On October 24, 2022 Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), reported that Chief Medical Officer, Arturo Molina, M.D., M.S., F.A.C.P. will be leaving the company to pursue other opportunities, effective November 4, 2022 (Press release, Sutro Biopharma, OCT 24, 2022, View Source [SID1234622308]). Sutro will continue its executive search for a new CMO. In the interim, Bill Newell CEO, with support from Sutro’s senior clinical development team, will oversee all clinical activities and related functions.

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"We thank Arturo for his many contributions to the Company and wish him well as he pursues his future endeavors," said Bill Newell, Sutro’s Chief Executive Officer. "We are at an exciting time in our company’s growth, with our platform yielding six next-generation, clinical-stage product candidates. I am confident in our team’s ability to execute on our clinical objectives for STRO-002, including the plans for a registrational directed trial in advanced ovarian cancer. Our experienced clinical and regulatory teams, together with our external clinical advisors—which I will directly oversee—remain fully engaged on our development of STRO-002."

On October 24, 2022 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reportes its financial results for the third quarter of fiscal year 2022 (Press release, Chugai, OCT 24, 2022, View Source [SID1234622293]).

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"Chugai achieved record-high revenues and profits for the first nine months of 2022 following the strong first half of the year. Domestic sales were driven by growing market penetration of new products including Vabysmo, the new ophthalmic drug launched in May 2022, while Hemlibra continued to increase overseas sales. Research and Development also progressed well in the third quarter, particularly for in-house projects which are expected to propel our medium- to long-term growth. The world’s first filing for regulatory approval of our anti-C5 recycling antibody, crovalimab, was accepted in China. In addition, clinical development was initiated for DONQ52, a new bispecific antibody. We will continue to focus all our efforts on innovation to address unmet medical needs so that we can contribute to patients waiting for new treatments," said Dr. Osamu Okuda, Chugai’s President and CEO.

Third Quarter Financial Results (Core results, January to September 2022)
Chugai reported record-high financial results for the first nine months in 2022, as revenues increased by 7.7% and operating profit increased by 2.9% over the same period last year.

An increase in domestic and overseas sales outweighed a decrease in royalties and other operating income, resulting in a 7.7% increase in total revenues. Domestic sales increased by 6.9%. Sales in the Oncology field decreased by 2.4% as the impact of the NHI drug price revision and biosimilars in mature products, including Avastin and Herceptin, exceeded the sales growth from a new product Polivy, which was approved for an additional indication in August this year, and a mainstay product Kadcyla as well as Foundation Medicine business. In the Specialty field, renamed from the Primary field following the organizational change in July, sales increased by 17.1% due to the contributions from the supply of Ronapreve to the government in the first quarter, as well as an approximately 20% increase in sales of the mainstay product Hemlibra. Steady market penetration of new products, including Vabysmo launched in May, also contributed. The increase in overseas sales was driven by a 2-times increase of Hemlibra owing to the full-scale export to Roche at regular shipping price and a more than 20% increase in Actemra, which obtained emergency use authorization and regulatory approval for severe COVID-19 in the U.S. and Europe, respectively, since last June. On the other hand, royalties and other operating income decreased by approximately 40%, mainly due to a significant decrease in royalty income related to the initial shipments of Hemlibra.

Cost to sales ratio improved by 1.2 percentage points year-on-year to 40.7%, mainly due to a change in the product mix. Operating expenses grew by 4.3% as both marketing and distribution and research and development expenses increased, while general and administration expenses decreased. Marketing and distribution expenses increased mainly due to foreign exchange effects. Research and development expenses increased mainly due to the progress of projects under development and foreign exchange effects. General and administration expenses decreased primarily due to decreases in various expenses, as well as recognizing gains on sales of property, plant and equipment. As a result, Core operating profit totaled ¥299.0 billion (+2.9%).

Quarterly Financial Results (Core results, July to September 2022)
Revenues and operating profit for the third quarter (Jul-Sep) both decreased by approximately 20% against the same period last year. The leading cause of the decreases were that the supply of Ronapreve to the government, which was ¥42.8 billion yen in the same period last year, did not occur in the quarter under review, along with the significant decrease in royalty income related to the initial shipments of Hemlibra. Sales decreased by approximately 20%. While overseas sales increased by 3.7%, domestic sales decreased by less than 30% with the impact of Ronapreve, resulting in a decrease in overall sales. In domestic sales, the Oncology field reported a 5.1% decrease as mature products such as sales of Avastin and Herceptin decreased due to the NHI drug price revision and biosimilar impact, despite increases in a new product Polivy and a mainstay product Kadcyla. Sales of the Specialty field decreased by more than 40%, primarily for the supply of Ronapreve to the government last year. Excluding Ronapreve, sales of the Specialty field increased by 1.4%, driven by the contribution from new products including Vabysmo, which was launched in May this year. Overseas sales increased by 3.7% as the increase of Hemlibra owing to the full-scale export to Roche at regular shipping price outweighed a more than 30% decrease in sales of Actemra caused by a delay in production. In addition, we launched Edirol in China in July. Royalties and other operating income decreased by less than 40% chiefly due to the significant decrease in royalty income related to the initial shipments of Hemlibra. The cost to sales ratio improved by approximately eight percentage points against the same period last year, mainly due to a higher proportion of in-house products in total sales. Operating expenses were flat against the same period last year. No changes have been made in the full-year forecasts announced at the beginning of the fiscal year, while revenues and operating profit both decreased for the quarter under review.

R&D activities
The Company also made good progress in research and development. Among in-house projects, which will contribute to the Company’s medium-to long-term growth, Maruho launched the anti-IL-31 receptor antibody Mitchga in August as a treatment for itching associated with atopic dermatitis. Maruho is the licensee of the product in Japan. The world’s first filing of regulatory application for the anti-C5 recycling antibody, crovalimab, was accepted in China with a priority review designation for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). Clinical development of an existing product Enspryng has started for new indications, myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) and autoimmune encephalitis (AIE). In addition, clinical development of a new bispecific antibody project, DONQ52, has been initiated for celiac disease, a disease with no approved drug treatments available. Furthermore, Chugai entered into an agreement with Roche to out-license NXT007, which is being developed as the next-generation project following Hemlibra.
As for in-licensed products from Roche, an additional indication for Polivy was approved as the first new treatment in 20 years for previously untreated diffuse large B-cell lymphoma. Chugai also filed an application for approval of RG6264, a fixed-dose subcutaneous combination of pertuzumab and trastuzumab, for the treatment of HER2-positive breast and colorectal cancer. Pertuzumab and trastuzumab are the same monoclonal antibodies as in Perjeta and Herceptin, respectively. Several new oncology projects have been added to our pipeline, including SHP2 inhibitor RG6433 and KRAS G12C inhibitor RG6330 for solid tumors.
In drug discovery research, Chugai entered into a license agreement with Noile-Immune Biotech in August for their PRIME CAR-T technology, making steady progress in its efforts toward multi-modality drug discovery through external collaboration.

On October 24, 2022 Yumanity Therapeutics, Inc., a Delaware corporation ("Yumanity"), reported that entered into an Asset Purchase Agreement (the "Asset Purchase Agreement") with Janssen Pharmaceutica NV ("Janssen") (Filing, 8-K, Yumanity Therapeutics, OCT 24, 2022, View Source [SID1234622307]). Concurrently with the execution of the Asset Purchase Agreement, on June 5, 2022, Yumanity entered into an Agreement and Plan of Merger with Kineta, Inc., a Washington corporation ("Kineta"), and Yacht Merger Sub, Inc., a Washington corporation and wholly-owned subsidiary of Yumanity (the "Merger Agreement" and the transactions contemplated thereby, the "Merger").

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Amendment to PIPE Securities Purchase Agreement

As previously reported in the Current Report on Form 8-K filed by Yumanity with the U.S. Securities and Exchange Commission (the "SEC") on June 6, 2022 (the "Original Report"), Yumanity previously entered into a securities purchase agreement (the "Securities Purchase Agreement"), dated June 5, 2022, with certain investors (the "PIPE Investors"), pursuant to which, and on the terms and subject to the conditions of which, the PIPE Investors agreed to purchase an aggregate of 14,354,067 shares (subject to proportional adjustment for any reverse stock split) of common stock of Yumanity, par value $0.001 per share ("Common Stock"), for $2.09 per share, for an aggregate purchase price of $30 million, in a private placement expected to close immediately following, and conditioned upon, the closing of the Merger (the "Private Placement").

On October 24, 2022, the PIPE Investors and Yumanity agreed to change the purchase price per share to $1.65 per share of Common Stock such that the PIPE Investors will purchase an aggregate of 18,181,818 shares of Common Stock in the Private Placement. October 24, 2022, Yumanity, Kineta and each of the PIPE Investors entered into an amendment to the Securities Purchase Agreement (the "Securities Purchase Agreement Amendment"), to (i) amend the per share purchase price and aggregate number of shares to be purchased, each as reflected therein, and (ii) provide for the issuance of an aggregate of 6,031,668 warrants to purchase shares of Kineta (the "Warrants"). The Warrants were issued by Kineta and will be treated in the same manner as all other outstanding warrants of Kineta at the effective time of the Merger, as described in the Registration Statement (as defined below), and will receive a portion of the consideration allocated to other Kineta securityholders under the terms of the Merger Agreement. For the avoidance of doubt, the Warrants are not issued by Yumanity. Any Warrants issued to a PIPE Investor will only be exercisable following the closing of the Private Placement and will expire in the event any PIPE Investor fails to consummate the Private Placement pursuant to the terms of the Securities Purchase Agreement, as amended by the Securities Purchase Agreement Amendment.

Amendment to Registration Rights Agreement

As previously reported in the Original Report, Yumanity previously entered into a Registration Rights Agreement (the "Registration Rights Agreement"), dated June 5, 2022, with the PIPE Investors concurrently with the execution of the Securities Purchase Agreement. Pursuant to the Registration Rights Agreement, Yumanity will prepare and file a resale registration statement with the SEC within 60 calendar days following the closing of the Private Placement covering the shares of Yumanity’s common stock issued in the Private Placement. Yumanity has also agreed, among other things, to indemnify the PIPE Investors and their respective directors, officers, stockholders, members, partners, employees and agents, and each person who controls such PIPE Investor, from certain liabilities and to pay certain expenses incurred by Yumanity in connection with the registration of the shares issued in the Private Placement.

On October 24, 2022, the PIPE Investors and Yumanity entered into an amendment to the Registration Rights Agreement (the "Registration Rights Agreement Amendment"). The Registration Rights Agreement Amendment amended the Schedule of Purchasers attached to the Registration Rights Agreement to reflect the number of shares purchased by each PIPE Investor pursuant to the Securities Purchase Agreement Amendment.

The foregoing descriptions of the Securities Purchase Agreement Amendment, the Warrants, the Registration Rights Agreement Amendment and the transactions contemplated thereby are not complete and are subject to, and qualified in their entirety by reference to, the text of the Securities Purchase Agreement Amendment, the Warrants and the Registration Rights Agreement Amendment, forms of which are included as Exhibit 10.1, Exhibit 10.2 and Exhibit 10.3, respectively, to this Current Report on Form 8-K (this "Current Report"), and incorporated herein by this reference.

On October 24, 2022 Veracyte, Inc. (Nasdaq: VCYT) reported data that provide new insights into thyroid tumor behavior (Press release, Veracyte, OCT 24, 2022, View Source [SID1234622306]). The findings were derived from whole-transcriptome analyses of Veracyte’s extensive thyroid nodule database and were presented at the American Thyroid Association Annual Meeting, held October 19-23 in Montreal .

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In one study, Veracyte researchers reviewed over 300 pathology reports from the training sets used to develop the company’s market-leading Afirma Genomic Sequencing Classifier (GSC). Levels of tumor invasion and metastasis were scored and tested against over 400 literature-derived gene expression signatures to identify potential predictors of these tumor behaviors. They found that the top-performing signatures were able to stratify nodules as low-risk with a negative predictive value for no invasion or metastasis of 95% and 100%, respectively. Conversely, the highest-performing signatures had a positive predictive value of 57% for invasion and 41% for metastasis.

"We evaluated gene expression-based signatures with the potential to predict thyroid tumor invasion and metastasis. This information could potentially be used to help personalize surgery and therapy decisions for patients with thyroid cancer," said Joshua Klopper, M.D., Veracyte’s medical director, Endocrinology, who presented the poster. "Moreover, these findings underscore the potential to utilize our significant thyroid nodule database and whole-transcriptome capabilities to help unlock the next phase of innovation in thyroid cancer care."

Additional data presented at the ATA conference demonstrate the Afirma GSC’s ability to inform diagnosis and treatment decisions for patients with thyroid nodules. While thyroid stimulating hormone receptor (TSHR) mutations are mostly associated with benign thyroid nodules, researchers found that when the Afirma GSC identified a thyroid nodule with a TSHR mutation and a result that was "suspicious" for cancer, the risk of malignancy was significantly higher at 15.3%, compared to those classified by the Afirma GSC as benign where the extrapolated risk is <1.5%.

About the Afirma GSC

Veracyte estimates that each year in the United States approximately 565,000 people with thyroid nodules undergo fine-needle aspiration (FNA) biopsies to assess potentially cancerous nodules. Up to 30 percent of these patients receive indeterminate results – meaning their nodules are not clearly benign or malignant based on traditional cytopathology evaluation. Historically, most of these patients were directed to surgery to remove all or part of their thyroid, with 70% to 80% of these nodules proving to be benign. The Afirma Genomic Sequencing Classifier helps physicians identify patients with benign thyroid nodules among those with indeterminate FNA results, so that they may avoid unnecessary thyroid surgery. The test was developed with RNA whole-transcriptome sequencing and machine learning technology to provide physicians with clinically actionable results from the same FNA biopsy used for initial cytopathology. As part of the Afirma offering, the Xpression Atlas provides genomic alteration content from the same FNA samples used in Afirma GSC testing to help physicians decide, with greater confidence, on the surgical or therapeutic approach for their patients.

On October 24, 2022 Step Pharma, the world leader in CTPS1 inhibition for the targeted treatment of cancer, reported that the first patient has been successfully dosed with STP938, in a Phase 1/2 trial in adult subjects with relapsed/refractory B cell and T cell lymphomas (Press release, Step Pharma, OCT 24, 2022, View Source [SID1234622305]).

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The dose-escalation part of the open label, non-randomised Phase 1/2 trial comprises multiple cohorts dosed with STP938, administered as an oral monotherapy, ascending in a stepwise manner. The primary objective in Phase I is to assess the safety and tolerability of STP938.

Brian Schwartz, Chief Medical Officer of Step Pharma, commented:

"We are developing STP938, a highly selective, first-in-class treatment based on ground-breaking genetics. The dosing of the first patient into our Phase 1/2 trial is an important step to identify an optimal dose to take forward into further clinical development for relapsed/ refractory T cell and B cell lymphomas."

STP938 is a first-in-class oral cancer therapeutic that specifically inhibits nucleotide synthesis and the enzyme cytidine triphosphate synthase 1 (CTPS1) in particular, originally identified as an essential gene for lymphocyte proliferation. By targeting CTPS1, Step Pharma has unlocked the ability to selectively target the de novo pyrimidine synthesis pathway in cancer cells. This ground-breaking approach should enable the highly selective treatment of both blood cancers and solid tumours.