In normal times, well over 40,000 delegates would be making their way to Chicago right now to attend the American Society of Clinical Oncology (ASCO) annual meeting. As we know, these are certainly not normal times, with all conference activities disrupted or canceled because of the COVID-19 pandemic. As a result, delegates will “attend” from their own homes and tune into to the presentations from leading cancer researchers at the ASCO20 virtual scientific program, which starts on May 29. The meeting will also be closely watched by analysts and investors alike. There is no doubt that favorable data presented at the event will advance a company's stock valuation significantly. Equally, candidate cancer therapies that do not live up to expectations will see their developers face the ire of investors. Our two-part feature will examine how the equities of public biopharmaceutical companies that are developing cancer therapies perform over the course of the event.
Up until recently, the price-weighted BioWorld Cancer index that includes 21 representative companies developing therapies targeting various cancers, but excluding big pharmaceutical companies such as Bristol Myers Squibb Co., Pfizer Inc. and Merck & Co. Inc., had taken a beating, slumping by more than 22% by the end of March. Since then, there has been a dramatic turnaround driven by impressive performances from many of the index members.
By market close Thursday, the index has recorded a monthly increase of almost 19%, tracking well ahead of the improving general markets, and contributing to a year-to-date performance of about 6%. (See BioWorld Cancer Index, below.)
Fueling the increase has been Rockville, Md.-based Macrogenics Inc., with its shares (NASDAQ:MGNX) jumping a whopping 219% in May. Today, the company reported that during a mid-cycle communication with the FDA, the agency notified the firm that it is no longer planning to hold an Oncologic Drugs Advisory Committee meeting to discuss the BLA for margetuximab and continues to anticipate meeting the PDUFA goal date for the application review, which has been set for Dec. 18. Margetuximab, an investigational, Fc-engineered, monoclonal antibody that targets HER2, is being evaluated in SOPHIA, a phase III trial testing the combination with chemotherapy compared to trastuzumab plus chemotherapy in patients with HER2-positive metastatic breast cancer.
Also, this week, the company revealed plans for a clinical study that is intended to support U.S. registration of flotetuzumab, a bispecific CD123 x CD3 DART molecule, for patients with acute myeloid leukemia (AML) who are refractory to induction therapy. After discussions with the FDA, it will conduct a single-arm, registration-enabling study to evaluate flotetuzumab in up to 200 patients with primary induction failure or early relapse AML. Complete remission (CR) and CR with partial hematological recovery will be the primary endpoint of the pivotal study.
The company will be making several presentations at ASCO, including providing results from a phase I study of MGD-013, an investigational, first-in-class, Fc-bearing bispecific tetravalent DART molecule designed to bind PD-1 and LAG-3 and sustain/restore the function of exhausted T cells, in advanced solid and hematologic malignancies.
Also pushing 68% higher this month are shares of New York-based TG Therapeutics Inc. (NASDAQ:TGTX). The increase gave the company the opportunity to complete a follow-on offering with the pricing of an underwritten public offering of 8.5 million shares of common stock at $18 each with gross proceeds expected to be $153 million. A further $23 million could be added to the total if the underwriters exercise in full their option to purchase an additional 1.275 million shares.
The company anticipates using net proceeds to help support the continued development of ublituximab and umbralisib (U2). This month, the independent data safety monitoring board recommended that the UNITY-CLL study be stopped early for superior efficacy after an interim analysis showed its U2 combination helped patients with chronic lymphocytic leukemia (CLL).
At ASCO, the company will present the final results from the GENUINE phase III trial, evaluating ublituximab in high-risk CLL patients, “which is the first randomized trial to demonstrate a PFS benefit with the addition of an anti-CD20 antibody to ibrutinib, compared to ibrutinib monotherapy,” noted company CEO Michael Weiss.
South San Francisco-based Allogene Therapeutics Inc. (NASDAQ:ALLO), which is developing allogeneic CAR T (AlloCAR T) therapies for cancer, has seen its shares move 61% higher this month on the strength of news about data it will be reporting at ASCO, in collaboration with development partner Servier. It will be drawn from the company’s phase I dose-escalation ALPHA study of ALLO-501 in relapsed/refractory non-Hodgkin lymphoma. This study utilizes ALLO-647, an anti-CD52 monoclonal antibody, as a part of its differentiated lymphodepletion regimen.
The ASCO abstract includes preliminary data on the first nine patients treated with escalating doses of ALLO-501 and lower-dose (39 mg) ALLO-647. No dose-limiting toxicities or graft-vs.-host disease was observed. Although the data are based on a small number of patients, the overall response rate was 78% (with three complete responses and four partial responses. As of the January 2020 data cutoff, there was a median follow up of 2.7 months, with four patients in ongoing response and three patients having progressed at two, four and six months.
The company reported that during its virtual presentation May 29, data on 11 patients across ALLO-501 cell dose cohorts and the lower dose (39 mg) of ALLO-647 will be presented, as well as additional patients treated with ALLO-501 and the higher dose (90 mg) of ALLO-647.