On February 1, 2022 Massive Bio reported that New York City Health Business Leaders (NYCHBL), the organization that serves as the gateway to New York’s healthcare ecosystem, has recognized the company on its NYC Digital Health 100, showcasing the most exciting and innovative health start-ups in New York (Press release, Massive Bio, FEB 1, 2022, View Source [SID1234607570]).

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"We are very excited and honored to be included among many other great startups in the healthcare industry. Massive Bio has been headquartered in New York City since being founded in 2015, so being selected to this list is especially rewarding. We will continue connecting cancer patients in New York City and around the world to leading edge therapies in clinical trials" said Massive Bio Co-Founder and CEO Selin Kurnaz.

"This year, the NYC Digital Health 100 is comprised of an incredibly diverse set of companies and leaders who are working to innovate and solve some of the most complex challenges across all facets of the healthcare ecosystem," said Bunny Ellerin, co-founder and CEO, NYCHBL. "We are delighted to recognize these companies and celebrate and support their growth in the New York area."

Massive Bio’s mission of providing cancer patients with access to new therapies and clinical trials combined with an artificial intelligence (AI) powered platform can give patients new opportunities to treat their cancer. With over 18,000 actively recruiting cancer clinical trials, Massive Bio’s Clinical Trial Matching System (CTMS) provides improved outcomes for cancer patients as well as contributes to faster drug development in cancer research.

The NYC Digital Health 100 was released in conjunction with the NYCHBL Healthcare Innovation Report 2022, an in-depth look at the data, trends and insights that define the healthcare industry in NY. In 2021, 182 companies raised an historic high of $9.0B, a 150% increase from 2020 ($3.6B) and 87% of the investments went to start-ups in areas including virtual care, patient engagement and mental health. View the full report here.

NYC Digital Health 100 Methodology
To compile the NYC Digital Health 100, NYCHBL used its dynamic database of digital health companies in the region and then invited companies to complete applications with quantitative and qualitative data to broaden the consideration set. A company qualified for consideration if it maintained headquarters or an office (over 10 people) in the New York region. Companies were judged on a number of factors, including but not limited to: strength of leadership, number of employees, funding (if known), revenue (if known), market fit, differentiated offerings, approach to diversity and equity, and community engagement.

On February 1, 2022 Gilead Sciences, Inc. (Nasdaq: GILD) reported that the company’s Board of Directors has declared an increase of 2.8% in the company’s quarterly cash dividend, beginning in the first quarter of 2022 (Press release, Gilead Sciences, FEB 1, 2022, View Source [SID1234607586]). The increase will result in a quarterly dividend of $0.73 per share of common stock. The dividend is payable on March 30, 2022, to stockholders of record at the close of business on March 15, 2022. Future dividends will be subject to Board approval.

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On January 31, 2022 Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for cancer and other serious diseases, reported that key program and business updates (Press release, FierceBiotech, JAN 31, 2022, View Source [SID1234607518]).

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Initiating rolling BLA submission for omidubicel. Following the recent receipt of positive Type B meeting correspondence from the U.S. Food and Drug Administration (FDA), Gamida Cell will initiate a rolling Biologics License Application (BLA) submission for omidubicel, a potentially life-saving treatment for patients with blood cancers in need of a stem cell transplant, in the first quarter of 2022 and plans to complete the full BLA submission in the first half of 2022.
Evaluating strategic alternatives for omidubicel. In parallel with the planned BLA submission, the company will be assessing alternatives for the commercialization of omidubicel, including potential U.S. or global partnerships.
Reducing operating expenses. With the objective of extending its cash runway into mid-2023, consistent with the timeline for potential U.S. approval of omidubicel, the company is reducing operating expenses primarily by implementing a workforce reduction of approximately 10% and delaying other hiring and planned spending in 2022.
Readying to advance GDA-201. The company is addressing comments received from FDA in connection with the clinical hold placed on the IND submission for GDA-201, its lead NAM-enabled innate NK cell immunotherapy. Gamida Cell expects to initiate a company-sponsored Phase 1/2 clinical study in patients with follicular and diffuse large B-cell lymphomas in 2022.
Advancing genetically modified NK cell immunotherapy programs. The company continues to advance itsNAM-enabled genetically modified NK pipeline, which utilizes CAR, membrane bound- and CRISPR-mediated strategies to increase targeting, potency and persistence against hematologic malignancies and solid tumors. The company plans to execute preclinical proof of concept studies for these genetically modified NK therapeutic targets and to select pipeline candidates for IND enabling studies by the end of 2022.
"We are pleased that productive interactions with the FDA enable us to initiate a rolling submission of the BLA for omidubicel this quarter and to complete the full BLA submission during the first half of this year," said Julian Adams, Ph.D., Chief Executive Officer of Gamida Cell. "As we advance omidubicel towards potential approval, we will be assessing strategic alternatives for the best way to bring this important therapy to patients, including potential U.S. or global commercialization partnerships. With the strategic steps we are taking, we believe Gamida Cell will be in a stronger position to support omidubicel through the regulatory approval process while we also continue to advance our NK cell pipeline programs, all as intended to serve our goal of providing access to life-saving cell therapies to patients in need."

2022 Financial Guidance

Gamida Cell ended 2021 with approximately $96.1 million in cash and cash equivalents (unaudited). The company expects cash used for ongoing operating activities in 2022 to range from $60 million to $70 million in cash and cash equivalents based on its current operating plans. The company anticipates that its current cash will support the company’s ongoing operating activities into mid-2023, excluding any additional financing or business development activities that may be undertaken. Gamida Cell plans to report its fourth quarter and full-year 2021 financial results on March 16, 2022, at which time the company will provide an update on its 2022 milestones and more detailed financial guidance.

About Omidubicel

Omidubicel is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with blood cancers. Omidubicel is the first bone marrow transplant graft to receive Breakthrough Therapy Designation from the U.S. FDA and has also received Orphan Drug Designation in the U.S. and EU. Gamida Cell has completed an international, multi-center, randomized Phase 3 study (NCT0273029) evaluating the safety and efficacy of omidubicel in patients with hematologic malignancies undergoing allogeneic bone marrow transplant compared to a comparator group of patients who received a standard umbilical cord blood transplant. That study achieved its primary endpoint, demonstrating a highly statistically significant reduction in time to neutrophil engraftment, a key milestone in a patient’s recovery from a bone marrow transplant. The Phase 3 study also achieved its secondary endpoints of reduced time to platelet engraftment, reduced infections and shorter days of hospitalization. For more information about omidubicel, please visit View Source

Omidubicel is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.

About GDA-201

Gamida Cell applied the capabilities of its nicotinamide (NAM)-enabled cell expansion technology to develop GDA-201, an innate NK cell immunotherapy for the treatment of hematologic and solid tumors in combination with standard of care antibody therapies. GDA-201, the lead candidate in the NAM-enabled NK cell pipeline, has demonstrated promising initial clinical trial results. GDA-201 addresses key limitations of NK cells by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs. Furthermore, GDA-201 improves antibody-dependent cellular cytotoxicity (ADCC) and tumor targeting of NK cells. For more information about GDA-201, please visit View Source

GDA-201 is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.

On January 31, 2022 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported that initiation of IND-enabling studies for IDE161, a potential first-in-class PARG inhibitor development candidate (Press release, Ideaya Biosciences, JAN 31, 2022, View Source [SID1234607534]). The company also exercised its option for an exclusive worldwide license from Cancer Research Technology Ltd., dba Cancer Research UK (CRUK), and University of Manchester.

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IDE161 is a potential first-in-class small molecule inhibitor of poly (ADP-ribose) glycohydrolase, or PARG, a novel target in the same clinically validated pathway as poly (ADP-ribose) polymerase, or PARP. IDEAYA plans to evaluate IDE161 in patients having tumors with homologous recombination deficiencies (HRD), including BRCA1 and BRCA2, and potentially other genetic alterations identified through IDEAYA’s biomarker discovery platform.

"We are very excited about potential development opportunities for IDE161. We have shown dose-dependent in vivo efficacy of PARG inhibitors as monotherapy with tumor regression or stasis in multiple CDX models and PDX models, including in ovarian cancer, gastric cancer and breast cancer models. Significantly, we have observed in vivo efficacy of PARG inhibitors in BRCA1 and BRCA2 models which are refractory to or have acquired resistance to PARP inhibitors, suggesting an opportunity for clinical differentiation," said Dr. Michael White, Senior Vice President and Chief Scientific Officer of IDEAYA.

"We identified IDE161 through our internal drug-discovery platform, and in parallel, we have invested significantly in translational biology and biomarker discovery. We believe PARG inhibitors could be substantially impactful for BRCA1 and BRCA2 patients non-responsive to PARP inhibitors. We are excited to advance IDE161 as a first-in-class development candidate toward the clinic," said Yujiro Hata, President and Chief Executive Officer of IDEAYA.

IDEAYA is targeting an IND submission for IDE161 in the fourth quarter of 2022, subject to satisfactory completion of ongoing preclinical and IND-enabling studies.

Following the option exercise with Cancer Research UK and University of Manchester, IDEAYA holds exclusive worldwide license rights covering a broad class of PARG inhibitors. IDEAYA owns or controls all commercial rights in IDE161, subject to certain economic obligations pursuant to its exclusive, worldwide license with Cancer Research UK and University of Manchester.

On January 31, 2022 Immix Biopharma, Inc. (Nasdaq: IMMX) ("ImmixBio", "Company", "We" or "Us"), a biopharmaceutical company pioneering Tissue-Specific Therapeutics (TSTx)TM targeting oncology and immuno-dysregulated diseases, reported that it has initiated IMX-110 Good Manufacturing Practice ("GMP") scale-up manufacturing, potentially accelerating the timeline to clinical data from two ImmixBio clinical trials planned for 2022: first, planned monotherapy IMX-110 clinical trial in soft tissue sarcoma ("STS"); second, planned combination IMX-110 + BeiGene anti-PD-1 tislelizumab clinical trial in advanced solid tumors (Press release, Immix Biopharma, JAN 31, 2022, View Source [SID1234607519]).

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"Initiating GMP manufacturing 36 days after the closing of our IPO puts us on a path of potentially accelerating our clinical trials," said Ilya Rachman, MD PhD, CEO of ImmixBio. "We believe this step paves the way to execute our planned milestones at an accelerated pace."

About IMX-110

The U.S. Food and Drug Administration ("FDA") has approved orphan drug designation ("ODD") for IMX-110 for the treatment of soft tissue sarcoma. Additionally, the FDA has approved rare pediatric disease ("RPD") designation to IMX-110 for the treatment of a life-threatening pediatric cancer in children, rhabdomyosarcoma. RPD qualifies ImmixBio to receive fast track review and a priority review voucher (PRV) at the time of marketing approval of IMX-110. IMX-110 is currently being evaluated in a phase 1b/2a clinical trial in patients with advanced solid tumors. Learn more at www.immixbio.com/iMX-110