ALX Oncology’s Evorpacept Receives Fast Track Designation from FDA as First-Line Treatment for Head and Neck Squamous Cell Carcinoma

On August 1, 2022 ALX Oncology Holdings Inc., ("ALX Oncology") (Nasdaq: ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, reported that the U.S. Food and Drug Administration ("FDA") has granted Fast Track designation to evorpacept, a next generation CD47 blocker, in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, for the first-line treatment of adult patients with PD-L1 positive advanced head and neck squamous cell carcinoma ("HNSCC") (Press release, ALX Oncology, AUG 1, 2022, View Source [SID1234617202]).

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The FDA’s decision is informed by the results of ALX Oncology’s phase 1 clinical trial, ASPEN-01, that showed preliminary antitumor activity and a favorable safety profile in checkpoint inhibitor-naïve patients with second-line or greater advanced HNSCC treated with evorpacept and pembrolizumab (n=10). The preliminary objective response rate of 40% in this limited population represents an improvement over historical anti-PD-1 monotherapy activity in a similar population and supported the initiation of the ASPEN-03 (NCT04675294) study in May 2021 in collaboration with Merck (known as MSD outside the US and Canada). ASPEN-03 is a randomized phase 2 multi-center study to investigate the anti-tumor efficacy of evorpacept plus pembrolizumab in patients with first-line metastatic or unresectable, recurrent PD-L1 positive HNSCC.

"The FDA’s Fast Track designation for the first-line treatment of HNSCC with evorpacept in combination with pembrolizumab builds upon evorpacept’s prior Fast Track designation in the first-line HNSCC population in combination with pembrolizumab and standard chemotherapy highlighting the potential clinical utility of evorpacept in this difficult-to-treat disease," said Sophia Randolph, M.D., Ph.D., Chief Medical Officer, ALX Oncology. "We are pleased by the patient enrollment progress being made across our HNSCC phase 2 program (NCT04675294; NCT04675333) as we seek to advance evorpacept to help patients living with this disease."

About FDA Fast Track Designation
The FDA’s Fast Track program is designed to facilitate the development and expedite the review of medicines that may treat serious or life-threatening conditions and address significant unmet medical needs. The designation provides the opportunity for more frequent meetings with the FDA over the course of drug development. In addition, the Fast Track program allows for eligibility for Accelerated Approval and Priority Review if relevant criteria are met, as well as for Rolling Review, which enables a drug company to submit portions of the Biologic License Application to the FDA as they are completed.

About HNSCC
HNSCC is a serious and life-threatening disease with poor prognosis despite current available standard of care therapies. According to the Global Cancer Observatory, HNSCC was the 6th most common cancer globally in 2018 and the incidence of HNSCC is expected to increase 30% by 2030. For 2022, the National Cancer Institute estimates about 54,000 new cases of HNSCC will be diagnosed and nearly 11,230 of men and women will die from HNSCC in the United States.

Immunocore announces upcoming oral presentation of initial Phase 1 data of ImmTAC® candidate IMC-F106C targeting PRAME at European Society for Medical Oncology (ESMO) Congress 2022

On August 1, 2022 Immunocore Holdings plc (Nasdaq: IMCR) ("Immunocore" or the "Company"), a commercial-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, autoimmune and infectious diseases, reported that initial data from its Phase 1 study of IMC-F106C, the first PRAME x CD3 ImmTAC bispecific in multiple solid tumors has been accepted for an oral presentation during a proffered paper session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022 in Paris (Press release, Immunocore, AUG 1, 2022, View Source [SID1234617201]).

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Oral Presentation Details

Title: Results from Phase 1 dose escalation of IMC-F106C, the first PRAME × CD3 ImmTAC bispecific protein in solid tumors

Presenter: Dr. Omid Hamid
Date and Time: Friday, September 9, 2022; 4:50 PM CEST
Session: Proffered Paper session, Investigational immunotherapy
Abstract ID: 728O
Poster Presentation Details
The following four posters will be presented on Saturday, September 10, 2022; 9:00 – 17:00 CEST

Title: A propensity score weighted comparison of tebentafusp or pembrolizumab versus combination ipilimumab and nivolumab in untreated metastatic uveal melanoma

Presenter: Dr. Josep Maria Piulats
Abstract ID: 823P
Title: Safety and efficacy of infrequent tebentafusp treatment omissions in patients with metastatic uveal melanoma

Presenter: Prof. Max Schlaak
Abstract ID: 821P
Title: Long-term survivors on tebentafusp in phase 2 trial of previously treated patients with metastatic uveal melanoma

Presenter: Dr. Takami Sato
Abstract ID: 843P
Title: ImmTAC redirect T cells against patient-derived tumor organoids and three-dimensional melanospheres; effects augmented by type I interferons

Presenter: Dr. Peter Kirk
Abstract ID: 1692P
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About ImmTAC Molecules
Immunocore’s proprietary T cell receptor (TCR) technology generates a novel class of bispecific biologics called ImmTAC (Immune mobilizing monoclonal TCRs Against Cancer) molecules that are designed to redirect the immune system to recognize and kill cancerous cells. ImmTAC molecules are soluble TCRs engineered to recognize intracellular cancer antigens with ultra-high affinity and selectively kill these cancer cells via an anti-CD3 immune-activating effector function. Based on the demonstrated mechanism of T cell infiltration into human tumors, the ImmTAC mechanism of action holds the potential to treat hematologic and solid tumors, regardless of mutational burden or immune infiltration, including immune "cold" low mutation rate tumors.

About KIMMTRAK
KIMMTRAK is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function. KIMMTRAK specifically targets gp100, a lineage antigen expressed in melanocytes and melanoma. This is the first molecule developed using Immunocore’s ImmTAC technology platform designed to redirect and activate T cells to recognise and kill tumour cells. KIMMTRAK has been approved for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma in the United States, European Union, Canada, Australia, and the United Kingdom.

IMPORTANT SAFETY INFORMATION

Cytokine Release Syndrome (CRS), which may be serious or life-threatening, occurred in patients receiving KIMMTRAK. Monitor for at least 16 hours following first three infusions and then as clinically indicated. Manifestations of CRS may include fever, hypotension, hypoxia, chills, nausea, vomiting, rash, elevated transaminases, fatigue, and headache. CRS occurred in 89% of patients who received KIMMTRAK with 0.8% being grade 3 or 4. Ensure immediate access to medications and resuscitative equipment to manage CRS. Ensure patients are euvolemic prior to initiating the infusions. Closely monitor patients for signs or symptoms of CRS following infusions of KIMMTRAK. Monitor fluid status, vital signs, and oxygenation level and provide appropriate therapy. Withhold or discontinue KIMMTRAK depending on persistence and severity of CRS.

Skin Reactions

Skin reactions, including rash, pruritus, and cutaneous edema occurred in 91% of patients treated with KIMMTRAK. Monitor patients for skin reactions. If skin reactions occur, treat with antihistamine and topical or systemic steroids based on persistence and severity of symptoms. Withhold or permanently discontinue KIMMTRAK depending on the severity of skin reactions.

Elevated Liver Enzymes

Elevations in liver enzymes occurred in 65% of patients treated with KIMMTRAK. Monitor alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total blood bilirubin prior to the start of and during treatment with KIMMTRAK. Withhold KIMMTRAK according to severity.

Embryo-Fetal Toxicity

KIMMTRAK may cause fetal harm. Advise pregnant patients of potential risk to the fetus and patients of reproductive potential to use effective contraception during treatment with KIMMTRAK and 1 week after the last dose.

The most common adverse reactions (≥30%) in patients who received KIMMTRAK were cytokine release syndrome, rash, pyrexia, pruritus, fatigue, nausea, chills, abdominal pain, edema, hypotension, dry skin, headache, and vomiting. The most common (≥50%) laboratory abnormalities were decreased lymphocyte count, increased creatinine, increased glucose, increased AST, increased ALT, decreased hemoglobin, and decreased phosphate.

For more information, please see full Summary of Product Characteristics (SmPC) or full U.S. Prescribing Information (including BOXED WARNING for CRS).

Chemomab Therapeutics to Report Second Quarter 2022 Financial Results and Provide a Business Update

On August 1, 2022 Chemomab Therapeutics Ltd. (Nasdaq: CMMB), (Chemomab), a clinical stage biotechnology company focused on the discovery and development of innovative therapeutics for fibrotic and inflammatory diseases with high unmet need, reported the company will release its second quarter 2022 financial results and provide a business update on Friday, August 12, 2022 at 8:00 am Eastern Time (Press release, Chemomab, AUG 1, 2022, View Source [SID1234617200]).

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During the event, Chemomab’s management team will review second quarter 2022 performance, discuss recent and upcoming developments and conduct a live question-and-answer session.

A replay of the call will be available on Chemomab’s website for 90 days at www.chemomab.com.

Live Webcast and Conference Call at 8:00 am Eastern Time, Friday, August 12, 2022

Click this Webcast link to access the live webcast or replay.

The live webcast and replay can also be accessed at the News & Events section of the Investors page on the Chemomab website at investors.chemomab.com/events.

Please call 5-10 minutes before the scheduled start time, enter the conference passcode and ask the operator for the Chemomab conference call.

Precision BioSciences to Report Second Quarter 2022 Financial Results on August 8, 2022

On August 1, 2022 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company developing ARCUS-based ex vivo allogeneic CAR T and in vivo gene editing therapies, reported that it will publish financial results for the second quarter 2022 and provide a business update on August 8, 2022 (Press release, Precision Biosciences, AUG 1, 2022, View Source [SID1234617199]).

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PerkinElmer Announces Financial Results for the Second Quarter of 2022

On August 1, 2022 PerkinElmer, Inc. (NYSE: PKI), a global leader committed to innovating for a healthier world, reported financial results for the second quarter ended July 3, 2022 (Press release, PerkinElmer, AUG 1, 2022, View Source [SID1234617198]).

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The Company reported GAAP earnings per share from continuing operations of $1.42, as compared to GAAP earnings per share from continuing operations of $2.19 in the same period a year ago. GAAP revenue for the quarter was $1.23 billion, as compared to $1.23 billion in the same period a year ago. GAAP operating income from continuing operations for the quarter was $251 million, as compared to $332 million for the same period a year ago. GAAP operating profit margin was 20.4% as a percentage of revenue, as compared to 27.1% in the same period a year ago.

Adjusted earnings per share from continuing operations for the quarter was $2.32, as compared to $2.83 in the same period a year ago. Adjusted revenue for the quarter was $1.23 billion, as compared to $1.23 billion in the same period a year ago. Adjusted operating income from continuing operations for the quarter was $402 million, as compared to $411 million for the same period a year ago. Adjusted operating profit margin was 32.7% as a percentage of adjusted revenue, as compared to 33.5% in the same period a year ago.

Adjustments for the Company’s non-GAAP financial measures have been noted in the attached reconciliations.

"Our strong performance in the quarter is a testament to our operational and commercial execution as well as our portfolio evolution over the last three years," said Prahlad Singh, president and chief executive officer of PerkinElmer. "With today’s divestiture announcement, we position the company to transform into a pureplay, high growth, high margin life sciences and diagnostics company with even more focus to capitalize on attractive end markets. This transformation will in turn lead to significant financial strength, allowing us to continue to scale and accelerate our innovation investments, which help our customers bridge the chasm from research to clinic, and clinic to cure."

Financial Overview by Reporting Segment for the Second Quarter

Discovery & Analytical Solutions

Second quarter 2022 revenue was $661 million, as compared to $513 million in the same period a year ago. Reported revenue increased 29% and organic revenue increased 13% as compared to the same period a year ago.
Second quarter 2022 operating income from continuing operations was $70 million, as compared to $64 million for the same period a year ago.
Second quarter 2022 adjusted operating income was $178 million, as compared to $101 million for the same period a year ago.
Diagnostics

Second quarter 2022 revenue was $569 million, as compared to $716 million for the same period a year ago. Reported revenue decreased 20% and organic revenue decreased 19% as compared to the same period a year ago.
Second quarter 2022 operating income from continuing operations was $201 million, as compared to $286 million for the same period a year ago.
Second quarter 2022 adjusted operating income was $245 million, as compared to $328 million for the same period a year ago.
Initiates Third Quarter and Raises Full Year 2022 Guidance

For the third quarter of 2022, the Company forecasts revenue of approximately $1.02-1.03 billion and adjusted earnings per share to be in a range $1.40-1.45.

For the full year 2022, the Company now forecasts revenue of $4.60-4.64 billion and adjusted earnings per share of $7.80-7.90.

Guidance for the third quarter and full year is provided on a non-GAAP basis and cannot be reconciled to the closest GAAP measures without unreasonable effort due to the unpredictability of the amounts and timing of events affecting the items the Company excludes from these non-GAAP measures. The timing and amounts of such events and items could be material to the Company’s results prepared in accordance with GAAP.

Announces Agreement with the Intention to Divest Applied, Food, and Enterprise Services Businesses

The Company is also announcing today that it has entered into an agreement with the intention to divest its Applied, Food, and Enterprise Services businesses to New Mountain Capital for a total consideration of $2.45 billion. The transaction is expected to close in the first quarter of 2023, subject to regulatory approvals and other customary closing conditions. Management will provide additional detail regarding this transaction in a separate release and on today’s webcast. A presentation highlighting this transaction will be available on the Investors section of the Company’s website, www.perkinelmer.com.

Webcast Information

The Company will discuss its second quarter 2022 results, its outlook for business trends, and its intended divestiture of its Analytical, Food, and Enterprise Services businesses during a webcast on August 1, 2022, at 8:00 a.m. Eastern Time. A live audio webcast and presentation will be available on the Investors section of the Company’s website, www.perkinelmer.com.

Use of Non-GAAP Financial Measures

In addition to financial measures prepared in accordance with generally accepted accounting principles (GAAP), this earnings announcement also contains non-GAAP financial measures. The reasons that we use these measures, a reconciliation of these measures to the most directly comparable GAAP measures, and other information relating to these measures are included below following our GAAP financial statements.

Factors Affecting Future Performance

This press release contains "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements relating to estimates and projections of future earnings per share, cash flow and revenue growth and other financial results, developments relating to our customers and end-markets, and plans concerning business development opportunities, acquisitions and divestitures. Words such as "believes," "intends," "anticipates," "plans," "expects," "estimates", "projects," "forecasts," "will" and similar expressions, and references to guidance, are intended to identify forward-looking statements. Such statements are based on management’s current assumptions and expectations and no assurances can be given that our assumptions or expectations will prove to be correct. A number of important risk factors could cause actual results to differ materially from the results described, implied or projected in any forward-looking statements. These factors include, without limitation: (1) markets into which we sell our products declining or not growing as anticipated; (2) the effect of the COVID-19 pandemic on our sales and operations; (3) fluctuations in the global economic and political environments; (4) our failure to introduce new products in a timely manner; (5) our ability to execute acquisitions and divestitures, such as the divestiture of the Applied, Food and Enterprise Services businesses, license technologies, or to successfully integrate acquired businesses and licensed technologies into our existing business or to make them profitable, or successfully divest businesses; (6) our ability to compete effectively; (7) fluctuation in our quarterly operating results and our ability to adjust our operations to address unexpected changes; (8) significant disruption in third-party package delivery and import/export services or significant increases in prices for those services; (9) disruptions in the supply of raw materials and supplies; (10) our ability to retain key personnel; (11) significant disruption in our information technology systems, or cybercrime; (12) our ability to realize the full value of our intangible assets; (13) our failure to adequately protect our intellectual property; (14) the loss of any of our licenses or licensed rights; (15) the manufacture and sale of products exposing us to product liability claims; (16) our failure to maintain compliance with applicable government regulations; (17) regulatory changes; (18) our failure to comply with healthcare industry regulations; (19) economic, political and other risks associated with foreign operations; (20) the United Kingdom’s withdrawal from the European Union; (21) our ability to obtain future financing; (22) restrictions in our credit agreements; (23) discontinuation or replacement of LIBOR; (24) significant fluctuations in our stock price; (25) reduction or elimination of dividends on our common stock; and (26) other factors which we describe under the caption "Risk Factors" in our most recent quarterly report on Form 10-Q and in our other filings with the Securities and Exchange Commission. We disclaim any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.