEC) on April 30, 2020. A preliminary prospectus supplement and accompanying prospectus related to the offering will be filed with the SEC and will be available on the SEC’s website located at View Source Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering, when available, may be obtained by contacting: Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717 Attention: Prospectus Department, by telephone at (833) 297-2926, or by email at [email protected]; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, New York, NY 10055, by telephone at (888) 474-0200 or by email at [email protected]; or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, by telephone at (800) 621-0687 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 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.

On May 21, 2020 Clovis Oncology, Inc. (NASDAQ: CLVS), reported that six abstracts featuring data from clinical and real-world evidence studies evaluating Rubraca (rucaparib) in multiple tumor types have been accepted for presentation or publication at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Scientific Program taking place May 29 – 31 (Press release, Clovis Oncology, MAY 21, 2020, View Source [SID1234558386]).

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The accepted abstracts summarize findings from clinical trials in which Rubraca was evaluated as a single-agent therapy in ovarian cancer, metastatic castration-resistant prostate cancer (mCRPC) and malignant mesothelioma, and in combination with irinotecan in multiple advanced solid tumors, as well as findings from real-world evidence studies of the epidemiology and current treatment landscape of mCRPC.

"We continue to be encouraged by data demonstrating the potential of Rubraca beyond ovarian cancer and look forward to sharing new findings from some of the studies exploring its broader utility and value," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "This year’s virtual ASCO (Free ASCO Whitepaper) scientific program provides a timely opportunity to share key clinical updates with the research and medical community, continuing the important dialogue around the adoption and utilization of PARP inhibitors more broadly, and Rubraca in particular."

The following Clovis-sponsored Rubraca abstract has been selected for poster discussion and is available now in the ASCO (Free ASCO Whitepaper) meeting library.

Abstract Number: 6015, Poster Number: 186 – Characterization of Patients (pts) with Long-term Responses to Rucaparib in Recurrent Ovarian Cancer (OC)

Presenting Author: Elizabeth M. Swisher, MD
Session: Gynecologic Cancer
The poster and a discussant presentation will be available on demand by accessing the ASCO (Free ASCO Whitepaper) meeting library beginning Friday, May 29 at 8:00am EDT. In addition, the poster will be available at View Source once it becomes available in the ASCO (Free ASCO Whitepaper) meeting library.

The two following Clovis-sponsored abstracts are available now in the ASCO (Free ASCO Whitepaper) meeting library:

Abstract Number: e19319 (online abstract publication) – Real-world Evidence of Treatment Patterns and Pharmacy Costs Among Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) in a Managed Care Population in the United States

Authors: Kelvin A. Moses, MD, PhD, et al.
Abstract Number: e13592 (online abstract publication) – Epidemiology and Mortality of Metastatic Castration-Resistant Prostate Cancer (mCRPC) in a Managed Care Population in the United States

Authors: Katrine Wallace, PhD, et al.
Additionally, the following three investigator-sponsored abstracts describing studies of Rubraca have also been selected for presentation as part of the 2020 ASCO (Free ASCO Whitepaper) scientific program and are available now in the ASCO (Free ASCO Whitepaper) meeting library.

Abstract Number: 3513, Poster Number: 243 – Phase 1 Study of Rucaparib and Irinotecan in Advanced Solid Tumors with Homologous Recombination Deficiency (HRD) Mutations

Presenting Author: Mallika S. Dhawan, MD
Session: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
The poster and a discussant presentation will be available on demand by accessing the ASCO (Free ASCO Whitepaper) meeting library beginning Friday, May 29 at 8:00am EDT.

Abstract Number: 9057, Poster Number: 250 – MiST1: A Phase IIa Trial of Rucaparib in Patients Harboring BAP1/BRCA1 Deficient Relapsed Malignant Mesothelioma

Presenting Author: Dean A. Fennell, FRCP, PhD
Session: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
The poster will be available on demand by accessing the ASCO (Free ASCO Whitepaper) meeting library beginning Friday, May 29 at 8:00am EDT.

Abstract Number: TPS6102, Poster Number: 273 – NOGGO Ov-42/MAMOC: Rucaparib Maintenance After Bevacizumab Maintenance Following Carboplatin-Based First-Line Chemotherapy in Ovarian Cancer Patients

Presenting Author: Elena I. Braicu, MD, PhD
Session: Gynecologic Cancer
The poster will be available on demand by accessing the ASCO (Free ASCO Whitepaper) meeting library beginning Friday, May 29 at 8:00am EDT.

About Rubraca (rucaparib)

Rucaparib 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.

Rubraca U.S. FDA Approved Indications

Ovarian Cancer

Rubraca is indicated for the maintenance treatment of adult women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

Rubraca is indicated for the treatment of adult women with a 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. Select patients for therapy based on an FDA-approved companion diagnostic for Rubraca.

Prostate Cancer

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.

Select Important Safety Information

Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) occur in patients treated with Rubraca, and are potentially fatal adverse reactions. In 1146 treated patients, MDS/AML occurred in 20 patients (1.7%), including those in long term follow-up. Of these, 8 occurred during treatment or during the 28 day safety follow-up (0.7%). The duration of Rubraca treatment prior to the diagnosis of MDS/AML ranged from 1 month to approximately 53 months. The cases were typical of secondary MDS/cancer therapy-related AML; in all cases, patients had received previous platinum-containing regimens and/or other DNA damaging agents. In TRITON2, MDS/AML was not observed in patients with mCRPC (n=209) regardless of homologous recombination deficiency (HRD) mutation.

Do not start Rubraca until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1). Monitor complete blood counts for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities (> 4 weeks), interrupt Rubraca or reduce dose and monitor blood counts weekly until recovery. If the levels have not recovered to Grade 1 or less after 4 weeks or if MDS/AML is suspected, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. If MDS/AML is confirmed, discontinue Rubraca.

Based on its mechanism of action and findings from animal studies, Rubraca can cause fetal harm when administered to a pregnant woman. Apprise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for 6 months following the last dose of Rubraca. For males on Rubraca treatment who have female partners of reproductive potential or who are pregnant, effective contraception should be used during treatment and for 3 months following the last dose of Rubraca.

Most common adverse reactions in ARIEL3 (≥ 20%; Grade 1-4) were nausea (76%), fatigue/asthenia (73%), abdominal pain/distention (46%), rash (43%), dysgeusia (40%), anemia (39%), AST/ALT elevation (38%), constipation (37%), vomiting (37%), diarrhea (32%), thrombocytopenia (29%), nasopharyngitis/upper respiratory tract infection (29%), stomatitis (28%), decreased appetite (23%), and neutropenia (20%).

Most common adverse reactions in Study 10 and ARIEL2 (≥ 20%; Grade 1-4) were nausea (77%), asthenia/fatigue (77%), vomiting (46%), anemia (44%), constipation (40%), dysgeusia (39%), decreased appetite (39%), diarrhea (34%), abdominal pain (32%), dyspnea (21%), and thrombocytopenia (21%).

Most common adverse reactions in TRITON2 (≥ 20%; Grade 1-4) were fatigue/asthenia (62%), nausea (52%), anemia (43%), AST/ALT elevation (33%), decreased appetite (28%), rash (27%), constipation (27%), thrombocytopenia (25%), vomiting (22%), and diarrhea (20%).

Co-administration of rucaparib can increase the systemic exposure of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, which may increase the risk of toxicities of these drugs. Adjust dosage of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, if clinically indicated. If co-administration with warfarin (a CYP2C9 substrate) cannot be avoided, consider increasing frequency of international normalized ratio (INR) monitoring.

Because of the potential for serious adverse reactions in breast-fed children from Rubraca, advise lactating women not to breastfeed during treatment with Rubraca and for 2 weeks after the last dose.