On October 29, 2021 Daiichi Sankyo’s investigational GPR20 directed antibody drug conjugate DS-6157 reported that entered the clinic as a potential treatment for patients with advanced gastrointestinal stromal tumor (GIST), the company has terminated the clinical program due to a lack of clinical response (Press release, Daiichi Sankyo, OCT 29, 2021, https://www.biospace.com/article/daiichi-sankyo-scraps-phase-i-adc-aimed-at-gist-following-poor-clinical-findings/ [SID1234593974]).

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Daiichi Sankyo announced the decision in its third quarter financial report this morning. The company said that the Phase I data yielded "no clear responses in GIST patients at any dose level in Phase I dose escalation. Based on those results, the company opted to terminate the development of DS-6157 without proceeding to dose escalation.

DS-6157 is a potential first-in-class GPR20 targeting ADC. By using ADCs, companies aim to produce the payload of cytotoxic chemotherapy to cancer cells by using linker technology attached to a monoclonal antibody. When delivered, the drug binds to a specific target on the cancer cell. In the case of DS-6157, that target was cancer cells that express G Protein-Coupled Receptor (GPR20), which are typically found in gastrointestinal stromal tumors. Preclinical data showed that DS-6157 specifically binds to GPR20 on the surface of individual tumor cells.

DS-6157 was the fifth DXd ADC from the oncology pipeline of Daiichi Sankyo to enter clinical development, and it is the second drug type developed with Sarah Cannon Research Institute. In the Phase I study initiated in May 2020, the company was assessing the drug in GIST patients who have progressed on, or are intolerant to, standard treatment. Typical treatment for this type of cancer includes recommended surgery and targeted therapy with tyrosine kinase inhibitors.

Other than its notice that there were no clear responses in GIST patients, Daiichi Sankyo has not shared clinical results from the Phase I study. The company did note that it is continuing to examine the study’s information to explore "possible mechanisms of the non-responsiveness." The company plans to present the Phase I data at a scientific conference sometime in 2022.

GIST is a rare, genomically driven sarcoma of the gastrointestinal tract. More than half of GISTs start in the stomach. Most of the others form in the small intestine, but GISTs can begin anywhere along the gastrointestinal tract.

While DS-6157 development has been scrapped for this indication, Daiichi Sankyo maintains a strong pipeline of ADC drugs. Earlier this year, Enhertu, an ADC co-developed with AstraZeneca, was approved to treat gastric cancer by the U.S. Food and Drug Administration. It was the first HER2-directed drug to be approved for this indication in the past 10 years.

Enhertu was previously approved as a treatment for adults with unresectable or metastatic HER2-positive breast cancer who have had two or more previous anti-HER2-based therapies in the metastatic setting.

Daiichi Sankyo’s DXd ADC portfolio comprises seven antibody drug assets, including Enhertu. Other ADC candidates include datopotamab deruxtecan, a TROP2 directed ADC, which is also being jointly developed with AstraZeneca; patritumab deruxtecan, a HER3 directed ADC; DS-7300, a B7-H3 directed ADC; and DS-6157, a GPR20 directed ADC. The last three assets are being developed in collaboration with Sarah Cannon Cancer Institute.

Johnson & Johnson has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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On October 29, 2021 Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) reported that it will host a conference call and live webcast on Monday, November 1, 2021, at 8:30 a.m. Eastern Time to report its third quarter 2021 financial results and recent portfolio execution (Press release, Kiniksa Pharmaceuticals, OCT 29, 2021, View Source [SID1234593969]).

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A live webcast will be accessible through the Investors & Media section of the company’s website at www.kiniksa.com. A replay of the webcast will also be available on Kiniksa’s website within approximately 48 hours of the event. The conference call can be accessed by dialing (866) 614-0636 (U.S. and Canada) or (409) 231-2053 (international) using conference ID number 1699563.

On October 29, 2021, CASI Pharmaceuticals, Inc. ("CASI" or "Company"), reported that it entered into a Common Stock Sales Agreement (the "Sales Agreement") with H.C. Wainwright & Co., LLC ("HCW") (Filing, 8-K, CASI Pharmaceuticals, OCT 29, 2021, View Source [SID1234593965]). Pursuant to the terms of the Sales Agreement, the Company may sell from time to time, at its option, shares of the Company’s common stock, par value $0.01 per share, through HCW, as sales agent, with an aggregate sales price of up to $20 million (the "Shares"). The Company does not currently intend to make any sales under the Sales Agreement at the present time and will use discretion in initiating sales, taking into account among other factors, market conditions, the trading price of the Company’s common stock, alternative financing opportunities, and need for capital. The Company believes that it is in the best interests of its stockholders to have the flexibility to raise additional capital under favorable market conditions to support its efforts to build long-term stockholder value.

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Any sales of Shares pursuant to the Sales Agreement will be made under the Company’s effective "shelf" registration statement (the "Registration Statement") on Form S-3 (File No. 333-250801) which became effective on December 2, 2020 and the related prospectus supplement and the accompanying prospectus, as filed with the Securities and Exchange Commission (the "SEC") on October 29, 2021.

Under the terms of the Sales Agreement, the Company may sell shares of its common stock through HCW by any method permitted that is deemed an "at the market offering" as defined in Rule 415 under the Securities Act of 1933, as amended (the "Securities Act"). HCW will use its commercially reasonable efforts consistent with its normal trading and sales practices to sell the Company’s common stock from time to time, based upon the Company’s instructions (including any price, time or size limits or other customary parameters or conditions the Company may impose). Actual sales will depend on a variety of factors to be determined by the Company from time to time, including (among others) market conditions, the trading price of the Company’s common stock, capital needs and determinations by the Company of the appropriate sources of funding for the Company. The Company is not obligated to make any sales of common stock under the Sales Agreement and the Company cannot provide any assurances that it will issue any Shares pursuant to the Sales Agreement. The Company will pay a commission rate of 3.0% of the gross sales price per share sold and agreed to reimburse HCW for certain specified expenses, including the fees and disbursements of its legal counsel in an amount not to exceed $50,000 and have agreed to reimburse HCW an amount not to exceed $2,500 per quarter during the term of the Sales Agreement for legal fees to be incurred by HCW. The Company has also agreed pursuant to the Sales Agreement to provide HCW with customary indemnification and contribution rights.

The Company or HCW upon notice to the other, may suspend the offering of the Shares under the Sales Agreement at any time. The offering of the Shares pursuant to the Sales Agreement will terminate upon the sale of Shares in an aggregate offering amount equal to $20 million, or sooner if either the Company or HCW terminate the Sales Agreement pursuant to its terms.

The foregoing description of the Sales Agreement is not complete and is qualified in its entirety by reference to the full text of the Sales Agreement, a copy of which is filed as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference. The Sales Agreement is also incorporated by reference into the Registration Statement.

A copy of the opinion of Arnold & Porter Kaye Scholer LLP relating to the legality of the Shares issuable under the Sales Agreement, is filed as Exhibit 5.1 to this Current Report on Form 8-K and is also incorporated by reference into the Registration Statement.

The above disclosure shall not constitute an offer to sell or the solicitation of an offer to buy the securities discussed herein, nor shall there be any offer, solicitation, or sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

The representations, warranties and covenants contained in the Sales Agreement were made solely for the benefit of the parties to the Sales Agreement. In addition, such representations, warranties and covenants (i) are intended as a way of allocating the risk between the parties to the Sales Agreement and not as statements of fact, and (ii) may apply standards of materiality in a way that is different from what may be viewed as material by stockholders of, or other investors in, the Company. Moreover, information concerning the subject matter of the representations and warranties may change after the date of the Sales Agreement, which subsequent information may or may not be fully reflected in public disclosures.

On October 29, 2021 Apollo Intelligence reported that Despite the FDA’s recent hold on select chimeric antigen receptor (CAR) T-cell clinical trials for cancer treatments using allogeneic products, new data show US oncologists, hematologists, and hematology-oncologists remain highly enthusiastic about the potential for CAR T-cell therapies for their patients (Press release, Apollo Intelligence, OCT 29, 2021, View Source [SID1234592208]).

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Data were sourced on October 20-21, 2021, by InCrowd, real-time market insights company and a brand of Apollo Intelligence (Apollo), global insights innovator for the life sciences industry, as part of InCrowd’s Instant Insights series on timely topics.

Allogenic CAR T-cell therapies—using cells from sources other than the patient — are promising because they potentially enable access to off-the-shelf treatments, versus autologous CAR T-cell therapies which use cells taken from the patient. On October 8, the FDA placed a select hold on allogenic CAR T-cell clinical trials conducted by one manufacturer following reports of a chromosomal abnormality in one patient of the manufacturer’s allogenic CAR T-cell trial.

Despite the FDA’s action, InCrowd found that 72% of cancer specialist respondents are excited about the future of CAR T-cell therapy in general.

Sixty-two percent believe other allogenic CAR T-cell clinical trials will emerge and succeed.
Forty-two percent said these allogenic CAR T-cell trials will reconvene as soon as soon as more data is released.
Only 12% of US cancer specialists said the FDA’s hold causes them concern with all gene therapy technologies.
Just 13% said allogenic CAR T-cell therapy is not a viable therapy to research further.
Two-thirds (67%) of respondents agree that the FDA’s hold on the select allogenic CAR T-cell therapy clinical trials had no impact on their perception of allogenic CAR T-cell therapy in general.

"The InCrowd Instant Insights data show that the FDA’s actions had very little impact on oncologists’ perceptions of allogeneic or autologous CAR T-cell therapy and gene therapy in general," said Daniel S. Fitzgerald, CEO of Apollo Intelligence, parent company to InCrowd. "It’s encouraging to see that cancer specialists in the US remain optimistic about the promise of CAR T-cell therapies for helping their patients."

The one-minute InCrowd survey included n=76 US oncologists, hematologists, and hematology-oncologists responding on October 20-21, 2021. Respondents reported that they were at least somewhat knowledgeable about new and emerging cancer treatments such as CAR T-cells, bispecific T cell engager (BiTE) antibodies, and antibody-drug conjugates (ADC.) For more visit InCrowd.