On November 30, 2021 Jemincare, a leading pharmaceutical company from China, reported its wholly owned subsidiary company, Shanghai Jemincare Pharmaceutical Co., Ltd., had licensed exclusive worldwide ex-China rights to the Kras inhibitor, JMKX1899, to HUYABIO International, the leader in accelerating global development of China’s pharmaceutical innovations (Press release, HUYA Bioscience, NOV 30, 2021, View Source [SID1234596302]). Jemincare will retain the relevant rights in greater China area.

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Kras is one of the most mutated oncogenes in human cancers. The prevalent G12C mutation drives tumor growth and metastasis and has become an important validated target for therapy especially in lung and colorectal cancer. Targeting the GTP pocket of Kras in the switch-II region, which has made Kras druggable, enables the development of more potent and potentially effective inhibitors.

JMKX1899 is a KRAS inhibitor independently developed by Jemincare. Data from preclinical studies shows it has strong blood-brain-barrier crossing capability and has no risk of hERG inhibition and drug-drug-interaction. Jemincare has filed the IND to NMPA in Oct. 2021. The parties will work closely to file IND in US FDA in 2021 to move towards clinical development.

Mr. Hong Liang, President of Jemincare Pharmaceutical Group, said, "We are delighted to work with HUYABIO to explore global development of this unique KRAS inhibitor. This is our first new chemical entity program out-licensed to a global partner. HUYABIO has generated a lot of experience to bring innovative drugs from China to global market. We look forward to generating the clinical efficacy and safety data from global clinical trial since the candidate has huge potential to fill strong unmet needs."

Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO, said, "We are excited to have added the clinical stage Kras inhibitor to our oncology pipeline especially to test in combination with our SHP inhibitor against a variety of solid tumors. We’re delighted to have an excellent partner Jemincare to co-develop combinations that can benefit patients worldwide."

On November 30, 2021 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer, and Taiho Pharmaceutical Co., Ltd., ("Taiho"), an R&D driven specialty pharma company with a focus on oncology, reported that Taiho exercised its option for anti-TIGIT antibodies domvanalimab (development code: AB154) and AB308 from Arcus Biosciences ("Arcus"), in Japan and certain other territories in Asia (excluding China) (Press release, Taiho, NOV 30, 2021, View Source [SID1234596229]). This option exercise is based on an option and license agreement between Taiho and Arcus contracted in September 2017. Taiho has already obtained exclusive rights to etrumadenant (AB928), an adenosine A2a/A2b receptor antagonist, and zimberelimab (AB122), an anti-PD-1 monoclonal antibody. This is the third option exercise to an Arcus program.

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In exchange for the exclusive license, Taiho will make an option exercise payment, as well as additional payments upon achievement of clinical, regulatory and commercialization milestones, and, if any products from the program are approved, will pay royalties on net sales of such products.

Domvanalimab is an Fc-silent anti-TIGIT antibody currently under development by Arcus. Similar to PD-1, TIGIT is an immune checkpoint receptor that is expressed on immune cells such as T cells and NK cells. By binding to its ligand CD155, expressed on tumor cells, TIGIT suppresses anti-tumor immune responses, which are thought to be involved with poor prognosis in various types of cancers. Domvanalimab is believed to activate anti-tumor immune responses by blocking CD155 from binding to TIGIT, making it possible for CD155 to bind to and trigger the activating receptor CD226.

Domvanalimab is being developed primarily as a combination therapy with anti-PDx checkpoint inhibitors. The Phase 2 (ARC-7) and Phase 3 (ARC-10) trials of domvanalimab in combination with zimberelimab are currently being conducted by Arcus in first-line metastatic PD-L1≥50% non-small cell lung cancer. A Phase 3 trial (PACIFIC-8) of domvanalimab in combination with durvalumab (Imfinzi, AstraZeneca) is being initiated in Stage III non-small cell lung cancer. Development in other cancer types is also being planned.

Through this collaboration, Taiho will further support the development and commercialization of domvanalimab and will continue its mission to deliver innovative drugs to patients and medical professionals.

About AB308

AB308 is an Fc-enabled anti-TIGIT antibody currently under development by Arcus. In combination with zimberelimab, AB308 is being investigated in an ongoing Phase 1b trial in people with advanced solid and hematologic malignancies.

About Zimberelimab

Zimberelimab is an anti-PD-1 monoclonal antibody currently under development by Arcus. Preliminary data from clinical trials have suggested that zimberelimab has an efficacy and safety profile similar to that of other approved anti-PD-1 monoclonal antibodies.

In addition to combination studies with domvanalimab, Arcus is conducting Phase 1/2 clinical trials of zimberelimab in combination with other Arcus programs in various types of cancers. In Japan, Taiho is conducting a Phase 1 platform trial for zimberelimab in combination with other Taiho products.

On November 30, 2021 Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a commercial-stage biopharmaceutical company developing innovative medicines to improve the lives of people with cancer, reported a corporate restructuring intended to prioritize clinical development of select programs, streamline commercial operations, maintain a focus on discovery research and extend the Company’s cash runway (Press release, Deciphera Pharmaceuticals, NOV 30, 2021, View Source [SID1234596247]).

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Following a detailed review of its portfolio and growth opportunities, Deciphera will focus its resources on the continued advancement of vimseltinib and DCC-3116, while discontinuing the rebastinib program. The Company will streamline commercial operations for QINLOCK in the U.S. and focus commercialization efforts on a select number of key European markets. These changes are expected to result in a significant reduction in operating expenses and extend the Company’s cash runway into 2024.

"The decision to realign our resources and restructure our organization was difficult, but one which will allow us to focus on the critical programs that will drive our future growth. I would like to personally express my appreciation to our colleagues who are impacted by this decision. We are immensely grateful for their dedication and their contributions to advancing our mission," said Steve Hoerter, President and Chief Executive Officer of Deciphera. "We remain excited by the strength of our pipeline and the opportunity for QINLOCK to continue to benefit patients with advanced GIST. We have a clear and positive path forward with a committed team that is fully invested in the future of Deciphera."

The Company intends to reduce expenses and extend its existing cash runway through the following restructuring initiatives and prioritization of its pipeline:

The Company will implement an organizational restructuring that will result in a workforce reduction of approximately 35%, or approximately 140 positions. The restructuring is expected to affect U.S. employees across all areas of the organization including the QINLOCK commercial team, research and development, and general and administrative support functions.
Deciphera will remain focused on the commercialization of QINLOCK for the treatment of fourth-line GIST in the U.S. with a reduced commercial team. In Europe, Deciphera will maintain a limited direct commercial presence that will support the launch of QINLOCK in two key markets, Germany and France, and work to provide access to QINLOCK in additional European countries through other channels. Further clinical development of QINLOCK will be discontinued, including the Phase 1b/2 MEK combination study, which had been planned to start in the fourth quarter of 2021.
Deciphera is prioritizing the clinical development of its vimseltinib and DCC-3116 programs, discontinuing the development of the rebastinib program, and continuing with a focused investment in its next generation of research programs, designed to provide first-in-class or best-in-class treatments for patients.
Vimseltinib: The Company expects to initiate the Phase 3 MOTION study for vimseltinib, an orally administered, potent, and highly selective switch-control kinase inhibitor of CSF1R, for the treatment of tenosynovial giant cell tumor (TGCT) before the end of the year.
DCC-3116: Deciphera will continue to advance the clinical development of DCC-3116, a first-in-class ULK kinase inhibitor designed to inhibit autophagy for the treatment of patients with advanced or metastatic tumors with a mutant RAS or RAF gene. DCC-3116 is currently being investigated as a single agent and in combination with trametinib in an ongoing Phase 1 study. Deciphera expects to present initial data from the dose escalation phase of the Phase 1 study in 2022. In addition to the ongoing Phase 1 study, the Company is actively exploring preclinical combinations of DCC-3116 with multiple additional targeted oncology agents with diverse mechanisms of action.
Rebastinib: Deciphera will discontinue development of rebastinib, which was expected to enter a Phase 3 study in patients with platinum-resistant ovarian cancer in 2022.
Research: The Company intends to continue to invest in the development of new product candidates using its novel switch-control inhibitor approach.
Deciphera had cash, cash equivalents, and marketable securities of $392 million as of September 30, 2021. Collectively, these changes are expected to extend the Company’s cash runway into 2024 through significant reductions in the Company’s operating expenses including personnel-related costs and external expenses. Deciphera expects to recognize a one-time cash charge in the fourth quarter of approximately $32 million associated principally with the workforce reduction and discontinuation of continued clinical development of rebastinib and ripretinib.

On November 30, 2021 ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that it intends to offer and sell, subject to market and other conditions, $175 million of shares of its common stock in an underwritten public offering (Press release, ImmunoGen, NOV 30, 2021, View Source [SID1234596266]). ImmunoGen also intends to grant the underwriters a 30-day option to purchase up to an additional fifteen percent (15%) of the number of shares of common stock offered in the public offering at the public offering price, less underwriting discounts and commissions. All of the shares of common stock to be sold in the offering are to be offered by ImmunoGen. There can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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ImmunoGen intends to use the net proceeds of the offering to fund its operations, including, but not limited to, commercialization activities, clinical trial activities, supply of drug product, business development activities, capital expenditures, and working capital.

Jefferies, Cowen, and Guggenheim Securities are acting as joint book-running managers for the proposed offering. Canaccord Genuity is acting as lead manager for the proposed offering.

The securities described above are being offered by ImmunoGen pursuant to a shelf registration statement that was previously filed with the Securities and Exchange Commission (SEC) and became effective upon filing. This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering, when available, may also be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by e-mail at [email protected] or by telephone at (877) 821-7388; Cowen and Company, LLC c/o Broadridge Financial Solutions, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY,11717, by email at [email protected] or by telephone at (833) 297-2926; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, or by email at [email protected] or by telephone at (212) 518-9544.

On November 30, 2021 CytRx Corporation (OTCQB: CYTR) ("CytRx" or the "Company"), a specialized biopharmaceutical company focused on research and development for the oncology and neurodegenerative disease categories, reported a presentation on Centurion BioPharma Corporation’s ("Centurion BioPharma") plans for a world-class cancer center in Las Vegas, Nevada (Press release, Cytran, NOV 30, 2021, View Source [SID1234596286]). Centurion BioPharma is a private wholly-owned subsidiary that focuses on advancing the Company’s proprietary, albumin binding ultra-high potency LADR (Linker-Activated Drug Release) oncology drug candidates and ACDx diagnostic.

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The presentation, which can be found here, highlights how the planned center would:

Be incorporated as a 501(C)3 not for profit organization and funded with $100 million or more in tax deductible gifts and grants raised from outside organizations, including foundations, philanthropists and other individual donors.
Centurion BioPharma would receive a percentage of the funds raised from the cancer center for the completion of its Investigational New Drug (IND)-enabling studies and clinical trials.
Establish a world-class oncology team dedicated to delivering compassionate care and truly innovative cancer treatments.
Implement approved therapies that have been proven to possess clinical benefit as well as be a scientific hub for additional research and new clinical trials for the next generation of cancer-fighting drugs.
Help establish Las Vegas, Nevada as a future center for medical tourism, allowing residents of Nevada and non-residents to receive best-in-class treatment.
Move Centurion BioPharma’s headquarters to Las Vegas, Nevada while it maintains a satellite office in Los Angeles, California.
Steven A. Kriegsman, Chairman and Chief Executive Officer of CytRx and Executive Chairman of Centurion BioPharma, commented:

"At CytRx and Centurion BioPharma, we believe establishing a best-in-class healthcare center in the city of Las Vegas can provide advanced cancer care and research for patients, establish Las Vegas as an important hub for further groundbreaking treatments and assist in the development of Centurion BioPharma’s LADR technology. Over the last three years, Centurion BioPharma has made critical strides in the development and diagnostics of its therapies. A combination immunotherapy including aldoxorubicin, which was developed by the Centurion BioPharma research team, was recently proven successful in a Phase 2 trial for advanced metastatic pancreatic cancer. We believe that establishing a major cancer center in Las Vegas – which we aim to complete with philanthropic support – will enable Centurion BioPharma to continue its important scientific research and pursue transformational treatment programs."