On November 19, 2019 Myovant Sciences (NYSE: MYOV), a healthcare company focused on developing innovative treatments for women’s health and prostate cancer, reported that the Phase 3 HERO study of once-daily, oral relugolix (120 mg) met its primary efficacy endpoint and all six key secondary endpoints in men with advanced prostate cancer (Press release, Myovant Sciences, NOV 19, 2019, https://investors.myovant.com/news-releases/news-release-details/myovant-sciences-announces-97-response-rate-positive-phase-3 [SID1234551479]). These results support a New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) in the second quarter of 2020 and future regulatory submissions in Europe and Japan.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"An oral gonadotropin-releasing hormone, or GnRH, antagonist for advanced prostate cancer has been an aspiration for many years," said Neal Shore, M.D., Medical Director of the Carolina Urologic Research Center and HERO Program Steering Committee Member. "If approved, relugolix would become the first-of-its-kind oral option for men with advanced prostate cancer."

In the primary endpoint responder analysis, 96.7% (95% CI: 94.9%, 97.9%) of men receiving once-daily, oral relugolix achieved sustained testosterone suppression to castrate levels. A responder was defined as achieving and maintaining testosterone suppression to less than or equal to 50 ng/dL from Week 5 through Week 48. For the study to be successful, the lower bound of the 95% confidence interval of the response rate had to be at least 90%.

Five key secondary endpoints demonstrated superiority to leuprolide acetate, including rapid suppression of testosterone at Day 4 and Day 15, profound suppression of testosterone at Day 15, rapid suppression of prostate-specific antigen (PSA) at Day 15, and suppression of follicle-stimulating hormone (FSH) at Week 24 (all p-values < 0.0001). In addition, relugolix demonstrated non-inferiority to leuprolide acetate on sustained testosterone suppression through 48 weeks (96.7% vs. 88.8%, respectively) with a between-group difference of 7.9% (95% CI: 4.1%,11.8%), the primary endpoint required for regulatory submissions outside of the U.S. In addition, the pharmacodynamic results showed no testosterone flare after initiation of relugolix and mean testosterone levels returned to normal levels within 90 days after treatment discontinuation.

"With the exciting results from the HERO study demonstrating the potential of relugolix to provide unique benefits compared to leuprolide, we look forward to submitting an NDA to the FDA," said Lynn Seely, M.D., President and CEO of Myovant Sciences. "We are now closer to our goal of bringing a precision oral medicine to the broad spectrum of men with advanced prostate cancer."

The overall incidence of adverse events in the relugolix and leuprolide acetate groups was comparable (92.9% vs. 93.5%, respectively). In the relugolix group, 3.5% of men discontinued the study early due to adverse events compared with 2.6% of men in the leuprolide acetate group. The most frequently reported adverse events, reported in at least 10% of men in the relugolix group, were hot flashes, fatigue, constipation, diarrhea, and arthralgia. Unadjudicated major adverse cardiovascular events were reported in 2.9% of men in the relugolix group versus 6.2% of men in the leuprolide acetate group. These events included non-fatal myocardial infarction, non-fatal stroke, and all-cause mortality.

Conference Call
Myovant will hold a conference call today, November 19, 2019 beginning at 8:30 a.m. EST / 5:30 a.m. PST. The dial-in numbers are 1-800-532-3746 for domestic callers and +1-470-495-9166 for international callers. A live webcast of the conference call will also be available on the investor relations page of Myovant’s website at investors.myovant.com and will remain archived on Myovant’s website for at least 30 days.

About the Phase 3 HERO Program
This randomized, open-label, parallel-group, multinational clinical study was designed to evaluate the safety and efficacy of relugolix in men with androgen-sensitive advanced prostate cancer who required at least one year of continuous androgen deprivation therapy. Patients enrolled in the study were randomized 2:1 to receive a single loading dose of relugolix 360 mg followed by relugolix 120 mg once daily, or to treatment with leuprolide acetate 3-month depot injection, respectively.

The primary efficacy endpoint of the study to support U.S. approval was the ability of relugolix to achieve and maintain testosterone suppression to castrate levels (< 50 ng/dL) through 48 weeks.

Approximately 1,100 patients are planned to be enrolled in this study, including approximately 430 patients with metastatic prostate cancer to support the analysis of a secondary endpoint of castration resistance-free survival, data which are expected in the third quarter of 2020, and 138 Chinese patients (enrolled in China and Taiwan) to support registration in China.

About Prostate Cancer
Prostate cancer is the second most prevalent form of cancer in men and the second leading cause of death due to cancer in men in the U.S. Approximately three million men in the U.S. are currently living with prostate cancer, and approximately 170,000 men are estimated to be newly diagnosed in 2019. Advanced prostate cancer is prostate cancer that has spread or come back after treatment and may include men with biochemical recurrence (rising PSA in the absence of metastatic disease on imaging), locally advanced disease, or metastatic disease. Treatment for advanced prostate cancer typically involves androgen deprivation therapy, which reduces testosterone to very low levels, commonly referred to as castrate levels. GnRH agonists, such as leuprolide acetate, or slow-release injections are the current standard of care for medical castration. However, GnRH agonists may be associated with mechanism-of-action limitations, including the potentially detrimental initial rise in testosterone levels that can exacerbate clinical symptoms, which is known as clinical or hormonal flare, and delayed testosterone recovery if the drug is discontinued.

About Relugolix
Relugolix is a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist that reduces testicular testosterone production, the hormone primarily responsible for stimulating prostate cancer, and ovarian estradiol production, a hormone known to stimulate the growth of uterine fibroids and endometriosis. Myovant is developing a relugolix monotherapy tablet (120 mg) for men with advanced prostate cancer and relugolix combination tablet (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) for women with heavy menstrual bleeding associated with uterine fibroids and for women with endometriosis-associated pain.

Earlier this year, Myovant announced positive top-line data from two Phase 3 studies, LIBERTY 1 and LIBERTY 2, evaluating relugolix combination therapy for uterine fibroids, as well as positive results from a separate bioequivalence study supporting a potential one tablet, once-daily dosing regimen. Myovant expects to submit an NDA to the FDA for uterine fibroids in April 2020. Myovant also expects to announce top-line results from two Phase 3 studies, SPIRIT 2 and SPIRIT 1, evaluating relugolix combination therapy for endometriosis-associated pain in the first and second quarters of 2020, respectively.

On November 19, 2019 Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company committed to giving patients back their innate ability to fight cancer, reported financial results for the quarter ended September 30, 2019 and provided an update on clinical and corporate developments (Press release, Affimed, NOV 19, 2019, View Source [SID1234551478]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are excited to commence patient dosing in our Phase 2 study of AFM13 in support of registration, bringing us one step closer to delivering a potential new treatment for pTCL patients, who have very few treatment options," said Dr. Adi Hoess, Affimed’s CEO. "In addition, the IND for the first ever clinical trial bringing together an innate cell engager (AFM13) and adoptive NK cell transfer has cleared. This study of AFM13 and MD Anderson’s NK cell product could address a much broader group of patients with CD30-expressing lymphomas, including Hodgkin lymphoma, cutaneous T-cell lymphoma and diffuse large B-cell lymphoma."

Program Updates
AFM13 (CD30/CD16A)

In November 2019, the first patient was dosed in a Phase 2 registration-directed study of AFM13 as monotherapy in relapsed or refractory patients with CD30-positive peripheral T cell lymphoma (pTCL). The results of the study, if positive, could form the basis for a Biologics License Application submission and support an accelerated approval given the unmet medical need for safe and effective new treatments in this hard-to-treat patient population. The study will also enroll a cohort of patients with transformed mycosis fungoides, an aggressive subtype of cutaneous T cell lymphoma.
The U.S. Food and Drug Administration (FDA) cleared an investigational new drug application (IND) for an investigator-sponsored Phase 1 study, in which the University of Texas MD Anderson Cancer Center (MDACC) plans to investigate the combination of AFM13 with allogeneic NK cells. MDACC intends to administer a stable complex of AFM13 pre-mixed with cord blood-derived allogeneic NK cells in different doses (numbers of pre-loaded NK cells) to patients with relapsed/refractory CD30-positive lymphoid malignancies. The combination represents a novel approach to further improve response rates and durability of responses in this patient population.
AFM24 (EGFR/CD16A)

In October 2019, Affimed received clearance of its IND for AFM24 from the FDA, enabling the company to proceed with its planned Phase 1/2a clinical study of the tetravalent, bispecific epidermal growth factor receptor (EGFR)- and CD16A-binding innate cell engager in patients with advanced cancers known to express EGFR. The clearance of the IND follows the company’s IND submission in late-September 2019. Affimed expects the study, which is aimed at establishing safety and identifying initial signals of efficacy of AFM24, to initiate in the first quarter of 2020.
Pipeline Updates
Affimed selected two new CD16A-binding innate cell engager candidates (AFM28 and AFM32) from our ROCK platform for undisclosed targets that the company plans to advance into preclinical studies in 2020 with the aim of supporting future IND submissions. The selection of the new development candidates follows Affimed’s evaluation of innate immune cell activity versus a number of potential targets that are expressed in multiple hematological and solid tumor malignancies.
Genentech Collaboration
In November 2019, Genentech exercised its final option for an exclusive target under the ongoing, multi-program strategic oncology collaboration agreement to develop and commercialize novel NK cell engager-based immunotherapeutics generated from Affimed’s ROCK platform to treat multiple cancers. The target selection triggers a payment in an undisclosed amount to Affimed from Genentech.
Management Changes
Affimed announced the appointment of Cassandra Choe-Juliak, MD, MS as Acting Chief Medical Officer to succeed Dr. Leila Alland, effective November 30, 2019. Dr. Alland will transition out of her current role and will serve as a consultant for the company. Dr. Choe-Juliak has over 13 years of experience in drug development and medical affairs in immuno-oncology/oncology for both hematological and solid tumor malignancies. Since joining Affimed in July 2017, she has served as the clinical leader for the AFM13 development program.
Dr. Hoess commented, "Cassandra’s deep expertise in drug development and strong leadership skills have been, and will continue to be, a tremendous asset to Affimed and our clinical team as we advance our pipeline of innate cell engagers. I would also like to thank Leila for her many contributions to Affimed and wish her success in her future endeavors."

Financial Highlights
(Figures for the third quarter and nine months ended September 30, 2019 and 2018 are unaudited.)
Cash, cash equivalents and current financial assets totaled €76.5 million as of September 30, 2019, compared to €108.8 million as of December 31, 2018. In November 2019, Affimed completed a public equity offering with net proceeds, after deducting underwriting discounts and commissions and estimated offering expenses, of approximately $32 million (€29 million). Based on its current operating and budget assumptions, the company anticipates that its cash, cash equivalents and current financial assets as of September 30, 2019, together with the proceeds from the stock offering, will enable the Company to fund its planned clinical development and early development activities at least into the fourth quarter of 2021.

Net cash used in operating activities was €30.6 million for the nine months ended September 30, 2019, compared to net cash used in operating activities of €24.9 million for the nine months ended September 30, 2018. The increase is primarily due to higher cash expenditure for research and development efforts.

Total revenue was €2.1 million for the three months ended September 30, 2019 compared to €0.3 million for the three months ended September 30, 2018. The increase in revenue is attributable to the recognition of €1.9 million as revenue from the Genentech collaboration in the third quarter of 2019.

Research and development (R&D) expenses for the third quarter of 2019 were €11.7 million, compared to R&D expenses for the third quarter of 2018 of €9.8 million. The increase was primarily related to higher expenses related to manufacturing activities for clinical study material for AFM13, startup activities for the AFM13 registration study in pTCL and early stage development and discovery activities.

General and administrative expenses for the third quarter of 2019 were €2.8 million compared to €2.4 million for the third quarter of 2018.

Net loss was €10.9 million, or €0.17 per common share, for the third quarter of 2019, compared to a net loss of €12.0 million, or €0.19 per common share, for the third quarter of 2018.

Note on International Financial Reporting Standards (IFRS)
Affimed prepares and reports the consolidated financial statements and financial information in accordance with IFRS as issued by the International Accounting Standards Board. None of the financial statements were prepared in accordance with Generally Accepted Accounting Principles in the United States. Affimed maintains its books and records in Euro.

Conference Call and Webcast Information
Affimed will host a conference call and webcast today, Tuesday, November 19, 2019 at 8:30 a.m. Eastern time to discuss the company’s financial results and recent corporate developments. To access the call, please dial +1 (631) 510-7495 for U.S. callers, or +44 (0) 2071 928000 for international callers, and reference conference ID 8758067 approximately 15 minutes prior to the call. An audio webcast of the conference call can be accessed in the "Webcasts" section on the "Investors" page of the Affimed website at View Source A replay of the webcast will be available on Affimed’s website shortly after the conclusion of the call and will be archived for 30 days following the call.

On November 19, 2019 Celyad (Euronext Brussels and Paris, and Nasdaq: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell therapies, reported an update on its operational developments for the third quarter ended September 30, 2019 (Press release, Celyad, NOV 19, 2019, View Source [SID1234551477]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Filippo Petti, CEO of Celyad stated, "We have reported a steady stream of encouraging news from our pipeline throughout the third quarter and subsequent weeks, including preliminary Phase 1 data for our first-in-class, non-gene edited allogeneic CYAD-101 CAR-T product candidate, the introduction of our proprietary OptimAb manufacturing process to our autologous relapsed/refractory acute myeloid leukemia program led by CYAD-01, and CYAD-02, the acceptance of the IND application for our next-generation candidate CYAD-02, and the advancement of our shRNA technology platform related to our CYAD-200 series of allogeneic product candidates. We continue to establish our position as innovative leaders in the industry as we focus on our core mission of developing innovative CAR-T therapies for cancer patients."

"In addition, with the closing of our global equity offering in September, we believe the company has sufficient capital resources to enable it to complete its next major clinical milestones, including the upcoming data releases from the CYAD-01 program in relapsed/refractory acute myeloid leukemia," continued Filippo Petti.

Third Quarter 2019 and Recent Business Highlights

Successfully dosed the first relapsed/refractory (r/r) acute myeloid leukemia (AML) patient in the DEPLETHINK Phase 1 trial with CYAD-01 produced with OptimAb manufacturing process.
Presented preliminary data from the ongoing dose-escalation Phase 1 alloSHRINK trial evaluating CYAD-101 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 34th Annual meeting.
Results from the trial demonstrated a favorable tolerability profile for CYAD-101, with encouraging anti-tumor activity in the refectory metastatic colorectal cancer (mCRC). Two patients experienced a confirmed partial response, and five patients experienced stable disease for a period of three months or more. In addition, there was no clinical or laboratory evidence of graft-versus-host disease (GvHD).
Completed enrollment in the dose-escalation segment of the alloSHRINK trial with additional results from the trial anticipated during first half 2020.
Continued advancement of proprietary non-gene edited allogeneic short hairpin RNA (shRNA) platform related to the CYAD-200 series of shRNA-based allogeneic CAR-T candidates.
Closed global equity offering with gross proceeds of $20.0 million (approximately €18.2 million) in September 2019.
Third Quarter 2019 Financial Review

As of September 30, 2019, the Company ended the quarter with a treasury position of €44.6 million ($48.8 million), which includes net proceeds of €17.0 million from the global equity offering in September 2019. Net cash burn over the third quarter of 2019 amounted to €6.1 million, in line with expectations. The Company confirms its previous guidance that its treasury position should be sufficient, based on the current scope of activities, to fund operating expenses and capital expenditure requirements into first half 2021.

Pipeline Updates

CYAD-01 – Autologous NKG2D-based CAR-T

CYAD-01 continues to advance the Phase 1 THINK and DEPLETHINK clinical trials for the treatment of patients with relapsed/refractory (r/r) acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). In September, the Company successfully administered CYAD-01 produced with the OptimAb manufacturing process to a patient enrolled in cohort 3 (300 million cells) of the Phase 1 DEPLETHINK trial. The proprietary OptimAb manufacturing process utilizes a shortened cell culture and incorporates a selective PI3K inhibitor. This results in a product that is enriched for T cells with a memory-like phenotype. Preclinical data demonstrate that CYAD-01 produced using the OptimAb manufacturing process drives improved anti-tumor activity in an aggressive AML model compared to CYAD-01 produced with the mAb manufacturing process.

The Company is scheduled to present the latest clinical results from the Phase 1 THINK and DEPLETHINK trials, which utilized CYAD-01 produced with the previous mAb manufacturing process, as well as provide updates on the development program for r/r AML and MDS and proprietary OptimAb manufacturing process at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting being held on December 7-10 in Orlando, Florida.

CYAD-02 – Autologous NKG2D-based CAR-T

In June, the U.S. Food & Drug Administration accepted the Investigational New Drug (IND) application for CYAD-02, a next-generation, autologous NKG2D-based CAR-T candidate. CYAD‑02 incorporates short hairpin RNA (shRNA) technology to target the NKG2D ligands MICA and MICB. The single shRNA modulates the expression of both ligands, which translates to encouraging increases in vivo engraftment and anti-tumor activity in preclinical studies.

The Company is scheduled to present preclinical data for CYAD-02 at the upcoming ASH (Free ASH Whitepaper) conference. In addition, the company plans to initiate the Phase 1 CYCLE-01 study evaluating the CYAD-02 following preconditioning chemotherapy in r/r AML in early 2020.

CYAD-101 – TIM-based Allogeneic NKG2D-based CAR-T

Celyad’s first-in-class, non-gene edited allogeneic clinical candidate CYAD-101 continues to advance in the alloSHRINK Phase 1 trial. At the SITC (Free SITC Whitepaper) 34th Annual Meeting, the Company presented preliminary data from the ongoing alloSHRINK trial assessing safety and clinical activity of CYAD-101 in patients with relapsed or refractory metastatic colorectal cancer (mCRC) who had progressed beyond second line metastatic chemotherapy. Preliminary data showed no clinical evidence of GvHD has been observed following 35 injections of CYAD-101, supporting the ability of the company’s novel inhibitory peptide T cell receptor (TCR) inhibiting molecule (TIM) to reduce signaling of the TCR complex through a non-gene edited approach. Treatment with CYAD-101 with prior FOLFOX preconditioning chemotherapy to control the host-versus-graft (HvG) reaction was well-tolerated, with no report of dose-limiting toxicity. No patients discontinued treatment due to adverse events. In addition, the regimen demonstrated encouraging anti-tumor activity, with two patients experiencing a confirmed partial response according to RECIST 1.1 criteria, and five patients experiencing stable disease of more than or equal to three months of duration. Tumor burden decrease was observed in six out of 12 patients in total.

Preliminary results from the completed dose-escalation segment of the alloSHRINK trial are expected in the first half of 2020. This will include three additional patients at dose level three (one billion cells per infusion) of the trial, for a total of nine patients in the cohort, as planned per the protocol.

Based on the data presented to date, the Company plans to expand the trial to further evaluate CYAD-101 with prior FOLFOX chemotherapy in refractory mCRC patients. Enrollment in the expansion segment of the trial is expected to begin in mid-2020 following the production of additional CYAD-101 cells.

CYAD-200 Series – shRNA-based Allogeneic CAR-Ts

The Company continues to pursue the development of the proprietary non-gene edited allogeneic shRNA SMARTvector platform and progress towards filing IND applications for the CYAD-200 series of shRNA-based allogeneic CAR-T candidates, including CYAD-211, the Company’s CAR-T therapy targeting B-cell maturation antigen (BCMA) for the treatment of multiple myeloma.

Key Upcoming Milestones

Poster presentations of THINK Phase 1 trial and DEPLETHINK Phase 1 trial evaluating CYAD-01 produced with the mAb manufacturing process for the treatment of r/r AML and MDS at the 61st ASH (Free ASH Whitepaper) Annual Meeting, which will be accompanied by an investor and analyst event (live and webcast) hosted by company on Monday, December 9th.
Initiation of the Phase 1 dose-escalation CYCLE-01 trial evaluating CYAD-02, following preconditioning chemotherapy, for the treatment of r/r AML and MDS is expected in early 2020.
Anticipated completion of enrollment of the DEPLETHINK Phase 1 trial evaluating CYAD-01 produced with the OptimAb manufacturing process during first half 2020.
Updated results from the completed dose-escalation segment of the alloSHRINK trial are expected in first half 2020, including an additional three patients at dose level three (one billion cells per infusion) of the trial.
Submission of IND application for CYAD-211 (shRNA-based allogeneic BCMA CAR-T candidate) for the treatment of patients with multiple myeloma is anticipated during first half 2020.
Initiation of the dose-expansion segment of the alloSHRINK trial is anticipated to begin in mid-2020.

Upcoming Conferences

Celyad’s management team is scheduled to participate in the following conferences during the remainder of 2019:

Jefferies London Healthcare Conference, November 20 – 21
Evercore ISI HealthCONx Conference, December 3 – 5
61st ASH (Free ASH Whitepaper) Annual Meeting, December 7-10

On November 19, 2019 West Pharmaceutical Services, Inc. (NYSE: WST), a global leader in innovative solutions for injectable drug administration, reported that management will present an overview of the business at the Jefferies 2019 London Healthcare Conference in London, United Kingdom on Wednesday, November 20, 2019 (Press release, West Pharmaceutical Services, NOV 19, 2019, View Source [SID1234551474]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live audio webcast will be accessible from the Company’s website at www.westpharma.com/en/investors.

On November 19, 2019 The Gray Foundation reported an event in Lower Manhattan raised more than $8.5 million for research on BRCA-related cancers (Press release, The Gray Foundation, NOV 19, 2019, View Source [SID1234551473]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Eyewitness News reporter and cancer survivor Stacey Sager proudly took part in the Basser Jean Bash at Cipriani Wall Street.

It raised money for The Basser Center for BRCA at Penn Medicine’s Abramson Cancer Center.

Stacey is on the center’s leadership council.

It is making great progress in the fight against the genetic mutations that cause some breast and ovarian cancers