On May 13, 2020 Bio-Path Holdings, Inc., (NASDAQ: BPTH), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, reported an upcoming virtual poster presentation at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place from May 29-31, 2020 (Press release, Bio-Path Holdings, MAY 13, 2020, View Source [SID1234558025]).

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Dr. Maro Ohanian, Department of Leukemia, University of Texas M.D. Anderson Cancer Center, will discuss the Phase 2 study design of BP1001 (liposomal Grb2 antisense), the Company’s lead drug candidate, in combination with decitabine as a potential treatment for patients diagnosed with acute myeloid leukemia or high-risk myelodysplastic syndrome.

Details for the virtual poster presentation are as follows:

Date: Friday, May 29, 2020

Presentation Time: 8:00 am Eastern Time

Session: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant

Abstract: TPS7561

Poster: 334

Title: A phase II study of BP1001 (liposomal Grb2 antisense oligonucleotide) in patients with hematologic malignancies

On May 13, 2020 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of agents designed to activate immune response to cancers and infectious diseases, reported the FDA acceptance of the IND application for an allogeneic iNKT therapy, agenT-797, submitted by its subsidiary, AgenTus Therapeutics. A clinical trial for the treatment of patients with cancer is expected to commence 2H2020 (Press release, Agenus, MAY 13, 2020, View Source [SID1234557874]). AgenTus has also submitted a separate IND for the treatment of COVID-19, which is expected to clear soon.

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"We are extremely pleased to rapidly advance our proprietary iNKT cell therapy to the clinic to combat cancer and also address the urgent COVID-19 pandemic," said Dr. Walter Flamenbaum, CEO of AgenTus Therapeutics. "We expect our clinical trials to demonstrate the key features of agent-797 and the benefits of combinations of our allogeneic iNKTs with Agenus’ pipeline of checkpoint antibodies in solid tumors."

"I am heartened by our team’s efforts to rapidly advance our allogeneic iNKT cells to treat patients with cancer and COVID-19," said Dr. Garo Armen, Chairman and CEO of Agenus and Chairman of AgenTus Therapeutics. "Our iNKTs are streamlined for treating large numbers of patients from a single batch. They are manufactured without the need for genetic manipulation, are expected to suppress graft-versus-host disease, can be manufactured affordably, and are designed for quick access by patients."

Separately, Agenus indicated that it is contemplating several options with regard to its AgenTus Therapeutics subsidiary. This is given its previous guidance and the advancement of AgenTus’ first cell therapy candidates towards the clinic. These options include the potential spinning out of AgenTus and issuing a portion of its holdings in AgenTus to Agenus shareholders in the form of a stock dividend. Agenus expects that such a decision will be made by the end of this year.

On May 13, 2020 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported updated safety and initial efficacy data contained in an abstract scheduled as an oral presentation at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held May 29–31, 2020 (Press release, Arvinas, MAY 13, 2020, View Source [SID1234557897]). The presentation will share updated data from the dose escalation portion of Arvinas’ Phase 1/2 clinical trial of ARV-110 in men with metastatic castration-resistant prostate cancer. The abstract describes two patients with ongoing confirmed prostate-specific antigen (PSA) responses, including one with an unconfirmed partial tumor response.

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"We are thrilled to present the first evidence that our PROTAC protein degrader, ARV-110, can provide clinical efficacy," said John Houston, Ph.D., President and Chief Executive Officer at Arvinas. "This is a significant milestone for our technology platform and for the field of targeted protein degradation."

"While still early, we are pleased to see a safety profile to date for ARV-110 that continues to support dose escalation," added Ron Peck, M.D., Chief Medical Officer at Arvinas. "Our trial of ARV-110 has enrolled a particularly heavily pre-treated population of patients who have exhausted most available treatment options. Most patients received both enzalutamide and abiraterone as well as prior chemotherapy. Despite this, ARV-110 demonstrated the first evidence of antitumor activity in this difficult-to-treat patient population."

The presentation will include data collected since the abstract submission date. Dose escalation continues, with enrollment initiated above the previously disclosed daily dose of 280 milligrams.

Abstract details are as follows:
Presentation Title: First-in-human phase I study of ARV-110, an androgen receptor PROTAC degrader in patients with metastatic castrate-resistant prostate cancer following enzalutamide and/or abiraterone
Abstract Number: 3500
Session Type: Oral Abstract Session
Session Track: Development Therapeutics – Molecularly Targeted Agents and Tumor Biology

For a copy of the abstract, please visit ASCO (Free ASCO Whitepaper)’s official website.

About ARV-110
ARV-110 is an orally bioavailable PROTAC protein degrader designed to selectively target and degrade the androgen receptor (AR). ARV-110 is being developed as a potential treatment for men with metastatic castration-resistant prostate cancer.

ARV-110 has demonstrated activity in preclinical models of AR mutation or overexpression, both common mechanisms of resistance to currently available AR-targeted therapies.

About Metastatic Castration-Resistant Prostate Cancer (mCRPC)
In the United States, prostate cancer is both the second most prevalent cancer in men and the second leading cause of cancer death in men. The American Cancer Society predicts that one in nine men will be diagnosed with prostate cancer in his lifetime. Metastatic castration-resistant prostate cancer (mCRPC) is defined by disease progression despite androgen deprivation therapy and is often correlated with rising levels of prostate-specific antigen (PSA).

Current AR-targeted standard of care treatments for mCRPC are less effective in patients whose disease has increased levels of androgen production, AR gene or gene enhancer amplification, or AR point mutations. Up to 25 percent of patients do not respond to second-generation hormone therapies like abiraterone and enzalutamide, and the vast majority of responsive patients will ultimately become resistant, resulting in poor prognoses for men diagnosed with this devastating condition.

On May 13, 2020 AstraZeneca reported that it will present ground-breaking new results across its broad portfolio of cancer medicines during the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program, 29 to 31 May 2020 (Press release, AstraZeneca, MAY 13, 2020, View Source [SID1234557913]). AstraZeneca will present 98 abstracts, including 19 oral presentations with one plenary and 10 late-breakers.

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Presentations will showcase the Company’s leadership in the treatment of early lung cancer with a late-breaking plenary presentation of the unprecedented results from the Phase III ADAURA trial for Tagrisso (osimertinib) in the adjuvant treatment of patients with Stage IB, II and IIIA epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC). Data from the DESTINY programme will highlight the transformative potential of Enhertu (trastuzumab deruxtecan) across HER2-driven tumours, including in lung, breast, gastric and colorectal cancers.

José Baselga, Executive Vice President, Oncology R&D, said: "AstraZeneca continues to deliver results with the goal of transforming clinical practice. Our science at ASCO (Free ASCO Whitepaper) this year shows the potential for treatment of early-stage EGFR-mutated lung cancer, where we aim to provide the hope of cure with Tagrisso; to rewrite the rules on the treatment of patients with HER2-positive tumours with Enhertu across a range of cancer settings; and to advance our next wave of pipeline medicines focused on treating patients earlier and overcoming resistance."

Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: "One constant throughout these uncertain times is our unwavering commitment to changing the practice of medicine for patients living with cancer. Our new oncology medicines Tagrisso, Imfinzi, Lynparza, and Enhertu are demonstrating incredible momentum at ASCO (Free ASCO Whitepaper), building on their established benefits for patients by delivering powerful data in new settings and bending cancer survival curves. This year’s data at ASCO (Free ASCO Whitepaper) reinforce our belief that we can one day eliminate cancer as a cause of death."

Leadership in lung cancer across stages of disease

As AstraZeneca continues to advance lung cancer research and development from early to late-stage settings, the Company will present new data for Tagrisso, Imfinzi (durvalumab), Enhertu, and potential new medicine savolitinib. Beyond ADAURA, an oral presentation of the final analysis of the Phase III CASPIAN trial confirms the sustained, clinically meaningful overall survival (OS) benefit of Imfinzi for patients with extensive-stage small cell lung cancer (ES-SCLC). Another oral presentation reinforces the potential of Enhertu for patients with HER2-mutant NSCLC (see below). Results from a Phase II trial of savolitinib in patients with mesenchymal-epithelial transition (MET) exon 14 skipping mutations will also be presented.

Transforming treatment across HER2-driven cancers

AstraZeneca, in collaboration with Daiichi Sankyo Company, Limited (Daiichi Sankyo) will present new data from several trials highlighting the transformative potential of Enhertu, including detailed results from the Phase II DESTINY-Gastric01 trial which showed a statistically significant and clinically meaningful improvement in objective response rate and OS for patients with HER2-positive metastatic gastric cancer. Enhertu was recently granted Breakthrough Therapy Designation in the US for patients in this setting. Phase II data will also be presented for HER2-positive colorectal cancer and HER2-mutant NSCLC, two cancer settings for which there are currently no approved HER2-targeted medicines. Additionally, subgroup analyses from the Phase II DESTINY-Breast01 trial will reinforce the durable and consistent responses seen with Enhertu in HER2-positive metastatic breast cancer.

Advancing treatment in other cancer types with high unmet need

AstraZeneca will present data from several trials highlighting how the Company’s leading research is progressing treatment in other cancers where a high unmet medical need remains, including:

An oral presentation of results from Study 22 for the Imfinzi plus tremelimumab combination using a novel regimen in advanced liver cancer
Final OS results from the Phase III SOLO2 trial for Lynparza (olaparib) maintenance treatment in patients with BRCA-mutated platinum-sensitive relapsed ovarian cancer in an oral presentation. Lynparza is developed and commercialised in collaboration with MSD (MSD: known as Merck & Co., Inc. inside the US and Canada)
Multiple trials underscoring the impressive profile of Calquence (acalabrutinib), including data from the Phase II ACE-CL-001 trial with more than four years of follow up. The presentations represent the most mature safety and efficacy data to date with Calquence monotherapy in patients with chronic lymphocytic leukaemia
Key AstraZeneca presentations during the ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program
Lead author

Abstract title

Presentation details1

Immuno-Oncology

Paz-Ares, L

Durvalumab ± tremelimumab + platinum-etoposide in first-line ES-SCLC: Results from the Phase III CASPIAN study

Abstract #9002

Oral Abstract Session – Lung Cancer – Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

Chen, Y

First-line durvalumab plus platinum-etoposide in ES-SCLC (CASPIAN): Impact of brain metastases on treatment patterns and outcomes

Abstract #9068

Poster #261

Poster Session – Lung Cancer – Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

Naidoo, J

Non-pneumonitis immune-mediated adverse events with durvalumab in patients with unresectable, Stage III NSCLC (PACIFIC)

Abstract #9048

Poster #241

Poster Session – Lung Cancer – Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

Kelley, RK

Efficacy, tolerability, and biologic activity of a novel regimen of tremelimumab in combination with durvalumab for patients with advanced hepatocellular carcinoma (Study 22)

Abstract #4508

Oral Abstract Session – Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary

Oh, Do-Youn

Phase II study assessing tolerability, efficacy and biomarkers for durvalumab ± tremelimumab and gemcitabine/cisplatin in chemo-naïve advanced biliary tract cancer

Abstract #4520
Poster #128

Poster Session – Gastrointestinal Cancer: Gastroesophageal, Pancreatic, and Hepatobiliary

Lim, E

A Phase I, open-label multi-center study to assess the safety, pharmacokinetics, and the preliminary antitumor activity of AZD4635 both as monotherapy and in combination in patients with advanced solid malignancies: results from prostate cancer patients

Abstract #5518
Poster #99

Poster Session – Genitourinary Cancer – Prostate, Testicular, and Penile

DNA damage response

Poveda, A

Final overall survival results from SOLO2: a Phase III trial assessing maintenance olaparib in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA mutation

Abstract #6002

Oral Abstract Session – Gynecologic Cancer

Cadoo, K

Olaparib treatment in patients with platinum-sensitive relapsed ovarian cancer by BRCA mutation and homologous recombination deficiency status: Phase II LIGHT study

Abstract #6013
Poster #184

Poster Discussion – Gynecologic Cancer

Lee, J

Cediranib in combination with olaparib in patients without a germline BRCA1/2 mutation with recurrent platinum-resistant ovarian cancer: Phase IIb CONCERTO trial

Abstract #6056
Poster #227

Poster Session – Gynecologic Cancer

Poveda, A

Olaparib maintenance monotherapy for non-germline BRCA1/2-mutated platinum-sensitive relapsed ovarian cancer patients: Phase IIIb OPINION interim analysis

Abstract #6057
Poster #228

Poster Session – Gynecologic Cancer

Liu, J

A Phase III study comparing single-agent olaparib or the combination of cediranib and olaparib to standard platinum-based chemotherapy in recurrent platinum-sensitive ovarian cancer

Abstract #6003

Oral Abstract Session – Gynecologic Cancer

Gelmon, K

Real-world clinical effectiveness and safety of olaparib monotherapy in HER2-negative gBRCA-mutated metastatic breast cancer: Phase IIIb LUCY interim analysis

Abstract #1087

Poster #172

Poster Session – Breast Cancer – Metastatic

Tumour drivers and resistance

Herbst, R

Osimertinib as adjuvant therapy in patients with Stage IB–IIIA EGFRm NSCLC after complete tumor resection: ADAURA

Abstract #LBA5

Plenary Session
Sunday 31 May, 1:00pm EDT

Lu, S

Phase II study of savolitinib in patients with pulmonary sarcomatoid carcinoma and other types of NSCLC harboring MET exon 14 skipping mutations

Abstract #9519

Poster #285

Poster Discussion – Lung Cancer – Non-Small Cell Metastatic

Choueiri, T

SAVOIR: A Phase III study of savolitinib vs. sunitinib in patients with MET-driven papillary renal cell carcinoma

Abstract #5002

Oral Abstract Session – Genitourinary Cancer – Kidney and Bladder

Julia, K

Concurrent osimertinib plus gefitinib for first-line treatment of EGFR-mutated NSCLC

Abstract # 9507

Oral Abstract Session – Lung Cancer- Non-Small Cell Metastatic

Piotrowska, Z

ECOG-ACRIN 5162: A Phase II study of osimertinib 160 mg in NSCLC with EGFR exon 20 insertions

Abstract #9513

Poster #279

Poster Discussion – Lung Cancer – Non-Small Cell Metastatic

Hamilton, E

A Phase I dose escalation and expansion study of the next generation oral SERD AZD9833 in women with ER-positive, HER2-negative advanced breast cancer (SERENA-1)

Abstract #1024

Poster #109

Poster Discussion – Breast Cancer – Metastatic

Schmid, P

A Phase III trial of capivasertib and paclitaxel in first-line treatment of patients with metastatic triple-negative breast cancer (CAPItello­290)

Abstract #TPS1109

Poster #194

Poster Session – Breast Cancer – Metastatic

Haematology

Ghia, P

Acalabrutinib vs Idelalisib plus Rituximab or Bendamustine plus Rituximab in Relapsed/Refractory Chronic Lymphocytic Leukemia: ASCEND Final Results

Abstract #8015

Poster #348

Poster Discussion – Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia

Byrd, C

Acalabrutinib in Treatment-Naïve Chronic Lymphocytic Leukemia: Mature Results From Phase II Study Demonstrating Durable Remissions and Long-Term Tolerability

Abstract #8024

Poster #357

Poster Session – Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia

Furman, R

Safety of Acalabrutinib Monotherapy in Hematologic Malignancies: Pooled Analysis From Clinical Trials

Abstract #8064

Poster #397

Poster Session – Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia

Antibody drug conjugates

Smit, E

Trastuzumab deruxtecan in patients with HER2-mutated metastatic NSCLC: Interim results of DESTINY-Lung01

Abstract # 9504

Oral Abstract Session – Lung Cancer- Non-Small Cell Metastatic

Shitara, K

Trastuzumab deruxtecan in patients with HER2-positive advanced gastric or gastroesophageal junction adenocarcinoma: A randomized, Phase II, multicenter, open-label study (DESTINY-Gastric01)

Abstract #4513

Poster #121

Poster Session – Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary

Siena, S

A Phase II, multicenter, open-label study of trastuzumab deruxtecan in patients with HER2-expressing metastatic colorectal cancer: DESTINY-CRC01

Abstract #4000

Oral Abstract Session – Gastrointestinal Cancer – Colorectal and Anal

Modi, S

Trastuzumab deruxtecan for HER2-positive metastatic breast cancer: DESTINY-Breast01 subgroup analysis

Abstract #1036

Poster #121

Poster Session – Breast Cancer- Metastatic

1. Beginning Friday, 29 May 2020 8:00 AM EDT oral presentations, poster discussions and poster sessions will be available on demand for 180 days including video and slide presentations and discussant commentary.

AstraZeneca in Oncology

AstraZeneca has a deep-rooted heritage in oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With six new medicines launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers. In addition to AstraZeneca’s main capabilities, the Company is actively pursuing innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by the investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.

On May 13, 2020 Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of cancer and autoimmune diseases, reported that Bassil Dahiyat, Ph.D., president and chief executive officer, will participate in a fireside chat at the 2020 RBC Capital Markets Global Healthcare Virtual Conference on Wednesday, May 20, 2020 at 4:15 p.m. ET / 1:15 p.m. PT (Press release, Xencor, MAY 13, 2020, View Source [SID1234557930]).

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A live webcast will be available under "Events & Presentations" in the Investors section of the Company’s website located at www.xencor.com. A replay will be posted on the Xencor website approximately one hour after the live event and will be available for 30 days.