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Thursday, July 6, 2023

Supremes’ ban on racial favoritism applies to companies too

 If your employer’s diversity goals are blocking you from getting promoted, last week’s Supreme Court ruling against racial preferences at Harvard is promising news.

The conservative justices reminded the nation that the Civil Rights Act of 1964 bars racial discrimination not just in college admissions but also in employment.

That includes reverse discrimination against non-minorities.

The justices signaled that racial preferences in hiring and promoting are on the chopping block.

Quotas, minority-only internships, “affinity programs” and diversity training are all likely to be challenged.

Justice Neil Gorsuch explained in his concurrence that when Congress enacted the Civil Rights Act, it used the same words in Title VI, which bars federally funded colleges from discriminating, as in Title VII, which prohibits employers from discriminating.

Both parts of the law “have the same meaning” and are “essentially identical,” he wrote.

Weighing those words, employers are bracing for an avalanche of lawsuits.

“There is no more profound impact awaiting HR and recruiting space than this decision, certainly in the last 15 to 20 years,” says Valerie Capers Workman of the recruiting firm Handshake.

A protest in support of affirmative action at Harvard University on July 1, 2023 after the Supreme Court ruling.
A protest in support of affirmative action at Harvard University on July 1, 2023 after the Supreme Court ruling.
Photo by Scott Eisen/Getty Images

“The court’s decision should be a wake-up call to employers,” warns Andrea Lucas, a member of the Equal Employment Opportunity Commission.

The justices explained that college admissions is “zero sum.”

Harvard’s racial targets for blacks and Hispanics led to 11.1% fewer Asian-Americans accepted.

Hiring and promoting are also zero-sum.

If one person gets the job, another doesn’t.

In recent weeks, complaints have been filed with the federal EEOC against Mars, Inc., the candy company, for openly touting that it will increase racial diversity in top management from 16% to 30% and against the retailer Nordstrom, for pledging to increase “the representation of black and Latinx individuals in people-manager roles by at least 50%” by the end of 2025. 

Companies boast about diversity plans, ignoring their harmful impact on non-minority workers who also want a fair chance to be hired or promoted.

In 2021, a white male employee won a $10 million jury verdict against Novant Health, Inc., for allegedly firing him to advance its goal of more diversity in management.

The jury found Novant violated Title VII of the Civil Rights Act. 

Expect more verdicts like this.

Similarly, in 2022, several employees sued American Express for offering financial incentives to managers to reduce the number of whites in their departments.

Asian-American protestors calling affirmative action discriminatory outside of the Supreme Court.
Asian-American protestors calling affirmative action discriminatory outside of the Supreme Court.
REUTERS/Evelyn Hockstein/File Photo

The litigants claimed AmEx sent a message that being white is “an impediment to getting ahead in the company.”

Minority-only programs are also being challenged.

The pharmaceutical giant Pfizer launched an internship program reserved for blacks, Hispanics and Native Americans but relented in February under legal pressure to open it to all races.

Now BlackRock, the financial behemoth, faces a complaint over its analyst program for minorities.

In the Harvard case, companies including Apple, Procter & Gamble and Johnson & Johnson filed a brief defending the college for producing a “diverse” pipeline of graduates they could hire. 

The companies insisted diversity would result in more sales, profits and innovation.

But the justices dispensed with the racist canard that diversity of skin color produces diverse viewpoints. 

Clarence Thomas suggested that two white students, one from Appalachia and one from a wealthy San Francisco suburb, “may offer more diverse viewpoints than two students, one white and the other black, from Manhattan’s Upper East side.”

John Roberts pointed out the obvious — that it’s racist stereotyping to ascribe different thinking to a person based solely on skin color.

For 60 years, the Civil Rights Act has made it illegal to hire or promote based on race. 

But after George Floyd’s death in 2020, many companies launched ambitious efforts to diversify their workforces.

Though well-intentioned, they caused harm and resentment. 

They also flagrantly violated federal law and the nation’s bedrock principle of color-blind equality.

The justices are voicing an urgently needed warning not just to colleges but also to the corporate world to change course.

Roberts is right. The best way to end discrimination is to end all discrimination.

Tell the nation’s big companies to treat all employees equally, regardless of their skin color. 

https://nypost.com/2023/07/05/scotus-affirmative-action-ruling-comes-for-corporate-dei/

Overweight is now linked to 18 types of cancer

 For years, doctors have sounded the alarm over the link between cancer and obesity.

Being overweight or obese raises the risk of developing several different types of cancer, including breast, bowel, kidney and pancreatic.

In all, 13 types of the disease were previously known to be associated with overweight body types — but now, that number has climbed to 18 different cancers.

And the risk of developing cancer begin when people are young — between the ages 18 and 40.

“The results of our study support a re-evaluation of the cancer burden associated with overweight and obesity, which currently is likely underestimated,” said Dr. Heinz Freisling, co-author of the study, as quoted in the Independent.

The researchers looked at the electronic health records of more than 2.6 million people in Catalonia, Spain. The people were 40 years or older in 2009 and were then free of cancer.

But by 2018 — just nine years later — over 225,000 of the study participants had been diagnosed with cancer.

A doctor speaks with a patient.
A total of 18 cancers have now been linked to overweight or obesity, up from 13.
Getty Images/iStockphoto

The researchers also sorted the data by including decades of the participants’ health records showing a body mass index of 25 or greater, which indicates a person may be overweight or obese.

The results of the study, published in Nature Communications, revealed that having a BMI of 25 or greater led to a greater risk of developing 18 different types of cancer.

Specifically, the researchers found that those who were overweight in early adulthood — ages 18 to 40 — had an increased risk of cancer.

And people who were overweight or obese for a longer period of time also had a higher risk of developing cancer. Finally, those with a much higher degree of obesity in their youth had a greater risk of cancer.

“Our findings seem to indicate that longer exposures to overweight and obesity (with or without accounting for the degree of overweight and obesity), as well as developing overweight and obesity at younger ages in early adulthood might increase cancer risk,” the researchers wrote.

A person on a scale
Being overweight or obese as a child or young adult is associated with an increased risk of cancer.
Getty Images/iStockphoto

The study adds to a large and growing body of medical evidence showing the long-term risks of childhood obesity, including cognitive function and brain structure.

The additional types of cancer the researchers linked to overweight or obesity include leukemia, non-Hodgkin lymphoma, head and neck cancers and bladder cancer.

The 13 cancers previously associated with being overweight or obese are adenocarcinoma of the esophagus, breast (in women who have gone through menopause), colon and rectum, uterus, gallbladder, upper stomach, kidney, liver, ovaries, pancreas, thyroid, meningioma (a type of brain cancer) and multiple myeloma, according to the Centers for Disease Control and Prevention.

“This large study has future public health implications since additional cancers, such as leukemia and non-Hodgkin lymphoma, have [now] been shown to be linked with overweight and obesity,” said Dr. Panagiota Mitrou, director of research, policy and innovation at the World Cancer Research Fund.

“Our own evidence shows that maintaining a healthy weight throughout life is one of the most important things people can do to reduce their cancer risk, and early prevention in adulthood is key.”

https://nypost.com/2023/07/06/being-overweight-is-linked-to-18-types-of-cancer-new-study/

Hillstream Licenses Tech to Develop Proprietary HER2 and HER3 Antibody Drug Conjugates

 Anti-HER2 and Anti-HER3 monoclonal antibodies designed to have a high drug-to-antibody ratio intended enhance the bystander killing effect and be effective against a number of epithelial tumors

Antibody CDRs against HER2 and HER3 Conformational Domain Bridging Epitopes can be used in multiple formats including bi- and tri-specific antibodies, antibody drug conjugates (ADCs), CAR-T and CAR-NKs

 Hillstream BioPharma, Inc. (Nasdaq: HILS) ("Hillstream" or the "Company"), a biotechnology company developing therapeutic candidates targeting drug resistant and devastating cancers using immuno-oncology targeted novel biologics, today announced the signing of an exclusive agreement with Applied Biomedical Science Institute (ABSI) to license technology for human antibodies targeting novel HER2 and HER3 Conformational Epitopes. The goal is to develop proprietary multi-format biologics, including bi-specific antibodies, and antibody drug conjugates (ADCs). The HER2/HER3 binding ADC is targeted to have a high drug-to-antibody ratio which should increase the anti-tumoral efficacy with an enhanced bystander killing effect. Hillstream intends to combat drug resistant cancers such as HER2-positive metastatic breast cancer, gastric cancer, lung cancer and ovarian cancer.

The ErbB family of cell surface proteins, including ErbB2 or HER2 (human epidermal growth factor receptor) and Erb3 or HER3, are some of the most well-known and validated oncology drug targets. Antibodies and biologics against HER2 starting with HERCEPTIN® (trastuzumab) approved in 1998 for breast cancer, and PERJETA®, KADCYLA® and PHESGO® generated $8.4 billion in 2022 sales for Roche/Genentech. These antibodies bind to domains II or IV of the extracellular portion of the HER2. HER2 is also one of the most validated antigens for antibody drug conjugates (ADCs) to treat HER2 positive cancers with two approved antibodies, Roche/Genentech’s KADCYLA® and Daiichi Sankyo/AstraZeneca’s ENHERTU®.

The Applied Biomedical Science Institute has developed technology to target novel functional epitopes of the cancer targets HER2 and HER3. The monoclonal antibodies being developed at ABSI are distinct from the currently approved anti-HER2 antibodies. ABSI has granted Hillstream an exclusive license agreement, and Hillstream will have the opportunity to develop HER2 and HER3 antibodies, including multi-specific, ADC, and Quatramer-based therapeutics utilizing portions of these antibodies.

Less Than Half of New Drug Approvals Add Therapeutic Value Over Existing Treatments: Study

 A new study published in The BMJ Wednesday has found that despite the number of new drugs being approved in the U.S. and Europe, less than half are adding true therapeutic value to patients.  

The study examined a group of 124 first indications approved by the FDA and European Medicines Agency (EMA) between 2011 and 2020. Less than half, 47% in Europe and 41% in the U.S., of first indications had high therapeutic value ratings. The largest subset was for cancer disorders. 

The results were more disappointing for supplemental indications compared with initial indications. Only a third of the 335 supplemental indications approved had high therapeutic value for patients. When restricted to the first three approved indications, second line approvals were 36% less likely and third line approvals were 45% less likely to have a high-value rating compared to first indication approvals.  

The study’s authors concluded that information should be clearly communicated to patients and be reflected in the drug pricing when therapeutic value is not added over other available treatments. 

Led by Kerstin Vokinger, professor of law and medicine at the University of Zurich, the study relied on assessing therapeutic value using ratings from European health technology assessment (HTA) groups. Currently, the U.S. does not widely use the HTA system, a potential tool for improving efficiency in healthcare.  

“The lack of systematic health technology assessment in the U.S. is an important knowledge gap for decision making in the U.S. healthcare system,” Beate Wieseler, head of drug assessment at Germany's Institute for Quality and Efficiency in Health Care, contends in an editorial linked to the study. “Some attempts have been made to close this gap, such as the value framework for cancer treatments developed by the American Society of Clinical Oncology. However, this framework covers only one aspect of healthcare—why the U.S. has not adopted HTA more widely is difficult to understand.” 

The FDA and EMA do not require new drug treatments to prove value over existing treatments in order to garner approval. A positive risk-benefit ratio is needed, but not greater value.  

Some healthcare stakeholders believe the system should be changed to require drugmakers to prove therapeutic benefit. Often cancer treatments are approved based on tumor response, without requiring the proof of longer survival or improved quality of life.  

“This study confirms previous research on the limited or unclear added value of new drugs,” according to Wieseler, who said the findings were sobering. 

Wieseler points out the importance of having multiple options for patients as side effects and responses can vary greatly from one patient to another.

Garnering supplemental indications for an approved drug is often an important, less risky strategy for pharmaceutical companies. Studies released earlier this year indicated the cost of developing a new drug now exceeds $2 billion per therapy on average.  

Wieseler suggests de-incentivizing the development of drugs with similar benefits and rewarding investigational assets with proven added patient benefit, relative to the current available care, with expedited approval or prolonged market exclusivity as potential solutions. 

https://www.biospace.com/article/less-than-half-of-new-drug-approvals-add-therapeutic-value-over-existing-treatments-study-/

Takeda, F-star Sign Potential $1B Immuno-Oncology Agreement

 Takeda has entered into a strategic discovery collaboration and licensing agreement with British biotech F-star Therapeutics to develop next-generation and multi-specific antibodies for undisclosed cancer indications, the companies announced Wednesday.  

The partners did not reveal how much Takeda paid upfront for the pact but said that F-star will receive research funding from the Japanese multinational for the duration of the collaboration. F-star will also be entitled to potential future development and commercial milestones of up to $1 billion, depending on whether the partnership’s programs reach their milestones.

F-star is also eligible for royalties on any potential annual net sales for commercial products that emerge from the agreement.

In exchange, Takeda will gain access to F-star’s proprietary platform, which produces novel tetravalent and bispecific antibodies with “drive strong dual immune activation capabilities,” according to the biotech’s website.

Using what it calls the 2 + 2 approach, F-star creates two new binding regions on the antibody’s Fc domain, which it has dubbed an Fcab.

The company achieves this “not by bolting on any additional domains or adding any additional linkers, but rather by changing about 15 surface-exposed amino acids,” Neil Brewis, F-star’s chief scientific officer, said in the company’s explainer video for its platform.  

The result is an antibody with four binding sites—called tetravalency—which in turn drives the potency of F-star’s molecules. The company’s antibodies differentiate themselves from other immuno-oncology therapies through what Brewis calls the three C’s: cross-linking, clustering and conditionality.

“Cross-linking means bringing an immune cell together with a tumor cell. Clustering means activating the immune cell receptors by bringing them together. And finally, conditionality means we only activate where our bi-specific see both targets, and that’s in the tumor microenvironment,” Brewis said.

Under Wednesday’s agreement, F-star and Takeda will jointly leverage this novel antibody approach to tackle undisclosed immuno-oncology indications. Takeda will have exclusive worldwide and royalty-bearing license to research, develop and commercialize antibodies that carry Fcabs arising from the partnership. F-star will retain rights to antibodies with other Fcabs.

F-star and Takeda have signed two other immuno-oncology pacts over the last year. The first, inked in July 2022, covers one bi-specific antibody and is worth $1 million upfront, putting all research, development and commercialization responsibilities on Takeda. The second deal came in March 2023 and carried similar terms as the first contract but financial details were not disclosed.

https://www.biospace.com/article/takeda-f-star-sign-potential-1b-immuno-oncology-agreement/

MaxCyte Signs Strategic Platform License with Lyell

Lyell Immunopharma to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform in its T cell product candidates targeting solid tumors.

 MaxCyte, Inc., (Nasdaq: MXCT; LSE: MXCT), a leading, cell-engineering focused company providing enabling platform technologies to advance the discovery, development and commercialization of next-generation cell-based therapeutics and to support innovative, cell-based research, today announced the signing of a strategic platform license (SPL) with Lyell Immunopharma, Inc., a clinical stage T cell reprogramming company.

Under the terms of the agreement, Lyell Immunopharma obtains non-exclusive clinical and commercial rights to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform. In return, MaxCyte is eligible to receive platform licensing fees, clinical milestone payments and sales-based payments.

https://finance.yahoo.com/news/maxcyte-signs-strategic-platform-license-120500824.html