On March 28, 2022 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported financial results for the full-year ended December 31, 2021 and recent corporate highlights (Press release, Checkpoint Therapeutics, MAR 28, 2022, View Source [SID1234611047]).

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James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "The past year represented a truly transformational period for Checkpoint Therapeutics, with the foundation laid for multiple significant potentially value enhancing catalysts in 2022. Following the positive topline results from our ongoing registrational trial of cosibelimab in metastatic cutaneous squamous cell carcinoma announced earlier this year, we look forward to a planned Biologics License Application submission for cosibelimab later in 2022." Mr. Oliviero continued, "We remain focused on expeditiously advancing our pipeline of product candidates with the goal of expanding patient access globally to potentially life-saving novel oncology therapies through a disruptive pricing strategy."

2021 and Recent Corporate Highlights:

In January 2022, Checkpoint announced positive topline results from the ongoing registration-enabling clinical trial evaluating the safety and efficacy of its anti-PD-L1 antibody, cosibelimab, administered as a fixed dose of 800 mg every two weeks in patients with metastatic cutaneous squamous cell carcinoma ("cSCC"). The study met its primary endpoint, with cosibelimab demonstrating a confirmed objective response rate of 47.4% (95% CI: 36.0, 59.1) based on independent central review of 78 patients enrolled in the metastatic cSCC cohort using Response Evaluation Criteria in Solid Tumors version 1.1 criteria. Checkpoint intends to submit a Biologics License Application for cosibelimab in late 2022, followed by a Marketing Authorization Application submission in Europe and other territories worldwide. With a potentially favorable safety profile versus anti-PD-1 therapy and a plan to commercialize at a substantially lower price, Checkpoint believes cosibelimab has the potential to be a market disruptive product in the $30 billion and growing PD-(L)1 class.
In December 2021, Checkpoint announced the initiation of the CONTERNO study, a global, randomized Phase 3 trial of cosibelimab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of patients with non-squamous non-small cell lung cancer.
During the second quarter of 2021, Checkpoint had productive interactions with the FDA regarding its ongoing development program for olafertinib (formerly CK-101), a third-generation epidermal growth factor receptor inhibitor being evaluated by its partner in an ongoing double-blind, randomized Phase 3 study in China.
In March 2021, Checkpoint announced the formation of a Scientific Advisory Board comprised of clinical and scientific thought leaders in oncology. Members include Wayne A. Marasco, M.D., Ph.D., F. Stephen Hodi, Jr., M.D., Bruce E. Johnson, M.D., Roy S. Herbst, M.D., Ph.D., David Miller, M.D., Ph.D., and Emily Ruiz, M.D., M.P.H.
Financial Results:

Cash Position: As of December 31, 2021, Checkpoint’s cash and cash equivalents totaled $54.7 million, compared to $40.8 million at December 31, 2020, an increase of $13.9 million.
R&D Expenses: Research and development expenses for the year ended December 31, 2021, were $48.5 million, compared to $16.4 million for the year ended December 31, 2020, an increase of $32.1 million. Research and development expenses for the year ended December 31, 2021 included $7.3 million of non-cash stock expenses, compared to $5.2 million in non-cash stock expenses for the year ended December 31, 2020.
G&A Expenses: General and administrative expenses for the year ended December 31, 2021 were $8.5 million, compared to $7.9 million for the year ended December 31, 2020, an increase of $0.6 million. General and administrative expenses for the year ended December 31, 2021 included $3.5 million of non-cash stock expenses, compared to $3.1 million in non-cash stock expenses for the year ended December 31, 2020.
Net Loss: Net loss attributable to common stockholders for the year ended December 31, 2021 was $56.7 million, or $0.75 per share, compared to a net loss of $23.1 million, or $0.41 per share, for the year ended December 31, 2020.

On March 28, 2022 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it obtained regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) for the anti-HER2 humanized monoclonal antibodies, Perjeta for intravenous infusion 420mg/14 mL [generic name: pertuzumab] (hereafter, Perjeta) and Herceptin for intravenous infusion 60 and 150 [generic name: trastuzumab] (hereafter, Herceptin), for the additional indication of advanced or recurrent HER2-positive colon cancer or rectal cancer not amenable to curative resection that has progressed after cancer chemotherapy (Press release, Chugai, MAR 28, 2022, View Source [SID1234611046]).

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"There are many effective treatments available for colorectal cancer, however, recent genetic studies have revealed that some patients do not respond adequately to standard treatment. We are very pleased that now we have the opportunity to offer the combination therapy of Perjeta and Herceptin to these patients, as a new treatment option based on personalized medicine," said Chugai’s President and CEO, Dr. Osamu Okuda. "HER2-positive colorectal cancer is a rare subtype that accounts for 1~5% of all colorectal cancers. This approval opens the way for personalized medicine for this subtype for the first time in Japan and overseas. I would like to thank everyone who supported us for this approval, especially those who participated in the investigator-initiated study which formed the basis of this trial, including patients, their families and medical professionals. We are committed to providing information on the proper use of this combination therapy so that it may contribute to the treatment of colorectal cancer."

The approval is based on the results of an investigator-initiated phase II clinical trial (TRIUMPH study) conducted in Japan that evaluated the efficacy and safety of the combination of Perjeta and Herceptin in 30 patients with HER2-positive, curatively unresectable advanced or recurrent colorectal cancer who had previously undergone chemotherapy. The primary endpoint was the objective response rate as determined by the investigator’s judgment. Objective response was observed in 29.6% of patients confirmed HER2 expression in tumor tissue and 28.0% of patients diagnosed with HER2-positive and RAS wild-type by liquid biopsy. Major adverse events included infusion-related reactions, diarrhea, decreased appetite, nausea, stomatitis and nasopharyngitis.

HER2 protein overexpression and gene amplification should be determined with the pathological testing kit VENTANA ultraView Pathway HER2 (4B5) provided by Roche Diagnostics K.K. and Pathvision HER-2 DNA Probe Kit provided by Abbott Japan Joint company. Both tests obtained regulatory approval on March 17, 2022 and March 10, 2022, respectively, as companion diagnostics for Perjeta and Herceptin to identify patients with HER2 positive colorectal cancer who may benefit from the combination therapy.

[Approval Information (Perjeta)] * This additional section only

Indications

Advanced or recurrent HER2-positive colon cancer or rectal cancer not amenable to curative resection that has progressed after cancer chemotherapy
Dosage and administration

For cases of advanced or recurrent HER2-positive colon cancer or rectal cancer not amenable to curative resection that has progressed after cancer chemotherapy, the usual adult dosage is a loading dose of 840 mg pertuzumab (genetical recombination) and subsequent doses of 420 mg every 3 weeks, each administered by intravenous infusion over 60 minutes, in combination with trastuzumab (genetical recombination). If the first infusion is well tolerated, subsequent infusions may be administered over a shorter time of at least 30 minutes.
[Approval Information (Herceptin)] * This additional section only

Indications

Advanced or recurrent HER2-positive colon cancer or rectal cancer not amenable to curative resection that has progressed after cancer chemotherapy
Dosage and administration

Use Regimen B for advanced or recurrent HER2-positive colon cancer or rectal cancer not amenable to curative resection that has progressed after cancer chemotherapy, in combination with pertuzumab (genetical recombination).
Regimen B: The usual adult dosage is a loading dose of 8 mg/kg (body weight) trastuzumab (genetical recombination) and subsequent doses of 6 mg/kg every 3 weeks, each administered by intravenous infusion over at least 90 minutes.

If the first infusion is well tolerated, subsequent infusions may be administered over a shorter time of at least 30 minutes.

About Perjeta

Perjeta is a humanized monoclonal antibody that targets human epidermal growth factor receptor type 2 (HER2), which is involved in the growth of tumor cells. Perjeta in combination with Herceptin blocks the HER-signaling system more extensively. The drug was launched in 2013 for "inoperable or recurrent HER2-positive breast cancer." The indication was amended as "HER-2 positive breast cancer," after obtaining regulatory approval for the additional indication of "neoadjuvant and adjuvant therapy in HER2-positive breast cancer" in 2018.

About Herceptin

Herceptin, like Perjeta, is a humanized monoclonal antibody that targets human epidermal growth factor receptor type 2 (HER2), which is involved in the growth of tumor cells. Herceptin was launched in 2001 for "metastatic breast cancer overexpressing HER2." In 2011, it was approved for the treatment of patients with "advanced or recurrent gastric cancer overexpressing HER2 not amenable to curative resection," and in 2021 for "advanced or recurrent HER2-positive salivary gland cancer not amenable to curative resection."

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On March 28, 2022 Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, reported that Vish Seshadri, Ph.D., Chief Executive Officer of Abeona Therapeutics, will participate in a panel discussion titled, "Cell Therapy: How the Definition has Expanded with Time, and the Potential Applications for Rare Diseases," at the Cantor Fitzgerald Virtual Rare Disease Summit on Wednesday, March 30, 2022 at 4:00 p.m. ET (Press release, Abeona Therapeutics, MAR 28, 2022, View Source [SID1234611045]).

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Those interested in participating in the Cantor Fitzgerald Virtual Rare Orphan Disease Summit are encouraged to contact their Cantor Fitzgerald representative.

On March 28, 2022 EXACT Therapeutics AS ("EXACT-Tx", Euronext Growth: EXTX), a clinical stage precision health company utilising Acoustic Cluster Therapy (ACT) across multiple therapeutic areas, reported that its Board of Directors has today appointed Dr Per Walday as Chief Executive Officer (CEO) (Press release, Exact Therapeutics, MAR 28, 2022, View Source [SID1234611044]).

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A successful senior executive in the healthcare industry, Per has experience from research to commercialization of therapeutics and medical devices globally, including drug-device combination within the field of oncology. As CEO of PCI Biotech (OSE: PCIB), Per built an effective organization that progressed the platform technology into a pipeline of assets including in late stage clinical programs through FDA and EMA regulatory paths. Prior to this, Per spent almost two decades with Nycomed Imaging and GE Healthcare based in Norway where, as Global Head Project Management, he was responsible for all development programs of new pharmaceutical products. These included R&D efforts within the field of ultrasound and microbubbles which paved the way for what would become years later EXACT-Tx’s Acoustic Cluster Therapy (ACT). Per has a six months’ notice period; start date with EXACT-Tx to be agreed.

Dr Masha Strømme, Executive Chair of the Board, commented: "The Board and I are very excited to welcome Per as CEO of EXACT-Tx: He brings intimate knowledge of ultrasound along with therapeutic expertise and strong leadership. We are thrilled to have Per lead EXACT-Tx through the next phase of its development".

Dr Per Walday, Chief Executive Officer-designate of EXACT-Tx, said: "I am very excited to be joining EXACT-Tx and very impressed by the potential of its proprietary technology. Remarkable innovation and progress have been made with the ACT platform since I led the development of related ultrasound technology initially aimed for diagnostic use in GE Healthcare. The global ambitions and the potential of ACT to meet current needs in both immuno-oncology and neurology harmonise well with my background and interests. I aim to further maximise the value of the innovative ACT platform for ultrasound mediated drug enhancement and accelerate our journey towards becoming a leading precision health company."

On March 28, 2022 Abbott (NYSE: ABT) reported that it will announce its first-quarter 2022 financial results on Wednesday, April 20, 2022, before the market opens (Press release, Abbott, MAR 28, 2022, View Source [SID1234611043]).

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The announcement will be followed by a live webcast of the earnings conference call at 8 a.m. Central time (9 a.m. Eastern), and will be accessible through Abbott’s Investor Relations website at www.abbottinvestor.com. An archived edition of the call will be available later that day.