On August 5, 2020 RGENIX, Inc., a clinical stage biopharmaceutical company developing first-in-class small molecule and antibody cancer therapeutics, reported that it has been selected to present at multiple virtual healthcare investor conferences taking place during the month of August (Press release, Rgenix, AUG 5, 2020, View Source [SID1234562893]).

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These conferences include:

LifeSci Partners Summer Symposium
August 5, 2020 at 11:30 A.M EDT

BTIG Virtual Biotechnology Conference 2020
August 11, 2020 at 3:30 P.M. EDT

2020 Wedbush PacGrow Healthcare Conference
August 12, 2020 at 9:10 A.M. EDT

Canaccord Genuity 40th Annual Growth Conference
August 13, 2020 at 8:00 A.M. EDT

Links to the live and archived versions of these presentations are available on Rgenix’s website within the News section.

On August 5, 2020 Veracyte, Inc. (Nasdaq: VCYT) reported the publication of new data demonstrating that the Percepta classifier significantly reduces invasive procedures in lung cancer diagnosis by classifying nearly 40 percent of patients as "low risk" when bronchoscopy is inconclusive (Press release, Veracyte, AUG 5, 2020, View Source [SID1234562877]). The findings, from a large, prospective clinical study involving 35 centers, also suggest that these results are durable over a one-year follow-up and that the classifier results do not delay time to diagnosis among those patients with lung cancer. The study appears online in CHEST, the journal of the American College of Chest Physicians.

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"Lung nodules are often difficult to diagnose when bronchoscopy results are indeterminate following initial work-up of the patient. As a result, physicians must determine whether to direct patients to further, invasive procedures or just monitor them, at the risk of missing a cancer and delaying necessary treatment," said Giulia C. Kennedy, Ph.D., Veracyte’s chief scientific officer and chief medical officer. "The real-world findings published in CHEST show that use of the Percepta classifier significantly alters physicians’ pre-test clinical plans for an invasive procedure, enabling some patients to safely avoid the potential morbidity, mortality and cost associated with unnecessary, invasive procedures without delaying or shifting the stage of diagnosis among those who have lung cancer."

The real-world registry study prospectively evaluated physicians’ management of lung nodules, as well as resulting clinical outcomes, at 35 academic and community-based U.S. medical centers. Researchers evaluated the impact of Percepta results on clinical decision-making for 213 patients with a low or intermediate pre-test risk of malignancy and a non-diagnostic bronchoscopy.

Comparing physicians’ pre-test to post-test plans for these patients, researchers observed a major shift following the Percepta classifier result. Among 67 patients for whom physicians had initially planned a subsequent invasive procedure, the Percepta test down-classified the risk of malignancy in 34.3 percent. Of these down-classified patients, physicians changed management plans for 73.9 percent – from an invasive procedure to surveillance – and 61 percent avoided a procedure for up to 12 months after initial evaluation.

In addition, researchers observed a larger absolute reduction in procedure rates among down-classified patients (61 percent vs. 52 percent, p<0.01), compared to those patients with unchanged risk.

Lastly, the time to diagnosis was not significantly delayed when comparing Percepta test down-classified patients to patients who were not down-classified (p=0.58), among all patients in the pre-test low and intermediate risk group who had confirmed lung cancers.

"The findings from this real-world multicenter study reinforce the large and growing body of evidence demonstrating that the Percepta classifier can reduce unnecessary invasive procedures for lung nodule patients when bronchoscopy findings are inconclusive," said Bonnie Anderson, Veracyte’s chairman and chief executive officer. "These data are particularly important as physicians seek ways to limit their patients’ exposure to invasive procedures. We believe they will help support physician adoption of and payer reimbursement for the Percepta classifier."

About the Percepta Classifier

The Percepta classifier is a novel genomic test that helps physicians determine individual patients’ lung cancer risk when results from bronchoscopy – a non-surgical procedure standardly used to assess lung nodules for cancer – are inconclusive. Veracyte estimates that approximately 545,000 bronchoscopies are performed each year to evaluate suspicious lung nodules and that up to 60 percent of these produce inconclusive results. The Percepta classifier was developed using advanced genomic technology and machine learning, and is based on novel "field of injury" science – which identifies genomic changes associated with lung cancer in current or former smokers using a simple brushing of the person’s airway. The test is covered by Medicare.

On August 5, 2020 Clovis Oncology, Inc. (NASDAQ: CLVS) announced today treatment of the first patient in the Phase 2 portion of the LIO-1 trial evaluating the combination of lucitanib, Clovis’ investigational angiogenesis inhibitor, including vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3), and Opdivo (nivolumab), Bristol Myers Squibb’s PD-1 inhibitor, for the treatment of gynecologic cancers (Press release, Clovis Oncology, AUG 5, 2020, View Source [SID1234562876]). The LIO-1 trial is sponsored by Clovis as part of its broad clinical collaboration with Bristol Myers Squibb.

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"The Phase 2 part of the LIO-1 trial will advance our scientific understanding of the potential for an inhibitor of multiple tyrosine kinases, including VEGF, such as lucitanib, to be combined with a PD-1 inhibitor for the treatment of gynecologic cancers," said Dr. Erika Hamilton, Director of the Breast and Gynecologic Research Program, Sarah Cannon Research Institute at Tennessee Oncology. "It is estimated that nearly 100,000 women will be diagnosed with a gynecologic cancer in the U.S. this year alone, and it is vital that we identify new treatment options, in particular new combinations, for these women."

The Phase 2 part of LIO-1 is an open-label study to evaluate the safety and efficacy of lucitanib and Opdivo in patients with advanced gynecological solid tumors, including a broad spectrum of ovarian and endometrial subtypes including clear cell disease and patients with cervical cancer. The primary endpoint is confirmed best overall response rate based on investigator assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. The study will be conducted in the U.S. and Europe, in collaboration with the European Network for Gynaecological Oncological Trial groups (ENGOT) for European study sites.

The Phase 2 dosing regimen for the LIO-1 study is based on results from the recently completed Phase 1b dose-escalation portion of the LIO-1 study. Abstracts describing the initial results of the Phase 1b portion of the LIO-1 study, as well as a trials-in-progress description of the Phase 2 study design of LIO-1, have been accepted as ePosters at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020 in September.

"The initiation of the Phase 2 stage of the LIO-1 clinical trial is an important milestone for the lucitanib development program, and I am grateful to our team and our investigators for their commitment to initiating this study safely and expeditiously in this new COVID-19 era," said Patrick J. Mahaffy, President and Chief Executive Officer of Clovis Oncology. "Importantly, we look forward to sharing initial Phase 1b data from LIO-1 at the upcoming virtual ESMO (Free ESMO Whitepaper) Congress, as well as data for each of our commercial and development-stage products. We are committed to pursue innovative clinical studies, both monotherapy and in combination, that are supported by a strong scientific rationale and offer the potential to provide additional treatment options with meaningful clinical benefit to a broad group of cancer patients."

More information about the LIO-1 trial (NCT04042116) is available here.

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 (PDFGRα/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 may reverse this immunosuppression and augment response to immunotherapy.

Lucitanib is an unlicensed medical product.

On August 5, 2020 Kaleido Biosciences, Inc. (Nasdaq: KLDO), a clinical-stage healthcare company with a chemistry-driven approach to targeting the microbiome to treat disease and improve human health, reported that Michael Bonney, Executive Chair, will participate in a fireside chat at the virtual Canaccord Genuity 40th Annual Growth Conference on Thursday, August 13, 2020 at 3:30 p.m. ET (Press release, Kaleido Biosciences, AUG 5, 2020, View Source [SID1234562875]).

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A live webcast will be available in the Investors & Media section of Kaleido’s website at View Source An archived replay will be accessible for 90 days following the event.

On August 5, 2020 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) therapies for cancer, reported financial results for the quarter ended June 30, 2020. (Press release, Allogene, AUG 5, 2020, View Source [SID1234562874])

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"We are incredibly pleased with the progress we’ve made across our AlloCAR T platform, which now includes ongoing clinical trials for ALLO-501, ALLO-501A and ALLO-715," said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. "The ALLO-501 data we presented at ASCO (Free ASCO Whitepaper) in May solidifies our belief in the potential of AlloCAR T therapy in hematologic malignancies. We look forward to presenting initial data in a second hematologic malignancy, multiple myeloma, later this year as we advance the same innovative approach to solid tumors in 2021."

Recent Highlights

Anti-CD19 AlloCAR T Program
Initial data from ALLO-501’s ALPHA trial provided support for the Company’s approach to AlloCAR T therapy. Allogene intends to leverage ALLO-501 to optimize trial design and dose selection as it prepares for a potentially pivotal Phase 2 trial of ALLO-501A in 2021.

•ALLO-501 ALPHA Phase 1 Trial
In May 2020 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, the Company presented initial data from its dose escalation Phase 1 ALPHA study of ALLO-501 in relapsed/refractory non-Hodgkin lymphoma (NHL). This study utilizes ALLO-647, the Company’s anti-CD52 monoclonal antibody (mAb), as a part of its differentiated lymphodepletion regimen. The next readout from this trial is expected to be in late 2020 or early 2021.

As per the ASCO (Free ASCO Whitepaper) presentation, 22 patients were evaluable for safety and 19 patients were evaluable for efficacy with at least one tumor assessment as of the May 2020 data cutoff.
◦Responses were observed across all cell doses and NHL histologies (diffuse large B-cell lymphoma and follicular lymphoma).
◦Across all evaluable patients, there were seven complete responses (CR) and five partial responses (PR) for an overall response rate (ORR) of 63% and CR rate of 37%.
◦In CAR T naïve patients (n=16) the ORR was 75% and the CR rate 44%.
◦Higher dose ALLO-647 was associated with a higher CR rate.
◦With a median follow-up of 3.8 months, nine of the 12 responding patients (75%) remained in response as of the data cutoff on May 11, 2020.
◦No dose limiting toxicities, graft-vs-host disease, or Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) was observed. Cytokine release syndrome occurred in 32% of the patients, was mainly mild to moderate

in severity and manageable with standard recommendations. Four patients (18%) experienced serious adverse events (SAE), all of which resolved.

•ALLO-501A ALPHA2 Phase 1 Trial
ALLO-501A is a next generation anti-CD19 AlloCAR T intended for Phase 2 development. During the second quarter, the Company initiated enrollment in the Phase 1 portion of the ALPHA2 trial. This abbreviated dose escalation study is a single-arm, open-label, multicenter trial of ALLO-501A in patients with R/R large B-cell lymphoma. The Company expects to begin the Phase 2 portion of this study in 2021.

Anti-BCMA AlloCAR T Program
The Company continues to progress its robust anti-BCMA strategy centered around ALLO-715 for the treatment of multiple myeloma (MM).

•ALLO-715 UNIVERSAL Phase 1 Trial
◦The ALLO-715 Phase 1 UNIVERSAL trial in patients with relapsed/refractory MM utilizes ALLO-647 as part of the lymphodepletion platform. The initial dose escalation portion of the UNIVERSAL trial using 39mg of ALLO-647 is now complete. The trial continues to enroll patients with initial data anticipated in Q4 2020.
•ALLO-715 + nirogacestat
◦An Investigational New Drug (IND) application is expected to be submitted in the second half of 2020 to evaluate ALLO-715 in combination with SpringWorks’ investigational gamma secretase inhibitor, nirogacestat, in patients with relapsed/refractory MM.
•ALLO-605 (TurboCAR)
◦The Company presented preclinical data on its internally developed TurboCAR technology platform at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 23rd Annual Meeting in May. TurboCAR technology allows cytokine activation signaling to be engineered selectively into CAR T cells. TurboCAR has the potential to improve efficacy, overcome cell exhaustion, and reduce dosing requirements of AlloCAR T therapy.
◦In 2021, an IND is expected to be submitted for the Company’s first TurboCAR candidate, ALLO-605, an investigational BCMA-directed AlloCAR T therapy for MM.

Solid Tumor AlloCAR T Program
•ALLO-316 (anti-CD70)
◦The Company continues to progress pre-clinical work on ALLO-316, its anti-CD70 AlloCAR T clinical candidate. ALLO-316 has potential application in both hematologic malignancies and solid tumors. The initial focus for this investigational therapy will be renal cell carcinoma with an IND planned by the end of 2020.
Manufacturing Updates
Construction continues on the Company’s state-of-the-art cGMP cell manufacturing facility in Newark, California. The Company continues to expect to initiate cGMP manufacturing from this facility in 2021.

Second Quarter Financial Results
•Research and development expenses were $47.3 million for the second quarter of 2020, which includes $8.0 million of non-cash stock-based compensation expense.
•General and administrative expenses were $15.9 million for the second quarter of 2020, which includes $8.8 million of non-cash stock-based compensation expense.
•Net loss for the second quarter of 2020 was $61.0 million, or $0.53 per share, including non-cash stock-based compensation expense of $16.8 million.
•In June, the Company closed on a secondary offering that raised $632.5 million in gross proceeds prior to deducting underwriting discounts, commissions and offering expenses. This included the exercise in full by the Underwriters of their option to purchase additional shares of common stock. As a result, the Company had $1.1 billion in cash, cash equivalents, and investments as of June 30, 2020.

2020 Financial Guidance
•Allogene continues to expect full year GAAP net losses to be between $260 million and $280 million including estimated non-cash stock-based compensation expense of $70 million to $75 million and excluding any impact from potential business development activities.

Conference Call and Webcast Details
Allogene will host a live conference call and webcast today at 5:30 a.m. Pacific Time / 8:30 a.m. Eastern Time to discuss financial results and provide a business update. To access the live conference call by telephone, please dial 1 (866) 940-5062 (U.S.) or 1 (409) 216-0618 (International). The conference ID number for the live call is 2189084. The webcast will be made available on the Company’s website at www.allogene.com under the Investors tab in the News and Events section. Following the live audio webcast, a replay will be available on the Company’s website for approximately 30 days.